Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events
Authors: Teiger Emmanuel , Thambo Jean-Benoit , Defaye Pascal , Hermida Jean-Sylvain , Abbey Sélim , Klug Didier , Juliard Jean-Michel , Pasquie Jean-Luc , Rioufol Gilles , Lepillier Antoine , Elbaz Meyer , Horvilleur Jerome , Brenot Philippe , Pierre Bertrand , Le Corvoisier Philippe , Amabile Nicolas , Andronache Marian , Anselme Frederic , Armero Sebastien , Aubry Pierre , Audureau Etienne , Babuty Dominique , Bakouboula Babe , Bars Clement , Baruteau Alban-Elouen , Bille Jacques , Bonnet Jean-Louis , Brigadeau Francois , Brochet Eric , Bun Sok-Sithikun , Cailla Guillaume , Cesari Olivier , Champagnac Didier , Chevalier Philippe , Combes Nicolas , Comet Bertrand , Commeau Philippe , Dearo Jean-Claude , Dompnier Antoine , Farah Bruno , Garot Philippe , Gras Daniel , Giraudeau Cedric , Granier Mathieu , Guerin Patrice , Iriart Xavier , Jalal Zakaria , Jesel-Morel Laurence , Jeu Antoine , Kamtchueng Priscille , Lellouche Nicolas , Meneveau Nicolas , Nighoghossian Norbert , Otmani Akli , Pelliere Remy , Pillière Remy , Pons Maxime , Popovic Batric , Pujadas Pénélope , Rossi Roland , Roux Antoine , Saludas Yannick , Spaulding Christian , Statiev Victor , Ternacle Julien , Traulle Sarah , Winum Pierre-François 
Published: March 2018

Background—
Percutaneous left atrial appendage (LAA) closure is an emerging option for patients with atrial fibrillation at high risk for cerebrovascular events. The multicenter FLAAC registry (French Nationwide Observational LAA Closure Registry) was established to assess LAA closure outcomes in everyday practice.

Methods and Results—

Four hundred thirty-six patients referred from April 2013 to September 2015 to 33 French interventional cardiology centers for percutaneous LAA closure were included prospectively in the FLAAC registry. Mean age was 75.4±0.4 years. The stroke risk was high (mean CHA
2
DS
2
–VASc score, 4.5±0.1) and most patients had experienced clinically significant bleeding (HAS-BLED score, 3.1±0.05). The device used was Amplatzer LAA occluder in 58% and the Watchman device in 42% of the patients. The procedural success rate was 98.4%. Median postprocedure follow-up was 12.0 (11.8–12.0) months and a single patient was lost to follow-up. During the periprocedural and subsequent follow-up period, procedure-related severe adverse events occurred in 21 (4.9%) and 10 (2.3%) patients, respectively. One-year cumulative incidences of ischemic stroke and cerebral hemorrhage were 2.9% (1.6–5.0) and 1.5% (0.7–3.2), respectively. Overall, 1-year mortality was 9.3% (6.9–12.5) with 7 of the 39 deaths related or possibly related to the device or procedure.

Conclusions—
This nationwide prospective registry shows that, in the French population, LAA closure is mainly used in patients with high comorbidity rates and a poor prognosis. LAA closure in such patients seems reasonable to decrease the stroke rate. The overall health status of these patients should be taken into account during the preprocedural evaluation process.

Clinical Trial Registration—

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT02252861.