LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry

• Published in: Clinical research in cardiology 2024-10, Vol.113 (10), p.1451-1462
• Main Authors: Ansari, Uzair, Brachmann, Johannes, Lewalter, Thorsten, Zeymer, Uwe, Sievert, Horst, Ledwoch, Jakob, Geist, Volker, Hochadel, Matthias, Schneider, Steffen, Senges, Jochen, Akin, Ibrahim, Fastner, Christian
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Atrial Appendage - surgery; Atrial Fibrillation - complications; Bleeding; Cardiac arrhythmia; Cardiac Catheterization - methods; Cardiology; Effectiveness; Embolism; Female; Fibrillation; Follow-Up Studies; Germany - epidemiology; Hospitals; Humans; Ischemia; Male; Medicine; Medicine & Public Health; Middle Aged; Occlusion; Original Paper; Patients; Prospective Studies; Recurrence; Registries; Risk; Risk Factors; Risk groups; Secondary Prevention - methods; Stroke; Stroke - epidemiology; Stroke - etiology; Stroke - prevention & control; Thromboembolism; Thromboembolism - epidemiology; Thromboembolism - etiology; Thromboembolism - prevention & control; Transient ischemic attack; Treatment Outcome
• ISSN: 1861-0684; 1861-0692; 1861-0692
• DOI: 10.1007/s00392-024-02376-8

Background Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group. Aim This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke. Methods LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events. Results A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p  = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p  = NS). Kaplan–Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p  = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p  = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p  = NS). Conclusions Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients. ClinicalTrials.gov identifier NCT02230748. Graphical Abstract LAA occlusion in patients with and without prior stroke – results from the multicentre German LAARGE registry