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Title: | Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry |
Author: | Cruz González, Ignacio Torres Saura, Francisco Trejo Velasco, Blanca Fernández Díaz, José Antonio Fajardo Molina, Ricardo Valle Fernández, Raquel del Moreno Terribas, Gerardo Martí Sánchez, David López Mínguez, José Ramón Gómez Blázquez, Iván Sanmartín Pena, Juan Carlos Botas, Javier Martín Lorenzo, Pedro Palazuelos, Jorge Albarrán Rincon, Ramón Mohandes, Mohsen Rodríguez Entem, Felipe José Martí, Gerard Valero, Ernesto Gutiérrez, Hipólito Amat Santos, Ignacio J. Nombela Franco, Luis Salinas, Pablo Teruel, Luis Gómez Hospital, Joan Antoni Arzamendi, Dabit Torres Sanabria, Mario Calle Pérez, Germán Cañadas Pruaño, Dolores Pérez de Prado, Armando Benito González, Tomás Arroyo Úcar, Eduardo Estévez Loureiro, Rodrigo Caneiro Queija, Berenice Ibañez Criado, José L. Ruiz Nodar, Juan M. |
Keywords: | Fibril·lació auricular Implants artificials Atrial fibrillation Artificial implants |
Issue Date: | 29-Dec-2021 |
Publisher: | Elsevier B.V. |
Abstract: | 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1016/j.ijcha.2021.100941 |
It is part of: | IJC Heart & Vasculature, 2021, vol. 38 |
URI: | http://hdl.handle.net/2445/182998 |
Related resource: | https://doi.org/10.1016/j.ijcha.2021.100941 |
ISSN: | 2352-9067 |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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