{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T13:09:32Z","timestamp":1776863372823,"version":"3.51.2"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T00:00:00Z","timestamp":1776643200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cardiovasc. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093), moderate mitral regurgitation (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091), and migraine (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091). Patients with a larger baseline ASD indexed diameter (&amp;gt;15.18\u2005mm\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) and a smaller device-to-defect ratio (&amp;lt;1.47) showed an increased risk of residual leaks after PLLA device implantation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcvm.2026.1804642","type":"journal-article","created":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T05:24:22Z","timestamp":1776662662000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.3389","volume":"13","author":[{"given":"Yi-Fan","family":"Li","sequence":"first","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong Provincial Key Laboratory of South China Structural Heart Disease","place":["Guangzhou, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhao-Feng","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong Provincial Key Laboratory of South China Structural Heart Disease","place":["Guangzhou, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo-Ning","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Shenzhen Children\u2019s Hospital","place":["Shenzhen, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun-Jun","family":"Shen","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong Provincial Key Laboratory of South China Structural Heart Disease","place":["Guangzhou, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shu-Shui","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong Provincial Key Laboratory of South China Structural Heart Disease","place":["Guangzhou, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu-Mei","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong Provincial Key Laboratory of South China Structural Heart Disease","place":["Guangzhou, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhi-Wei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangdong Provincial Key Laboratory of South China Structural Heart Disease","place":["Guangzhou, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,4,20]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1213","DOI":"10.1016\/j.jacc.2004.12.072","article-title":"Cardiac perforation after device closure of atrial septal defects with the amplatzer septal occluder","volume":"45","author":"Divekar","year":"2005","journal-title":"J Am Coll 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