Interventional closure of the left atrial appendage for stroke prevention - experience from a high volume center

Abstract

Purpose: Since the PROTECT AF study was published, Left atrial appendage (LAA) closure is an alternative therapy for stroke prevention in AF. However, real-world and long term efficacy and safety have yet to be investigated. Therefore the aim of the present study was to evaluate procedure outcomes in clinical routine at a high volume center. Method: 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 LAA was sealed successfully at 45-day, oral anticoagulant (OAC) or dual antiplatelets was discontinued while aspirin was continued lifelong. 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). Successful implantation rate was 98.9%, whereas 2 were not implanted due to anatomical reason. There was no procedure related death, myocardial infarction and systemic thromboembolization. Two cardiac tamponade were occurred. One patient showed a possibility of TIA. Three device embolizations were occurred shortly after procedure. As minor complication, pericardial effusion was recognized in 2 patients and air embolization was occurred in 3 patients. Intracardiac thrombus was developed during procedure in 3 patients. Five puncture site complication were reported. Overall procedure related complication rate was 10.6% (major: 3.3%, minor: 7.3%). At 45-day follow up, 99.4% of the patients showed successful sealing of LAA and 94.6% of the patients discontinued OAC. The patient who had thrombus on the device (4.2%) or with another underlying disease remained on OAC. One patient was diagnosed as TIA at 27-day after procedure (TIA rate: 0.11 (0.02-0.80)). There were no occurrence of stroke, major bleeding and death. Minor bleedings were reported in 3 patients ((bleeding rate: 0.24 (0.08-0.76)). At 6-month follow up, 1 patient died with cardiac decompensation (device unrelated) and TIA was occurred in 1 patient during this period (TIA rate: 0.12 (0.02-0.91)). Minor bleeding was occurred in 2 patients (bleeding rate: 0.28 (0.09-0.87)). Thrombus on the device was disappeared in 5 patients (71.4%) and no other de novo thrombus were documented. Conclusion: LAA closure in a high volume center is safe and feasible. Despite an over all procedure related complication rate of 10.6%, life threatening complications are rare. We could discontinuate OAC 45-day after implantation safely.