Long-term effect of anticoagulation following left atrial appendage occlusion with the LARIAT device in patients with nonvalvular atrial fibrillation: impact on thromboembolism, bleeding and mortality. Real life data

INTRODUCTION: Indications for left atrial appendage occlusion (LAAO) are varied and patients require individual management strategies. However, currently no guidelines exist for postprocedure oral anticoagulation (OAC) after an LAAO procedure. AIM: To evaluate the effect of OAC on thromboembolism, bleeding and mortality following the LAAO procedure for patients with AF. MATERIAL AND METHODS: One hundred and thirty-nine consecutive patients with nonvalvular atrial fibrillation (NVAF) who underwent LAAO with the LARIAT device were followed for at least 40 months. Decisions about OAC and its modifications were individualized based on clinical presentation, patient and physician preferences. RESULTS: Following LAAO, 52 (41%) patients did not receive OAC (No-OAC group) and 75 (59%) patients received OAC (OAC group), without any intergroup differences in CHADS(2), CHA(2)DS(2)-VASc score or other thromboembolic risk factors. The median HAS-BLED score was higher in the OAC-group (median 3 (3–4) vs. 3 (2–4), p = 0.014). During a median follow-up time of 51 (43–57) vs. 55 (48–59) months in the No-OAC group and in the OAC group (p = 0.19) there were no significant differences between groups in ischemic stroke/TIA, 0 (0%) vs. 2 (2.7%), other thromboembolic events, 0 (0%) vs. 1 (1.3%), life-threatening, disabling or major events, 2 (3.7%) vs. 2 (2.7%), or annual mortality rate, 1.9% vs. 0.9%, respectively. CONCLUSIONS: There is no need for OAC after the LAAO procedure. Omitting OAC after an LAAO procedure in AF patients: (1) has similar stroke prevention rates as patients on OAC, (2) has similar bleeding prevention rates as patients on OAC, (3) has similar safety endpoints and long-term efficacy as patients on OAC.