Abstract：
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.
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.
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.
摘要：
背景：AmplatzerTMPFO封堵器于2019年5月在日本获准上市，AmplatzerPFO封堵器日本上市后监测(PFOJapanPMS)研究于2019年12月启动。该分析显示了日本PFOPMS研究患者的30天临床结果。方法和结果：日本PFOPMS是一项前瞻性单臂非随机多中心临床研究。符合条件的患者需要进行卵圆孔未闭（PFO）闭合，并使用AmplatzerTMPFO封堵器进行了植入尝试。技术成功定义为封堵器的成功递送和释放;手术成功定义为手术后1天内无严重不良事件(SAE)的技术成功。主要安全终点包括手术后30天内预定义的装置和/或手术相关的SAE。从2019年12月到2021年7月，在53个日本地点招募了500名患者。平均（±SD）患者年龄为52.7±15.4岁，29.8%的患者年龄>60岁。技术和程序成功率都很高（99.8％和98.8％，分别)。Further,只有一个主要安全性终点事件(0.2%):手术后26天发生的无症状阵发性心房颤动发作.
结论：在这项真实世界的日本研究中，近三分之一的患者年龄>60岁，使用AmplatzerTMPFO封堵器成功且安全地进行了PFO封堵,与手术相关的房性心律失常的发生率较低。
结论：在这项真实世界的日本研究中，近三分之一的患者年龄>60岁，使用AmplatzerTMPFO封堵器成功且安全地进行了PFO封堵,与手术相关的房性心律失常的发生率较低。
