Left Atrial Appendage Closure in Patients Refusing Oral Anticoagulation: The LAAC-REFUSAL Study.

Abstract

Background: The benefit of left atrial appendage closure (LAAC) in patients refusing oral anticoagulation (OAC) despite medical recommendations is unknown. We aim to assess the efficacy and the safety of LAAC in patients refusing OAC.

Methods: Data on consecutive patients with atrial fibrillation undergoing percutaneous LAAC between 2009 and 2022 in 4 European centers were collected and patients undergoing LAAC due to refusal of OAC (refusal group) were compared with patients receiving LAAC for more established indications (control group). The primary end point of the study was the composite of cardiovascular death, stroke, or systemic embolism. The secondary end points included technical success and procedural complications. Events during follow-up were compared with those predicted by CHA2DS2VASC and hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile International Normalized Ratio, elderly, drugs/alcohol concomitantly (HASBLED) score risks.

Results: Of the 2649 patients submitted to LAAC, 119 were performed due to OAC refusal (4.5%). Two-hundred-thirty-eight (8.9%) control patients were identified. Refusal as compared with the control group included younger and lower-risk patients. At 3 years, the primary end point was significantly lower (4.2% versus 17.2%; adjusted hazard ratio: 0.37; 95% CI: 0.14-0.99; P=0.048) in the refusal in respect to the control group. Technical success and procedural complications were similar between groups. In the refusal group, the annual rate of thromboembolic events and major bleedings were 2.3% and 1.9%, respectively, corresponding to 62% and 47% risk reductions as compared with the rates expected by risk scores.

Conclusions: In this multicenter cohort of consecutive patients with atrial fibrillation submitted to LAAC, OAC refusal appeared as an infrequent indication. In this subgroup, LAAC was confirmed to be feasible and safe. The ischemic outcomes rates at 3 years are promising. Further studies are needed to better understand the potential effects of preferring LAAC over OAC.