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

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, M...

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Published in:International journal of cardiology. Heart & vasculature 2022-02, Vol.38, p.100941-100941, Article 100941
Main Authors: Cruz-González, Ignacio, Torres Saura, Francisco, Trejo-Velasco, Blanca, Antonio Fernández Díaz, José, Fajardo Molina, Ricardo, del Valle-Fernández, Raquel, Moreno Terribas, Gerardo, Martí Sánchez, David, López-Mínguez, José-Ramón, Gomez-Blazquez, Ivan, Sanmartin Pena, Juan-Carlos, Botas, Javier, Martin Lorenzo, Pedro, Palazuelos, Jorge, Albarrán Rincon, Ramón, Mohandes, Mohsen, Rodriguez Entem, Felipe-Jose, Martí, Gerard, Valero, Ernesto, Gutiérrez, Hipólito, Amat-Santos, Ignacio J., Nombela-Franco, Luis, Salinas, Pablo, Teruel, Luis, Gomez-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, Jose L., Ruiz-Nodar, Juan M.
Format: Article
Language:English
Subjects:
Atrial fibrillation
Devices
Left atrial appendage occlusion
Outcomes
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Summary: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. 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. 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. 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.
ISSN:2352-9067
2352-9067
DOI:10.1016/j.ijcha.2021.100941