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用于左心耳封堵的Watchman与Amulet:当前证据及未来展望

Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives.

作者信息

Frazzetto Marco, Sanfilippo Claudio, Costa Giuliano, Contrafatto Claudia, Giacalone Chiara, Scandura Salvatore, Castania Giuseppe, De Santis Jessica, Sanfilippo Maria, Di Salvo Maria Elena, Tamburino Corrado, Barbanti Marco, Grasso Carmelo

机构信息

Division of Cardiology, A.O.U. Policlinico "G. Rodolico San Marco", 95123 Catania, Italy.

Faculty of Medicine and Surgery, Università degli Studi di Enna "Kore", 94100 Enna, Italy.

出版信息

J Clin Med. 2024 Aug 8;13(16):4651. doi: 10.3390/jcm13164651.

DOI:10.3390/jcm13164651
PMID:39200792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11355803/
Abstract

Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates. The Amulet device, a newer alternative, promises enhanced design features for more efficient appendage sealing. Current data highlight that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in terms of peri-device leaks, device-related thrombosis, and mortality. Both devices are indicated for patients who are unable to tolerate OAC, given their similar risk and safety profiles. Newer clinical studies are directed at establishing the efficacy of both devices as the primary method for stroke prevention in AF as an alternative to OAC.

摘要

左心耳封堵术(LAAC)是对不适合长期抗凝治疗的非瓣膜性心房颤动患者进行卒中预防的关键干预措施。Amulet和Watchman是全球植入最多的用于实施LAAC的装置,本综述的目的是对它们的疗效、安全性以及短期和长期结果进行全面比较。Watchman装置是首个获得美国食品药品监督管理局(FDA)批准的装置,已得到广泛研究,并显示出卒中及系统性栓塞发生率显著降低。Amulet装置作为一种较新的替代产品,其设计特点有望得到改进,从而实现更有效的心耳封堵。目前的数据表明,这两种装置在LAAC方面具有相似的疗效和安全性。虽然这两种装置在术中并发症发生率方面存在差异,但在装置周围渗漏、与装置相关的血栓形成及死亡率方面,它们的短期至长期结果相似。鉴于它们具有相似的风险和安全性,这两种装置均适用于无法耐受口服抗凝药(OAC)的患者。新的临床研究旨在确定这两种装置作为房颤卒中预防的主要方法替代OAC的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/8e7dd486303b/jcm-13-04651-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/6378bdeca18b/jcm-13-04651-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/969485c6d8d7/jcm-13-04651-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/769899501d7a/jcm-13-04651-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/8e7dd486303b/jcm-13-04651-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/6378bdeca18b/jcm-13-04651-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/969485c6d8d7/jcm-13-04651-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/769899501d7a/jcm-13-04651-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e56/11355803/8e7dd486303b/jcm-13-04651-g004.jpg

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本文引用的文献

1
Left Atrial Appendage Occlusion: Current Advances and Remaining Challenges.左心耳封堵术:当前进展与尚存挑战
JACC Adv. 2022 Nov 16;1(5):100136. doi: 10.1016/j.jacadv.2022.100136. eCollection 2022 Dec.
2
Single antiplatelet therapy following Amplatzer left atrial appendage occlusion.经 Amplatzer 左心耳封堵术后的单一抗血小板治疗。
EuroIntervention. 2024 Mar 4;20(5):e301-e311. doi: 10.4244/EIJ-D-23-00684.
3
First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.美国使用Amulet的首次经验:来自EMERGE LAA批准后研究的早期见解。
JACC Cardiovasc Interv. 2024 Jan 19. doi: 10.1016/j.jcin.2023.11.027.
4
2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.2023 ACC/AHA/ACCP/HRS 指南:心房颤动的诊断与管理——美国心脏病学会/美国心脏协会联合临床实践指南委员会的报告。
Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.
5
Device-Related Thrombus After Left Atrial Appendage Occlusion: Clinical Impact, Predictors, Classification, and Management.左心耳封堵术后器械相关血栓:临床影响、预测因素、分类和管理。
JACC Cardiovasc Interv. 2023 Nov 27;16(22):2695-2707. doi: 10.1016/j.jcin.2023.10.046.
6
Efficacy and safety of the new generation Watchman FLX device compared to the Watchman 2.5: a systematic review and meta-analysis.新一代Watchman FLX装置与Watchman 2.5相比的疗效和安全性:一项系统评价和荟萃分析。
Am J Cardiovasc Dis. 2023 Oct 15;13(5):291-299. eCollection 2023.
7
DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis.经左心耳封堵术(LAAC)联合 WATCHMAN FLX 后,DAPT 与 OAC 相当:一项全国登记研究分析。
JACC Cardiovasc Interv. 2023 Nov 27;16(22):2708-2718. doi: 10.1016/j.jcin.2023.08.013. Epub 2023 Nov 8.
8
One-Year Outcomes After Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: A Prespecified Analysis of the SWISS-APERO Randomized Clinical Trial.使用Amulet或Watchman装置进行经皮左心耳封堵术后一年的结果:SWISS-APERO随机临床试验的预先设定分析
Circulation. 2024 Feb 6;149(6):484-486. doi: 10.1161/CIRCULATIONAHA.123.067599. Epub 2023 Oct 24.
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JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1555-1567. doi: 10.1016/j.jacep.2023.04.013. Epub 2023 May 18.