Publications by authors named "Henri Justino"

67 Publications

Ultrasound-guided intraoperative trans-epicardial needle biopsy of an intracardiac tumor.

Ann Pediatr Cardiol 2020 Oct-Dec;13(4):346-348. Epub 2020 Jul 24.

Department of Pediatrics, Section of Pediatric Cardiology, Texas Children's Hospital, Houston, TX, USA.

We describe the use of a novel interventional approach to the histopathologic diagnosis of a ventricular septal tumor using intraoperative ultrasound-guided trans-epicardial biopsy without the need for cardiopulmonary bypass in a 2-year-old child. This novel approach has not been previously reported. Multidisciplinary collaboration between cardiothoracic surgery, cardiology, cardiac imaging, and interventional radiology provided the ability to perform cardiac biopsy. This technique may be used in specific cases of cardiac tumors where tissue diagnosis is important, but surgical resection is deemed excessively risky or impossible.
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http://dx.doi.org/10.4103/apc.APC_45_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727904PMC
July 2020

SAPIEN S3 valve deployment in the pulmonary position using the gore DrySeal sheath to protect the tricuspid valve.

Catheter Cardiovasc Interv 2020 Nov 30;96(6):1287-1293. Epub 2020 Jun 30.

Department of Pediatrics, Charles E. Mullins Cardiac Catheterization Laboratories, Texas Children's Hospital, and Lillie Frank Abercrombie Section of Cardiology, Baylor College of Medicine, Houston, Texas, USA.

Background: Tricuspid valve injury can occur during implantation of a SAPIEN valve in the pulmonary position. We describe our experience using a long Gore DrySeal (GDS) sheath to protect the tricuspid valve during advancement of the Commander delivery system.

Methods: Retrospective single center review of all patients who underwent placement of a SAPIEN valve in the right ventricular outflow tract between January 2016 and April 2020. Patients were divided into two groups: delivery of the valve using standard technique (Group I), and with the use of a GDS (Group II), for comparison.

Results: There were 48 patients in total: 25 in Group I and 23 in Group II. In Group II, the first 10 patients had a 29 mm S3 placed through a 26 French (Fr), 65 cm GDS. We then performed additional crimping of the S3 onto the balloon after the balloon catheter was withdrawn to position the valve on the balloon outside the body. Subsequently, seven had a 29 mm S3 placed through a 24 Fr GDS, and four had a 26 mm S3 placed through a 22 Fr GDS including one weighing 16 kg. Two had a 23 mm S3 placed through a 22Fr GDS as the 20Fr GDS was not available in our lab. Severe tricuspid valve injury occurred in 2/25 (8%) of Group I patients and 0/23 of Group II patients.

Conclusion: Use of a long GDS may protect the tricuspid valve from injury during implantation of the S3 valve in the pulmonary position, and is technically feasible in smaller patients.
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http://dx.doi.org/10.1002/ccd.29120DOI Listing
November 2020

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.

Catheter Cardiovasc Interv 2020 Nov 20;96(6):1266-1276. Epub 2020 May 20.

Cedars-Sinai Medical Center, Los Angeles, California, USA.

Objectives: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure.

Background: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature.

Methods: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up.

Results: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g.

Conclusions: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.
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http://dx.doi.org/10.1002/ccd.28973DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754477PMC
November 2020

Radiation Safety in the Cardiac Catheterization Laboratory Is Our Responsibility: A Call to Humility and Action!

Authors:
Henri Justino

Circ Cardiovasc Interv 2020 05 15;13(5):e009236. Epub 2020 May 15.

Charles E. Mullins Cardiac Catheterization Laboratories, Lillie Frank Abercrombie Section of Cardiology, Department of Pediatrics, Texas Children's Hospital and Baylor College of Medicine, Houston, TX.

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009236DOI Listing
May 2020

Inhaled Tranexamic Acid As a Novel Treatment for Pulmonary Hemorrhage in Critically Ill Pediatric Patients: An Observational Study.

Crit Care Explor 2020 Jan 29;2(1):e0075. Epub 2020 Jan 29.

Section of Critical Care Medicine, Department of Pediatrics, Baylor College of Medicine, Houston, TX.

Objectives: To describe the use of inhaled or endotracheally instilled tranexamic acid in critically ill pediatric patients for the treatment of pulmonary hemorrhage, which can be severe, life-threatening, and include potentially high-risk management procedures.

Design: Retrospective observational study from 2011-2018 with patients followed until hospital discharge.

Setting: Free-standing children's hospital with an annual ICU volume of more than 3,500 yearly admissions.

Patients: Pediatric patients, ages 0 to 18 years, admitted to an ICU and who received at least one dose of inhaled or endotracheally instilled tranexamic acid were included.

Interventions: Inhaled or endotracheally instilled tranexamic acid.

Measurements And Main Results: This study described the efficacy and adverse effects of patients who received inhaled or endotracheally instilled tranexamic acid. A total of 19 patients met inclusion criteria; median age was 72 months (11-187 mo), most patients were female (11, 58%), and almost half our patients (8, 42%) had congenital heart disease. Nine of 19 encounters (47%) had diffuse alveolar hemorrhage, four (21%) had pulmonary hemorrhage related to major aortopulmonary collateral arteries, two (11%) had mucosal airway bleeding, two (11%) were iatrogenic, one had a pulmonary embolism, and one patient did not have their etiology of pulmonary hemorrhage determined. Cessation of pulmonary hemorrhage was achieved in 18 of 19 patients (95%) with inhaled tranexamic acid with no major adverse events recorded.

Conclusions And Relevance: We demonstrate that inhaled tranexamic acid may be safely used to treat pulmonary hemorrhage from varied etiologies in critically ill pediatric patients. Prospective studies are required in this vulnerable population to determine optimal dosing and delivery strategies, as well as to define any differential effect according to etiology.
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http://dx.doi.org/10.1097/CCE.0000000000000075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7063899PMC
January 2020

Rivaroxaban, a direct Factor Xa inhibitor, versus acetylsalicylic acid as thromboprophylaxis in children post-Fontan procedure: Rationale and design of a prospective, randomized trial (the UNIVERSE study).

Am Heart J 2019 07 1;213:97-104. Epub 2019 May 1.

Duke University Medical Center, Durham, NC 27710. Electronic address:

Background: The Fontan procedure is the final step of the 3-stage palliative procedure commonly performed in children with single ventricle physiology. Thrombosis remains an important complication in children after this procedure. To date, guideline recommendations for the type and duration of thromboprophylaxis after Fontan surgery are mainly based on extrapolation of knowledge gained from adults at risk for thrombosis in other clinical settings. Warfarin is being used off-label, and because of its multiple interactions with other drugs and food, a new alternative is highly desirable. Rivaroxaban, a direct Factor Xa inhibitor with a predictable pharmacokinetic profile, is a candidate to address this medical need.

Study Design: The UNIVERSE study is a prospective, open-label, active-controlled, multicenter study in children 2 to 8 years of age who have single ventricle physiology and had the Fontan procedure within the 4 months preceding enrollment. This study consists of 2 parts. In Part A, rivaroxaban pharmacokinetics, pharmacodynamics, safety, and tolerability are assessed to validate the pediatric dosing selected. In Part B, safety and efficacy of rivaroxaban versus acetylsalicylic acid are evaluated for thromboprophylaxis in children post-Fontan procedure. Children in each part will receive study drug for 12 months. Part A has been completed with 12 children enrolled. Enrollment into Part B is currently ongoing.

Conclusions: The UNIVERSE study aims to provide dosing, pharmacokinetics/pharmacodynamics, safety, and efficacy information on the use of rivaroxaban, an oral anticoagulant, versus acetylsalicylic acid, an antiplatelet agent, in children with single ventricle physiology after the Fontan procedure.
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http://dx.doi.org/10.1016/j.ahj.2019.04.009DOI Listing
July 2019

Comparison of drug eluting versus bare metal stents for pulmonary vein stenosis in childhood.

Catheter Cardiovasc Interv 2019 Aug 8;94(2):233-242. Epub 2019 May 8.

Charles E. Mullins Cardiac Catheterization Laboratories, Lillie Frank Abercrombie Section of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

Objective: Comparison of outcomes using bare metal (BMS) and drug-eluting (DES) stents in pulmonary vein stenosis (PVS).

Background: PVS is a serious condition with frequent restenosis after surgical and percutaneous interventions. After experiencing encouraging results with DES, we sought to compare outcomes of BMS and DES in native and post-surgical PVS.

Methods And Results: A retrospective review of all patients who underwent stent implantation between 08/93 and 11/17 for PVS at Texas Children's Hospital was performed. BMS were used to treat 58 lesions in 37 patients and 105 DES used to treat 105 lesions in 41 patients. Mean age at first stent implant was 2.9 ± 3.5 years in BMS and 16.2 ± 18.8 months in DES group. Of those with follow-up catheterization, mean lumen loss rate from stent implant to first follow-up catheterization was 0.85 ± 1.47 mm/month over 6.4 ± 6.4 months in the BMS group (n = 44 lesions) compared to 0.16 ± 0.31 mm/month over 6.8 ± 7.4 months in the DES group (n = 86 lesions), p < .01. Follow-up for the BMS group was 14 months (6 days-22.3 years), with 13 mortalities, eight lesions were re-stented and six complete occlusions were noted. Follow-up for DES group (including four cross-overs) was 17.5 months (3 days-9 years), with 10 mortalities, seven lesions were re-stented, 11 had complete occlusion, 20 new adjacent lesions in the same vessel underwent stenting and 12 stents were intentionally fractured.

Conclusion: DES have significantly lowered lumen loss rate when compared to BMS at medium term follow-up and can be fractured to enable larger diameters. Availability of larger diameter DES would be ideal.
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http://dx.doi.org/10.1002/ccd.28328DOI Listing
August 2019

Hybrid approach to ventricular septal defect enlargement.

Catheter Cardiovasc Interv 2019 Nov 14;94(5):732-737. Epub 2019 Apr 14.

Division of Cardiology, Department of Pediatrics, UC Davis Children's Hospital, Sacramento, California.

The need for creation or enlargement of a ventricular septal defect (VSD) is a rare occurrence. It is most frequently required in patients with double-outlet right ventricle who develop restriction of a remote muscular VSD or obstruction of a perimembranous VSD secondary to atrioventricular (AV) valve attachments to the interventricular septum. Surgical and transcatheter options for VSD creation or enlargement are associated with several risks including heart block, AV valve injury, and perforation. We report the first description of a hybrid approach to VSD creation and enlargement in two patients.
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http://dx.doi.org/10.1002/ccd.28227DOI Listing
November 2019

Congenital coronary artery fistula: Presentation in the neonatal period and transcatheter closure.

Congenit Heart Dis 2018 Sep 19;13(5):782-787. Epub 2018 Sep 19.

The Lillie Frank Abercrombie Section of Pediatric Cardiology, Department of Pediatrics, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas.

Background: Congenital coronary artery fistula is a rare coronary anomaly. Most commonly, such fistulae drain into the right side of the heart or the pulmonary artery. Children with coronary artery fistulae are generally asymptomatic, although they may have left ventricular enlargement in the setting of a moderate sized left to right shunt. Symptoms of congestive heart failure or ischemia are very rare in neonatal period, and suggest the presence of a very large shunt and/or coronary steal.

Methods: Single center retrospective review of transcatheter intervention on coronary artery fistulae presenting with symptoms in the neonatal period from January 2000 to March 2018. Patients with associated congenital heart diseases (except atrial septal defect) were excluded. Patient records, catheterization data, angiograms and noninvasive imaging were reviewed.

Results: Two patients underwent transcatheter intervention for symptomatic coronary artery fistula in the first few weeks of life. The first patient had multiple right and left coronary artery to right ventricle fistulae and presented with severe biventricular systolic dysfunction. Transcatheter closure of the fistulae was performed using multiple Gianturco coils. The second patient had a large left main coronary artery to left ventricle fistula (with left anterior descending and circumflex coronary artery atresia) presenting with symptoms of ischemia. This large fistula was closed using one Amplatzer Vascular Plug type-II and two Micro-Vascular Plugs. Both patients had improvement in symptoms post intervention and are doing well at the last follow up at 12 years and 7 months respectively.

Conclusions: We hereby describe the rare presentation of symptomatic coronary artery fistulae in the neonatal period and their successful transcatheter management. This is also the first description of left anterior descending and circumflex coronary artery atresia in the setting of a large left main coronary artery to left ventricle fistula.
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http://dx.doi.org/10.1111/chd.12653DOI Listing
September 2018

Controversy About a High-Risk and Innovative Fetal Cardiac Intervention.

Pediatrics 2018 09 10;142(3). Epub 2018 Aug 10.

Children's Mercy Hospital Bioethics Center, Kansas City, Missouri

A 20-week-old fetus was diagnosed with critical pulmonary valve stenosis. Given the ultrasound findings, the outcome was difficult to predict. The fetal cardiologists discussed the possibility of a pulmonary valvuloplasty (an experimental procedure) with the parents, wherein the fetal right ventricle would be punctured with a long 18G needle, and through it, a wire advanced across the pulmonary valve, allowing for balloon dilation of the valve. The experimental procedure had been performed at a handful of centers. There were some reports of success. The parents sought an opinion at one of the referral centers that had tried the procedure. The doctors there recommended against it. The doctors at the original center were unsure whether they should try the procedure. The parents wanted it. In this ethics rounds, doctors and the parents discuss the arguments for and against a high-risk, innovative in utero procedure.
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http://dx.doi.org/10.1542/peds.2017-3595DOI Listing
September 2018

Two- and Four-dimensional Ultrasonography of an Interatrial Stent in a Fetus With Hypoplastic Left Heart Syndrome.

J Ultrasound Med 2019 Feb 29;38(2):549-551. Epub 2018 Jul 29.

Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.

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http://dx.doi.org/10.1002/jum.14718DOI Listing
February 2019

Outcomes after Balloon Pulmonary Valvuloplasty for Critical Pulmonary Stenosis and Incidence of Coronary Artery Fistulas.

Am J Cardiol 2018 06 13;121(12):1617-1623. Epub 2018 Mar 13.

Department of Pediatrics, The Lillie Frank Abercrombie Section of Pediatric Cardiology, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas. Electronic address:

Outcome data for neonates with critical pulmonary stenosis (PS) is limited. We aimed to review the outcomes after balloon pulmonary valvuloplasty (BPV) for neonates with critical PS at our institution. All neonates with critical PS who underwent BPV from 1990 to 2017 were included. A total of 44 neonates underwent BPV for critical PS. Nonright ventricular dependent coronary artery fistulas was seen in 6/44 (13.6%) patients. Tricuspid valve z-scores were -1.9 (interquartile range [IQR] -3.04, -0.48) in those with coronary artery fistulas as compared with -0.27 (IQR -0.5, 0.8) in those without (p = 0.03). Fifteen of forty-four subjects (34.1%) patients underwent reintervention with 10 patients (22.7%) requiring an alternate source of pulmonary blood flow (3 patients subsequently underwent right ventricular overhaul, 2 underwent Glenn operations, and 1 underwent repeat BPV). Five patients underwent reintervention for right ventricular outflow tract obstruction. Pulmonary valve annulus z-score was significantly smaller in those who needed reintervention -2.4 (IQR -2.9 to -0.95) versus -0.59 (IQR -1.3, -0.15); p = 0.02. At a median follow-up of 8.2 (IQR 3.4 to 13.1) years, moderate or severe pulmonary regurgitation was seen in 22/42 (53.7 %) patients with biventricular circulation, 3 requiring pulmonary valve repair/replacement. In conclusion, coronary artery fistulas occur in a significant number of patients with critical pulmonary stenosis, occurring more frequently in patients with small tricuspid valves. Reintervention is required for 1/3 of patients. Patients with small pulmonary valve annuli are more likely to undergo reintervention for right ventricular outflow tract obstruction. Significant pulmonary regurgitation is common and may require eventual pulmonary valve replacement.
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http://dx.doi.org/10.1016/j.amjcard.2018.02.049DOI Listing
June 2018

Interventions in children with renovascular hypertension: A 27-year retrospective single-center experience.

Congenit Heart Dis 2018 May 10;13(3):349-356. Epub 2018 Apr 10.

Department of Pediatrics, Texas Children's Hospital and Baylor College of Medicine, Lillie Frank Abercrombie Section of Cardiology, Houston, Texas.

Background: Renovascular hypertension (RVH) can be caused by renal artery stenosis (RAS) and/or middle aortic syndrome (MAS).

Methods: Patients who received surgical or transcatheter treatment for RVH between 1/1991 and 11/2017 were retrospectively reviewed using age = adjusted blood pressure ratio (BPR).

Results: Fifty-three patients diagnosed with RVH at a median age of 4.5 (0-18) years were included. Vascular involvement ranged from MAS with RAS (20), RAS only (32), and MAS only (1). The first intervention was transcatheter in 47 patients (transcatheter group: angioplasty = 41, stenting = 5, and thrombectomy = 1), and surgical in 6 patients (surgical group), occurring at a median age of 6.2 (0.1-19.6) years. There was a change toward transcatheter interventions as the first procedure over the study period. First reinterventions in the transcatheter group (27 lesions in 18 patients) were repeat transcatheter (in 20 lesions) and surgery (7 lesions) at a median of 92 (2-2555) days; in the surgical group (5 lesions in 4 patients) first reinterventions were transcatheter (4 lesions) and repeat surgery (1) at a median of 2.2 (1.1-12.0) years. A total of 136 transcatheter and 30 surgical discrete interventions were performed. There was a significant decline in antihypertensive medications and BPR at 4-6 months after the first intervention and on last follow-up in patients initially treated by transcatheter means while the decline was not significant in the surgical group (limited by small sample size). Complications were significantly more common in the surgical group (P < .01), 11/27 (41%) vs 10/136 (7.4%). Four patients died (2 from each group): 2 with congenital renal artery atresia and MAS, 2 with MAS and RAS. The median follow-up interval was 3.6 (0.1-35.2) years.

Conclusion: Pediatric patients with RVH treated with transcatheter means as the first intervention had significant improvement in BPR, as well as decline in antihypertensive medications and were less likely to suffer major complications.
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http://dx.doi.org/10.1111/chd.12608DOI Listing
May 2018

Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits.

JACC Cardiovasc Interv 2018 03;11(6):554-564

Division of Pediatric Cardiology, Lucille Packard Children's Hospital at Stanford University, Palo Alto, California; Department of Pediatrics, Lucile Packard Children's Hospital Heart Center, Stanford University School of Medicine, Palo Alto, California; Department of Cardiothoracic Surgery, Lucile Packard Children's Hospital Heart Center, Stanford University School of Medicine, Palo Alto, California.

Objectives: This study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter.

Background: The Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits.

Methods: The study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes.

Results: A total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year).

Conclusions: In this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.
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http://dx.doi.org/10.1016/j.jcin.2018.01.239DOI Listing
March 2018

Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: A multicenter study.

J Thorac Cardiovasc Surg 2018 04 6;155(4):1712-1724.e1. Epub 2017 Dec 6.

Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital, Stanford University, Palo Alto, Calif.

Background: Stented bioprosthetic valves (BPVs) are commonly used for surgical pulmonary valve (PV) replacement in postoperative congenital heart disease, but develop structural failure in a time-related fashion. The Melody transcatheter PV (TPV) (Medtronic, Minneapolis, Minn) has been used to treat BPV dysfunction, but there have been few studies in this population.

Methods: We performed a retrospective, multicenter study to evaluate Melody valve function in patients who underwent TPV replacement (TPVR) into a dysfunctional pulmonary BPV.

Results: One hundred patients who underwent TPVR at 10 centers between January 2010 and June 2015 were enrolled. The median patient age was 22 years (range, 5-79 years), and 32 patients were age <18 years. The underlying diagnosis was tetralogy of Fallot in 80 patients, and moderate or severe pulmonary regurgitation (PR) was present in 84%. The TPV was implanted into various types of BPVs, with a median size of 23 mm (range, 19-33 mm). At hospital discharge, PR was mild or less in all but 1 patient, and the mean Doppler right ventricular outflow tract (RVOT) gradient was reduced from a mean of 29.3 ± 12.0 mm Hg to 16.2 ± 6.9 mm Hg (median, 29 mm Hg to 16 mm Hg; P < .001). During follow-up (median, 12.4 months), no patients underwent reintervention on the TPV. Endocarditis was diagnosed in 1 patient who was managed medically without intervention. The mean RVOT gradient at the most recent follow-up was ≤35 mm Hg in all patients, and was similar to that at early postimplantation. PR was more than mild in only 1 patient. Hemodynamic outcomes did not differ between patients with small BPVs (≤23 mm) and those with large BPVs (≥25 mm).

Conclusions: TPVR restores competence and relieves the obstruction of dysfunctional surgical BPVs, with excellent early results in both small and large BPVs, highlighting the potential for TPVR to extend the life of existing BPVs in adults and children. Collaboration between surgeons and cardiologists is important to determine the optimal lifetime management, combining surgical PV replacement and TPVR in this population.
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http://dx.doi.org/10.1016/j.jtcvs.2017.10.143DOI Listing
April 2018

Intentional longitudinal and side-cell stent fractures: Intermediate term follow up.

Catheter Cardiovasc Interv 2018 05 23;91(6):1110-1118. Epub 2018 Jan 23.

Department of Pediatrics, Texas Children's Hospital and Baylor College of Medicine, C. E. Mullins Cardiac Catheterization Laboratories, Lillie Frank Abercrombie Section of Cardiology, Houston, Texas.

Background: Use of small diameter stents in young children and jailing of side branches pose significant challenges to future re-interventions. We sought to assess the capacity to induce longitudinal fractures in undersized stents to increase vessel diameter, and side cell fractures to enlarge stenotic jailed branches.

Methods: Retrospective review of patients who underwent attempted intentional stent fractures (ISF) from 01/06-02/17.

Results: Twenty-two patients, median age 4.4 (1.1-47.8) years, weighing 14.3 (6.9-102) kg underwent attempted ISF in 32 vessels. Initial stent implant occurred at a median age of 1.0 (0.1-34.1) years, at the following sites: pulmonary arteries (11), pulmonary veins (14), systemic veins (6), and aorta (1). Initial diameters of the stents were 3.5-12 mm. Thirteen vessels had overlapping stents. Using high-pressure balloons, longitudinal ISF was achieved in 23 and side cell ISF in eight vessels. One longitudinal ISF attempt was unsuccessful. Three lesions were immediately re-stented after longitudinal ISF, and three lesions treated with angioplasty (1) or stenting (2) after side cell ISF. Only one complication occurred (pseudoaneurysm in a pulmonary artery after longitudinal ISF requiring placement of a covered stent). At a median follow up of 2.0 years (2 days - 10.8 years), eight patients had 16 additional interventions for restenosis at site of ISF.

Conclusions: ISF can be induced safely in a variety of vascular beds using high-pressure balloons both longitudinally or through side cells. Longitudinal ISF only rarely requires immediate placement of a new stent; however, late restenosis may occur, requiring re-stenting.
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http://dx.doi.org/10.1002/ccd.27469DOI Listing
May 2018

First Report of Biventricular Percutaneous Impella Ventricular Assist Device Use in Pediatric Patients.

ASAIO J 2018 Sep/Oct;64(5):e134-e137

Lillie Frank Abercrombie Section of Pediatric Cardiology, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

There is a growing interest in the use of percutaneously delivered ventricular assist devices (PVAD) in the pediatric patient population. A 16 year old female and 18 year old male both status post heart transplantation presented with evidence of graft rejection and acute severe global systolic and diastolic heart failure necessitating hemodynamic catheterization and inotropic support. Both underwent percutaneous Impella CP LVAD (Abiomed, Danvers, MA) placement with close monitoring of right ventricular function. Although pulmonary artery wedge pressure (PAWP) improved, persistently elevated central venous pressures (CVP) and ongoing renal and liver injury prompted insertion of Impella RP RVAD. Explantation of bilateral devices was achieved within 4 days in the 18 year old patient. He would go on to require total artificial heart support before successful retransplantation. Despite bilateral PVAD support and antirejection medications, our 16 year old patient went on to develop multisystem organ failure and ultimately passed away after withdrawal of life-sustaining therapies. We report the first description of biventricular percutaneous Impella VAD for the treatment of acute decompensated heart failure in a pediatric institution. This innovative VAD option for older children/adolescents represents a less-invasive advancement in mechanical support technology with potential applicability across the pediatric population.
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http://dx.doi.org/10.1097/MAT.0000000000000732DOI Listing
March 2019

Contralateral Pulmonary Hypertension Following Resuscitation of Unilateral Ductal Origin of a Pulmonary Artery: A Multi-institutional Review.

Pediatr Cardiol 2018 Jan 25;39(1):71-78. Epub 2017 Sep 25.

The Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.

In isolated unilateral ductal origin of a pulmonary artery (DOPA), intervention to establish reperfusion of the affected lung without direct re-anastomosis may lead to pulmonary hypertension (PH) in the contralateral lung. Multicenter retrospective review of patients with unilateral DOPA, who underwent palliation with a ductal stent (DS) or Blalock-Taussig (BT) shunt with subsequent development of PH in the contralateral lung, was conducted. Ten patients (4 females; median weight 3.2 kg, range 2.1-5.2) who underwent DS or BT shunt and developed contralateral PH were identified. Eight infants had right-sided DOPA. Stents/shunt used had a median diameter of 3.5 mm (range 2.5-5.2). After DS in 9 patients, 7 patients were exclusively treated with medical therapies, whereas 2 patients received intermediate procedures: one received an additional contralateral DS and other underwent surgical banding of the DS prior to PA reimplantation. Seven patients who underwent DS and one patient with BT shunt underwent PA reimplantation at median of 3.3 (0.6-18) months. PA pressure was documented to be normal in 5 patients immediately following PA reimplantation, 1 year later in 2 patients, and 1 patient is on Tadalafil with elevated PVR of 5.5 indexed Wood units. One patient died and one patient is awaiting surgery with normal PA pressure. We describe the development of severe contralateral PH following DS or BT shunt as the initial intervention for unilateral DOPA. Pulmonary hypertension resolved in 7/8 patients who underwent surgical PA reimplantation. The cause of PH in the normally connected lung in these cases remains unclear.
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http://dx.doi.org/10.1007/s00246-017-1729-zDOI Listing
January 2018

Pulmonary vein stenosis with collateralization via esophageal varices: Long-term follow-up after successful treatment with drug-eluting stent.

Congenit Heart Dis 2018 Jan 18;13(1):124-130. Epub 2017 Sep 18.

Lillie Frank Abercrombie Section of Cardiology, Department of Pediatrics, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas, USA.

Objective: We describe the long-term follow-up of a child with recurrent hemoptysis due to severe pulmonary vein stenosis decompressing via collaterals to esophageal varices.

Design: Case report SETTING: Tertiary children's hospital PATIENT: Single child through ages 2- to 11-year old INTERVENTIONS: The child underwent cutting balloon angioplasty, bare metal stenting, and implantation of a PTFE-covered stent, all of which failed rapidly. Only after placement of a paclitaxel drug eluting stent did he have prolonged relief from hemoptysis and long-term patency of the treated vein. The stents were serially dilated to keep up with somatic growth of the child, eventually culminating in the need to induce intentional stent fracture.

Conclusions: We highlight novel transcatheter techniques to treat this vexing condition, discuss mechanisms of disease treatment and progression, and present the only patient with this rare combination of lesions to have achieved both longstanding pulmonary vein patency and resolution of esophageal varices.
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http://dx.doi.org/10.1111/chd.12537DOI Listing
January 2018

Tailoring stents to fit the anatomy of unique vascular stenoses in congenital heart disease.

Catheter Cardiovasc Interv 2017 Nov 1;90(6):963-971. Epub 2017 Sep 1.

Division of Pediatric Cardiology, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California.

Background: Unique and small anatomical features often preclude the use of available vascular stents in pediatric patients with congenital heart disease (CHD).

Objectives: To report our experience and outcomes tailoring stents to fit unique anatomy, particularly in small children and infants with CHD.

Methods: Stent tailoring techniques included trimming, folding, and flaring. Patients receiving a tailored stent November 2002 to February 2015 were included in a retrospective analysis.

Results: Forty-one tailored stents were implanted in 30 patients with median age and weight of 0.8 years (6 days to 17 years) and 8.1 kg (2.9-47.9 kg). Thirty stents were placed intraoperatively and 11 percutaneously. Sites included branch pulmonary arteries (BPA; n = 32), pulmonary veins (n = 6), SVC (n = 1), and the ventricular septum (n = 2). Twenty-three (56%) stents were trimmed with or without folding to avoid jailing of side branches, 16 (39%) stents were folded or flared with or without trimming to avoid excessive proximal protrusion, and two (5%) stents were folded back at both ends for implantation in ventricular septal defects. Final stent lengths were 6-15 mm. Minimal vessel diameters increased from 2.8 ± 1.4 mm to 6.7 ± 2.6 mm (P < 0.001). Complications included two intraoperative BPA tears, three pinhole balloon leaks, two intraoperative stent dislodgements, one transient heart block, and one lung reperfusion injury. Follow-up catheterization included 36 re-dilations and implantation of four additional stents over a median of 4.1 years. In-stent restenosis was the indication in 25 (69.4%) re-interventions.

Conclusion: Tailored stents can be safely implanted to fit unique anatomy in small patients. Re-interventions can effectively treat restenosis and accommodate ongoing vessel growth.
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http://dx.doi.org/10.1002/ccd.27234DOI Listing
November 2017

Trans-splenic Access for Portal Venous Interventions in Children: Do Benefits Outweigh Risks?

Cardiovasc Intervent Radiol 2018 Jan 24;41(1):87-95. Epub 2017 Jul 24.

Division of Cardiology, Department of Pediatrics, Texas Children's Hospital, Houston, TX, USA.

Background: The primary concern of trans-splenic access for portal interventions is the risk of life-threatening intraperitoneal bleeding.

Objective: To review the clinical indications and efficacy and evaluate the risk factors for intraperitoneal bleeding during trans-splenic portal interventions in children.

Materials And Methods: A retrospective review of consecutive patients who underwent trans-splenic portal interventions at a tertiary care pediatric institution between March 2011 and April 2017 was performed. Forty-four procedures were performed in 30 children with a median age of 5 (0.3-18) years. Clinical indications, technical success, procedural success, and incidence of complications were recorded. Potential risk factors for intraperitoneal bleeding were evaluated using Wilcoxon rank and Fisher's exact tests.

Results: Trans-splenic access was 100% successful. In 35/44 (79%) procedures, the subsequent intervention was successful including recanalization of post-transplant portal vein occlusion in 10/13, embolization of bleeding Roux limb varices in 8/8, recanalization of chronic portal vein thrombosis in native liver in 7/13, splenoportography and manometry in 6/6, and occlusion of portosystemic shunts in 4/4 procedures. Intraperitoneal bleeding occurred during 12/44 (27%) procedures and was managed with analgesics, blood transfusion, and peritoneal drainage without the need for splenectomy or splenic artery embolization. Statistically significant correlation of bleeding was found with intraprocedural anticoagulation, but not with patient age, weight, platelet count, INR, ascites, splenic length, splenic venous pressure, vascular sheath size, or tract embolization technique.

Conclusion: Trans-splenic access is a useful technique for successful pediatric portal interventions. Although it entails a substantial risk of intraperitoneal bleeding, this can be managed conservatively.
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http://dx.doi.org/10.1007/s00270-017-1756-4DOI Listing
January 2018

Intra-procedural continuous dialysis to facilitate interventional catheterization in pediatric patients with severe renal failure.

Catheter Cardiovasc Interv 2017 Nov 12;90(5):784-789. Epub 2017 Jul 12.

Lillie Frank Abercrombie Section of Cardiology, Baylor College of Medicine, and Texas Children's Hospital, Houston, Texas.

Background: Interventional catheterization procedures may be needed for patients with severe renal failure who are dependent on dialysis. To avoid the risk of fluid overload and electrolyte derangement during complex procedures in this oliguric/anuric patient population, we performed intra-procedural dialysis, either continuous renal replacement therapy (CRRT) or continous cycling peritoneal dialysis (CCPD).

Methods: We performed a retrospective review of a cohort of pediatric patients, ages 0-18 years, with dialysis-dependent renal failure who received CRRT or CCPD during catheterization procedures from January 2013 to March 2016.

Results: Eight patients underwent a total of nine interventional catheterization procedures while receiving intra-procedural dialysis. Median age was 4.5 years (range 8 months to 17 years) and weight, 11.6 kg (11.2-62.6 kg). Six patients had end-stage renal disease (ESRD) and two patients had acute kidney injury (AKI), one due to hepatorenal syndrome and one due to multifactorial causes associated with congenital heart disease. The most common reason for catheterization was occlusive venous thrombosis requiring recanalization. CRRT was used during five cases and CCPD during four cases. Median procedure time was 337 min (95-651 min) and median contrast dose 4.2 mL kg (1.2-8.2 mL kg ). Euvolemia was maintained based on pre- and post-catheterizations weights, and no significant electrolyte abnormalities occurred based on lab monitoring during and post-procedure.

Conclusions: Intra-procedural dialysis using CRRT or CCPD enables even small pediatric patients with severe renal failure to undergo long and complex interventional catheterizations by reducing the risk of fluid overload and electrolyte abnormalities. Collaboration between nephrology, cardiology, and dialysis teams is necessary for successful management of this challenging patient population.
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http://dx.doi.org/10.1002/ccd.27188DOI Listing
November 2017

Multicenter Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits.

Circ Cardiovasc Interv 2017 Jun;10(6)

From the Division of Cardiology, Seattle Children's Hospital, University of Washington (B.H.M., T.K.J.); Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital at Stanford, Palo Alto, CA (D.B.M.); Necker Enfants Malades Hospital, Paris, France (Y.B.); Pediatric and Congenital Cardiology, UZ Leuven, Belgium (M.G.); Division of Pediatric Cardiology, Children's Healthcare of Atlanta, Emory University, Atlanta, GA (D.W.K., E.K.G.); Division of Pediatric Cardiology, Department of Pediatrics and Communicable Diseases, University of Michigan C.S. Mott Children's Hospital Congenital Heart Center, Ann Arbor (M.L.B.); Division of Cardiology, Department of Pediatrics, University of Utah, Salt Lake City (M.H.M.); Department of Pediatric Cardiology, Nationwide Children's Hospital, Columbus, OH (A.K.A., D.B.); Division of Pediatric Cardiology, Washington University School of Medicine, St. Louis, MO (S.D.); Division of Pediatric Cardiology, Riley Hospital for Children, Indianapolis, IN (M.H.); Division of Pediatric Cardiology, Department of Pediatrics, University of Nebraska, Children's Hospital and Medical Center, Omaha (J.W.D.); Lillie Frank Abercrombie Section of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston (H.J., A.M.Q.); and Division of Cardiology, UCSF Benioff Children's Hospital, University of California, San Francisco (J.J.M.).

Background: Follow-up of transcatheter pulmonary valve replacement (TPVR) with the Melody valve has demonstrated good short-term and long-term outcomes, but there are no published studies focused on valve performance in the Contegra bovine jugular vein conduit.

Methods And Results: This is a retrospective, multicenter study of the short- and intermediate-term outcomes of Melody TPVR within the Contegra conduit in the right ventricle to pulmonary artery position. Data from 13 centers were included in the analysis. During the study period, 136 patients underwent 139 catheterizations for attempted Melody TPVR with a median follow-up of 3 years (1 day to 9.1 years). Of the 136 patients, 117 underwent successful Melody TPVR. Two patients underwent a second Melody TPVR. The majority of patients underwent placement of ≥1 stents before transcatheter pulmonary valve implantation. There was a significant reduction in peak conduit pressure gradient acutely after transcatheter pulmonary valve implantation (39 versus 10 mm Hg; <0.001). At most recent follow-up, the maximum pulmonary valve gradient by echocardiogram remained significantly reduced relative to prevalve implant measurements (65.9 versus 27.3 mm Hg; <0.001). The incidence of Melody transcatheter pulmonary valve stent fracture (3.4%) and infectious endocarditis (4.3%) were both low. Serious adverse events occurred in 3 patients.

Conclusions: Melody TPVR in Contegra conduits is safe and effective and can be performed in a wide range of conduit sizes with preserved valve function and low incidence of stent fracture and endocarditis.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.004914DOI Listing
June 2017

Radiation Safety in Children With Congenital and Acquired Heart Disease: A Scientific Position Statement on Multimodality Dose Optimization From the Image Gently Alliance.

JACC Cardiovasc Imaging 2017 07 18;10(7):797-818. Epub 2017 May 18.

Division of Cardiology, Department of Medicine, and Department of Radiology, Columbia University Medical Center and New York-Presbyterian Hospital, New York, New York (Image Gently Alliance representative). Electronic address:

There is a need for consensus recommendations for ionizing radiation dose optimization during multimodality medical imaging in children with congenital and acquired heart disease (CAHD). These children often have complex diseases and may be exposed to a relatively high cumulative burden of ionizing radiation from medical imaging procedures, including cardiac computed tomography, nuclear cardiology studies, and fluoroscopically guided diagnostic and interventional catheterization and electrophysiology procedures. Although these imaging procedures are all essential to the care of children with CAHD and have contributed to meaningfully improved outcomes in these patients, exposure to ionizing radiation is associated with potential risks, including an increased lifetime attributable risk of cancer. The goal of these recommendations is to encourage informed imaging to achieve appropriate study quality at the lowest achievable dose. Other strategies to improve care include a patient-centered approach to imaging, emphasizing education and informed decision making and programmatic approaches to ensure appropriate dose monitoring. Looking ahead, there is a need for standardization of dose metrics across imaging modalities, so as to encourage comparative effectiveness studies across the spectrum of CAHD in children.
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http://dx.doi.org/10.1016/j.jcmg.2017.04.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5542588PMC
July 2017

Outcomes After Decompression of the Right Ventricle in Infants With Pulmonary Atresia With Intact Ventricular Septum Are Associated With Degree of Tricuspid Regurgitation: Results From the Congenital Catheterization Research Collaborative.

Circ Cardiovasc Interv 2017 May;10(5)

From the Department of Pediatrics, Emory University School of Medicine, Atlanta, GA (C.J.P., R.S., G.T.N., C.M., M.K.); Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia (A.C.G., D.J.G.); Department of Pediatrics, Baylor College of Medicine, Houston, TX (A.M.Q., S.A.M., H.J.); Division of Cardiology, Children's Hospital of Philadelphia, PA (N.M.); and The Heart Institute, Cincinnati Children's Hospital Medical Center, OH (W.W., L.S.R., B.H.G.).

Background: Outcomes after right ventricle (RV) decompression in infants with pulmonary atresia with intact ventricular septum vary widely. Descriptions of outcomes are limited to small single-center studies.

Methods And Results: Neonates undergoing RV decompression for pulmonary atresia with intact ventricular septum were included from 4 pediatric centers. Primary end point was reintervention post-RV decompression; secondary end points included circulation type at latest follow-up. Ninety-nine patients (71 with pulmonary atresia with intact ventricular septum and 28 with virtual atresia) underwent RV decompression at median 3 (25th-75th, 2-5) days of age. Seventy-one patients (72%) underwent at least 1 reintervention after decompression. Median duration of follow-up was 3 years (range, 1-10). Freedom from reintervention was 51% at 1 month and 23% at 3 years. In multivariable analysis, reintervention was associated with virtual atresia (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.28-091; =0.027), smaller RV length (HR, 0.94; 95% CI, 0.89-0.99; =0.027), and ≤mild tricuspid regurgitation (TR; HR, 3.58; 95% CI, 2.04-6.30; <0.001). Patients undergoing surgical shunt or ductal stent were less likely to have virtual atresia (HR, 0.36; 95% CI, 0.15-0.85; =0.02) and more likely to have higher RV end-diastolic pressure (HR, 1.07; 95% CI, 1.00-1.15; =0.057) and ≤mild TR (HR, 3.50; 95% CI, 1.75-7.0; <0.001). Number of reinterventions was associated with ≤mild TR (rate ratio, 1.87; 95% CI, 1.23-2.87; =0.0037). Multivariable analysis indicated that <2-ventricle circulation status was associated with ≤mild TR (odds ratio, 18.6; 95% CI, 5.3-65.2; <0.001) and lower RV area (odds ratio, 0.81; 95% CI, 0.72-0.91; <0.001).

Conclusions: Patients with pulmonary atresia with intact ventricular septum deemed suitable for RV decompression have a high reintervention burden although most achieve 2-ventricle circulation. TR ≤mild at baseline is strongly associated with reintervention and <2-ventricle circulation at medium-term follow-up. Degree of baseline TR may be an important marker of long-term outcomes in this population.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.004428DOI Listing
May 2017

Percutaneous Mechanical Circulatory Support Using Impella Devices for Decompensated Cardiogenic Shock: A Pediatric Heart Center Experience.

ASAIO J 2018 Jan/Feb;64(1):98-104

Cardiogenic shock remains a significant cause of mortality and morbidity in children with heart failure. Percutaneous mechanical circulatory support may be an additional tool to augment left heart support and decompression in addition to conventional therapies. This report aims to review the clinical and hemodynamic outcomes of the Impella device at a pediatric center. A retrospective review of all implants between October 2014 and November 2016 was conducted. Clinical outcomes, device implant techniques, complications, and hemodynamic data were collected. Statistical analysis was performed on hemodynamic and echocardiographic data. There were 10 Impella device placements in 8 patients with a median age of 17 years (6.5-25) and support duration of 8 days (1-21). Implant diagnosis included 5 patients with either posttransplant rejection or allograft vasculopathy, 2 patients with myocarditis, and 1 patient with refractory ventricular tachycardia. Extracorporeal membrane oxygenation support was required in 4 patients. Significant reduction in pulmonary capillary wedge pressures/left atrial pressures (p = 0.031) and increase in near infrared spectroscopy (p = 0.039) was seen pre- and post-Impella implant. All patients survived to discharge from the intensive care unit with one late death. Percutaneous mechanical circulatory support is a viable option in experienced pediatric centers as a mode to augment cardiac output or to decompress the left heart in patients on extracorporeal membrane oxygenation or with cardiogenic shock.
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http://dx.doi.org/10.1097/MAT.0000000000000581DOI Listing
July 2018

A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients.

Catheter Cardiovasc Interv 2017 Jul 15;90(1):124-129. Epub 2017 Mar 15.

Lillie Frank Abercrombie Section of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.

Objectives: The objective was to review the use of Impella devices (Abiomed Inc, Danvers, MA) for temporary circulatory support in pediatric and adolescent patients (age ≤ 21 yrs).

Background: Options for minimally invasive circulatory support in children are limited, and published data are confined to case reports and small case series.

Methods: This was a retrospective, multicenter review of Impella implants in pediatric and adolescent patients from 2009-15, using standardized data collection and INTERMACS definitions.

Results: A total of 39 implants were performed in 38 patients from 16 centers. Median age and weight were 16 yrs (4-21 yrs) and 62 kg (15-134 kg). The primary indication for implant was cardiogenic shock in 28 patients (72%). Cardiac allograft rejection, myocarditis, or cardiomyopathy were the underlying diagnosis in 23 patients (59%); 11 patients had congenital heart disease. The median duration of support was 45 hr (1-1224 hr). Indications for explant included ventricular recovery in 16 patients, transition to another device in 12, death in 5, and transplant in 1. Survival was 85% at 7 days and 68% at 30 days. Major adverse events occurred in 8 patients: hemolysis in 3, bleeding in 2, stroke in 1 (unclear if related to Impella), sepsis in 1, and critical leg ischemia in 1. An increase in aortic regurgitation was noted in three patients, with no evidence of valve injury.

Conclusion: Temporary circulatory support with Impella devices is feasible in pediatric and adolescent patients, with acceptable risk profiles. More experience and follow up is needed to improve technical performance and patient selection. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.26973DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5511055PMC
July 2017

Transcatheter closure of patent ductus arteriosus using the AMPLATZER™ duct occluder II (ADO II).

Catheter Cardiovasc Interv 2017 May 4;89(6):1118-1128. Epub 2017 Mar 4.

Department of Pediatric Cardiology, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas.

Objectives: The study purpose is to evaluate the safety and efficacy of the ADO II device for closure of patent ductus arteriosus (PDA) in children.

Background: Transcatheter treatment of PDA has been evolving for 40+ years and is the treatment of choice. The AMPLATZER™ Duct Occluder (ADO) device was developed for larger diameter ducts and is not ideal in all PDAs. ADO II was developed for small to moderate-sized ducts.

Methods: This is a single-arm, multicenter study evaluating safety and efficacy of the ADO II device. Patients <18 years were screened for a PDA ≤5.5 mm in diameter and 3-12 mm in length. Right and left heart catheterization was performed, and hemodynamic data were obtained at the time of implant. The diameter of the left pulmonary artery (LPA) and descending aorta, and the presence of any pre-existing pressure gradients across the LPA or aortic arch were assessed at baseline and 6 months post-implant.

Results: A total of 192 patients were enrolled. The median implant time was 74 min. Median fluoroscopy time was 12 min. A retrograde (aortic) approach was used in 33% of procedures and demonstrated a statistically significant reduction in fluoroscopy time (P value = 0.0018) compared to an antegrade approach. The device was successfully implanted in 93% of patients, with complete closure in 98% of successful implantations.

Conclusions: In this prospective study, the ADO II was safe and effective for closure of small to moderate PDAs. Implantation is simple and the ability for retrograde aortic delivery reduces procedure-related radiation exposure. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.26968DOI Listing
May 2017

The Medtronic Micro Vascular Plug™ for Vascular Embolization in Children With Congenital Heart Diseases.

J Interv Cardiol 2017 Apr 16;30(2):177-184. Epub 2017 Feb 16.

The Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

Objectives: To describe the early multi-center, clinical experience with the Medtronic Micro Vascular Plug™ (MVP) in children with congenital heart disease (CHD) undergoing vascular embolization.

Background: The MVP is a large diameter vascular occlusion device that can be delivered through a microcatheter for embolization of abnormal blood vessels.

Methods: A retrospective review of embolization procedures using the MVP in children with CHD was performed in 3-centers. Occlusion of patent ductus arteriosus using the MVP was not included.

Results: Ten children underwent attempted occlusion using the MVP. The most common indication to use the MVP was failed attempted occlusion using other embolic devices. Five, single ventricle patients (median age 3-years, median weight 14.9 kg) underwent occlusion of veno-venous collaterals following bidirectional Glenn operation. Three patients (Median age 8 years) underwent occlusion of coronary artery fistulae (CAF). Two patients (age 7 months and 1 year) underwent occlusion of large aorto-pulmonary collaterals. A 7-day-old child with a large CAF required 2 MVPs and an Amplatzer Vascular Plug (AVP-II) for complete occlusion. Occlusion of all other blood vessels was achieved using a single MVP. One MVP embolized distally in an 8-years-old child with a large CAF. There were no other procedural complications or during follow-up (median 9 months).

Conclusions: The MVP is a new, large-diameter vascular embolization device that can be delivered through a microcatheter. It may play an important role in providing highly effective occlusion of abnormal vessels in children.
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http://dx.doi.org/10.1111/joic.12369DOI Listing
April 2017

Utility and Safety of Combined Interventional Catheterization and Electrophysiology Procedures in a Children's Hospital.

Pacing Clin Electrophysiol 2017 Jun 3;40(6):661-666. Epub 2017 May 3.

The Lillie Frank Abercrombie Section of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

Background: Interventional cardiac catheterization (cath) and electrophysiology (EP) procedures are not routinely performed together. There are several perceived barriers affecting this practice, though there are also advantages for both the patient and practitioner to a combined approach.

Methods: This was a single-center retrospective study reviewing combined cath and EP procedures with a preprocedural intention to intervene at Texas Children's Hospital from 2001 to 2014. We excluded procedures in which the intended procedure was purely diagnostic in nature.

Results: A total of 121 patients requiring 125 procedures were identified, of which 61 patients underwent 62 procedures that met our inclusion criteria. Potential subgroups of interest included adult congenital heart disease patients (26% of cohort), single ventricle anatomy (34%), and heterotaxy (19%) and collectively 58% of procedures involved a patient in one of these groups. The combined nature of the procedure did not preclude a cath or EP intervention in any patient. There were no mortalities. There were three adverse events, affecting 4.8% of procedures.

Conclusions: Combined interventional cardiac cath and EP procedures in pediatric patients and those with congenital heart disease can be performed safely in a high-volume center. These combined procedures save patients the risk and inconvenience of multiple procedures, and further investigation into cost savings is warranted.
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http://dx.doi.org/10.1111/pace.13047DOI Listing
June 2017