Carl H Backes1,2,3,4, Brian K Rivera5, Jeffrey A Bridge4,6, Aimee K Armstrong2,3,4, Brian A Boe2,3,4, Darren P Berman2,3,4, Tyler Fick4, Ralf J Holzer7,8, Ziyad M Hijazi7,8, Sylvia Abadir9, Henri Justino10, Lisa Bergersen11, Charles V Smith12, Haresh Kirpalani13. 1. Centers for Perinatal Research, carl.backesjr@nationwidechildrens.org. 2. Cardiovascular and Pulmonary Research, and. 3. The Heart Center, The Research Institute at Nationwide Children's Hospital, Nationwide Children's Hospital, Columbus, Ohio. 4. Department of Pediatrics, The Ohio State University, Columbus, Ohio. 5. Centers for Perinatal Research. 6. Innovation in Pediatric Practice, and. 7. Department of Pediatrics, Weill Cornell Medical College, New York, New York. 8. Cardiac Catheterization and Interventional Therapy, Sidra Cardiac Program, Sidra Medical and Research Center, Doha, Qatar. 9. Department of Pediatric Cardiology, CHU mère-enfant Sainte-Justine, Université de Montréal, Quebec, Canada. 10. Section of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas. 11. Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts. 12. Center for Developmental Therapeutics, Seattle Children's Research Institute, University of Washington School of Medicine, Seattle, Washington; and. 13. Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Abstract
CONTEXT: Patent ductus arteriosus (PDA) is a precursor to morbidity and mortality. Percutaneous (catheter-based) closure is the procedure of choice for adults and older children with a PDA, but use during infancy (<1 year) is not well characterized. OBJECTIVE: Investigate the technical success and safety of percutaneous PDA closure during infancy. DATA SOURCES: Scopus, Web of Science, Embase, PubMed, and Ovid (Medline) were searched through December 2015 with no language restrictions. STUDY SELECTION: Publications needed to clearly define the intervention as percutaneous PDA closure during infancy (<1 year of age at intervention) and must have reported adverse events (AEs). DATA EXTRACTION: The study was performed according to the Systematic Reviews and Meta-Analysis checklist and registered prospectively. The quality of the selected studies was critically examined. Data extraction and assignment of AE attributability and severity were independently performed by multiple observers. Outcomes were agreed on a priori. Data were pooled by using a random-effects model. RESULTS: Thirty-eight studies were included; no randomized controlled trials were found. Technical success of percutaneous PDA closure was 92.2% (95% confidence interval [CI] 88.8-95.0). Overall AE and clinically significant AE incidence was 23.3% (95% CI 16.5-30.8) and 10.1% (95% CI 7.8-12.5), respectively. Significant heterogeneity and publication bias were observed. LIMITATIONS: Limitations include lack of comparative studies, lack of standardized AE reporting strategy, and significant heterogeneity in reporting. CONCLUSIONS: Percutaneous PDA closure during infancy is feasible and associated with few catastrophic AEs; however, the limitations constrain the interpretability and generalizability of the current findings.
CONTEXT: Patent ductus arteriosus (PDA) is a precursor to morbidity and mortality. Percutaneous (catheter-based) closure is the procedure of choice for adults and older children with a PDA, but use during infancy (<1 year) is not well characterized. OBJECTIVE: Investigate the technical success and safety of percutaneous PDA closure during infancy. DATA SOURCES: Scopus, Web of Science, Embase, PubMed, and Ovid (Medline) were searched through December 2015 with no language restrictions. STUDY SELECTION: Publications needed to clearly define the intervention as percutaneous PDA closure during infancy (<1 year of age at intervention) and must have reported adverse events (AEs). DATA EXTRACTION: The study was performed according to the Systematic Reviews and Meta-Analysis checklist and registered prospectively. The quality of the selected studies was critically examined. Data extraction and assignment of AE attributability and severity were independently performed by multiple observers. Outcomes were agreed on a priori. Data were pooled by using a random-effects model. RESULTS: Thirty-eight studies were included; no randomized controlled trials were found. Technical success of percutaneous PDA closure was 92.2% (95% confidence interval [CI] 88.8-95.0). Overall AE and clinically significant AE incidence was 23.3% (95% CI 16.5-30.8) and 10.1% (95% CI 7.8-12.5), respectively. Significant heterogeneity and publication bias were observed. LIMITATIONS: Limitations include lack of comparative studies, lack of standardized AE reporting strategy, and significant heterogeneity in reporting. CONCLUSIONS: Percutaneous PDA closure during infancy is feasible and associated with few catastrophic AEs; however, the limitations constrain the interpretability and generalizability of the current findings.
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