Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry
Résumé
Objectives The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice. Background 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. Methods This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure. Results 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(2)DS(2)-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 = .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. Conclusions 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. Registration NCT02252861.