@article{10902/25089,
year = {2022},
month = {2},
url = {http://hdl.handle.net/10902/25089},
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 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.},
organization = {Acknowledgments: We would like to express our gratitude to Jose Santaursula Pastor for the production of the figures in this work.},
publisher = {Elsevier},
publisher = {Volume 38, February 2022, 100941},
title = {Impact of operator's experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry},
author = {Cruz-González, Ignacio and Torres Saura, Francisco and Trejo-Velasco, Blanca and Fernández Díaz, José Antonio and Fajardo Molina, Ricardo and Valle-Fernández, Raquel del and Moreno Terribas, Gerardo and Martí Sánchez, David and López-Mínguez, José Ramón and Gómez-Blázquez, Iván and Sanmartín-Peña, Juan Carlos and Botas, Javier and Martín Lorenzo, Pedro and Palazuelos, Jorge and Albarrán Rinco, Ramón and Mohandes, Mohsen and Rodríguez Entem, Felipe and Martí, Gerard and Valero, Ernesto and Gutiérrez, Hipólito},
}