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

Autor:	Cruz-González I; Cardiology Department, University Hospital of Salamanca, Institute of Biomedical Research of Salamanca, Spain.; Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Madrid, Spain., Torres Saura F; Interventional Cardiology Unit, University Hospital del Vinalopó, Elche, Spain., Trejo-Velasco B; Cardiology Department, University Hospital of Salamanca, Institute of Biomedical Research of Salamanca, Spain., Antonio Fernández Díaz J; Interventional Cardiology Unit, University Hospital Puerta de Hierro, Madrid, Spain., Fajardo Molina R; Cardiology Department, University Hospital Torrecárdenas, Almería, Spain., Del Valle-Fernández R; Cardiology Department, University Hospital Central de Asturias, Oviedo, Spain., Moreno Terribas G; Interventional Cardiology Unit, Cardiology Department, University Hospital Clinico San Cecilio Granada, Spain.; Medical School, University of Granada, Spain., Martí Sánchez D; Cardiology Department, Hospital Central de la Defensa, Madrid, Spain.; Medical School, University of Alcalá, Madrid, Spain., López-Mínguez JR; Cardiology Department, Infanta Cristina University Hospital of Badajoz, Spain.; Medical School, University of Extremadura, Badajoz, Spain., Gomez-Blazquez I; Cardiology Department, University Hospital 12 de Octubre, Madrid, Spain., Sanmartin Pena JC; Cardiology Department, Clinic University Hospital of Santiago, Santiago de Compostela, Spain., Botas J; Cardiology Department, University Hospital Fundación Alcorcón, Madrid, Spain.; Rey Juan Carlos University School of Medicine, Madrid, Spain., Martin Lorenzo P; Interventional Cardiology Unit, Cardiology Department, University Hospital of Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain., Palazuelos J; Cardiology Department, Hospital La Luz, Madrid, Spain., Albarrán Rincon R; Cardiology and Cardiac Surgery Department, University Clinic of Navarra, Pamplona, Spain., Mohandes M; Interventional Cardiology Unit, Joan XXIII University Hospital, Tarragona, Spain., Rodriguez Entem FJ; Cardiology Department, University Hospital Marqués de Valdecilla, Santander, Spain., Martí G; Cardiology Department, University Hospital Vall d́Hebron, Barcelona, Spain., Valero E; Cardiology Department, Clinic University Hospital of Valencia, Valencia, Spain., Gutiérrez H; Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Madrid, Spain.; Cardiology Department, Clinic University Hospital of Valladolid, Spain., Amat-Santos IJ; Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Madrid, Spain.; Cardiology Department, Clinic University Hospital of Valladolid, Spain., Nombela-Franco L; Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain., Salinas P; Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain., Teruel L; Cardiology Department, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain., Gomez-Hospital JA; Cardiology Department, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain., Arzamendi D; Cardiology Department, University Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Torres Sanabria M; Cardiology Department, University Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Calle Pérez G; Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain., Cañadas Pruaño D; Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain., Pérez de Prado A; Cardiology Department, University Hospital of León, Leon, Spain., Benito González T; Cardiology Department, University Hospital of León, Leon, Spain., Arroyo-Úcar E; Interventional Cardiology Unit, University Hospital del Vinalopó, Elche, Spain., Estévez-Loureiro R; Interventional Cardiology Unit, University Hospital Álvaro Cunqueiro, Vigo, Spain., Caneiro-Queija B; Interventional Cardiology Unit, University Hospital Álvaro Cunqueiro, Vigo, Spain., Ibañez Criado JL; Cardiology Department, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante, Spain., Ruiz-Nodar JM; Cardiology Department, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante, Spain.; Facultad de Medicina, Universidad Miguel Hernández, Sant Joan, Alicante, Spain.
Jazyk:	angličtina
Zdroj:	International journal of cardiology. Heart & vasculature [Int J Cardiol Heart Vasc] 2021 Dec 29; Vol. 38, pp. 100941. Date of Electronic Publication: 2021 Dec 29 (Print Publication: 2022).
DOI:	10.1016/j.ijcha.2021.100941
Abstrakt:	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), CHA 2 DS 2 -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. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2021 Published by Elsevier B.V.)
Databáze:	MEDLINE
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