Department of Cardiology, Charité - Universitätsmedizin Berlin, Berlin Institute of Health (BIH), Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Partner Site Berlin, Berlin, Germany.
EuroIntervention. 2018 Aug 3;14(5):e590-e597. doi: 10.4244/EIJ-D-18-00344.
Left atrial appendage occlusion (LAAO) is a stroke prevention therapy for patients with non-valvular atrial fibrillation (AF). This study reports one-year outcomes from patients enrolled in the prospective global Amulet registry.
A total of 1,088 patients were recruited, aged 75±9 years; 65% of patients were male. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.6 and 3.3±1.1, respectively. Eighty-three percent (83%) of patients had contraindications to anticoagulation (OAC); 72% had a history of major bleeding. An AMPLATZER Amulet LAA occluder was successfully implanted in 99% of cases. Transoesophageal echocardiography one to three months after implant showed no residual flow or flow <3 mm in 98.4%. The observed ischaemic stroke rate was 2.9%/year. Device-related thrombus was noted in 1.7% of patients. There were ten cases between 0 and 90 days and eight cases between 91 and 365 days. Patients discharged without OAC (>80%), in particular those on single aspirin therapy, did not appear to have a higher risk of device-related thrombus. In the first year, major bleeding occurred at an annualised rate of 10.3%. All-cause mortality was 8.4% at one year.
In the global prospective Amulet registry of patients at high risk of stroke and bleeding, the annualised ischaemic stroke rate was 2.9%. The LAA was sealed in 98.4% after one to three months and device-related thrombus was observed in 1.7% of cases with only a minority of all patients on anticoagulation treatment.
左心耳封堵术（LAAO）是预防非瓣膜性心房颤动（AF）患者中风的一种治疗方法。本研究报告了前瞻性全球 Amulet 注册研究中入组患者的一年随访结果。
共招募了 1088 名年龄 75±9 岁的患者；其中 65%为男性。CHA2DS2-VASc 和 HAS-BLED 评分分别为 4.2±1.6 和 3.3±1.1。83%（83%）的患者存在抗凝（OAC）禁忌证；72%的患者有大出血史。99%的患者成功植入了 AMPLATZER Amulet LAA 封堵器。植入后 1-3 个月行经食管超声心动图检查，98.4%的患者未见残余分流或分流<3mm。观察到的缺血性中风发生率为 2.9%/年。1.7%的患者发生器械相关血栓。其中 10 例发生在 0-90 天之间，8 例发生在 91-365 天之间。未服用 OAC（>80%）出院的患者，特别是服用单一阿司匹林治疗的患者，似乎没有更高的器械相关血栓风险。在第一年，大出血的年化发生率为 10.3%。一年时全因死亡率为 8.4%。
在高卒中风险和出血风险的全球前瞻性 Amulet 注册研究中，缺血性卒中的年化发生率为 2.9%。在 1-3 个月后，98.4%的左心耳被封堵，1.7%的患者发生器械相关血栓，仅有少数患者（所有患者的比例均较小）接受抗凝治疗。
