Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry. (February 2022)

• Record Type: Journal Article
• 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.;
• Is Part Of: IJC heart & vasculature. Volume 38(2022)
• Publication Date: 2022-02
• Subjects: ICE intracardiac echocardiography -- LAA left atrial appendage -- LAAO left atrial appendage occlusion -- OAC oral anticoagulation -- TEE transesophageal echocardiography; Atrial fibrillation -- Left atrial appendage occlusion -- Devices -- Outcomes; Cardiovascular system -- Diseases -- Periodicals; Cardiovascular system -- Pathophysiology -- Periodicals; 616.1005
• DOI: 10.1016/j.ijcha.2021.100941
• Languages: English
• ISSNs: 2352-9067

Abstract

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), CHA2 DS2 -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.