Long-term follow-up results of percutaneous closure of atrial septal defect with a novel biodegradable poly-L-lactic acid device in pediatrics: data from a prospective, single-center trial.

Background: The poly-L-lactic acid (PLLA) occluder is a novel, fully biodegradable device designed for percutaneous atrial septal defect (ASD) closure. First-in-human studies have demonstrated its preliminary safety and efficacy. Objective: This study aimed to evaluate the 5-year safety and efficacy of the PLLA device for percutaneous ASD closure in a single-center pediatric cohort. Methods: From May 2018 to August 2019, 36 patients with clinically significant ASD were enrolled and underwent percutaneous closure using the PLLA device. Follow-up assessments were conducted at discharge and at 1, 3, 6, 12, 24, 36, 48, and 60 months post-implantation. The primary endpoint was a composite of clinical success, defined as successful closure and absence of major complications at the 60-month follow-up. Results: Successful device implantation was achieved in 35 of 36 patients (97.2%). All of the 35 patients completed the 5-year follow-up. The closure success rate and complete closure rate at 5 years were 85.7% (30/35) and 77.1% (27/35), respectively. Clinically significant residual leaks at 5- year visit were observed in 5 patients (14.3%). A total of 5 complications (14.3%) occurred, consisting of cardiac arrhythmia ( Conclusion: Long-term follow-up confirms a favorable safety profile for percutaneous ASD closure using the PLLA device, with a cumulative complication rate of 14.2% and no major adverse events reported over 5 years. However, the incidence of residual leaks remains noteworthy, suggesting suboptimal long-term efficacy in pediatric patients and in cases involving large defects.