Impact of operator's experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

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, Mar...

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Authors: 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-Peña, Juan Carlos, Botas, Javier, Martín Lorenzo, Pedro, Palazuelos, Jorge, Albarrán Rinco, Ramón, Mohandes, Mohsen, Rodríguez Entem, Felipe, Martí, Gerard, Valero, Ernesto, Gutiérrez, Hipólito
Format: article
Publication Date:2022
Country:España
Institution:Universidad de Cantabria (UC)
Repository:UCrea Repositorio Abierto de la Universidad de Cantabria
Language:English
OAI Identifier:oai:repositorio.unican.es:10902/25089
Online Access:http://hdl.handle.net/10902/25089
Access Level:Open access
Keyword:Atrial fibrillation
Left atrial appendage occlusion
Devices
Outcomes
Description
Summary: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 cente?s 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 operato?s experience with its previous device iteration or the number of Watchman FLX devices implanted.

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