AIMS To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. METHODS AND RESULTS Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). CONCLUSION Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

中文翻译：

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使用 Amplatzer™ Amulet™ 装置封堵左心耳：前瞻性全球观察研究的完整结果

目的 评估使用 Amplatzer™ Amulet™ 封堵器进行左心耳封堵 (LAAO) 的安全性和有效性。方法和结果 符合 LAAO 条件的房颤患者被招募到一项前瞻性全球研究中。植入程序是在超声心动图指导下进行的。经食管超声心动图 (TOE) 在 LAAO 后 1-3 个月进行。植入物和后续 TOE 由 CoreLab 评估。主要终点是 2 年时缺血性卒中和心血管死亡的复合终点。严重的不良事件由独立的临床事件委员会裁定。共纳入 1088 名患者，年龄 75.2±8.5 岁；64.5% 是男性。CHA2DS2-VASc 和 HAS-BLED 评分分别为 4.2 ± 1.6 和 3.3 ± 1.1。共有 71.7% 的患者既往有大出血，82. 8% 有口服抗凝剂的禁忌症。种植成功率为 99.1%。主要不良事件（术后≤7 天）发生率为 4.0%，包括死亡 (0.3%)、中风 (0.4%)、大血管 (1.3%) 和装置栓塞 (0.2%)。共有 80.2% 的患者出院仅接受抗血小板治疗。在随访 TOE 时，98.4% 的患者周围设备流量 <3 mm。在 1.6% 的病例中发现了设备相关血栓 (DRT)。2 年时 8.7% 的患者发生心血管死亡或缺血性卒中。与 CHA2DS2-VASc 预测率相比，缺血性卒中发生率为 2.2%/年，减少了 67%。大出血（出血学术研究联盟类型 ≥ 3）的发生率为 10.1%/年（第 1 年）和 4.0%/年（第 2 年）。结论 使用 Amplatzer Amulet 装置跟随 LAAO，与预测风险相比，缺血性卒中发生率降低了 67%。98.4% 的病例完全关闭，仅 1.6% 的病例出现 DRT。