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Amplatzer™ Amulet™ Occluder 观察性研究中按年龄组比较左心耳封堵术疗效和临床结局的对照数据。

Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study.

机构信息

Department of Cardiology, Hospital Clinic I Provincial de Barcelona, Barcelona, Spain.

Department of Cardiology, Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.

出版信息

Europace. 2021 Feb 5;23(2):238-246. doi: 10.1093/europace/euaa262.

DOI:10.1093/europace/euaa262
PMID:33279979
Abstract

AIMS

Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up.

METHODS AND RESULTS

We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age.

CONCLUSIONS

Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

摘要

目的

左心耳封堵术(LAAO)可考虑用于非瓣膜性心房颤动(NVAF)患者,以及存在抗凝相对/绝对禁忌证的患者。本研究旨在总结在短期和长期随访中,年龄对 LAAO 结局的影响。

方法和结果

我们比较了前瞻性、多中心 Amplatzer™ Amulet™ Occluder 观察性研究(雅培,明尼苏达州普利茅斯)中年龄<70 岁、≥70 岁且<80 岁和≥80 岁的受试者。严重不良事件(SAE)从植入后至 LAAO 后 2 年的随访期间进行报告,并由独立的临床事件委员会进行裁决。总体而言,前瞻性纳入了 1088 名受试者。其中 265 名受试者(24.4%)<70 岁,491 名受试者(45.1%)≥70 岁且<80 岁,332 名受试者(30.5%)≥80 岁,其中大多数(≥80%)患者存在抗凝禁忌证。与预期的一样,CHA2DS2-VASc 和 HAS-BLED 评分随年龄增加而增加。所有组的植入成功率均较高(≥98.5%),且各组中与手术或器械相关的 SAE 比例相似。在随访期间,各组之间观察到的缺血性卒中发生率无显著差异,与<70 岁、≥70 岁且<80 岁和≥80 岁的受试者的预测发生率相比,相应的风险降低分别为 62%、56%和 85%。大出血和死亡率随年龄增加而增加,而器械相关血栓形成的发生率随年龄增加而增加趋势。

结论

尽管 AF 患者的年龄增加使缺血性卒中的风险增加,但与所有年龄组的预测发生率相比,LAAO 降低了缺血性卒中的风险,且在手术 SAE 方面没有差异。

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