1. LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.
- Author
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Ansari U, Brachmann J, Lewalter T, Zeymer U, Sievert H, Ledwoch J, Geist V, Hochadel M, Schneider S, Senges J, Akin I, and Fastner C
- Subjects
- Humans, Male, Female, Germany epidemiology, Aged, Prospective Studies, Treatment Outcome, Risk Factors, Aged, 80 and over, Secondary Prevention methods, Thromboembolism prevention & control, Thromboembolism etiology, Thromboembolism epidemiology, Follow-Up Studies, Cardiac Catheterization methods, Recurrence, Middle Aged, Atrial Fibrillation complications, Registries, Atrial Appendage surgery, Stroke prevention & control, Stroke etiology, Stroke epidemiology
- Abstract
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., Gov Identifier: NCT02230748., (© 2024. The Author(s).)
- Published
- 2024
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