{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T13:50:08Z","timestamp":1776693008093,"version":"3.51.2"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,11,12]],"date-time":"2019-11-12T00:00:00Z","timestamp":1573516800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National Key R&D Program of China","award":["2016YFC1100305"],"award-info":[{"award-number":["2016YFC1100305"]}]},{"name":"Shenzhen Sanming Medical Project of China","award":["SZSM201612057"],"award-info":[{"award-number":["SZSM201612057"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the feasibility, safety, and effectiveness of a novel, absorbable atrial septal defect (ASD) closure device made of poly\u2010<jats:sc>l<\/jats:sc>\u2010lactic acid (PLLA) in a swine model of ASD and for the first time in humans.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A preclinical safety study was conducted using a swine model of ASD. In a clinical setting, five pediatric patients underwent ASD closure with the PLLA device with fluoroscopic and transthoracic echocardiography guidance. The procedural results and clinical outcomes at 1\u2009day, 30\u2009days, 3\u2009months, and 6 months after closure were analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The 24\u2010 and 36\u2010month follow\u2010up results of the preclinical study demonstrated that the PLLA device exhibited good endothelialization and degradability in the swine model. In the clinical study, successful device implantation was achieved in all five patients (median age, 3.6\u2009years; range, 3.1\u20136.5\u2009years). The mean defect size was (13.6\u2009\u00b1\u20092.7) mm. Follow\u2010up at 30\u2009days, 3 months, and 6 months was completed in all five cases. The complete defect closure rates with no residual shunt at 30\u2009days, 3 months, and 6 months follow\u2010up were 60% (3\/5), 80% (4\/5), and 80% (4\/5), respectively. No device dislodgement, significant aortic valve or mitral valve regurgitation, new onset cardiac arrhythmia, or other adverse events were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The study results demonstrated that it is feasible to implant the PLLA device for closure of small to medium sized ASDs without significant residual shunts or severe adverse events in humans. The PLLA device exhibited good endothelialization and degradability in the swine model at 24 and 36\u2009months. Further studies to evaluate long\u2010term safety and effectiveness with the device in a large cohort of patients are warranted.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28529","type":"journal-article","created":{"date-parts":[[2019,11,12]],"date-time":"2019-11-12T14:41:34Z","timestamp":1573569694000},"page":"282-293","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first\u2010in\u2010human experience"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3217-8893","authenticated-orcid":false,"given":"Yi\u2010Fan","family":"Li","sequence":"first","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu\u2010Mei","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease  Guangzhou China"},{"name":"The Second School of Clinical Medicine Southern Medical University  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo\u2010Ning","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology Shenzhen Children's Hospital  Shenzhen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhao\u2010Feng","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shu\u2010Shui","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3338-9385","authenticated-orcid":false,"given":"Zhi\u2010Wei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,11,12]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.12.072"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8191.2009.00871.x"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2003.10.030"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.24875"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2018.06.076"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.08.112"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.26784"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.02.057"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.664672"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22429"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.2478\/v10019-012-0029-8"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22033"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2010.06.012"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25783"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/imi.0b013e31822a2c42"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1155\/2012\/735989"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/joic.12550"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-17-00006"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10439-011-0368-4"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1159\/000446313"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.27852"},{"issue":"1","key":"e_1_2_9_23_1","first-page":"3","article-title":"Interventional treatment of common congenital heart diseases: the common view of Chinese medical experts. Part one: interventional treatment of atrial septal defect","volume":"20","author":"Committee on Congenital Heart Diseases IMBO","year":"2011","journal-title":"J Interv Radiol"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0304(199712)42:4<388::AID-CCD7>3.0.CO;2-7"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/biot.201000135"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/SCS.0000000000005163"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13346-017-0463-7"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.micron.2018.12.006"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1536\/ihj.17-227"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.28529","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.28529","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.28529","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.28529","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T22:28:21Z","timestamp":1694125701000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.28529"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,12]]},"references-count":28,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,2]]}},"alternative-id":["10.1002\/ccd.28529"],"URL":"https:\/\/doi.org\/10.1002\/ccd.28529","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,12]]},"assertion":[{"value":"2019-04-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-09-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}