Title of presented paper: Comparison of adverse effects associated with left atrial appendage closure between LARIAT and AtriClip device based on MAUDE database.

Introduction and aim. Left atrial appendage closure (LAAC) is an alternative treatment method to reduce the risk of thromboembolism. Epicardial closure can be performed with LARIAT devices or with AtriClip devices. Manufacturer and User Facility Device Experience (MAUDE) database contains device reports submitted to the U.S. Food and Drug Administration (FDA) by mandatory reporters. The aim of this study was to evaluate and compare the adverse effects of epicardial LAAC between LARIAT and AtriClip device based on MAUDE. Material and methods. Two independent researchers queried the MAUDE to obtain LARIAT and AtriClip device reports from July 2012 to July 2022. Records were included according to study protocol. Results. 460 reports were obtained from the MAUDE database. 287 studies were included. Problem with device occurred in 46.8% of reports for LARIAT (29/62) vs. 67.1% for AtriClip (151/225) (p<0.001). It coexisted with patient complications in 100.0% of cases with device problem in LARIAT (29/29) vs. 14.6% in AtriClip (22/151) (p<0.001). Pericardial effusion and hemorrhage appeared more often in LARIAT group (43.5% vs. 2.2%, p<0.001, 45.2% vs. 14.4%, p<0.001, respectively). Stroke occurred in AtriClip group more often (0.0% vs. 7.8%, p=0.042). Left atrial appendage (LAA) and right ventricle (RV) were perforated more often during LARIAT procedure (80.0% vs. 31.6%, p<0.001, 16.0% vs. 0.0%, p=0.021). Conclusion. Adverse effects of the procedure with the usage of two different devices differ significantly. Patients who undergo LARIAT procedure are more prone to pericardial effusion and hemorrhage, as well as LAA and RV perforation. [ABSTRACT FROM AUTHOR]