Left atrial appendage closure for stroke prevention - long term results from high volume center

Abstract

Purpose: Left atrial appendage (LAA) closure is an alternative therapy for preventing stroke in AF. In addition, ASA Plavix Study (ASAP) described effectiveness in the patients with contraindication to warfarin. However, real-world and long term outcomes have yet to be investigated. Therefore the aim of the present study was to evaluate efficacy and safety in clinical routine at a high volume center. Methods: This was an open-label non-randomized study. LAA closure was performed to 179 patients since 2009 to 2012. After implantation, patients remain on warfarin for 45-day. Patients seriously contraindicated to warfarin were under therapy with dabigatran or aspirin or clopidogrel or aspirin+clopidogrel. If TEE criteria for successful sealing of the LAA were fulfilled at 45-day, oral anticoagulant (OAC) or dual antiplatelets was discontinued while aspirin was continued lifelong. Major adverse events were defined as death, stroke, transient ischemic attack (TIA), systemic embolism, and major bleeding requiring invasive treatment or blood transfusion. Results: 179 patients (72.7±9.0 y.o., female=74) were enrolled. The mean CHADS2 score was 2.8±1.1 (CHA2DS2VASC: 4.3±1.5). The mean follow up time was 2-year (range 0.6 to 3.5-year). Successful implantation rate was 98.9% and there was no procedure related death, myocardial infarction and systemic thromboembolization. Major complication rate was 3.3% (cardiac tamponade: 2, possibility of TIA: 1, device embolization: 3). Minor complication rate was 7.3% (pericardial effusion: 2, air embolization: 3, Intracardiac thrombus: 3, puncture site complication: 5). At 45-day follow up, 99.4% of the patients showed successful sealing of LAA and 94.6% discontinued OAC. Seven patients (4.2%) had thrombus on the device and remained on OAC. The thrombus was disappeared in 5/7 patients and no other de novo thrombus was documented after 6-month. Major adverse events were reported in 10 patients (5.6%) during follow up. Two ischemic strokes and 2 TIA attacks were occurred (1.1 events per 100 patient-years). Bleedings were reported in 6 patients (1.6 events per 100 patient-years). All of 6 deaths were device unrelated (accident, cancer, cardiomyopathy, cirrhosis, pneumonia, and cardiac decompensation). Conclusion: We got a novel primary success rate and 94.6% of the patients were able to discontinue OAC safely. Stroke, TIA and bleeding rate were also content. Majority of the complications were procedure related and life threatening complications were rare. LAA closure in a high volume center is safe and feasible.