4-year follow-up results of percutaneous closure of atrial septal defect with the total biodegradable poly-L-lactic acid device: date from a prospective, single-center trial

Abstract Background The poly-L-lactic acid (PLLA) device is a novel, total biodegradable occluder dedicated to percutaneous closure of atrial septal defect (ASD) .Closure of ASD with the PLLA device has proven to be relatively safe and effective in our preclinical and first-in-human studies. Objective The aim of the study was to evaluate long-term safety and efficacy of the PLLA device in percutaneous closure of ASD in a large cohort of patients. Methods A prospective study enrolling patients who had a clinically significant ASD was conducted in our institution from May 2018 to August 2019. Percutaneous ASD closure was undertaken with the PLLA device. Evaluations were scheduled pre-hospital discharge and again at 1, 3, 6, 12, 24, 36 and 48 months post implantation. Primary endpoints were a composite of clinical success, including closure success and no major complications at the 48-month follow-up evaluation. Results A total of 52 patients (35 children, 55.8% females, median age 7.55 years, median weight 28.75Kg) underwent an attempt at percutaneous ASD closure with PLLA device. Successful device implantation was achieved in 50 (96.1%) of 52 patients with delivery attempts. All the 50 patients (100%) completed 4-year follow-up visit. Closure success at 4-year follow-up were 84% (42/50), with 8 patient (16%) reported to have clinically significant leaks, including 2 large residual leaks, 5 moderate residual leaks, and 1 small residual leak. 10 complications occurred, with 1 event of cardiac arrhythmia during procedure, and 9 follow-up events, consisting in cardiac arrhythmias (n=6), moderate or large mitral regurgitation (n=2), and headache (n=1). Conclusion Percutaneous ASD closure with PLLA device in human seems to be safe. However, increased occurrence of residual leaks overtime indicated that long-term efficacy of PLLA device in human was sub-optimal.TTE follow-up of a case with PLLA device