Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX : Insights from the FLX-SPA registry
Cruz-González, Ignacio (Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares)
Torres Saura, Francisco (Hospital Universitario del Vinalopó. Unidad de Cardiología Intervencionista)
Trejo-Velasco, Blanca (Hospital Universitario de Salamanca. Servicio de Cardiología. Instituto de Investigación Biomédica de Salamanca)
Fernández Díaz, José Antonio (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Fajardo Molina, Ricardo (Hospital Universitario Torrecárdenas. Servicio de Cardiología)
del Valle-Fernández, Raquel (Hospital Universitario Central de Asturias. Servicio de Cardiología)
Moreno Terribas, Gerardo (Universidad de Granada)
Martí Sánchez, David (Universidad de Alcalá. Facultad de Medicina y Ciencias de la Salud)
López-Mínguez, José Ramón (Universidad de Extremadura. Facultad de Medicina)
Gomez-Blazquez, Ivan (Complejo Hospitalario Universitario de Santiago de Compostela)
Sanmartin Pena, Juan-Carlos (Servicio de Cardiología. Hospital Clínico Universitario de Santiago)
Botas, Javier (Universidad Rey Juan Carlos (URJC). Facultad de Ciencias de la Salud)
Martin Lorenzo, Pedro (Hospital Universitario de Gran Canaria Dr. Negrín)
Palazuelos, Jorge (Servicio de Cardiología. Hospital La Luz)
Albarrán Rincon, Ramón (Clínica Universitaria de Navarra. Departamento de Cardiología y Cirugía Cardiaca)
Mohandes, Mohsen (Hospital Universitari Joan XXIII de Tarragona)
Rodriguez Entem, Felipe-Jose (Hospital Universitario Marqués de Valdecilla (Santander, Cantabria))
Martí, Gerard (Hospital Universitari Vall d'Hebron)
Valero, Ernesto (Hospital Clínico Universitario de Valencia. Servicio de Cardiología)
Gutiérrez, Hipólito (Hospital Clínico Universitario de Valladolid)
Amat-Santos, Ignacio J. (Hospital Clínico Universitario de Valladolid)
Nombela-Franco, Luis (Hospital Clínico San Carlos (Madrid))
Salinas, Pablo (Hospital Clínico San Carlos (Madrid))
Teruel, Luis (Institut d'Investigació Biomèdica de Bellvitge)
Gómez-Hospital, Joan-Antoni (Institut d'Investigació Biomèdica de Bellvitge)
Arzamendi, Dabit (Institut d'Investigació Biomèdica Sant Pau)
Torres Sanabria, Mario (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Calle Pérez, Germán (Hospital Universitario Puerta del Mar (Cadis, Andalusia))
Cañadas Pruaño, Dolores (Hospital Universitario Puerta del Mar (Cadis, Andalusia))
Pérez de Prado, Armando (Hospital Universitario de León. Servicio de Cardiología)
Benito-González, Tomás (Complejo Asistencial Universitario de León)
Arroyo-Úcar, Eduardo (Hospital Universitario del Vinalopó. Unidad de Cardiología Intervencionista)
Estévez-Loureiro, Rodrigo (Hospital Álvaro Cunqueiro (Vigo))
Caneiro-Queija, Berenice (Hospital Álvaro Cunqueiro (Vigo))
Ibañez Criado, José L. (Hospital General Universitario de Alicante (Alacant, País Valencià))
Ruiz-Nodar, Juan M. (Universidad Miguel Hernández de Elche. Facultad de Medicina)

Date:	2022
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), CHADS-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.
Grants:	Instituto de Salud Carlos III PI19/00658
Note:	Altres ajuts: European Regional Development Fund (ERDF), "A way to make Europe"; Gerencia Regional Salud de CyL (GRS 3031/A/19).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Atrial fibrillation ; Left atrial appendage occlusion ; Devices ; Outcomes
Published in:	International journal of cardiology. Heart & vasculature, Vol. 38 (february 2022) , p. 100941, ISSN 2352-9067

DOI: 10.1016/j.ijcha.2021.100941
PMID: 35024431

8 p, 973.3 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles