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

Ignacio Cruz-González; Francisco Torres Saura; Blanca Trejo-Velasco; José Antonio Fernández Díaz; Ricardo Fajardo Molina; Raquel Del Valle-Fernández; Gerardo Moreno Terribas; David Martí Sánchez; José-Ramón López-Mínguez; Ivan Gomez-Blazquez; Juan-Carlos Sanmartin Pena; Javier Botas; Pedro Martin Lorenzo; Jorge Palazuelos; Ramón Albarrán Rincon; Mohsen Mohandes; Felipe-Jose Rodriguez Entem; Gerard Martí; Ernesto Valero; Hipólito Gutiérrez; Ignacio J Amat-Santos; Luis Nombela-Franco; Pablo Salinas; Luis Teruel; Joan-Antoni Gomez-Hospital; Dabit Arzamendi; Mario Torres Sanabria; Germán Calle Pérez; Dolores Cañadas Pruaño; Armando Pérez de Prado; Tomás Benito González; Eduardo Arroyo-Úcar; Rodrigo Estévez-Loureiro; Berenice Caneiro-Queija; Jose L Ibañez Criado; Juan M Ruiz-Nodar

doi:10.1016/j.ijcha.2021.100941

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

Int J Cardiol Heart Vasc. 2021 Dec 29:38:100941. doi: 10.1016/j.ijcha.2021.100941. eCollection 2022 Feb.

Authors

Ignacio Cruz-González^{1

2}, Francisco Torres Saura³, Blanca Trejo-Velasco¹, José Antonio Fernández Díaz⁴, Ricardo Fajardo Molina⁵, Raquel Del Valle-Fernández⁶, Gerardo Moreno Terribas^{7

8}, David Martí Sánchez^{9

10}, José-Ramón López-Mínguez^{11

12}, Ivan Gomez-Blazquez¹³, Juan-Carlos Sanmartin Pena¹⁴, Javier Botas^{15

16}, Pedro Martin Lorenzo¹⁷, Jorge Palazuelos¹⁸, Ramón Albarrán Rincon¹⁹, Mohsen Mohandes²⁰, Felipe-Jose Rodriguez Entem²¹, Gerard Martí²², Ernesto Valero²³, Hipólito Gutiérrez^{2

24}, Ignacio J Amat-Santos^{2

24}, Luis Nombela-Franco²⁵, Pablo Salinas²⁵, Luis Teruel²⁶, Joan-Antoni Gomez-Hospital²⁶, Dabit Arzamendi²⁷, Mario Torres Sanabria²⁷, Germán Calle Pérez²⁸, Dolores Cañadas Pruaño²⁸, Armando Pérez de Prado²⁹, Tomás Benito González²⁹, Eduardo Arroyo-Úcar³, Rodrigo Estévez-Loureiro³⁰, Berenice Caneiro-Queija³⁰, Jose L Ibañez Criado³¹, Juan M Ruiz-Nodar^{31

32}

Affiliations

¹ Cardiology Department, University Hospital of Salamanca, Institute of Biomedical Research of Salamanca, Spain.
² Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Madrid, Spain.
³ Interventional Cardiology Unit, University Hospital del Vinalopó, Elche, Spain.
⁴ Interventional Cardiology Unit, University Hospital Puerta de Hierro, Madrid, Spain.
⁵ Cardiology Department, University Hospital Torrecárdenas, Almería, Spain.
⁶ Cardiology Department, University Hospital Central de Asturias, Oviedo, Spain.
⁷ Interventional Cardiology Unit, Cardiology Department, University Hospital Clinico San Cecilio Granada, Spain.
⁸ Medical School, University of Granada, Spain.
⁹ Cardiology Department, Hospital Central de la Defensa, Madrid, Spain.
¹⁰ Medical School, University of Alcalá, Madrid, Spain.
¹¹ Cardiology Department, Infanta Cristina University Hospital of Badajoz, Spain.
¹² Medical School, University of Extremadura, Badajoz, Spain.
¹³ Cardiology Department, University Hospital 12 de Octubre, Madrid, Spain.
¹⁴ Cardiology Department, Clinic University Hospital of Santiago, Santiago de Compostela, Spain.
¹⁵ Cardiology Department, University Hospital Fundación Alcorcón, Madrid, Spain.
¹⁶ Rey Juan Carlos University School of Medicine, Madrid, Spain.
¹⁷ Interventional Cardiology Unit, Cardiology Department, University Hospital of Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Spain.
¹⁸ Cardiology Department, Hospital La Luz, Madrid, Spain.
¹⁹ Cardiology and Cardiac Surgery Department, University Clinic of Navarra, Pamplona, Spain.
²⁰ Interventional Cardiology Unit, Joan XXIII University Hospital, Tarragona, Spain.
²¹ Cardiology Department, University Hospital Marqués de Valdecilla, Santander, Spain.
²² Cardiology Department, University Hospital Vall d́Hebron, Barcelona, Spain.
²³ Cardiology Department, Clinic University Hospital of Valencia, Valencia, Spain.
²⁴ Cardiology Department, Clinic University Hospital of Valladolid, Spain.
²⁵ Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.
²⁶ Cardiology Department, Bellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
²⁷ Cardiology Department, University Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
²⁸ Cardiology Department, University Hospital Puerta del Mar, Cádiz, Spain.
²⁹ Cardiology Department, University Hospital of León, Leon, Spain.
³⁰ Interventional Cardiology Unit, University Hospital Álvaro Cunqueiro, Vigo, Spain.
³¹ Cardiology Department, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante, Spain.
³² Facultad de Medicina, Universidad Miguel Hernández, Sant Joan, Alicante, Spain.

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 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.

Keywords: Atrial fibrillation; Devices; ICE, intracardiac echocardiography; LAA, left atrial appendage; LAAO, left atrial appendage occlusion; Left atrial appendage occlusion; OAC, oral anticoagulation; Outcomes; TEE, transesophageal echocardiography.