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1.
Pediatr Cardiol ; 2024 May 10.
Article in English | MEDLINE | ID: mdl-38727825

ABSTRACT

This study aimed to evaluate the current state of congenital interventional cardiology training worldwide, with a focus on case volumes, competency assessment, and the need for ongoing mentorship during early career stages. A survey was conducted among program directors (PDs) of congenital interventional training programs across the globe. The survey gathered data on training pathways, case volumes, types of procedures performed, trainee competency assessment, and the role of ongoing mentorship. Of the 79 PDs who completed the survey, it was observed that training pathways and case volumes varied significantly, particularly between the United States and other countries. Most PDs reported an annual laboratory case volume of >500 congenital cardiac cases, with most cases being interventional. While trainees demonstrated competency in simple procedures (diagnostic cases, simple ASD closure), complex interventions (such as patent ductus arteriosus closure in premature infants) require ongoing mentorship for graduates. PDs recommended a minimum case volume of 400 total cases for trainees, including 250 interventional cases. In addition to case volumes, assessing trainee competency was deemed important, with clinical reasoning, judgment, skillset, teamwork, and complication management being key areas of evaluation. The study highlights the variability in congenital interventional cardiology training and the need for ongoing mentorship during the early career years. External mentorship programs, facilitated by national and international societies, are proposed to provide critical support for early career interventionalists thus enhancing patient care for congenital heart disease. Ultimately, the findings of this survey may serve as a framework for future training standards and guidelines in this specialized field.

2.
Pediatr Cardiol ; 44(1): 132-140, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36029321

ABSTRACT

The aim of the study was to determine the variables associated with high-quality (HQ) versus low-quality (LQ) three-dimensional rotational angiography (3DRA) and create guides for optimization of approach to 3DRA in congenital cardiac catheterization (CCC). CCC has adopted 3DRA as a mainstay, but there has not been systematic analysis of approach to and factors associated with HQ 3DRA. This was a single-center, retrospective study of 3DRAs using Canon Infinix-I platform. Reconstructions were graded by 3 interventionalists. Quality was dichotomized into HQ and LQ. Univariable analyses and multivariable logistic regression models were performed. From 8/2016 to 12/2018, 208 3DRAs were performed in 195 CCCs; median age 7 years (2, 16), weight 23 kg (12, 57). The majority of 3DRAs were performed in patients with biventricular physiology (N = 137, 66%) and in pulsatile sites (N = 144, 69%). HQ 3DRA (N = 182, 88%) was associated with greater total injection volume [2.20 mL/kg (1.44, 3.29) vs. 1.62 mL/kg (1.10, 1.98), p = 0.005] and more dilute contrast solution [60% (50, 100) vs. 100% (60, 100), p = 0.007], but not with contrast volume administered (p = 0.2) on univariable analysis. On multivariable logistic regression, HQ 3DRA was significantly associated with patient weight [OR 0.97 (95% CI (0.94, 0.99), p = 0.018], total injection volume [OR 1.04 (95% CI 1.01, 1.07) p = 0.011], and percent contrast solution [OR 0.97 (95% CI 0.95, 1.00), p = 0.022]. These data resulted in creation of scatter plots and a novel 3DRA Nomogram for estimating the probability of HQ 3DRA. This is the first study to create evidence-based contrast dose guides and nomogram for 3DRA in CCC. HQ 3DRA was associated with lower weight, higher total injection volumes, and more dilute contrast solution.


Subject(s)
Imaging, Three-Dimensional , Plastic Surgery Procedures , Humans , Child , Retrospective Studies , Imaging, Three-Dimensional/methods , Angiography/methods , Cardiac Catheterization/methods
3.
Pediatr Cardiol ; 44(5): 973-995, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37149833

ABSTRACT

Patch augmentation of the right ventricular outflow tract (RVOT) and pulmonary artery (PA) arterioplasty are relatively common procedures in the surgical treatment of patients with congenital heart disease. To date, several patch materials have been applied with no agreed upon clinical standard. Each patch type has unique performance characteristics, cost, and availability. There are limited data describing the various advantages and disadvantages of different patch materials. We performed a review of studies describing the clinical performance of various RVOT and PA patch materials and found a limited but growing body of literature. Short-term clinical performance has been reported for a multitude of patch types, but comparisons are limited by inconsistent study design and scarce histologic data. Standard clinical criteria for assessment of patch efficacy and criteria for intervention need to be applied across patch types. The field is progressing with improvements in outcomes due to newer patch technologies focused on reducing antigenicity and promoting neotissue formation which may have the ability to grow, remodel, and repair.


Subject(s)
Heart Defects, Congenital , Tetralogy of Fallot , Ventricular Outflow Obstruction , Humans , Pulmonary Artery/surgery , Ventricular Outflow Obstruction/surgery , Heart Ventricles/surgery , Heart Defects, Congenital/surgery , Vascular Surgical Procedures/methods , Treatment Outcome , Tetralogy of Fallot/surgery
4.
Cardiol Young ; 33(9): 1730-1732, 2023 Sep.
Article in English | MEDLINE | ID: mdl-36924160

ABSTRACT

We present the first-in-paediatric uses of a mechanical aspiration system for percutaneous removal of right atrial masses in three patients, including central line-related thrombus and metastatic tumour. Percutaneous mechanical removal of right atrial masses can be performed safely and effectively.


Subject(s)
Atrial Fibrillation , Heart Diseases , Thrombosis , Humans , Child , Thrombectomy , Suction , Thrombosis/surgery
5.
Pediatr Cardiol ; 43(3): 497-507, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34812909

ABSTRACT

Single ventricle patients typically undergo some form of advanced diagnostic imaging prior to superior cavopulmonary connection (SCPC). We sought to evaluate variability of diagnostic practice and associated comprehensive risk. A retrospective evaluation across 4 institutions was performed (1/1/2010-9/30/2016) comparing the primary modalities of cardiac catheterization (CC), cardiac magnetic resonance (CMR), and cardiac computed tomography (CT). Associated risks included anesthesia/sedation, vascular access, total room time, contrast agent usage, radiation exposure, and adverse events (AEs). Of 617 patients undergoing SCPC, 409 (66%) underwent at least one advanced diagnostic imaging study in the 60 days prior to surgery. Seventy-eight of these patients (13%) were analyzed separately because of a concomitant cardiac intervention during CC. Of 331 (54%) with advanced imaging and without catheterization intervention, diagnostic CC was most common (59%), followed by CT (27%) and CMR (14%). Primary modality varied significantly by institution (p < 0.001). Median time between imaging and SCPC was 13 days (IQR 3-33). Anesthesia/sedation varied significantly (p < 0.001). Pre-procedural vascular access did not vary significantly across modalities (p = 0.111); procedural access varied between CMR/CT and CC, in which central access was used in all procedures. Effective radiation dose was significantly higher for CC than CT (p < 0.001). AE rate varied significantly, with 12% CC, 6% CMR, and 1% CT (p = 0.004). There is significant practice variability in the use of advanced diagnostic imaging prior to SCPC, with important differences in associated procedural risk. Future studies to identify differences in diagnostic accuracy and long-term outcomes are warranted to optimize diagnostic protocols.


Subject(s)
Fontan Procedure , Heart Defects, Congenital , Univentricular Heart , Diagnostic Imaging , Fontan Procedure/adverse effects , Heart Defects, Congenital/diagnostic imaging , Heart Defects, Congenital/surgery , Humans , Infant , Retrospective Studies
6.
Catheter Cardiovasc Interv ; 98(2): E262-E274, 2021 08 01.
Article in English | MEDLINE | ID: mdl-33780150

ABSTRACT

OBJECTIVE: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. BACKGROUND: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. METHODS: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing. RESULTS: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both. CONCLUSIONS: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Pulmonary Valve Insufficiency , Pulmonary Valve , Adolescent , Adult , Cardiac Catheterization/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Humans , Prosthesis Design , Pulmonary Valve/diagnostic imaging , Pulmonary Valve/surgery , Pulmonary Valve Insufficiency/surgery , Treatment Outcome , Young Adult
7.
Cardiol Young ; 31(9): 1407-1411, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33597057

ABSTRACT

BACKGROUND: Three-dimensional printing is increasingly utilised for congenital heart defect procedural planning. CT or MR datasets are typically used for printing, but similar datasets can be obtained from three-dimensional rotational angiography. We sought to assess the feasibility and accuracy of printing three-dimensional models of CHD from rotational angiography datasets. METHODS: Retrospective review of CHD catheterisations using rotational angiography was performed, and patient and procedural details were collected. Imaging data from rotational angiography were segmented, cleaned, and printed with polylactic acid on a Dremel® 3D Idea Builder (Dremel, Mount Prospect, IL, USA). Printing time and materials' costs were captured. CT scans of printed models were compared objectively to the original virtual models. Two independent, non-interventional paediatric cardiologists provided subjective ratings of the quality and accuracy of the printed models. RESULTS: Rotational angiography data from 15 catheterisations on vascular structures were printed. Median print time was 3.83 hours, and material costs were $2.84. The CT scans of the printed models highly matched with the original digital models (root mean square for Hausdorff distance 0.013 ± 0.003 mesh units). Independent reviewers correctly described 80 and 87% of the models (p = 0.334) and reported high quality and accuracy (5 versus 5, p = NS; κ = 0.615). CONCLUSION: Imaging data from rotational angiography can be converted into accurate three-dimensional-printed models of CHD. The cost of printing the models was negligible, but the print time was prohibitive for real-time use. As the speed of three-dimensional printing technology increases, novel future applications may allow for printing patient-specific devices based on rotational angiography datasets.


Subject(s)
Heart Defects, Congenital , Printing, Three-Dimensional , Angiography , Cardiac Catheterization , Child , Heart Defects, Congenital/diagnostic imaging , Humans , Models, Anatomic , Retrospective Studies
8.
Catheter Cardiovasc Interv ; 95(2): 294-299, 2020 02.
Article in English | MEDLINE | ID: mdl-31609061

ABSTRACT

Computational fluid dynamics (CFD) can be used to analyze blood flow and to predict hemodynamic outcomes after interventions for coarctation of the aorta and other cardiovascular diseases. We report the first use of cardiac 3-dimensional rotational angiography for CFD and show not only feasibility but also validation of its hemodynamic computations with catheter-based measurements in three patients.


Subject(s)
Angioplasty, Balloon , Aortic Coarctation/diagnostic imaging , Aortic Coarctation/therapy , Aortography , Hemodynamics , Imaging, Three-Dimensional , Models, Cardiovascular , Patient-Specific Modeling , Adolescent , Angioplasty, Balloon/instrumentation , Aortic Coarctation/physiopathology , Child , Feasibility Studies , Female , Humans , Hydrodynamics , Male , Predictive Value of Tests , Reproducibility of Results , Stents , Treatment Outcome
9.
Catheter Cardiovasc Interv ; 95(2): 270-279, 2020 02.
Article in English | MEDLINE | ID: mdl-31609082

ABSTRACT

OBJECTIVE: We describe the technical considerations of transcatheter implantation of the CardioMEMS™ HF System (Abbott, Abbott Park, IL) in adult patients with complex palliated congenital heart disease (CHD) and advanced heart failure (HF). BACKGROUND: Ambulatory pulmonary artery (PA) pressure monitoring with implantable hemodynamic monitors (IHMs) has been shown to reduce HF-related hospital admissions in non-CHD populations. HF is a common late cardiovascular complication in adult CHD necessitating better understanding of IHM application in this population. METHODS: We analyzed adults with complex CHD and advanced HF who were referred for CardioMEMS™ device implantation (2015-2018). Feasibility of device implantation, defined by successful device implantation and calibration, and procedural outcomes were evaluated. RESULTS: CardioMEMS™ was successfully implanted in all 14 adults (35.5 ± 9.2 years old, 72 ± 12 kg) with complex CHD (single ventricle/Fontan, n = 8 [57%]; d-transposition of the great arteries/atrial switch, n = 6 [43%]). The device was delivered via femoral venous access in 13 (93%) patients and implanted in the left PA in 12 (86%). A long sheath was used in 8 (57%) patients, including 5/6 with an atrial switch operation. There was one device migration that did not require retrieval. CONCLUSIONS: Transcatheter implantation of an IHM is feasible in select complex adult CHD patients with advanced HF. Further studies evaluating integration of ambulatory hemodynamics and the impact on clinical care are needed. This technology has the potential to improve medical management of advanced HF in patients with Fontan and atrial switch physiologies and provide new insights into their ambulatory hemodynamics.


Subject(s)
Arterial Pressure , Blood Pressure Monitoring, Ambulatory/instrumentation , Blood Pressure Monitors , Heart Defects, Congenital/therapy , Heart Failure/diagnosis , Palliative Care , Pulmonary Artery/physiopathology , Remote Sensing Technology/instrumentation , Adult , Female , Heart Defects, Congenital/complications , Heart Defects, Congenital/diagnosis , Heart Defects, Congenital/physiopathology , Heart Failure/etiology , Heart Failure/physiopathology , Heart Failure/therapy , Humans , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Young Adult
10.
Catheter Cardiovasc Interv ; 96(6): 1266-1276, 2020 11.
Article in English | MEDLINE | ID: mdl-32433821

ABSTRACT

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.


Subject(s)
Cardiac Catheterization/instrumentation , Ductus Arteriosus, Patent/therapy , Infant, Extremely Premature , Infant, Very Low Birth Weight , Septal Occluder Device , Birth Weight , Cardiac Catheterization/adverse effects , Coronary Circulation , Ductus Arteriosus, Patent/diagnostic imaging , Ductus Arteriosus, Patent/physiopathology , Female , Gestational Age , Hemodynamics , Humans , Infant, Newborn , Male , Prospective Studies , Prosthesis Design , Time Factors , Treatment Outcome , United States
11.
Catheter Cardiovasc Interv ; 96(3): 626-632, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32216096

ABSTRACT

OBJECTIVES: We aimed to evaluate the effect of technical aspects of fetal aortic valvuloplasty (FAV) on procedural risks and pregnancy outcomes. BACKGROUND: FAV is performed in cases of severe mid-gestation aortic stenosis with the goal of preventing hypoplastic left heart syndrome (HLHS). METHODS: The International Fetal Cardiac Intervention Registry was queried for fetuses who underwent FAV from 2002 to 2018, excluding one high-volume center. RESULTS: The 108 fetuses had an attempted cardiac puncture (mean gestational age [GA] 26.1 ± 3.3 weeks). 83.3% of attempted interventions were technically successful (increased forward flow/new aortic insufficiency). The interventional cannula was larger than 19 g in 70.4%. More than one cardiac puncture was performed in 25.0%. Intraprocedural complications occurred in 48.1%, including bradycardia (34.1%), pericardial (22.2%) or pleural effusion (2.7%) requiring drainage, and balloon rupture (5.6%). Death within 48 hr occurred in 16.7% of fetuses. Of the 81 patients born alive, 59 were discharged home, 34 of whom had biventricular circulation. More than one cardiac puncture was associated with higher complication rates (p < .001). Larger cannula size was associated with higher pericardial effusion rates (p = .044). On multivariate analysis, technical success (odds ratio [OR] = 10.9, 95% confidence interval [CI] = 2.2-53.5, p = .003) and later GA at intervention (OR = 1.5, 95% CI = 1.2-1.9, p = .002) were associated with increased odds of live birth. CONCLUSIONS: FAV is an often successful but high-risk procedure. Multiple cardiac punctures are associated with increased complication and fetal mortality rates. Later GA at intervention and technical success were independently associated with increased odds of live birth. However, performing the procedure later in gestation may miss the window to prevent progression to HLHS.


Subject(s)
Aortic Valve Stenosis/therapy , Balloon Valvuloplasty , Cardiac Catheterization , Fetal Therapies , Hypoplastic Left Heart Syndrome/prevention & control , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Balloon Valvuloplasty/adverse effects , Cardiac Catheterization/adverse effects , Cardiac Catheterization/mortality , Europe , Female , Fetal Death/etiology , Fetal Therapies/adverse effects , Fetal Therapies/mortality , Humans , Hypoplastic Left Heart Syndrome/mortality , Live Birth , North America , Pregnancy , Registries , Risk Assessment , Risk Factors , Severity of Illness Index , Treatment Outcome , Ultrasonography, Prenatal
12.
Pediatr Cardiol ; 41(3): 486-502, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32198592

ABSTRACT

There is no better representation of the need for personalization of care than the breadth and complexity of congenital heart disease. Advanced imaging modalities are now standard of care in the field, and the advancements being made to three-dimensional visualization technologies are growing as a means of pre-procedural preparation. Incorporating emerging modeling approaches, such as computational fluid dynamics, will push the limits of our ability to predict outcomes, and this information may be both obtained and utilized during a single procedure in the future. Artificial intelligence and customized devices may soon surface as realistic tools for the care of patients with congenital heart disease, as they are showing growing evidence of feasibility within other fields. This review illustrates the great strides that have been made and the persistent challenges that exist within the field of congenital interventional cardiology, a field which must continue to innovate and push the limits to achieve personalization of the interventions it provides.


Subject(s)
Cardiology/trends , Heart Defects, Congenital/surgery , Artificial Intelligence , Heart Defects, Congenital/diagnostic imaging , Humans , Imaging, Three-Dimensional , Patient-Centered Care/trends
13.
Fetal Diagn Ther ; : 1-9, 2020 Jul 07.
Article in English | MEDLINE | ID: mdl-32634804

ABSTRACT

INTRODUCTION: Invasive fetal cardiac intervention (FCI) for pulmonary atresia with intact ventricular septum (PAIVS) and critical pulmonary stenosis (PS) has been performed with small single-institution series reporting technical and physiological success. We present the first multicenter experience. OBJECTIVES: Describe fetal and maternal characteristics of those being evaluated for FCI, including pregnancy/neonatal outcome data using the International Fetal Cardiac Intervention Registry (IFCIR). METHODS: We queried the IFCIR for PAIVS/PS cases evaluated from January 2001 to April 2018 and reviewed maternal/fetal characteristics, procedural details, pregnancy and neonatal outcomes. Data were analyzed using standard descriptive statistics. RESULTS: Of the 84 maternal/fetal dyads in the registry, 58 underwent pulmonary valvuloplasty at a median gestational age of 26.1 (21.9-31.0) weeks. Characteristics of fetuses undergoing FCI varied in terms of tricuspid valve (TV) size, TV regurgitation, and pulmonary valve patency. There were fetal complications in 55% of cases, including 7 deaths and 2 delayed fetal losses. Among those who underwent successful FCI, the absolute measurement of the TV increased by 0.32 (±0.17) mm/week from intervention to birth. Among 60 liveborn with known outcome, there was a higher percentage having a biventricular circulation following successful FCI (87 vs. 43%). CONCLUSIONS: Our data suggest a possible benefit to fetal therapy for PAIVS/PS, though rates of technically unsuccessful procedures and procedure-related complications, including fetal loss were substantial. FCI criteria are extremely variable, making direct comparison to nonintervention patients challenging and potentially biased. More uniform FCI criteria for fetuses with PAIVS/PS are needed to avoid unnecessary procedures, expose only fetuses most likely to sustain a benefit, and to enable comparisons to be made with nonintervention patients.

14.
J Pediatr ; 212: 144-150.e3, 2019 09.
Article in English | MEDLINE | ID: mdl-31262530

ABSTRACT

OBJECTIVES: To describe longer term outcomes for infants <6 kg undergoing percutaneous occlusion of the patent ductus arteriosus (PDA). STUDY DESIGN: This was a retrospective cohort study of infants <6 kg who underwent isolated percutaneous closure of the PDA at a single, tertiary center (2003-2017). Cardiopulmonary outcomes and device-related complications (eg, left pulmonary artery obstruction) were examined for differences across weight thresholds (very low weight, <3 kg; low weight, 3-<6 kg). We assessed composite measures of respiratory status during and beyond the initial hospitalization using linear mixed effects models. RESULTS: In this cohort of lower weight infants, 92 of 106 percutaneous occlusion procedures were successful. Median age and weight at procedure were 3.0 months (range, 0.5-11.1 months) and 3.7 kg (range, 1.4-5.9 kg), respectively. Among infants with pulmonary artery obstruction on initial postprocedural echocardiograms (n = 20 [22%]), obstruction persisted through hospital discharge in 3 infants. No measured variables were associated with device-related complications. Rates of oxygenation failure (28% vs 8%; P < .01) and decreased left ventricular systolic function (29% vs 5%; P < .01) were higher among very low weight than low weight infants. Pulmonary scores decreased (indicating improved respiratory status) following percutaneous PDA closure. CONCLUSIONS: Percutaneous PDA occlusion among lower weight infants is associated with potential longer term improvements in respiratory health. Risks of device-related complications and adverse cardiopulmonary outcomes, particularly among very low weight infants, underscore the need for continued device modification. Before widespread use, clinical trials comparing percutaneous occlusion vs alternative treatments are needed.


Subject(s)
Ductus Arteriosus, Patent/therapy , Therapeutic Occlusion , Cohort Studies , Female , Follow-Up Studies , Humans , Infant , Infant, Low Birth Weight , Infant, Newborn , Male , Retrospective Studies , Therapeutic Occlusion/methods , Time Factors , Treatment Outcome
15.
Catheter Cardiovasc Interv ; 94(3): 416-421, 2019 Sep 01.
Article in English | MEDLINE | ID: mdl-31276274

ABSTRACT

The Gore Viabahn VBX balloon-expandable endoprosthesis (W. L. Gore & Associates, Flagstaff, AZ) is a flexible covered stent that is FDA-approved for the treatment of iliac artery stenosis, including lesions at the aortic bifurcation. In this case series, we report the first use of the VBX covered stent in congenital heart disease, highlighting several of its unique advantages.


Subject(s)
Angioplasty, Balloon/instrumentation , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Heart Defects, Congenital/surgery , Palliative Care , Peripheral Vascular Diseases/surgery , Stents , Adult , Female , Heart Defects, Congenital/diagnostic imaging , Heart Defects, Congenital/physiopathology , Humans , Infant, Newborn , Male , Peripheral Vascular Diseases/diagnostic imaging , Peripheral Vascular Diseases/physiopathology , Prosthesis Design , Treatment Outcome
16.
Catheter Cardiovasc Interv ; 94(4): 607-617, 2019 Oct 01.
Article in English | MEDLINE | ID: mdl-31419019

ABSTRACT

OBJECTIVES: To investigate whether age and valve size at implant contribute to outcomes after Melody transcatheter pulmonary valve replacement (TPVR). BACKGROUND: Patient age and valve size at implant contribute to longevity of surgical pulmonary valves. METHODS: All patients discharged with a Melody valve in the pulmonary position, as part of three prospective Melody valve multicenter studies, comprised the study cohort. Acute and time-related outcomes were analyzed according to age: children (≤12 years), adolescents (13-18 years), young adults (19-29 years), and older adults (≥30 years). RESULTS: Successful Melody valve implantation occurred in 49 children, 107 adolescents, 96 young adults, and 57 older adults. Pediatric patients (≤18 years) were more likely to have TPVR for conduit stenosis than adults (62% vs. 44%); children had the smallest conduits. After TPVR, pediatric and adult patients had similar decreases in right ventricular (RV) size by MRI, but adults had improved percentage predicted peak VO2 (58% preimplant to 64% postimplant, p = .02) and FEV1 (69% pre to 71% post, p = .005). Younger age was associated with shorter freedom from RVOT dysfunction, reintervention, and explant. Children had the shortest freedom from endocarditis (p = .041), but all other groups had 5-year freedom from endocarditis of ≥90%. CONCLUSIONS: Younger age was associated with shorter time to RVOT dysfunction, reintervention, and explant after Melody TPVR. Patients ≥13 years of age were at low risk for endocarditis and explant to 5 years. A better understanding of time-related outcomes by age will aid in the comparison of therapeutic options for TPVR candidates. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT00740870 (NCT00740870), https://clinicaltrials.gov/ct2/show/NCT01186692 (NCT01186692), and https://clinicaltrials.gov/ct2/show/NCT00688571 (NCT00688571).


Subject(s)
Cardiac Catheterization/instrumentation , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Pulmonary Valve/surgery , Adolescent , Age Factors , Canada , Cardiac Catheterization/adverse effects , Child , Clinical Trials as Topic , Databases, Factual , Device Removal , Endocarditis/etiology , Endocarditis/physiopathology , Endocarditis/surgery , Europe , Female , Heart Valve Prosthesis Implantation/adverse effects , Hemodynamics , Humans , Male , Progression-Free Survival , Prosthesis Design , Prosthesis Failure , Pulmonary Valve/diagnostic imaging , Pulmonary Valve/physiopathology , Reoperation , Risk Factors , Time Factors , United States , Ventricular Outflow Obstruction/etiology , Ventricular Outflow Obstruction/physiopathology , Ventricular Outflow Obstruction/surgery , Young Adult
17.
Pediatr Cardiol ; 40(2): 445-453, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30506273

ABSTRACT

To stratify diverse procedure types into categories with similar radiation exposure in cardiac catheterization for congenital heart disease. Radiation exposures for a comprehensive list of specific procedure types and stratification of outcomes based on radiation risk are not currently available. Data between January 2014 and December 2015 were collected on all cases performed at sites participating in C3PO-QI (Congenital Cardiac Catheterization Outcomes Project-Quality Improvement Initiative) and 9 centers were included. Using expert consensus, 40 unique procedure types were defined by diagnostic characteristics or the intervention(s) performed, and dose area product (DAP) per kilogram of body weight (µGy × m2/kg) was summarized. Using empiric and consensus methods, three radiation risk categories were created. A total of 11,735 cases were included for analysis. Thirteen (n = 7918) procedure types with median DAP/kg < 100 were categorized in the low radiation exposure category (median DAP/kg 39). The medium exposure category (n = 1807) consisted of 16 procedure types with median DAP/kg values ranging 100 to < 200 (overall median DAP/kg 131). Finally, the high radiation exposure category (n = 1073) consisted of 11 procedure types with median DAP/kg ≥ 200 (overall median DAP/kg of 231). The radiation exposure risk categories created in this multi-center dataset are a critical step towards the development of a robust risk adjustment methodology for radiation exposure in catheterization for congenital heart disease.


Subject(s)
Cardiac Catheterization/adverse effects , Fluoroscopy/adverse effects , Heart Defects, Congenital/surgery , Radiation Exposure , Radiography, Interventional/adverse effects , Adolescent , Child , Child, Preschool , Consensus , Humans , Infant , Prospective Studies , Quality Improvement , Radiation Dosage , Risk Assessment/methods , Risk Factors , Young Adult
18.
J Pediatr ; 198: 36-45.e3, 2018 07.
Article in English | MEDLINE | ID: mdl-29650415

ABSTRACT

OBJECTIVE: To quantify outcomes of infants (<1 year of age) diagnosed with pulmonary vein stenosis (PVS). STUDY DESIGN: MEDLINE (PubMed), Scopus, and Web of Science were searched through February 1, 2017, with no language restrictions. Publications including infants diagnosed with primary PVS, defined as the absence of preceding intervention(s), were considered. The study was performed according to Meta-analysis of Observational Studies in Epidemiology guidelines, the Systematic Reviews, and Meta-Analysis checklist, and registered prospectively. The quality of selected reports was critically examined. Data extraction was independently performed by multiple observers with outcomes agreed upon a priori. Data were pooled using an inverse variance heterogeneity model with incidence of mortality the primary outcome of interest. RESULTS: Forty-eight studies of 185 infants were included. Studies were highly diverse with regards to the participants, interventions, and outcomes reported. The median (range) age at diagnosis was 5.0 (0.1-11.6) months. Pooled mortality was 58.5% (95% CI 49.8%-67.0%, I2 = 21.4%). We observed greater mortality incidence among infants with 3 or 4 vein stenoses than in those with 1 or 2 vein stenoses (83.3% vs 36.1%; P < .01). We observed greater mortality among infants with bilateral than unilateral disease (78.7% vs 26.0%; P < .01). CONCLUSIONS: Studies of primary PVS during infancy are highly variable in their methodological quality and estimates of clinical outcomes; therefore, estimates of prognosis remain uncertain. Multicenter, interdisciplinary collaborations, including alignment of key outcome measurements, are needed to answer questions beyond the scope of available data.


Subject(s)
Stenosis, Pulmonary Vein/diagnosis , Stenosis, Pulmonary Vein/therapy , Female , Humans , Infant , Infant, Newborn , Male , Outcome Assessment, Health Care , Stenosis, Pulmonary Vein/mortality
19.
Echocardiography ; 35(9): 1439-1441, 2018 09.
Article in English | MEDLINE | ID: mdl-30080938

ABSTRACT

A pregnant female presented at 37 weeks of gestation in labor. The fetus was noted to be tachycardic on fetal monitor. Postnatally, the male neonate was still noted to be tachycardic with heart rates in the low 200 bpm range. EKG was consistent with tachycardia, but rhythm diagnosis was not definitively made. Echocardiogram with M-mode analysis clearly demonstrated 2:1 atrial to ventricular contraction pattern consistent with atrial flutter. The neonate was subsequently transferred to a tertiary pediatric hospital where the diagnosis of atrial flutter was confirmed.


Subject(s)
Atrial Flutter/diagnostic imaging , Echocardiography/methods , Atrial Flutter/physiopathology , Diagnosis, Differential , Female , Heart/diagnostic imaging , Heart/physiopathology , Humans , Infant, Newborn , Male , Pregnancy
20.
Eur Heart J ; 38(26): 2070-2077, 2017 Jul 07.
Article in English | MEDLINE | ID: mdl-28430913

ABSTRACT

AIMS: We sought to identify factors associated with major adverse events (MAE) after cardiac catheterization in adolescents and adults with congenital heart disease (CHD), and create the first model to individualize risk discussions in this growing population. METHODS AND RESULTS: Improving Pediatric and Adult Congenital Treatment (IMPACT), a National Cardiovascular Data Registry, contains congenital catheterization data from over 87 hospitals in the United States. Demographics, pre-procedure, and procedural variables were collected for patients over age 10. Multivariable logistic regression was used to identify significant predictors of MAE, a composite of death, urgent surgery or procedure due to a catheterization complication, transfusion, embolic stroke, tamponade, extracorporeal membrane oxygenation or ventricular assist device placement, and device embolization, malposition or thrombosis requiring surgical intervention. A risk score was built based on the effect sizes of each predictor and validated in a split sample. A MAE occurred in 686 (2.5%) of the 27 293 index procedures meeting inclusion criteria. The independent multivariate predictors of MAE were older age, pre-procedural anticoagulation use, renal disease, lower haemoglobin, lower oxygen saturation, non-elective procedure, higher index procedure risk and having had no prior cardiac procedures. Being underweight or overweight had borderline significance and was added to the model. The C-statistic for the model was robust at 0.787 in the derivation and 0.773 in the validation cohort. CONCLUSION: The factors predicting adverse events after cardiac catheterization in adolescents and adults with CHD are different than in the general population. Validation of this model in other national or multi-institutional datasets is the next step.


Subject(s)
Cardiac Catheterization/adverse effects , Heart Defects, Congenital/surgery , Adolescent , Adult , Aged , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heart Defects, Congenital/epidemiology , Heart-Assist Devices/statistics & numerical data , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Registries , Risk Factors , United States/epidemiology , Young Adult
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