Abstract

ABSTRACT Background: To study the safety and efficacy of percutaneous left atrial appendage closure (LAAC) in combination with transcatheter aortic valve replacement (TAVR) as treatment option for patients with severe aortic stenosis (AS), atrial fibrillation (AF) and high bleeding risk. Methods: During a 14-month period, 308 patients underwent TAVR. Of these, 118 patients (38%) were known to have AF and 20 patients with a high bleeding risk were treated with LAAC (TAVR + LAAC group) vs. 98 patients who were continued on medical therapy for stroke prevention (TAVR + medical group). In case of combined TAVR + LAAC, TAVR was performed first, followed by LAAC 4−10 days later. Clinical 1-year follow-up data were available for all patients. In the TAVR + LAAC group, both TAVR and LAAC procedures were performed successfully without any major procedural complication. Following LAAC, all patients, except one, received double anti-platelet therapy (DAPT) for a period of 3 months, followed by single anti-platelet therapy (SAPT). Results: At 1-year follow-up, there were no reports of stroke, thromboembolism (TE) or major bleeding in the TAVR + LAAC population, whereas in the TAVR + (N)OAC group, a stroke/TE was reported in four patients (5%; p = 0.236) and a major bleeding was noted in eight patients (10%; p = 0.036). Conclusions: Treatment of patients with severe AS, AF, and a high bleeding risk with combined TAVR and LAAC is feasible and safe with no procedural complications. Medium-term safety and efficacy outcomes are promising. Large-scale studies and longer-term follow-up are warranted to confirm these findings.

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