Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry
Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry
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DOI：
10.4244/eij-d-18-00344
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发表时间：
2018-08-01
期刊：
影响因子：
6.2
通讯作者：
Hildick-Smith, David
中科院分区：
文献类型：
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作者：
Landmesser, Ulf;Tondo, Claudio;Hildick-Smith, David
目的：左心耳封堵术（LAAO）是一种预防非瓣膜性房颤（AF）患者卒中的治疗方法。本研究报告了前瞻性全球Amulet注册研究中招募的患者的1年结局。方法和结果：共招募了1，088例患者，年龄为75 +/- 9岁; 65%的患者为男性。CHA（2）DS（2）-VASc和HAS-BLED评分分别为4.2 +/- 1.6和3.3 +/- 1.1。83%的患者有抗凝（OAC）禁忌症; 72%的患者有大出血史。99%的病例成功植入AMPLATZER Amulet左心耳封堵器。植入后1 - 3个月的经食管超声心动图显示无残余血流或血流80%，特别是接受阿司匹林单药治疗的患者，似乎没有更高的器械相关血栓风险。第一年，大出血的年发生率为10.3%。一年内全因死亡率为8.4%.Conclusions：在卒中和出血高危患者的全球前瞻性Amulet登记研究中，年缺血性卒中发生率为2.9%。1 - 3个月后，98.4%的左心耳被凝闭，在1.7%的病例中观察到器械相关血栓，只有少数患者接受抗凝治疗。
Aims: 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.Methods and results: A total of 1,088 patients were recruited, aged 75 +/- 9 years; 65% of patients were male. The CHA(2)DS(2)-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 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.Conclusions: 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.