Safety and efficacy of left atrial appendage closure in routine practice in France: Results of the French Nationwide Left Atrial Appendage Closure Registry

Abstract

Left atrial appendage closure is an emerging option for the prevention of thromboembolic events in patients with atrial fibrillation and contraindication to anticoagulant agents. However, data in this field are scarce, and large registries are required to help physicians assess the risk/benefit ratio of left atrial appendage closure in such patients. The aim of the prospective, observational multicenter, FLAAC (French nationwide Left Atrial Appendage Closure) registry was to assess the clinical outcome of patients after left atrial appendage closure in routine practice in France. This study was conducted in 37 French interventional cardiology departments. The primary outcome was defined as the proportion of patients with thromboembolic events during the first year after left atrial appendage closure. Between April 2013 and September 2015, a total of 838 patients were prospectively included. The mean age of these patients was 75.4 ± 8.9 years and 63% were men. The device was successfully implanted in 98.6% of the patients. The rate of thromboembolic events one year after left atrial appendage closure was 2.5%. The all cause one-year mortality rate was 8.0%. Nine (1.1%) deaths were considered as related or possibly related to the procedure. Most of the patients died from the underlying cardiovascular disease (2.4%) or known comorbidities (3.0%), reflecting the high-risk nature of patients treated by left atrial appendage closure in routine practice. Finally, 11 (1.3%) patients died from a major bleeding event during the follow-up period. Percutaneous left atrial appendage closure is a reasonable option to decrease the thromboembolic event rate in patients with atrial fibrillation and no other option for thromboembolic risk reduction. Patients considered for left atrial appendage closure should undergo a comprehensive preprocedural assessment of frailty and comorbidities.