Prospective multicenter observational cohort of 1,660 patients with non-valvular atrial fibrillation undergoing stand-alone left atrial appendage occlusion (LAAO) at 16 European centres between 2010 and 2024. Median age 76 years (IQR 70-81); 38% women; median CHA2DS2-VASc 4. Indication was significant bleeding in 83.7% — most often on DOAC (68.8%) and less often VKAs (24.9%); main bleeding sites were lower (27.9%) and upper (21.7%) GI tract, with 17.4% history of haemorrhagic stroke. Technical success 95.5% (limited mainly by residual leak 2.2% and tamponade 1.4%); procedural success 90.5% (vascular complications 3.7%, periprocedural death 1.1%). Results were comparable across devices. Virtually all patients received dual antiplatelet therapy post-procedure.
The balance between thromboembolic complications and bleeding risk in anticoagulated patients with atrial fibrillation remains challenging, with left atrial appendage occlusion (LAAO) representing a potential alternative. Our prospective multicenter study aimed to evaluate the feasibility, safety, technical, and procedural outcomes of the contemporary practice of stand-alone LAAO.
The SALAMANDER (Stand-Alone Left Atrial Appendage Occlusion for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation Disease) registry is a real-world, multicenter, observational cohort study conducted at 16 cardiac centers in Europe between 2010 and 2024, evaluating the safety and efficacy of LAAO using contemporary devices.
A total of 1660 patients were enrolled, with a median age of 76 (interquartile range, 70-81) years and 38% being women. The median CHA2DS2-VASc score was 4 (interquartile range, 3-5). The most common indication for LAAO was significant bleeding (83.7% of patients), most frequently during treatment with direct oral anticoagulants (68.8%) more than vitamin K antagonists (24.9%). The predominant bleeding sites were the lower (27.9%) and upper (21.7%) gastrointestinal tracts, with 17.4% having a history of hemorrhagic stroke. The most common antithrombotic regimen before the procedure was direct oral anticoagulants (48.9%), while postprocedural therapy most often included dual antiplatelet therapy (50%). The technical success rate was 95.5%, with residual leak (2.2%) and tamponade (1.4%) as the main causes of failure. Procedural success was 90.5%, most often limited by vascular complications (3.7%), periprocedural death (1.1%), and major bleeding (0.7%). Technical and procedural success rates did not differ significantly between the devices used.
In this large prospective cohort, technical and procedural success rates were similar across all LAAO devices, suggesting comparable safety and efficacy. Postprocedural therapy typically involves dual antiplatelet therapy, with all patients requiring some pharmacological treatment. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05144958.
