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Percutaneous Closure of Patent Ductus Arteriosus
Megan Barcroft1, Christopher McKee2, Darren P Berman3
1Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Insights
Closing patent ductus arteriosus (PDA) percutaneously is feasible in infants under 1.5 kg. However, varied adverse events complicate safety assessments, necessitating improved clinical trial designs for better efficacy and risk evaluation.
Area of Science:
- Neonatal Cardiology
- Pediatric Interventional Procedures
- Congenital Heart Disease
Background:
- Patent ductus arteriosus (PDA) is common in premature infants.
- Percutaneous closure is an alternative to surgical ligation.
- Current safety data for percutaneous PDA closure is limited and heterogeneous.
Purpose of the Study:
- To assess the safety and efficacy of percutaneous patent ductus arteriosus closure in low-birth-weight infants.
- To identify risks and benefits associated with post-device closure syndrome.
- To highlight the need for standardized surveillance in clinical trials.
Main Methods:
- Review of existing literature on percutaneous PDA closure in infants <1.5 kg.
- Analysis of adverse event data and post-device closure syndrome.
- Comparison with outcomes of surgical ductal ligation.
Main Results:
- Percutaneous PDA closure is technically feasible in infants weighing less than 1.5 kg.
- Significant heterogeneity exists in reported adverse events, impacting safety profile assessment.
- Lack of comparative trials and inconsistent surveillance limit confidence in current safety and efficacy estimates.
Conclusions:
- While percutaneous PDA closure is feasible, robust comparative data is needed.
- Standardized and comprehensive assessments in clinical studies are crucial.
- Future research should focus on infants at highest risk for adverse ductal events.
Abstract:
Percutaneous-based patent ductus arteriosus closure is technically feasible among infants less than 1.5 kg. However, marked heterogeneity in the type and nature of adverse events obscures current safety profile assessments. Although data on the risks of postdevice closure syndrome remain promising, a lack of comparative trials of surgical ductal ligation and inconsistent surveillance across published studies obscure confidence in present estimates of safety and efficacy. To minimize risk and yield the greatest benefits, clinical studies of patent ductus arteriosus treatment should consider incorporating more robust assessments to ensure that infants at greatest risk for adverse ductal consequences are included.
