Author + information
- Received November 2, 2017
- Revision received December 27, 2017
- Accepted January 26, 2018
- Published online April 2, 2018.
- Laurent Fauchier, MDa,∗ (, )
- Alexandre Cinaud, MDa,
- François Brigadeau, MDb,
- Antoine Lepillier, MDc,
- Bertrand Pierre, MDa,
- Selim Abbey, MDd,
- Marjaneh Fatemi, MDe,
- Frederic Franceschi, MDf,
- Paul Guedeney, MDg,
- Peggy Jacon, MDh,
- Olivier Paziaud, MDc,
- Sandrine Venier, MDh,
- Jean Claude Deharo, MDf,
- Daniel Gras, MDd,
- Didier Klug, MDb,
- Jacques Mansourati, MDe,
- Gilles Montalescot, MDg,
- Olivier Piot, MDc and
- Pascal Defaye, MDh
- aTrousseau University Hospital, Faculty of Medicine, François Rabelais University, Tours, France
- bLille University Hospital, Lille, France
- cCardiology Center of the North, Saint Denis, France
- dNew Clinics of Nantes, Nantes, France
- eBrest University Hospital, Brest, France
- fLa Timone University Hospital, Marseille, France
- gSorbonne Paris 6 University, ACTION Study Group, Institute of Cardiology, National Institute of Health and Medical Research 1166, Institute of Cardiometabolism and Nutrition, Paris, France
- hGrenoble University Hospital, Grenoble, France
- ↵∗Address for correspondence:
Dr. Laurent Fauchier, Service de Cardiologie et Laboratoire d’Electrophysiologie Cardiaque, Centre Hospitalier Universitaire Trousseau, Avenue de la République, 37044 Tours, France.
Background Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF).
Objectives This study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure.
Methods The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017.
Results A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices [Atritech, Boston Scientific, Natick, Massachusetts] and 197 Amplatzer devices [St. Jude Medical, Minneapolis, Minnesota]). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio [HR]: 1.07 per 1-year increase; 95% confidence interval [CI]: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up.
Conclusions Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406)
- antithrombotic therapy
- thrombus on device
- transesophageal echocardiography
- transient ischemic attack
Dr. Deharo has received research grants from Abbott and Boston Scientific. Dr. Defaye has received research grants from or served as a consultant for Boston Scientific, Abbott, Medtronic, and Livanova. Dr. Fauchier has served as a consultant or speaker for Bayer, Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, Medtronic, and Novartis; and has served as a consultant for Boston Scientific, St. Jude Medical, Biotronik, and Medtronic. Dr. Klug has served as a consultant for Boston Scientific and St. Jude Medical. Dr. Guedeney has received research grants from the Fédération Française de Cardiologie and the ACTION Coeur Group. Dr. Jacon has received research grants from or served as a consultant for Boston Scientific, Abbott, Medtronic, and Livanova. Dr. Montalescot has received research grants to the institution or consulting or lecture fees from ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie AG, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham and Women’s Hospital, Cardiovascular Research Foundation, Celladon, CME Resources, Daiichi-Sankyo, Eli Lilly, Europa, Elsevier, Fédération Française de Cardiologie, Fondazione Anna Maria Sechi per il Cuore, Gilead, ICAN, Janssen, Lead-Up, Menarini, Medtronic, MSD, Pfizer, and Sanofi, The Medicines Company, TIMI Study Group, and WebMD. Dr. Mansourati has received research and expertise fees from Abbott and Boston Scientific. Dr. Paziaud has received a research grant from Abbott; and has served as a consultant for Boston Scientific. Dr. Piot has received a research contract and hospitality from Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 2, 2017.
- Revision received December 27, 2017.
- Accepted January 26, 2018.
- 2018 American College of Cardiology Foundation