PO-671-07 SAFETY OF AMULET LAA OCCLUDER AND WATCHMAN DEVICE FOR LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH ATRIAL FIBRILLATION

Abstract

Left atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure with Amplatzer Amulet LAA Occluder and Watchman Device being the most used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in in the safety profile of the Amplatzer Amulet LAA occluder device in comparison to Watchman device. The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA occluder and Watchman device. Patients who underwent LAA closure using Watchman or Amulet devices from July 2015 to August 2020 at the American University of Beirut Medical Center were included in the analysis. Primary endpoints included peri-operative and post procedural complications (thromboembolic events, bleeding complications, vascular access complications, pericardial effusion/tamponade, device positional complications and in-hospital death). The study included 37 patients (21 had Watchman devices, 16 had Amplatzer Amulet LAA occluder devices, 28 were men, mean age 76.57 +/- 9.3 years).Seven patients who developed post-procedural iatrogenic atrial septal defects (4 in the Watchman group vs 3 in the Amulet group, p-value= 0.982).Three patients developed pericardial effusion (1 in the Watchman vs 2 in the Amulet group, p- value = 0.394). Only one patient developed peri-device leak (1 in the Watchman group vs none in the Amulet group, p-value =0.283).One device could not be deployed (1 in the Amulet group vs none in the Watchman group, p-value= 0.191).None of the patients developed in-hospital death, cardiac tamponade, device embolism, device thrombosis, stroke/TIA, cranial bleeding, or arrhythmias after the procedure. The rate of peri-operative complications was similar between both groups.Both groups displayed low rates of adverse events in the peri-operative and post-operative period. There was no significant difference in the safety profile of Amplatzer Amulet LAA occluders and Watchman devices. There was a low incidence of peri-operative and post-operative adverse events with the implanted devices.