Author + information
- Received December 26, 2012
- Revision received March 13, 2013
- Accepted March 19, 2013
- Published online June 25, 2013.
- Vivek Y. Reddy, MD∗∗ (, )
- Sven Möbius-Winkler, MD†,
- Marc A. Miller, MD∗,
- Petr Neuzil, MD, PhD‡,
- Gerhard Schuler, MD†,
- Jens Wiebe, MD§,
- Peter Sick, MD⋮ and
- Horst Sievert, MD§
- ∗Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, New York
- †University of Leipzig Heart Center, Leipzig, Germany
- ‡Cardiology Department, Homolka Hospital, Prague, Czech Republic
- §CardioVascular Center Frankfurt, Frankfurt, Germany
- ⋮Krankenhaus der Barmherzigen Bruder, Regensburg, Germany
- ↵∗Reprint requests and correspondence:
Dr. Vivek Y. Reddy, Helmsley Electrophysiology Center, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy.
Background The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation.
Methods A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death.
Results The mean CHADS2 score and CHA2DS2-VASc (CHADS2 score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS2 scores of the patient cohort.
Conclusions LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578)
Boston Scientific provided financial support for the ASAP trial. Drs. Reddy, Mobius-Winkler, Neuzil, Schuler, Sick, and Sievert have received grant support and/or consulting fees from Boston Scientific, the manufacturer of the Watchman device. Drs. Miller and Wiebe have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 26, 2012.
- Revision received March 13, 2013.
- Accepted March 19, 2013.
- American College of Cardiology Foundation