Interventional left atrial appendage occlusion is effective and safe in high-risk patients with prior stroke: comprehensive insights from the multicenter German LAARGE registry

Abstract

Abstract Background Interventional left atrial appendage occlusion (LAAO) is an alternative therapeutic strategy equivalent to non-vitamin K antagonist oral anticoagulation (OAC) in preventing thromboembolism (TE) for non-valvular atrial fibrillation (AF) patients with contraindications to OAC. However, patients with prior stroke are at relevant higher risk for TE than general patient populations. These patients are often prone to multimorbidity, are at high risk for bleeding, and may well benefit from LAAO. Purpose To investigate the performance of LAAO in secondary prevention after prior stroke versus patients without history of stroke and to reveal any potential differences in effectiveness and safety. Methods Data from multicenter German LAARGE was used, which is a prospective, non-randomized registry on clinical reality of LAAO with different standard commercial devices. Effectiveness was primarily assessed by the combined absence of all-cause death or non-fatal stroke within 365 days after the procedure, and secondarily by the absence of transient ischemic attack (TIA) or systemic embolism. Safety was assessed with data documenting adverse events during index hospitalization or follow-up. Results 638 patients from 38 centers were consecutively included. 137 patients had a history of stroke (21.5%) and 501 patients had none. Stroke patients had a significantly pronounced cardiovascular comorbidity: CHA2DS2-VASc score 5.9+1.3 vs. 4.1+1.4 and HAS-BLED score 4.6+1.0 vs. 3.7+1.1, respectively (each p<0.001). A high procedural success (98.5 vs. 97.4%, p=NS) was accompanied by low periprocedural MACCE or major complication rates (0% vs. 0.6 and 4.4 vs. 4.0%, respectively; each p=NS). Primary effectiveness outcome measure was not statistically different between both groups on follow-up (freedom from all-cause death or non-fatal stroke: 87.8 vs. 87.7%), while TIA (0 vs. 0.5%), systemic embolism (0.9 vs. 0%) as well as severe bleeding events (0 vs. 0.7%; each p=NS) were extremely rare. Conclusions Patients with history of stroke, though showing significantly pronounced multimorbidity, demonstrated a similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC in this selected group of high-risk AF patients with contraindications to standard care.All-cause death or non-fatal stroke (KM)