Percutaneous closure using the poly-L-lactic acid (PLLA) device in pediatric patients with atrial septal defect

This prospective, single-center, first-in-human trial evaluated percutaneous closure using the poly-L-lactic acid (PLLA) device in a cohort of 36 pediatric patients with atrial septal defect. Follow-up assessments were conducted at discharge and at 1, 3, 6, 12, 24, 36, 48, and 60 months post-implantation. The primary outcome was a composite of clinical success, defined as successful closure and absence of major complications at the 60-month follow-up.

Successful device implantation was achieved in 35 of 36 patients (97.2%). At the 5-year visit, the closure success rate was 85.7% (30 of 35), and the complete closure rate was 77.1% (27 of 35). Clinically significant residual leaks were observed in 5 patients (14.3%) at the 5-year visit.

Safety data indicated that total complications occurred in 5 patients (14.3%). Specific adverse events included cardiac arrhythmia (n=3), moderate mitral regurgitation (n=1), and migraine (n=1). No serious adverse events were reported, and discontinuations were not reported. No p-values or confidence intervals were reported for these outcomes.

Key limitations include the single-center design, the pediatric cohort, and the fact that this is a first-in-human study. Consequently, the preliminary safety and efficacy data should be interpreted with caution. Funding sources and conflicts of interest were not reported, and the study did not report on broader practice relevance or causality.