{"title":"日本实际情况下的卵圆孔孔 (PFO) 封闭--AmplatzerTM PFO 封堵器日本上市后监测研究的 30 天临床结果。","authors":"Teiji Akagi, Hidehiko Hara, Hideaki Kanazawa, Shigefumi Fukui, Yoichiro Hashimoto, Yasuyuki Iguchi, Toru Iwama, Hiroharu Kataoka, Akio Kawamura, Hiroyuki Kawano, Koichi Oki, Hiroshi Yamagami","doi":"10.1253/circj.CJ-24-0080","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The Amplatzer<sup>TM</sup> PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients.</p><p><strong>Methods and results: </strong>PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the Amplatzer<sup>TM</sup> PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure.</p><p><strong>Conclusions: </strong>In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the Amplatzer<sup>TM</sup> PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.</p>","PeriodicalId":50691,"journal":{"name":"Circulation Journal","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Patent Foramen Ovale (PFO) Closure in Japan - 30-Day Clinical Outcomes From the Amplatzer<sup>TM</sup> PFO Occluder Japan Post-Marketing Surveillance Study.\",\"authors\":\"Teiji Akagi, Hidehiko Hara, Hideaki Kanazawa, Shigefumi Fukui, Yoichiro Hashimoto, Yasuyuki Iguchi, Toru Iwama, Hiroharu Kataoka, Akio Kawamura, Hiroyuki Kawano, Koichi Oki, Hiroshi Yamagami\",\"doi\":\"10.1253/circj.CJ-24-0080\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The Amplatzer<sup>TM</sup> PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients.</p><p><strong>Methods and results: </strong>PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the Amplatzer<sup>TM</sup> PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure.</p><p><strong>Conclusions: </strong>In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the Amplatzer<sup>TM</sup> PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.</p>\",\"PeriodicalId\":50691,\"journal\":{\"name\":\"Circulation Journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2024-08-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1253/circj.CJ-24-0080\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/5/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1253/circj.CJ-24-0080","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/11 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Real-World Patent Foramen Ovale (PFO) Closure in Japan - 30-Day Clinical Outcomes From the AmplatzerTM PFO Occluder Japan Post-Marketing Surveillance Study.
Background: The AmplatzerTM PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients.
Methods and results: PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the AmplatzerTM PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure.
Conclusions: In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the AmplatzerTM PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.
期刊介绍:
Circulation publishes original research manuscripts, review articles, and other content related to cardiovascular health and disease, including observational studies, clinical trials, epidemiology, health services and outcomes studies, and advances in basic and translational research.