Safety and efficacy of catheter-based left atrial appendage closure in patients with contraindications for long-term anticoagulation.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) and the role of postinterventional anticoagulation often evokes controversy in daily practice. This study aimed to evaluate LAAC in patients with non-rheumatic atrial fibrillation, high thromboembolic risk and contraindications for long-term anticoagulation in a clinical scenario. METHODS: Between 2010-2015, LAAC was attempted in 118 patients (47 women). RESULTS: Devices were successfully implanted in 95% (Watchman™ device: N.=97; Amplatzer™ Cardiac Plug/Amulet: N.=14; Amplatzer PFO Occluder: N.=1). Mean age was 75±8.35 years. Mean HAS-BLED and CHA2DS2VASc scores were 4.3 and 4.9, respectively. Median follow-up was 447 days (IQR: 183-789 days). The primary safety endpoint was defined as major bleeding according to the International Society on Thrombosis and Hemostasis. The combined efficacy endpoint included ischemic strokes, transitory ischemic attacks (TIA) and systemic embolisms. Procedural complication rate was 3.4%. After successful intervention, either a therapy with anticoagulants (N.=62) or dual antiplatelet therapy (DAPT, N.=50) was prescribed temporarily. Medication was reduced if implantation proved satisfying in a 6-week follow-up transesophageal echocardiography, which was the case in 79% of these patients. During follow-up, one patient suffered a TIA (0.6%/year). No other efficacy event was observed. Eleven major bleedings occurred (6.6%/year): one each under DAPT plus phenprocoumon, DAPT plus rivaroxaban, acetylsalicylic acid (ASA) plus rivaroxaban, two under DAPT, two under ASA plus low molecular weight heparin, and four under ASA only. CONCLUSIONS: In the present study, catheter-based LAA occlusion prevented thromboembolisms with high efficacy. Major bleedings were however common in patients with, but also without anticoagulation, independent from time course.