LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.

IF 3.8 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Clinical Research in Cardiology Pub Date : 2024-10-01 Epub Date: 2024-01-31 DOI:10.1007/s00392-024-02376-8
Uzair Ansari, Johannes Brachmann, Thorsten Lewalter, Uwe Zeymer, Horst Sievert, Jakob Ledwoch, Volker Geist, Matthias Hochadel, Steffen Schneider, Jochen Senges, Ibrahim Akin, Christian Fastner
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Abstract

Background: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group.

Aim: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke.

Methods: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events.

Results: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS).

Conclusions: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients.

Clinicaltrials:

Gov identifier: NCT02230748.

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LAA 闭塞术对既往中风的极高危心房颤动患者有效且安全:德国 LAARGE 多中心登记的结果。
背景:对于有长期口服抗凝药(OAC)禁忌症的非瓣膜性心房颤动(AF)患者,介入性左心房阑尾封堵术(LAAO)可降低血栓栓塞事件的风险。曾中风的患者复发中风的风险会相应增加,因此 LAAO 在这一特殊的高危患者群体中的有效性可能会降低。目的:LAARGE 登记的这项子研究调查了 LAAO 在有中风史的非瓣膜性房颤患者中用于二级预防的有效性和安全性:LAARGE 是一项关于 LAAO 临床实践的前瞻性非随机登记项目。目前的子研究采用了指数手术和 1 年随访的数据。通过记录全因死亡率、非致死性血栓栓塞、手术相关并发症和出血事件来评估有效性和安全性:共有来自德国 38 家医院的 638 名患者连续接受了研究,并分为两组:137 名有中风病史的患者(21.5%)和 501 名无中风病史的患者。两组患者的植入成功率一致(98.5% 对 97.4%,P = NS),而围手术期 MACCE 和其他并发症很少(分别为 0% 对 0.6% 和 4.4% 对 4.0%;P = NS)。卡普兰-梅耶估计结果显示,两组随访时的主要疗效指标(免于全因死亡或非致死性中风)无显著差异(87.8% vs. 87.7%,p = NS)。随访期间,短暂性脑缺血发作或全身性栓塞的发生率较低(分别为 0% vs. 0.5% 和 0.9% vs. 0%;各 p = NS)。出院后严重出血事件很少发生(0% vs. 0.7%,p = NS):结论:与未发生过中风的患者相比,既往中风患者接受 LAAO 的有效性和安全性相似。LAAO可作为OAC的可行替代方案,用于非瓣膜性房颤患者的中风二级预防:Gov 标识符:NCT02230748。
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来源期刊
Clinical Research in Cardiology
Clinical Research in Cardiology 医学-心血管系统
CiteScore
11.40
自引率
4.00%
发文量
140
审稿时长
4-8 weeks
期刊介绍: Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery. As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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