PICS – AICS 2013

Preparing and Loading Stents:
Frank Ing

Surgical Cutdowns:
Michel Ilbawi

Transcatheter Pulmonary Valve Implantation – “Down to the Wire”:
Evan Zahn

Moderators: Marc Gewillig and John Cheatham

Closed Cell Stents: Tom Forbes

Open Cell Stents: Jackie Kreutzer

Hybrid Stents: Jo DeGiovanni

Covered Stents: Marc Gewillig

OPTIMIZING DEVICE/VALVE DESIGN Moderators: Zahid Amin and Larry Latson

Occulotech–PLD’s and ACCELL Coating: Hakan Apkinar

Optimization of the GORE® Septal Occluder: Jake Goble

Lifetech: Nguyen Lan Hieu

Moderators: Craig Fleishman and Girish Shirali

Imaging Guides for Radiofrequency Perforation for Aortic Atresia:
Mario Carminati

CT to Evaluate Atrial Erosion Following ASD Closure:
Anthony Hlavacek

Debate: Echo Assessment of the Right Ventricle is an Acceptable Alternative to MRI in the Setting of tPVR
Pro: Craig Fleishman
Con: Mark Fogel

Moderators: Dan Levi, Masood Sadiq, and Maiy El Sayed

Operability in Defects with Elevated PVR–Is There a Limit?:
Carlos Zabal

History of Balloon Mitral Valvuloplasty in Children and Adults:
Savitri Shrivastava

Novel Use of Available Resources for Catheterization in the Developing World:
Bharat Dalvi

Transcatheter VSD Closure in China:
Shiliang Jiang

PDA Closure in South America:
Raul Rossi

Update on Initiatives:
Damien Kenny

Moderators: Ted Feldman, James Hermiller, and Pat McCarthy

Anatomical Specimens and Relevance to Closure:
Mark Reisman

Transseptal Puncture – Evolving Technology:
Zoltan Turi

WATCHMAN – Where Do We Stand?:
Saibal Kar

ACP – Updated Results:
Kevin Walsh

Epicardial Devices:
Mark Reisman

Devices in Development:
Saibal Kar

Debate: Chronic Atrial Fibrillation and ASD – Transcatheter Therapy is Preferable to Surgery Pro: Horst Sievert
Con: Michel Ilbawi

Moderators: Mark Galantowicz, John Cheatham, and Dietmar Schranz

Anatomical Correlations Relevant to Intervention:
Paul Weinberg

Stenting the Atrial Septum – Options for Stent Delivery and Modification:
Marc Gewillig

Progressive Retrograde Coarctation Following the Hybrid – Treatment Options:
Ralf Holzer

Collaterals Post Stage 2 – Do They Need to be Closed?:
Herbert Stern

Pulmonary Artery Interventions Following Stage 1:
Jo DeGiovanni

Debate: The Sano Procedure Leads to More Favorable Pulmonary Artery Growth Compared to the Hybrid Procedure
Pro: Shunji Sano Con: Lee Benson

NURSING AND ASSOCIATED PROFESSIONALS Moderators: Sharon Cheatham and Kathleen Nolan

Informatics in the Cath Lab: Sharon Bradley-Skelton
The Value of Patient/family Education in Interventional Cath: Emily Kish
Risk Stratification: Elaine McCarthy
Percutaneous Valve Replacement – Not Just for Conduits: John P. Cheatham
Quality of Life after TPVI: Ruby Whalen
Emergencies in the Cath Lab: Karen Iacono
Covered Stents: Update on Current and Future Trials: Richard Ringel
No Boundaries – Mission Trips & CHD: Gina Langlois
“Analyze This” – Interactive Session: Kathleen Nolan

Moderators: John Bass, David Balzer, and Alex Javois

Biodegradable Stents: Dietmar Schranz

Stem Cell Therapy for Percutaneous Valves: Massimo Caputo
Low Profile Delivery Design for Transcatheter Valve Systems: Steve Bailey
Transcatheter Ventricular Assist Devices: Cliff Kavinsky
The Future of Radiation Protection: Michael de Moor

Debate: Europe is a Better Place to Be For Transcatheter Intervention in Congenital Heart Disease
Pro: Shakeel Qureshi
Con: Larry Latson

Getting An Idea Off The Ground – Biodegradable Stents:
Dan Levi

Moderators: Robert Siegel, Pat McCarthy, and Olaf Franzen

Anatomical Specimens and Relevance to Closure:
Mark Reisman

Taped Case – MitraClip and MVP Software: Scott Lim
Update on Evolving Mitral Valve Repair Systems: Ted Feldman
Transcatheter Mitral Valve Replacement: Matthew Gillespie
Device Development for Mitral PVL – Case Presentation: Omar Goktekin
Percutaneous Mitral Annuloplasty – TITAN Trial Results: David Reuter

Debate: Transapical Approach is the Best Option for Mitral PVL
Pro: Ziyad Hijazi Con: Robert Sommer

MITRAL VALVE INTERVENTIONS Moderators: Robert Siegel, Pat McCarthy, and Olaf Franzen Anatomical Specimens and Relevance to Closure: Mark Reisman
Taped Case – MitraClip and MVP Software: Scott Lim
Update on Evolving Mitral Valve Repair Systems: Ted Feldman
Transcatheter Mitral Valve Replacement: Matthew Gillespie
Device Development for Mitral PVL – Case Presentation: Omar Goktekin
Percutaneous Mitral Annuloplasty – TITAN Trial Results: David Reuter

Debate: Transapical Approach is the Best Option for Mitral PVL
Pro: Ziyad Hijazi Con: Robert Sommer

TAVR Moderators: James Hermiller, Ziyad Hijazi, and Clifford Kavinsky
Taped Case – Edwards 29mm Valve: Reda Ibrahim
Taped Case – Core Valve: Olaf Franzen
Commercialization of the SAPIEN Valve – Life Without PARTNER: Roberto Cubeddu
Stroke Following TAVR – Minimizing Risk – Reda Ibrahim

Debate: TAVR is Cost Effective in the Non-Surgical Elderly Population Pro: Eric Horlick Con: Pat McCarthy


Anatomy of the Atrial Septum – Understanding Erosion:
Paul Weinberg

Imaging Modalities to Evaluate Atrial Erosion Following ASD Closure: Girish Shirali

RESPECT – Where Does it Leave Us with PFO Closure?: Werner Budts

Update on the ADO II AS in Ductal Closure in the Premature Infant: Joaquim Miro

Recognition and Management of Porto-systemic Shunts in Congenital Heart Disease: Henri Justino

Covered Stents in CHD – Are BMS Outside of the US Becoming Obsolete?: Elchanan Bruckheimer

RVOT Conduit Rupture During tPVR – Pre-procedural Risk Identifiers: Thomas Jones

Tissue Engineering in the Management of HLHS: Shunji Sano

Moderators: Neil Wilson and Shakeel Qureshi

Moderators: Mark Fogel and Giacomo Pongiglione

How to Work in the Branch Pulmonary Arteries (Taped Case): Ziyad Hijazi
Transapical Injectable Pulmonary Valve Implantation: Massimo Caputo
Cutting Balloon vs High Pressure Balloon Angioplasty: Lisa Bergersen
High Pressure Ballooning to Crack Small Diameter Stents in the PA’s: Phillip Moore

Debate: Surgical Arterioplasty is Destined to Require Further Intervention
Pro: Zahid Amin Con: Emile Bacha

Live Cases

Hospital Privado de Córdoba, Córdoba, Argentina Case #1
Live Case Operators: Operator: Dr. Alejandro Peirone Assistant: Dr. Juan Díaz

• 18 year old woman. Asymtomatic. Found to have a murmur recently.

Physical Findings:
• Her weight is 63 kg. Mild II/IV systolic ejection murmur at the upper left sternal border, fixed splitting of the 2nd heart sound.

Pertinent Tests: EKG:
• SR, incomplete RBBB. Chest

• Mild cardiac enlargement, increased pulmonary vascular markings.

Echo (TEE):
• Moderate size ostium secundum type ASD measuring 13-14 mm, RA and RV enlargement.

Intended Intervention:
• Percutaneous ASD closure using the pfm Nit-Occlud ASD-R device.

Hospital Privado de Córdoba, Córdoba, Argentina Case #2
Live Case Operators:
Operator: Dr. Alejandro Peirone
Assistant: Dr. Juan Díaz

• 8 year old girl. History of recurrent upper respiratory tract infections. Referred recently for evaluation of a heart murmur. Mild exercise intolerance.

Physical Findings:
• Her weight is 28 kg. Grade II/IV systolic ejection murmur best heard at the left medium sternal border radiating superiorly as well as a widely split and fixed S2.

Pertinent Tests:

• SR, RBBB with an rsR´ pattern in V1.

Chest X-ray:
• Mild cardiac enlargement, increased pulmonary vascular markings, prominent MPA segment.

Echo (TEE):
• Moderate size ostium secundum type ASD measuring 10-12 mm, RA and RV enlargement.

Intended Intervention:
• Percutaneous ASD closure using the pfm Nit-Occlud ASD-R device.

Hospital Privado de Córdoba, Córdoba, Argentina

Case #3

Live Case Operators:
Operator: Dr. Alejandro Peirone
Assistant: Dr. Juan Díaz

• 7 year old girl. History of recurrent upper respiratory tract infections. Referred recently for evaluation of a heart murmur.

Physical Findings:
• Her weight is 22 kg. Grade III/IV continuous murmur best heard at the upper left sternal border (infraclavicular area). Bounding peripheral pulses. Clear lungs. No hepatomegaly.

Pertinent Tests:

• SR, LVH.

Chest X-ray:
• Mild cardiac enlargement (with LAE), increased pulmonary vascular markings.

Echo (TEE):
• Moderate-large size PDA with a minimal lumen diameter (PA end) 3-4 mm, LA and LV enlargement.

Intended Intervention:
• Percutaneous PDA closure using the pfm Nit-Occlud PDA-R device.

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Case #1

Live Case Operators:
Dr Tarek Momenah

• 7 year old boy asymptomatic

Physical Findings:
• Well looking boy
• Weight : 23 kg
• Height : 123 cm
• H/R 102/min
• R/R 20 /min
• BP 99/67 mmHg
• Femoral pulses well palpable and good volume
• CVS: Normal heart sounds and soft continuous murmur.
• Chest: Clear

Pertinent Tests:
•Normal sinus rhythm

•Mod PDA dilated LA and LV

Intended Intervention:
•Transcatheter PDA closure

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #2

Live Case Operators:
Dr Tarek Momenah

• 45 year old man with history of ROSS procedure done in past at the age of 30 years utilizing a homograft.
• Subsequent F/U shows homograft stenosis and regurgitation with symptoms on exertion • December 2011, he underwent transcatheter Melody valve implantation.
• Recent follow up showed increased gradient across the Melody valve.
• Fluoroscopy showed stent fracture of melody valve.

Physical Findings:
• Normal pulses and perfusions. Normal heart sounds and no murmur. Chest is clear and no organomegaly

Pertinent Tests:

• Normal sinus rhythm Chest

• Normal

• Gradient of 55mmHg across RVOT with mild PI

CT Scan:
• Will be shown in meeting

Intended Intervention:
• Re stent and implantation of second pulmonary valve

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #3

Live Case Operators:
Dr Tarek Momenah

• 40 year old woman with history of transient ischemic attacks and brief loss of consciousness twice over the last year. Otherwise, she is healthy.

Physical Findings:
• Normal pulses and perfusions. Normal heart sounds and no murmur. Chest is clear and no organomegaly.

Pertinent Tests:

• Normal sinus rhythm

Chest X-ray:
• Normal

• TEE positive bubble contrast

Intended Intervention:
• PFO Closure

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #4

Live Case Operators:
Dr Tarek Momenah

• 10 year old girl S/P ASD, VSD surgical closure. She had surgical Carpentier Edward valve size 19 implantation.

Physical Findings:
• Normal pulses and perfusions. Normal heart sounds and no murmur. Chest is clear and no organomegaly.

Pertinent Tests:

• Normal sinus rhythm

Chest X-ray:
• Normal

• Moderate pulmonary stenosis, severe pulmonary insufficiency

Intended Intervention:
• Pulmonary valve implantation

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #5

Live Case Operators:
Dr Tarek Momenah

• 11 year old girl diagnosed to have small perimembranous VSD and RPA stenosis.

Physical Findings:
• Normal pulses and perfusions. Normal heart sounds and loud systolic murmur. Chest is clear and no organomegaly.

Pertinent Tests:
• Normal sinus rhythm with normal axis

Chest X-ray:
• Normal

• Small restrictive VSD and mild RPA stenosis

CT angio:
• Lung Perfusion scan: Rt 30 Lt 60

Intended Intervention:
• RPA stenting

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #6

Live Case Operators:
Dr Tarek Momenah

• 10 year old girl with obesity and obstructive sleep
apnoea, S/P adrenalectomy, persistent hypernatremia.

Physical Findings:
• Normal pulses and perfusions. Normal heart sounds and systolic murmur. Chest is clear and no organomegaly.

Pertinent Tests:
• Normal sinus rhythm, no arrhythmia or block

Chest X-ray:
• Normal

• Dilated RA and RV dilatation. Trivial TR, Moderate

ASD secundum picture still ASD and 4 chamber Intended Intervention:
• ASD device closure

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Case #7

Live Case Operators:
Dr Tarek Momenah

• 6 month old boy, asymptomatic. Feeding well and gaining weight.

Physical Findings:
• Weight 7 kg. Normal pulses and perfusions. Normal heart sounds and loud systolic murmur at LUSB. Chest is clear and no organomegaly.

Pertinent Tests:

• Normal sinus rhythm, left axis and LVH

Chest X-ray:
• Normal

• Thickened tricuspid aortic valve leaflet with severe aortic stenosis peak gradient of 63mmHg and mean of 31mmHg, mild LVH and mildly dilated ascending aorta.

Intended Intervention:
• Percutaneous aortic balloon valvuloplasty

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #8

Live Case Operators:
Dr Tarek Momenah

• 25 year old man with H/O systemic hypertension. On antihypertensive medications.

Physical Findings:
• HR 84/min
• BP 160/84 mmHg
• Normal heart sounds and no murmur. Chest is clear and no organomegaly.
• Diagnostic cath done shows complete interruption of the aorta, after left subclavian.

Pertinent Tests:

• Will discuss during the meeting.


Intended Intervention:
• Transcatheter perforation of atretic aorta and tenting of interrupted aortic arch.

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #9

Live Case Operators:
Dr Tarek Momenah

• 3 year old girl asymptomatic, incidental murmur.

Physical Findings:
• Normal pulses and perfusions. Wide splitting of second heart sounds and ES murmur. Chest is clear and no organomegaly.

Pertinent Tests:
• First degree heart block and incomplete RBBB

• Fenestrated ASD Picture

Intended Intervention:
• Closure of fenestrated ASD.

Prince Salman Heart Center – King Fahad Medical City, Riyadh, Saudi Arabia
Live Case #10

Live Case Operators:
Dr Tarek Momenah

• 14 year old girl diagnosed recently to have coarctation of aorta. She has H/O systemic hypertension.

Physical Findings:
• Weight : 49 kg
• Height : 150cm
• Weak femoral pulses and perfusions. Normal heart sounds and ESM in interscapular region. Chest is clear and no organomegaly.

Pertinent Tests:
• Sinus rhythm, LVH
• Coarctation of aorta with gradient of 53 mmHg

Intended Intervention:
• Referred from other hospital for stenting of aortic coarctation.

Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Live Case #1

Live Case Operators:
Carlos A.C. Pedra, Rodrigo N. Costa, Marcelo Ribeiro, Wanda Nascimento, and Luis Otávio Santanna

• 28 year old man, Weight: 60 kgs, Height: 1.63 m
• Arterial Hypertension discovered during an orthopedic surgery
• Asymptomatic
• On Enalapril, Diuretics

Physical Findings:
• BP: 150/90
• Diminished pulses inferior limbs
• Mild systolic ejection murmur mid sternal border irradiated to the furcula
• Mild systolic murmur heard in the left inter scapular area at the back

Pertinent Tests:
• Sinus rhythm, LVH
• Normal LV systolic fxn, Bicuspid aortic valve, CoA with difficult assessment of the local gradient (inadequate suprasternal windows), abnormal Doppler pattern in the DAo with diastolic tail.
• Not performed
Catheterization (11/12):
• Subatretic CoA with 50 mmHg gradient (pictures)

Intended Intervention:
• CoA stenting using the Large Advanta V12 covered stent under general anesthesia in the new hybrid room with 3D RTA (3 Dimensional Rotational Angiography) capability

Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Live Case #2

Live Case Operators:
Carlos A.C. Pedra, Simone Fontes Pedra, Rodrigo N. Costa, Marcelo Ribeiro, Wanda Nascimento, and Luis Otávio Santanna

• 73 year old woman, Weight: 64 kgs, Height: 1.58 m
• Fatigue and dyspnea on exertion for many years
• Hypertension
• On B blockers, ASA, Diuretics, Amlodipine

Physical Findings:
• BP: 150/90
• Mild systolic ejection murmur mid sternal border
• Fixed splitting of the 2nd heart sound with mildly increased pulmonary component

Pertinent Tests:
• Sinus rhythm, RVH
Echo (TTE and TEE):
• Normal LV systolic fxn, LV hypertrophy, Abnormal LV diastolic fxn (relaxation), Increased RA and RV, RV systolic pressure estimated at 45-55 mmHg, ASD 19X15 mm shunting
• Not performed
Catheterization (11/12):
• Normal coronary arteries; PAP: 50/20 (30); RA: 10; Ao: 140/90; LV: 140/18; Qp/Qs: 2.3
Intended Intervention:
• ASD closure using a fenestrated Figulla device under general anesthesia and 3D TEE guidance.

Arnold Palmer Hospital For Children, Orlando, Florida
Case #1

Live Case Operators:
David Nykanen MD and Matthew Schwartz MD
• 9 month old TGA/VSD, juxtaposed RA appendage
• ASO, VSD closure (Complex RVOT reconstruction with homograft as PA bifurcation rightward)
• Post op SVC obstruction asymptomatic
• ASA 20.5 mg daily

Physical Findings:
• Wt: 7 kg, Thriving, 1-2/6 SEM. No DM
• No hepatomegaly or ascites

Pertinent Tests:
LPS : Rt 74%, Lt 2
• Sinus, normal axis, borderline LVH
• No residual shunt, No RV/LV OTO, Diffuse LPA hypoplasia with flow acceleration, RSVC thrombus, good biventricular function.

Intended Intervention:
• LPA angioplasty / Stent

Arnold Palmer Hospital For Children, Orlando, Florida
Case #2

Live Case Operators:
David Nykanen MD and Matthew Schwartz MD

• Multiple muscular VSD’s (Large Apical VSD)
• Double orifice mitral valve (No MS/MR)
• PA Band October 18, 2010
• Asymptomatic

Physical Findings:
• Wt: 10 kg, SpO2 99% in Room Air
• 3/6 harsh SEM. No DM
• No hepatomegaly or ascites

Pertinent Tests:
• Sinus, RBBB, RVH
• Large posterior apical VSD
• Additional small mid to low muscular ventricular septal defects.
• Double orifice mitral valve without stenosis or regurgitation, atypical mitral chordal attachments from the mitral valve extending across the left ventricular outflow tract without LVOTO ventricular outflow tract obstruction, moderate right ventricular hypertrophy, including prominent moderator band without evidence of obstruction. ? LV non compaction.

Intended Intervention:
• Transcatheter closure of VSD
• Surgical removal of PA band

Miami Children’s Hospital, Miami, Florida
Live Case #1

Live Case Operators:
Darren Berman, MD and Roberto Cubeddu, MD

• A.S. is a 17 year old male born with TOF.
• 2 month old (2/1996; Haas) – Complete repair with transannular patch
• Developmentally delayed, b/l deafness with cochlear implants
• Foster parents, felt to be asymptomatic

Physical Findings:
• HR 90/min, RR 18/min, BP 117/76, O2 Sat 100%, 48.6kg
• HEENT/Neck: Microcephalic, no JVD
• CV: well healed midline sternotomy, dynamic precordium, reg rate, clear S1, single S2, 3/6 to-fro murmur over LUSB Ext: warm, 2+pulses in UE and LE, no LE edema

Pertinent Tests:
• Normal sinus rhythm, RBBB, QRS duration 145ms
• Mild TR – RVp ~34mmHg + RAp
• Mild PS (PSG 27mmHg, mean Doppler gradient 17mmHg)
• Severe PR, with flow reversal in BPA’s
• Moderate-severe RV dilation
• RV function fair to normal (subjective)
• Normal LV function (EF 60%)

• Contraindicated due to cochlear implants

Cath (10/2012):
• C.I. 3.5 L/min/m2
• Mild PS
• Severe PR
• Moderate RV dilation Echo

Intended Intervention:
• Trans-catheter pulmonary valve implantation.

Miami Children’s Hospital, Miami, Florida
Live Case #2

Live Case Operators:
Darren Berman, MD and Roberto Cubeddu, MD

• L.W. 65 year old woman with 6 month history of exertional dyspnea and palpitations referred for CV evaluation.
• Trans-thoracic echo 10/2012: hemodynamically significant secundum ASD associated with RA/RV enlargement and moderate pulmonary HTN

• Hypothyroidism
• Essential HTN

Physical Findings:
• BP 135/85 mmHg, NSR rate 68/min, RR 18/min, O2 Sat 97%, 209 Lbs
• Obese, African american female, NAD
• HEENT/Neck: no JVD
• CV: RRR, S1, accentuated S2, 2/6 soft parasternal flow murmur
• Ext: warm, 2+pulses, no LE edema, no clubbing
• Neuro: unremarkable

Pertinent Tests:
• Normal sinus rhythm, normal QRS and axis, rate 74 bpm
• Preserved LV size and function: EF 55%
• Mod-severe dilated RA/ RV chambers
• Mild-mod TR
• Moderate pulmonary HTN
• (RVSP 55mmHg)
• Secundum ASD (Left to right shunting color Doppler) Pre-op 3D TEE
• Complex multifenestrated secundum ASD with adequate rim margins; largest defect measuring approximately 18-20 mm

Intended Intervention:
• Trans-catheter closure of multifenestrated ASD

University of Mississippi Medical Center, Jackson, Mississippi
Live Case #1

Live Case Operators:
Makram R. Ebeid, MD and Tom Jones, MD

• 18 year old, Truncus arteriosus s/p surgery as an infant in a different state using 12 mm conduit. In 1999 underwent replacement of the RV to PA conduit using pulmonary homograft. Operative note could not be located.

Physical Findings:
• General: Delayed, suggestive of Di George syndrome
• wt. 61 kg, Ht 160 cm BP 113/71
• Chest CTA,
• Active precordium with RV lift
• 3/6 Harsh ejection systolic murmur heard along the entire precordium
• 2/6 early diastolic murmur at the left sternal border
• Liver palpable at the right coastal margin
• He and his grandmother do not want surgery

Pertinent Tests:
• Mild truncal valve regurge and mild truncal valve stenosis
• Severe PI; Severe PS (peak Gradient 97 mmhg, mean gradient 61 mmhg)
• RV volume 74 ml/M2 with moderate RVH, dilated RA severe homograft stenosis and moderate PI.

Intended Intervention:
• Placement of covered stent followed by Melody valve.

University of Mississippi Medical Center, Jackson, Mississippi
Live Case #2

Live Case Operators: Makram R. Ebeid, MD and Tom Jones, MD

• 6 year old with Tricuspid atersia Type 1A. At age 1 day underwent BAS followed by a B/T shunt. At age 6 months underwent a Glenn procedure with extended post op course requiring multiple indwelling lines. Pre Fontan cath showed mild LPA stenosis which was balloon dilated. At age 3 years he underwent fenestrated Fontan procedure with 16 mm Gortex conduit including a 4 mm fenestration. Previous cardiac catheterizations suspected occluded femoral veins.

Physical Findings:
• General: playful NAD
• Wt: 20.3 Kg, ht 105 cm, BP 96/64, sats 90-92 %
• Chest: CTA
• Cardiac: S1 7 S2 Single no murmurs
• Soft abdomen

Pertinent Tests:
Previous cardiac catheterizations suspected mild LPA stenosis and occluded femoral veins.
• Normal LV function
• Laminar flow in the Fontan
• Unable to see LPA well
• Small fenestration

Intended Intervention:
• Transhepatic cardiac catheterization
• Assessment of the LPA and the fenestration
• Possibly transhepatic LPA stenting and Fenestration closure

University of Mississippi Medical Center, Jackson, Mississippi
Live Case #3

Live Case Operators:
Makram R. Ebeid, MD and Tom Jones, MD

• 9 year old. TGV, s/p Arterial switch.

Physical Findings:
• Wt: 70.6 kg, Ht: 152 cm, BP: 117/63
• Chest CTA, 3/6 medium pitch long ejection systolic murmur heard along the left chest.

Pertinent Tests:
• NSR Echo:
• Mild – moderate supra PS and LPA stenosis gradient 79 mmhg.
• Moderate long segment LPA stenosis
DOPPLER of Femoral Vessels:
• Occluded femoral vessels

Intended Intervention:
• Transhepatic stenting of LPA

JFK Medical Center, West Palm Beach, Florida
Live Case #1

Live Case Operators:
Robert Cubeddu, MD, Marcos Nores, MD, Ziyad Hijazi, MD, Mark Rothenberg, MD, Larry Lovitz, MD, Arvind Kapila, MD, and Lance Lester, MD

• 88 year old male with critical aortic stenosis + CHF NYHA III
• High risk / high frailty index
• Moderate pulmonary HTN
• History of prostate CA
• Essential HTN
• Hyperlipidemia

Physical Findings:
• BP 128/66 mmHg, NSR rate 68/min, RR 18/min, O2 Sat 97%
• Frail elderly male
• HEENT/Neck: no JVD
• CV: RRR, 3/6 high pitch SEM with soft S2.
• Ext: warm, 1+ pitting edema
• High frailty index

Pertinent Tests:
• Normal sinus rhythm, RBBB, rate 74 bpm
• Preserved LV size and function: EF 55%
• Critical AS: AVA 0.8cm2; mean gradient 41mmHg, Vmax 4.1m/s
• Moderate MR
• Moderate pulmonary
HTN Labs:
• Normal serum creatinine and Hb


Prospective Randomized Trial of Transthoracic vs Transesophageal Echocardiogram for Definitive Assessment and Guidance of Transcatheter Closure of ASD in Children using the Amplatzer® Septal Occluder.
Sergio Bartakian

More Acute Angle of Approach Identifies Patients Who Benefit From Hybrid Transapical Placement of Transcatheter Pulmonary Valve.
Michael D. Seckeler

Improved Outcomes in HLHS with Restrictive Atrial Septum, a Single Institution Experience.
Alejandro Torres

NuMED Covered Cheatham-Platinum Stent (CCPS) for the Treatment of Right Ventricle to Pulmonary Artery (RV-PA) Conduit Disruption During Transcatheter Pulmonary Valve Replacement (TPVR).
Ram Bishnoi

Risk Factors of Significant Adverse Events in Adults Undergoing Cardiac Catheterization in Pediatric Catheterization Laboratories — Congenital Cardiovascular Interventional Study Consortium (CCISC).
Daisuke Kobayashi

Success of Balloon Angioplasty for Recurrent Coarctation in Neonatal Univentricular and Biventricular Norwood-Type Arch Reconstructions.
Wendy Whiteside

Transcatheter Interventions in Post Fontan Patients – A 24 Years Single Centre Experience.
Vikram Kudumula

The Flow Detection System, a Novel Technique to Detect Cardiac Right to Left Shunts.
Mark Reisman

Eighteen Year Experience with Bronchial Casts and Protein Losing Enteropathy.
Bharat Ramchandani

Use of Ultra-High Pressure Balloon Angioplasty for Resistant Vascular Stenosis in Congenital Heart Disease.
Ryan Callahan

Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Transcatheter Heart Valve (COMPASSION):One-year follow-up.
Damien Kenny

Transcatheter Device Closure of Atrial Septal Defects in Patients Weighing < 10 Kg is Safe and Effective.
Joanne Chisolm

Radiofrequency Perforation in Pulmonary Atresia and Intact Ventricular Septum: A Single Center Experience.
Benjamin Auld

Intentional Stent Fractures in Structural Heart Disease: When Breaking the Chains is the Only Way!
Mehul Patel

A Novel Biodegradable Stent for Use in Congenital Heart Disease: Mid Term Results in a Rabbit Model.
Surendranath R. Veeram Reddy

Diagnostic Utility of 3-Dimentional Rotational Angiography in Pediatric Cardiac Catheterization.
Osamah Aldoss

Medium-to-Long Term Outcomes of Percutaneous Transcatheter Closure of Congenital Ventricular Septal Defects.
Kiran Mallula

Occlutech Duct Occluder – Initial Human Experience.
Mazeni Alwi

Feasibility of Dilation of Homograft RV to PA Conduits Beyond Their Native Diameter: Implications for Conduit Stenting and Placement of Percutaneous Pulmonary Valves.
Aimee Liou

Transcatheter Embolization of Aortopulmonary Collaterals using the Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System.
Joseph Casadonte

Practical Evaluation of a New Left Atrial Appendage Occluder (Lifetech LAmbre Device in a Canine Model).
Yat-Yin Lam


P-1 Percutaneous Balloon-Expandable Covered Stent Implantation for Treatment of Traumatic Aortic Injury in Children and Adolescents. Bryan Goldstein

P-2 Altered Right Ventricular Diastolic Function in Children with Unrepaired Ventricular Septal Defect. Gretel Monreal

P-3 Transcatheter Closure of PDAs at the Seriously Ill Premature Babies. Osman Baspinar

P-4 Report a Case of Percutaneous Occlusion of Antegrade Pulmonary Blood Flow in Post Operative Bidirectional Cavo Pulmonary and Pulmonary Artery Banding. Denoel M. Oliveira

P-5 Intermediate And Longterm Follow-Up after Patent Ductus Arteriosus Closure With Amplatzer Device. Tharak Yarrabolu

P-7 Partial Anomalous Pulmonary Venous Return into the IVC in a 28-Year-Old Woman: A Variant of Scimitar Syndrome Amenable to Interventional Treatment. Heike Schneider

P-8 Dilatation of Coarctation of the Aorta with Andrastent XL/XXL. Jacek Bialkowski

P-9 Transcatheter Closure of Patent Foramen Ovale with Different Nitinol Wire Mesh Occluders. Mateusz Knop

P-10 When the Delivery System of the Premere PFO Device Could Not Be Retrieved? A Case Report. François Godart

P-11 Transcatheter Closure of Perimembranous Ventricular Septal Defect with the Amplatzer Duct Occluder. Yun-Ching Fu

P-12 Our Experience of Transcatheter VSD Closure at the Children in Turkey. Osman Baspinar

P-13 Morphology of the Patent Ductus Arteriosus (PDA) Does Not Preclude Successful PDA Stent Implantation in High Risk Patients Undergoing Hybrid Stage I Palliation. Michael R. Recto

P-14 One–Year Follow Up Data after Successful Partial Closure of a Large ASD with Severe PHTN using Custom made Occlutech-Flex II® Device. Eusatchio Onorato

P-15 Percutaneous Repair of Right-to-Left Shunt after PFO Closure. Clinical and Procedural Impact. Case Report. Eustaquio Onorato

P-16 Mid-Term Results of Percutaneous Closure of Atrial Septal Defect and Patent Foramen Ovale using the Occlutech FIGULLA FLEX I/II Closure Device. Multicenter Italian Experience. Eustaquio Maria Onorato

P-17 Transthoracic Echocardiography Guided Percutaneous ASD Closure in Children: Is Less More? Rasha Ammar

P-18 Contrast Induced Nephropathy in High Risk Pediatric Patients Undergoing Cardiac Catheterization. Michelle Lipton

P-19 Combined Surgical and Transcatheter (Hybrid) Procedures for Adults with Congenital Heart Disease. Marc Cribbs

P-20 The Occlutech Figulla Devices for ASD Occlusion. Comparison with the Amplatzer Septal Occluder. François Godart

P-21 Percutaneous Closure of Patent Ductus Arteriosus in Small Infants with Significant Lung Disease Offers Faster Recovery of Respiratory Function when Compared to Surgical Ligation. Anas Abu Hazeem

P-22 Percutaneous Recanalization of Occluded Innominate Vein-Superior Vena Cava Connection after Resection of Mediastinal Mass. Michael D. Seckeler

P-23 Outcomes and Predictors of Reintervention in Patients with Pulmonary Atresia and Intact Ventricular Septum Treated with Radiofrequency Pulmonary Valvotomy. Matthew C. Schwartz

P-24 Transcatheter Left Atrial Decompression in Hypoplastic Left Heart Syndrome with Intact Atrial Septum: Evolution of a Single-Center Perinatal Strategy. David Kwiatkowski

P-25 Intracardiac Echocardiography Is Safe In Pediatric and Adolescent Patients. Beth Medford

P-26 Balloon Aortic Valvuloplasty for Critical Aortic Stenosis in Neonates and Small Infants. Snehal Kulkarni

P-27 Balloon Pulmonary Valvuloplasty in Severe Pulmonary Valve Stenosis Presenting Late with RV Dysfunction in Children. Amjad Mehmood

P-28 Transcatheter Valve-in-Valve Tricuspid Valve Replacement in Congenitally Malformed Hearts. Jeremy Asnes

P-29 Hybrid Approach for Pulmonary Atresia with Intact Ventricular Septum: Early Single Center Results and Comparison to the Standard Surgical Approach. Jeffrey Zampi

P-30 Secundum ASD Closure using the Amplatzer Septal Occluder (ASO) in Patients Under 8 kg: Results of the Multicenter MAGIC Atrial Septal Defect Study. Ram Bishnoi

P-31 Interventional Catheterization in Children Less Than 2.500g. Edmundo Clarindo Oliveira

P-32 Percutaneous Closure of ASD Larger Than 30mm. Edmundo Clarindo Oliveira

P-33 A Retrospective Review of Pulmonary Valve Implantation and Immediate Outcomes: A Comparison of Three Implantation Techniques. Roberta Rodeman

P-34 Diastolic Performance of Single Systemic Right Ventricle May Not Improve after Stage 2 Palliative Surgery. Michael D. Seckeler

P-35 Hemoptysis in Congenital Heart Disease. Anas Abu Hazeem

P-36 Prospective Risk Stratification of Pediatric Cardiac Catheterization Procedures: A Simple Scoring System. David Nykanen

P-37 Application of a Novel Electromagnetic Catheter Tracking System to Eliminate Fluoroscopy During Guidance of Heart Catheterizations. George Hamilton Baker

P-38 Feasibility of Transcatheter Closure of Sinus Venosus ASD and Large Secundum ASD with Absent Superior or Inferior Rim. Abdulwahab Hussein

P-39 The Role of Interventional Cardiac Catheterization in Fontan Patients. Zuzana Venczelova

Sunday Jan 20
P-1 Percutaneous PDA Closure in Infants Weighing 5kg or Less: 10-year Experience at the National Institute of Cardiology Mexico City. Juan Pablo Sandoval

P-2 Initial Mexican Experience with the Helex Septal Occluder in Congenital Heart Disease. Joan Johnson Herrera

P-3 After Fontan Procedure – Are the Hypatopathy and Related Cardiovascular Factors be Assessed by Transient Elastography? Lucy Eun

P-4 Transcatheter Treatment of Patent Foramen Ovale Combined with Abnormal Drainage of Left Superior Vena Cava to Left Upper Pulmonary Vein. Lucy Eun

P-5 Hybrid Technique for Closure of a Large Coronary Artery to Left Ventricle Fistula in a Toddler. Eric Eason

P-6 Fetal Pulmonary Valvuloplasty by Percutaneous Transhepatic Access in a Lamb Model. Flora Wong

P-7 Invasive Blood Pressure and Flow Measurements in the Fetus: A Percutaneous Catheterization Technique in the Pregnant Sheep Model. Flora Wong

P-8 Experience with the Cook Formula Stents in Paediatric Cardiac Interventions. Oliver Stumper

P-9 Cardiac Catheterization on ECMO Support. Corey Stiver

P-10 PDA Closure with NIT OCCLUD® PDA-R in Patients Under 10kg. Jesus Damsky Barbosa

P-11 ASD Closure with NIT OCCLUD® ASD-R and PFO (PFM). Jesús Damsky Barbosa

P-12 The Incidence and Consequence of Innominate Vein Collaterals in Single Ventricle Patients. Todd Gudausky

P-13 Occluders Device Use in the Treatment of Congenital Heart. Carlos Mariño Vigo

P-14 Off Label Use of the Amplatzer Duct Occluder II Additional Sizes (ADO II AS) Device. Vikram Kudumula

P-15 Transcatheter Retrieval of Cardiovascular Foreign Bodies – A 15-Year Single Centre Experience. Vikram Kudumula

P-16 Visualization of Post-surgical Right Ventricular Outflow Tract (RVOT) Aneurysm by 3-Dimensional Rotational Angiography (3DRA). Mirella Molenschot

P-17 Outcomes of Secundum ASD Closure by Different Brands of Double Disc Device. Worakan Promphan

P-18 Atrial Septostomy with Stenting in Patients with Idiopathic Pulmonary Arterial Hypertension. Bagrat Alekyan

P-19 Endovascular Closure of Congenital and Acquired Pathological Communications using Amplatzer Occluders. Bagrat Alekyan

P-20 Hybrid Methods for the Treatment of Congenital Heart Diseases. Leo Bockeria

P-21 Endovascular Treatment of Critically Ill Neonates with Valvular Aortic and Pulmonary Arterial Stenosis. Bagrat Alekyan

P-22 Stenting of Aortic Coarctation and Re-coarctation. Bagrat Alekyan

P-23 Transcatheter Closure of a Post Traumatic Muscular Ventricular Septal Defect with a Nit-Occlud-PFO Device under Intracardiac Echocardiographic Guidance. Kadirova Saule

P-24 Novel Techniques for Advancing Large Sheaths through Difficult Anatomy during Melody Valve Implantation. Lourdes Prieto

P-25 Use of the Melody Valve in Congenital Heart Disease: Tips and Tricks from a Single Center. Dhaval Parekh

P-26 Varity of Communications of the Heart Chambers and Large Vessels and Their Possible Transcatheter Corrections. Alimbaev Serik

P-29 Transfemoral Stent Implantation as a Bridging Therapy in a Critical, Very-Low-Birth-Weight Gemini Newborn of 700gr Weight. Gregor Krings

P-30 Retrospective Review of a Single Center Experience with the Amplatzer Vascular Plug I and II. Saar Danon

P-31 Experience in Percutaneous Closure of Patent Foramen Ovale – Evaluation, Follow Up and Results in Short, Mid and Long Terms. Fábio Augusto Selig

P-32 Spectrum of Midaortic Syndrome Patients Presenting to a Tertiary Children’s Hospital. Mehul Patel

P-33 Transcatheter Aortic Valve Replacement in the Real World: Early Experience in a Single Center. Noa Holoshitz

P-34 Single Center Outcome Analysis Comparing Re-intervention Rates of Surgical Arterioplasty with Stenting for Branch Pulmonary Artery Stenosis in a Pediatric Population. Neil Patel

P-35 Initial Mexican Experience with the Amplatzer Vascular Plug IV in a Patient with Tetralogy of Fallot (TOF) and Collateral Aortopulmonary Circulation. Veronica Vasquez

P-36 Initial Pediatric Experience with a Novel 3.3 French Catheter System. Alex Golden

P-37 Successful Transcatheter Perforation of Pulmonary Valve using the High-Penetration Guide Wire used for Chronic Total Coronary Artery Occlusion (CTO wire) and 2.7 French Micro-Catheter without Reaching of the Tip of 4Fr Guiding Catheter onto Pulmonary Valve in Pulmonary Atresia with Intact Ventricular Septum (PAIVS): 2 Case Reports. Wataru Soda

P-38 Palliation of Obstructed Infradiaphragmatic TAPVR in Single Ventricle Heterotaxy via Ductus Venosus Stenting. Sanjay Sinha

P-39 Succesful Transcatheter Closure of Perimembranous Ventricular Septal Defect with Inlet Extension using ADO I. Mashail Bin Obaidan

P-40 Comparison of Ultra-High-Pressure Balloon and High-Pressure Balloon on Percutaneous Transluminal Pulmonary Angioplasty. Keijiro Ibuki

P-41 Stenting of the Right Ventricular Outflow Tract Provides Excellent Initial Palliation. Oliver Stumper

P-42 Closure of Large Atrial Septum Defects with Deficient Rim by use of a Steerable Long Sheath. Gregor Krings


P-1 Transcatheter Device Closure of Ruptured Sinus of Valsalva: Immediate Results and Short Term Follow Up. Neeraj Awasthy

P-2 Unconventional uses of Septal Occluder Devices. Neeraj Awasthy

P-3 A Novel Murine Model for the In Vivo Assessment of Corrodible Cardiovascular Implants: Determination of Iron Implant Degradation Kinetics, Corrosion Product Localization and Transcriptional Response after Implantation of Iron Tubes in the Tail Vein of Mice. Matthias Peuster

P-4 Multicentric Experience in Argentine with the “CARDIA ULTRASEPT” Device in Atrial Septal Defect (ASD) Closure. Victorio Lucini

P-5 Challenges of Interventions for Associated Lesions in Cases of Apical Non-Compaction. I.B Vijayalakshmi

P-6 Challenges of Transcatheter Interventions for Congenital Heart Diseases in Dextrocardia. I.B Vijayalakshmi

P-7 Prosthetic Valve Thrombolysis: Initial Experience with Tissue Plasminogen Activator. Bhanu Duggal

P-8 How Does the Alteration in the Early-Stage Palliation for Hypoplastic Left Heart Syndrome Influence the Our Subsidiary Transcatheter Therapy? Atsuko Kato

P-9 Pulmonary Artery Thrombosis after Comprehensive Stage 2 Surgical Palliation: Incidence and Treatment. Andrew R. Yates

P-10 Safety and Preliminary Results of a Standard Care Protocol to Prevent Pulmonary Artery Thrombosis after Comprehensive State 2. Andrew R. Yates

P-11 Pulmonary Artery Growth after Stenting of the Right Ventricular Outflow Tract. Bharat Ramchandani

P-12 Fetal Interventions for Congenital Heart Disease. Are Outcomes Reproducible? Fabricio Pereira

P-13 Coarctation Stenting with the New Advanta V12 Covered Stent. Mid-term Outcomes. Fabricio Pereira

P-14 Balloon Dilation of Supravalvar Pulmonary Stenosis Following Arterial Switch Operation. Mark Law

P-15 Transhepatic Access Revisited in the Modern Era of Interventional Cardiology for Congenital Heart Disease. Fabricio Pereira

P-16 Complete Ductal Spasm During Performance of Transcatheter Ductal Occlusion. Sarosh Batlivala

P-17 Which Patient is Suitable for MitraClip? Who is the Super Responder? Per Jacobsen

P-18 Validation of a Pre-Screening Program for Transcatheter Atrial Septal Defect Closure. George Nicholson

P-19 Bidirectional Cavopulmonary Anastmosis with Additional Pulmonary Flow versus Disconnected Pulmonary Arterial Supply. Amal El Sisi

P-20 Transcatheter Palliative Rastelli Procedure in a 9 Year Old Patient with Pulmonary Atresia and Multiple Major Aorto-Pulmonary Collateral Arteries. Su-Jin Park

P-21 Central Blood Volume Index as Volumetric Preload Indicator in Patients Undergoing Cardiac Catheterization. James C. Fudge

P-22 New Therapeutic Strategies for Patients with Atrial Septal Defect and Severe Pulmonary Arterial Hypertension: Combination of Advanced Medical Therapy and Catheter Closure. Daisuke Toyomura

P-23 Intravascular Ultrasound Facilitates Percutaneous Closure of Perivalvar Leak after Transcatheter Aortic Valve Replacement. Victor (Sam) Lucas

P-24 Initial Experience in Native Aortic Coarctation Stenting with Advanta V12 LD Covered Stent in Children Weighing Less Than 25 kg. Liliana María Ferrín

P-25 Novel Technique for Obtaining Access to the Umbilical Vein and/or Artery in the Cath Lab for Intervention after Failed Attempts at Placement at the Bedside in the NICU. Mary Porisch

P-26 Placement Endocardial Pacemaker in DDDR Mode, in a Child Postoperative Complex Cardiac Surgery. A Case Report. Veronica Vasquez

P-27 Medium-Term CT Evaluation of Stent Geometry and Integrity of the Edwards SAPIEN Transcatheter Heart Valve in the Pulmonary Position. Hani Ghawi

P-28 Pulmonary Flow Control using Balloon Angioplasty for Right Ventricular-Pulmonary Artery Shunt with a Hemoclip in Hypoplastic Left Heart Syndrome. Kenji Baba

P-29 Incidence of Acute Kidney Injury Following Routine Practice of Cardiac Catheterization within 48 hours of Cardiopulmonary Bypass. Nicholas Huggins

P-30 Transcatheter Intervention for Inferior Vena Cava Obstruction: Techniques and Outcomes. Himesh Vyas

P-31 Early Experience with Transcatheter Pulmonary Valve Replacement in Patients with a Dysfunctional Gore-Tex Bivalve. Jeremy Ringewald

P-32 Transcatheter Device Closure of Ruptured Sinus of Valsalva: Have We Achieved the Desired Objective? Neeraj Awasthy

P-33 Long Term Results of Percutaneous Balloon Valvoplasty of Congenital Aortic Stenosis: Independent Predictors of Outcome. Neeraj Awasthy

P-34 Hyponatremic-Hypertensive Syndrome: A Rare Presentation in a Child with Takayasu Arteritis. Neeraj Awasthy

P-35 A Case of Atrial Septal Defect: Tackling a Few Masqueraders. Neeraj Awasthy

P-36 Occlusion of Pulmonary Arterio-Venous Malformations (PAVM) in Infancy and Childhood, using Amplatzer Vascular Plug II (AVP II) & Coils. Varun Aggarwal

P-37 Transcatheter ASD Closure using Occlutech Figulla® Flex in Children Less Than 10 Years Under Transthoracic Echocardiographic Guidance. Elaheh Malakan Rad

P-38 Transcatheter Rim Implantation: A Hypothetic Design for a Novel Device as a Bridge to Transcatheter Closure of Secundum Atrial Septal Defects without Adequate Rims. Elaheh Malakan Rad

P-39 Late Resolution of Atrioventriuclar Block after Tramscatjeter ASD Closure with the GORE HELEX Septal Occluder. Amanda Nedved

PICS & AICS Abstracts: January 19–22, 2013


Sergio Bartakian, Howaida El-Said, John Moore, University of California, San Diego, San Diego, CA, USA
Objective: To determine whether TTE can provide safety and efficacy equivalent to TEE for assessment and guidance of transcatheter ASD occlusion using the Amplatzer septal occluder (ASO) in pediatric patients. Background: Most centers currently employ TEE for definitive ASD assessment and guidance of transcatheter ASD occlusion with the ASO. Methods: A prospective randomized trial of ASD closure using the ASO from March 2008 to April 2012. Key inclusion criteria were: isolated secundum ASD, age 2–18 years, and adequate TTE windows. Forty patients were enrolled and randomized to either TEE or TTE. In the TEE group, we used conventional ‘‘stop flow’’ balloon sizing. In the TTE group, we used the average ASD diameter from three standard views times 1.2 to determine device size. Baseline and follow-up (1–2 days, 1 month, and 6–12 months) ECGs, TTEs, and examinations were obtained for all patients. Results: Patient general and hemodynamic characteristics were similar in both groups. Procedural success was 100% in both groups. The average TEE stop flow diameter was similar to the scaled TTE diameter (15.35 6 4.62 vs. 16.57 6 5.47 mm; P = 0.46). Device size (16.0 6 4.94 vs. 16.37 6 5.05 mm, P = 0.82) and ratio of device to defect size (1.0 6 0.06 vs. 0.99 6 0.03, P = 0.52) were also similar. Total fluoroscopy (13.6 6 6.17 vs. 8.9 6 8.45 min, P = 0.007), procedure (70.6 6 22.98 vs. 51.1 6 17.61 min, P = 0.005), and room (126.8 6 28.41 vs. 95.7 6 20.53 min, P = 0.0004) times were all significantly shorter in the TTE group. Neither group had significant procedural complications or in follow-up. Rates of shunt resolution were also similar. Conclusions: This study suggests that the use of TTE is as efficacious and safe as TEE for assessment and guidance of ASD occlusion using the ASO. Reduced fluoroscopy time appears to be a safety advantage of TTE. TTE may also reduce costs because of lower requirements for laboratory time and ancillary staff.

Michael D. Seckeler,1 D. Scott Lim,2 1 Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA, 2 University of Virginia Health Systems, Charlottesville, VA, USA
Background: While transcatheter pulmonary valve implantation has allowed many patients with previous surgical palliation of congenital heart lesions to undergo minimally invasive procedures for valve replacement, some may have anatomical issues which make valve implantation difficult or impossible from a transvenous approach. Hybrid techniques allow a cardiac surgeon to provide novel access routes so the interventional cardiologist can safely implant a pulmonary valve in patients with challenging anatomy. Methods: In the previous 12 months, 25 patients have undergone implantation of a Melody1 percutaneous pulmonary valve (Medtronic, Minneapolis, MN) at the University of Virginia, and three of these have been via a hybrid, transapical approach. Angles of approach (inferior vena cava-to-tricuspid valve and tricuspid valve-to-ventricular apex) were measured from coronal imaging of the right ventricular inflow, body and outflow tract from preprocedural cardiac MRI, or CT scans and compared between patients undergoing transvenous and hybrid Melody1 valve placement using Mann–Whitney U test. ROC curve was used to test the sensitivity and specificity of angle of approach for identifying patients undergoing hybrid Melody1 placement. Results: Hybrid patients had a lower weight (38 vs. 77 kg, P = 0.04) and longer median postprocedure length of stay (3 vs. 1 day, P < 0.001). There were similar procedural complication rates (33 vs. 11%, P = NS) and right ventricular outflow tract gradients by Doppler echocardiography on final follow-up (25 vs. 31 mm Hg, P = NS). Preprocedure coronal images were available for all hybrid patients and six transvenous patients. There was a trend toward a smaller total angle of approach in the hybrid patients (102.58 vs. 121.78, P = 0.07). ROC analysis using a total angle of approach <1068 gave an AUC of 0.889 (P = 0.07), a sensitivity of 100%, and specificity of 67%. Conclusions: Our findings suggest that a smaller total angle of approach on preprocedural CT or MRI scans may predict the need for a hybrid rather than transvenous approach for Melody1 valve placement. Identifying appropriate patients for hybrid placement will improve the chances of a successful procedure.

Alejandro Torres, Tasneem Hoque, Marc Richmond, Emile Bacha, Julie Vincent, Children’s Hospital of New York Presbyterian, New York, NY, USA
Background: Survival of HLHS patient has improved over time. However, mortality in those with a restrictive atrial septum (HLH-RS) remains high. We report outcomes and impact of neonatal intervention on HLH-RS at our institution. Methods: All newborns with HLHS from January 2003 to December 2010 were included. Patients who underwent catheterization for LA decompression <72 hr of life were classified as HLH-RS. Patients without a restrictive septum (HLH-NRS) formed the control group. Results: Of 141 patients diagnosed with HLHS, 20 (14%) presented with a restrictive atrial septum. Catheterization was performed <24 hr in 10 patients (50%), between 24 and 48 hr in eight (40%), and 48–72 hr in two patients. Initial mean septal gradient (MSG) by Doppler was 17.5 6 5 mm Hg. In 12/20 patients (60%), MSG was the sole indication for intervention. Access to LA was achieved in 19/20 patients via native PFO in 7 patients and by creation of atrial communication in 12 patients. RF was used in eight patients, RF followed by transseptal needle in three, and transseptal needle alone in one patient. Static balloon septoplasty was used in 10 patients, septal stenting in 8, and traditional septostomy in 1 patient. Procedure was successful in 17/20 (84%) with a drop in mean LA pressure from 21 6 6 mm Hg to 11 6 3 mm Hg (P < 0.001) and in MSG to 5.2 6 4 mm Hg (P < 0.001). Residual MSG was similar regardless of intervention type. No patient required reintervention before Norwood. The procedure was unsuccessful in three patients (inability to cross atrial septum in one, stent dislodgement in one, and no change in LA pressure post-septoplasty in 1 patient). Serious complications occurred in only 2 patients (stent dislodgment and pericardial effusion). No procedural deaths occurred. Median follow-up was 36 months (0.4–104). Initial hospitalization survival was 16/20 (80%) for the HLH-RS group and 114/121(94%) for the HLH-NRS (P = 0.028). Twenty of 141 patients (14%) were lost to follow-up and 9 (6%) underwent heart transplant. Overall survival was 10/16 (62%) for HLHS-RS patients and 77/95 (81%) for HLH-NRS (P = 0.1). Survival after initial discharge was 10/12 (83%) for HLH-RS and 77/88 (87%) for HLH-NRS patients (P = 0.67). No predictors for HLH-RS outcome were identified. Conclusion: Neonatal mortality in HLH-RS has improved but remains higher than HLH-NRS. However, survival is similar after discharge from initial hospitalization. Balloon septoplasty and septal stenting are equally effective in LA decompression for HLH-RS patients.

Ram Bishnoi, Allen Everett, Richard Ringel, Johns Hopkins University, Baltimore, MD, USA
Introduction: On January 25, 2010, the Melody transcatheter pulmonary valve (TPV) was approved for replacement of the pulmonary valve for patients with CHD, who have dysfunctional right ventricle to pulmonary artery conduits. RV-PA homograft conduits are frequently calcified and rigid. Dilation of these conduits prior to transcatheter pulmonary valve replacement (TPVR), poses a significant risk of conduit tearing or rupture. The covered Cheatham-platinum stent (CCPS) has been used in the Prevention or Treatment of Aortic Wall Injury trial in coarctation of the aorta (COAST II) with excellent results. There were 650 Melody valve implants in 2011 and 23 CCPS were implanted under emergency use (EU) or compassionate use (CU) conditions into RV-PA conduits during Melody valve implant procedures for an estimated occurrence of 3.5%. Aims: The aim of this study is to retrospectively assess the effectiveness and safety of the CCPS for treating RV-PA conduit disruption and preventing the development or worsening of rupture into the mediastinum during additional enlargement of the conduit. Methods: Data regarding 50 CCPS implants during TPVR procedures (48 Melody and 2 Edwards Sapien valves) were retrospectively reviewed from multiple institutions around the country. Catheterization records and 6 months follow-up visit data were collected. Outcomes of the valve implant associated with CCPS use were compared to the reported effectiveness and safety of the valve implants reported in the original pivotal trial. Results: From September 2009 (September 17, 2012) to July 2012 (July 17, 2012), 50 patients received CCPS during TPV implant procedure (16 for CU and 34 for EU). Patient age ranged from 5.5 to 56 years (mean 21.4 6 3.7 years). Forty-one patients had pulmonary or aortic homografts, four had Hancock conduit, two had Contegra conduit, one had Medtronic mosaic valve, and the remaining two patients had no conduit (native RVOT). Conduit size ranged from 14 to 27 mm (21.1 6 3.7 mm). Thirty-five patients had mixed disease and the remaining 15 had isolated conduit stenosis. The mean preintervention minimum angiographic conduit diameter ranged from 4 to 16.81 mm (10.4 6 3.3). Nine patients had pre-existing tears, 30 patients developed tears after performing conduit dilation and three developed tears after TPV implantation and for the remaining seven patients the CCPS was used prophylactically. Average largest balloon size used for dilation prior to tear recognition ranged from 12 to 22 mm (18.4 6 2.4). The average ratio of the largest balloon prior to conduit tear to minimum conduit diameter ranged from 1.15 to 3.5 (1.9 6 0.57). The average ratio of the largest balloon to initial conduit diameter ranged from 0.6 to 1.3 (0.91 6 0.17). Conduit tears were repaired or prevented by covered stents in 49 out of 50 patients. A total of 69 covered stents were used (single CPSS for 33 patients, two each for 15 patients and three each for the remaining two). CCPS were implanted through the newly implanted Melody valve in two patients and effectively sealed the rupture, but they required another Melody valve implantation for valve incompetence. The mean preimplant peak-to-peak RVOT gradient ranged from 19 to 110 mm Hg (45.5 6 17.5) compared to 0–30 mm Hg (10.6 6 6.3) postimplant. No CCPS related complications were reported. On echo at 6 months, peak Doppler RVOT gradient ranged from 11 to 40 mm Hg (22.7 6 8.4) and mean gradient 4–20 mm Hg (12.86 6 5.0). Average Doppler mean gradient was 22.4 6 8.1 mm Hg at 6 months follow-up in original pivotal trial compared to 12.86 6 5.0 mm Hg in this study. Valve competence was maintained during the follow-up, with 94% of patients having no/trivial PR, which is comparable to the original pivotal trial (93%). Conclusions: In this retrospective multicenter review, the CCPS was successful on all attempts in preventing or treating RV-PA conduit disruption occurring during TPV implant procedures without complication and without negatively impacting the function of the transcatheter valve. The postimplantation RVOT gradient and the follow-up Doppler peak and mean gradients were comparable to the results in the original pivotal Melody valve trial. Prospective study of this use of the CCPS will help to confirm its benefits and hopefully inform us as to when prophylactic covered stent implantation should be considered.

Daisuke Kobayashi,1 David Nykanen,2 Wei Du,1 Thomas Forbes,1 1 Children’s Hospital of Michigan, Detroit, MI, USA, 2 Arnold Palmer Medical Center, Orlando, FL, USA
Background: Patients with congenital heart disease increasingly survive into adulthood and cardiac catheterization plays an important role in their management. The current practice of cardiac catheterizations on adults with congenital heart disease in pediatric catheterization laboratories (PCL) has not been well described. Objective: We sough to describe demographic and procedural data, significant adverse events (SAE), and assess the predictors of SAE in adults undergoing cardiac catheterization in PCL, utilizing a multi-institutional database. Method: Data were prospectively collected using a multicenter registry congenital cardiovascular interventional study consortium (CCISC). The demographic, procedural, hemodynamic data, and SAE were collected. Predictors of SAE were assessed by univariate and multivariate analysis. Results: Among 11,489 registered patients from 17 centers between 2008 and June 2012, 2,341 adults (20.4%) were identified with a mean age of 37.3 years (sd = 16.0). The incidence of SAE was 3.6% in adults, compared to 6.8% and 2.4% in children aged <1 year and 1–18 years (P < 0.001), respectively. In univariate analysis, age, weight, inotropic support, procedure type, physiologic score, airway status, systemic illness, ASA status, and general anesthesia were correlated with SAE. Final multivariable model includes age 50 years (odds ratio [OR] = 1.826, P = 0.012), ventilator use (OR = 4.059, P = 0.015), systemic illness (OR = 2.120, P < 0.001), and general anesthesia (OR = 1.776, P = 0.012). Patients with SAE were more likely to have incomplete planned procedure, longer procedure time, fluoroscopy time, and extended length of stay. Conclusion: Adults undergoing cardiac catheterization in PCL had the higher incidence of SAE than children but lower incidence than infants. Older age, ventilator use, systemic illness, and general anesthesia were highly correlated with significant adverse events in adults undergoing in PCL.

Wendy Whiteside, Jennifer Hirsch-Romano, Sunkyung Yu, Aimee Armstrong, University of Michigan, C.S. Mott Children’s Hospital, Ann Arbor, MI, USA
Objectives: The aim of this study was to determine the success of balloon angioplasty (BA) in relief of recurrent coarctation in both single ventricle (SV) and two ventricle (2V) patients following Norwood-type arch reconstructions. Background: A Norwood-type arch reconstruction (NTAR), patch augmentation of the aorta using cardiopulmonary bypass, has been utilized at our center for 2V patients with a diffusely hypoplastic aortic arch and for all SV patients undergoing a Norwood procedure (NP). While the incidence of recurrent coarctation and the use of BA in treatment in patients following the NP have been well cited, its application in the 2V population following NTAR is not known. Methods: Neonates who underwent a NP or a NTAR at the University of Michigan Congenital Heart Center between January 2000 and December 2010 were retrospectively reviewed, and patients with recurrent coarctation requiring intervention were identified. Results: A NP was performed in 366 patients and a NTAR was performed in 88 patients. Thirty-five SV patients (9.6%) and 17 2V patients (19.3%) required intervention for recurrent coarctation, and all but two of these patients had BA as the primary intervention. Median time from initial surgery to first intervention was 0.5 (IQR 0.1–1.2) years. BA was successful in 22 SV patients (71%) and 10 2V patients (71%) with reduction in peak systolic ejection gradient by 83% in SV and 77% in 2V patients. Of the procedural characteristics evaluated, higher initial peak-to-peak gradient (P = 0.04), location of coarctation proximal to the left subclavian artery (P = 0.02), and smaller diameter of the descending aorta at the diaphragm (P = 0.03) were associated with balloon failure. Freedom from subsequent re-coarctation in all patients following balloon angioplasty was 85% at 1 month, 74% at 1 year, and 71% at 5 years. Conclusions: While the incidence of recurrent coarctation in 2V patients following NTAR is greater, the use of BA in 2V patients following NTAR has similar success to that in SV patients following the NP and should continue to be considered in this patient population.

O-7 TRANSCATHETER INTERVENTIONS IN POST-FONTAN PATIENTS—A 24 YEARS SINGLE CENTER EXPERIENCE Vikram Kudumula, Vinay Bhole, Bharath Ramchandani, Patrick Noonan, Rami Dhillon, Paul Miller, Chetan Mehta, Joseph De Giovanni, Oliver Stumper, Birmingham Children’s hospital, Birmingham, UK Introduction: There is significant early and late morbidity following Fontan palliation for univentricular hearts. Various transcatheter interventional procedures were employed to address these complications. We reviewed our institutional experience of transcatheter interventions in post-Fontan patients. Methods: Retrospective review of all Fontan patients who underwent interventional catheterization since April 1988 at Birmingham Children Hospital, United Kingdom. Results: A total of 635 Fontan operations were performed from April 1988 to March 2012. (early mortality 2.3%, 5-year survival 93.3% and 10-year survival 90.5%—50% had RV dependant circulation) A total of 180 catheter interventions were performed in 77 patients (12.1%). Only 37 were performed before 2000 compared to 143 after 2000 (P < 0.05). Interventions were more commonly required in patients with RV dependant circulation 51 (66%) compared to patients with LV dependant circulation 26 (34%) [P < 0.05]. Interventions performed included LPA stent = 45 patients, balloon PAs = 22 patients, stent fenestration = 38 patients, balloon fenestration = 4 patients, occlusion of fenestration = 38 patients, electrophysiology procedures = 7 patients, other = 26 patients. Median number of interventions/patient was 2 (range 1–5). Median age at intervention was 6.6 (range 2.0–18.5) years and median weight was 20 (range 11–95) kg. Median time interval between Fontan surgery and intervention was 12 (0–204) months. 50/180 (28%) interventions were undertaken within 30 days of Fontan completion. Two patients died early after catheter fenestration for severe low cardiac output state and pleural effusions in one and severe bronchial casts in the other. Conclusion: Transcatheter interventions after Fontan surgery are an integral part in the postoperative management of early and late Fontan complications.

Mark Reisman,1 Jonathon Tobis,2 Robert Sommer,3 Karanivir Grewal,4 Nathan Laufer,5 David Thaler,6 1 Swedish Heart and Vascular Insititute, Seattle, WA, USA, 2 David Geffin School of Medicine, UCLA, Los Angeles, CA, USA, 3 Columbia University Medical Center, New York, NY, USA, 4 Riverside Methodist Hospital, Columbus, OH, USA, 5 Arizona Heart and Vascular Center, Phoenix, AZ, USA, 6 Tufts Medical Center, Boston, MA, USA
Background: The Flow Detection System (FDS) (Cardiox Corporation, Columbus, OH) is designed to identify abnormal circulatory pathways in the heart, such as right-to-left cardiac shunts (RLS) (e.g., patent foramen ovale (PFO)). FDS enables a rapid minimally invasive technique with an integrated and automated measured Valsalva process and requires neither operator interpretation nor patient sedation. FDS procedure includes a practice Valsalva step, during which the patient is provided coaching by the device through visual feedback. During the actual procedure, the sufficiency and duration of the Valsalva pressure generated, as well as the sufficiency of the release, are measured to assure that only those procedures with an effective Valsalva maneuver are valid. FDS also employs a fluorescing indicator dye, indocyanine green (ICG) (Pulsion Medical Systems AG, Munich, Germany), given via intravenous injection, and time-synched by the system, which is measured by non-invasive spectroscopic sensors on each ear. The ICG dye arrival time and magnitude is measured by the FDS device, which determines whether the dye arrives in a single bolus, or in the case of an abnormal circulatory pathway, (e.g., RLS), in two stages, in which case the relative amount of dye that arrived through the abnormal pathway is compared to the relative amount of dye that traveled through the normal pathway, to produce the novel Shunt Conductance Index (SCI). The SCI reflects the percentage of volume in the right side of the heart that transits the shunt during the Valsalva maneuver. FDS evaluation typically takes 15–20 min to complete and can be performed in the clinic or office setting by a single clinician that need not be a physician. Total time commitment for the patient is about 30 min. TEE is typically performed in the hospital setting, requires multiple clinicians (including an MD), sedation or anesthesia and takes about 1 hr to complete. Methods: This was a multicenter, non-randomized clinical trial for comparison of three diagnostic tests for the detection of RLS. Power Mmode transcranial Doppler (TCD) and FDS tests were conducted sequentially during the same appointment on subjects who previously underwent or were scheduled to undergo TEE with bubble study evaluation. Subjects were selected from a pool of candidates who either had closure of a known PFO and were receiving follow-up care or had PFO evaluation and returned to the clinic to participate in a confirmatory clinical trial. TEE results fell into two categories: negative results, defined as no bubbles detected crossing into the left atrium (LA), and positive results, with at least one bubble detected in the LA. TCD results were categorized as negative if the Spencer grade was 0, I, or II, or positive if the Spencer Grade was III–V. Considering TEE as the gold standard for statistical comparison, the sensitivity, specificity, positive and negative predictive values, and accuracy of FDS were assessed; FDS was also compared with TCD to determine the positive and negative percent agreement, positive and negative predictive values, and accuracy. Results: Data were analyzed using two groups, FDS vs. TEE (n = 43) and FDS vs. TCD (n = 44). Conclusions: FDS provides excellent sensitivity and specificity relative to TEE and TCD in the detection of abnormal circulatory pathways such as PFO, is significantly less invasive for the patient than TEE, and assures satisfactory Valsalva performance without the need for specially trained personnel.

Bharat Ramchandani, Patrick Noonan, Joseph De Giovanni, Rami Dhillon, Chetan Mehta, Vinay Bhole, Oliver Stumper, Birmingham Childrens Hospital, Birmingham, West Midlands, UK
Objective: To review the incidence and our clinical experience with bronchial casts (BC) and protein losing enteropathy (PLE) in congenital heart disease (CHD) Methods: Retrospective case notes review and data analysis of patients with CHD who developed BC or PLE between 1994 and 2012. Patients: Between 1994 and 2012, 14 patients with univentricular circulation developed Fontan failure either in the form BC (N = 6) or PLE (N = 8). Additionally, one patient had undergone a 1.5 type repair (N = 1) and developed PLE thereafter. The median time to development of BC and PLE was 3.7 years and 1.5 years, respectively, post their last cardiac surgery. All patients underwent cardiac catheterization. Eleven patients underwent Fontan fenestration stenting (five for BC and six for PLE). Seven patients required de novo fenestration creation using the Brockenborough needle. Five patients with PLE were on optimal medical management pre-catheter intervention. Results: In patients with BC, the Fontan pressure was reduced by a mean of 2.4 mm Hg and there was complete resolution of symptoms in all patients at a mean interval of 3.5 months post-fenestration stenting. One patient with severe BC arrested during the diagnostic catheterization secondary to acute airway occlusion. In the PLE group, there was symptom resolution in three patients with normalization of biochemical markers and symptom improvement in one patient post-fenestration stenting at median interval of 10 (9–15) months. In the other two patients who had fenestration stenting there was no improvement leading to death in one and cardiac transplantation in the other. One patient with PLE had satisfactory hemodynamics and responded to medical therapy alone. In two other patient with PLE surgical intervention was required to address hemodynamic abnormalities leading to complete resolution of PLE. Conclusion: BC and PLE are life threatening complications in CHD especially in the Fontan circulation. Aggressive therapy with transcatheter fenestration creation and stenting and appropriate medical management may induce remission in a significant proportion of patients.

Ryan Callahan, Sara Trucco, Zachary Turner, Jacqueline Kreutzer, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA Background: Vascular stenosis, either congenital or acquired, is seen within a wide spectrum of congenital heart morphologies causing signifi- cant morbidity/mortality. Transcatheter approaches include balloon angioplasty (BA) using low pressure (LP; <8 atm), high pressure (HP; 8–18 atm), ultra-high pressure (UHP; >18 atm), and cutting balloon (CB) angioplasty as well as stent implantation (SI). CB angioplasty and SI do increase success rate, but many lesions cannot be stented and CB angioplasty is limited by size to < 8 mm. Data are limited regarding the safety and efficacy of UHP BA. Thus, this study evaluates the safety and efficacy of UHP BA at Children’s Hospital of Pittsburgh. Methods: Retrospective review of all consecutive patients (N = 72) who underwent BA using balloons expandable to UHP, between January 5, 2007 and January 3, 2010, was performed. Success of each individual BA was defined as resolution of waist. Procedural success of each lesion was defined as an increase in vessel diameter 50%. Comparison of means was performed using unpaired t-tests. Results: Four hundred-twenty-seven angioplasties were performed on 164 stenotic lesions, including branch pulmonary arteries, surgical grafts, systemic veins, pulmonary veins, and coarctation of aorta. Waist resolution was 66% (29/44) for LP, 81% (21/26) for CB, 71% (149/210) for HP, and 67% (99/147) for UHP. For all non-UHP BA (18 atm) waist resolution was 71% (199/280) which is not a statistically significant difference compared to UHP (P = 0.4). Of the 164 lesions, 85 included UHP (alone, or after other balloons) and achieved procedural success in 67% (57/85). Success when no UHP was used was 52% (41/79), P = 0.051. Fourteen percent of the lesions (23/164) were resistant with residual waist regardless of balloon type. Vessel recoil, defined as resolution of waist without 50% diameter increase occurred in 35% (57/164) of lesions. Vascular trauma occurred in 7/147 (4.8%) angioplasties using UHP (six confined tears, one aneurysm) and 10/280 (3.6%) using non-UHP (10 confined tears), P = 0.6. There were no unconfined tears, four reperfusion injuries, and no deaths. Conclusion: Despite available novel technologies of BA, there continues to be failure related to highly resistant lesions as well as vessel recoil. UHP BA is safe and should be considered routinely in the treatment of vascular stenosis resistant to lower pressure BA.

Damien Kenny,1 Saibal Kar,2 Evan Zahn,2 John Rhodes,3 Michael Mullen,4 Raj Makkar,2 Girish Shirali,5 Mark Fogel,6 John Fahey,7 Mary Heitschmidt,1 Ziyad. M Hijazi,1 1 Rush University Medical Center, Chicago, IL, USA, 2 Cedar Sinai Medical Center, Los Angeles, CA, USA, 3 Duke Family Medicine Center, Durham, NC, USA, 4 The Heart Hospital, London, UK, 5 Children’s Mercy Hospital, Kansas City, KS, USA, 6 Children’s Hospital of Philadelphia, Philadelphia, PA, USA, 7 Yale New Haven Hospital, New Haven, CT
Background: Early safety and efficacy of the Edwards SAPIEN transcatheter heart valve (THV) in the pulmonary position has been established through a multicenter clinical trial. This study provides one-year follow-up results in an extended number of patients undergoing SAPIEN THV implantation for moderate-to-severe pulmonary regurgitation with or without stenosis. Methods: Eligible patients were screened if body weight was greater than 35 kg and in situ conduit diameter 16 mm and 24 mm. Standardized implantation and follow-up protocols were used. Results: From April 2008 until June 2012, 43 patients (15 females) completed 12-month follow-up from a total of 50 total implants in 57 enrolled patients. Mean weight was 72.45 6 22.9 kg. Indication for THV implantation was mixed (72%), stenosis (19%) and regurgitation (9%). Ten patients underwent implantation of 26 mm valve. Intraprocedural mean right ventricular systolic pressure decreased from 53.3 6 17.5 mm Hg to 39.6.1 6 13.2 mm Hg (P < 0.01). At mean follow-up of 24.1 6 11.7 months patients with class I NYHA symptoms increased from 18.6% preprocedure to 77.6%. At one-year, mean estimated RV pressure decreased from 62.42 6 20.1 mm Hg to 47.84 6 14.0 mm Hg (P < 0.01). Pulmonary regurgitation was mild or less in 100% of patients. Freedom from re-intervention was 95.3%. One patient who did not receive the SAPIEN died secondary to bacterial endocarditis involving the surgical valve. Conclusions: Transcatheter pulmonary valve replacement using the Edwards SAPIEN THV demonstrates excellent valve function and durability at one-year follow-up.

Joanne Chisolm, Sharon Cheathm, Ralf Holzer, John Cheatham, Nationwide Children’s Hospital, Columbus, OH, USA
Background: Few data exist regarding transcatheter closure (TC) of atrial septal defects (ASD) in infants and small children. We report TC of ASD in patients weighing 10 kg. Methods: A retrospective chart review was performed on all patient who underwent TC of ASD between July 2002 and September 2012. Patients weighing 10 kg were identified and clinical, procedural, and outcome data analyzed. Results: A total of 42 patients, median age 1 year (2 months–2.3 years) and median weight 7.8 kg (2.6–10 kg), underwent cardiac catheterization with the intent for ASD device closure. Ninety-three percent of patients had co-morbid conditions: prematurity (54%), additional cardiac defect (55%), bronchopulmonary dysplasia (38%), failure to thrive (33%), and other congenital anomaly (31%). ASD closure was successful in 39 patients; 3 patients with absent or nearly absent rims were referred for surgical closure. Echo guidance was used in all patients; transesophageal in 37, transthoracic in 3, and intracardiac in 2. Deficient rims were described in 23. Multiple defects were identified in 24%, however all were closed with a single TC device. Median Qp:Qs was 2:1 (1:1–3.3:1). Median primary defect size was 10 mm (5–25 mm). Forty-eight percent of defects were balloon sized with median diameter of 13.2 mm (6–20 mm). Transhepatic access was used in 2 patients, femoral access for all others with delivery sheath sizes of 6–11 Fr. Amplatzer septal occluder used in 38 patients, Amplatzer Cribriform occluder in 1 patient, and Helex septal occluder in 1 patient. Device recapture/reposition was required in 18 patients, and 7 required a change in device size. Fourteen patients had concomitant transcatheter procedures: PDA/collateral occlusion n = 10, pulmonary valvuloplasty n = 3, branch pulmonary artery angioplasty n = 1, BT shunt occlusion n = 1. Median fluoroscopy time for all patients was 22.5 min. (10.8–76.8 min); 17.1 min (10.8–48.5 min) for patients with only TC of ASD. There were three procedural adverse events: SVT requiring treatment in two and inadvertent extubation with TEE probe in one patient. There were two deaths prior to hospital discharge unrelated to catheterization or device. Follow-up was available in 27 patients with median time to follow-up of 4.1 year (47 days–9.5 years). No residual shunt or interference with adjacent cardiac structure was reported. Conclusion: Transcatheter closure of ASD is technically feasible, safe, and effective in infants and small children and should be considered to eliminate atrial level shunts in patients with lung disease or failure to thrive.

RADIOFREQUENCY PERFORATION IN PULMONARY ATRESIA AND INTACT VENTRICULAR SEPTUM: A SINGLE CENTER EXPERIENCE Benjamin Auld, Martin Hosking, Kevin Harris, British Columbia Children’s Hospital, Vancouver, British Columbia, Canada Background: Percutaneous radiofrequency perforation (RFP) of the pulmonary valve is frequently used as a primary therapy in children born with pulmonary atresia and intact ventricular septum (PAIVS). Recent reports suggest that there is significant procedure related early mortality (6–21%) raising concern about this approach to management. We sought to determine the safety and efficacy of RFP for PAIVS in a single center. Methods: The study retrospectively reviewed all cases of PAIVS that were treated primarily with RFP by a single operator from 1999 through 2012. We collected baseline echocardiographic and angiographic data, technical aspects of the procedure, adverse events, acute, and long-term outcomes. Results: RFP was performed in 16 patients. The acute complication rate requiring intervention was 6% (1/16). Two patients were noted to have a ductal hematoma which were managed conservatively. There was no acute mortality and all children were alive at most recent follow-up (median 5.4 years, IQR 3.66–8.68 years). Seventy-five percent (12/16) of children have a biventricular circulation, 6% (1/16) a 1½ ventricle repair, and 19% (3/16) requiring Fontan track palliation. Overall, 44% (7/16) were treated with a BT shunt following catheter intervention. Tricuspid valve (TV) annulus z-scores showed a median of 1.71 (IQR 1.96 to 1.29) with a median TV/MV ratio of 0.7. We saw a median TV growth of 2.0 mm/year and PV growth of 2.0 mm/year. Conclusions: Radiofrequency perforation is an excellent primary therapy for PAIVS. In our experience, this procedure is technically feasible, safe and with appropriate patient selection typically results in a biventricular circulation. The rate of BTS placement remains high and given the lack of need for further surgery in most children, prolonged prostaglandin therapy may be considered to avoid the need for surgical intervention in this population.

Mehul Patel, Henri Justino, Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA
Background: Implantation of small diameter stents in young children and/or jailing of side branches pose significant challenges to future interventions. With the widespread use of stents in small children there is now a growing need to manage this unique dilemma. Aim: With the advent of new high-pressure balloons, we sought to assess the capacity to induce longitudinal fractures in undersized stents to achieve a larger vessel diameter, and side cell fractures to enlarge stenotic jailed branches. Methods: Retrospective review of patients (pts) undergoing attempted intentional stent fractures from January 2006 to August 2012 at a single institution. Results: Thirteen patients (11 males), aged 12.1 6 12.6 years, weighed 40.1 6 33.9 kg at the time of attempted intentional stent fracture. All but one stent fracture attempts were performed by a single operator. The mean age at the time of first stent implantation was 8.2 6 10.6 years. The primary sites for stent implantation included pulmonary veins (n = 2), SVC/innominate veins (2), branch pulmonary arteries (3), coarctation (1), IVC/iliac veins (2), and RV-PA conduit (1). Types of stents were Genesis XD (n = 2), Mega LD (1), Palmaz 4 series (2), Palmaz 8 series (3), and ‘‘coronary’’ type (5; 2 drug-eluting). Initial stent diameters were 4–13 mm. Two patients had two overlapping stents and one had three overlapping stents at the stented segment to be fractured. Using noncompliant balloons such as Dorado (n = 5), Atlas (5), Conquest (2), and Bluemax (1), longitudinal fracture was achieved in five and side cell expansion with strut fracture in seven; one had unsuccessful longitudinal stent fracture. The balloon diameter ranged from 4 to 14 mm and the inflation pressures ranged from 14 to >30 atm (beyond upper limit of inflation device). One patient had balloon rupture during the procedure with no consequence. One side cell fracture allowed the implantation of a second stent through the newly created orifice. There were no procedural complications. The mean follow-up period was 1.63 6 1.34 years, with no clinical evidence of aneurysms or dissections. Conclusions: Intentional stent fractures can be induced safely using high-pressure balloons both longitudinally to expand undersized stents or through side cells to expand stenotic jailed branches.

Surendranath R. Veeram Reddy, Tre Welch, Jian Wang, James Richardson, Joseph M. Forbess, Alan W. Nugent, University of Texas Southwestern Medical Center, Dallas, TX, USA
Background: We have reported initial results of small diameter double opposing helical (DH) PLLA biodegradable stents (BDS). There are no large diameter BDS available. Objective: Evaluate 4, 5, and 6-mm diameter low molecular weight (LMW) and medium MW (MMW) DH BDS (degradation time 9–12 months and > 24 months, respectively). Assess deliverability, vessel patency, and inflammation after 9 months and also safety by intentional embolization of stent segments and jailing of side branches. Methods: Seven New Zealand white rabbits (3.4 kg) underwent implantation of LMW (n = 7), MMW (n = 3), and metal stent (n = 7) in the descending aorta (DAO). Angiography, IVUS, and histopathology were performed after 9 months. Five BDS were left jailing major abdominal aorta branches. BDS segments were embolized into DAO in two rabbits. Results: All stent implantations were achieved via a 6 Fr sheath. There was one death due to aortic dissection with access and the other six survived to 9 months. None had evidence of GI tract, lower limb, or renal ischemia. Angiography showed unobstructed blood flow with no difference between BDS and metal stents. IVUS demonstrates good stent apposition to the DAO wall with minimal luminal loss. All BDS had minimal neointimal hyperplasia on histopathology. There were no adverse events due to embolized fragments or diminished flow to jailed side branches in all stents. Both BDS (1 LMW) and metal stents (3) migrated distally in the normally compliant aorta. Conclusions: Up to 6 mm diameter BDS can be delivered via a 6 Fr sheath with minimal vessel inflammation. Design alterations may prevent stent migration. Further studies are necessary with larger BDS diameters including assessment of vessel growth and vasoreactivity after complete biodegradation.

Osamah Aldoss, Thomas Fagan, Jeffrey Darst, Uyen Truong, Brian Fonseca, Childrens Hospital Colorado, Aurora, CO, USA
Background: Use of 3-Dimentional Rotational Angiography (3DRA) in pediatric cardiac catheterization is rapidly increasing in frequency; however, data related to its diagnostic potential are limited. We evaluated the diagnostic utility of using the three modalities of 3DRA [rotational angiography (RA), multi-planer reformation (MPR), and 3-dimentional reconstruction (3DR)] in pediatric cardiac catheterization. Methods: Retrospective review of 3DRA images was conducted with grading of the three modalities as inferior (gr 1), similar (gr 2), or superior (gr 3) to the diagnostic quality of fixed plane angiography. Results: One hundred fifteen 3DRA studies were performed on 87 patients between August 2010 and March 2012. The 3DRA studies were classified by anatomy of interest: pulmonary arteries (PA), aorta (AO), cavo-pulmonary anastomosis (CPA), and others (pulmonary veins, coronaries, balloon occlusion PA shunts).Most common reason for gr 1 was limited opacification and surgical clips artifact. Conclusions: In pediatric cardiac catheterization, 3DRA imaging was of diagnostic quality and frequently provided additional clinically relevant data when compared to fixed plane angiography.

Kiran Mallula, Nadeen Faza, Damien Kenny, Qi-ling Cao, Ziyad Hijazi, Rush University Medical Center, Chicago, IL, USA
Objective: Procedural success with transcatheter ventricular septal defect (VSD) closure is well reported. However, longer-term outcome data are limited. The aim of this study was to describe longerterm outcomes of transcatheter closure of congenital VSDs over 10 years. Methods: Retrospective chart review of all patients undergoing transcatheter VSD closure was performed after IRB approval. Results: A total of 72 procedures (muscular defects n = 40, perimembranous defects n = 19, and residual postoperative defects n = 13) were performed in 62 patients (25 males). Median age at closure was 5.5 (range 0.07–78) years. Median size of the defect irrespective of location was 5.8 mm (range 3.5–12 mm). Devices deployed included Amplatzer muscular VSD occluders (n = 81), Amplatzer membranous VSD occluders (n = 7), Amplatzer duct occluders (n = 9), flipper coils (n = 8), and Amplatzer cribriform device (n = 1). Median procedure time was 119 min (range 44–351 min). There were 12 (16.6%) procedural complications with one patient requiring surgical extraction secondary to embolization. One other patient had device embolization that was retrieved successfully. Median follow-up period was 1.6 years (0.5–8.8 years). All patients had a minimum follow-up of 6 months. There was no mortality. There was complete closure of defects in 58/ 62 patients (93.5%) at last follow-up. These shunts were not clinically significant. None of the patients developed sustained complete heart block or significant arrhythmia. None of the cohort developed endocarditis. Conclusions: Percutaneous closure of congenital VSDs is safe and effective and is associated with minimal complications. Longer-term follow-up suggests excellent clinical outcomes with no late complications seen.

Abdelbasit Mohammed Ahmed Elbashier, Mazeni Alwi, Geetha Kandavello, Hasri Samion, Ziyad Hijazi, 1 Institut Jantung Negara (National Heart Institute), Kuala Lumpur, Malaysia, 2 Rush University Medical Center, Chicago, MI, USA
Objective: To evaluate the feasibility, safety, and efficacy of the new Occlutech duct occluder for closure of patent ductus arteriosus (PDA). Background: The device is a self-shaping device made of Nitinol wires, consisting of a retention disc and shank joined by a tether theoretically to allow articulation between the two. Polyethylene terephthalate (PET) patches are integrated ductally in the shank to assure a better obturation of the duct defect. Two subsequent design changes were made, the final being the removal of the tether to ensure correct position of the shank in the PDA. Methods: A prospective non-randomized pilot study conducted from November 2011 to September 2012. Patients weighing less than 6 kg or those with associated cardiac anomalies that required cardiac surgery were excluded. Large PDA was defined as narrowest PDA diameter size 3.5 mm associated with symptomatic heart failure. All PDA were closed following the standard method technique. All devices were delivered via 5/6 Fr sheath. All patients were followed up by transthoracic echocardiography for 24 hr, 1 month (earlier if indicated), 3 month, 6 month, and 12 month after implantation. Results: Twenty-six patients with type A PDA (16 females, 10 males), with a median age of 23 months (6 months–36 years) and median weight 9.2 kg (6–56 kg) were included .The median PDA narrowest diameter was 2.7 mm (1.8–4.6 mm). Of included patients six patients had large PDA as defined. Mean fluoroscopy time was 9.2 min. All patients with large PDA had significant residual shunt immediately postimplantation. Two patients (PDA size 4.4 mm and 3 mm) needed removal of the earlier device design due to malposition following release and AGA occluder was implanted. With current design, five patients with large PDA showed significant residual shunt through the device despite correct position, which became insignificant within 1 to 2 weeks. Complications: There was no device embolization, hemolysis, obstruction to left pulmonary artery or descending aorta in all cases. One patient developed insignificant tricuspid regurgitation during retrieval of a released device. Conclusion: Occlutech ductal occluder is safe, feasible, and effective. However patients with large PDA tended to have delayed complete closure.

Aimee Liou,1 Linda Drake,2 Henri Justino,1 1 Baylor College of Medicine, Houston, TX, USA, 2 Texas Children’s Hospital, Houston, TX, USA
Background: Percutaneous balloon angioplasty (BA) 6 stenting is an accepted therapy for relieving obstruction in right ventricle (RV) to pulmonary artery (PA) conduits. Historically, balloon size for BA 6 stenting of homograft conduits was limited to the native diameter of the conduit due to risk of conduit rupture. Aim: To report our experience with BA 6 stenting of homograft RVPA conduits beyond their native diameter to (1) treat RV hypertension, (2) prolong conduit lifespan, and (3) to prepare for percutaneous pulmonary valve placement. Methods: Retrospective single center review of patients (pts) with RVPA homograft conduits who underwent catheterization for conduit stenting or re-dilation of a stented conduit from 2001 to 2012. Results: Forty-seven pts underwent 64 caths: In 17/47 pts (36%), a balloon smaller than the native diameter of the conduit was used. In 5 pts (11%), the maximum balloon size chosen to dilate the conduit or implant the stent was the same size as the native diameter of the conduit. In 25 pts (53%), the maximum balloon size chosen for conduit stent implantation or re-dilation exceeded the native diameter of the conduit (maximal balloon:native conduit ratio of 105–160%). After conduit recoil, final stent:native conduit diameter ratio was 79–153%. There were no cases of conduit rupture or leak. In 10 cases (16%), a percutaneous pulmonary valve (Melody) was implanted after conduit dilation, with two having a conduit whose native diameter was <16 mm. Conclusions: RV-PA homograft conduits, particularly if non-calcified or minimally calcified, can safely be dilated to sizes significantly greater than their native diameter. This has important implications: (1) Stents implanted in minimally calcified conduits should be selected such that the stent itself is not a limitation to expandability of the conduit (when appropriate, stents reaching >18 mm diameter should be used); (2). Small conduits (<16 mm rated diameter) may still be amenable to stenting and/or Melody valve placement, prolonging the conduit lifespan to a greater extent than was previously thought possible.

Joseph Casadonte, Danyal Khan, Miami Children’s Hospital, Miami, FL, USA
Background: Aortopulmonary collaterals (APC) are commonly found in patients with cyanotic heart disease. The APC compete with the normal pulmonary blood flow, in patients, who have undergone Glenn or Fontan surgery. APCs are also seen in patients with cystic fibrosis (CF), where they are known to cause hemoptysis. Transcatheter occlusion of APC has previously been described using coils, vascular plugs, and poly vinyl alcohol (PVA) particles. We present a series of patients in which the APCs were embolized using Trufill n-butyl cyanoacrylate (n-BCA) liquid. Methods: From 2009 to 2012, a total of 17 catheterization procedures were performed (in 16 patients), in which APC were embolized using nBCA. The mean age is 8.5 years (4 months–21 years) with a mean weight of 29 kg (7–72 kg). Three patients had CF and had presented with hemoptysis. The rest of the patients had cyanotic congenital heart disease and had undergone Bidirectional Glenn or Fontan procedures. One of the congenital heart disease patients had two cath procedures (2.5 years apart) for hemoptysis. Results: The procedure of n-BCA embolization of APC was technically successful in all patients. Three patients with cystic fibrosis who presented with hemoptysis had symptomatic improvement and have not needed repeat catheterization. One patient with cyanotic congenital heart disease, who presented with hemoptysis, had acute improvement. However 2.5 years later, she had recurrent hemoptysis and required more APCs to be embolized. The only complication attributable to n-BCA use also occurred in this patient. Following occlusion of APC arising from the left lateral thoracic artery, she developed erythema of the overlying skin followed few days later by the formation of a small ulcer (presumably due to ischemia of soft tissue/skin). The ulcer resolved without any specific treatment. There were no other major n-BCA related complications such as cerebro vascular accident, pulmonary embolism, or instances of catheters getting ‘‘glued’’ to vessel wall. Conclusion: n-BCA is a liquid embolic agent that is FDA approved for embolization of cerebral arteriovenous malformations. PVA particles, that were previously used for cerebral AVMs have a high recanalization rate and have therefore been replaced by Trufill n-BCA or Onyx liquid embolic system for embolization of cerebral AVMs. APC have been embolized previously using coils, vascular plugs, and PVA particles—all of which are associated with a varying incidence of recanalization. We felt that n-BCA would provide a more permanent form of APC occlusion with decreased incidence of recanalization. However, caution should be exercised especially while embolizing arteries/APCs that might have branches extending to the subcutaneous tissue. Since n-BCA might be less forgiving as compared to other methods of vessel occlusion.

Yat-Yin Lam,1 Bryan P. Yan,1 Shephal K. Doshi,2 Jai-Wun Park,3 1 SH Ho Cardiovascular and Stroke Centre, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, 2 Saint John’s Heart Center, Santa Monica, CA, USA, 3 Asklepios Klinik Harburg, Hamburg, Germany
Background: Transcatheter left atrial appendage (LAA) occlusion was proven non-inferior to warfarin in preventing stroke in patients with non-valvular atrial fibrillation (NVAF). Aim: The study evaluated the safety and feasibility of a novel LAA occluder (LAmbreTM, Lifetech Scientific Corp., Shenzhen, China) for stroke prevention in a canine model. Device Description: LAmbre is a nitinol-based, self-expanding device comprising a hook-embedded umbrella and a cover which secure the device to the LAA wall and seal the LAA opening, respectively (Figure 1). The umbrella is specially designed to allow full recapture and repositioning and a 8–10 Fr sheath is required for delivery of a 16–36 mm device. The umbrella and the cover are both sewn with PET membrane for optimal sealing of LAA after placement. Methods: Twenty-four canines (23 6 3 kg) received LAmbre implants via fluoroscopic-guided transseptal puncture from June 2011 to August 2012 under general anesthesia. All dogs received 1-week antibiotics and 4-week aspirin (80 mg daily) after implants and they were sacrificed in groups at day 1–3 (n = 5), 1- (n = 8), 3- (n = 5), and 6-months (n = 6) for gross and microscopic examinations. Transthoracic echocardiography was performed immediately after implant, at day 3 and before sacrifice. Results: The device was successfully implanted in all canines and found to be fully retrievable and repositionable. The mean implant size was 24 6 3 mm and an average 36 6 7% of device oversizing with reference to the measured landing zone diameter was required. One dog died on day 3 after device embolization as a result of improper device selection (only 21% oversizing). Postimplant angiography and TTE showed wellpositioned device without pericardial effusionor impingement on surrounding structures. Complications detected during follow-ups included small device-related thrombus (n = 1) and clinically insignificant pericardial effusion at 1-month (n = 1). Complete healing on the atrial facing surface with continued obliteration of LAA opening were confirmed by gross and microscopic examinations in dogs that been followed up 3months (n = 11). No infarct was detected in major organs. Conclusions: Our preliminary data suggested LAA closure with LAmbredevice is safe, feasible with high implant success rate in canines. Human trials are needed.

Amanda Nedved,1 Steve Kaine,1 Karina Carlson,1 Michael Bingler,1 1 Children’s Mercy Hospital and Clinics, Kansas City, MO, USA, 2 University of Missouri-Kansas City, Kansas City, MO, USA
Introduction: Atrial septal defects (ASD) account for approximately 10% of all congenital heart defects. Transcatheter device closure has become a widely acceptable alternative to surgical closure. Atrioventricular (AV) node conduction disturbances including complete heart block are among the rare complications associated with this procedure. We describe the first known case of prolonged heart block associated with implantation of the GORE1 HELEX1 septal occluder. Case Description: An asymptomatic 6-year-old boy with Trisomy 21 and a moderate sized (10 mm) centrally located ASD was referred for device closure. His baseline EKG showed sinus rhythm and a typical rsR’ pattern in lead V1. Immediately upon deployment of the right atrial loops of a 25 mm device, he developed complete AV block lasting several minutes. He had a stable escape rhythm and after several minutes reverted to high-grade second-degree AV block. The decision was made to release the device and monitor for return of sinus rhythm. He was observed in the hospital and received high-dose steroid therapy. He remained in high-degree AV block but with intermittent periods of sinus capture. He was discharged home 5 days postprocedure on a steroid taper. At the 6-week follow-up, a 24-hr Holter showed sinus rhythm with sinus arrhythmia and no AV block or dropped beats. At the 6-month follow-up, the patient continued to have had an AV sequential rhythm with questionable wandering atrial pacemaker, but no AV block. Discussion: We report the first known case of prolonged heart block following placement of the HELEX1 septal occluder. We review the literature of previously reported heart block following ASD device closure including possible risk factors. We suggest a framework for making treatment recommendations based on proposed physiologic mechanisms and on the onset and severity of device related AV block.

Neeraj Awasthy, S. Radhakrishnan, Savitri Sheivastava, Fortis Escorts Heart Institute, Delhi, India
Introduction: This is a retrospective study comprising of 13 patients with isolated rupture of the sinus of Valsalva (RSOV) who underwent transcatheter device closure. Results: The mean age of presentation was 39 6 10.0 years. New York Heart Association (NYHA) class at the time of presentation was II (six patients) and III (six patients), class IV (one patient). The RSOVs were all closed using a patent ductus arteriosus device. The mean procedural time was 30 6 5.4 min, while the fluoroscopic time was 20 6 7 min. The average hospital stay was 2 6 1.1 days. Successful immediate closure was achieved in all except one. There was one hospital mortality. The patients were followed up for a mean of 3 years (ranging from 1 month to 5 years). All had complete closure of the shunt in follow-up. During the learning curve, we modified the technique making subtle changes such as use of buddy wire, kissing technique for right ventricular outflow tract opening, and use of braded sheaths in all cases. At the time of the last follow-up all the patients were in NYHA class I. Conclusion: We conclude that in the short-term, transcatheter closure of isolated RSOV is a viable alternative to surgical repair though long-term data are required particularly in a procedure which has been traditionally subjected to surgical therapy. Very large RSOV in patients presenting with congestive cardiac failure or shock as in one of our patients may not be subjected for this technique.

Neeraj Awasthy, S. Radhakrishnan, Savitri Shrivastava, Fortis Escorts Heart Institute, Delhi, India
Device closure is now accepted modality of treatment for cardiac septal defects. We are reporting the efficacy of closure of nonseptal defects with devices conventionally used for septal cardiac defects. Study design: Retrospective study. Material and Methods: Forty-seven patients, age group 2–67 years. They were divided into two groups; group 1: with no available customized device, group 2: for which customized devices are available but alternate devices have been used. These included 38 in group 1: ruptured sinus of Valsalva (duct occluder n = 11), coronary arteriovenous (CAV) fistula (duct occluder; n = 5), closure of mitral paravalvular leak (n = 4; duct occlude devices = 3,VSD device: n = 1) and aortic paravalvular leak (n = 2 duct occluder, n = 2, vascular plug = 2), closure of AP window (duct occluder, n = 3), Fontan fenestration closure (asd septal occluder, patent foramen ovale device, vascular plug n = 3, 1 each). pulmonary AV fistula (duct occluder; n = 2), systemic AV fistula(vascular plug; n = 1), closure of ascending aorta perforation (septal occluder, n = 1), occlusion of subclavian artery (vascular plug; n = 1), splenic artery (duct occluder; n = 1), Blalock Taussig shunt (duct occluder, n = 1). In group 2: there were 9 patients, VSD closure by ADO II device (n = 6), PDA closure by muscular VSD device (n = 2), and ASD device (n = 1). Results: Residual shunt was detected in two patients each of coronary AV fistula and mitral paravalvular leak .No shunt detected in ruptured sinus of Valsalva, fenestrated Fontan, and ascending aorta perforation. Complications: Local site hematoma was observed in four patients. Hematuria was observed in four patients. It subsided with conservative management. There was one mortality observed in table during the attempted closure of a very large RSOV with gross congestive heart failure. On follow-up ranging from 2 months to 6 years, all the patients are asymptomatic. There was no late complication related to device in any patient. Conclusion: It is feasible in selected lesions, which traditionally have been subjected to surgical interventions, to treat successfully, non-surgically with the use of non-prototype occluder devices without significant complications.

Bryan Goldstein,1 Russel Hirsch,1 Matthew Zussman,1 Julie Vincent,2 Alejandro Torres,2 John Coulson,3 Richard Ringel,3 Robert Beekman,1 1 Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA, 2 Morgan Stanley Children’s Hospital, New York, NY, USA 3 Johns Hopkins Hospital, Baltimore, Maryland
Objectives: To describe the use of balloon-expandable covered endovascular stents for percutaneous treatment of traumatic aortic injury (TAI) in children and adolescents. Background: Surgical treatment of pediatric acute TAI following blunt chest trauma is standard of care. The use of endovascular stent grafts for treatment of TAI in adults is common, but has important limitations in children. Methods: Participants of the multicenter Coarctation Of the Aorta Stent Trial (COAST) had access to an investigational large-diameter, balloonexpandable, covered stent (covered Cheatham-platinum stent, NuMED, Hopkinton NY) on an emergency-use basis. Between 2008 and 2011, six covered stents were implanted in four patients at three COAST centers for treatment of TAI. Records were reviewed and relevant data extracted. Results: Median patient age was 13.5 years (range 11–14) and weight was 58 kg (40–130). All patients sustained severe extra-cardiac injuries that were felt to preclude safe open surgical repair of TAI. Median aortic isthmus and stent implantation balloon diameters were 16.4 mm (13.2–19) and 19 mm (16–20), respectively. Stent implantation was technically successful in all attempts. Complete exclusion of the aortic wall injury was achieved in all cases. There were no access site complications. At a median follow-up of 24 months, there was one early death (related to underlying head trauma), and one patient with recurrent aortic aneurysm who required additional stent implantation. Conclusions: Balloon-expandable covered stent implantation for treatment of pediatric TAI following blunt trauma is generally safe and effective. Availability of this equipment may alter the standard approach to treatment of pediatric TAI.

Gretel Monreal,1 Luciana Martins,2 Katharine Belfrage,2 Loren Wold,2 John Kovalchin,2 Mark Gerhardt,1 1 Wexner Medical Center at The Ohio State University, Columbus, OH, USA, 2 Nationwide Children’s Hospital, Columbus, OH, USA
Background: Ventricular septal defect (VSD) in asymptomatic children is often unrepaired. Emphasis is predominantly placed on repair outcomes; however there is a paucity of literature assessing patients with unrepaired VSD. We previously demonstrated the presence of RV diastolic dysfunction despite the absence of overt hemodynamic abnormalities in a porcine model of VSD. In the present study, we test the hypothesis that children with unrepaired VSD have underlying abnormal RV diastolic function despite normal systolic function. Methods and Results: We retrospectively queried our institutional echocardiography database for children 3 months to 18 years old with unrepaired isolated restrictive VSD. Measurements included LV and RV systolic and diastolic function, and Doppler tissue imaging. Data from 106 control and 121 VSD patients (52% muscular, 48% perimembranous) were studied. VSD jet velocity and gradient measured 4.0 6 0.07 m/sec and 68.6 6 2.3 mm Hg. LV systolic function in VSD patients was identical to controls; however, children with unrepaired VSD demonstrated alterations in cardiac structure (increased LA diameter, LV dimensions, and LV wall thickness) and RV diastolic function (reduced tricuspid E/A ratio and prolonged RV relaxation time). A subgroup of VSD patients (6.6%) with definitive criteria for RV diastolic dysfunction had reduced LV fractional shortening and LV medial S0 compared to the rest of the VSD patients (34.7% 6 1.0 vs. 39.1% 6 0.5 and 0.07 m/sec 6 0.005 vs. 0.08 m/sec 6 0.001, respectively). Conclusions: Most children with unrepaired VSD have normal LV and RV systolic function; nevertheless, a subgroup has echocardiographic evidence of RV diastolic dysfunction, potentially as a response to persistent shunting. Children with unrepaired VSD may represent a population at risk for RV diastolic dysfunction with some requiring eventual intervention. The long-term implications of these findings are uncertain, emphasizing the need for further studies to understand the natural history of RV function in patients with unrepaired VSD.

Osman Baspinar,1 Metin Kilinc,1 Ahmet Irdem,1 Derya Aydin Sahin,1 Zatigul Safak Taviloglu,2 Ercan Sivasli,2 1 Department of Pediatric Cardiology, Gaziantep University Medical Faculty, Gaziantep, Turkey, 2 Department of Newborn Intensive Care Unit, Gaziantep University Medical Faculty, Gaziantep, Turkey
Aim: The aim of this study was to evaluate our institutional experience of transcatheter closure of PDA in the seriously ill premature babies. Currently, available technology is not designed for these age groups. Transcatheter occlusion of PDA at the preterm babies challenges the interventionist. Methods: Eight seriously ill premature children underwent PDA closure with different devices. The approach was venous in all patients. The Amplatzer duct occluder (ADO) type II, Cook detachable coil, and ADO type II additional sizes were used. Arterial access and catheter manipulation within the cardiac chambers were avoided whenever feasible. The patients had many co-morbid problems; respiratory distress syndrome in all, necrotizan enterocolitis in six patients; intravascular coagulation in three; and pulmonary hemorrhage in 1 patient. All patients were receiving mechanical ventilation before intervention. Results: Gestational age ranged from 27 to 31 weeks. The mean birth weight was 1,067 6 232 (range 900–1,550) g, and the mean weight at the time of procedure was 1,862 6 534 (range 1,190–2,820) g. The mean age was 41 (range 17–90) days. The median PDA diameter was 2.3 (range 1–3.5) mm. Four-French venous sheaths were used. All implantations were technically successful. Echocardiography confirmed no residual shunts on the following day. During manipulation, cardiac perforation occurred in one patient and the patient died. Another patient died six days later after procedure because of co-morbid problems. PDAs were completely occluded without significant obstruction of the pulmonary arteries or aorta. Additional sizes were used six times; the others were used one time. Conclusions: In these special age groups, delicate catheter and guidewire manipulation is needed. Especially, the lower profile and symmetry of ADO additional sizes give the opportunity to close premature PDAs. Transcatheter technique is possible in the seriously ill preterm infants. And it is a safe alternative to surgical ligation especially in the severe ill patients.

Luiz A. Christiani, Alan E. Silva, Denoel M. Oliveira, Baby Cor Cardiologia Ped e Fetal, RJ/ Rio de Janeiro, Brazil
Substrate: Bidirectional Glenn used as surgical staged palliation for complex congenital heart disease has often defended the thesis that additional sources of pulmonary flow, especially the pulsed anterograde may be valuable in the long-term evolution, although difficult, their quantification, in many cases, the extra flow becomes excessive, and need to be occluded. Methods: The patient is male syndromic (Down), 2 years 5 months, 8.3 kg, total atrioventricular septal defect unbalanced with hypoplastic right ventricle and atrioventricular regurgitation, is being treated by surgery at 9 months; palstia of valves AV, pulmonary banding surgery, and bidirectional Glenn evolving with congestion and superior vena cava syndrome and important colateral circulation to inferior vena cava hospitalization by pleural effusion, irritability, and saturation around 84%, underwent cardiac catheterization under general anesthesia, by femoral vein reached pulmonar artery. Temporary occlusion with Berman catheter for 30 min for review, after this period occlusion with Amplatzer muscular VSD number ‘‘6’’. Result: After procedure, the saturation was stable at around 78%, extubated in the catheterization laboratory without the need for drugs and discharged without medication with significant clinical improvement, disappearance of syndrome theft of flow-VCS > VCI, reduction in irritability and improves the quality of life. Conclusion: Percutaneous occlusion of antegrade flow in pulmonary circulations, in patients with bidirectional Glenn or Fontan Type, may be necessary in the evolution of some patients. Literature reports with occlusion by other prostheses. The procedure is feasible, safe, and efficient and can add significant improvement in quality of life and longterm evolution.

Tharak Yarrabolu, P. Syamasudar, University of Texas, Houston, TX, USA
Background: The purposes of this study is to document the results of Amplatzer duct occluder (ADO) closures of patent ductus arteriosus (PDA) in a large number of patients with particular emphasis on longterm follow-up in an attempt to provide evidence for feasibility, safety, and effectiveness of this method of PDA closure. Immediate and shortterm results of ADO occlusion of PDA have been documented in a limited number of children. Methods: During a seven-year period ending in December 2009, 103 patients with PDA were taken to cath lab with intent to occlude the PDA. In three patients, no attempt was made to occlude the PDA either because of severe pulmonary hypertension (N = 2) or very large size (N = 1). Transcatheter ADO closure of PDA was attempted in 100 patients, aged 0.36–35.6 years (median, 1.8); in 99 (99%) the ADO was successfully deployed and in 1 the device was unstable and was uneventfully withdrawn. The follow-up data review protocol is approved by IRB. Results: The PDA measured 1–6.73 mm (median 2.67) at the narrowest diameter; they were occluded with devices measuring from 6/4 to 12/10 mm, delivered via 5 Fr to 7 Fr sheaths. The Qp:Qs decreased from 1.95 6 0.95 to 1. Effectiveness of the occlusion, defined as no or trivial residual shunt, on the morning following implantation was achieved in 97.9% (97 of 99) of patients. All types of PDAs (Krichenko) irrespective of shape, size, and length could be occluded with ADO. Follow-up data, 1–60 months after implantation, were available in all patients; none had residual shunt. No evidence for left pulmonary artery or descending aortic obstruction was seen on echo-Doppler studies. None of the patients required re-intervention. Conclusions: This large, single-institution experience with long-term follow-up confirms the feasibility, safety, and effectiveness of Amplatzer device closure of the PDA. All types of PDAs irrespective of shape, length, and diameter can be effectively occluded.

James Hill, Kenneth Saliba, Tamar Preminger, Cleveland Clinic, Cleveland, OH, USA
Patent foramen ovale (PFO) is a known risk factor for paradoxical embolus, especially in the presence of other risk factors such as hypercoagulable states or central lines. A PFO is a common incidental finding in infants and children. However, paradoxical emboli are not common in infants, and so PFO closure is rarely indicated in this age group. We present two cases of PFO closures in identical 8 kg twin boys with Hurler’s syndrome who had central lines for planned bone marrow transplants, with embolic stroke in one. We discuss the treatment options as well as the special challenges based on the patients’ age, size, and diagnoses. We discuss the technical aspects and safety of percutaneous PFO or atrial septal defect (ASD) closure in this patient population, as these are the smallest patients described in the literature who have undergone PFO or ASD closure with the Helex Septal Occluder.

Heike Schneider, Jana Dieks, Michael Steinmetz, Thomas Paul, GeorgAugust-University Goettingen, Goettingen, Germany
Scimitar syndrome is a rare congenital heart defect with partial anomalous pulmonary venous return (PAPVR) of right pulmonary vein(s) to the inferior caval vein. The syndrome is commonly associated with hypoplasia of the right lung and right pulmonary artery, pulmonary sequestration, and dextroposition of the heart. Treatment of the PAPVR usually requires a surgical approach. We present a 28-year-old woman suffering from dyspnea, who was diagnosed with PAPVR at the age of 17 years after a typical curvilinear pattern—the so called Scimitar sign—was detected on chest X-ray. Anatomical characteristics were further evaluated using echocardiography and MRI studies. The Scimitar vein was slightly stenotic proximal to its drainage into the inferior vena cava. Furthermore, all three right-sided pulmonary veins were connected via the Scimitar vein and drained not only into the inferior caval vein but also into the left atrium. Cardiac catheterization confirmed the diagnosis and showed a significant left-to-right shunt and mild pulmonary hypertension. Balloon test occlusion of the inferior portion of the Scimitar vein documented unobstructed drainage of all right pulmonary veins into the left atrium, thus, interventional closure was a treatment option. The patient underwent occlusion of the inferior portion of the Scimitar vein with an Amplatzer Vascular Plug II without obstructing the right lower pulmonary vein or a hepatic vein. At 4 months follow-up, the patient was asymptomatic and clinically well and the device was in good position without residual flow.

Jacek Bialkowski, Malgorzata Szkutnik, Mediacla University of Silesia, SCCS, Zabrze, Poland
Background: Stenting in coarctation of the aorta (CoA) has emerged as an alternative to surgery with good intermediate result. Recently, new bare metal stent made of a cobalt-chromium alloy (Co-Cr) (namely Andrastents XL/XXL, Andramed GmbH) was introduced to clinical practice. The stents has a hybrid cell design and therefore has a strong radial force, high flexibility, and good radio-opacity and it should be advantageous in implantation in CoA. Objective: To evaluate the use of Andrastents in the management of CoA at a single tertiary care center with immediate result and midterm follow-up. Methods: Andrastents were implanted for a 30 months period in 30 patients: 26 with native CoA and 4 with recurrent after previous surgery (ReCoA). The stents were manually mounted on high pressure balloons and delivered through 10–14 Fr Mullins sheaths using a conventional femoral approach. Results: Mean patient age was 28.3 6 15.6 (ranged from 9 to 65) years. The systolic gradient across the native CoA decreased from a mean 48.3 6 20.2 before to 11.9 6 10.2 mm Hg after the procedure and in case of ReCoA from 37.8 6 20.7 before to a mean 9.7 6 12.4 mm Hg after the procedure. No aneurysm formation, stent migration, or rupture of the aorta were observed in any patient during the procedure. The mean fluoroscopy time was 6.1 6 2.3 min. Procedural outcome remained favorable during mean follow-up 1.1 6 0.8 without stent fracture. Planned redilatation of implanted stent was performed between 4 and 14 months in six patients. In one man with secondary LV failure, EF 15% (49 years old), the procedure was performed urgently during cardiogenic shock with good clinical result. Conclusions: Implantation of Andrastents XL/XXL are very good therapeutical option for the treatment of native and recurrent CoA.

Mateusz Knop, Malgorzata Szkutnik, Jacek Bialkowski, Medical University of Silesia, SCCS, Zabrze, Poland
Background: The use of Amplatzer devices (A) for percutaneous patent foramen ovale (PFO) closure is common clinical practice. Recently, new device very similar to A namely Cardio-O-Fix (COF) were introduced as new armamentarium. This occluder is cheaper than Amplatzer, but it is lack of published data comparing results of applications of both devices. The aim of the present study was to asses immediate and mid-term clinical outcome of patients with PFO after paradoxical embolism event (EE) who underwent transcatheter PFO closure with Amplatzer PFO occluder (group A) or Cardio-O-Fix PFO occluder (group COF). Methods: Overall, 63 consecutive patients underwent percutaneous closure of PFO—38 with A device and the results were compared to those in 25 patients treated with COF. Stroke or transient ischemic attack (TIA) was considered recurrent EE. Pre- and at least 6 month postintervention right to left shunting (RLS) were evaluated with intravenous contrast injection by transcranial Doppler examination of middle cerebral artery (TCT). Results: The procedure was successfully completed in all patients in both groups. No procedure related complications were observed during hospitalization. Large residual RLS was noted at 6 months in 8/38 patients (21%) in group A and 6/25 (24%) in group COF. In group A, 3/38 patients (7.9%) had postprocedural new neurological events: 1 patient TIA (double) and 2 new strokes. From this, patients in one TCD and TEE were positive, but new atherosclerotic changes in vertebral arteries developed. No recurrence of EE was recorded in COF group. Conclusion: Transcatheter closure of PFO with Amplatzer and Cardio-OFix occluders are clinically safe and effective. The latter device has similar outcome when compared to Amplatzer device in midterm follow-up. Still lack of randomized trials results in estimating the value of PFO transcatheter closure in prevention of cryptogenic neurological events.

Supratim Sen, Philip Roberts, Children’s Hospital at Westmead, Sydney, Australia
Background: Transcatheter device occlusion of PDA is a well-established and safe procedure with a high success rate. Previous reports describing pseudoaneurysms as complications with PDA devices have alluded to femoral artery pseudoaneurysms at the vascular access site. A literature review did not identify reports of acute dissection and pseudoaneurysm formation during transcatheter PDA occlusion. Case report: A 3.1 kg 74-day-old infant with a moderate ASD, PDA, and pulmonary valve stenosis was planned for transcatheter balloon pulmonary valvotomy (BPV) and PDA device closure. PV annulus measured 8 mm. An aortogram with a 4 Fr vessel sizing pigtail with the end cut off showed a long and tubular PDA with a slight constriction at the pulmonary end. BPV was performed with a 9 mm 3 cm Tyshak II balloon. A 4-4 ADO II AS device was deployed from the aortic side. The device was however freely mobile on stability testing and pushed through the duct into the MPA with easy retrieval of the fully deployed device back into the aorta. The delivery system and unreleased device were removed. Repeat angiography into the PDA with a cut pigtail catheter demonstrated dissection and pseudoaneurysm of the duct with two exit points into the MPA. Transthoracic echocardiography confirmed a tissue flap at the proximal pulmonary end of the duct and a pseudoaneurysm which prolapsed into the MPA. The infant was referred for surgical PDA ligation. Post ligation, there was no residual PDA with resolution of the pseudoaneurysm. Conclusions: The dissection could have occurred during BPV, during retrieval of the occlusion device or with positioning the cut vessel sizing pigtail during the second aortogram. We feel the injury most likely occurred with the cut pigtail catheter. This highlights the risks associated with the sharp edges of a cut catheter.

Francois Godart, Ali Houeijeh, Morgan Recher, Charles Francart, Congenital Heart Disease Department, Lille, France
The premere PFO (St. Jude Medical) closure system is a small occluder characterized by a dual-arm-anchor device with the right one covered by polyester patch. It is usually employed in PFO closure without a large aneurysm, multiple defects, or a wide tunnel. We report here a case report in which the delivery system could not be easily retrieved. From 2006, 90 patients underwent transcatheter closure of PFO with the Premere system mainly for recurrent stroke. The procedure is usually performed under local anesthesia with fluoroscopic guidance and endocardiac echocardiography using the Acunav ultrasound catheter (Siemens). Device implantation succeeded in all but one. The fluoroscopic time was 5.6 6 3.0 min. We did not experience any embolization. At the beginning of our experience, one patient had air embolism that resolved without any sequelae. Recently, after correct positioning of the two anchors in a 48-year-old man, the delivery system could not be retrieved from the delivery sheath. The tether could be cut by advancing the cutter. We realized then that the Acunav catheter has been entrapped by the lasso of the releasing mechanism. In fact by pulling back the Acunav catheter in the IVC, the lasso became free and the delivery system catheter could be taken out. The patient left the cath lab with a well placed device and no residual shunting on control echo. This drawback could be also explained by the fact that the lasso is poor radio-opaque. To our best knowledge, such complication has not been reported. Transcatheter closure of PFO using the premere PFO system is effective and safe. With the use of endocardiac echocardiographic catheter, this later may be caught by the lasso after release. To avoid this complication, special care should be dedicated to place the distal tip of the echocardiographic catheter far away from the lasso during release.

Yun-Ching Fu, Ming-Chih Lin, Sheng-Je Lin, Yeak-Wun Quek, HsuTing Cheng, Chi-Lin Ho, Tsung-Cheng Shyu, Sheng-Ling Jan, Taichung Veterans General Hospital, Taichung, Taiwan
Background: Perimembranous ventricular septal defect (PmVSD) is the most common congenital heart disease. The standard closure method is open heart surgery. So far, there is no US FDA approved device for closure. The defect usually has an ampulla-like aneurysm which resembles the patent ductus arteriosus. This study aimed to investigate the feasibility of the Amplatzer duct occluder to close the perimembranous VSD with aneurysm. Materials and methods: Between January 2010 and August 2012, 20 patients (9 males) with perimembranous VSD underwent the attempt of VSD closure using the Amplatzer duct occluder. The median age was 18.6 (2.1–53.5) years and the median weight was 48.5 (12–86) kg. Five patients also had pulmonary hypertension. Seven patients had aortic valve prolapse. Five patients had trivial aortic regurgitation. Symptoms included exercise intolerance in 10 patients, palpitation in 7, chest pain in 6, and failure to thrive in 3. The median VSD size was 4.0 (1.9–7.8) mm and the median Qp/Qs was 1.47 (1.23–2.67). Results: All devices were successfully implanted to close the VSDs. The median device size was 10/8 (5/4–12/10) mm. The median fluoroscopy time was 23.1 (12.8–49.7) min and the median procedure time was 81.5 (35–148) min. Complications included transient complete heart block in one patient and hemolysis in one. The complete closure rate was 90% (18/20) on the following and follow-up days. No change of aortic or tricuspid regurgitation was noted. Conclusions: Transcatheter closure of PmVSD with aneurysm using the Amplatzer duct occluder is technically feasible and safe in patients weighing more than 12 kg.

Juan Pablo Sandoval, Jose Antonio Garcia Montes, Carlos Zabal, National Institute of Cardiology IGNACIO Chavez, Mexico City, Mexico Background.
Patent ductus arteriosus (PDA) represents the leading isolated congenital heart defect in our country. Several methods and devices have been developed for transcatheter closure over the past two decades, although the Amplatzer ductal occluder (ADO, St. Jude Medical Plymouth, MN) is the only FDA approved device and is considered suitable for children older than 6 months of age with weight of 6 kg or more. Aim/Objective: We sought to analyze the effectiveness and outcome of percutaneous PDA closure in infants weighing 5 kg or less. Methods: We performed a retrospective analysis of children weighing 5 kg that underwent percutaneous PDA closure over the last 10 years (between 2001 and 2011) at the National Institute of Cardiology Mexico City. Patients with symptomatic PDA’s were included (e.g., failure to thrive and/or clinical evidence of heart failure). Results: A total of 36 patients (f = 25) were included for review. The mean age at catheterization was 7.3 months (range 2 weeks–21 months). Mean body weight was 4.3 kg (ranged 2.8–5). Mean angiographic PDA minimal diameter was 3.6 mm (range 1.2–7). Mean systolic pulmonary artery pressure (mSPAP) was 43 6 10.3 mm Hg and Qp/Qs was 3 6 1.4. An ADO was used in 33 patients and an Amplatzer Vascular Plug II (AVP II) was used in the other three. In one patient, a Nit-Occlud device was first selected for closure without optimal angiographic result, it was retrieved before deployment and a 5/4 ADO was placed successfully. In one patient, additional right pulmonary artery (RPA) angioplasty with stent implantation was performed before PDA closure due to a severe RPA proximal stenosis and in other two patients simultaneous aortic valvuloplasty was performed due to aortic stenosis. The procedure was considered successful in 35 cases (97%), a decrease in mSPAP to 33 6 6.3 mm Hg was seen after closure. In only one patient, an ADO was deployed originating significant aortic obstruction requiring surgical removal and PDA ligation. No other major or minor complications were encountered. Mean procedural time was 72 min (range 30–120) and mean fluoroscopy time was 11.2 6 7.8 min. Conclusions: Percutaneous PDA closure is effective in low-body weight infants and should be considered in this group of patients.

Joan Johnson, Juan Pablo Sandoval, Jose Antonio Garcia Montes, Carlos Zabal, National Institute of Cardiology, Mexico City, Mexico
Background: Secundum atrial septal defect (ASD) is one of the most common congenital heart defects. Left untreated ASD produces right heart volume overload with well-established complications such as worsening functional capacity, heart failure, atrial dysrhythmias, and pulmonary hypertension. Patent foramen oval (PFO) has been implicated in the pathogenesis of cryptogenic stroke (CS), transient ischemic attacks (TIA), and migraine. The Helex septal occluder (HSO) (W.L. Gore and Associates, Flagstaff, AZ) is a low profile, double disk occluder device composed of an expanded polytetrafluoroethylene membrane bonded to a single nitinol wire frame. The HSO became available in Mexico in 2010 and is approved by national health authorities for closure of both defects. Objective: To describe the initial experience in a single-center with the use of the HSO for percutaneous closure of congenital heart defects. Methods: We performed a retrospective analysis in patients that underwent percutaneous closure with the HSO at our institution between 2010 and 2012. Results: A total of 14 patients (female = 11) were included for review: 12 patients with secundum ASD, one patient with PFO with an aneurismatic interatrial septum and history of stroke, and one patient with univentricular Fontan repair that underwent elective transcatheter fenestration closure 2 years after surgery. Mean age was 11.4 6 9.9 years, mean weight was 35 6 18 kg. In ASD patients, mean diameter of the defect was 9.5 mm 6 2.8 mm measured by intracardiac echocardiography (ICE), mean pulmonary artery pressure (mPAP) was 15 6 3 mm Hg with Qp:Qs 1.8 6 0.6. Successful occlusion occurred in 13 cases (92%). Only one patient with ASD suffered device misplacement/embolization that required retrieval and an Amplatzer Septal Occluder (ASO) was used for closure. Occlusion was successful in the PFO and the Fontan fenestration. All patients were discharged on aspirin for the following six months. Mean follow-up was achieved in all patients at 6 months, all of them were asymptomatic in NYHA functional class I and transthoracic echocardiography revealed adequate device position in all patients with no residual shunt. Conclusions: The Helex septal occluder is safe and effective for small to medium-size secundum ASD and its use can be considered in additional interatrial defects with positive results.

Osman Baspinar,1 Mehmet Kervancioglu,1 Ahmet Irdem,1 Orhan Ozer,2 Derya Aydin Sahin,1 Metin Kilinc,1 1 Department of Pediatric Cardiology, Gaziantep University Medical Faculty, Gaziantep, Turkey, 2 Department of Adult Cardiology, Gaziantep University Medical Faculty, Gaziantep, Turkey
Objectives: We investigated safety, efficacy, and follow-up results of transcatheter closure of perimembranous and muscular VSDs at the experience of our center in Turkey. Methods: In the last three years, 61 patients (55.7% girls, 44.3% boys) underwent transcatheter closure of VSDs (43 with perimembranous, 18 with muscular). All patients had echocardiographic signs of left ventricle volume overload or minimal aortic regurgitation. Perimembraneous interventricular septum aneurysm was noted in 18 cases. VSD closure was performed with standard techniques. Amplatzer VSD device and ductal occluder (St. Jude Medical Inc.; Plymouth, MN) were used in all subjects. Results: The procedure was successful in 58 patients (95.1%). Median age was 9 (0.5–26) years, median weight 27 (5.4–75) kg. The median Qp/Qs ratio was 1.8 (1–3.8), and the median VSD size as assessed by angiography was 5 (2.3–15) mm. The median distance of the defect from the aortic valve was 4 (1.8–8) mm. Retrograde implantation of the device was deployed in two patients. Additional two secundum ASD and one PDA closure was performed at the same time. No deaths occurred. Total occlusion rate was 98.3% during the follow-up. Residual shunts were trivial. The median follow-up duration was 17.5 (1–39.5) months. One patient had severe pulmonary hypertension and multiple muscular VSD. In this patient, we only closed two big defects with two muscular devices, and we started antihypertensive therapy. There were three unsuccessful procedures. Reasons of them were tricuspid valve trapping in two patients; one of them was sent to the urgent surgical intervention and the other patient had two separated defects close to each other, and the process was cancelled, and the patient was sent to the surgery at the follow-up. A total of 25 early complications (41%) occurred. They were tricuspid valve trapping in two cases, aortic regurgitation in six cases (trivial and/or mild degree), and minor rhythm disturbances in 10 cases, complete heart block in five cases (one week later in one patient), and needle puncture related complications in two cases. Complete block was transient in all of them, transient pacemakers were implanted in three cases, and sinus rhythm was restored after steroid treatment. Implanted devices were muscular in 21 cases, membranous devices in 32, duct occluder type one in 1 case, type two in 4 cases. Conclusions: Transcatheter VSD closure can be performed safely and successfully. The major concern is the occurrence of complete block. Long-term investigation is needed to assess the efficacy and safety compared to surgery.

Michael R. Recto, Sandra Doyle, Vitor Guerra, Song Gui Yang, Thomas Yeh, Jr, Tulane University, New Orleans LA, USA
Background: Hybrid palliation for hypoplastic left heart syndrome (HLHS) is gaining acceptance as an alternative to the Norwood operation. Advantages include shorter recovery and comparable survival. Complications include development of restrictive atrial communication, arch obstruction, proximal and distal coarctation secondary to inadequate coverage of the patent ductus arteriosus (PDA) following ductal stenting. Purpose: To describe the three main types of ductal morphology encountered in patients undergoing PDA stent implantation as part of hybrid stage I palliation. Methods: The echocardiograms and angiograms of high risk patients (weight <2.5 kg, history of prematurity, restrictive atrial septum requiring atrial stent implantation, chromosomal abnormality) who underwent hybrid stage I palliation for HLHS between May 2005 and August 2012 were retrospectively reviewed. All angiograms pre- and post-stent implantation and angiograms performed prior to comprehensive stage II operation were reviewed. A prote´ge´ GPS self-expanding stent 1 mm larger than the diameter of the PDA was utilized in all cases except 1 patient with a long tortuous PDA with stenosis midway between the pulmonary and aortic ends who required a stent 2 mm larger than the region of stenosis. Results: Twelve patients were identified. Mean age 6.7 days (range 3– 15 days), mean weight 2.5 kg (range 1.7–3.6 kg). Three types of ductal morphology were identified: short and horizontal (ductal length <2 cm) (three patients), long and horizontal (length 2–3 cm) (eight patients), and tortuous (length 2.5 cm) (one patient). All patients underwent successful ductal stenting. One patient developed proximal coarctation secondary to inadequate coverage of the pulmonary end of the PDA underwent successful placement of a balloon expandable stent to relieve the stenosis 69 days after the initial procedure. The patient with the long, tortuous PDA with mid ductal stenosis who received an oversized selfexpanding stent remained widely patent until stage II. Mean follow-up time between initial PDA stent implantation procedure and comprehensive stage II of 7 months has shown no evidence of ductal stenosis regardless of ductal morphology. Conclusions: Midterm follow-up indicates that PDA stents remain widely patent regardless of ductal morphology until stage II. The one patient who developed proximal coarctation did not have the proximal PDA adequately covered at the time of the initial procedure.

Eustaquio Onorato,1 Bindo Missiroli,1 Carmelo Zimbalatti,1 Placido Grillo,1 Gaetano Morabito,1 1 Clinica Montevergine, Mercogliano (Av), Italy, 2 Humanitas Gavazzeni Clinic, Bergamo, Italy
Background: Patent foramen ovale (PFO) closure can be attained to a reasonably high degree of completeness. Moderate to large residual shunts (RS) after PFO closure poses a significant clinical dilemma firstly due to the fact that they can add a higher risk for recurrent neurological events regardless of antiplatelet or anticoagulant therapy and secondly in terms of therapeutical choices, as the surgical approach may be needed. The possible causes of RS are inappropriate device selection (undersized device or partial device malposition) or the association with septum primum multifenestration. Moreover, if a neurological recurrence occurs in patients deemed closed, it is mandatory to consider the presence of atrial fibrillation, device thrombosis, atherosclerotic progression of aortic plaques or a non-paradoxical source of embolic event. The management of RS after PFO closure has not been clearly established in clinical practice. In this report, we describe our experience with closing a RS by the implantation of a second occluder device. Methods and Results: A 53-year-old lady, aura migraineur, with previous transient ischemic attack (TIA) was found to have a PFO with a permanent significant right-to-left shunt documented by contrast transthoracic/transesophageal echocardiography (cTTE /cTEE) and by contrast-enhanced transcranial Doppler (ceTCD). PFO anatomy was complex due to the association with a huge atrial septal aneurysm (ASA). Minor thrombophylic disorder (MTHFR gene mutation) was detected and a sister has been diagnosed with Lupus. On March 2012 she underwent uneventful percutaneous PFO closure with a Figulla Flex I PFO 27/30 mm device that partially covered the entire ASA. Clopidogrel 75 mg was recommended for the first two months and aspirin 100 mg for at least 6 months. Nonetheless, a moderate RS was detected by cTEE and ceTCD at 4 months follow-up with unclear clinical relevance. The presence of pulmonary arteriovenous malformations was ruled out. A percutaneous reintervention using a second device was accomplished using a Figulla Flex II PFO 16/18 mm device. The procedure was done with local anesthesia under fluoroscopic guidance and rotational intracardiac echocardiography (Ultra-ICE, Bostn Scientific Technologies) with simultaneous cTTE. Rotational ICE documented a small residual defect placed infero-anteriorly on the partially uncovered septum primum. Complete residual shunt closure was achieved. The 1-month postprocedural cTEE and ceTCD revealed no interatrial RS. Conclusions: The prevention of RS depends on precise anatomical defi- nition of PFO and associated septal abnormalities (ASA, multiple defects). Percutaneous repair of RS after PFO closure using the Occlutech Figulla Flex PFO device is feasible, safe, and effective, ensuring definitive abolition of the shunt and avoiding surgical approach. Longterm cTCD and cTTE/TEE follow-up should be pursued at regular intervals postoperatively in order to confirm the abolition of the shunt. Further randomized clinical trials are necessary to assess the predictive value of RS and the long-term efficacy of catheter closure when compared to pharmacological or surgical closure.

Eustaquio Maria Onorato,1 Vittorio Ambrosini,1 Bindo Missiroli,2 Carmelo Zimbalatti,2 Rocco Aldo Osanna,3 Antonio Pitı`, 4 Paolo Rubino,1 1 Clinica Montevergine, Mercogliano (Av), Italy, 2 S.Anna Hospital, Catanzaro, Italy, 3 San Carlo Hospital, Potenza, Italy, 4 Humanitas Gavazzeni Clinic, Bergamo, Italy
Purpose: To assess the safety and efficacy of percutaneous closure of atrial septal defect (ASD) and patent foramen ovale (PFO) with or without atrial septal aneurysm (ASA) using the novel Occlutech Figulla Flex I/II ASD/PFO closure device. Methods: Between April 2010 and September 2012, we performed transcatheter ASD and PFO closure in 224 consecutive symptomatic patients (pts). Twenty-six ASDs (female/male = 2.3/1; mean age 40 6 18 years, range 14–65) and 198 PFOs (female/male = 2.9/1; mean age 48 6 15 years, range 12–75) were included. Patients were preprocedurally submitted to cardiological/neurological examination including contrast transthoracic/transesophageal echocardiography (cTTE/cTEE), brain CT/NMR imaging and contrast-enhanced transcranial Doppler (cTCD). Indication for ASD closure was significant left-to-right shunt associated with RV overload and mild-to-moderate pulmonary artery hypertension. Eleven ASDs (47.8%) were more than 30 mm in diameter. Closure of PFO was clinically indicated for secondary prevention in pts with previous cryptogenic cerebrovascular events due to presumed paradoxical embolism. Preprocedurally thromboembolic events were: 103 ischemic stroke (56.8%) and 78 transient ischemic attack (43.2%). Atrial septal aneurysm was observed in 35 pts (17.1%); a prominent redundant Eustachian valve was present in 25 pts (12.2%). Thrombophylic disorders were present in 10 pts (5.5%). Forty pts were aura migraineurs (19.6%). Primary prevention of cerebrovascular accidents was done in three professional scuba divers with multiple episodes of decompression sickness with large RLS via PFO. All procedures were performed with local anesthesia under fluoroscopic guidance and rotational intracardiac echocardiography (Ultra-ICE) achieving accurate device placement. Clopidogrel was recommended for 2 month and aspirin for at least 6 months after ASD/PFO closure. Results: Device implantation was successful in all pts, except one. The in-hospital complications were: self-limited supraventricular arrhythmia in 25 pts (12.2%); new onset transient atrial fibrillation in 1 pt (0.5%); minimal groin hematoma in 15 pts (7.3); mild pericardial effusion which appeared not to be related to the procedure in 1 pt; massive coronary air embolism with prolonged inferior ST segment elevation and transient cardiac arrest successfully resuscitated without further sequelae in 1 pt. cTTE/cTEE and cTCD 6 months after PFO closure (n = 105) revealed four moderate residual shunts with unclear clinical relevance (4.2%). Nonetheless, in two cases a second device implantation has been successfully performed with abolition of the residual shunt. In the ASD group (n = 18), one mild-to-moderate residual shunt was observed after implantation of a 39 mm device four months before. No device malfunction, erosion, valvular regurgitation, or thrombus formation occurred so far. Conclusions: Catheter ASD/PFO closure using Occlutech Figulla Flex I/ II devices appear to be easy, safe, and effective, ensuring high closure rate and low complication rate. Mid-term follow-up results appear favorable with respect to recurrent thromboembolic events. Further studies with adequate follow-up are warranted to confirm long-term efficacy.

Rasha Ammar, Ranya Hegazy, Ciro University children Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt
Background: TEE guidance during percutaneous ASD closure remains the gold standard, unsurpassed by none but the use of ICE. However TTE can offer a reasonable time—saving substitute especially in children where subcostal views are superior. It can also be used when more recent imaging is not feasible or unavailable. In this study, we aim to evaluate the safety and efficiency of transthoracic Echocardiography monitoring during device ASD closure in children. Methods and Results: Between January 2011 and July 2012, 21 children with ASD secundum were percutaneously closed using Occlutech-FigullaN occluder. The procedures were carried out under general anesthesia, biplane fluoroscopy, and transthoracic echocardiograhic guidance. The mean age was 3.7 years (62.3) years. Mean weight at closure was 8.4 (63.9) kg. The indications for closure were: FTT, PHT, RA, and RV dilation. Thorough TTE was performed in multiple views to observe ASD number, position, long axis and short axis diameters, and rims. Patients were divided into two groups based on their largest ASD diameters: 12 patients with ASD diameter 7–15 mm (group A); 9 with ASD diameter 16–22 mm (group B). Occlutech-Figulla-N septal occluders were successfully deployed in all patients. Mild residual shunt at the end of procedure was detected by TTE in two cases (in group B) and resolved at one month follow-up. No mortality or major complications occurred. Postoperative follow-up TTE was performed at day 1, weekly for the first month and monthly for the remaining 5 months. At the end point of the study, no significant complications or mortality were detected. Conclusions: Transthoracic echocardiographic guidance during percutaneous ASD device closure is a safe and efficient substitute to TEE or ICE in children. Posterior rims are difficult to visualize and hence cautious selection of cases is mandatory.

Michelle Lipton,1 David Nykanen,2 Abdo Asmar,1 1 University of Central Florida College of Medicine, Orlando, FL, USA, 2 Arnold Palmer Hospital for Children, Orlando, FL, USA
Objective: The purposes of this study were to determine the incidence of contrast induced nephropathy (CIN) in high-risk pediatric patients from the CICU undergoing cardiac catheterization and to describe any factors that may predispose critical patients to CIN. Design: Retrospective analysis of all patients under the age of 18 admitted to the CICU who underwent cardiac catheterization using the contrast Omnipaque 300 over four years period using RIFLE criteria modified for pediatrics with univariate logistical models. Results: Seventy-nine patients met the criteria for inclusion; 36 males and 43 females, mean age 643 6 1,227 days and weight 9.8 6 16.4 kg. Eighteen patients had pre-existing renal abnormalities or impaired function. Within the 24 hr prior to catheterization, a total of 42 patients were mechanically ventilated, none were dialyzed, 3 were undergoing mechanical cardiopulmonary support, and 44 were hemodynamically unstable. There were five deaths on the same admission. Fourteen patients had CIN accounting for an overall occurrence of 17.7%. By pRIFLE criteria, 10/ 79 (13%) developed risk, 3/79 (4%) developed injury, and 1/79 (1%) developed failure. Recorded contrast dose for the patients that developed CIN (8.2 6 3.5 cc/kg, range 4.2–16.9) was not different from those that did not develop CIN (9.0 6 6.0 cc/kg, range 0.3–25.2) P = 0.63. Conclusions: The incidence of CIN in this high-risk population was less than expected relative to studies in adults despite a very high and likely underestimated contrast load. Factors that likely play a role in predicting risk for CIN include: pre-existing renal disease, interventional procedures, and concomitant use of peripheral vasodilators. Further prospective study utilizing sensitive markers of renal dysfunction is warranted.

Marc Cribbs, Curt Daniels, Sharon Cheatham, John Cheatham, Ralf Holzer, Ali Zaidi, Nationwide Children’s Hospital, Columbus, OH, USA
Background: Most children with congenital heart disease (CHD) in the US survive to adulthood. Despite this, many adults with CHD (ACHD) require multiple reoperations, which is associated with increased morbidity and mortality. Exploring ways to reduce reoperations and cardiopulmonary bypass time (CPB) is necessary. Methods: Retrospective chart review of patients 18 years of age who underwent a Hybrid procedure from January 1, 2006 to July 1 2011 was performed. ‘‘Hybrid’’ was defined as combined surgical pulmonary valve replacement (PVR) with transcatheter pulmonary artery (PA) stent implantation or perventricular Melody valve placement in the pulmonary position. Results: Sixteen patients, seven females, age 31 6 8 years (18–45), 75% with a history of tetralogy of Fallot, met inclusion criteria. Preprocedure, 81% had RV systolic dysfunction (RVEF 45%) and RV enlargement (mean RV EDVi 124 6 39 ml/m2 ). Six patients had a history of ventricular tachycardia and five had prior atrial arrhythmias. The mean number of sternotomies per patient prior to Hybrid procedure was 2 6 1.4 (1–6). Twelve patients underwent surgical PVR with transcatheter PA stent placement with a CPB time of 171 6 80 min. Perventricular Melody valve placement was performed in four patients (CPB 0 min). There was no procedural and discharge mortality across the entire cohort. Conclusions: Hybrid procedures may reduce the number and length of interventions in ACHD patients and could minimize or eliminate the need for CPB. Such techniques must be studied further to improve outcomes in this growing cohort of patients.

Franc¸ois Godart, Ali Houeijeh, Morgan Recher, Charles Francart, Department of Congenital heart disease, Lille, France
Many devices are nowadays available for atrial septal defect (ASD) occlusion but the Amplatzer septal occluder (ASO) is clearly the most widely used for many years. We report here one center experience in transcatheter closure of ASD using the Occlutech Figulla ASD occluder. A comparison is performed with the ASO during the same period of time. From September 2009, 126 patients underwent ASD occlusion. Percutaneous closure was realized under general anesthesia with TEE control. Patients received intravenous heparin (100 IU/kg) at the beginning of the procedure. Choosing of device size was performed after a balloon test occlusion and measurement of the stretched diameter. None of them had pulmonary artery hypertension. One hundred five patients had ASD occlusion with ASO: 64 females, 41 males, with a mean age of 32.5 6 5 years, a mean device size of 20.4 6 6.9 mm. The fluoroscopic time was 6.3 6 9.3 min, irradiation dose 19.2 6 23.2 Gycm2 . Implantation succeeded in all but two who had surgical repair later on. Another patient had device embolization in the aorta. The device was retrieved by catheterization and this patient underwent 2 months later transcatheter occlusion with another ASO. During the same period of time, 21 patients underwent ASD occlusion with the Occlutech Figulla device including five patients with the Flex II occluder: 12 females, 9 males, with a mean age of 41.7 6 21 years, a mean device size of 20.7 6 4.8 mm. The fluoroscopic time was 4.4 6 2.7 min, irradiation dose 14.3 6 18.1 Gycm2 . Device implantation succeeded in all but one who had surgical repair later on. No other complication was noticed. During follow-up, 2 patients with ASO had tiny residual shunt and 1 in the Figulla group had a persistent shunt due to another small defect. Transcatheter closure of ASD with the Occlutech device is feasible and safe with no learning curve since the implantation technique is similar to the Amplatzer device. In addition, use of larger introducing delivery sheath for the Figulla device compared to the ASO is not a problem in the adult population but may be a limiting factor in younger children. Finally, the results of the Occlutech Figulla devices compare favorably with those of Amplatzer devices. However, additional long-term results including more patients are mandatory.

Anas Abu Hazeem, Matthew Gillespie, Haley Thun, David Munson, Matthew Schwartz, Yoav Dori, Jonathan Rome, Andrew Glatz, Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Background: Surgical ligation via thoracotomy has traditionally been used to close the patent ductus arteriosus (PDA) in small infants, but this has been associated with initial deterioration in respiratory function and need for escalated ventilatory support. More recently, percutaneous closure of PDA in this population became feasible. We sought to describe our experience with percutaneous PDA closure in small infants on significant respiratory support and compare to matched surgical patients. We hypothesized that both methods would be safe and effective, but percutaneous closure would be followed by a shorter period of worsened respiratory status. Methods: We retrospectively reviewed all patients <4 kg with significant lung disease requiring positive pressure ventilation that underwent percutaneous closure of PDA between January 2000 and April 2012 and matched to contemporary surgical patients on gestational age (GA), birth weight (BW), procedure weight (WT), and mode of ventilation. Patients were deemed to have returned to baseline respiratory status when the product of mean airway pressure and FiO2 returned to preprocedural levels. Results: Eight patients were identified that underwent percutaneous closure and were matched 1:1 to eight surgical patients. Median BW, GA, and WT were 1.43 kg (0.52–2.97), 29.8 weeks (24–39), and 2.8 kg (2.2–3.9) for catheter patients and 1.55 kg (0.48–3.04), 29 weeks (23– 37), and 2.75 kg (2.3–4.2) for surgical patients. In the percutaneous group, Qp/Qs ranged from 1 to >4 and PVRi 0.9 to 6.7 Wood Units. The Amplatzer Ductal Occluder was used in two patients and the Amplatzer Vascular Plug II in six with complete occlusion in all. Two patients developed mild aortic coarctation and 1 mild LPA stenosis. There were three femoral artery and one femoral vein thrombi (all resolved with medical therapy). Surgical complications included: signifi- cant respiratory and cardiac compromise, rib fractures, subcutaneous emphysema, and urinary retention. The median time to return to baseline respiratory status was significantly shorter in the percutaneous closure group (17 hr, range 0–113) compared to the surgical group (53 hr, range 13–219), P < 0.05. Conclusion: Percutaneous closure of PDA in small infants on respiratory support is equivalent in safety and efficacy and may offer shorter recovery time than surgical ligation.

Michael D. Seckeler, Chet Villa, Russel Hirsch, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
Introduction: Central venous occlusion can occur in the presence of chronic indwelling catheters, after cardiac surgery or, less frequently as a result of extrinsic compression from mediastinal masses. Obstructed venous return with inadequate collateralization may result in impaired ventricular preload, and symptoms of dizziness, fatigue, or chest pain. Case report: A 15-year-old male presented with new onset dizziness with activity shortly after resection of a large mediastinal mass secondary to histoplasmosis. MR angiography was suggestive of extrinsic compression of the superior vena cava (SVC) and complete occlusion of the innominate vein by inflammatory tissue. He was brought to the cardiac catheterization laboratory, where the procedure was performed under general anesthesia. Vascular access was obtained in the right femoral and left subclavian veins. Apart from a 3 mm Hg gradient from the high SVC to the right atrium, intracardiac hemodynamics was normal. Angiography demonstrated SVC narrowing from 15 down to 8 mm, with return to normal caliber at the right atrial junction. Simultaneous contrast injections in the SVC and innominate vein revealed a 12 mm gap between the proximal end of the innominate vein and SVC, with a collateral entering superiorly back into the SVC and retrograde flow in the hemi-azygous vein. From the femoral approach, the SVC was stented with a Palmaz XL 3110 stent mounted on a 14 mm Z-med II balloon, followed by redilation with a 14 mm Atlas balloon. There was no residual gradient. Then, approaching from the subclavian vein, a 56 cm transseptal needle in a 7 Fr introducer sheath was advanced across the fibrous tissue between the distal innominate vein and the SVC, entering at a point superior to the previously placed stent. Once position was confirmed within the lumen of the SVC, the tract was dilated with a 7 mm Conquest balloon, stented with a 7 mm 22 mm Atrium covered stent and further dilated with a 9 mm Conquest balloon. The final gradient from the innominate vein to the SVC was 1 mm Hg. There were no procedural complications. Conclusion: Successful percutaneous recanalization of occluded central vessels to normalize cardiac physiology is possible with careful mapping and understanding of the surrounding tissue substrate. Continued followup and anti-coagulation will be vital to ensure continued patency of recanalized vessels.

Hussein Abdulwahab, Ibn Bitar Cardiac Center, Baghdad, Iraq
Transcatheter closure of sinus venosus ASD or large ASD with absent superior or inferior rim has been challenging and is usually not recommended. Therefore, our goal was to assess the feasibility of transcatheter closure of such defects. To provide a stable rim for device anchorage, we have used a covered CP stent in the superior vena cava. Part of the stent will act as the superior rim of the defect. Therefore, we have used 45 mm length and cutting part of it and deployment of the stent in the SVC with part protruding into the right atrium. Three female patients underwent such trial, age ranged from 14 to 31 years with large sinus venosus ASD (One of them had sinus venosus ASD and two with large defects and absent superior rim). The patient with sinus venosus ASD had small tiny residual shunt after closure, while the other two patients had complete closure immediately after closure. At 6 weeks follow-up, the sinus venosus patient had complete closure as documented by transesophageal echocardiography. Long-term follow- up data are still needed to assess long-term safety and efficacy of this technique.

Matthew C. Schwartz,1 Andrew C. Glatz,2 Yoav Dori,2 Jonathan J. Rome,2 Matthew J. Gillespie,1 1 Arnold Palmer Hospital for Children, Orlando, FL, USA, 2 The Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Background: Radiofrequency valvotomy (RFV) is an effective initial treatment in patients with pulmonary atresia and intact ventricular septum (PA-IVS) and mild-to-moderate right ventricle and tricuspid valve hypoplasia. Risk factors for the need for additional interventions in these patients are poorly defined. Methods: All patients with PA-IVS who underwent RFV at the Children’s Hospital of Philadelphia between January 2000 and July 2011 were reviewed. Patients with Ebstein’s anomaly were excluded. Results: Twenty-three patients met inclusion criteria. All underwent successful valvotomy with no procedural deaths and one major complication. Excluding two patients with limited follow-up, six (29%) patients underwent no subsequent interventions and nine (42%) patients required surgical right ventricular outflow tract augmentation. All patients with adequate follow-up have a biventricular circulation including 16 (84%) with oxygen saturations >95%. Patients that did not require any right ventricular outflow tract intervention after valvotomy had a significantly lower gradient across the pulmonary valve following valvotomy compared to patients who did require subsequent intervention (9.9 mm Hg 6 8.4 vs. 19.1 mm Hg 6 10.4, P = 0.05). Significantly more patients that required a neonatal intervention after valvotomy had a tricuspid valve z-score <0.7 than patients that did not require additional intervention in the neonatal period (2 (15%) vs. 7 (70%), P = 0.008). Conclusions: In our cohort of patients with PA-IVS, RFV was an effective and safe first step in establishing a biventricular circulation. Postvalvotomy pulmonary valve gradient may be a risk factor for subsequent outflow tract intervention and tricuspid z-score <0.7 may put patients at risk for subsequent intervention in the neonatal period.

David Kwiatkowski, Robert Beekman, Bryan Goldstein, David Morales, Peter Manning, Alistair Phillips, Erik Michelfelder, James Cnota, Allison Divanovic, Michael Seckeler, Russel Hirsch, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
Background: Hypoplastic left heart syndrome with intact atrial septum (HLHS/IAS) has high neonatal mortality, with survival depending upon prompt relief of atrial septal obstruction. While some success has been reported with fetal intervention, our institution has undertaken a program of cardiac catheterization laboratory (CCL) delivery with immediate atrial septal stent placement. We report on the evolution of this process aimed at expediting left atrial (LA) decompression. Methods: Single-center chart review of all cases of CCL delivery for prenatally diagnosed HLHS with intact or highly restrictive atrial septum from 2007 to 2012 at a large quaternary care children’s hospital. Results: With extensive collaboration between interventional and perinatal cardiology, obstetric and cardiothoracic surgery teams, six patients with HLHS/IAS have undergone cesarean delivery in the CCL since 2007. The first two patients underwent percutaneous transhepatic atrial septal stent delivery. One of these was successful, with the second complicated by atrial perforation, tamponade, and death. The third patient had femoral venous access but procedural failure, and immediately transitioned to a successful open surgical atrial septectomy in the CCL. These percutaneous challenges prompted modification to the current protocol with CCL delivery, immediate sternotomy, and per-atrial transcatheter atrial septal stent placement. Procedural survival in the three peratrial approaches was 100%, with no complications and two patients surviving to their next palliative surgery. In all successful procedures, stents were deployed in less than 1 hr after delivery, the fastest being 37 min. Discussion: In this single-institution series of HLHS/IAS, we have noted systematic improvement in procedural success with evolution to the current strategy of CCL delivery and immediate per-atrial stent placement for initial palliation. In the three per-atrial stent cases, successful decompression of the LA enabled further medical management and two patients to complete hybrid stage I surgical palliation. While on-going improvements to this practice are necessary, a per-atrial approach appears to provide an efficient and efficacious means to LA decompression in these high-risk neonates.

Beth Medford, Nathan Taggart, Jonathan Johnson, Allison Cabalka, Frank Cetta, Guy Reeder, Donald Hagler, Mayo Clinic, Rochester, MN, USA
Purpose: Intracardiac echocardiography (ICE) use is common during interventional cardiac catheterization in adults. We describe our experience with ICE in pediatric and adolescent patients. Methods: We reviewed all cases using ICE in patients 21 years old from January 2002 to February 2012. Demographics and variables reviewed included indication for ICE, type of interventional procedure, ICE-related morbidity, procedure morbidity, and procedural and fluoroscopy time. All studies were performed using the Acuson AcuNavTM ICE system. Results: One hundred nineteen patients (65 females, mean age 13.1 6 6.1 years, range 1–21 years) underwent ICE. In 100 patients (84%), ICE was used to facilitate closure of a patent foramen ovale (PFO) or atrial septal defect (ASD). Other interventional procedures for which ICE was used included occlusion of complex shunts (3), creation of an ASD or Fontan fenestration (3), and to assess Melody valve function after placement (6). ICE was used in diagnostic cases to identify or describe the presence of intracardiac or Fontan conduit thrombus (2), intracardiac shunt (3), prosthetic valve regurgitation (1), and abnormal pulmonary venous anatomy (1). An 8 Fr catheter was used in 53% of cases; a 10 Fr catheter was used in the remainder. Mean procedure time = 170 6 65 min (fluoroscopy time 23 6 13 min), Procedural/fluoroscopy times were longer in non-PFO/ASD cases (P < 0.002 for both). The use of ICE allowed for 51/119 (43%) patients to have procedures without general anesthesia. ICE imaging identified deficiency of critical defect rims in seven patients and complex/multiple ASDs in two patients, all of whom were referred for surgical closure. Only two patients (1.7%) experienced minor complications—groin hematomas that resolved without sequelae. Conclusion: ICE is safe in pediatric patients. As in the adult population, ICE eliminates the need for a second operator in the lab. It may eliminate the need for general anesthesia, and complication rates are extremely low. ICE is a reasonable alternative to TEE to clarify complex anatomy and facilitate catheter-based interventions in children.

Snehal Kulkarni, Tanuja, Kokilaben Ambani Hospital, Mumbai, India
Background: Balloon aortic valvuloplasty (BAV) is the preferred treatment for congenital aortic valve stenosis (AS) in neonates and infants. We describe immediate and intermediate outcomes of balloon aortic valvuloplasty in neonates and small infants at our center. Methods: It is a retrospective analysis of patients who underwent BAV at our institution over the past 3 years. The following endpoints were evaluated: moderate-to-severe aortic insufficiency by echocardiography (AI), need for reintervention, and death. Results: Between January 2009 and June 2012, balloon aortic valvuloplasty was performed in 20 infants with congenital valvar aortic stenosis. The age of the patients ranged from 2 days to 5 months, with 12 patients (57%) belonging to the neonatal age group (1 month), body weight ranged from 3.8 6 1.3 kg and the smallest neonate weighed 1.7 kg. The balloon-annulus ratio was 0.92 6 0.1. Immediately after valvuloplasty, the mean systolic pressure gradient across the aortic valve decreased from 60 6 14.4 to 22 6 11 mm Hg (P < 0.001). Out of 20 infants, two infants died (mortality rate of 10%). Both patients had significantly thickened and dysplastic aortic valves with hypoplastic mitral valve (mean z score = 3.1). There were no late deaths and survivors were followed for a mean of 6 months. Of the remaining 18 patients, 3 (15.7%) had immediate moderate aortic regurgitation (AI) but none had severe AI. There was no significant relationship between occurrence of AR and balloon-annulus ratio. Repeat valvuloplasty was performed in four (14%) infants at a mean interval of 3 months. One patient had associated lesions with small left heart structures and one patient had an unicupid dysplastic aortic valve. The remaining two patients had high post BAV gradients of > 25 mm Hg. Conclusion: BAV confers good immediate and interim benefits to most patients with congenital AS. Neonates with thick, dysplastic aortic valves, associated lesions of LV inflow and those with high post-BAV gradients experienced worse outcomes and needed.


Zuzana Venczelova, Jozef Masura, Children’s Cardiac Center, Bratislava, Slovakia
Background: Residual postoperative findings are common in Fontan patients. Many of them can be successfully managed in the catheterization laboratory. Methods: We conducted a retrospective study of all catheterization interventions performed in our Fontan patients between 1994 and 2012. The angiographic and hemodynamic data as well as the data from the inpatient and outpatient clinic were analyzed. Results: In our database, 233 Fontan patients were identified; a total of 138 interventions were performed in 100 of them (1–7 procedures per patient, in 11 procedures, more than 1 intervention was performed). In 27 patients (19.6%), the intervention was performed in the early postoperative period (before discharge). The main indications were hemodynamic instability and effusions. In 73 patients, the intervention was performed during the later follow-up period; the main indication was cyanosis or pulmonary branch stenosis. The most commonly performed intervention was fenestration closure (in 77 patients, in the long-term, 2 patients developed exsudative enteropathy). In eight patients, the fenestration was opened or enlarged (with an improvement of clinical status in four patients). In 36 procedures, collateral vessels, A-V fistulae or LSVC were closed. In 20 procedures, a pulmonary branch stenosis was treated (LPA in 16 patients, RPA in 4 patients with 12 stents implanted). Complications occurred during nine procedures (three arrhytmia, two febrilities, one endocarditis, one stent embolization, two other). Radiofrequency ablation was necessary in two patients (in three interventions in total) and in one patient, aortic isthmus stenting was performed. The median age of patients at the time of catheterization was 6.3 years (range 2–30.4 years), the median time between the Fontan operation and the interventional procedure was 28 months (range 1 day– 16.7 years). The median weight of patients at the time of procedure was 21 kg (range 9–75 kg). During the follow-up period, four patients died. Conclusion: In cardiac centers which perform a fenestrated Fontan operation, the most frequent intervention is the fenestration closure, which is generally well tolerated, with a significant increase in oxygen saturations. By contrast, an emergent fenestration dilation or stenting can improve the acute hemodynamic situation in the early postoperative period. LPA stenting and collaterals closure are also often needed and can be safely performed.

I.B. Vijayalakshmi, Sri Jayadeva institute of Cardiovascular Sciences and Research, Bangalore, India
Background: Isolated left ventricular non-compaction is reported extensively. But apical non-compaction (ANC) of both ventricles and septum is not reported much in literature. For the first time in the world, we are reporting the challenges of various interventions for different associated lesions in ANC. Aim: To know the challenges and feasibility of transcatheter interventions for the associated lesions in cases of ANC to reduce the pump failure. Material and Results: Out of 62 consecutive patients diagnosed as ANC by echocardiography, 28 (45.2%) underwent various transcatheter interventions, formed the material for this study. Age ranged 3 days to 35 years (mean 6.6 years). Eight cases had left ventricular (LV) dysfunction, 7 had right ventricular (RV) dysfunction, three had biventricular dysfunction, 46% had pulmonary artery hypertension (PAH), and two patients (3.2%) had thrombus in LV and RV. The device closure was done in 3 PDAs, 14 VSD, 1 ASD, 1 aorto-right ventricular tunnel. Balloon dilatation done for four aortic stenosis (AS), two pulmonary stenosis (PS), one coarctation of aorta, five patients underwent two procedures simultaneously (ABV and PBV, ABV and PTMC, ABV and PDA device closure, ASD and VSD device closure and PDA and VSD device closure). Three cases of VSD were postoperative residual shunts with severe PAH and in one case two devices were deployed. One 5 kg infant had large apical VSD and tubular PDA closed with ADO II. Hybrid surgery (14 mm septal occluder) was done for a large mid muscular VSD in 7 kg child. Device closure done for mid muscular VSD with dextrocardia. In one case procedure was abandoned as 18 mm VSD device slipped. Discussions: Procedures in ANC is risky in the presence LV/or RV dysfunction with or without thrombosis. Positioning the device in apical VSD in ANC cases is very challenging as the device gets caught in trabeculae in RV and if more tug is given the device slips through spongy myocardium. The results of interventions are very gratifying as the superadded pump failure due to pressure or volume overload caused by associated lesions improves significantly. One patient with severe AS and mitral stenosis had reverse May Thurner syndrome (obstruction of right common iliac vein by right common ileac artery), hence procedure was done through left femoral puncture. Conclusion: Associated lesions in ANC worsen the pump failure. Transcatheter interventions though challenging are feasible safe effective and are life saving. Transcatheter interventions certainly reduce the morbidity and mortality in ANC patients who are at high risk for surgery or redo surgery.

Amjad Mehmood, Uzma Kazmi, Ahmed Usaid, Najam Haider, Masood Sadiq, Army Cardiac Centre, Lahore, Pakistan
Background: Patients with isolated pulmonary valve stenosis (PVS) tend to present late and may have associated RV dysfunction. Dysplatic pulmonary valve stenosis (DPVS) present a subset of this group where the optimal management becomes even more challenging. Objectives: To compare the result of BPV between severe DPVS and isolated PVS presenting late and determine various factors affecting the outcome. Material and Methods: All patients presenting to single tertiary care hospital from June 2006 to May 2012 with severe PVS undergoing BPV were included in the study. Patients with critical PS were excluded. The patients were divided into dysplastic (group 1) and isolated doming (group 2) pulmonary valves based on echocardiographic appearance of the valves. Immediate percentage reduction in gradient across PV and complications in either group were analyzed along with frequency of RV dysfunction, balloon to annulus ratio, predilatation, and balloon stabilization. Results: A total of 162 patients underwent BPV. The age ranged from 3 months to 14 years with median 2 years and mean 6 SD 3.7 4.0 years. There was a male predominance (M:F;2.1:1). DPV was found in 76 patients (46.9%). Thirty-four patients (21%) had RV dysfunction at the time of intervention. There was no significant difference between frequency of RV dysfunction between both groups (P = 0.4). Balloon stabilization was significantly more difficult in group 1 (P = 0.01). Mean balloon to annulus ratio was 1.3 6 0.2 with no significant difference between the two groups (P = 0.4). Average preprocedure systolic gradient across PV fell from 93 6 35 mm Hg to 29 6 20 mm Hg with mean percentage reduction of 67.2 6 19.8%. Percentage reduction in gradient was significantly lower in group 1 (62.9 6 22.5% vs. 70.6 6 16.6%, P = 0.02). Ninety patients (55.6%) had a successful and 67 (41.4%) partially successful BPV. DPV and poor balloon stabilization were significantly associated with partial relief or failed attempt (P = 0.038 and <0.001 respectively). RV dysfunction was significantly associated with various arrhythmias (3.7%, SVT 3, significant sinus bradycardia 3) during procedure (P = 0.001). There was no significant correlation between balloon to annulus ratio to gradient reduction in either group (P = 0.78). Conclusion: Severe PVS presents late with 1/3rd having RV dysfunction. DPV and poor balloon stabilization are most important factor determining the outcome of BPV. RV dysfunction is significantly associated with arrhythmias during intervention.

Jeremy Asnes, John Fahey, William Hellenbrand, Yale School of Medicine, New Haven, CT, USA
Three consecutive patients have undergone successful percutaneous valve-in-valve tricuspid valve implantation (vvTVR) irrespective of original bioprosthetic valve (BV) size. Patients were 27, 27, and 19 years old and had BSAs of 1.2, 3, and 2.4 m2 . Primary diagnoses were tricuspid atresia with RA-to-RV valved conduit single lung ‘‘Fontan,’’ TV dysplasia, and Ebstein anomaly. The most recent surgical tricuspid valve replacements (sTVRs) had been performed using 25 mm, 33 mm, and 29 mm CarpentierEdwards BVs at 8, 9, and 7 years previously. Indications for vvTVR were stenosis in patients 1 and 2 and severe regurgitation in patient 3. RA awave to RVEDP gradients were 4 (Fontan pathway), 12, and 6 mm Hg. Low-pressure balloon sizing demonstrated BV orifice diameters of 19, 21.5, and 22.5 mm. vvTVR was performed from the left femoral, right internal jugular, and right femoral veins (FV). Melody transcatheter pulmonary valves (MTVs) were implanted on a 22 mm Ensemble system in the 25 mm BV and on 24 mm BIB catheters in the 29 and 33 mm BVs. BIB catheters were introduced via 22 Fr Kelly-Timmerman sheaths. The MTV implanted at 22 mm was post-dilated with a 22 mm Atlas balloon. Following MTV implantation, RA a-wave to RVEDP gradients were 1 and 2 mm Hg in patients 1 and 3. The postimplant RVEDP was not measured in patient 2. Immediate postimplant MTV insufficiency assessed by intracardiac echocardiography was none, mild, and trivial. FV sites for both Ensemble and Kelly-Timmerman were closed using overlapping ProGlide systems. There were no procedural complications. Time from implant has been 7, 5, and 2 months. There have been no readmissions. The most recent echocardiograms show no, trivial, and trivial MTV insufficiency. All patients showed improvement in symptoms. NYHA class improved from III to II, III to II, and II to I. In our experience, the MTV can be safely and successfully implanted in the TV position within BVs as large as 33 mm from either the femoral or jugular approach. Use of a 24 mm balloon results in an external MTV diameter of 26.4 mm and facilitates stable implantation in large BVs without causing significant insufficiency of the MTV.

Jeffrey Zampi,1 Jennifer Hirsch-Romano,1 Bryan Goldstein,2 Justin Shaya,3 Aimee Armstrong,1 1 University of Michigan Congenital Heart Center, Ann Arbor, MI, USA, 2 The Heart Institute at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA, 3 University of Michigan Medical School, Ann Arbor, MI, USA
Background: Pulmonary atresia with intact ventricular septum (PA/IVS) is a rare complex congenital heart defect with significant morphologic heterogeneity. A subset of PA/IVS patients with the prospect of a biventricular circulation typically undergo surgical pulmonary valvotomy and Blalock-Taussig (BT) shunt placement on cardiopulmonary bypass (CPB). A recently described hybrid procedure, involving perventricular pulmonary valve perforation and balloon valvuloplasty with or without BT shunt, was shown to be safe and effective in single center series. This is the first report comparing the short-term outcomes between the hybrid procedure and the standard surgical approach. Methods: Medical record review was performed for patients with PA/ IVS who had either surgical or hybrid right ventricular decompression between January 2002 and December 2011 at our institution. Preoperative variables, procedural, and immediate postprocedural data, and shortterm follow-up data were collected and compared between the cohorts. Results: Seven patients with PA/IVS underwent a hybrid procedure; perventricular pulmonary valvuloplasty with BT shunt placement in five and valvuloplasty alone in two. The procedure was technically successful in all attempts, and none required CPB. No patients required surgical re-intervention prior to hospital discharge, and none died prior to hospital discharge or on follow-up (median follow-up 28.4 months, IQR 23.1–37.2). Surgical RV decompression using CPB was performed in 17 patients, who had fewer preoperative risk factors for surgical morbidity/ mortality than the hybrid group. The median CPB time for the surgical cohort was 80 min (IQR 69–108) compared to 0 min for the hybrid cohort. The patient outcomes were similar between the cohorts with similar rates of postoperative complications (58.8 vs. 57.1%) and no deaths prior to hospital discharge. One surgical patient underwent a second surgery for RV to pulmonary artery conduit placement. Conclusions: The hybrid approach to PA/IVS is an attractive alternative to the standard surgical approach. The short-term patient outcomes are comparable, despite more risk factors in the hybrid group. Moreover, no patient in the hybrid cohort required surgical re-intervention prior to discharge, thus avoiding cardiopulmonary bypass in the neonatal period.

Ram Bishnoi, Richard Ringel, Allen Everett, Carl Owada, John Coulson, Johns Hopkins Hospital, Baltimore, MD, USA
Background: The Amplatzer septal occluder (ASO) was approved by the FDA in 2001, but children less than 8 kg were excluded from the pivotal trial. Nevertheless, the ASO is being used in this patient population with very limited feasibility, safety, and efficacy data. Aims: The objective of this study was to determine the safety and effectiveness of the ASO for ASD closure in infants weighing less than 8 kg. Methods: The MAGIC ASD registry database used for this analysis began on November 20, 2004, ended on January 6, 2011, and enrolled patients from 13 hospital centers across the United States. One thousand thirty-one patients underwent attempted transcatheter closure of ASD. Forty-nine out of the 1,031 patients weighed less than 8 kg. Catheterization records and follow-up visit data were collected. Indications for ASD closure were failure to thrive, significant right heart enlargement, hemodynamically significant shunts, and poor clinic status (respiratory support, congestive heart failure, chronic lung disease, pulmonary hypertension, and feeding problems). Results: Patients ranged in age from 1 to 24 months (8.8 6 4.8). Their weights ranged from 2.3 to 7.7 kg (5.6 6 1.5 kg). Nine patients had trisomy 21 and 13 patients had very significant chronic lung disease with pulmonary hypertension and other prematurity related multisystem problems. Defect size ranged from 4.0 to 19 mm (8.4 6 3.6). Stop-flow sizing was performed in 10 patients. Thirty-seven patients had single ASDs, nine had two defects, two patients had three, and one patient had a multiply fenestrated ASD. Five patients had aneurismal atrial septum. Additional interventional procedures included PDA coiling, LPA stenting, pulmonary balloon valvuloplasty and device closure of a left SVC. Pulmonary artery systolic pressure ranged from 15 to 90 mm Hg (36.5 6 12.7). The pulmonary to systemic flow ratio ranged from 0.7 to 4.89 (1.95 6 0.95). Pulmonary vascular resistance index ranged from 0.69 to 6.41 WU*M2 (2.1 6 1.1). The pulmonary to systemic vascular resistance ratio ranged from 0.05 to 0.53 (0.2 6 0.1). An ASO was successfully implanted in 48 of 49 infants (one patient had insufficient rims) and ranged from 4 to 20 mm (9.6 6 3.7 mm) in size. At 24 hr postimplantation, 13 patients had a small residual shunt, 9 had a trivial shunt, and the remaining 26 had no residual shunt. One patient had a brief episode of atrial tachycardia. There were no other procedure related complications. One had pre-existing pericardial effusion that was drained before the device implantation. Follow-up data were available for 25 patients and ranged from 0.5 to 8 years. Clinical development and growth significantly improved in all children with failure to thrive, all ventilator or oxygen dependent children could be weaned after ASD closure. Diuretics and pulmonary vasodilator medications were also weaned successfully. There were four late deaths. One patient died 6 months postimplant from aspiration and autopsy showed evidence of acute and chronic aspiration pneumonitis. The ASO was found to be well positioned and endothelialized with no residual defect. Two other patients with ventilator dependent chronic lung disease died 6 and 21 months postimplant. One child died 12 months after the ASD closure likely due to a neurological event. Conclusions: The ASO device can safely and successfully close ASDs in infants weighing <8 kg. In this small series, implantation has a high success rate and low complication rate. Short-term results especially in children with poor weight gain and lung disease are very encouraging, but continued follow-up of these patients is very important to determine long-term safety.

Lucy Eun, Byung Won Yoo, Young Hwan Park, Han Ki Park, Jae Young Choi, Yonsei University, Seoul, Republic of Korea
Objectives: This study aimed to evaluate the congestive hepatopathy in the patients with Fontan circulation using transient elastography (TE) and other non-invasive methods, and to investigate whether the related risk factors are correlated with the liver stiffness (LS). Methods: We evaluated 46 patients with more than 5 years after the Fontan procedure (Fontan group) and 26 patients who had hepatic congestion caused by right side heart failure (RHF group), with laboratory test, serum fibrosis marker, ultrasound, and TE. We reviewed the records of cardiac catheterization taken within 1 year in 19 patients among the Fontan group. Results: Nineteen patients of the Fontan group (41.3%) showed abnormal findings in the abdominal ultrasound without significant abnormality in the laboratory test and APRI. The LS value was much higher in the Fontan group (21.1 6 8.0 kPa) than that in the RHF group (10.0 6 9.0 kPa). Serum level of total bilirubin and albumin, white blood cell count (WBC) and APRI showed a significant correlation with LS. Also the age at evaluation (r = 0.42, P = 0.004), the age at the Fontan procedure (r = 0.51, P < 0.001), and IVC diameter (r = 0.35, P = 0.02) were significantly correlated. The frequency of abnormal ultrasound findings increases with LS value (P = 0.002). Eighty-nine percent in the subgroup with the highest LS value (30 kPa) showed abnormalities and 44.4% in them showed liver cirrhosis. In catheterization data, the IVC pressure showed the significant inverse correlation with the LS value, IVC diameter, the age of patients, and the duration with Fontan circulation. Conclusions: This study revealed that the congestive hepatopathy have been progressed in a significant number of patients with long-term Fontan circulation, and the TE is a reliable method to assess the risk and the severity of hepatopathy in these patients. It also revealed that the age of patients and the age at the completion of Fontan operation were the risk factors, and the IVC dilatation was a possible marker to reflect the risk and severity of hepatopathy. We suggest that regular screening test using TE is useful in long-term management of the patients with Fontan circulation, to predict the risk of hepatopathy and to sensitively recognize a progression of the liver disease. More longitudinal longterm follow-up studies and liver biopsy studies to validate the diagnostic accuracy of TE and to investigate of the specific LS range in these patients should be needed.

Edmundo Clarindo Oliveira,1 Marco Antonio Moura,1 and Jose Augusto Barbosa,1 1 Hospital das Clinicas UFMG, Belo Horizonte/MG, Brazil, 2 Hospital Felicio Rocho, Belo Horizonte/MG, Brazil
Introduction: The role of interventional catheterization for treatment of congenital cardiac disease has grown with the emergence of new devices and the improvement of existing ones, and also the increasing experience of the groups involved. However interventions in premature neonates or infants weighing less than 2.5 kg are still considered a challenge, related to technical difficulties and lack of tools specific to this age group. Objective: To describe the service experience with these patients in several clinical settings. Methods: seven patients aged 3–66 days old and weighing 1,000–2,300 g (mean, 1,765 g) were submitted to the following procedures: perforation of the pulmonary valve using guidewire (0.014u SHINOB-PLUD Johnson) in three patients (1,800, 2,000, and 2,080 g) with pulmonary valve atresia with intact ventricular septum; removal catheter shattered in a patient with 1,000 g; STENT implantation for treatment of aortic coarctation in a patient (1,180 g) with refractory cardiac heart failure in controlled ventilation and systemic infection treatment; STENT implantation for the treatment of aortic recoarctation ten days after the surgery due interrupted aortic arch, in a patient (2,300 g) in anasarca and acute renal failure; STENT implantation in the right ventricle outflow tract in a patient (1,180 g) diagnosed with Fallot’s tetralogy, esophageal atresia, and tracheoesophageal fistula; pulmonary valvuloplasty in a premature infant (2,100 g) also diagnosed with Fallot’s tetralogy, without surgical condition. Results: All of the procedures were successful, with venous access done by puncture and arterial access obtained by dissection. Conclusions: Interventions can be performed safely and good results can be achieved in this special group of patients, since the risks, indications, and staff experience are respected.

Edmundo Clarindo Oliveira, Marco Antonio Moura, Jose Augusto Barbosa, Hospital Felicio Rocho, Belo Horizonte MG, Brazil
Introduction: Percutaneous closure of atrial septal defect (ASD) has been done with success and is considered the best option nowadays. Therefore, ASD > 30 mm, with small rims, are a challenge to the interventionist. Objective: To demonstrate the experience of the group with percutaneous closure of ASD in this special group of patients. Method: About 64/469 (13, 6%) had ASD > 30 mm. Ages between 8 and 65 years (m = 34, 6), 38/64 (59%) female. Femoral vein was punctured in 63 patients and hepatic vein in one patient. Transesophageal echo was used in 60, transthoracic echo in one and intracardiac echo in three patients, respectively. The balloon and partial deployment of the left disc in pulmonary vein techniques were used to put the left disc in a good position in three and two patients, respectively. Results: The procedures were done with success in all patients. Three patients had AF converted with amiodarone and one had transient SVT. Sixty-three patients went home 24 hr after the intervention and one stayed in the hospital for six days due to the cardiac surgery after device displacement. All of them had improvement of their functional class. RV diameter decreased to normal or near normal dimensions in all of them also. Conclusions: The percutaneous closure of large ASD is a challenging procedure but it can be done safely, with high rate of success when the experience of the group has increased. Percutaneous closure of ostium secundun ASD, even the large ones, should be the first choice of treatment.

Rasha Ammar,1 Eusatchio Onorato,2 Hakan Akpinar,3 1 Pediatric Cardiology Department, Cairo University, Cairo, Egypt, 2 Division of Invasive Cardiology, Casa di Cura ‘‘Montevergine’’, Mercogliano (Avellino) and Humanitas Gavazzeni Clinic, Bergamo, Italy, 3 Occlutech, Istanbul, Turkey
Background: Partial closure has been reported for ASD closure in the elderly and in cases of severe PHTN, with variable results. Some case reports describe different techniques of creating the fenestration. We report the one-year postoperative follow-up data of a 36-year-old female with severe PHTN in whom partial closure was successfully achieved using a manufactured fenestrated ASD Occlutech-Flex II 1 occluder. Method and Results: Successful partial closure of a Large ASD secundum measuring 39 mm using a manufacturer made fenestrated device; Occlutech Flex II 1ASD occluder. The waist measured 48 mm and left atrial disc (LA) disc: 64 mm, with a fenestration of 8 mm. Preload reduction 2 months prior to closure was achieved and heparin for the 1st week, followed by Aspirin for 1 year. Daily TTE follow-up for the first 2 weeks followed by weekly and then monthly till 12 months postprocedure. At 12 months follow-up, the fenestration is still patent. Pulmonary artery pressure (PAP) dropped from 90 mm Hg to 53 mm Hg, right ventricular diastolic dimensions (RVEDD) decreased and left ventricular end diastolic dimensions (LVEDD) increased. NYHA functional class improved from IV to II in one year. No device malfunction or thrombus formation was detected. Conclusion: Partial closure is safe and succeeds in reducing the magnitude of the shunt when using a custom made fenestrated. Long-term follow-up is crucial to plan total closure of the defect.

Matthias Peuster,1 Sylvia Arnold,2 Thomas Hassel,3 Andrea MeyerLindenberg,2 Hansjoerg Hauser,4 Friedrich-Wilhelm Bach,3 Muhammad Badar,4 Andreas Drynda,5 Peter Mueller, 1 University of Chicago, Chicago, IL, USA, 2 University of Veterinary Medicine Hannover, Hannover, Germany, 3 Institute of Materials Science, Hannover, Germany, 4 Helmholtz Centre for Infection Research, Braunschweig, Germany, 5 University of Magdeburg, Magdeburg, Germany
For the development of biodegradable medical implants it is necessary to identify suitable materials. To evaluate iron as a degradable biomaterial a new mouse model was developed. Methods: Iron implants were inserted into the tail vein of 65 mice, 17 underwent sham operation. Implant degradation characteristics as well as cellular and molecular responses were monitored. Follow-up ranged from 1 to 9 months before the mice were euthanized. Results: Iron degradation proceeded gradually over the time of the followup. Ultimately, complete degradation was confirmed by micro-computed tomography. Histological analysis and gene expression data from whole-genome microarray analyses indicated a limited inflammatory reaction. No evidence of cellular responses to excess iron ions was detected. Iron-containing deposits were detected in the vicinity of the implant. In addition, individual cells in various organs reacted positively with an iron-specific stain. Conclusion: A simple and robust mouse model was established that permits a first detailed in vivo evaluation of novel degradable vascular implant materials. While slowly degrading iron implants lead to a limited local inflammation without signs of toxicity, degradation products accumulated locally as well as in various distant organs. Gene expression analysis supported the conclusion that the iron accumulated as a metabolically inactive precipitate. The mouse model can therefore reveal cellular and molecular details which serve to identify critical implant material aspects and possibly to reduce the need for more extensive testing in larger animals.

Roberta Rodeman, Sharon Cheatham, Roslyn Colvin, Joanne Chisolm, Patrick McConnell, Ralf Holzer, Mark Galantowicz, John Cheatham, Nationwide Children’s Hospital, Columbus, OH, USA
Background: Traditionally, surgery was the only option for pulmonary valve replacement (PVR) to relieve right ventricular outflow (RVOT) obstruction and restore pulmonary valve function after previous palliation. Transcatheter options are currently available including percutaneous pulmonary valve implant (PPVI), as well as perventricular pulmonary valve implant (PVPVI), performed off cardiopulmonary bypass. Purpose: The purpose of this study was to compare outcomes of three valve implant techniques from one institution. Methods: An IRB approved retrospective chart review was performed on all patients that underwent surgical PVR (group 1), PPVI (group 2), and PVPVI (group 3) between May 2008 and June 2012. Analysis of variance was performed followed by multiple pairwise comparisons for age, weight, height, body surface area, anesthesia time, procedure time, blood transfusion, hospital length of stay, and hospital cost. Fluoroscopy time was compared in group 2 and group 3. Pre- and post-valve stenosis and regurgitation was compared using the paired t test. The alpha level was set at 0.05. Results: A total of 119 patients with similar demographics were identified and procedures reviewed; median age 20 years (range 5–63 years). Group 1 n = 32; group 2 n = 81; group 3 n = 6. Significant differences between pairwise comparisons were noted between group 1 and group 2 with anesthesia time (P = 0.016), procedure time (P = 0.004), blood transfusion (P = 0.016), and hospital length of stay (P = <0.0001). Hospital cost was significantly different amongst all groups (P = <0.0001) with group 3 being the most costly. Pre- and post-regurgitation was significantly different in all groups. Change in valve stenosis was only significant in group 2 (P = <0.0001). Median fluoroscopy time was not significantly different between groups 2 and 3 (63 vs. 34 min). Conclusions: All three techniques effectively treat pulmonary valve dysfunction. The data suggests that anesthesia time, procedure time, blood transfusions, and hospital length of stay is less for patients undergoing PPVI compared with surgical PVR. Hospital cost for PVPVI is more expensive compared to surgical PVR and PPVI. There was no significant difference between pre- and post-valve stenosis in this surgical PVR cohort. The small sample size in group 3 reduces the power for detecting differences.

Eric Eason, Satinder Sandhu, Paolo Rusconi, Peter Ferrer, Division of Pediatric Cardiolgoy, University of Miami, Miami, FL, USA
Background: Successful percutaneous closure of smaller coronary artery fistulas has been well described. However the treatment of larger fistulas has been limited to surgical closure. Objective: We demonstrate the safe and effective closure of a large left anterior descending artery (LAD) to the left ventricle (LV) by hybrid approach and occlusion with combined vascular plug/coil deployment. Methods: We reviewed the medical record including echocardiograms, angiograms, and hemodynamic data. Results: The diagnosis of a large coronary artery fistula was made at birth by transthoracic echo and confirmed by a cardiac catheterization at 3 days of life. At 21 months of age the LV end diastolic dimension (EDD) had increased to a Z-score of 1.2. On cardiac catheterization using a carotid artery cut down approach, the coronary artery fistula measured 13.3 mm in diameter and a 16 mm Amplatzer I Vascular plug (St. Jude Medical, St. Paul, MN) was placed with persistent residual flow. At 3 years there was substantial residual flow through the vascular plug with an increase in the LVEDD to a Z-score of 2.1. On repeat cardiac catheterization, multiple coils were placed within the vascular plug with minimal flow on subsequent angiograms. A repeat echo 1 month later showed LVEDD dimensions decreased to a Z-score of 0.5 with trace residual shunt. Conclusion: Large coronary to LV fistulas can be safely closed using a hybrid carotid artery cut down approach to avoid injury to the femoral artery. Residual shunting through an Amplatzer Vascular Plug can be further occluded by placing coils within the device.

Victorio Lucini,1 Granja Miguel,2 Luis Trentacoste,3 Jesus Damsky Barbosa,1 Marcelo Rivarola,4 Liliana Ferrin,5 Adelia Marques,1 1 P. Elizalde Children’s Hospital, Buenos Aires, Argentina, 2 Italian Hospital of Buenos Aires, buenos Aires, Argentina, 3 R Gutierrez Children’s Hospital, Buenos Aires, Argentina, 4 Sanatorio Mitre, Buenos Aires, Argentina, 5 Instituto de Cardiologia, Corrientes, Argentina
Objective: Assessment of effectiveness and safety of the CARDIA ULTRASEPT atrial septal defect (ASD) closure device, and short- to medium-term follow-up of patients submitted to ASD closure with it. Material and Method: The ULTRASEPT is the VIth generation of CARDIA ASD closure devices. It was carried out with a retrospective analysis of 43 patients (pts) submitted to ASD closure with this device between August 2010 and July 2012. Data collection was done by analyzing patient’s clinical histories. During the quoted period, 43 pts were submitted to the procedure. Isolated ostium secundum ASD: 32 pts; multiple or multifenestrated ASD: 5 pts; PFO: 5 pts; Fontan fenestration: 1 pt. Age: mean 25 years (range 3–69 years); weight: mean 47 kg (range 12–83 kg). Mean follow-up: 11.02 m. In this study, it was assessed: effectiveness of the implantation procedure, the occurrence of complications related to the procedure or the prosthesis used, and the persistence of residual shunt. Results: Effectiveness: successful implant in 39 patients (93%). Noneffective procedure in 3 patients (6.9%). In one patient (2.3%), the ASD couldn’t be occluded due to insufficient posteroinferior rim. One patient (2.3%) had a tear in the interatrial septum during procedure, with unstable position of the device and significant residual shunt. The device was recaptured with a snare and the patient sent to a programmed surgery. Complications: In one patient the device embolized at 24 hr, and was sent to surgery to retrieve the device and ASD closure, without complications. One patient had two ASD distance from each other. It was occluded the one with the biggest diameter and was left a 3 mm defect without hemodynamic repercussion in the follow-up (fu). Residual shunt: Transtoracic echo was done at 24 hr, 1 month, 3 month, and 6 month after procedure, 97.6% (42 pts) of the patient presented complete occlusion at 24 hr control. One patient presented residual shunt after procedure during follow-up. It has 2 ASD distance from each other. There weren’t mortality or significant complications. We haven’t found fracture or an injury due to erosion during the short- and medium-term follow-up. Conclusion: ASD closure with ULTRASEPT was safe, effective, and well tolerated procedure, with very small number of major complication in our small series of patients.

Andrew Edwards,1 Alex Veldman,1 Ilias Nitsos,1 Yuen Chan,2 Nadine Brew,1 Samuel Menahem,3 Dietmar Schranz,4 Flora Wong,1 1 The Ritchie Centre, Monash University, Melbourne, Victoria, Australia, 2 Department of Pathology, Monash Medical Centre, Melbourne, Victoria, Australia, 3 Fetal Cardiac Unit, Monash Medical Centre, Melbourne, Victoria, Australia, 4 Pediatric Heart Center, Justus-Liebig University, Giessen, Germany
Background/hypothesis: Fetal pulmonary valvuloplasty may ameliorate hypoplastic right heart syndrome and mitigate postnatal disease. Fetal heart access by direct fetal heart puncture is well-described. We have recently developed a percutaneous transhepatic fetal cardiac catheterization technique, which may be safer and offer technical advantages. We hypothesized that fetal pulmonary valvuloplasty could be performed by a percutaneous transhepatic approach at mid-gestational age. Materials and Methods: Nine fetal lambs at 97–100 (term 147) days gestation (average weight: 1,215 g) under maternal general anesthesia were studied. Under ultrasound guidance, the fetal hepatic vein was percutaneously punctured using a 16GA IV cannula with needle in situ. A 2.6/1.8 Fr coronary catheter (FineCrossTM MG, Terumo) was inserted into the cannula over a 0.014 inch floppy guidewire, and the IVC, RA, RV, pulmonary artery, ductus arteriosus, and descending aorta catheterized. After removing the guiding catheter, but with the guidewire in place, a coronary percutaneous coronary angioplasty (PTCA) catheter was positioned across the pulmonary valve, and several inflations of the balloon were performed simulating a valvuloplasty. Seven fetuses were euthanized postprocedure, and two were euthanized after term-delivery, for postmortem examination. Results: Percutaneous cannulation of the fetal hepatic vein followed by RA and RV catheterization was successful in all cases. One fetus died during catheterization following RV perforation. In the remaining eight cases the coronary catheter was advanced to the descending aorta. Pulmonary valvuloplasty was successful in five cases using catheters with a 6-mm long balloon, and postmortem showed minimal hemorrhage without cardiac trauma. The procedure was unsuccessful in two cases (both survived) using a 12-mm long balloon which could not be turned into the pulmonary artery, but the fetuses survived and postmortem showed small RV perforations. In one case, the PTCA catheter could not be inserted as the cannula became dislodged. Conclusions: Fetal pulmonary valvuloplasty by percutaneous transhepatic cardiac catheterization is feasible, providing an alternative route for human fetal cardiac intervention.

Alex Veldman,1 Andrew Edwards,1 Ilias Nitsos,1 Nadine Brew,1 Samuel Menahem,2 Dietmar Schranz,3 Flora Wong,1 1 The Ritchie Centre, Monash University, Melbourne, Victoria, Australia, 2 Fetal Cardiac Unit, Monash Medical Centre, Melbourne, Victoria, Australia, 3 Pediatric Heart Center, Justus-Liebig University, Giessen, Germany
Introduction: Fetal blood flow and pressure remain an area of high scientific interest. Non-invasive techniques in assessing these parameters are limited in accuracy and precision. Fetal surgery to insert flow probes of catheters creates an artificial environment for the fetus that might limit the generalization of such measurements. Here, we report on the feasibility of flow and pressure measurements in the venous and arterial circulation of the fetal lamb using an ultrasound guided percutaneous transhepatic fetal cardiac catheterization technique through the maternal abdominal wall. Methods: Eight fetal lambs at 97–100 days gestation (term 147 days, average weight: 1,252 g) under maternal general anesthesia were examined. Under ultrasound guidance, the fetal hepatic vein was percutaneously punctured using a 16GA intravenous cannula with needle in situ. A 2.6/1.8 Fr Terumo Finecross catheter (Terumo Cardiovascular, Leuven, Belgium) was inserted over a 0.014 inch floppy-guidewire, and the IVC, RA, RV, pulmonary artery, ductus arteriosus, and descending aorta catheterized. After removal of the guidewire, blood pressure was recorded in the descending aorta (DAO). A 0.014 inch Doppler guide wire was inserted and the Doppler tracing was recorded (Flowire and Combomap Volcano Cooperation, Cordova, CA) Results: In all fetuses, the catheter was successfully advanced into the abdominal aorta through IVC, RA, RV, MPA, DA and DAO. Mean BP in the DAO was 34.1 mm Hg (range 24.8–46.2 mm Hg). High quality Doppler traces could be recorded in DAO, MPA, and DA. In the DAO, systolic blood flow velocity ranged mainly from 45 to 65 cm/sec while diastolic blood flow being documented between 10 and 15 cm/sec. In the MPA, systolic blood flow velocity ranged mainly from 25 to 35 cm/sec while diastolic blood flow being documented between 10 and 15 cm/sec. Conclusion: The ultrasound guided percutaneous transhepatic fetal cardiac catheterization technique presented here is feasible in the lamb model from 2/3 gestation onwards. This technique provides a unique and minimal invasive future opportunity to assess fetal physiology in a variety of maternal conditions, such as maternal hyper/hypoxia, infection, volume depletion/shock, and others.

Michael D. Seckeler,1 Edward O’Leary,2 K. Anitha Jayakumar,3 1 Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA, 2 University of Virginia, Charlottesville, VA, USA, 3 Sanger Heart and Vascular Institute, Levine Children’s Hospital, Charlotte, NC, USA
Background: Staged single-ventricle palliation relies on passive flow through the pulmonary circuit to generate adequate preload and cardiac output. Methods: Single center, retrospective review of patients with singleventricle anatomy undergoing pre-stage 2 (PS2) and/or pre-stage 3 (PS3) hemodynamic evaluation from 1995 through April 2012. Data included demographics, cardiac diagnoses, hemodynamic data, and mortality. Patients with single left ventricles (SLV) were compared to those with single right ventricles (SRV), and PS2 and PS3 data were compared for patients who underwent subsequent stage 3 palliation. Results: One hundred eight patients underwent PS2 cath, 57 (53%) SLV, and 51 (47%) SRV. At PS2 cath, there was significantly higher mean left atrial pressure in the SRV group (7.7 vs. 5.7 mm Hg, P = 0.002) and a trend toward higher mean left pulmonary artery pressure (15.1 vs. 13.4 mm Hg, P = 0.071), mean right atrial pressure (6.9 vs. 5.9 mm Hg, P = 0.061), and end-diastolic pressure (9.1 vs. 8 mm Hg, P = 0.054). There was no difference in mean right pulmonary artery pressure (13.7 vs. 13.8 mm Hg, P = NS) or pulmonary vascular resistance (1.5 vs. 1.5 iWu, P = NS). Seventy-eight patients underwent subsequent PS3 cath, 44 (56%) SLV, and 34 (44%) SRV. The SRV group had significantly higher mean left pulmonary artery pressure (11.4 vs. 10 mm Hg, P = 0.044), higher mean right and left atrial pressure (5.9 vs. 4.7 mm Hg, P = 0.041 and 6.4 vs. 5.1 mm Hg, P = 0.033), and end-diastolic pressure (7.6 vs. 6.6 mm Hg, P = 0.048) and a trend toward higher mean right pulmonary artery pressure (11.6 vs. 10.4 mm Hg, P = 0.056). There was no difference in pulmonary vascular resistance (1.6 vs. 1.6 iWu, P = NS). SLV patients had a significant decrease in end-diastolic pressure after stage 2 surgery (7.7 vs. 6.6 mm Hg, P = 0.042), but the SRV patients did not (8.6 vs. 7.6 mm Hg, P = NS). Overall mortality was 10%, with 6 (12%) in the SLV group and 5 (11%) in the SRV group, which was not statistically different. Conclusions: Intrinsic differences in morphology, function, and response to performing as the systemic ventricle between single right and left ventricles may cause a persistently higher ventricular end-diastolic pressure that could limit passive flow through the pulmonary circuit and lead to poorer performance after stage 3 palliation for SRV patients.

Lucy Eun, Do Hoon Kim, Soo Jin Park, Nam Kyun Kim, Jae Young Choi, Yonsei University, Seoul, Republic of Korea
Patent foramen ovale (PFO) has been known to be the cause of transient ischemic attacks or stroke, and transcatheter device closure has been the treatment of choice for these defects. Combined defect of abnormal drainage of left superior vena cava (LSVC) to left superior pulmonary vein (LSPV) in PFO patients is not a very common combination, but if present, both can act as a pathway for paradoxical embolism. We believe that simultaneous device closure of PFO, using AMPLATZER PFO occluder, and persistent LSVC, using the Amplatzer vascular plug II is not yet reported in Korea. A 37-year-old female was referred to our hospital with sudden onset of left upper extremity weakness. Brain MRI showed signs of stroke and on transthoracic echocardiography (TTE) performed to exclude a possible cardiac origin of cerebral embolism, PFO was suspected and transcatheter closure of PFO was scheduled. Contrast echocardiography performed via the left upper extremity prior to the procedure showed sequential filling of the bubble in the left atrium (LA) followed by left ventricle and then through the PFO to the right atrium. For a thorough evaluation, heart CT was performed and an abnormal connection of LSVC to left superior pulmonary vein (LSPV), draining to LA was shown, and it was also confirmed in the angiogram. Through the right femoral vein, the abnormal connection between LSVC and LSPV was closed using the AMPLATZER vascular plug II (diameter = 12 mm). Afterwards, transcatheter PFO closure with AMPLATZER PFO occluder (diameter = 25 mm) was also performed. We report a successful closure of persistent LSCV connected to LSPV using an AMPLATZER vascular plug II. Because this combined anomaly of PFO and persistent LSVC can be treated by a single transcatheter intervention, if clinically suspected, a complete evaluation for this anomaly should be considered.

Oliver Stumper, Bharat Ramchandani, Patrick Noonan, Vinay Bhole, Rami Dhillon, Chetan Mehta, Birmingham Children’s Hospital, Birmingham, UK
Introduction: Balloon expandable stents are an integral part in the catheter treatment of congenital heart disease (CHD). In the growing child, stents have to be dilatable to greater diameters over time. All current stent designs have limitations. The pre-mounted Cook Formula stent is a recent 316 stainless steel open-cell design licensed for peripheral vascular work. Methods: extensive ex vivo studies were carried out to better understand the stent behavior regarding shortening and ability to overdilate the stent. Subsequently, 36 stents were implanted in 35 children (median age 1.25 (0.03–9.8) years; median weight 8.2 (3.6–43) kg). Results: Stents were implanted in the right ventricular outflow tract in 13 patients with Fallot-type lesions, in 11 for branch pulmonary artery stenosis (4 post-Fontan), 5 conduit stenosis, 2 Fontan fenestrations, 2 PDA in hybrid stage I Norwood and one each SVC and CoA. Stent delivery up to 7 mm was over a 0.014@ wire via a 4 Fr/5 Fr sheath or 6 Fr guidecatheter. About 8 mm or 10 mm stents (from March 2012) were placed over a 0.035@ wire using a 7 Fr Mullins sheath. Stent tracking and delivery was excellent. There was no stent shortening for dilatation to nominal diameter and beyond. Eighteen stents were primarily or subsequently overdilated without any shortening. The 5 mm stent could be dilated to 10 mm, and the 10 mm stent could be dilated to 17 mm without shortening. There was one circumferential balloon fracture requiring retrieval, and one stent slipped and was removed. Conclusion: The Cook formula stent is a versatile pre-mounted balloonexpandable stent that can be significantly overdilated with virtually no shortening. This allows for precise placement without protrusion into adjacent vessel. It is a great addition to the range of stents for use in the catheter treatment of complex CHD in children.

Corey Stiver, Thomas Preston, Daniel Gomez, Joanne Chisolm, Sharon Cheatham, Patrick McConnell, Mark Galantowicz, John Cheatham, Ralf Holzer, Nationwide Children’s Hospital, Columbus, OH, USA
Introduction: Extracorporeal membrane oxygenation (ECMO) has been a beneficial therapy in patients with profound respiratory or cardiac failure, but little data exist on cardiac catheterization performed on ECMO support. Methods: A retrospective chart review was performed on patients who underwent cardiac catheterization on ECMO between August 2003 and November 2011 and findings analyzed. Results: Thirty catheterizations were done in 26 patients, median age 11 weeks (1 day to 19 years). The median time on ECMO prior to cardiac catheterization was 1.5 days (<1–13 days). The underlying diagnosis was congenital heart disease in 19, cardiomyopathy in 6, and non-cardiac disease in 1 patient. The principal indication for cardiac catheterization included evaluation for possible pathology amenable to transcatheter or surgical therapy (n = 18), left atrial decompression (n = 8), planned transcatheter intervention for known pathology (n = 3), and other indications (n = 1). Procedures were performed in the Hybrid Cardiac Catheterization Suite (n = 18) or Hybrid Operating Suite (n = 6), cardiothoracic ICU (n = 5), as well as pediatric ICU (n = 1). The median time from arrival in the catheterization suite to vascular access was 68.5 (43–148) min. The ECMO cannula was used for vascular access in four patients. The majority of cases were performed using single plane fluoroscopy (n = 22), and positioning of one patient was reversed on the table due to the ECMO cannula. The median case time was 137.5 (9.8–328) min and median fluoroscopy time 34.3 (7.5– 72) min. Atrial septal interventions were performed in eight cases (four of which were intact), pulmonary artery rehabilitation in one, pulmonary vein stent in one, pulmonary artery stent in two, Blalock-Taussig shunt stent in one, aortic coarctation stent in one, and covered aortic stent in one patient. No intervention was performed in 15/30 (50%) of cases. Major adverse events occurred in 6/30 (20%) cases: hemothorax (n = 2), reperfusion injury (n = 1), stent migration (n = 1), intra-abdominal bleed after transhepatic access (n = 1), ventricular tachyarrhythmia (n = 1). 18/26 (69%) of patients were successfully weaned from ECMO support, with 16/26 (62%) surviving to hospital discharge. Conclusions: Cardiac catheterization on ECMO support requires careful consideration of procedural location, transport, and vascular access. Hemorrhagic complications are not infrequent and may be exacerbated by continued need for heparin.

Jesus Damsky Barbosa,1 Victorio Lucini,1 Adelia Marques Vitorino,1 Jorge Gomez,2 Liliana Ferrı´n,3 Fernanda Biancolini,1 Miguel Granja,1 Ana De Dios,3 1 Children’s Hospital “Pedro de Elizalde”, Buenos Aires, Argentina, 2 Hospital “Gervasio Posadas”, Buenos Aires, Argentina, 3 Heart Institute, Corrientes, Argentina
Introduction: We reviewed the outcome of 28 patients (pts) less that 10 kg with patent ducts arteriosus (PDA) that underwent PDA closure with NIT OCCLUD1 PDA-R. Material and Methods: Between April 2010 and September 1, 2012, 29 PDA closure procedures were performed with NIT OCCLUD1 PDA-R. Mean follow-up (FU): 9 months. Gender: 17 females and 12 males. Age: mean 12.3 months (m) (6–26 m). Weight: mean 7.780 kg (3.400–10 kg). Qp:Qs > 2.5:1. Pulmonary pressure: 8/28 patients were normal (17.85%); 20/28 patients (82.15%) had pulmonary hypertension: five mild, seven moderate, and nine severe. Mean pulmonary diameter: 4.04 mm (2.5–4.5 mm). Mean aortic diam: 9.3 mm (5–14 mm). Mean length: 8.8 mm (5–12 mm). Mean device size: 4.3 mm (3–7 mm). One patient was treated with Sildenafil due to high pulmonary resistance (4 WU). In the 3-month follow-up (FU) the treatment was suspended. Three patients were on mechanical ventilation (MRA) for bronchiolitis syndrome at the time of the procedure. One patient had a residual postsurgical duct. Results: Complete occlusion was found by Echo in 23/29 patients (78.57%) at 24 hr control. At 1-month FU 27/28 patients (96.4%) had complete occlusion. Only one patient remained with trivial shunt till 12- month FU (93.75% closure rate). This patient had complete closure at 2-year FU. The three patients that required MRA were successfully weaned in 48 hr. In one patient (3.400 kg) the device was positioned into the duct with reversal disc not properly configured, after 24 hr, the disc was totally opened and protruding into the descending aorta with 20 mm Hg of gradient by Echo. At 6-month FU gradient was reduced to 10 mm Hg. No further complications occurred. Conclusions: (1) PDA closure in patient less thanr 10 kg can be performed without complications with NIT OCCLUD1 PDA-R device. (2). Occlusion rates, although lower immediately after the procedure than with other devices, increase over time reaching near 100% after 12 months. (3). When the device was properly configured, although gradient across the descending aorta was moderate, large devices in small children were used without the need to replace or retrieve then.

Jesu´s Damsky Barbosa,1 Vitorio Lucini,1 Adelia Marques Vitorino,1 Luis Trentacoste,2 Marcelo Rivarola,2 Jorge Gomez,3 Liliana Ferrin,4 Ana De Dios,1 Miguel Granja,5 1 Children’s Hospital ‘‘Pedro de Elizalde’’, Buenos Aires, Argentina, 2 Children’s Hospital “Ricardo Gutie´rrez”, Buenos Aires, Argentina, 3 Franchı´n Institution, Buenos Aires, Argentina, 4 Heart Institute, Corrientes, Argentina, 5 Italian Hospital, Buenos Aires, Argentina
Objectives: The aim of this study is to assess the immediate and midterm results in patients (pts) who underwent percutaneous atrial septal defect (ASD) closure with NIT OCCLUD1 ASD-R and PFO (PFM). Material and Method: From November 2009 to September 2012, 39 pts underwent endovascular ASD closure with NIT OCCLUD1 ASD-R and PFO. Mean follow-up (FU): 13.5 months (1–36). Gender: 26 females and 13 males. Age: mean 19 years (4–60 years old). Weight: mean 36 kg (15–68 kg). All the procedures were performed under general anesthesia and simultaneous transesophageal echocardiography (TEE). Vascular access was through femoral vein. All the pts with Qp:Qs 1.6:1 and normal pulmonary pressure. The ASD was measured with TEE and balloon sizing with stop flow technique. Balloon sizing was not carried in seven pts due to their thick rims so the size of device used was the diameter by TEE. Mean ASD diameter: 11.3 (8–22 mm). In three pts the ASD was multifenestrated. Balloon sizing was not performed and a PFO device was selected for these. Follow-up: 24 hr, 3 months, 6 months, 1 year, and annually after procedure. Results: Immediate results: 29/39 pts (74.3%) had complete occlusion and 10/39 pts (25.3%) had minimal residual shunt. Three months after procedure all pts had complete occlusion. Six pts had 36-month FU in which they did not show complications such as arrhythmias, perforations, thrombus formation, or dislodgment of the device. Conclusions: (1). The percutaneous closure of small to moderate size ASD with NIT OCCLUD1 ASD-R and PFO was feasible and safe. (2). All the patients had completely closed ASD at 3 month of follow-up. (3). There were no complications in the small number of pts who had 36 months follow-up.

Timothy Maher, Andrew Pelech, Yumei Cao, Pippa Simpson, Todd Gudausky, Medical College of Wisconsin, Milwaukee, WI, USA
Background: Following the bidirectional glenn SHUNT (BDG), many patients develop innominate veno-venous collaterals. These collaterals decompress the innominate vein, reduce pulmonary perfusion, and contribute to increased cyanosis. To better understand the ‘‘natural history’’ of venous collateral development and the impact these collateral vessels have on BDG performance and patient survival, we reviewed our institutional experience with the BDG shunt from 2000 through 2011. Methods: All subjects with adequate pre- and post-Glenn angiographic imaging of the innominate vein, pulmonary arteries, and aortic arch were included. Echocardiographic, hemodynamic, and angiographic data were collected. Comparisons were made between patients with and without venous collaterals. Results: A total of 158 patients underwent a BDG shunt and had adequate angiography. At pre-Glenn catheterization 51/158 (32.3%) patients had identified innominate venous collaterals. The collaterals measured 2.6 mm in diameter in 5/51 patients. One patient had coil occlusion and two patients had surgical ligation of the collaterals. No significant differences in hemodynamic or angiographic parameters were noted between patients with and without collaterals. At post-Glenn catheterization 90/153 (58.8%) patients had identified collaterals. The collaterals measured 2.6 mm in diameter in 40/90 patients. Twenty-one patients had catheter occlusion and six patients had surgical ligation of their collaterals. No significant differences in hemodynamic or angiographic parameters were noted between groups. Following BDG 13 patients died and 6 underwent heart transplantation. 12/14 (85.7%) patients were found to have collaterals at catheterization. Venous collaterals were present significantly less often in the remainder of the cohort 78/139 (56.1%, P = 0.04). Conclusion: Innominate venous collaterals are common in single ventricle patients before and after the BDG. Many patients spontaneously develop venous collaterals after the BDG. Small venous collaterals noted prior to BDG tend to increase in size when reimaged after surgery. Generally, innominate venous collaterals are well tolerated in single ventricle patients after BDG. However, most of the patients who died or required heart transplantation after BDG were noted to have innominate venous collaterals which may have been poorly tolerated.

Carlos Marin˜o Vigo, Cesar Salinas Mondragon, Carlos Pedra, Freddy Prada, Maria Lapoint Montes, Teresa Velasco, Isabel Zarate, Instituto Nacional de Salud del Nin˜o, Lima, Peru
Objective: To describe the clinical outcomes of treatment with occluder devices in patients with congenital heart susceptible of interventional treatment. Background: Globally various institutions are using these devices. In our country, the National Institute of Child Health (NICH) is one of the first institutions to use. Material and Methods: We retrospectively reviewed the medical records of patients with congenital heart disease treated with interventional occluder devices in (NICH) from 2007 to 2010. Results: Forty-eight patients with PDA (n = 38), ASD (n = 10), and coronary fistula (n = 02) was attempted percutaneous closure of heart defect with occluder devices such PDA occluder (Amplatzer), Nit Occlud PDA, ASD septal occluder (Amplatzer), Solysafe ASD, and Vascular Plug II (Amplatzer). The clinical profile: average age 7.5 years (range of 1–15 years), weight 8.4–50 kg. For cases of PDA minimum diameter pulmonary was 1.6–7.6 mm, using PDA Amplatzer (20 cases) and Nit Occlud PDA (15 cases). Success rate: 35/38 (92%). For cases of ADS, the average size of the defect was 15.4 mm (TEE) using Amplatzer ASD device (7 cases) and Solysafe ASD (2 cases). Success rate: 9/10 (90%). In cases of coronary fistulas, the case no.1 (8 years): right coronary artery fistula to RA was occluded by multiple coils, and case no.2 (10 years): left coronary artery fistula to RA was occluded with Vascular Plug II. No major complications and hospital stay was less than 48 hr and immediate positive developments. Conclusions: The use of occlusive devices in the treatment of congenital heart defects: patent ductus arteriosus, atrial septal defect, and coronary fistulas became an effective and safe procedure, with short hospital stay and low complication rate.

Vikram Kudumula, Vinay Bhole, Bharath Ramchandani, Chetan Mehta, Oliver Stumper, Birmingham Children’s hospital, Birmingham, UK
Aim: To review our institutional experience with the off label use of the new Amplatzer duct occluder II additional sizes (ADO II AS) device in children. Methods: Retrospective record review of all children who underwent ADO II AS device implantation for off label indications. Results: We used the ADO II AS device in six patients (median age: 3.75 (range 1.25–9.75) years, median weight: 13.35 (range 8–20) kg for off label indications since January 2011. Three patients underwent implantation to close a previously created stent fenestration of a failing Fontan circulation (two for prolonged pleural effusions and one for bronchial casts). Devices used were one 3/4, 4/4, 5/4 each. The device was implanted with the appropriate delivery sheath crossing a cell of the stent and anchoring the proximal disc outside the lumen of the stent. The SaO2 were (82%, 88%, and 78%) before the procedure and increased to (95%, 96%, and 95%) after the procedure. Postprocedure angiogram has shown tiny residual flow across the fenestration in all three patients thereby offering the option of re-crossing the stent fenestration, should symptoms recur. Two patients underwent occlusion of major aorto-pulmonary collaterals using a 3/2 and a 3/4 ADO II AS device with good result achieving complete occlusion. Another patient with critical pulmonary valve stenosis who had stenting of PDA and balloon pulmonary valvuloplasty in the past had successful occlusion of the stented PDA with 4/6 ADO II AS device. The median procedure time was 51 (47–236) min. No complications were encountered. Conclusion: The ADO II AS device can be used effectively and safely for a variety of occlusion procedures.

Vikram Kudumula, Patrick Noonan, Vinay Bhole, John Stickley, Joseph De Giovanni, Rami Dhillon, Paul Miller, Chetan Mehta, Oliver Stumper, Birmingham children’s hospital, Birmingham, UK
Background: Transcatheter retrieval of cardiovascular foreign bodies is well established but there are no large pediatric studies in the literature. We reviewed our 15-years experience of transcatheter retrieval of foreign bodies from the cardiovascular system. Methods: Retrospective record review of all children with transcatheter foreign body retrieval. Cases of retrieval of malpositioned PDA coils were also included. Results: Transcatheter retrieval of foreign bodies from the cardiovascular system was attempted in 78 patients (median age 4 (0.02–16) years and median weight 15 (1.7–74) kg). During this time period there were 5,500 interventional cardiac catheter procedures performed. Retrieved foreign bodies included embolized devices (n = 46), central venous and arterial line tips (n = 15), guide wires (n = 3), stents (n = 8), ruptured balloon tip (n = 4), fractured ventriculo atrial shunt (n = 1), and fractured sheath introducer (n = 1). The incidence of embolization for ASD, VSD, and PDA devices/coils was 1.9% (9/466), 2.8% (4/140), and 3% (32/1,066), respectively. Retrieval sites included pulmonary arteries (PAs) (n = 33), aorta (n = 11), PDA (n = 9), central veins (n = 7), right atrium (n = 7), right ventricle (n = 3), RV to PA conduit (n = 3), left atrium (n = 1), and left ventricle (n = 4). Transcatheter retrieval was successful in 70/78 (90%) and had to be performed surgically in six patients. In two patients, the PDA coils were embolized into small distal PAs and after unsuccessful transcatheter retrieval attempts they were left in the distal PAs. Mean sheath size was 8 (4–16) Fr. Gooseneck snare was the most commonly used retrieval device. Mean procedure time was 100 (15–316) min and fluoroscopy dose was 40 (0.4–320) Gy/cm2 . There were no procedural deaths. Complications included transient loss of foot pulses in five and excess blood loss requiring transfusion in two. Conclusion: Transcatheter retrieval of cardiovascular foreign bodies can be performed safely in the majority of children including infants thus obviating need for the surgery. It is essential to have a comprehensive inventory of retrieval equipment and interventional staff conversant with its use.

Mirella Molenschot, Matthias Freund, Hans Breur, Gregor Krings, University Medical Center Utrecht, Wilhelmina Children’s Hospital, Utrecht, The Netherlands Introduction: Aneurysms can occur after right ventricular outflow tract (RVOT) surgery, especially when distal stenoses are present. Since 1 year, we routinely use 3-dimensional rotational angiography (3DRA) in patients with pulmonary artery (PA) stenoses to visualize complex bifurcation morphology prior to stent implantation. We summarize our experience of formerly unknown RVOT aneurysms (RVOTA) which were discovered by coincidence. Patients: Five patients, median weight 6 kg (4–60 kg), median age 0.8 years (0.2–25 years), were scheduled for hart catheterization (HC): two had single ventricle morphology (SV) at stage 1 of palliation (shunt), one truncus arteriosus (TA), and two tetralogy of fallot (ToF). All patients underwent HC under general anesthesia and 3DRA was performed using rapid pacing and multiple site contrast injections. Results: One rotational angiography with multiple site contrast injections (RVOT and ascending aorta) identified the expected pulmonary stenoses, but furthermore revealed the unexpected RVOTA with high resolution in all patients. Two patients received PA stents. RVOTA was resected surgically in four patients. 3DRA delineated the critical proximity between coronary artery and RVOTA in two patients, visualized severe left PA compression by RVOTA in one patient and was essential to exclude the RVOTA with covered stents in one patient scheduled for Melody procedure. One SV patient remains unsuitable for second stage palliation due to elevated pulmonary resistance and the RVOTA was accepted so far. Conclusion: Non-invasive imaging by CT or MRI is the gold standard in congenital heart disease, but is challenging in patients < 5 kg and with high heart rates. When performing HC for PA stenting, 3DRA offers high-resolution information in complex topography ‘‘in-one-run.’’ Furthermore, 3DRA can reveal unexpected and essential findings leading to major changes in interventional or surgical strategy.

Worakan Promphan,1 Chaiyasit Wongwipaporn,2 Napa Siriwiwattana,3 Worawut Tassanawiwat,4 Aungkana Gengsakul,5 1 Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand, 2 Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand, 3 Rajvithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand, 4 Sappasittiprasong Hospital, Ubon Ratchathani, Thailand, 5 Phramongkutklao Hospital, Bangkok, Thailand
Background: In Thailand, three brands of double disc nitinol devices are now available: Amplatzer septal occluder (ASO); Cocoon septal occluder (CSO), and Occlutech septal occluder (OSO). The aim of this study was to evaluate safety and efficacy in a mid-term follow-up among different brands of double disc device for transcatheter ASD closure in adults. Method: One hundred forty-eight cases were enrolled in the study. Inclusion criteria were those with significant intracardiac shunt, symptoms related to right heart failure, or pulmonary arterial hypertension (PAH). Patients with ASD diameter > 35 mm, reverse atrial shunt, systemic PAH not responding to reactivity testing or contraindication for antiplatelet or anticoagulant therapy were excluded from the study. Patients’ survival and clinical events occurrence were determined from reviews of medical records or direct patient contact. Major procedural complication included all events leading to death, need for cardiac surgery, life-threatening hemodynamic decompensation, and permanent lesion resulting from the procedure. Results: Majority of cases were female (77%). Mean pulmonary artery pressure (mPAP) was 21.7 6 9.7 mm Hg. Mean age was 40.0 6 15.4 years. Atrial fibrillation occurred in nine cases (6%). Fifty-seven of cases (37%) had deficient aortic rim. ASO was implanted in 60, CSO in 52, and OSO in 36 cases. There was no significant difference among age, sex, mPAP, and ASD diameter in each group. Procedural success was 93, 94, and 100% in ASO, CSO, and OSO group. Median diameter of device implanted in ASO, CSO, and OSO group was 28, 28, and 24 mm, respectively. Mean follow-up time was 31.3, 21.8, and 19.4 months in ASO, CSO, and OSO group. Residual shunt in day 1 was 41.7, 42.1, and 42.9% of ASO, CSO, and OSO group. There was no residual shunt in all groups 1 month after implantation. Device embolization occurred in three cases (1 in each group). Two patients had massive pericardial effusion (1 in ASO, 1 in CSO) requiring surgical treatment. One patient of CSO group with AF developed stroke a month after implantation. There was no mortality in all groups. Conclusion: In midterm follow-up, all three brands of double disc device showed favorable outcomes without significant complications.

Bagrat Alekyan, Manolis Pursanov, Sergeyi Gorbachevskyi, Bakoulev Scientific Center for cardiovascular surgery RAMS, Moscow, Russia
Objective: Atrial septostomy (AS) can be beneficial in patients with severe pulmonary arterial hypertension (PAH) because it procedures a pathway by which systemic cardiac output can increase. The biggest problem is the creation of an appropriate size of ASD without any deterioration. The aim of this study was to analyze the result of these procedures. Methods: Between January 2006 and September 2012, AS was performed in 31 patients with idiopathic PAH. Median age at the time of AS was 14 years (range, 5–34 years). Indication for AS was class III or IV modified NYHA classification with right ventricular dysfunction but normal or slightly decreased cardiac output. The procedure was performed using fluoroscopy, intubation, general anesthesia, and TEE. ‘‘Palmaz’’ stents were inserted in all cases. In all cases but one atrial septum was intact. Results: Cardiac catheterization revealed PAH in all patients. Median systolic pulmonary artery pressure (PAP) was 105 6 45 mm Hg (range, 80–188 mm Hg). Median systemic blood saturation was 90 6 2% (range, 88–94%). Sizes of created ASD were 5 mm in 21 patients, 6 mm in 9, and 8 mm in a patient 34 years old. Immediately after, procedure was increasing of PAP in all patients even in patient with PAP of 188 mm Hg (203 mm Hg) and moderate decreasing of systemic blood saturation—89 6 2% (range, 84–95%). One patient died at the time of ASD creation (2.8%). The cause of death was damage of the right atrial wall. The patients were followed up for a mean period of 25.3 month (range, five month to four years). There were two late deaths (one month and two years after procedure). The estimated probability of survival at one year was 93%, and at two years—87%. In follow-up there was functional improvement in six patients with slightly decreasing of PAP. Conclusions: AS with stent improves clinical status, hemodynamic variables, and possibly survival in selected patients with idiopathic PAH. It may be a real bridge to lung transplantation.

Bagrat Alekyan, Vladimir Podzolkov, Manolis Pursanov, Bakoulev Scientific Center for cardiovascular surgery RAMS, Moscow, Russia
Purpose: To show the possibilities of Amplatzer occluders in the management of patients with different congenital and acquired cardiac and vascular communications. Material and methods: Amplatzer occluders have been implanted in 72 patients with different pathological, cardiac, and vascular communications. In 26 cases, the occluder was used for the closure of antegrade blood flow in the pulmonary artery trunk after hemodynamic Fontan correction and bidirectional cavapulmonary anastomosis, in 7 cases—for the closure of large aorto-pulmonary collateral arteries (LAPCA), in 7 cases—for the closure of coronary-cardiac fistula, in 7 cases—for the closure of veno-venous fistula, in 6 cases—for the closure of paraprosthetic fistula after MV and AoV replacement, in 4 cases—for the closure of aorto-pulmonary septal defect (APSD), in 3 cases—for the closure of a communication between the RA and the LV, in 3 cases—for the closure of pulmonary veins collector after radical correction of total anomalous pulmonary veins return, in 3 cases—for the closure of arterio-venous fistula, in 2 cases—for the closure of Valsalva sinus rupture into the RV after radical correction of tetralogy of Fallot, in 1 case—for the closure of recanalized systemic-pulmonary anastomosis, in 1 patient—for the closure of a giant aneurysms of the right vertebral artery, in 1 patient—for the closure of fenestration of extracardiac conduit after Fontan operation, in 1 patient—for the closure of anastomosis Blelock-Taussig after Rastelli operation. Results: Amplatzer occluder was successfully implanted in all 72 patients. After the closure of antegrade blood flow in the PA trunk, clinical improvement was noted in all patients. Occluder implantation also led to successful closure of coronary-cardiac fistula, iatrogenous communication between the LV and the RA, paraprosthetic fistula, aorto-pulmonary septal defect, and other communications mentioned above. Occluder-related complications were encountered neither in early nor in late postoperative period. Conclusions: The use of Amplatzer occluders is an effective and safe therapeutic procedure for the closure of different pathological cardiac and vascular communications provided the respect of indications.

Leo Bockeria, Bagrat Alekyan, Manolis Pursanov, Bakoulev Scientific Center for cardiovascular surgery RAMS, Moscow, Russia
Purpose: To show the feasibility of hybrid treatment for the correction of CHD. Material and Methods: Hybrid interventions have been applied in 146 patients with different congenital heart defects. One hundred eighteen patients with left heart hypoplasia syndrome (age from 12 to 72 years) underwent bilateral narrowing of the pulmonary artery with subsequent PDA stenting through the pulmonary trunk. In one patient with TF and ductal origin of the left pulmonary artery, the ductus was stented through ascending aortic approach. A 5-months-old patient underwent transventricular closure of 5 mm large perimembranous VSD under echocardiographic guidance. Another 9-years-old patient with tetralogy of Fallot and previous stenting of the pulmonary artery underwent further intraoperative stent deployment with simultaneous radical correction of the defect. A 5-months-old patient with single ventricle and severe aortic coarctation underwent narrowing of the pulmonary artery after successful stenting of the aortic isthmus. The first stage of correction in four patients with valvular aortic stenosis and coarctation of the aorta consisted in balloon valvuloplasty of valvular aortic stenosis, with subsequent correction of aortic coarctation immediately after the endovascular stage (three patients) and in 24 hr (one patient). An outlet into the pulmonary artery was created in three patients with one type pulmonary artery atresia and intact ventricular septum. One patient with common truncus arteriosus and truncal valve stenosis underwent balloon valvuloplasty of truncal valve stenosis after bilateral narrowing of the pulmonary artery. A 2-days-old patient with coarctation of aorta, aortic valve stenosis, and hypoplasia of left ventricule. Intraoperative angiography was performed in 13 cases. Results: Twenty-one out of 29 neonates with left heart hypoplasia syndrome were discharged in satisfactory condition after bilateral narrowing of the pulmonary arteries and PDA stenting, before the second stage of hemodynamic correction. Stent dislocation into the pulmonary trunk occurred in one patient, urgent Norwood operation was performed. Seven in-hospital deaths were due to increasing multi-organ failure. A patient with TF and ductal origin of the left pulmonary artery died after PDA stenting because of increasing pulmonary edema. Radical correction of the defect was successfully performed in a patient with tetralogy of Fallot, in whom the pulmonary artery diameter has been enlarged intraoperatively from 10 to 15 mm. A patient who underwent aortic coarctation stenting and pulmonary artery narrowing was discharged in satisfactory condition. Conclusion: combined use of endovascular and surgical methods of treatment is a new and perspective trend in the treatment of congenital heart defects. Such hybrid techniques including open surgery and endovascular interventions are complementary and rather effective methods of treatment. They permit to decrease the duration of the procedure, and in some cases—to abandon the use of heart-lung machine, to decrease the rate of complications and the duration of in-hospital stay. Bilateral narrowing of the pulmonary arteries and PDA stenting are the first stage of hemodynamic correction in patients with left heart hypoplasia syndrome.

Bagrat Alekyan, Manolis Pursanov, Alexeyi Kim, Bakoulev Scientific Center for cardiovascular surgery RAMS, Moscow, Russia
Purpose: The analysis of the results of balloon angioplasty of valvular aortic and pulmonary arterial stenoses in critically ill neonates. Material and methods: From 1998 through 2012, we have operated 75 neonates with valvular aortic stenosis (AS) and 52 neonates with valvular pulmonary artery stenosis (PS) aged from 2 hr to 30 days. Mean weight of patients was 3.21 6 0.52 kg. All patients were critically ill. Preoperative left ventricular-aortic peak systolic pressure gradient in patients with AS was 80.8 6 13.34 mm Hg. Peak pulmonary transvalvular gradient in patients with PS was 95.97 6 18.9 mm Hg, arterial blood saturation varied from 21% to 88%. We preferred to use Tyshak-mini (Nu Med, Canada) balloons for balloon valvuloplasty (BVP) of the aortic valve and pulmonary artery valve. Results: Survival after transluminal balloon valvuplasty for AS was 87.5% (n = 76), the procedure efficacy—96.5%. Peak systolic pressure gradient on the aortic valve decreased by 69% on the average and was 23.9 6 10.2 mm Hg (P < 0.05). The complications were seen in 29.8% (n = 17) of all patients. Mortality was 12.3% (n = 7). After BVP for PS survival was 97.8% (n = 44), the procedure efficacy was 87.2% (n = 39). Peak systolic pressure gradient on the pulmonary arterial valve decreased by 75.8% on the average and was 23.6 6 16 mm Hg (P < 0.05). Arterial blood saturation with oxygen increased on the average from 59.7 6 17.5% to 79.6 6 11.5% (P < 0.05). The complications after procedure were seen in 6.7% (n = 3) of patients with PS. Long-term follow-up was obtained in 41 (72.1%) patients after BVP for AS and in 37 (84.1%) after BVP for PS. The follow-up duration ranged from 2 months to 10 years. The survival was 100%. Good long-term results were obtained in 41.5% (n = 17) patients with AS and in 89.2% (n = 33) with PS. Aortic valve restenosis was seen in 26.8% (n = 11) (P < 0.05), aortic valve insufficiency of 2 degree in 12.2% (n = 5) (P < 0.05), restenosis and insufficiency of the aortic valve were revealed in 14.6% (n = 6) (P < 0.05). Reoperations were necessary in 13 (31.7%) patients (P < 0.05). After BVP for PS valvular restenosis was seen in only one patient (3%). Conclusion: Balloon valvuloplasty for critical valvular aortic and pulmonary artery stenosis in neonates is an effective procedure. In the long-term follow-up, 68.3% of neonates after BVP for AS did not require reoperations, after BVP for PS restenosis developed in only 3% of neonates.

Bagrat Alekyan, Manolis Pursanov, Tamara Sandodze, Bakoulev Scientific Center for cardiovascular surgery RAMS, Moscow, Russia
Purpose: To show immediate and late results of stenting in patients with coarctation and re-coarctation of the aorta. Material and methods: By September 2012 stenting for aortic coarctation (CoA) and re-coarctation (reCoA) has been performed in 67 patients. There were 40 patients with CoA and 27 with reCoA. The patient’s age varied from 5 months to 41 years, and the weight from 5 to 90 kg. Depending on angiocardiographic semiotics, we have conditionally divided the stenoses of aortic isthmus into four types. The 1st angiographic type was seen in 28.6%, the 2nd in 32.2%, the 3rd in 21.4%, and the 4th in 17.8% of patients. In aortic isthmus stenoses of the 1st, 2nd, and 3rd types we have implanted bare stents: ‘‘PALMAZ,’’ ‘‘PALMAZ XL,’’ ‘‘Palmaz- Genesis’’ (Cordis, USA), and ‘‘CP’’ (NuMed, Canada). Results: Stenting of CoA and reCoA was effective in all cases. Good immediate angiographic, clinical, and hemodynamic results were obtained in 65 patients. In two cases satisfactory results were obtained. Both patients were after surgical resection of aortic coarctation with the creation of end-to-end anastomosis. Three patients (5.1%) had poststenting thrombosis of the femoral artery, necessitating surgical intervention. After the stenting of the CoA, mean systolic pressure gradient at the stenotic site decreased from 47 6 9.6 mm Hg to 3.1 6 1.3 mm Hg, in patients with the reCoA from 46 6 4.6 mm Hg to 2.7 6 1.8 mm Hg (P < 0.001). Systolic pressure in the ascending aorta decreased from 147.6 6 32.5 to 134.5 6 22.1 mm Hg, and diastolic pressure increased from 82.1 6 20.8 to 91.2 6 21.4 mm Hg. Systolic pressure in the descending aorta increased, respectively, from 103.9 6 28.2 to 125.9 6 26.4 mm Hg, and diastolic pressure from 81.7 6 17.1 to 83.8 6 17.9 mm Hg. In the long-term (13 months after the stenting), one patient had a complication in the form of aneurysm in the stented area. The patient underwent successful endografting of the thoracic aorta with ‘‘Valient’’ stent-graft (Medtronic, USA). Conclusions: Aortic insthmus stenting is feasible in most patients with CoA and reCoA of the aorta. In aorthic isthmus stenosis of the 1st, 2nd, and 3rd types it is possible to use bare stents, while in cases of the 4th type stenoses and in the presence of para-coarctation aneurysms coated stents are preferable. Technical success of the procedure was 100%. Stenting in aortic CoA and reCoA is a safe method of treatment, which can serve as an alternative to surgical correction in most cases.

Alimbaev Serik, Kadirova Saule, Kozlik-Feldmann Rainer, Abikeeva Lyazzat, 1 National Research Cardiac Surgery Center, Astana, Kazakhstan, 2 Ludwig-Maximilians-University, Mu¨nchen, Germany
Objectives: Teams treating structural heart disease inside the catheter laboratory are sometimes faced with unusual anatomic situations. We are reporting about a case of post-traumatic muscular VSD (mVSD) in which a transcatheter closure with a non-self-centering double umbrella device was performed utilizing intracardiac echocardiography (ICE) for procedure guidance. Methods: A 47-years-old male received emergency surgery because of pericardial tamponade after a knife injury of the thorax 1 month ago. A cut of the free right ventricular wall was sutured at this time. However, echocardiography demonstrated a 0.92–1.22 cm oval shaped mVSD with increasing hemodynamic relevance and elevated pulmonary pressures to 46/17–26 mm Hg, over the next 4 weeks. For interventional closure a 20 mm Nit-occlud-PFO occluder, a symmetric double umbrella with a very flat left-sided single layer disc was chosen for defect closure. During the intervention, ICE was used for guiding all stages of device implantation. Results: The defect was closed by Nit-occlud-PFM device well without protruding parts to the free wall of both ventricles. The flat left disc fitted very well onto the left septal wall. In the echocardiography, a little residual shunt was seen through the occluder. There were no signs of hemolysis. One month later the residual shunt had vanished and the pulmonary pressure was normalized. Discussion: The described defect after a knife injury was located very anteriorly inside the septum. A centering umbrella device would have had the risk of affecting the free wall of the ventricles with the risk of perforation and development of malignant arrhythmias. The use of the non-centering Nit-occlud-PFO with the thin and flexible monolayer disc for left side was a good solution for interventional closure of the mVSD in our case. Because of the unusual anatomy of the defect the ICE was more informative than fluoroscopy while closing the defect. Conclusion: Transcatheter closure is an alternative choice of treatment for post-traumatic mVSD. An unusual defect anatomy forces sometimes the decision for the use of unusual devices in this special situation. ICE provides a reliable method of best control for correct positioning of the device. The open mind for using new different devices and utilizing the best possibility of imaging enlarges the probability of a good result.

Christopher Bellotti, Lourdes Prieto, Cleveland Clinic Children’s Hospital, Cleveland, OH, USA
Advancing large, long sheaths through difficult anatomy can prove challenging for even the most experienced interventionalist. The recent technique of pre-stenting the RVOT to create a landing zone for transcatheter pulmonary valve implantation requires advancement of relatively large sheaths across surgical anastomotic sites and often calcified conduits, in addition to maneuvering the curves associated with the RVOT. Irregularities and crevices at the transition from native tissue to conduit or within the conduit itself can cause the tip of the dilator or the edge of sheath to ‘‘stick’’ and not advance. We describe two simple and innovative techniques that facilitate accomplishing this sometimes arduous task. The first technique involves inflating a small balloon partially housed inside an advancing sheath. With the leading edge of the balloon protruding from the sheath, one can employ a ‘‘bumper-balloon’’ technique for advancement of the sheath. Alternatively, the ‘‘anchoring’’ technique uses a balloon dilation catheter inflated distal to an obstruction which anchors the guide wire over which a sheath can be advanced without loss of wire position or untoward damage to anatomy. This technique has been successfully used when difficult RVOT or branch pulmonary artery anatomy must be crossed with a large sheath before or after placement of landing zone stents as illustrated by three cases of Melody valve implantation.

Dhaval Parekh,1 Linda Drake,1 Candice Li,1 Henri Justino,1 Frank Ing,2 1 Baylor College of Medicine/Texas Children’s, Houston, TX, USA, 2 Children’s Hospital LA/ USC, Los Angeles, CA, USA
Background: Experience with the Melody valve has increased signifi- cantly since HDE approval in 2010. We report our clinical experience and describe several tips and tricks that have helped to deliver and implant the Melody valve. Methods: Retrospective data analysis of all Melody valve implantations from August 2010 to May 2012 with Wilcoxon Signed Rank test. Results: Fifty patients were consented and taken to the cardiac cath lab for possible Melody valve (MV) implantation. MV implantation was not attempted in 23 patients due to adequate relief of RVOT with balloon angioplasty (n = 14), coronary artery compression (n = 3), compliant RVOT (n = 2), or other reasons (n = 4). Twenty-seven patients underwent successful MV implantation with 100% procedural success with a mean follow-up of 406 6 225 days. For implanted patients, median age was 13 (9–40) years and median weight was 50.3 (22.6–113) kg. Primary diagnosis included ToF (13), pulmonary atresia (8), aortic stenosis s/p Ross procedure (3), d-TGA with pulmonary stenosis (2), and truncus arteriosus (1). Indication for valve implantation included stenosis (10), regurgitation (3), and mixed (14). Type of RVOT conduit consisted of homograft (15), porcine pericardial (7), bovine jugular (3), porcine cardiac (1), and monocusp PTFE (1). A prior conduit stent was present in 9. Procedural variations included heat curving the blue tip of the delivery system to allow smooth passage around the curvature of the RVOT in 27, ‘‘figure of 8’’ stitch for venous hemostasis in 21, pre-stenting for additional structural support in 12, IJ access for delivery of valve in 1, MV implant under conscious sedation in 1, ‘‘valve-in valve’’ implant for a fractured MV in 1, and double valve implant in both the pulmonary and tricuspid positions in 1. Post Melody RVOT gradient decreased from 34.3 6 16.9 mm Hg to 10.5 6 5.5 mm Hg and conduit diameter increased from 12.7 6 3.2 mm to 18.5 6 1.8 mm significantly (P < 0.0001). RV/ aortic ratio, pulmonary artery diastolic pressure, and follow-up RVOT gradient on echo all improved significantly (P < 0.0001). There were eight minor complications including arrhythmia (3), transient pulmonary edema (2), fever (2), and small hematoma (1). Conclusion: Procedural variations can improve and permit effective and safe implantation of the Melody valve in a variety of clinical presentations.

Alimbaev Serik, Bruckheimer Elchanan, Kozlik-Feldmann Rainer, Pya Yuriy, Kadirova Saule, Musaev Abdurashid, Besbaeva Gulzhan, 1 National Research Cardiac Surgery Center, Astana, Kazakhstan, 2 Schneider Children’s Medical Center, Petack Tikva, Israel, 3 LudwigMaximilians-University, Mu¨nchen, Germany
Aim: Vessels and communications between large vessels leading to significant hemodynamic alterations with the need for treatment. Background: There are broad variation possibilities of communications between heart chambers and large vessels or between vessels. The type of interventions depends on the anatomy and physiology of the communications. Methods: Five patients having communication anomalies were chosen. Patient 1, 1.5 years, large ventricular septal defect (VSD), patent ductus arteriosus (PDA), and communication/fistula from descending aorta to pulmonary artery. Pulmonary hypertension (PH) with Qp/Qs 1.1. Patient 2, 12 years, with a tunnel between right coronary sinus and left ventricular. Patient 3, 2.4 years, fistula between pulmonary artery and left atrium. Patient 4, 3 years, fistula between the vertebral artery and vena cava superior with left/right shunt. Patient 5, 14 years, fistula between right coronary sinus and right atrium. Results: Because of the PH in the patient 1 the fistula and the PDA were closed by a Vascular Plug II and a PDA occluder II as a first step of correction. In 3 months when Qp/Qs became 1.6 with decreasing PVR the VSD was surgically treated. For patient 2, a test occlusion with an Opto Pro balloon catheter was performed with positive result. A Vascular Plug II was stable established on the neck of the tunnel and closed the tunnel without shunt. But in angiography the occluder was situated too close to the right coronary artery (RCA) and because of a high risk of total occlusion of the RCA after release the ocluder was not left. In patient 3, a membranous VSD occluder was positioned into the fistula. Oxygen saturation raised from 70 to 100% after implantation. In patient 4, the fistula was successfully closed by a Nit-occlud PDA. For the fifth patient a Vascular Plug II for fistula occlusion was used. Conclusions: This study could show the existence of communications between right–left heart circulations and between the left chamber and arterial vessels. The correct choice of treatment depends on the anatomy of the pathologic communications and related other vessels located near there. Transcatheter closure of communications of the heart chambers and large vessels is a good choice today.

Sebastian Goreczny,1 Tomasz Moszura,1 Nicholas Hayes,2 Pawel Dryzek,1 Anna Mazurek-Kula,1 Jacek J. Moll,3 Andrzej Sysa,1 Jadwiga A. Moll,1 1 Cardiology Department, Polish Mother’s Memorial Hospital, Research Institute, Lodz, Poland, 2 Pediatric Cardiology Department, Evelina Children’s Hospital, London, UK, 3 Cardiac Surgery Department, Polish Mother’s Memorial Hospital, Research Institute, Lodz, Poland
Background: Aortic arch obstruction (COA) after the Norwood procedure (NP) remains a significant problem. It has been associated with atrioventricular valve regurgitation, deterioration of ventricular function, and with increased risk for death. We report our experience in arch interventions in patients after NP. Methods: Between December 2002 and August 2012, 42 patients underwent 55 catheterizations for COA after NP. Median age and weight were 6 months (1.2–62.6) and 6.1 kg (2.8–14.8) respectively. Thirty-six patients were after NP and 6 after BDG. Femoral vein access was used in 33 patients, femoral artery in 9. Single balloon was used in 28 patients, 2 balloons in 13 and 3 in 1. The first and largest balloon-toCOA ratio were 2.4 6 0.6 and 2.7 6 1.1 respectively. Results: Median PG decreased from 26 (7–82) to 8.5 mm Hg (0–34) (P < 0.0001). The first intervention was successful in 29/42 (69%) patients—PG < 10 mm Hg. Median coarctation index (CI) increased from 0.47 (0.19– 0.75) to 0.8 (0.6–1.1) (P < 0.001). Patients with successful and unsuccessful first intervention did not differ significantly in age, CI, and largest balloonto-COA ratio. The former had higher weight 6.3 kg (4.6–14.8) vs. 5.5 (2.8– 7) (P = 0.023) and lower initial PG 25 mm Hg (7–48) vs. 38 (15–82) (P = 0.0048). In the median follow-up of 2.9 years (0.01–8.7) four patients died, 26 advanced to BDG, 6 to Fontan, and 1 to biventricular repair. Ten (23.8%) patients required 13 reinterventions (balloon angioplasty—9, stent placement—4) after median time of 4.1 months (0.07–21.3). Patients with (10) and without reintervention (32) did not differ significantly in age, weight, and CI, whereas the former had higher largest balloon-to-COA ratio 2.9 (1.6–5.3) vs. 2.3 (1.5–4.2) (P = 0.026) and PG after the first intervention 12 mm Hg (1–34) vs. 7.5 (0–17) (P = 0.014). For the whole 55 catheterizations II/III degree a-v block occurred in two patients, supraventricular tachycardia (requiring cardioversion) in one, stent fragmentation (removed through carotid cut-down) in one, femoral vein thrombosis in five, and loss of femoral pulse in seven (transient—4, permanent—3). Conclusions: Percutaneous treatment of COA in patients after NP resulted in high acute success rate especially among patients with higher weight and lower initial gradient. Those with reinterventions had higher PG after the first intervention and higher largest-balloon-to-COA ratio.

Gregor Krings, Mirella Molenschot, Jan Strengers, Childrens University Hospital Utrecht, Utrecht, The Netherlands
Background: In newborns, surgical treatment is the therapy of choice when aortic coarctation is present. In very low birth weight (VLBW) critical newborns, the situation can differ when surgery cannot offer therapeutic option. Coronary-stent implantation can be used in critically ill VLBW newborns as a bridging-therapy. Objective: We report about a 700 g VLBW gemini with critical duct dependent aortic coarctation. Methods: Clinical, echocardiographic, and angiographic data were reviewed for the patient who underwent CoA stenting at 7th day of life. Evident ethic aspect due to the very low weight was present at all moments of discussion pre- and postinterventionally. Results: The patient was on intravenous infusion of 20 ng/kg/min Prostaglandin E2. When seven days old she showed clinical signs of severe pulmonary hyperperfusion and low systemic output. Neurological evaluation revealed no signs for cerebral bleeding and no other VLBW typically related comorbidity was present. Cardiosurgically resection of the coarctation was dismissed due to small size of the newborn and expected risk. After profound ethical discussion in the team and with the parents, stent implantation was performed using a 5.5 mm 16 mm cobalt-chromium coronary-stent. During high-pressure-dilatation, a 50% stenosis-waist in the stent resolved at 14 atm (picture) and the pressure-gradient dropped from 40 to 0 mm Hg. The stent was in good position and left subclavian artery remained unobstructed. The right femoral artery did not re-perfuse after intervention but sufficient collaterals had developed. At 8 month follow-up, the child clinically still presented well with a weight of 5.8 kg, an aortic descendens gradient of 25 mm Hg (CW-Doppler and non-invasive pressure measurement). Surgical intervention was performed with longitudinal incision of the stent and patchangioplasty. Conclusions: The course of this individual case is encouraging and the child develops in a normal way. Up to now our experience in CoA stenting in VLBW newborns with a weight below 1 kg is limited to two cases. Because of absence of comorbidity and the unproblematic followup the decision for intervention seems to have been made right.

Sebastian Goreczny,1 Pawel Dryzek,1 Tomasz Moszura,1 Jacek J. Moll,2 Andrzej Sysa,1 Jadwiga A. Moll,1 1 Cardiology Department, Polish Mother’s Memorial Hospital, Research Institute, Lodz, Poland, 2 Cardiac Surgery Department, Polish Mother’s Memorial Hospital, Research Institute, Lodz, Poland
Background: Fenestration allows for decompression of the Fontan circuit and augmentation of cardiac output; however it results in subnormal systemic arterial oxygen saturation and exposes the patient to the risk of paradoxical embolization and stroke. Aim of this study is to report single center experience in fenestration closure with various devices: Amplatzer septal occluder (ASO), Amplatzer duct occluder II (ADOII), covered Cheatham Platinum (CP), and Advanta V12 (AV12) stents. Methods: Between May 2004 and August 2012, 56 patients underwent closure of the fenestration. Patients were divided into three groups: group I: ASO (n = 31; 4–3 mm, 5–24 mm, 6–3 mm, 7–1 mm); group II: ADOII (n = 15 patients; 5/4–9 mm, 4/4–5 mm, 3/4–1 mm); Group III: covered stent (n = 10; V12—3, CP—7). Results: Median age and weight for the whole population were 6.4 years (2.45–16.18) and 20 kg (9.4–114), respectively. Mean O2 saturation and venous pressure in the tunnel increased from 84.8% 6 4.7 to 97.3% 6 2.1 (P < 0.001) and from 13.9 mm Hg 6 2 to 14.6 6 2 (P < 0.01). Median dose-area-product and time of fluoroscopy were 264.2 mcGcm2 (23.3–1,418) and 13.3 min (5.6–79.4), respectively. Comparison between groups showed that patients in group III were significantly older (8.4 vs. 5.9 years), heavier (27 vs. 18 kg), received more radiation (456.1 vs. 262.4 mcGcm2 ) and were referred for the interventions later after Fontan operation (25.9 vs. 13.1 months) than patients from group II. There were no significant differences between group I and II. Immediate closure of the fenestration (group I vs. group II vs. group III) occurred in 11 patients (21%), 0, 6 (60%) respectively and closure at discharge in 19 patients (61%), 7 (46%), 10 (100%) respectively. In the median follow-up of 23 months (1–99), closure of the fenestration was documented in 30 patients (97%), 14 (92%), 9 (90%), respectively. In one patient after implantation of AV12 stent, late reintervention with balloon dilatation was performed due to recurrence of flow across the fenestration. Conclusions: Fenestration closure with covered stents was performed in older, heavier patients and resulted in more patient radiation. Despite differences in the acute success rate, comparable, high percent of complete occlusion was observed in the follow-up.

Theodore Kremer,1 Saar Danon,1 Jodi Hundley,2 Saadeh Al-Jureidini,1 1 Saint Louis University, Saint Louis, MO, USA, 2 Cardinal Glennon Children’s Medical Center, Saint Louis, MO, USA
Background: The Amplatzer Vascular Plug is an established embolic device approved in 2004 for peripheral vascular embolizations. Since its approval, the Amplatzer Vascular Plug has been utilized for the occlusion of various vascular and intracardiac structures, and has been modified to include multiple versions. Although there are several publications relating to this, we provide the experience of a single institution that includes a patient population, not included in previous publications. Objective: To review the clinical applications, effectiveness, and complications of utilizing the Amplatzer Vascular Plug I and II to occlude vessels and intracardiac structures in patients with congenital cardiovascular disease. Methods: Perform a retrospective review of all cardiac catheterizations in which an Amplatzer Vascular Plug I or II was used at Cardinal Glennon Children’s Medical Center, in Saint Louis, Missouri, since the device was approved in 2004, as well as follow up data. Results: Forty-four patients with congenital cardiovascular disease underwent vascular occlusion of 46 structures using an Amplatzer Vascular Plug. Seven (15.2%) vessels were occluded with the Amplatzer Vascular Plug I and 39 (84.8%) vessels were occluded with the Amplatzer Vascular Plug II. The patients had a mean age of 5.83 years (range 0.38–21.7 years) and mean weight of 18.4 kg (range 6.3–59 kg). Of the 46 vessels occluded, there were 22 (47.8%) extracardiac Fontan fenestrations using a Gore-Tex tube, 7 (15.2%) patent ductus arteriosus (PDA), 4 (8.7%) superior vena cava (SVC), 2 (4.3%) venous collaterals, and 11 (23.9%) miscellaneous structures. Complete occlusion was observed in 91.3% of vessels either at the time of the catheterization or during subsequent follow-up imaging. Only minimal residual flow was observed in the remaining 8.7% of the vessels. There were no complications related to the use of the Amplatzer Vascular Plug. Conclusion: The Amplatzer Vascular Plug I and II is a safe and effective occlusion device for use in a wide variety of cardiovascular structures in congenital heart disease, and is an excellent device to occlude extracardiac Fontan fenestrations utilizing a Gore-Tex tube.

Fa´bio Augusto Selig, Enio Eduardo Gue´rios, Deborah Christina Nercolini, Eduardo Mendel, Lise Bocchino, CONCEPT—Center of Congenital and Structural Heart Diseases of Parana´, Curitiba, Parana´, Brazil
Introduction: Patent foramen ovale (PFO) is present in 25% of the adult population. PFO importance has been growing because of its association with cryptogenic ischemic stroke due to paradoxical embolism and migraine. This study demonstrates our center’s protocol for selecting and following up patients treated by percutaneous closure, as the results in short-, mid-, and long-terms. Methods: The including criteria were stroke or transient ischemic attack due to paradoxical embolism, severe chronic migraine without response to pharmacological treatment, Platypnea-Orthodeoxia Syndrome, or prophylactic in patients with major right to left shunts and professional risk or thrombophilic syndromes. All included patients were submitted to clinical and hematologic evaluations and graduation of migraine; Cranial CT scan or MRI; microbubble transesophageal echocardiogram and transcranial Doppler; 24 hr Holter; and Carotid Doppler. After the percutaneous treatment, all patients were submitted to the same clinical and complementary evaluation. Results: One hundred thirty patients in different age groups were included on the study, 80% of them with cryptogenic stroke. All patients except four evolved with great reduction of the migraines’ crisis. Patients with thrombophilia were submitted to anticoagulation treatment after the percutaneous closure. The devices implanted were Amplatzer, Occlutech, Cardia, Helex, and Solysafe; six patients received two devices, simultaneously or subsequently. Four patients had residual shunts: one was submitted to a second successful procedure, one went through surgical treatment and two were kept with clinical following up. After the percutaneous treatment, one patient with diabetes and hypertension had a second stroke and one with thrombophilia had a possible transient ischemic attack. Conclusions: In our experience, the percutaneous closure of patent foramen ovale is a safe and effective way to prevent new strokes due to paradoxical embolism, as an important adjuvant migraine treatment.

I.B. Vijayalakshmi, Sri Jayadeva institute of Cardiovascular Sciences and Research, Bangalore, India
Background: Several challenges are faced by interventional cardiologists while performing various percutaneous interventions for congenital heart disease (CHD) in patients with dextrocardia. The anatomical alterations in dextrocardia especially the lie of the interventricular septum (IVS) can cause impediment for device closure of ventricular septal defect (VSD) and atrial septal puncture, respectively. Aim: The aim of our study is to evaluate the challenges, feasibility, and efficacy of transcatheter interventions in children with CHD in dextrocardia. Materials and Results: Out of 60 patients of CHD with dextrocardia catheterized, only 9 patients (15%) underwent transcatheter interventions. The age ranged from 4 months to 16 years (mean 5.4 years), weight ranged from 4.0 to 40 kg (mean 14.3 kg). Eight patients had situs inversus with dextrocardia (mirror image dextrocardia) whereas only one patient with mid muscular VSD (MVSD) had situs solitus, dextrocardia (isolated dextrocardia). Three patients underwent successful device closure for patent ductus arteriosus (PDA). Two cases of MVSD were closed with Amplatzer septal occluder and Amplatzer duct occluder II (ADO II). Successful balloon valvuloplasty was done simultaneously for aortic stenosis and mitral stenosis in one patient of right sided May Thurner Syndrome (MTS). Balloon valvuoplasty was done in one case each with severe pulmonary stenosis and aortic stenosis. One very sick patient with inferior vena cava web died after cavoplasty and stenting. Acute hemodynamic results were satisfactory and no complications were encountered in any of the patients. Conclusion: The catheter interventions in CHD with dextrocardia though difficult are feasible. The device closure of PDA and MVSD is not difficult especially with ADO II. The balloon mitral and aortic valvuloplasty in the complex cardiac anatomy of situs inversus totallis is feasible and safe. Rarely right sided MTS may come in the way of right femoral access during transcatheter procedure.

Mehul Patel, Dhaval Parekh, Henri Justino, Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA
Background: Midaortic syndrome (MAS) is a rare condition presenting as systemic hypertension, claudication, mesenteric ischemia, or renal dysfunction. Surgical repair and percutaneous interventions remain challenging. Aim: To evaluate outcomes of MAS using various treatment strategies. Methods: Single centre retrospective review of patients (pts) presenting from January 1991 to August 2012. Results: There were 11 pts (3 males), aged 19 6 14 years (range 0.1– 27 years) at time of treatment. Four patients had discrete abdominal aortic (AA) stenosis, six had long segment narrowing, and one had aneurysm without stenosis. Diagnoses included: Takayasu aortitis (n = 3), idiopathic (6), neurofibromatosis type I (1), William syndrome (1). Location of AA stenosis was inter-renal (n = 5, 46%), supra-renal (4, 36%), and infra-renal (2, 18%). Initial interventions included medical management (2), surgery (3, at 10.7 6 9.7 years), balloon angioplasty (BA) 6 stent (n = 6, at 12.6 6 8.9 years, 37.3 6 26.9 kg). 4/6 pts received interventions on abdominal aorta only, and 2/6 received sidebranch interventions (renal, celiac, iliac). AA balloon diameters ranged from 4 to 14 mm, and inflation pressures were 5–12 atm. 4/6 pts received stents. AA catheter interventions reduced the gradient from 53.2 6 29.3 to 18.2 6 14.2 mm Hg (n = 4). One patient with diffuse hypoplasia failed BA and developed non-flow limiting dissection and was referred for surgery. Four patients who underwent percutaneous treatment required repeat intervention after a mean follow up period of 6.2 6 5.2 years; of these, two had delayed surgical graft placement and one underwent emergency surgery due to post-catheterization retroperitoneal hematoma. There was one procedural death (post-neonatal repair of AA aneurysm) and one death in a neonate presenting with complete occlusion of renal arteries in whom no interventions were performed. Conclusion: MAS is a heterogeneous condition, for which no ideal therapies exist. For MAS with discrete lesions, BA 6 stent implantation may be tried, but the risk of complications and need for repeat interventions remain high. Patients with diffuse disease or presenting in early childhood are particularly problematic, and remain at high risk, regardless of surgical or percutaneous approach.

Noa Holoshitz, Clifford Kavinsky, Robert March, Jeffrey Soble, Qi-Ling Cao, Tiana Riley, Chiranjeev Saha, Brian Birmingham, Damien Kenny, Ziyad Hijazi, Rush University Medical Center, Chicago, IL, USA
Introduction: Transcatheter aortic valve replacement (TAVR) has revolutionized the world of interventional cardiology. The PARTNER trial demonstrated superiority of the Edwards SAPIEN valve to standard medical therapy in patients with severe aortic stenosis who were considered to be inoperable and showed the valve to be non-inferior to surgical aortic valve replacement in patients considered to be at high risk for surgery. This lead to the approval of the SAPIEN valve by the FDA for use in in-operable patients with severe aortic stenosis. We report our experience with the SAPIEN valve in our first 18 patients. Methods: All patients who underwent TAVR at our center either through the PARTNER IIA or IIB trial or who had commercial placement of the SAPIEN valve were reviewed. Patient demographics, procedural records, and echocardiograms were reviewed and analyzed. Results: Between June 2011 and September 2012, 19 consecutive patients (11 females) underwent attempted TAVR at our institution. The mean age was 85 (6 8.6) years. Five patients underwent commercial TAVR with the SAPIEN valve and 14 patients underwent TAVR as part of the PARTNER II protocol with the SAPIEN XT valve (3 were in the IIA arm and 11 were in the IIB arm). All patients had NYHA class III–IV symptoms. Procedure times ranged between 75 and 192 min and fluoroscopy times ranged from 22.5 to 55.7 min. The procedure was successful in 18 of the 19 patients (94.7%) with the one unsuccessful case being because of inability to advance the 24 Fr in a patient with peripheral vascular disease and tortuous iliac vessels. There were no procedural deaths. There were three procedural complications (16.7%) including one patient with ventricular fibrillation requiring cardioversion and chest compressions during balloon valvuloplasty of the aortic valve, one pericardial effusion requiring pericardial drain, and one valve embolizatation into the ascending aorta. Thirty day mortality was 16.7%. The mean aortic valve gradient was reduced from 57.5 6 19 mm Hg before TAVR to 11.2 6 3.3 at 30 days (P < 0.001). Fifteen of the 18 patients (83.3%) had NYHA class I or II symptoms at 30 days. Conclusions: Single center short-term follow-up of a cohort of 18 patients undergoing TAVR with the Edwards SAPIEN and SAPIEN XT valves confirms procedural safety and efficacy as reported by the PARTNER trial.

Alex Golden, Christopher Bellotti, Cleveland Clinic Children’s Hospital, Cleveland, OH, USA
Background: Since its inception, pediatric interventional cardiology has been challenged by a significant paucity of catheters and devices designed specifically for use in children. The Mongoose 3.3 Fr catheters (PediaCath, Cleveland, OH) are a new group of catheters designed and FDA approved specifically for use in children. These catheters can be used with a 3 Fr sheath that provides a significant reduction in diameter of the sheath in comparison to a standard 4 Fr sheath. The Mongoose catheters are available in pigtail, JR, JL, JB1, multipurpose, and cobra tip shapes. This abstract highlights the initial use of the Mongoose catheters in children less than 15 kg. Methods: Three patients undergoing interventional cardiac catheterization had femoral arterial access obtained with a modified Seldinger method and placement of 3 Fr PediaCath sheaths in the artery. Patient 1 was a 4 month old male weighing 6.8 kg with a diagnosis of severe valvar pulmonary stenosis causing suprasystemic RV pressure. A 3.3 Fr Mongoose pigtail was used for monitoring during the pulmonary valvuloplasty. There was question of a small PDA on echocardiography and so an aortogram was performed with a power injection of 8 cc at 13 cc/ sec. Patient 2 was a 3 year old 13 kg girl with a moderate secundum atrial septal defect. She underwent device closure of the ASD and a 3.3 Fr Mongoose pigtail was used for arterial monitoring during the procedure. Patient 3 was a 3 year old 12.5 kg girl with severe valvar pulmonary stenosis. She underwent balloon valvuloplasty and a 3.3 Fr Mongoose JR catheter was used to cross the pulmonary valve anterograde. A 3.3 Fr Mongoose pigtail was used for arterial monitoring during the procedure. Results: Interventions were completed successfully in all patients. In no patient was it necessary to upsize the sheath in order to use a larger catheter for monitoring or angiography. Waveforms were not dampened. In the one patient who had an angiogram performed using a Mongoose pigtail, the injection was made with a power injector, which delivered 13 cc/sec without any problem. The angiogram was of a good quality, and indistinguishable to the operators from angiograms made with 4 Fr catheters. There were no vascular complications. Conclusions: The 3 Fr sheath used in these patients has an OD = 0.065 mm, whereas a 4 Fr sheath has an OD = 0.080 mm. This represents a 19% reduction in the diameter of the arterial sheath, which we hypothesize will provide a reduction in vascular complications secondary to access for cardiac catheterization in neonates and small children. Further experience and study will be necessary to determine whether comparison to standard 4 Fr sheaths will result in observable decreases in incidences of loss of pulse, femoral arterial thrombosis, and other vascular complications, which are common in infants and small children.

Veronica Vasquez, Juan Pablo Sandoval, Jose Antonio Garcia Montes, Carlos Zabal Cerdeira, National Institute of Cardiology, in Mexico City, Mexico
Objective: Evaluate the recently FDA-approved AMPLATZER1 Vascular Plug IV in the embolization of vascular lesions associated with congenital heart disease (CHD). Case report: We present the case of a 3-year-old female patient with tetralogy of Fallot (TOF) with hypoplastic pulmonary arteries (PA) and multiple direct and indirect collateral circulation to both lungs. The case was accepted for stent placement in the right ventricle outflow tract (RVOT) and collateral embolization looking forward to future PA growth and hopefully biventricular repair. Right and left cardiac catheterization was performed, through anterograde approach. A Palmaz genesis (PG3910b) stent mounted on a Power Flex 8 40 mm balloon was successfully placed in the RVOT. Afterwards, retrograde angiography at the right subclavian artery was performed to show an indirect tortuous aorto-pulmonary collateral supplying the apical portion of the right lung. An Amplatzer vascular plug II (AVP II) 10 mm was used for closure. Left subclavian angiography revealed a tortuous collateral supplying the left lung requiring an AVP II 8 mm for closure. Finally, descending aorta angiography revealed a direct aorto-pulmonary collateral dividing into two branches, the right branch supplying the basal portion of the right lung and the left branch irrigating the basal portion of both the right and left lung. A multipurpose catheter was advanced to the origin of the collateral and an Amplatzer vascular PLUG IV 4 mm was advanced and placed successfully with total occlusion after control angiography. Procedural time was 130 min. Conclusion: In our first experience with the AVP IV, successful closure of a tortuous aorto-pulmonary collateral was performed. This device is suitable for small vascular defects requiring percutaneous embolization. No major or minor complications were encountered.

Neil Patel, Damien Kenny, Zahid Amin, Michel Ilbawi, Ziad Hijazi, Ismael Gonzalez, Rush University Medical Center, Chicago, IL, USA
Introduction: Although catheter-based intervention is generally accepted as the treatment of choice for branch pulmonary artery stenosis, there are no data comparing need for re-intervention and time to re-intervention in patients undergoing transcatheter stenting versus surgical arterioplasty. Methods: Single center retrospective cohort study comparing patients who underwent surgical pulmonary arterioplasty and branch pulmonary artery stent placement between January 2008 and May 2012. All patients < 18 years who underwent surgical intervention or stent placement were included in the study. Need for re-intervention and the average time to re-intervention were assessed using chi-squared and independent sample t-test. Results: A total of 42 patients were included in the study. Seventeen patients (12 males) underwent surgical intervention and 25 patients (9 males) underwent stent placement. The mean weight at intervention of the surgical group was 11.3 6 9.1 kg and the stented group was 20.1 6 16.2 kg (P = 0.028). On mean follow-up of 828.3 6 431.8 days, 53% (9/17) of the surgical cohort, and 12% (3/25) of the stented cohort required re-intervention (P = 0.004). In all but two cases re-intervention was catheter-based. One patient had surgery performed at re-intervention and the other had a hybrid procedure. The average time to re-intervention for the surgical group was 337.4 6 2 days, and for the stent group it was 250 6 285.5 days (P = 0.677). When assessing only patients under 35 kg the mean weight at intervention was 11.3 6 9.1 for the surgical group and 13.0 6 6.8 for the stented group (P = 0.532). Fiftythree percent (9/17) of the surgical cohort, and 15% (3/20) of the stented cohort required re-intervention (P = 0.014). The average time to re-intervention remained the same as above. Conclusion: Children undergoing primary surgical branch pulmonary arterioplasty are more likely to require re-intervention than those undergoing stent placement. There was no significant difference in the time to re-intervention between the cohorts.

Wataru Soda,1 Kotaro Oyama,1 Shin Takahashi,1 Satoshi Nakano,1 Takashi Kobayashi,2 1 Department of Pediatric Cardiology, Iwate Medical University Memorial Heart Center, Mrioka, Iwate pref., Japan, 2 Department of Anesthesia, Iwate Medical University Memorial Heart Center, Morioka, Iwate pref., Japan
Background: Sometimes it is very difficult to deliver the tip of 4 or 5 Fr guiding catheter onto pulmonary valve in procedure of antegrade perforation of pulmonary valve in pulmonary atresia with intact ventricular septum (PAIVS). Case 1: 16 days old neonate with PAIVS. Body weight was 3.5 kg, end-diastolic volume of right ventricle was 8.1 ml (110% of normal) with tripartite portion (Alwi group A). Diameter of pulmonary valve was 7.8 mm in measurement of lateral angiography of main pulmonary artery. There was no sinusoidal communication. At first, we put a retrograde snare catheter (EN Snare, Merit Medical systems Inc. USA) onto pulmonary valve as a landmark to grasp precise position of pulmonary valve, and for snaring the wire after perforation of pulmonary valve, from 4 Fr femoral artery introducer sheath through a patent ductus arteriosus. We tried to deliver the tip of various types of 4 Fr guiding catheter onto pulmonary valve through the femoral introducer sheath, but any guiding catheter did not reach to valve. Finally, we put the tip of 4 Fr guiding catheter (Amplatz II Judkins Right, Technowood Inc. Japan) at proximal side of right ventricular outflow tract as a supportive catheter. Subsequently, we used 2.7 Fr micro-catheter (Akatsuki, Cathex Inc. Japan) through the guiding catheter, using 0.014 inch micro-wire (014 Begin PLUS, ASAHI INTECC inc. Japan) as a guiding, and succeeded to deliver a tip of AKATSUKI onto pulmonary valve. We exchanged a micro wire to chronic total coronary artery occlusion (CTO) wire (Astato XS 9-12, ASAHI INTECC Inc. Japan), and were able to perforate pulmonary valve using slowly twisting maneuver with torque. After successful perforation, AKATSUKI slid into main pulmonary artery. We exchange the Astato to 0.014 inch long stiff wire. EN Snare retrieved the wire and exteriorized through the right femoral introducer sheath, and fixed in place with clamps at its soft tip ends (arteriovenous railway technique). Progressive percutaneous transluminal pulmonary valvuloplasty was done from a diameter of 2.0 mm to a maximum diameter of 8.0 mm. Reduction in the right ventricular pressure was from 76 to 48 mm Hg. Case 2: Four days old neonate with PAIVS. Body weight was 3.6 kg, end diastolic volume of right ventricular was 6.4 ml (76% of normal) with tripartite portion (Alwi group A). Diameter of pulmonary valve was 6.9 mm. It was also impossible to deliver the tip of guiding catheter onto pulmonary valve, we put the tip of guiding catheter (GLIDECATH II COBRA, TERUMO Inc. Japan) in trabecular portion of right ventricle, and delivered only AKATSUKI to pulmonary valve without using a micro-guiding wire, and made perforation of valve using CTO wire (Astato 30, ASAHI INTECC Inc. Japan). With the same subsequent procedure, pulmonary valvotomy was successful. Reduction in the right ventricular pressure was from 96 to 30 mm Hg. Discussion: The Astato 30 is a high-penetration guide wire specially designed with tapered hydrophobic tip and 30 g tip load (Astato XS 9- 12 is 12 g tip load) for the lesion of CTO. Although radiofrequency valvotomy has become the standard of primary care of PAIVS, it is not permitted to use in Japan, and the feasibilities of CTO wire for valvotomy have been reported recently from some institutions. It is necessary for safe perforation of pulmonary valve that the tip of guiding catheter should reach to the valve with stability. But sometimes it is very diffi- cult, because of great morphological variability in PAIVS, such as enlarged right atrium, small diameter of tricuspid valve, and trabeculation of right ventricle. It should be feasible procedure to use the combination of antegrade micro-catheter and CTO wire for penetration of pulmonary valve in PAIVS, under the condition that guiding catheter dose not reach to pulmonary valve.

Daniel Levi, Sanjay Sinha, Eugene Shkolyar, Brian Reemtsen, University of California, Los Angeles, CA, USA
Two single ventricle patients with heterotaxy and infradiaphragmatic total anomalous pulmonary venous return (ID-TAPVR) underwent transcatheter palliation with stenting of the DV (Ductus Venosus). A third case involving DV stenting in a biventricular child with obstructed IDTAPVR and coarctation was also palliated in this fashion. Records of all three cases of DV stenting were reviewed retrospectively. The two children with single ventricle (SV), heterotaxy, and obstructive IDTAPVR were diagnosed prenatally by ultrasound and MRI. Both infants were delivered next door to the cardiac catheterization laboratory by C-section with surgical standby. Angiograms and echocardiogrmas were performed to assess the ductus venosus and verticle vein (VV) anatomy. The DV was crossed using coronary wires and a 5 Fr sheath was placed across the DV via the UV. Four, 4.5 and 5 mm coronary multilink ultra stents were used to stent the DV. All cases were technically successful and the DV was successfully stented open in all neonates. In both cases, heterotaxy, SV, the oxygen saturations improved acutely by 30–40% (pre-stent 50–55%, post 85–90%) and venous congestion on CXR resolved. In both cases, the patients went on to have successful semielective TAPVR repairs with BT shunts, without venous congestion at the time of repair. Stenting of the DV can successfully palliate obstructed ID-TAPVR. This can be especially useful in SV patients with obstructed TAPVR as it allows for surgical shunt placement or stenting of the DV electively and without pulmonary venous congestion. The course of the VV and cause of obstruction must be well defined as stenting of the DV does not always relieve and can even worsen the obstruction. In some cases, a jugular approach may be needed. Angiogram showing the venous return to the heart via the narrowed ductus venosus with notable pulmonary congestion (A). Angiogram after successful stenting of the ductus venosus with significantly less pulmonary congestion and appropriate blood return to the heart (B).

Mashail Bin obaidan, Abdulmajeed Alotay, Nabeel Abdulraziq, P-rince Sultan Cardiac Center, Riyadh/Riyadh, Saudi Arabia
Introduction: Transcatheter closure of perimembranous ventricular septal defect (PM VSD) is abandoned in many center and in some became restricted to certain age and criteria because of the risk of complete heart block (CHB). The risk of damaging the tricuspid valve (TV) in the presence of inlet extension is another risk. The authors present successful closure of such defect using Amplatzer occluder device for PDA with reasonable follow-up period in Prince Sultan Cardiac Center PSCC. Method: Through 2011, four patients underwent transcatheter closure of PM VSD with inlet extension, all patients were consented and procedure was done under general anesthesia. Transesophageal echocardiography was done in all, one has 3D assessment. Hemodynamics were assessed preprocedural, A-V loop was applied in two patients, ADOI were used in all, heparin and antibiotics were given during and 24-hr postprocedure, three patients were extubated same day and one the following day, all patients were kept on aspirin for 6 months. Result: Median age 17 kg, 3 females and 1 male, median age 7 years, median ventilatory duration is one day, median hospital stay is 2 days, median follow-up is 16 months, no immediate or early complication or deaths, normal ECG immediately and during follow-up period, normal echocardiography with no residual leak during follow-up period. Conclusion: In selected patients with PM VSD and inlet extension, ADOI device can be used safely and effectively to close the defect with no immediate or early complications.

Bhanu Duggal, Sanjay, Grant Medical College, Mumbai, India
Prosthetic valves thrombosis (PVT) is usually a life threatening condition requiring prompt treatment. Methods: This is a prospective study of eight consecutive patients with mechanical mitral valve thrombosis who received intravenous thrombolytic treatment with tenectaplase in our institution between January 2011 and May 2012. There were three females and five males in the study group. The mean age was 28.12 years. They presented with recent and sudden onset dyspnea and were in NYHA functional class III or IV. Three of these patients presented with biventricular failure. Prosthetic valve clicks were absent. Patients with contraindication to thrombolytic therapy were excluded. The mean time between mitral valve implantation and the thrombotic episode was 33.62 months (range 5–72 months). Thrombosed valves comprised three bileaflet valves (Saint Jude) and five tilting disc prostheses (Omniscience). Six of these patients were not receiving adequate anticoagulant therapy or had discontinued the anticoagulant therapy due to various reasons, at the time of diagnosis of the thrombosis. The clinical suspicion of Mitral valve thrombosis was confirmed by Doppler transthoracic echocardiography (TTE). The average mean gradients were 25–30 mm Hg. There was severe pulmonary hypertension (TR jet-100 mm Hg) in three of the five cases. Cinefluoroscopy confirmed the restricted mobility of the leaflets. In all cases, fibrinolytic therapy was chosen in agreement with the surgical team. The regimen used was based on the weight of the patient (30– 50 mg). It was administered as an intravenous bolus over 5 sec followed by heparin infusion. The patients were monitored by TTE every half an hour initially, and once a dramatic response in gradients was recorded, this was done every 1 hr. Successful thrombolysis was defined as hemodynamic normalization confirmed by cinefluoroscopy (normal mobility of tilting disks) or TTE/TEE data (normalization of transprosthetic gradient and valve area, normal mobility of leaflets) and was observed six patients. In two patients there was a dramatic clinical improvement but gradients were persistently between 8 and 10 mm Hg. There were no failures. There was one complication in the form of a transient ischemic stroke, which recovered spontaneously .after 48 hr.

Atsuko Kato, Keijiro Ibuki, Nao Hamamoto, Jun Yoshimoto, Norie Mitsushita, Masaki Nii, Song-Hae Kim, Kisaburo Sakamoto, Yasuo Ono, Shizuoka Children’s Hospital, Shizuoka, Japan
Objectives: The prognosis of hypoplastic left heart syndrome (HLHS) has improved dramatically with development of surgical techniques and perioperative care. The patients are more likely to require catheter interventions between staged palliative operations in order to maintain appropriate hemodynamics during early infancy. The pulmonary blood source in the Norwood procedure (NP) has evolved from the right ventriclepulmonary artery conduit (VPC) and modified Blalock-Taussig (BTS) shunt in our institute around 2005. Few reports have been published regarding whether the change in surgical strategy has affected catheter interventions. Methods: Overall 47 infants with HLHS received NP during the period from January 2000 to September 2012. Twenty-nine patients underwent NP with VPC, and 14 patients underwent NP with BTS. Two patients who had NP with a Glenn shunt were excluded. The incidence, location of interventions before Glenn shunt, and adverse event were retrospectively analyzed. Results: Overall, 69 catheterizations in 44 patients were performed, including 60 interventions in 33 (73%) patients, for closure of aorto-pulmonary collaterals (VPC n = 15, BTS n = 11; P = 0.249), dilatation of the shunt (VPC n = 7, BTS n = 7; P = 0.185), stent implantation in the shunt (VPC n = 5, BT n = 2, P = 0.702), dilatation of the aortic arch (VPC n = 5, BTS n = 2, P = 0.702) or balloon atrioseptostomy (BAS; VPC n = 4, BTS n = 1, P = 0.403). Of them, two patients in BT underwent a catheter intervention before NP (BAS n = 1, dilation of the pulmonary artery n = 1). Mean age and body weight at the first cathterization were 3.9 6 1.4 months and 2,847 6 427, 3.9 6 1.9 months (P = 0.816) and 2,842 6 379 g (P = 0.545), respectively. Complications included cardiopulmonary resuscitation (n = 1), and temporary heart block (n = 4) in VPC (18%), while no complication occurred in BTS (P = 0.07). Early mortality was observed in two cases in VPC after stent implantation, due to increased pulmonary blood flow and low cardiac output. Conclusions: No significant difference in catheter interventions was observed in respect of the type of shunt at NP. However, there was a tendency that catheter interventions were accomplished more safely to patients with HLHS with BTS, which might improve the morbidity and mortality among the patients.

Andrew R. Yates, Phillip T. Thrush, Bryce A. Kerlin, Karen M. Texter, Steven C. Cassidy, Mark Galantowicz, Ralf Holzer, John P. Cheatham, Nationwide Children’s Hospital, Columbus, OH, USA
Background: Pulmonary artery thrombosis (PAT) is reported in a small percentage of patients after superior cavo-pulmonary anastomosis (SCPA). With the hybrid approach for single ventricle palliation, an aortic arch reconstruction, PDA stent removal, atrial septectomy, and SCPA are performed during a comprehensive stage 2 surgical procedure. The potential complications related to this new surgical procedure are still being defined. We report our initial incidence of pulmonary artery thrombosis in this patient population. Methods: All comprehensive stage 2 (November 2002 to July 2010) were retrospectively identified from our institutional surgical database and cross-referenced to catheterization, echocardiographic, and autopsy reports documenting PAT. Demographics, surgical, transcatheter, and medical therapies employed and outcomes were reviewed. Results: Six cases of PAT were documented (10% of comprehensive stage 2 operations). Median age was 5.6 months (range 4.1–7.2) and weight of 5.8 kg (range 4.2–6.5). There was no difference in age, CPB time, cross clamp time, or echocardiographic parameters in those that developed PAT compared to those that did not. Most cases (5/6) occurred in the immediate postoperative period (median 5 days, range 1–7). Clinical suspicion was hypoxia in (5/5), SVC syndrome (3/5). PAT was identified in one patient during catheterization on postoperative day 34 due to persistent chylous effusions. All six patients were treated with interventional catheterization with thrombus identified in the Left pulmonary artery in 6/6 cases, right pulmonary artery in 2/6 cases, and within the SVC in 1/6 cases. AngioJet (2/6 cases), angioplasty (3/6 cases), and stent therapy (3/6 cases) were performed with improved saturations (median 41%, range 26–61 vs. 70% range 41–80, P = 0.03) and angiographic flow. Local infusion of alteplase was utilized post-catheterization in three cases with systemic alteplase utilized in the remaining three cases. A 30-day mortality was 50% (3/6) with only one long-term survivor in the group who required cardiac transplantation. Conclusion: The incidence of pulmonary artery thrombosis after comprehensive stage 2 palliation was 10% with significant associated mortality. A new standard care protocol has been developed to prevent PAT after Comprehensive stage 2.

Andrew R. Yates, Phillip T. Thrush, Bryce A. Kerlin, Karen M. Texter, Steven C. Cassidy, Mark Galantowicz, Ralf Holzer, John P. Cheatham, Nationwide Children’s Hospital, Columbus, OH, USA
Background: Pulmonary artery thrombosis has been identified as a potential complication after comprehensive stage 2 surgery. We developed a standard care protocol that included (1) intraoperative exit angiography, (2) aggressive anticoagulation, and (3) prospective monitoring for thrombotic complications. We hypothesized that our standard care protocol would decrease mortality, morbidity, and be safe compared to our historical control group. Methods: Analysis of outcomes and complications for 19 patients after comprehensive stage 2 standard care protocol implementation (August 2010 to July 2012) compared to 60 historical controls (February 2002 to July 2010). Results: Nineteen patients underwent comprehensive stage 2 with our standard care protocol compared to 60 historical controls. Exit angiography was performed in all 19 cases and resulted in management changes in 4/19 cases (21%) including stent therapy in three patients and surgical revision for left pulmonary artery stenosis in one patient. Anticoagulation was initiated at 26 6 6 hr postoperatively. There were no incidents of bleeding after anticoagulation was initiated which required intervention, even with temporary interruption of anticoagulation for removal of invasive devices. Two (10%) patients demonstrated an intracranial bleed (both small subdural hematomas) on clinically indicated neurological imaging while undergoing anticoagulation compared to 11/60 (18%) patients (subdural hemorrhage 6/11, intracerebral hemorrhage 5/11) before protocol initiation (P = 0.7) There have been no postoperative pulmonary artery thrombosis events (0/19 (0%) vs. 6/60 (10%), P = 0.18). There has been a trend toward decreased mortality with anticoagulation protocol (1/19 (5%) vs. 12/60 (20%), P = 0.17). Conclusion: A standard care protocol involving anticoagulation after comprehensive stage 2 has not resulted in increased bleeding complications and demonstrates a trend toward decreasing pulmonary artery thrombosis and increasing survival.

Keijiro Ibuki, Kumiyo Matsuo, Tao Fujioka, Atsuko Kato, Nao Hamamoto, Jun Yoshioto, Sung-Hae Kim, Norie Mitsushita, Masaki Nii, Yasuhiko Tanaka, Yasuo Ono, Shizuoka Children’s Hospital, Shizuoka city, Shizuoka, Japan
Background: It has been reported that ultra-high-pressure balloon (UHPB) is effective on percutaneous transluminal pulmonary angioplasty (PTPA), but there is lack of data about the appropriate balloon diameter (BD) selection compared to conventional high-pressure balloon (HPB). Objective: To assess the effectiveness and recommended BD of UHPB in contrast to HPB. Methods: Restrospective review of post-surgical congenital heart disease patients underwent PTPA in our institution between November 2002 to April 2012. Twenty-four lesions in 12 patients applied UHPB (CONQUEST) and 20 lesions in 19 lesions applied HPB (FOX or SYNERGY) were enrolled. Results: The mean age in UHPB group and HPB group were 6.8 6 3.4 years and 4.3 6 3.4 years old (P > 0.05) and the mean body weight were 18.2 6 6.6 kg and 13.4 6 5.7 kg (P > 0.05) at the time of PTPA, respectively. BD and minimal lumen diameter (MLD) were significantly smaller in UHPB than HPB, BD: 8.4 6 1.8 mm and 3.6 6 1.3mm (P = 0.008); MLD: 9.7 6 1.2 mm and 4.4 6 0.8 mm (P = 0.013). Although there are no significant differences about the ratio of BD to MLD, gain of MLD after PTPA was significantly larger in UHPB group than HPB group (UHPB; 164 6 5.9%, HPB; 135 6 2.7%, P = 0.0041). Conclusion: In PTPA with UHPB, the recommended BD revealed to be 2 to 3 times of MLD, which can provide superior advantage than conventional HPB.

Bharat Ramchandani, Chetan Mehta, Vinay Bhole, John Stickley, Oliver Stumper, Birmingham Children’s Hospital, Birmingham, West Midlands, UK
Objective: To assess the growth of the branch pulmonary arteries after stenting of the right ventricular outflow tract (RVOT) in the management of severely cyanotic patients as initial palliation. Methods: Retrospective case note review and serial echocardiographic analysis of patients who underwent RVOT stenting as initial palliation at a single tertiary centre over a 7-year period. Patients: Between 2005 and 2012, 46 patients underwent percutaneous stent implantation in the RVOT to improve pulmonary blood flow. Median age at stent implantation was 64 (range 7–501) days. Median weight was 4.01 (1.7–12.2) kg, with 10 patients weighing less than 3 kg. There was one procedural death (2.2%). One patient required emergency surgery and two needed a BT shunt within 2 weeks postprocedure (6.6%). Six further patients were excluded from analysis, as data were incomplete or follow-up was less than 90 days. Results: Thirty-six patients were available for longitudinal analysis of PA growth. Median RPA Z-score increased from 2.02 (4.68 to 1.77) to 0.65 (2.04 to 0.29) (P < 0.05) and median LPA Zscore increased from 1.27 (2.87 to 0.19) to 0.11 (4.12 to 1.97) (P < 0.05). Saturations increased from 77 (45–95)% to 92(81–100)% [P < 0.001]. Twenty-eight patients underwent delayed surgery (complete repair in 25, palliative in 3) at a median of 252 (2–758) days post-stenting. Conclusion: Stenting of the RVOT provides good palliation and excellent growth of the central pulmonary arteries.

Oliver Stumper, Bharat Ramchandani, Patrick Noonan, Vinay Bhole, Zdenka Reinhardt, Chetan Mehta, Paul Miller, Joseph De Giovanni, Birmingham Childrens Hospital, Birmingham, West Midlands, UK
Objective: To review the indication and outcome of stenting of the right ventricular outflow tract (RVOT) in the management of severely cyanotic patients as initial palliation. Methods: Retrospective case note review and data analysis of patients undergoing RVOT stenting at a single tertiary centre over a 7-year period. Patients: Between 2005 and 2012, 51 selected patients underwent cardiac catheterization with a view to stent a very narrow RVOT to improve pulmonary blood flow. In all, cardiac surgical intervention was deemed high risk due to presenting condition, weight, associated defects, underlying anatomy, or co-existing syndromes. In five patients the procedure was abandoned due to unfavorable anatomy or good response to balloon dilation. Median age at stent implantation was 64 (range 5–406) days. Median weight was 3.9 (1.7–12.2) kg, with 15 patients weighing less than 3 kg. Results: Forty-six patients underwent stent implantation. Premounted coronary stents were used in 30 patients, premounted renal stents in 10 patients. Median procedure time was 58 (24–260) and fluoroscopy time 16 (5.5–73) min. Saturations increased from 71 (52–83)% to 92 (81– 100)% [P < 0.001]. There was one procedural death (2.2%). One patient required emergency surgery for RVOT perforation and two needed a systemic-pulmonary artery shunt within 2 weeks postprocedure (6.6%). One patient suffered severe tricuspid valve damage. Fifteen further catheter interventions were carried out (balloon in 6, further stent in 9). Twenty-eight patients underwent delayed surgery (complete repair in 25, palliative in 3) at a median of 252 (2–758) days post-stenting. Thirteen patients remain well palliated after 127 (20–346) days. Conclusion: Stenting of the RVOT is an effective treatment option in the initial management of selected patients with much reduced pulmonary blood flow. Mortality is low compared to published results of surgical palliation or early repair.

Simone Pedra, Fabio Peralta, Luciana Crema, Marcelo Jatene, Rodrigo Costa, Ieda Jatene, Fabricio Pereira, Carlos Pedra, Hospital do Coracao da Associacao Sanatorio Sirio, Sao Paulo, SP, Brazil
Background: Fetal cardiac interventions have been performed in a few centers in the world, which raises the question of their reproducibility, safety, and efficacy. Objectives: To report a preliminary experience with cardiac fetal interventions. Methods: From October 2007 to September 2012, 21 interventions were performed in 20 fetuses (median age 29 weeks) under maternal blockade and fetal anesthesia by a multidisciplinary team. Twelve fetuses had critical aortic stenosis (AS) (two with hypoplastic left ventricles (LV) and three with severe mitral regurgitation (MR) and hydrops). Four had hypoplastic left heart syndrome (HLHS) and intact/highly restrictive atrial septum, one had pulmonary atresia and three critical pulmonary stenosis (CPS/IVS) and intact ventricular septum. Measures of outcomes included rates of procedural success, maternal, fetal and pregnancy complications, neonatal morbidity and mortality, and eventual type of circulation (biventricular, BV). Results: Success was achieved in 19 procedures (90.5%) with one failed aortic and one pulmonary valvuloplasties. There was one fetal loss. No maternal complications occurred. All patients with critical AS, severe MR, and hydrops died within 5 months. All patients with HLHS and restrictive atrial septum died after interventional/surgical procedures and prolonged hospitalizations. Patients with CP/IVS achieved a BV circulation after neonatal valvuloplasty and ductal stenting. A BV circulation was achieved in 4/7 patients with critical AS (one still in utero), including two with initial borderline LV in whom a surgical LV overhaul was performed at 9 months of age. Conclusions: The feasibility, safety, and efficacy of fetal cardiac interventions seem to be reproducible in this preliminary experience.

Carlos Pedra,1 Fabricio Pereira,1 Marcelo Ribeiro,1 Simone Pedra,1 Wanda Nascimento,1 Luis Otavio Santanna,1 Valmir Fontes,2 1 Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil, 2 Hospital do Coracao da Associacao Sanatorio Sirio, Sao Paulo, SP, Brazil
Background: There has been an increasing use of covered stents (CS) in the percutaneous treatment of coarctation of the aorta (CoA). Objective: We report the acute and mid-term outcomes of CoA stenting with the new premounted Advanta V12 CS. Methods: From December 2009 to September 2012, 36 patients (pts) (median age and weight: 18 years and 55 kg, respectively) underwent CoA stenting under general anesthesia through a percutaneous femoral approach (sheaths 8–12 Fr). Results: Successful implantation with 12, 14, and 16 mm balloons was achieved in all patients with no stent migration. Post-dilatation was employed in 25 patients due to slight stent recoil (average 1.8 mm). CoA diameter increased from a median of 4 mm (0–10) to 15 mm (11–20) (P < 0.001) and the gradient across the CoA decreased from a mean of 36 6 12 to 4 6 3 mm Hg (P < 0.001). There was one pulse loss that required a Heparin drip. Follow-up was available for 34 patients (median 1.5 years). Normal blood pressure was observed in 28 patients with 20 patients requiring no anti-hypertensive meds. Angio CT was performed after 1 year in 20 patients. All stents remained in their original position and there were no stent fractures and no aortic wall abnormalities. No patient underwent reintervention. Conclusions: In this preliminary experience with limited number of patients from a single center, the use of the new V12 Advanta CS resulted in excellent clinical outcomes with no aortic wall abnormalities on imaging follow-up studies. Although these findings are encouraging, more patients and a longer follow-up are needed.

Mark Law, Jeffrey Alten, William McMahon, University of Alabama at Birimingham, Birmingham, AL, USA
Background: Supravalvar main pulmonary artery stenosis can occur following arterial switch operation (ASO) for D-transposition of the great arteries (D-TGA). Previous reports regarding success of balloon angioplasty have suggested minimal to very modest benefit. Objective: To evaluate the outcome of transcatheter balloon dilation of discrete supravalvar pulmonary stenosis following arterial switch operation. Findings: From February 2008 through September 2012, 52 patients underwent ASO for D-TGA. Eight children (15%) were referred for balloon angioplasty of discrete main pulmonary artery (MPA) stenosis following arterial switch operation based on echocardiogram findings with peak supravalvar pulmonary valve narrowing gradient of 4.0 m/s 6 0.6 m/s (64 mm Hg peak-to-peak instantaneous). Average age/post surgery time was 10 months (4–16 months) with average weight 8.1 kg (4.0– 12.1 kg). Discrete supravalvar MPA narrowing measured 4.4 mm (61.4 mm) with pulmonary valve annulus 11.0 mm (61.8 mm). At catheterization, baseline right ventricle to femoral artery (RV/FA) ratio was 0.92 (61.6) with a 43 mm Hg (610.4 mm Hg) peak-to-peak supravalve gradient. Single balloon technique MPA dilation was performed with final average balloon 260% 6 40% of discreet narrowing and 108% 6 26% pulmonary valve annulus with balloon choice not to exceed 350% of MPA diameter or 150% of the pulmonary annulus. RV/FA ratio improved to 0.53 (60.07, P < 0.001), MPA narrowing increased to 7.6 mm (61.9 mm, P < 0.001), and gradient reduced to 16 mm Hg (65.2 mm Hg, P < 0.001). Follow-up echocardiogram gradient of 2.7 m/sec (60.5 m/sec, P < 0.01) was obtained at an average follow-up of 4.4 months (0–9 months). Procedural complications included one small MPA aneurysm that was stable on follow-up angiography. During the follow-up period, one patient died secondary to ongoing intractable chylous drainage, anasarca, and respiratory failure. No patient has required repeat catheter intervention or cardiac surgery. Conclusion: Balloon dilation is a safe and an effective treatment of discreet supravalvar pulmonary stenosis following arterial switch operation. Longer follow-up data are necessary to determine whether further interventions will be necessary.

Fabricio Pereira,1 Marcelo Ribeiro,2 Rodrigo Costa,2 Simone Pedra,2 Valmir Fontes,3 Carlos Pedra,2 1 IMIPE, Recife, PE, Brazil, 2 Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil, 3 Hospital do Coracao d Associacao Sanatorio Sirio, Sao Paulo, SP, Brazil
Background: Transhepatic access has been proposed as an alternative vascular route to the heart in patients (pts) with limited access through the more standard femoral and jugular veins. Objective: We report our experience with this approach in the modern era of interventional cardiac catheterization for congenital heart disease (CHD). Methods: From January 2005 to September 2012, 30 catheterizations were performed under general anesthesia in 28 pts with heterogeneous CHD (median age and weight: 5 months [1 day–62 years] and 6 kg [1– 84], respectively) through the hepatic access. Sixty percent of the patients had occluded standard vascular accesses, 30% had absence of the hepatic portion of the inferior vena cava, and the remaining were premature infants < 2 kg. Regular pediatric 20/21 G puncturing needles, 15 cm 20/21 G Chiba needles, and transeptal Brockenborough needles were employed according to the size of the patient. A hepatic vein was entered under sole fluoroscopic guidance using standard techniques. Sheaths from 4 to 12 Fr were used according to the type of procedure. Most (>90%) pts underwent interventional catheterizations including atrial septostomy (Rashkind, static, stenting), pulmonary valvuloplasty 6 ductal stenting, antegrade aortic valvuloplasty, pulmonary artery angioplasty (ballooning/stenting), atrial septal defect occlusion, and RF ablation of arrhythmic pathways. Closure of the hepatic tract was performed using coils or vascular plugs. Results: Vascular access was successfully obtained in all pts at a median time of 5 min (1–30), including two patients in whom the hepatic approach was employed twice. All, except one, intended procedures were completed successfully through the liver. Devices were implanted in the hepatic tract with no malposition. One 1.4 kg pt had transient heart block during progression of a 4 Fr dilator over a coronary wire. Another neonate had subcapsular hematoma with decreasing hematocrit requiring blood transfusion and aminocaproic administration in the intensive care unit. No patient died in the catheterization laboratory. Conclusions: Transhepatic access was feasible, safe, and effective in terms of enabling a variety of interventional procedures in a heterogeneous group of pts weighing 1–84 kg with CHD. The interventionalist should not hesitate to employ this strategy in cases with difficult standard vascular access.

Anas Abu Hazeem, Jonathan Rome, Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Introduction: Hemoptysis is a serious complication of congenital heart disease (CHD). We aim to identify risk factors for hemoptysis and describe when diagnostic work-up was high-yield and management effective. Methods: We searched our admission and discharge, catheterization and echocardiography databases between January 1, 1992 and February 1, 2012. Patients without CHD and those with pulmonary hemorrhage postoperatively were excluded. We described the subjects’ demographics, previous postoperative course, severity of presentation, management, and outcomes. We analyzed the event-free survival after aorto-pulmonary collaterals (APCs) embolization. Results: We identified 26 patients with 62 hemoptysis episodes. Age range was 1.2–40 years, 13 were males and 15 had recurrent symptoms. Thirteen patients had single ventricle physiology, six had pulmonary vein (PV) stenosis, six had restricted pulmonary blood flow with hypertrophied APCs, and one had scimitar syndrome with APCs. Possible risk factors for hemoptysis were: chronic cyanosis (32%), delayed stage II palliation of single ventricle patients (average age 29 months in this group), and high grade APCs (grade III or IV in all our patients). CT scan was valuable in identifying patients with lung disease and proximity of previously placed stents and devices to airway. Bronchoscopy was helpful in reaching a diagnosis or locating site of bleeding in 14 out of 18 studies done at our institution. Catheterization interventions were done in 34 including APCs embolization (29), PA stenting (1), and PV dilation (4). APCs embolization was successful in stopping acute bleeding in 73% of cases with adequate data. Only 45% of patients were free of symptoms after 84 months of follow-up. Five patients are deceased (19%), three died during an admission for hemoptysis and two died as a direct result of hemoptysis (8%). Conclusion: Hemoptysis can be a serious cause of morbidity and mortality in CHD. We identified chronic cyanosis, delayed stage II palliation, and high-grade collaterals as risk factors. Bronchoscopy can be helpful in locating bleeding site in acute cases and collateral artery embolization can be effective in stopping the acute bleed but recurrence is common.

Sarosh Batlivala, Matthew Gillespie, Andrew Glatz, Yoav Dori, Jonathan Rome, Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Objectives: To highlight the possibility of ductal spasm. Complete intracatheterization ductal spasm may mislead the physician and result in failure to occlude a hemodynamically significant patent ductus arteriosus (PDA). Background: Transcatheter ductal occlusion is a common procedure. Technology now allows for PDA occlusion in very small patients. Also, premature infant survival rates are improving. Current data suggest that PDAs in premature children are similar to fetal ductuses, suggesting they may remain patent. Methods: We reviewed angiograms from all transcatheter PDA occlusions performed at our institution since 2001 (N = 284). Six cases were identified. Ages ranged from 10 to 80 months (median 15.5) and gestational age ranged from 24 to 37 months (median 28 months). Retrospective data were collected including: gestational age, age at procedure, preprocedure echocardiographic parameters, PDA type and minimal size (after relief of spasm), occlusion device, and most recent clinical and echocardiographic follow-up data. Findings: Five patients were born prematurely. None had significant symptoms. All the PDAs were pressure restrictive and four of the six had echocardiographic evidence of left-heart volume overload. All patients had auscultatory examinationss by the catheterization physicians; all had murmurs consistent with a PDA. When reauscultated (3 of 6), the murmur was absent during ductal spasm. Minimal PDA diameters ranged from 1.5 to 4 mm (median 2 mm). The 5 premature patients required devices; the full-term child had coil placement. No complications occurred; all patients are well at follow-up. Discussion: The etiology of ductal spasm is unclear, but our experience suggests it is more common in premature children. More data are needed to understand how PDAs respond to transcatheter closure. Given the change in cardiac examination during ductal spasm, we recommend all interventionalists examine their patients in the laboratory to avoid a failure to occlude a hemodynamically significant ductus.

Per Jacobsen, Magnus Ba¨ck, Reidar Winter, Magnus Settergren, Department of cardiology, Karolinska University Hospital, Stockholm, Sweden
Background: The MitraClip system is effective in reducing mitral regurgitation (MR) and improving symptoms in patients with both functional and degenerative etiology. It is also a low risk procedure. However it is an expensive procedure. The aim of this study was to try to find the patients who will benefit the most from the MitraClip intervention. Method: Thirty consecutive patients with a mixed etiology of functional and degenerative mitral regurgitation were included in this study to evaluate who are the most eligible patients for the intervention. All patients had been denied open heart surgery at a thoracic conference due to high age and/or high comorbidity. Results: The group consisted of 20 men and 10 women with a mean age of 74 years. The average age among the women was 80 years. We decided based on 1 month follow-up with Minnesota living with heart failure questionnaire (MLWHF) to divide the patients into three groups: non responders (NR), <5 steps improvement; responders, >4 steps improvement; and super responders (SR), >24 steps improvement. In the material 40% of the women qualified as SR while 25% of the men were SR. Forty percent of the men were NR and 10% of the women were NR. Twenty-two patients also did 6 min walk test on follow-up confirming the results of the MLWHF. A multivariable analysis including gender, age, body mass index, ejection fraction, New York Heart Association class, grade of MR, result of MLWHF before the procedure was performed. The dependant variable outcome can be predicted from a linear combination of the independent variables: Gender P 0.022 and MLWHF before the procedure P <0.001. Conclusion: This study indicates that the female gender and a high scoring on the MLWHF may predict a responder or super responder to the MitraClip procedure.

George Nicholson, Robert Vincent, Dennis Kim, Children’s Healthcare of Atlanta/Emory University/Sibley Heart Center Cardiology, Atlanta, GA, USA
Background: While many secundum atrial septal defects (ASD) are amenable to transcatheter device closure, obviating the need for an open surgical procedure, there are some ASDs which may not be suitable for device placement. Prior to initiation of a formal prescreening program, approximately 25% of patients referred for device closure at our institution ultimately were determined to be unsuitable for device placement. This determination occurred on the day of the procedure, resulting in inefficiencies in work flow, staff utilization, and inconvenience for families. Furthermore, detailed discussion of the risks and benefits of device closure occurred only on the day of the procedure. We report our experience with an ASD prescreening evaluation and family consultation process. Results: Between June 30, 2009 and July 1, 2012, 84 patients referred for device occlusion of ASD underwent a comprehensive prescreening process including detailed transthoracic echocardiography and family consultation. Significant differences were noted in defect size, location, and rim assessments compared to the previous outpatient evaluation. Seventeen patients were determined to have an ASD that was not amenable to device closure (20%). Of those who underwent attempt at transcatheter device closure, all had successful device closure of the ASD. After detailed discussion with families, four (6%) elected to undergo surgical rather than device-based ASD closure. Conclusions: With the addition of a prescreening program for transcatheter ASD closure, our institution has decreased the incidence of same day procedure cancellation from 25% to 0%. The use of a comprehensive evaluation process for ASD device closure improves the likelihood of successful device implantation, increases workflow efficiencies, decreases extraneous costs, and improves informed consent.

Gregor Krings, Michiel Voskuil, Matthias Freund, Mirella Molenschot, Childrens University Hospital Utrecht, Utrecht, The Netherlands
Background: Closure of secundum type atrial septum defects (ASD) with an Amplatzer septal occluder (ASO) can be challenging in large defects with deficient aortic, posterior, or inferior rim. Different techniques have been described to manipulate the ASO during placement to prevent the cranial part from slipping through the ASD, i.e. ‘‘left upper pulmonary vein technique’’ (LUPV), ‘‘balloon assisted technique’’ (BAT), or modified delivery-sheath with diagonal orifice. We report over successful ASD closure with ASO using a steerable sheath (Bard USA, 8.3 and 9.8 Fr). Patients and Method: A large ASD with deficient rim was diagnosed in four adult patients by transthoracic echocardiography (TTE). The patients underwent percutaneous ASD closure under general anesthesia. The ASD morphology was studied by transesophageal echocardiography (TEE) and TTE, deficient rim stated and balloon sizing performed which revealed diameters from 28 to 32 mm. Different techniques of modified device-implantation had been used as LUPV, vertical device-alignment achieved by pushing the device with a second catheter and the use of a steerable long sheath. Results: In all four patients the use of a steerable long sheath (Bard, USA) led to successful device-closure of the ASD. Sheath-deflection after development of the left atrial disc made the maneuver simple and safe by positioning the ASO in one plane with the ASD. Conclusion: To our knowledge the use of a steerable long sheath for ASD closure was not published yet. In each of the four patients, the large ASD had been closed with ASO (28–32 mm) by use of the steerable sheath. With an inner diameter of 9.8 Fr the largest ASO to be delivered is 32 mm of size. This sheath-device is typically used for electrophysiological purpose but also suits the demands of ASD closure very well. Deflection and rotation can be easily controlled for closure of complex ASDs.

Amal El Sisi,1 Nevin Mamdouh,2 Amira Esmat,1 Rania El Qafas,1 Khaled Samir,2 Hasan Al Sisi,1 1 Cairo University, Cairo, Egypt, 2 Ain Shams University, Cairo, Egypt
Background: The bidirectional cavo-pulmonary shunt is a standard procedure in the palliation of patients with a functional single-ventricle heart until the Fontan operation. Most cavo-pulmonary anastomosis procedures are associated with disconnection of pulmonary forward flow or any other additional pulmonary flow. However in Egypt there is tendency to leave any additional pulmonary flow in order to gain time till the Fontan procedure. Methods: All patients with bidirectional cavo-pulmonary shunts attending pediatric cardiology outpatients in Cairo University and Ain Shams University were included in this comparative study. There were 45 cases followed up over a period of 1 year from January 2012 till present. Median age at operation was 11 (6–24 months old). Only three patients (6%) had the completion of Fontan operation during the study period. Results: Median time between the cavo-pulmonary anastomosis and catheter study was 28 months. The patients were divided into two groups: group 1 with extra source of pulmonary flow (33 patients (66%)) and group 2 without other source of pulmonary flow (12 patients (34%)). There were no significant differences between the two groups in age, weight, or percentage of prior palliation at the time of surgery. The diagnoses were similar in the two groups. At follow-up in outpatient clinic: weight in group 1 was significantly better than group 2 (P < 0.05). The oxygen saturation was significantly lower in group 2 (P < 0.01). Four patients from group 1 had procedures to minimize the extrapulmonary flow: one had surgical retightening of the band and three patients had catheter interventional procedures either closure of the shunts, collaterals, and/or device occlusion of the forward flow. Twentyfive patients had hemodynamic studies in preparation for Fontan operation, there was significant difference in pulmonary artery (PA) mean pressure, Qp/Qs and PA branches size. There was no significant difference between subgroups of group 1: with shunt, forward pulmonary flow, or aorto-pulmonary collaterals.

Su-Jin Park, Nam Kyun Kim, Jo Won Jun, Jae Young Choi, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Republic of Korea
Introduction: We introduce a case of transcatheter palliative Rastelli procedure. Case: A 9-year-old chronic ill-looking, cyanotic male patient visited our clinic with symptoms of dyspnea (NYHA class IV), poor development (weight less than 3 percentile for his age), and chronic fatigue. At birth, he was diagnosed with congenital heart disease at another institute, but the parents did not agree on any treatment. The pulse oxymetry on his arrival showed oxygen saturation in the late 60s. The echocardiographic diagnosis was functional single ventricle (extreme endocardial cushion defect with left ventricle hypoplasia, common atrium) with pulmonary atresia, multiple major aorto-pulmonary collateral arteries (MAPCAs), and grade 2 common atrioventricular valve regurgitation. Diagnostic cardiac catheterization was performed for accurate mapping of the pulmonary blood supply to each segment of the lung. On the angiogram, the atretic portion of the pulmonary artery (PA) was rather short, which gave us a chance to attempt on percutaneous pulmonary valvuloplasty (PPV). Initially, a chronic total occlusion coronary guide wire (Miracle 3, 0.014 inch) was passed through the PA, in retrograde fashion, and PPV was performed using a high pressure balloon (Z-med II). However, considering the patient’s age and the timing of PPV, we decided to place a stent (Express LD vascular 7 37 mm) on the RV outflow tract, creating a palliative Rastelli state. The patient underwent ballooning of the stent twice and his oxygen saturation currently has increased to 85%. The size of the right PA and left PA has increased from 5 mm and 4 mm to 12 mm and 8 mm after 2 years. Depending on the growth of both PA’s, we are planning on pulsatile bidirectional cavo-pulmonary shunt soon. Conclusion: In patients who have been neglected for a prolonged time, if the patient has favorable anatomic features, they can be candidates for rescue therapy. However, a precise initial diagnosis and mapping of the pulmonary circuit, including the native PA’s and MAPCA’s followed by a meticulous strategic approach is compulsory.

James C. Fudge,1 Naveen Thuramalla,2 Srinivas Badugu,1 Dalia LopezColon,1 Sharda Udassi,1 Gregg Rogers,1 Andre Shih,1 Mark S. Bleiweis,1 Jai P. Udassi,1 1 University of Florida, Gainesville, FL, USA, 2 Transonic Systems, Ithaca, NY, USA
Introduction: Accurate assessment of volumetric preload is important in the management of critically ill patients. Central venous pressure (CVP), which is frequently used to assess preload, has been shown to be inaccurate. The COstatus system (Transonic Systems Inc., NY) routinely measures cardiac index (CI) and central blood volume index (CBVI: blood volume in the heart, lungs, and major vessels normalized over body weight). The aim of this study was to compare stroke volume (SV) measured by the Fick method with CVP and CBVI in patients undergoing cardiac catheterization. Methods: Six patients (aged 19 6 8 years) admitted to the cardiac catheterization lab were studied per the IRB approved protocol. For COstatus, an extracorporeal arteriovenous loop set was connected between in situ catheters and warm isotonic saline was used as an indicator. For the Fick CO, oxygen content from pulmonary artery and arterial blood were used, while VO2 was obtained from published normal values. Measurements were corrected for sheath priming volumes. Results: SV (Fick) ranged between 46 and 76 ml/beat while SV (COstatus) ranged between 45 and 93 ml/beat; CVP ranged between 9 and 19 mm Hg; CBVI ranged between 14 and 34 ml/kg. Correlation between SV (Fick) vs. CVP was r 2 = 0.05; SV (Fick) vs. CBVI was r 2 = 0.84; CVP vs. CBVI was r 2 = 0.002; SV(Fick) vs SV (COstatus) was r 2 = 0.95. Conclusions: CO status measured CBVI showed a strong correlation with stroke volume measured by Fick while CVP showed a poor correlation, suggesting that CBVI is potentially a better marker of volumetric preload. Further studies are ongoing to statistically establish the relationship.

David Nykanen,1 Du Wei,2 Jaxk Reeves,3 David Wax,4 Shakeel Qureshi,5 Dan Gruenstein,6 Carlos Pedra,7 1 Arnold Palmer Medical Center, Orlando, FL, USA, 2 Children’s Hospital of Michigan, Detroit, MI, USA, 3 University of Georgia, Athens, GA, USA, 4 Ann and Robert H. Lurie Children’s Hospital, Chicago, IL, USA, 5 Evelina Children’s Hospital, London, UK, 6 University of Minnesota Amplatz Children’s Hospital, Minneapolis, MN, USA, 7 Instituto Dante Pazzanese de Cardiologia, Sao Paulo, SP, Brazil
Introduction: We sought to develop a simple scoring system to be applied to pediatric cardiac catheterization procedures in an effort to risk stratify patients prospectively for serious adverse events. Methods: Sequential cardiac catheterization data were prospectively collected using a multicenter international registry developed by the congenital cardiovascular interventional study consortium (CCISC). A simple 20-point scoring system was developed based on the literature and consensus opinion to prospectively assign risk of a serious adverse event (SAE). The original score was then modified to a 9-point scale using logistic regression and the backward stepwise model selection method. The predictive value of these two scores were compared to the assigned American Society of Anesthesia (ASA) score in terms of their ability to predict SAE using Sawa’s Bayesian information criterion (BIC) and area under the receiver operator curve (AUC). Results: Among 11,489 registered patients from 17 centers between 2008 and June 2012 there were 9,148 (79.6%) patients less than 19 years old at the time of catheterization. Mean (6SD) age was 5.7 6 3.7 years with range (0–18 years). Mean weight was 23.1 6 14.7 kg with range (0.3–149 kg). The incidence of SAE was 6.8% and 2.4% in children aged <1 year and 118 years (P < 0.001), respectively. Utilizing logistic regression to model the risk score; weight, cardiac diagnosis, procedure, inotropic support, and physiologic score were found to be significant predictors of SAE. The AUC for ASA was least predictive of the three models (0.608). It was greatest for the modified score (0.720) followed by the original score (0.703); indicating superiority of the modified score. Conclusions: It is possible to prospectively risk stratify pediatric patients undergoing cardiac catheterization for SAEs utilizing a simple scoring method. This may have broad application in clinical practice regarding outcomes analysis and development of quality assurance measures.

Daisuke Toyomura,1 Teiji Akagi,1 Yasufumi Kijima,1 Koji Nakagawa,1 Atsushi Yao,2 Toshiro Shinke,3 Tomotake Tokuno,4 Hiroshi Ito,1 Shunji Sano,1 1 Okayama University, Okayama, Japan, 2 Tokyo University, Tokyo, Japan, 3 Kobe University, Kobe, Japan, 4 Kyushu University, Fukuoka, Japan
Background: Therapeutic strategy for atrial septal defect (ASD) patients who complicated with severe pulmonary artery hypertension (PAH) still remains controversial. Recent advanced therapy for PAH and catheter intervention may provide new therapeutic approach in these patients. Method: Four ASD patient complicated with severe PAH (mean PAP > 50 mm Hg) were studied. Estimated initial systolic pulmonary pressure of onset ranged from 80 to 100 mm Hg, and Qp/Qs from 1.1 to 2.1. Medication for PAH which included prostacyclin analog (n = 1), phosphodieterase5 inhibitor (n = 2), and endothelin receptor antagonist (n = 4). After the confirmation of therapeutic efficacy of PAH therapy, catheter closure of ASD was performed. Mean device size was 28.5 mm. Results: Conclusion: Combination of advanced medical therapy for PAH and catheter closure of ASD may expand the therapeutic indication in this patient population.

Victor (Sam) Lucas, Stephen Ramee, Anil Verma, O-chsner Clinic, New Orleans, LA, USA
Background: Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe aortic stenosis and prohibitive surgical risk. Paravalvular aortic regurgitation (AR) after transcatheter aortic valve replacement is common and, when more than mild, is independently associated with increased morbidity and mortality. Nodular calcification at the valvular commissure is associated with paravavular AR after TAVR. Angiography and transesophageal echo does not define the precise anatomy associated with paravalvar leak making device closure difficult and incompletely effective. Methods: Three patients underwent TAVR complicated by at least moderate paravalvular aortic regurgitation related to native aortic valve nodular calcification. Percutaneous device closure with a single Amplatzer AVP 2 vascular plug was accomplished readily in each case from a retrograde aortic approach guided by coronary intravascular ultrasound (IVUS) imaging. The paravalvular leak was crossed easily retrograde with standard coronary guidewires through a 6 Fr guide catheter or 6 Fr sheath. A coronary IVUS pullback from left ventricle to ascending aorta next to the implanted valve clearly demonstrated the paravalve opening facilitating Amplatzer device sizing. Paravalvular leak closure was nearly complete immediately and resulted in dramatic clinical improvement in all. At follow-up, no significant leak was seen. Findings: Intravascular ultrasound facilitates percutaneous closure of paravalvular leak after transcatheter aortic valve replacement. Guided by IVUS, paravalvular leak closure can be accomplished readily at the same time as aortic valve implantation. REFERENCES 1. Nielsen HH, Egeblad H, Andersen HR, Thuesen L, Poulsen SH, Klaaborg KE, Jakobsen CJ, Hjortdal VE. Aortic regurgitation after transcatheter aortic valve implantation of the Edwards SAPIENTM valve. Scand Cardiovasc J, in press. 2. Device closure of paravalvular defects following transcatheter aortic valve replacement.

Liliana Marı´a Ferrı´n,1 Jesus Damsky Barboza,2 Jorge Gomez,3 1 Instituto de Cardiologia de Corrientes, Corrientes, Corrientes, Argentina, 2 Hospital Pedro de Elizalde, Buenos Aires, Capital Federal, Argentina, 3 Hospital Posadas, Buenos Aires, Argentina
Coarctation of the aorta may present in infant, children, and adults as 4 to 5% of congenital cardiac abnormalities. Stent therapy has become an accepted alternative treatment in native aortic coarctation, but requires a large delivery system. The Advanta V12 LD covered stent is premounted and requires a 9–11 Fr delivery system. Objectives: To report the initial experience using Advanta V12 LD stent in children less than 25 kg with the smallest possible delivery system. Methods: From April 2010 to August 2012, patients with native aortic coarctation weighing less than 25 kg were treated with Advanta V12 stent implantation using 7–11 Fr delivery system and high pressure balloon dilatation. Results: Eight patients with aortic coarctation aged 4–11 (mean age 6.12) years, with 16–23 kg (mean19.8 kg) underwent stent implantation. Coarctation diameter of (5.5 6 3.5 mm) increased to (13.5 6 2.2 mm). Peak pressure gradient decreased from 34.3 6 15) mm Hg to (2.5 6 2) mm Hg. The stent achieved the desired diameter in all cases. In two patients concomitant PDA were closed with stenting. Two patients required femoral artery embolectomy because of total occlusion of the artery. At short-term median follow-up of 16 months, all patients but one was alive, normotensive and well with no evidence of recoarctation or aneurysm. The first patient, who present concomitant aortic arch hipoplasy, remains with hypertention and transverse aortic gradient of 25 mm Hg, without gradient at stent level. Conclusion: These initial experience shows that the covered Advanta V12 stenting in children under 25 kg is safe and effective in the immediate treatment of native coarctation of the aorta through a low profile delivery system. Long-term follow up is required.

Mary Porisch, Thomas Summitt, Methodist Children’s Hospital, San Antonio, TX, USA
Introduction: Umbilical vessel access in the cath lab is frequently used in small neonates to perform interventional procedures. However, there are times when umbilical vein and artery catheter placement is unsuccessful at the bedside. We describe a technique for obtaining access in the cath lab in these cases. Methods: All neonatal caths from January 2010 to September 2012 were retrospectively reviewed. Thirty neonatal interventions were performed through either the umbilical vein and/or umbilical artery. Nine of the 30 had access obtained in the cath lab after failed attempts at the bedside and the NICU. A low lying UVC or UAC catheter or micropuncture dilator was placed to a level with good blood return. An angiogram was then performed with 1 cc of contrast to use as a road map. A 0.18 wire was then used to navigate into a distal position. A sheath was then placed over the wire. Results: The nine patients ranged in age from 2 to 6 days of life (mean 3.8 days). The weights ranged from 1.2 to 3.2 kg (mean 2.7 kg). All seven UVCs and two UACs were placed successfully with the above methods. The sheaths ranged in size from 4 to 7 Fr. The diagnosis included: critical aortic stenosis (3); HLHS with restrictive atria septum or coronary sinusoids (3); D-TGA (1); and critical PS (2). One of the HLHS patients had interrupted IVC. The procedures performed were: aortic balloon valvuloplasty (3); BAS or septostomy with static balloon (2); pulmonary balloon valvuloplasty (4); pulmonary balloon valvuloplasty (3); and PDA stent (2). All 9 procedures were successfully performed through the umbilical sheaths. There were no complications. At the end of the case, the sheaths were exchanged and umbilical catheters were placed in over the wire when indicated. In one patient, the IVC was interrupted and the umbilical vein allowed direct access to the heart. The catheters were navigated into the correct position. Conclusion: Access to the umbilical veins and arteries can successfully and safely be obtained in small infants who are either too sick for surgery or the patients is small increasing the risk of femoral access and vascular compromise. We did not find it more difficult to take the catheters from these positions.

Veronica Vasquez, Juan Pablo Sandoval Jones, Pedro Iturralde, Jose Antonio Garcia Montes, Carlos Zabal Cerdeira, Interventional Pediatric Cardiology, National Institute of Cardiology, Mexico City, Mexico
Objective: Children with complex congenital heart disease (CHD) are operated multiple times presenting rhythm disorders and require pacemaker placement. They have a heart structurally different, to be a challenge for group cardiologists, surgeons, and interventionalists to make the best decision. We report a case. Case report: Male with congenitally corrected TGA (CC-TGA) with ventricular septal defect (VSD), persistent ductus arteriosus (PDA), and coarctation of the aorta, who underwent at two years of age a coarctectomy with PDA closure and pulmonary artery banding. In follow-up at 5 years of age, there was evidence of aortic recoarctation. Angioplasty with stent was performed. At 7 years of age, a double switch operation was performed. During the immediate postoperative, the clinical outcome was regular. So was the catheterization laboratory was concluded infundibular stenosis, was operated on again, an extensive infundibular resection. His evolution was favorable and was discharged. Two months after surgery there was complete AV block with low cardiac output. Was agreed endocardial pacemaker placement in DDDR mode. Method: Angiography evidenced appropriate solution over the baffle contrast to right ventricle (RV), to the left, then to the confluent pulmonary arteries. Indirectly observed opacification of the left appendage. The pulmonary veins come to LA with passage of contrast medium to LV, located right across the baffle without obstructions. Left subclavian vein is punctured with introducer, two metal guides are passed by, a long introducer ventricular pacemaker lead with active fixation is passed to the apex of the RV to the left, with adequate capture and corroborating suitable parameters. The atrial pacemaker lead with active fixation is positioned at the origin of the left atrial appendage and confirms adequate capture, setting the pacemaker generator in subpectoral region. Conclusions: At follow-up the patient is in class I of the NYHA. We propose as an alternative using endocardial pacemaker in DDDR in patients after complex CHD surgery, but the literature is still limited in children operated on for complex CHD.

Hamilton Baker,1 David Kwartowitz,2 Fuad Mefleh,2 1 MUSC, Charleston, South CA, USA, 2 Clemson University, Clemson, SC, USA
Background: To date, radiation dose reduction in cardiac catheterization has aimed at modifying the existing technology to limit dose delivery. The inherent limitation of this approach is that ionizing radiation remains the principal imaging modality. We propose a paradigm shift away from ionizing radiation toward the use of a radiation-free, electromagnetic image guidance system (EMIGS) for guidance of heart catheterization. We sought to apply a prototype tracking system in a phantom model to guide mock catheterizations. Methods: An image loading engine was created to load and rescale DICOM images to an isotropic volume. An AuroraTM magnetic tracking system (NDI, Waterloo, ON) was used with a 0.5M cubic field in conjunction with a 6-DOF sensor-embedded Goodale-Lubin catheter. Validation was performed utilizing a Procrustes affine rigid point based registration algorithm with an iterative closest point surface-based registration. The catheter was represented by a single dot at the catheter tip, superimposed on a brief fluoroscopic loop. A simplified cardiac phantom was constructed to mimic the cardiac atria with a septal defect. Mock catheterizations were performed by a single user. Time was recorded to maneuver the catheter from IVC, across the septal defect, into the pulmonary vein orifice, withdrawn back to the right atrium and advanced to the SVC. Forty catheterizations were performed using fluoroscopy, then repeated using EMIGS. Times were compared by student’s T-test. Results: All mock catheterizations were successfully completed. There was no significant difference between fluoroscopy and EMIGS in time across the mock septal defect (Fluoroscopy = 7 sec, EMIGS = 6.5 sec) while total procedure time was significantly lower using EMIGS (Fluoroscopy = 25.7 sec, EMIGS = 21.8 sec). Conclusions: The EMIGS prototype performed well and was comparable to fluoroscopy in guiding simplistic, ex vivo, mock catheterizations with no radiation exposure. Electromagnetic catheter representation appears to be a promising imaging modality to augment, and potentially replace fluoroscopic catheter guidance for certain cardiac catheterizations. Further development is warranted.

Hani Ghawi, Damien Kenny, Mary Heitschmidt, John Hibbeln, Ziyad Hijazi, Rush University Medical Center, Chicago IL, USA
Background: Distortion of transcatheter heart valve (THV) stent shape and morphology secondary to stent fracture has been shown to impact on THV function. Follow-up evaluation of stent geometry may be an important indirect indicator of valve function. Objective: To evaluate and report medium-term CT follow-up data on stent geometry and consequent valve function in a group of patients undergoing transcatheter valve replacement with the Edwards SAPIEN THV. Methods: All patients were enrolled in the COMPASSION trial. Multislice computed tomography (MSCT) was performed as part of the study protocol at 6 and 12 months and yearly thereafter following valve implantation. Prosthesis eccentricity indices (EI), circularity ratios (CR), and expansion ratios (ER) were calculated. Valve function and re-interventional rates were correlated with MSCT findings. A circular deployment was defined as an eccentricity index < 0.1 and under-expansion by expansion ratio <90%. Results: Eighteen consecutive patients from a single implanting institution were included with a mean age of 24.98 6 13.70 years. All patients underwent pre-stenting. Peak Doppler gradients across the RVOT were reduced from 52.7 6 19.2 mm Hg to 25.1 6 9.5 mm Hg as calculated by Doppler on transthoracic echocardiography (P < 0.001). The mean EI, CR, ER, and Doppler gradients at 6, 12, and 24-months follow-up are outlined in Table I. The valve–stent complex maintained excellent symmetrical geometry throughout the follow-up period. Three patients required re-intervention. ER in those requiring re-intervention was significantly less than those not requiring re-intervention (P = 0.04). There was a weak correlation between the pressure gradient across the RVOT and the expansion ratio (R2 = 0.27). There were no stent fractures seen on follow-up. Conclusion: The Edwards SAPIEN THV in the pulmonary position maintains excellent symmetry and geometry without stent fracture on medium-term follow-up. ER was lower in those who required reintervention. ER may predict the need for re-intervention, however, larger cohorts are required to corroborate these findings.

Kenji Baba,1 Shin-ichi Ohtsuki,1 Takahiro Eitoku,1 Yoshihiko Kurita,1 Maiko Kondo,1 Yoshio Okamoto,1 Shingo Kasahara,2 Shunji Sano,2 Tsuneo Morishima,1 1 Department of Pediatrics, Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical, Sciences, Okayama, Japan, 2 Department of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, Pharmaceutical, Sciences, Okayama, Japan
Background: In order to control pulmonary flow for infants with hypoplastic left heart syndrome (HLHS), we recently applied Norwood using right ventriclular-pulmonary artery (RV-PA) shunt with a hemoclip. Our concept is that restrictive pulmonary flow by a hemoclip contributes to stability of hemodynamics at early period and that balloon angioplasty for RV-PA shunt with a hemoclip improves infants oxygen saturation. We sought to evaluate the efficacy of balloon angioplasty for RV-PA shunt with a hemoclip. Methods: We retrospectively reviewed 10 infants, who underwent balloon angioplasty for RV-PA shunt with a hemoclip between July 2008 and August 2012. Results: After balloon angioplasty for RV-PA shunt with a hemoclip, arterial saturation significantly improved (68.3 6 4.2% to 81.6 6 2.1%, P < 0.001) and the diameter of stenotic portion by a hemoclip signifi- cantly increased (2.5 6 0.5 mm to 3.7 6 0.4 mm, P < 0.001). Nine infants have completed stage II, one infant is awaiting for stage II. Conclusion: Balloon angioplasty for RV-PA shunt with a hemoclip was effective. Norwood using RV-PA shunt with a hemoclip could facilitate pulmonary flow control during stages.

Nicholas Huggins, Alan Nugent, Vinai Modem, Joseph Forbess, William Scott, Vivian Dimas, UT Southwestern Medical Center, Dallas, TX, USA
Background: Acute kidney injury (AKI) following either cardiopulmonary bypass (CPB) or contrast administration is described. Cyanosis is another risk factor for AKI. Preoperative cardiac catheterization (PCC) followed by CPB within days is common practice in large tertiary centers. The nephrotoxic effect of contrast followed by CPB within days has not been evaluated in pediatric patients. Methods: AKI in cyanotic single ventricle patients undergoing PCC either < 48 hr or > 5 days prior to CPB were compared. A retrospective analysis was performed at a single institution for patients with both PCC and CPB from January 2007 to November 2010. Two groups were identified: those undergoing bidirectional Glenn (BDG) anastomosis and those undergoing a Fontan procedure. Each group was divided into those undergoing PCC < 48 hr and those undergoing PCC > 5 days prior to CPB. AKI was defined as an absolute increase in serum creatinine (SCr) 0.3 mg/dL, a percentage increase of > 50% from baseline (based on pre-catheterization SCr) or reduction in urine output < 0.5 ml/kg/hr for > 6 hr. Duration of CPB, contrast dose, length of stay, and the requirement of dialysis were also evaluated. Results: One hundred twenty-two patients had a PCC and CPB in the study period, with 113 having complete data available for review (55 BDG, 58 Fontan). In both groups, there were no differences in weight, age, contrast dose, CPB time, ICU stay, and total length of stay. The median contrast dose was < 6 ml/kg for all groups. No patients required dialysis. In the BDG group, AKI occurred more often in patients with PCC >5 days prior to CPB (15/37) vs. < 48 hr (2/18) (P = 0.032). In the Fontan group there was more AKI in the > 5 days group (22/39) but this did not reach significance (P = 0.26). Logistic regression analysis only revealed presurgery SCr in BDG patients was a risk factor for post-CPB AKI (P < 0.001). Presurgery SCr in the Fontan group was not associated with AKI. All other variables including PCC SCr were not significant for either group. Conclusion: PCC within 48 hr of CPB and contrast load do not increase the risk of AKI post-CPB.

Himesh Vyas, Henri Justino, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX, USA
Introduction: Inferior vena cava (IVC) obstruction may present with acute or chronic venous insufficiency, or be discovered incidentally at catheterization (cath). There are limited data on transcatheter treatments for IVC obstruction and their outcomes. Aim: Review techniques and outcomes of transcatheter treatment of IVC obstruction. Methods: Single center review of patients (pts) undergoing percutaneous intervention for IVC obstruction over a 10 year period at a large tertiary children’s hospital. Pts with inferior systemic venous baffle stenosis after atrial switch operations were excluded. Results: 15 pts (male = 7) had 32 caths (median 2, range 1–3). Median (range) age at initial cath = 12 years (3 weeks–31 years) and weight = 35.3 kg (2.3–73.8). Cath indications included acute leg edema (n = 2), post-thrombotic syndrome (n = 8), or incidental finding at cath (n = 5). Obstruction location: suprahepatic IVC (2 pts), intrahepatic (2), periand suprarenal (3), infrarenal (12), common iliac (12), external iliac (8), and renal (1) veins. Total occlusions were encountered in 11 pts, and were crossed with the soft end (4) or stiff end of a wire (5), or transseptal needle (2). Primary cath (fluoro time = 60.7 min, 13.3–118) involved balloon angioplasty (BA) alone in 5/15 pts, with 10/15 pts having 4 (1– 15) stents, with adjunctive mechanical thrombectomy in 2. 14/15 pts had successful IVC interventions; only one had unsuccessful IVC recanalization. 3/5 pts who received primary BA required subsequent stent placement due to restenosis. Complications occurred in 4/32 caths, of which 3 were related to IVC interventions (suprahepatic IVC stent embolization (n = 1), aorto-IVC fistula (1), 1 acute stent thrombosis requiring thrombectomy), and 1 was unrelated to IVC intervention (atrial septal stent embolization in 1). At follow-up of 3 years (1 day– 5.4 years), 6/10 patients with symptoms had satisfactory resolution, 2 with partial resolution, 1 with no resolution (failed procedure), and 1 pt had a successful procedure but died later of unrelated causes. Remainder of patients was alive at last follow-up. Imaging follow-up available in 8 pts showed patent IVC in all pts with initially successful procedure. Conclusions: Transcatheter intervention for stenosis/occlusion of the IVC is feasible and can be performed with low risk and good mid-term outcomes. Re-interventions are commonly required, both to treat recurrent obstruction and to accompany somatic growth.

Jeremy Ringewald, Jeffrey Jacobs, Richard Martinez, Elsa Suh, Congenital Heart Institute of Florida, Tampa Bay, FL, USA
Introduction: Transcatheter pulmonary valve replacement (TCPVR) has led to a paradigm shift in the care of patients with congenital heart disease. TCPVR has been predominantly performed in patients with dysfunctional right ventricle to pulmonary artery conduits and other tissue valves. The Gore-Tex1 bivalve (GBV) is an additional option for surgical pulmonary valve replacement. We hypothesized that some patients with dysfunctional GBVs would be candidates for TCPVR. We report our early experience with TCPVR in patients with a dysfunctional GBV. Methods: Retrospective review of all patients taken to the cardiac catheterization laboratory for attempted TCPVR following surgical GBV pulmonary valve replacement. Results: Since April 2011 six patients have been brought to our cardiac catheterization laboratory with a dysfunctional GBV for possible TCPVR. All had undergone GBV 7–11 years previously. 4/6 were male and mean age was 27 years (range 19–41 years). All patients had marked pulmonary valve dysfunction: 4/6 with combined PS and PR, 2/6 with PR alone. 4/6 were symptomatic and 2/6 had ventricular arrhythmia. All underwent hemodynamic and angiographic assessment and balloon sizing of the GBV. 3/6 patients were judged to have a landing zone in the GBV adequate to consider TCPVR. This decision was based on the angiographic appearance of the GBV leaflets (annular integrity with diminished excursion), and a fluoroscopic circular waist < 23.5 mm in multiple views with balloon sizing. All three patients underwent pre-stenting of the GBV. All three patients then underwent successful TCPVR with a Melody1 valve delivered on an Ensemble1 delivery system. There were no major AEs. Follow-up for the three successfully implanted patients is brief at 5–8 months but by echocardiography all valves demonstrate < 1 PR and minimal PS. Conclusions: Although numbers and follow-up are limited, it appears feasible that some patients with a dysfunctional GBV are TCPVR candidates with encouraging early outcomes.

Neeraj Awasthy, S. Radhakrishnan, Savitri Shrivastava, Munesh Tomar, Fortis Escorts Heart Institute, Delhi, India
Introduction: Ruptured sinus of Valsalva (RSOV) has traditionally been managed by surgery. There are a few case series which do highlight the significant role of percutaneous intervention for RSOV. The relative concern about the interventional procedure has been persistent unsupported aneurysm that persists even after closure of the defect which would only reflect in follow-up studies. Study Design: Patients with isolated RSOV who underwent transcatheter device closure were reviewed with their follow-up. Results: There were a total of 13 patients. The mean age of presentation was 39 6 10.0 years. New York Heart Association (NYHA) class at the time of presentation was II (six patients) III (six patients), and class IV (one patient). The RSOVs were all closed using a patent ductus arteriosus device. The mean procedural time was 30 6 5.4 min, while the fluoroscopic time was 20 6 7 min. The average hospital stay was 2 6 1.1 days. There were no major complications. The patients were followed up for a mean of 3 years (ranging from 1 month to 5 years). All had complete closure of the shunt in follow-up. During the learning curve we modified the technique making subtle changes such as use of buddy wire, kissing technique for right ventricular outflow tract opening, and use of braded sheaths for the same. At the time of the last follow-up, all the patients were in NYHA class I and there was one hospital mortality, latter highlighting the importance of case selection for the procedure. No increase in distortion indices viz aortic annulus, aortic root, St junction, and ascending aortic dimensions were observed. Conclusion: We conclude that transcatheter closure of isolated RSOV is a viable alternative to surgical repair with good outcome on echocardiographic follow-up. Though a long-term data is required particularly with respect to aortic root distortion evaluated by other imaging modality like CT scan or MRI.

Neeraj Awasthy, Munesh Tomar, Sanjay Khatri, S. Radhakrishnan, Savitri Shrivastava, Fortis Escorts Heart Institute, Delhi, India
Balloon aortic valvoplasty forms the important therapeutic intervention in adolescents and young adults, but what remains a challenge is it is justifiable enough to prolong the waiting period of ultimate destiny of aortic valve replacement and remains subject of discussion. Objective: To evaluate long-term results and independent predictors of outcome of aortic valvoplasty particularly in adolescent and adults. Design: Retrospective follow-up study. Independent predictors of outcome identified by multiple logistic regression. Setting: Tertiary referral centre. Patients: One hundred forty consecutive patients treated at the median age of months (0–35 years). The follow-up period was up to 14 years (median 5.3, in survivors 6.4 years). After excluding those converted to univentricular circulation and /died less then 30 days, 136 constituted the study cohort. Interventions: Percutaneous balloon valvoplasty with mean (SD) balloon to annulus ratio 0.97 (0.08). Main outcome measures: Restenosis > 70 mm Hg, grade 3 aortic insufficiency, cusps disruption, surgery, death, and valvoplasty failure (significant restenosis or insufficiency or surgery or death). Results: The immediate mortality rate was 2.9% (n = 4) and the incidence of significant AR was the restenosis rate of 16.7% (n = 45), significant insufficiency developed in 22.3% (n = 60), surgery was needed in 20.1% (n = 54), and ‘‘valvoplasty failure’’ occurred in 41.6% (n = 112) patients. Mean (SEM) survival probability 14.4 years after the procedure was 0.89 (0.02) and mean (SEM) probability of surgery-free survival was 0.50 (0.08). The independent predictors were as follows. For restenosis: small aortic annulus; for cusp disruption: large aortic annulus; for insufficiency: bicuspid aortic valve; for need for surgery: bicuspid aortic valve; for death: small aortic annulus, low left ventricular shortening fraction, and low sequential number of thevalvoplasty; and for valvoplasty failure: small aortic annulus, bicuspid aortic valve, and high grade of mitral insufficiency. Conclusion: Independent predictors of unfavorable outcome are small aortic annulus, bicuspid aorticvalve, poor function of left ventricle, or mitral valve.

Neeraj Awasthy, Sanjay Khatri, Atul Mathur, S. Radhakrishnan, Fortis Escorts Heart Institute, Delhi, India
Hyponatremic-hypertensive syndrome (HHS) is a very uncommon disorder, in which hypertension is associated with profound hyponatremia. Although this condition is reported in adults, it is very uncommon in children. The most common cause of this disorder in children is known to be unilateral renal artery stenosis. Our patient presented symptomatic hyponatremia with hypertensive emergency with underlying unilateral renal artery stenosis as a part of Takayasu arteritis. To the best of our knowledge, this is the first reported association of Takayasu disease with HHS. The patient improved completely with normalization of blood pressure after successful percutaneous transluminal angioplasty. We wish to highlight this unique association because when diagnosed and appropriately managed, the patient may be completely cured of the potentially dangerous manifestations of HHS, as seen in our case.

Neeraj Awasthy, Promaod Ambadkar, S. Radhakrishnan, and K.S. Iyer, Fortis Escorts Heart Institute, Delhi, India
Lutembacher syndrome constituted by the association of congenital atrial septal defect (ASD) usually of the ostium secundum variety and mitral valve disease is a well known entity. Its association with absent coronary sinus, an ASD, and a persistent left superior vena cava (LSVC) draining into the left atrium (LA) (Ragib syndrome) in a single patient is rarely described in literature. We report this association in a 15-yearold boy who had been erroneously deemed to be inoperable prior to referral to our hospital in view of cyanosis in the presence of ASD and mitral stenosis. On evaluation by echocardiography followed by cine angiography, the cause of cyanosis was confirmed to be due to a LSVC draining into the LA along with an atrial septal defect and rheumatic mitral stenosis—a combination of Raghib and Lutembacher syndromes. He underwent successful surgical correction. What is interesting about the case is (1) presentation: diagnosed as ASD and inoperability because of cyanosis, (2) what was missed was unroofed coronary sinus, (3) what was ASD was a coronary sinus defect, (4) what was again missed was an associated mitral stenosis, and (5) the cause of deranged liver function test turned out to be right heart failure, it improved with improvement in CHF. We believe that this is the second such case to be reported in the English literature and first of this kind to undergo surgical intervention.

Axel Moysich, Kai Thorsten Laser, Deniz Kececioglu, Nikolaus A. Haas, Heart- and Diabetes Centre North-Rhine-Westphalia, Department of Congenital Heart Disease, Bad Oeynhausen, Germany
Introduction: Extremely tortuous aortic arches combined with arch hypoplasia and stenosis is a rare finding. Even after successful stenting of the transverse arch, the blood pressure may stay high because of the anatomical course of the aortic arch. Therefore in many centers a surgical approach is preferred. The E-XL Aortic Stent (JOTEC GmbH, Germany) was initially manufactured for aortic lesions, e.g. dissections. This retrospective study describes the immediate effectiveness of these stents in this specific patient group. Methods: We report on three patients (9, 11, and 23 years) with the described anatomy who were treated in our center. Despite successful stent-implantion in the transverse arch region, a relevant brachiocephalic hypertension and resting blood pressure gradient (20–40 mm Hg) remained. After angiographic documentation and measurements of the anatomy, the optimal stent size was selected. In two patients (9 and 11 years.), 18 70 mm E-XL aortic stents were implanted using a 12 Fr delivery system, in the GUCH-patient a 24 100 mm stent was used via a 14 Fr sheath by a transfemoral approach. Results: In all cases, stent implantation was successfully performed without complications. Due to the length and size of the stents implanted, the aortic arches were straightened up and their diameter adequately extended in all patients. Only minimal residual pressure gradients (< 10 mm Hg) were documented immediately after implantation. Discussion: Extremely tortuous aortic arches with hypoplasia and coarctation usually cause brachiocephalic arterial hypertension and interventional treatment may be a therapeutic challenge. The combination of the closed cell design with a high radial force at its ends and the open cell design in the middle section makes the E-XL aortic stent an interesting alternative to common stent implantation in these patients. Kinking seems to be avoided and the tortuous anatomy can be straightened up. This combination makes these stents useful offer these challenging patients an interventional treatment modality.

Axel Moysich, Kai Thorsten Laser, Deniz Kececioglu, Nikolaus A. Haas, Heart- and Diabetes Centre North-Rhine-Westphalia, Department of Congenital Heart Disease, Bad Oeynhausen, Germany
Introduction: Interventional closure of a patent arterial duct (PDA) has become a common and safe procedure in most pediatric cath labs. However, despite modern devices available, it still remains a challenge in those children with low body weight and a large PDA. Several new PDA occluder systems have been developed in the last years. One of them is the Nit-Occlud PDA-R device which was especially designed for large PDAs. The clinical experience and initial trial with this occluder published so far accepted only children with a body weight greater than 10 kg. Methods: We report our most recent experience in seven children (age 1–10, median 6 months) with a body weight from 4.1 to 9.7 kg (median 5.9 kg) with large PDAs. The occluder size is determined by the minimum diameter of the PDA, the occluder stent must be at least 1.5 times, better 2 times greater: in six cases, the Nit-Occlud PDA-R with an aortic disc of 12 mm, a stent of 7 mm, and a length of 8.5 mm was selected and in the seventh case one with an aortic disc of 14 mm, a stent of 8.5 mm, and a length of 9.5 mm. All devices were implanted using the femoral venous access with a 6 Fr sheath. Results: All seven devices were successfully implanted under sedation, without general anesthesia and without complications, e.g. dislocation with pulmonary or aortic obstruction. A sufficient occlusion of the PDA was documented by angiography and echocardiography in all cases. The patients were discharged from hospital two days after implantation. Discussion: The new Nit-Occlud PDA-R device is suitable even in children with a body weight below 10 kg, when a relative large PDA is present. The reinforced retention disc allows an optimal positioning in the aortic ampulla without obstruction and the flexible cylindrical plug helps to adapt this device to various duct anatomies. Results: All seven devices were successfully implanted under sedation, without general anesthesia and without complications, e.g. dislocation with pulmonary or aortic obstruction. A sufficient occlusion of the PDA was documented by angiography and echocardiography in all cases. The patients were discharged from hospital two days after implantation. Discussion: The new Nit-Occlud PDA-R device is suitable even in children with a body weight below 10 kg, when a relative large PDA is present. The reinforced retention disc allows an optimal positioning in the aortic ampulla without obstruction and the flexible cylindrical plug helps to adapt this device to various duct anatomies.

Axel Moysich, Kai Thorsten Laser, Deniz Kececioglu, Nikolaus A. Haas, Heart- and Diabetes Centre North-Rhine-Westphalia, Department of Congenital Heart Disease, Bad Oeynhausen, Germany
Introduction: Interventional ventricular septal defect (VSD) closure is not performed in all pediatric cath labs because of bad risk of AV-blocs. In our cath lab we are using the NIt-Occlud Leˆ device since 24 month. This retrospective study describes the effectiveness and complications implanting this occluder. Methods: We report on 17 children with a body weight from 7.4 to 48.7 kg (median 18 kg) with perimembranous VSD (10 patients) or muscular VSD (7 patients). After adequate angiographic documentation and measurements interventional VSD closure was performed with NItOcclud Leˆ devices in all cases. Results: All devices were successfully implanted under sedation, without general anesthesia and without periprocedural complications, e.g. embolization. A sufficient occlusion was documented by angiography in nine cases, residual shunt in eight cases, but disappeared 48 hr later. In two cases, hemolysis occurred transiently. In one case, a right bundle branch block appeared after releasing the occluder. This child developed a complete AV-block after one week, but was successfully treated with prednisolone. Discussion: Comparing the other currently available VSD occlusion systems the Nit-Occlud Leˆ device is built up of a flexible nitinol coil layer that adapts perfectly to the anatomy of the defect. Therefore, no permanent AV blocks were documented. Due to the polyester fibers in the distal part of the coil a rapid occlusion was expected, but transient hemolysis occurred in two cases.

Varun Aggarwal, Danyal Khan, Miami Children’s Hospital, Miami, FL, USA
Background: Pulmonary arterio-venous malformations (PAVMs) are abnormal direct connections between a pulmonary artery and a pulmonary vein without an intervening capillary bed. This leads to a right to left shunt resulting in low systemic oxygen saturation and possibly causing paradoxical embolism resulting in stroke, cerebral abscess, etc. Treatment of PAVM has ranged from surgical lobectomy to transcatheter embolization to medical treatment with Interferon. Methods: We retrospectively reviewed the catheterization records at Miami Children’s Hospital over the last 10 years. We found three patients who were brought to the cath lab for PAVM and underwent transcatheter embolization. Results: The ages of the patients were 2 weeks, 4 months, and 16 years. The two infants had presented with low oxygen saturations while the 16 year old presented with polycythemia. One of the infants had been placed on extra corporeal membrane oxygenation (ECMO) while the older infant had been intubated and placed on nitric oxide due to persistent hypoxia. Echocardiograms on the infants demonstrated normal intracardiac anatomy. Due to a high index of suspicion, on repeat echocardiogram, a bubble study (using agitated saline) demonstrated the presence of bubbles returning from the pulmonary veins, thereby indicating the presence of PAVM. The 16 year old was found to have a shadow on a chest X-ray. A CT scan of the chest diagnosed the PAVM. All the three patients underwent catheterization and the arterial feeding vessels to the PAVM were occluded using coils and Amplatzer vascular plug II (AVP II). The patients had an immediate improvement in saturations. No complications occurred during the catheterizations. Two patients had family history of telangiectasia but did not meet the full criteria for hereditary hemorrhagic telangiectasia (HHT). Conclusion: In patients with persistent unexplained hypoxia and a normal echocardiographic study, there should be a high index of suspicion for PAVM. PAVM can easily be diagnosed by supplementing the echocardiographic study with an intravenous injection of agitated saline (bubble study). PAVM can be effectively treated by transcatheter embolization.