Lakkireddy Dhanunjaya, Thaler David, Ellis Christopher R, Swarup Vijendra, Sondergaard Lars, Carroll John, Gold Michael R, Hermiller James, Diener Hans-Christoph, Schmidt Boris, MacDonald Lee, Mansour Moussa, Maini Brijeshwar, Anderson Jordan A, Gage Ryan, Windecker Stephan
Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas.
Tufts Medical Center, Boston, Massachusetts.
Heart Rhythm O2. 2022 Jul 20;3(5):493-500. doi: 10.1016/j.hroo.2022.07.004. eCollection 2022 Oct.
Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.
The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.
At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days.
A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%).
Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.
左心耳封堵术是口服抗凝药之外的另一种降低非瓣膜性心房颤动（NVAF）患者卒中风险的治疗方法。Amulet IDE试验比较了用于NVAF患者左心耳封堵的Amplatzer™ Amulet™封堵器（雅培公司）和Watchman™ 2.5装置（波士顿科学公司）。
本研究旨在描述Amulet IDE试验导入队列的结果。
在美国各研究点，导入阶段每个植入医生最多可为3例患者植入Amulet封堵器。Amulet IDE试验的主要终点包括安全性（与手术相关并发症、全因死亡或12个月时大出血的复合终点）、有效性（18个月时缺血性卒中或全身性栓塞的复合终点）以及45天时左心耳封堵率。
共纳入201例导入患者。99%的患者实现了器械成功植入，45天时98.9%的患者观察到器械封堵（残余分流束≤5 mm）。与随机分组的Amulet封堵器队列相比，导入队列的安全终点发生率在数值上更高（更差）（18.4%对14.5%）。6例患者（3.1%）在18个月内发生缺血性卒中，0例发生全身性栓塞，这与随机分组的Amulet封堵器队列的主要有效性终点发生率（2.8%）相似。
尽管在导入阶段术者对Amulet封堵器缺乏经验，但器械植入成功率很高，实现了较高的器械封堵率，且NVAF患者的卒中发生率较低。
