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
Abstract
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 (n = 3), moderate mitral regurgitation (n = 1), and migraine (n = 1). Patients with a larger baseline ASD indexed diameter (>15.18 mm/m2) and a smaller device-to-defect ratio (<1.47) showed an increased risk of residual leaks after PLLA device implantation.
Conclusion:…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 35 participants or records.
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