{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T06:07:18Z","timestamp":1788934038267,"version":"build-2803163510"},"reference-count":18,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"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>Post-myocardial infarction ventricular septal rupture (PIVSR) is a severe mechanical complication of acute myocardial infarction (AMI) with a poor prognosis. Current therapeutic strategies\u2014including pharmacotherapy, surgery, and off-label use of congenital occluders\u2014are associated with inherent limitations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The primary objective of this study was to evaluate the procedural feasibility, preliminary safety, and short-term performance of a novel dedicated Ventricular Septal Reconstruction Device (VSRD) for the treatment of PIVSR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study employed preclinical animal studies and a prospective first-in-human (FIM) clinical study. For the animal experiments, VSD-like defect creation was attempted in 14 Labrador retrievers; 11 underwent device-placement attempts, and 10 completed implantation and detachment with the VSRS 3226 device. Five animals were assessed at day 1 and five at day 60. The canine model was used to evaluate device deliverability, deployment, anchoring, shunt reduction, and short-term local tissue response in a VSD-like defect model rather than to reproduce infarct-related PIVSR pathology. For the first-in-human study, 4 PIVSR patients were enrolled; the transjugular approach was adopted, guidance was provided by transthoracic echocardiography (TTE) combined with left ventricular angiography, and follow-up duration exceeded 6 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In animal experiments, 11 of 14 animals proceeded to device-placement attempts, and 10 completed implantation and detachment; no device structural malfunction or delivery-system failure was recorded. Minor residual leakage was qualitatively observed in 4\/5 animals at day 1, whereas no leakage was detected in the separate five-animal day-60 group; tissue coverage consistent with endothelialization was observed at day 60, and no adverse events occurred among implanted animals during follow-up. In the first-in-human study, implantation was completed in all four patients; residual shunts were \u22642\u2005mm during follow-up, and no high-grade atrioventricular block or permanent pacemaker implantation occurred.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The VSRD demonstrated procedural feasibility and acceptable short-term safety and performance in this preclinical and first-in-human experience, in selected patients and a VSD-like animal model. Larger-scale clinical studies with longer follow-up are needed to evaluate its long-term safety, effectiveness, durability, and comparative performance. These findings should be interpreted cautiously because the clinical cohort was small, highly selected, and non-comparative.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcvm.2026.1892390","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T05:50:18Z","timestamp":1788933018000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A novel ventricular septal reconstruction device for post-myocardial infarction ventricular septal rupture: preclinical and first-in-human study results"],"prefix":"10.3389","volume":"13","author":[{"given":"Changjing","family":"Huang","sequence":"first","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nan","family":"Cai","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youqian","family":"Li","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yao","family":"Yao","sequence":"additional","affiliation":[{"name":"MicroPort\u00ae CardioFlow Medtech Corporation","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zexun","family":"Zhu","sequence":"additional","affiliation":[{"name":"MicroPort\u00ae CardioAdvent Medtech Corporation","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weike","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Ultrasound, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaibing","family":"Ren","sequence":"additional","affiliation":[{"name":"MicroPort\u00ae CardioAdvent Medtech Corporation","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siwei","family":"Wu","sequence":"additional","affiliation":[{"name":"MicroPort\u00ae CardioAdvent Medtech Corporation","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingfeng","family":"Liu","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingyuan","family":"Hou","sequence":"additional","affiliation":[{"name":"Guangdong Engineering Technological Research Center of Molecular Diagnosis in Cardiovascular Diseases","place":["Meizhou, China"]},{"name":"Institute of Cardiovascular Disease, Meizhou Clinical Institute of Shantou University Medical College","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haifeng","family":"Hong","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanlin","family":"Li","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhihui","family":"Hu","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhixiong","family":"Zhong","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhong","sequence":"additional","affiliation":[{"name":"Fifth Department of Cardiovascular Medicine, Meizhou People\u2019s Hospital","place":["Meizhou, Guangdong, China"]},{"name":"Guangdong Engineering Technological Research Center of Molecular Diagnosis in Cardiovascular Diseases","place":["Meizhou, China"]},{"name":"Meizhou Key Laboratory of Cardiovascular Translational Medicine","place":["Meizhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,9]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"2478","DOI":"10.1093\/eurheartj\/ehae363","article-title":"Ventricular septal defect complicating acute myocardial infarction: diagnosis and management. A clinical consensus statement of the association for acute CardioVascular care (ACVC) of the ESC, the European association of percutaneous cardiovascular interventions (EAPCI) of the ESC and the ESC working group on cardiovascular surgery","volume":"45","author":"Schlotter","year":"2024","journal-title":"Eur Heart J"},{"key":"B2","doi-asserted-by":"publisher","first-page":"5020","DOI":"10.1093\/eurheartj\/ehac511","article-title":"Post-infarction ventricular septal defect: percutaneous or surgical management in the UK national registry","volume":"43","author":"Giblett","year":"2022","journal-title":"Eur Heart J"},{"key":"B3","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1093\/icvts\/ivs444","article-title":"What is the best timing of surgery in patients with post-infarct ventricular septal rupture?","volume":"16","author":"Papalexopoulou","year":"2013","journal-title":"Interact Cardiovasc Thorac Surg"},{"key":"B4","doi-asserted-by":"publisher","first-page":"e1","DOI":"10.1016\/s1885-5857(09)71559-2","article-title":"ESC Guidelines on management of acute myocardial infarction in patients presenting with persistent ST-segment elevation","volume":"62","author":"Van de Werf","year":"2009","journal-title":"Rev Esp Cardiol"},{"key":"B5","doi-asserted-by":"publisher","first-page":"E1","DOI":"10.1002\/ccd.24776","article-title":"2013 ACCF\/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology foundation\/American Heart Association task force on practice guidelines","volume":"82","author":"O'Gara","year":"2013","journal-title":"Catheter Cardiovasc Interv"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1233","DOI":"10.1016\/j.jcin.2017.03.042","article-title":"The in vivo morphology of post-infarct ventricular septal defect and the implications\u00a0for\u00a0closure","volume":"10","author":"Hamilton","year":"2017","journal-title":"JACC Cardiovasc Interv"},{"key":"B7","doi-asserted-by":"publisher","first-page":"5276","DOI":"10.1097\/MS9.0000000000002294","article-title":"Surgical closure versus transcatheter closure for ventricular septal defect post-infarction: a meta-analysis","volume":"86","author":"Aramin","year":"2024","journal-title":"Ann Med Surg (Lond)"},{"key":"B8","doi-asserted-by":"publisher","first-page":"102016","DOI":"10.1016\/j.jscai.2024.102016","article-title":"Transcatheter closure of postinfarct VSD with the amplatzer PIVSD occluder: results of a US study","volume":"3","author":"Iyer","year":"2024","journal-title":"J Soc Cardiovasc Angiogr Interv"},{"key":"B9","doi-asserted-by":"publisher","first-page":"878","DOI":"10.1136\/heartjnl-2019-315751","article-title":"Transcatheter treatment of postinfarct ventricular septal defects","volume":"106","author":"Giblett","year":"2020","journal-title":"Heart"},{"key":"B10","doi-asserted-by":"publisher","first-page":"102071","DOI":"10.1016\/j.jscai.2024.102071","article-title":"Transcatheter closure of postinfarct ventricular septal defect: promises and uncertainties","volume":"3","author":"Jhand","year":"2024","journal-title":"J Soc Cardiovasc Angiogr Interv"},{"key":"B11","doi-asserted-by":"publisher","first-page":"391","DOI":"10.2143\/AC.62.4.2022283","article-title":"Percutaneous transcatheter ventricular septal defect closure in adults with amplatzer septal occluders","volume":"62","author":"Marinakis","year":"2007","journal-title":"Acta Cardiol"},{"key":"B12","first-page":"43","article-title":"Primary transcatheter closure of postinfarction ventricular septal defects with the amplatzer septal occluder- immediate results and up-to 5 years follow-up","volume":"1","author":"Demkow","year":"2005","journal-title":"EuroIntervention"},{"key":"B13","doi-asserted-by":"publisher","first-page":"94","DOI":"10.4244\/EIJV12I1A17","article-title":"Interventional post-myocardial infarction ventricular septal defect closure: a systematic review of current evidence","volume":"12","author":"Schlotter","year":"2016","journal-title":"EuroIntervention"},{"key":"B14","doi-asserted-by":"publisher","first-page":"e16708","DOI":"10.1016\/j.heliyon.2023.e16708","article-title":"Transcatheter closure of post-myocardial infarction ventricular septal defect: a systematic review and single-arm meta-analysis","volume":"9","author":"Yi","year":"2023","journal-title":"Heliyon"},{"key":"B15","doi-asserted-by":"publisher","first-page":"684","DOI":"10.1016\/j.cjco.2020.05.007","article-title":"Newly designed custom-made occluder for transcatheter closure of postinfarction ventricular septal rupture: a cutting-edge technology","volume":"2","author":"Onorato","year":"2020","journal-title":"CJC Open"},{"key":"B16","first-page":"555942","article-title":"Recurrent post infarction ventricular septal rupture following surgical repair: successful use of an innovative custom-made device","volume":"16","author":"Onorato","year":"2020","journal-title":"J Cardiol Cardiovasc Ther"},{"key":"B17","doi-asserted-by":"publisher","first-page":"620","DOI":"10.1002\/ccd.30571","article-title":"Transcatheter closure of large postinfarct ventricular septal defect: initial results of prototype occlutech\u00ae device including the first-in-human","volume":"101","author":"Lee","year":"2023","journal-title":"Catheter Cardiovasc Interv"},{"key":"B18","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1002\/ccd.10784","article-title":"Transcatheter closure of postinfarction ventricular septal defects using the new amplatzer muscular VSD occluder: results of a U.S. Registry","volume":"61","author":"Holzer","year":"2004","journal-title":"Catheter Cardiovasc Interv"}],"container-title":["Frontiers in Cardiovascular Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcvm.2026.1892390\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T05:50:19Z","timestamp":1788933019000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcvm.2026.1892390\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,9]]},"references-count":18,"alternative-id":["10.3389\/fcvm.2026.1892390"],"URL":"https:\/\/doi.org\/10.3389\/fcvm.2026.1892390","relation":{},"ISSN":["2297-055X"],"issn-type":[{"value":"2297-055X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,9]]},"article-number":"1892390"}}