Transcatheter PDA Occlusion in Infants <6 kg

Study Questions:

What are the risk factors associated with major adverse events (MAEs) in infants <6 kg undergoing transcatheter patent ductus arteriosus (PDA) occlusion?


The IMPACT Registry (Improving Pediatric and Adult Congenital Treatments) was used to identify infants <6 kg undergoing transcatheter PDA occlusion between January 1, 2013 and March 1, 2015. MAEs reported in the registry include cardiac arrest, cardiac tamponade requiring pericardial drainage, embolic stroke within 72 hours, device malposition or thrombus requiring surgery, device embolization requiring retrieval, unplanned cardiac or vascular surgery, subsequent cardiac catheterization within 72 hours, arrhythmia requiring treatment, acute arterial injury, and major bleeding event. Characteristics predictive of MAE or composite failure (procedural failure or MAE) were assessed. Individual safety metrics such as device embolization or malposition were examined for differences across weight thresholds: extremely low weight (ELW, <2 kg), very low weight (VLW, 2-<4 kg), and low weight (LW, 4-<6 kg).


Transcatheter PDA occlusion was attempted in 747 infants <6 kg at 73 hospitals, with 94.3% procedural success. MAEs were observed in 12.6% of cases; the most common were acute arterial injury in 3.5% and device embolization in 2.4%. Age <30 days at the time of the procedure was associated with greater risks of a MAE (odds ratio [OR], 3.4; 95% confidence interval [CI], 1.5-7.9) and composite failure (OR, 3.1; 95% CI, 1.4-6.9). Risk of embolization was higher among ELW (10.5%) than VLW (1.6%) or LW (2.5%) infants, p = 0.05.


The authors concluded that PDA occlusion is technically feasible in infants <6 g, although there is associated procedural risk.


Device closure of PDA is the procedure of choice for the majority of older infants, children, and adults. There are technical challenges in small and very young infants, related both to issues with vascular access as well as ductal anatomy. This study made use of the IMPACT Registry to understand procedural risks in patients <6 kg. A significant proportion (approximately one third) was born at <30 weeks’ gestation, with a similar proportion <4 kg at the time of the procedure. This study demonstrates that transcatheter occlusion of PDA in infants <6 kg has become reasonably common. Further comparative studies with surgical intervention will be helpful to determine the role of transcatheter PDA closure in this patient population.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pericardial Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Interventions, CHD and Pediatrics and Quality Improvement, Interventions and Structural Heart Disease

Keywords: Arrhythmias, Cardiac, Cardiac Catheterization, Cardiac Surgical Procedures, Cardiac Tamponade, Coronary Occlusion, Ductus Arteriosus, Patent, Heart Arrest, Heart Defects, Congenital, Hemorrhage, IMPACT Registry, Infant, National Cardiovascular Data Registries, Risk Factors, Stroke, Thrombosis

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