Long-term Event Reduction After Left Atrial Appendage Closure. Results of the Iberian Registry II

Abstract Introduction and objectives Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. Methods Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA 2 DS 2 -VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. Results A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA 2 DS 2 -VASc; P P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). Conclusions Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality.