Author + information
- Received September 19, 2011
- Revision received October 27, 2011
- Accepted November 8, 2011
- Published online March 6, 2012.
- Juan F. Viles-Gonzalez, MD⁎,
- Saibal Kar, MD†,
- Pamela Douglas, MD‡,
- Srinivas Dukkipati, MD⁎,
- Ted Feldman, MD§,
- Rodney Horton, MD∥,
- David Holmes, MD¶ and
- Vivek Y. Reddy, MD⁎,⁎ ()
- ↵⁎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 investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota).
Background During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations.
Methods Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95% confidence interval (CI).
Results Transesophageal echocardiography follow-up revealed that 32.0% of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95% CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95% CI: 0.11 to 6.40), 0.83 (95% CI: 0.33 to 2.09), and 0.48 (95% CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95% CI: 0.14 to 2.71; p = 0.530).
Conclusions These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.
The PROTECT AF trial was supported by Atritech, Inc. Dr. Kar has received clinical research grant support and consultant fees from Atritech, Inc. Dr. Douglas has received clinical research grant support from Atritech, Inc. Dr. Feldman has received clinical research grant support and consultant fees from Atritech, Inc. and Boston Scientific. Dr. Horton has received clinical research grant support and consultant fees from Atritech, Inc. Dr. Holmes has received research grant support from Atritech, Inc.; also, the Watchman LAA closure technology has been licensed to Atritech, Inc., and both Mayo Clinic and Dr. Holmes have contractual rights to receive future royalties from this license, but to date, no royalties have been received. Dr. Reddy has received clinical research grant support and consultant fees from Atritech, Inc. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.
- Received September 19, 2011.
- Revision received October 27, 2011.
- Accepted November 8, 2011.
- American College of Cardiology Foundation