Transcatheter left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation: results from the Belgian registry

Aims: This study aimed to assess the safety and efficacy at midterm follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. Methods and results: Between June 2009 and November 2016, 457 consecutive patients (63% male, 75 +/- 12 yrs, CHA(2)DS(2)-VASc 4 +/- 0.6, HAS-BLED 3.5 +/- 0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1.9%), four major bleedings (0.8%) and two device embolisations (0.4%). Among patients successfully implanted having a complete follow-up (672 patient-years, median follow-up 370 days), the actual annual stroke rate was 1.2%, lower than the expected stroke risk of 4% (70% reduction). The observed bleeding rate was 2%, while the calculated risk was 3.7% (46% reduction). Kaplan-Meier analysis showed a similar overall survival (93 +/- 2% and 87 +/- 3% versus 91 +/- 3% and 87 +/- 4%; p=0.35) and event-free survival (92 +/- 2% and 84 +/- 3% versus 88 +/- 3% and 80 +/- 5%; p=0.17) at one and two years, for the ACP/Amulet versus the WATCHMAN groups of patients, respectively. Conclusions: The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.