Transcatheter Occlusion of the Patent Ductus Arteriosus in 747 Infants <6 kg: Insights From the NCDR IMPACT Registry

• Published in: JACC. Cardiovascular interventions Vol. 10; no. 17; pp. 1729 - 1737
• Main Authors: Backes, Carl H, Kennedy, Kevin F, Locke, Megan, Cua, Clifford L, Ball, Molly K, Fick, Tyler A, Rivera, Brian K, Smith, Charles V, Holzer, Ralf J, Boe, Brian A, Berman, Darren P, Bergersen, Lisa, Armstrong, Aimee K
• Format: Journal Article
• Language: English
• Published: United States 11-09-2017
• Subjects: Age Factors; Body Weight; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Chi-Square Distribution; Ductus Arteriosus, Patent - diagnostic imaging; Ductus Arteriosus, Patent - physiopathology; Ductus Arteriosus, Patent - therapy; Female; Humans; Infant; Infant, Newborn; Male; Multivariate Analysis; Odds Ratio; Prosthesis Design; Registries; Risk Factors; Septal Occluder Device; Time Factors; Treatment Outcome; patent ductus arteriosus; adverse event(s); percutaneous; transcatheter; IMPACT registry
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2017.05.018

The authors sought to identify risk factors associated with major adverse events (MAEs) in infants <6 kg undergoing transcatheter patent ductus arteriosus (PDA) occlusion.
Transcatheter PDA occlusion is among the safest of interventional cardiac procedures in adults and older children, but use among infants <6 kg has not been characterized adequately.
Using the IMPACT (IMproving Pediatric and Adult Congenital Treatments) registry, we identified infants <6 kg undergoing transcatheter PDA occlusion (January 1, 2011, to March 1, 2015). Using mixed-effects multivariate regression, the authors assessed characteristics predictive of MAE or composite failure (procedural failure or MAE). Individual safety metrics (e.g., embolization, malposition) were also examined for differences across weight thresholds: extremely low weight (LW) (<2 kg), very LW (2 to <4 kg), and LW (4 to <6 kg).
Transcatheter PDA occlusion was attempted in 747 infants <6 kg at 73 hospitals. Rate of procedural success was 94.3%. MAEs were observed in 12.6% of cases; the most common events were acute arterial injury and device embolization in 3.5% and 2.4% of cases, respectively. Younger age (<30 days) was associated with greater risk of a MAE (risk ratio: 3.3; 95% confidence interval: 1.5 to 7.6) and composite failure (risk ratio: 3.0; 95% confidence interval: 1.4 to 6.7). Risk of embolization was higher among extremely LW (10.5%) than very LW or LW infants (1.6% and 2.5%, respectively; p = 0.050).
Among infants <6 kg, transcatheter PDA occlusion is technically feasible, but risks of MAE are noteworthy. These findings may help inform patient selection and procedural approach for transcatheter PDA occlusion and direct targeted research efforts to support the practice of evidence-based medicine.