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新一代WATCHMAN FLX与传统WATCHMAN 2.5用于经皮左心耳封堵术的短期安全性和有效性比较。

Comparison in Short-Term Safety and Efficacy between New-Generation WATCHMAN FLX and Conventional WATCHMAN 2.5 for Percutaneous Left Atrial Appendage Closure.

作者信息

Fukuda Nobuyuki, Imamura Teruhiko, Tanaka Shuhei, Kataoka Naoya, Ushijima Ryuichi, Ueno Hiroshi, Kinugawa Koichiro

机构信息

The Second Department of Internal Medicine, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan.

出版信息

J Clin Med. 2022 Mar 15;11(6):1618. doi: 10.3390/jcm11061618.

Abstract

Background: Percutaneous left atrial appendage closure using the WATCHMAN system, to prevent thrombosis and minimize anti-coagulant use in patients with non-valvular atrial fibrillation, has recently been introduced. The safety and efficacy of new-generation WATCHMAN FLX, as compared to conventional WATCHMAN 2.5, remain unknown. Methods: Consecutive patients who received percutaneous left atrial appendage closure using the WATCHMAN system in our institute, between June 2020 and December 2021, were retrospectively analyzed. Safety and efficacy during the 45-day observational period were compared between the two devices. Results: A total of 93 patients (73.0 ± 7.3 years old, 63 men) who received WATCHMAN FLX (n = 44) or WATCHMAN 2.5 (n = 49) were included. The device implant success rate was 100% in the FLX device group and 98% in the 2.5 device group. There were no procedure-related complications in the FLX group, and one non-relevant pericardial effusion in the 2.5 device group. During the 45-day observational period, there were no procedure-related adverse events. No patients in the FLX group had a peri-device leak >3 mm, whereas two patients in the 2.5 device group had a peri-device leak >3 mm. Anti-coagulants could be terminated in most of the patients (85% versus 88%; p = 0.68). Conclusions: Percutaneous left atrial appendage closure using new-generation WATCHMAN FLX seemed to be as safe and effective as conventional WATCHMAN 2.5 during the short-term observational period.

摘要

背景

最近引入了使用WATCHMAN系统进行经皮左心耳封堵术,以预防非瓣膜性心房颤动患者的血栓形成并尽量减少抗凝药物的使用。与传统的WATCHMAN 2.5相比,新一代WATCHMAN FLX的安全性和有效性尚不清楚。方法:回顾性分析2020年6月至2021年12月在我院接受使用WATCHMAN系统进行经皮左心耳封堵术的连续患者。比较两种装置在45天观察期内的安全性和有效性。结果:共纳入93例接受WATCHMAN FLX(n = 44)或WATCHMAN 2.5(n = 49)的患者(年龄73.0±7.3岁,男性63例)。FLX装置组的装置植入成功率为100%,2.5装置组为98%。FLX组无手术相关并发症,2.5装置组有1例无关的心包积液。在45天观察期内,无手术相关不良事件。FLX组无患者的装置周围漏血>3 mm,而2.5装置组有2例患者的装置周围漏血>3 mm。大多数患者(85%对88%;p = 0.68)可停用抗凝药物。结论:在短期观察期内,使用新一代WATCHMAN FLX进行经皮左心耳封堵术似乎与传统的WATCHMAN 2.5一样安全有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a2b/8949425/50f075430896/jcm-11-01618-g001.jpg

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