Abstract

Introduction: Percutaneous left atrial appendage (LAA) closure is an emerging alternative intervention for anticoagulant treatment in patients with atrial fibrillation and high risk of cerebrovascular events. Only few data are available on the prognosis of patients treated with this new interventional strategy. Hypothesis: The aim of the multicenter prospective French national LAA Closure registry (FLAAC) was to report the results of this procedure in daily practice in France. Methods: Patients referred from October 2013 to September 2015 to 36 French centers for percutaneous LAA closure were prospectively included in this observational registry. We report here the results of the 436 first patients with one year follow-up. Results: The mean (±SEM) age of the study population was 75.5 ± 0.4 years and 62.2 percent were men. Their average CHA 2 DS 2 -VASc and HAS-BLED scores were 4.5 ± 0.1 and 3.1 ± 0.1, respectively. Fifty-height percent of patients were treated with an Amplatzer ™ LAA Occluder and 42% with a Watchman ™ device. LAA closure was successful in 98.4% of patients (including 9 patients requiring two procedures with a different device). The mean follow-up period was 12.7 ± 0.2 months after implantation of the device and only one patient was lost to follow-up. In patients with successful device implantation, ischemic stroke and cerebral hemorrhage rates were 0.22 and 0.11% per month during the follow-up period. The survival rate was 91.1% (38 deaths/429), with 7 (1.6 %) deaths related or possibly related to the device or to the procedure. Other causes of death were cerebral ischemic and hemorrhagic events (0.2% and 0.7%, respectively), major non-cerebral hemorrhagic events (0.7%), known or suspected cardiovascular diseases (2.3 %) and other preexisting non-cardiovascular comorbidities (3.3%). Conclusion: In conclusion, this national prospective registry shows that LAA closure is mainly used in patients with very high risk of cerebrovascular events. In this population, this procedure appears to be a reasonable option in daily practice. The high percentage of deaths related to comorbidities suggests that patient global clinical status should also be evaluated to assess patient eligibility before the procedure.

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