Primary Results of the SALAMANDER Registry: A Multicenter Observational Cohort Study

Background 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. Methods 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. Results A total of 1660 patients were enrolled, with a median age of 76 (interquartile range, 70–81) years and 38% being women. The median CHA 2 DS 2 ‐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. Conclusions 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.

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Journal
Journal of the American Heart Association
Published
2026-05-14
DOI
https://doi.org/10.1161/jaha.125.046625
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
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article

Primary Results of the SALAMANDER Registry: A Multicenter Observational Cohort Study

Łukasz Lewicki, Marco Franzino, Marian Burysz, Piotr Suwalski et al.
Journal of the American Heart Association
Atrial Fibrillation Management and Outcomes
article

Primary Results of the SALAMANDER Registry: A Multicenter Observational Cohort Study

Łukasz Lewicki, Marco Franzino, Marian Burysz, Piotr Suwalski, Joanna Grygier, Anna Kurasz, Wiktor Kuliczkowski, Piotr Niezgoda, Paweł Kralisz, Grzegorz Smołka, Giorgio Benatti, Marek Grygier, Claudio Sanfilippo, Ewa Gaszewska-Żurek, Jerzy Sacha, J Jeske, Luigi Vignali, Brunon Tomasiewicz, Radosław Gocoł, Radosław Litwinowicz, Carmelo Grasso, Tomasz Mazurek, Federico Barocelli, Zbigniew F. Kalarus, Zenon Huczek, Krystian Wita, Piotr Drewla, Michał Święczkowski, Rafał Gałąska, Tomasz Bochenek, Krzysztof Bartuś, Krzysztof Struniawski, Mario Iannacone, Sławomir Dobrzycki, Sylwia Iwanczyk, P Scislo, J D Kasprzak, A Kaplon-Cieslicka, F D A D'ascenzo, F Bruno, Filippo L. GURGOGLIONE, Marco Frazzetto, Piotr Waciński, Michał Lelek, Fabrizio Ugo, Jacek Kubica, Mariusz Kowalewski, Klaudia Kowalska, Bernardo Cortese, Gregory Y.H. Lip, Dawid Miśkowiec, Wojciech Wańha, Davide Capodanno, Wojciech Wojakowski, Ovidio de Filippo, Adam Sukiennik, Marta Chamera, Facehauwe Mezque, Łukasz Kuźma, Maksymilian Mielczarek
article en

Abstract

Background 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. Methods 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. Results A total of 1660 patients were enrolled, with a median age of 76 (interquartile range, 70–81) years and 38% being women. The median CHA 2 DS 2 ‐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. Conclusions 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.

Journal of the American Heart Association
Opole University of Technology (PL), Poznan University of Medical Sciences (PL), Medical University of Lublin (PL), Ministry of Internal Affairs of the Republic of Tajikistan (TJ), Bydgoszcz University of Science and Technology (PL), Academy for Educational Development (US), Medical University of Białystok (PL), University of Liverpool (GB), Medical University of Silesia (PL), Medical University of Warsaw (PL), Maastricht University Medical Centre (NL), Pulmonary Vascular Research Institute (GB), Nicolaus Copernicus University (PL), Wroclaw Medical University (PL), University of Catania (IT), Liverpool Heart and Chest Hospital (GB), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Faculty (United Kingdom) (GB), John Paul II Hospital (PL), Regional Health (US), Service Public Fédéral Intérieur (BE), University Hospitals Parma Medical Center (US), Ospedale San Giovanni Bosco (IT), Medical University of Lodz (PL), Center for Vascular Biology Research (US), Innovative Research (United States) (US), University of Turin (IT), Liverpool John Moores University (GB), Gdańsk Medical University (PL), Aalborg University (DK)
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Atrial Fibrillation Management and Outcomes
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