Institut Català de la Salut
[Cruz-González I] Cardiology Department, University Hospital of Salamanca, Institute of Biomedical Research of Salamanca, Spain. Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Madrid, Spain. [Torres Saura F] Interventional Cardiology Unit, University Hospital del Vinalopó, Elche, Spain. [Trejo-Velasco B] Cardiology Department, University Hospital of Salamanca, Institute of Biomedical Research of Salamanca, Spain. [Fernández Díaz JA] Interventional Cardiology Unit, University Hospital Puerta de Hierro, Madrid, Spain. [Fajardo Molina R] Cardiology Department, University Hospital Torrecárdenas, Almería, Spain. [del Valle-Fernández R] Cardiology Department, University Hospital Central de Asturias, Oviedo, Spain. [Martí G] Servei de Cardiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2022-10-11T08:24:39Z
2022-10-11T08:24:39Z
2022-02
Left atrial appendage; Occlusion; Outcomes
Apéndice auricular izquierdo; Oclusión; Resultados
Apèndix auricular esquerre; Oclusió; Resultats
Background The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods Prospective, multicenter, “real-world” registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center’s prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted.
Article
Published version
English
Fibril·lació auricular; Malalties cerebrovasculars - Prevenció; Avaluació de resultats (Assistència sanitària); DISEASES::Cardiovascular Diseases::Heart Diseases::Arrhythmias, Cardiac::Atrial Fibrillation; ANATOMY::Cardiovascular System::Heart::Heart Atria::Atrial Appendage; DISEASES::Cardiovascular Diseases::Vascular Diseases::Cerebrovascular Disorders::Stroke; Other subheadings::Other subheadings::Other subheadings::/prevention & control; ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::arritmias cardíacas::fibrilación atrial; ANATOMÍA::sistema cardiovascular::corazón::atrios cardíacos::apéndice atrial; ENFERMEDADES::enfermedades cardiovasculares::enfermedades vasculares::trastornos cerebrovasculares::accidente cerebrovascular; Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
Elsevier
IJC Heart & Vasculature;38
https://doi.org/10.1016/j.ijcha.2021.100941
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
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