Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety.
Dhanunjaya Lakkireddy, Jacqueline Saw, Akash Makkar, Dipak Shah, Ruby Satpathy, Muhamed Saric, Rahul Sharma, Frank Cuoco, Robert Percell, George Manoukian, Ryan Gage, Jordan A Anderson, Himanshu Agarwal
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引用次数: 0
Abstract
Aims: The Watchman device is widely used for left atrial appendage occlusion but may be unsuitable in patients with complex anatomies, resulting in screening failures. The Amulet occluder, with its dual-seal design, may overcome these limitations. The aim of this analysis is to evaluate procedural success, closure, and clinical outcomes of Amulet occluder implantation in patients who failed Watchman screening.
Methods and results: This analysis from the ADVANCE LAA study included patients ineligible for Watchman (Screen Fail) compared to patients eligible for Amulet and Watchman (Device Eligible). Baseline characteristics, procedural details, cardiac imaging, and clinical events were assessed through 1 year. The safety endpoint composite was a composite of all-cause death, ischaemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or major endovascular intervention within hospital discharge or 7 days post-implant. Independent core laboratory and clinical events committee adjudicated imaging and adverse events, respectively. A total of 609 patients underwent Amulet implantation (Screen Fail: n = 97; Device Eligible: n = 512). Screen Fail patients had more complex anatomy and higher CHA2DS2-VASc and HAS-BLED scores. Despite these differences, implant success was high (96.9% vs. 98.0%; P = 0.446). Clinically relevant closure on transoesophageal echocardiography (≤3 mm peri-device leak) was achieved in ≥97% of patients in both groups at implant and 1-3 months. The peri-procedural safety endpoint composite rate was similar in both groups [3.1% vs. 2.7%; OR: 1.14 (0.32, 4.03); P = 0.742]. One-year rates of stroke (1.1% vs. 1.0%), major bleeding (9.6% vs. 6.2%), cardiovascular/unknown death (2.1% vs. 5.2%), and all-cause death (6.3% vs. 6.6%) were similar between groups (P > 0.05).
Conclusion: Amulet occluder implantation was feasible, safe, and effective in patients with or without failed Watchman screening, providing a viable option for both anatomically simple and complex anatomies.
背景与目的：Watchman装置广泛用于左心耳闭塞（LAAO），但可能不适用于解剖结构复杂的患者，导致筛查失败。护身符封堵器，其双密封设计，可以克服这些限制。本分析的目的是评估在未通过Watchman筛查的患者中植入护身符封堵器的手术成功、闭合和临床结果。方法：来自ADVANCE LAA研究的分析包括不符合Watchman （Screen Fail）条件的患者与符合Amulet和Watchman （Device eligible）条件的患者。基线特征、手术细节、心脏成像和1年内的临床事件进行评估。安全性终点组合为全因死亡、缺血性卒中、全身性栓塞或出院或植入后7天内需要心脏直视手术或主要血管内干预的器械/手术相关事件的组合。独立的核心实验室和临床事件委员会分别裁定成像和不良事件。结果：共609例患者植入了护身符（Screen Fail: n = 97; Device Eligible: n = 512）。筛检失败患者解剖结构更复杂，CHA2DS2-VASc和HAS-BLED评分更高。尽管存在这些差异，但种植成功率很高（96.9% vs. 98.0%; p = 0.446）。两组患者在种植和1-3个月时均有≥97%的患者实现了经食管超声心动图的临床相关闭合（装置周围泄漏≤3mm）。两组围手术期安全终点综合率相似（3.1% vs. 2.7%） （OR: 1.14 [0.32, 4.03]; p = 0.742）。卒中（1.1% vs. 1.0%）、大出血（9.6% vs. 6.2%）、心血管/未知死亡（2.1% vs. 5.2%）和全因死亡（6.3% vs. 6.6%）在两组间的发生率相似（p < 0.05）。结论：无论Watchman筛查失败与否，护身符咬合器植入术均是可行、安全、有效的，为解剖简单和解剖复杂的患者提供了可行的选择。
期刊介绍：
EP - Europace - European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology of the European Heart Rhythm Association of the European Society of Cardiology. The journal aims to provide an avenue of communication of top quality European and international original scientific work and reviews in the fields of Arrhythmias, Pacing and Cellular Electrophysiology. The Journal offers the reader a collection of contemporary original peer-reviewed papers, invited papers and editorial comments together with book reviews and correspondence.
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