Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman

IF 11.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2025-05-26 DOI:10.1016/j.jcin.2025.03.025

Matthew J. Price MD , Zhen Tan , Sarah Zimmerman MS , Jeptha P. Curtis MD , James V. Freeman MD, MPH, MS

{"title":"Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman","authors":"Matthew J. Price MD , Zhen Tan , Sarah Zimmerman MS , Jeptha P. Curtis MD , James V. Freeman MD, MPH, MS","doi":"10.1016/j.jcin.2025.03.025","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Procedural complications, device-related thrombus, and peridevice leak may limit the benefit of transcatheter left atrial appendage occlusion (LAAO). Although next-generation devices incorporate design modifications meant to address these phenomena, the longer term impact of these modifications on outcomes has not been described.</div></div><div><h3>Objectives</h3><div>The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.5 device.</div></div><div><h3>Methods</h3><div>The National Cardiovascular Data Registry LAAO Registry was used to identify: 1) patients who received the Watchman FLX; and 2) an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was ischemic stroke. A secondary analysis was performed using 2:1 propensity score matching.</div></div><div><h3>Results</h3><div>The study cohort consisted of 27,141 patients receiving each device. Among patients undergoing transesophageal echocardiography at 45 days, the rate of device-related thrombus was not different for Watchman FLX compared with Watchman 2.5 (0.4% vs 0.5%; <em>P</em> = 0.27) while the rate of any peridevice leak was significantly lower (14.7% vs 23.5%; <em>P</em> < 0.001). At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; <em>P</em> < 0.0001), ischemic stroke (adjusted HR: 0.82; 95% CI: 0.68-0.98; <em>P</em> = 0.02), and ischemic stroke or systemic embolism (adjusted HR: 0.74; 95% CI: 0.62-0.87; <em>P</em> = 0.0003). The findings of the propensity score matching analysis were similar.</div></div><div><h3>Conclusions</h3><div>Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device. These findings suggest that enhanced procedural safety and completeness of anatomical closure translate into better longer term safety and clinical effectiveness after transcatheter LAAO.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 10","pages":"Pages 1318-1326"},"PeriodicalIF":11.7000,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JACC. Cardiovascular interventions","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1936879825009409","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Procedural complications, device-related thrombus, and peridevice leak may limit the benefit of transcatheter left atrial appendage occlusion (LAAO). Although next-generation devices incorporate design modifications meant to address these phenomena, the longer term impact of these modifications on outcomes has not been described.

Objectives

The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.5 device.

Methods

The National Cardiovascular Data Registry LAAO Registry was used to identify: 1) patients who received the Watchman FLX; and 2) an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was ischemic stroke. A secondary analysis was performed using 2:1 propensity score matching.

Results

The study cohort consisted of 27,141 patients receiving each device. Among patients undergoing transesophageal echocardiography at 45 days, the rate of device-related thrombus was not different for Watchman FLX compared with Watchman 2.5 (0.4% vs 0.5%; P = 0.27) while the rate of any peridevice leak was significantly lower (14.7% vs 23.5%; P < 0.001). At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; P < 0.0001), ischemic stroke (adjusted HR: 0.82; 95% CI: 0.68-0.98; P = 0.02), and ischemic stroke or systemic embolism (adjusted HR: 0.74; 95% CI: 0.62-0.87; P = 0.0003). The findings of the propensity score matching analysis were similar.

Conclusions

Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device. These findings suggest that enhanced procedural safety and completeness of anatomical closure translate into better longer term safety and clinical effectiveness after transcatheter LAAO.

查看原文本刊更多论文

Watchman FLX经导管左心耳闭塞术与第一代Watchman的临床疗效比较

手术并发症、器械相关血栓和器械周围泄漏可能限制经导管左心耳闭塞术（LAAO）的益处。尽管下一代设备包含旨在解决这些现象的设计修改，但这些修改对结果的长期影响尚未得到描述。目的本研究的目的是比较Watchman FLX与Watchman 2.5器械的1年安全性和临床有效性。方法采用美国国家心血管数据注册中心LAAO注册中心对患者进行识别：1)接受Watchman FLX治疗的患者；2)在同一地点接受Watchman 2.5的患者数量相同，直接在每个地点的第一个Watchman FLX病例之前。主要终点为缺血性卒中。二次分析采用2:1倾向评分匹配。结果研究队列包括27,141名接受每种装置的患者。在45天接受经食管超声心动图检查的患者中，Watchman FLX与Watchman 2.5的器械相关血栓发生率无差异(0.4% vs 0.5%；P = 0.27)，而任何设备泄漏率明显较低(14.7% vs 23.5%；P & lt;0.001)。1年时，Watchman FLX与主要不良事件的风险显著降低相关(调整后HR: 0.84；95% ci: 0.80-0.88；P & lt;0.0001)、缺血性卒中(调整后HR: 0.82；95% ci: 0.68-0.98；P = 0.02)，缺血性卒中或全身性栓塞(调整后HR: 0.74；95% ci: 0.62-0.87；P = 0.0003)。倾向评分匹配分析的结果是相似的。结论与Watchman器械相比，使用Watchman FLX的LAAO导管在1年后发生重大不良事件和缺血性卒中的风险显著降低。这些发现表明，经导管LAAO术后手术安全性和解剖闭合完整性的提高可以转化为更好的长期安全性和临床有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.