Department of Cardiology, Henri Mondor University Hospital, AP-HP, Creteil, France.
Department of Pediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, France.
Catheter Cardiovasc Interv. 2021 Oct;98(4):788-799. doi: 10.1002/ccd.29795. Epub 2021 May 29.
The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice.
LAA closure has emerged as an alternative for preventing thromboembolic events (TE) in patients with non-valvular atrial fibrillation (NVAF). Clinical data in this field remains limited and few investigator-initiated, real-world registries have been reported.
This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure.
The FLAAC registry included 816 patients with a mean age of 75.5 ± 0.3 years, mean follow-up of 16.0 ± 0.3 months, high TE (CHA DS -VASc score: 4.6 ± 0.1) and bleeding risks (HAS-BLED score: 3.2 ± 0.05) and common contraindications to long-term anticoagulation (95.7%). Procedure or device-related serious adverse events occurred in 49 (6.0%) patients. The annual rate of ischemic stroke/systemic embolism was 3.3% (2.4-4.6). This suggests a relative 57% reduction compared to the risk of stroke in historical NVAF populations without antithrombotic therapy. By multivariate analysis, history of TE was the only factor associated with stroke/systemic embolism during follow-up (HR, 3.3 [1.58-6.89], p = 0.001). The annual mortality rate was 10.2% (8.4-12.3). Most of the deaths were due to comorbidities or underlying cardiovascular diseases and unrelated to the device or to TE.
Our study suggests that LAA closure can be an option in patients with NVAF. Long-term follow-up mortality was high, mostly due to comorbidities and underlying cardiovascular diseases, highlighting the importance of multidisciplinary management after LAA closure.
NCT02252861.
法国左心耳（LAA）封堵注册研究（FLAAC）旨在评估 LAA 封堵在日常实践中的安全性和有效性。
LAA 封堵已成为预防非瓣膜性心房颤动（NVAF）患者血栓栓塞事件（TE）的一种替代方法。该领域的临床数据仍然有限，仅有少数由研究者发起的真实世界注册研究报告。
这是一项在法国 36 个中心进行的全国性前瞻性研究。主要终点是成功 LAA 封堵后的 TE 发生率。
FLAAC 注册研究纳入 816 例患者，平均年龄 75.5±0.3 岁，平均随访 16.0±0.3 个月，TE（CHA2DS2-VASc 评分：4.6±0.1）和出血风险（HAS-BLED 评分：3.2±0.05）较高，且存在常见的长期抗凝禁忌证（95.7%）。49 例（6.0%）患者发生与操作或器械相关的严重不良事件。缺血性卒中和全身性栓塞的年发生率为 3.3%（2.4-4.6）。这表明与无抗血栓治疗的历史 NVAF 人群相比，风险降低了 57%。多变量分析显示，TE 史是随访期间发生卒中和全身性栓塞的唯一相关因素（HR，3.3[1.58-6.89]，p=0.001）。年死亡率为 10.2%（8.4-12.3）。大多数死亡是由于合并症或基础心血管疾病导致，与器械或 TE 无关。
我们的研究表明，LAA 封堵可作为 NVAF 患者的一种选择。长期随访死亡率较高，主要是由于合并症和基础心血管疾病，这突出了 LAA 封堵后多学科管理的重要性。
NCT02252861。
