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经皮左心耳封堵术治疗非瓣膜性心房颤动患者左心耳的初步结果:来自 TERMINATOR 注册研究的真实世界数据。

Initial results of transcatheter modification of left atrial appendage by obliteration with device in patients with nonvalvular atrial fibrillation: Real-world data from the TERMINATOR registry.

机构信息

Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.

Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.

出版信息

J Cardiol. 2024 May;83(5):298-305. doi: 10.1016/j.jjcc.2023.09.010. Epub 2023 Oct 5.

Abstract

BACKGROUND

Percutaneous left atrial appendage closure (LAAC) has increased for those who need alternative to long-term anticoagulation with non-valvular atrial fibrillation (NVAF).

METHODS AND RESULTS

From September 2019, after initiating WATCHMAN (Boston Scientific, Maple Grove, MN, USA) device implantation, we established Transcatheter Modification of Left Atrial Appendage by Obliteration with Device in Patients from the NVAF (TERMINATOR) registry. Utilizing 729 patients' data until January 2022, we analyzed percutaneous LAAC data regarding this real-world multicenter prospective registry. A total of 729 patients were enrolled. Average age was 74.9 years and 28.5 % were female. Paroxysmal AF was 37.9 % with average CHADS 3.2, CHADS-VASc 4.7, and HAS-BLED score of 3.4. WATCHMAN implantation was successful in 99.0 %. All-cause deaths were 3.2 %, and 1.2 % cardiovascular or unexplained deaths occurred during follow-up [median 222, interquartile range (IQR: 93-464) days]. Stroke occurred in 2.2 %, and the composite endpoint which included cardiovascular or unexplained death, stroke, and systemic embolism were counted as 3.4 % [median 221, (IQR: 93-464) days]. Major bleeding defined as BARC type 3 or 5 was seen in 3.7 %, and there was 8.6 % of all bleeding events in total [median 219, (IQR: 93-464) days].

CONCLUSIONS

These preliminary data demonstrated percutaneous LAAC with WATCHMAN device might have a potential to reduce stroke and bleeding events for patients with NVAF. Further investigation is mandatory to confirm the long-term results of this strategy using this transcatheter local therapy instead of life-long systemic anticoagulation.

摘要

背景

对于需要替代非瓣膜性心房颤动(NVAF)长期抗凝治疗的患者,经皮左心耳封堵(LAAC)的应用有所增加。

方法和结果

自 2019 年 9 月开始使用 Watchman(波士顿科学公司,明尼苏达州梅普尔格罗夫)装置植入以来,我们建立了经皮左心耳封堵通过器械闭塞治疗 NVAF 患者的 Transcatheter Modification of Left Atrial Appendage by Obliteration with Device in Patients from the NVAF(TERMINATOR)登记处。利用截至 2022 年 1 月的 729 例患者数据,我们分析了该真实世界多中心前瞻性登记处的经皮 LAAC 数据。共纳入 729 例患者,平均年龄为 74.9 岁,28.5%为女性。阵发性 AF 占 37.9%,平均 CHADS2 为 3.2,CHADS-VASc 为 4.7,HAS-BLED 评分为 3.4。Watchman 植入成功率为 99.0%。全因死亡率为 3.2%,随访期间有 1.2%的心血管或不明原因死亡(中位随访时间 222,IQR:93-464)。卒中发生率为 2.2%,包括心血管或不明原因死亡、卒中和系统性栓塞的复合终点发生率为 3.4%(中位随访时间 221,IQR:93-464)。主要出血定义为 BARC 类型 3 或 5 级,总出血事件发生率为 3.7%(中位随访时间 219,IQR:93-464)。

结论

这些初步数据表明,经皮使用 Watchman 装置行 LAAC 可能有潜力降低 NVAF 患者的卒中及出血事件风险。需要进一步研究来证实这种经皮局部治疗策略而非长期全身抗凝治疗的长期效果。

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