Author + information
- Houman Khalili, MD∗ ( and )
- George S. Hanzel, MD
- ↵∗Department of Cardiology, Beaumont Health System, 3601 13W Mile Road, Royal Oak, Michigan 48073
We read with great interest the report by Price et al. (1) on bleeding outcomes after left atrial appendage closure using the WATCHMAN device (Boston Scientific, Marlborough, Massachusetts) in a pooled analysis of the 2 randomized trials comparing WATCHMAN left atrial appendage closure to warfarin therapy. They noted no difference in overall rate of major bleeding over the 3-year follow-up period. The similar bleeding rate, however, was driven by the high rate of periprocedural bleeding in the WATCHMAN group. Bleeding was in fact reduced in the post-procedural period (>7 days) in the WATCHMAN arm compared with warfarin therapy.
Although the types and frequencies of periprocedural bleeding events were not presented, 1 potential contributor to the high periprocedural bleeding rate in a procedure that relies primarily on venous puncture could be the hemostatic valve. A recent class 2 Food and Drug Administration recall noted possible “cross-threading” of the hemostatic valve can lead to inadequate sealing and potentially undesired blood leakage (2). In addition, even without the cross-threading of the hemostatic valve, there can be significant blood loss with normal use of the delivery system, particularly during positioning of the pigtail in the left atrial appendage. Unfortunately, the hemostatic valve lacks a technology similar to the COPILOT Bleedback Control Valve (Abbott Vascular, Santa Clara, California) to avoid unwanted bleeding.
In our experience, there has been decreased undesired blood loss over the years as we have learned how to best manage the hemostatic valve to minimize, but not completely eliminate, bleeding. It would be of interest to see the periprocedural bleeding trend over time in the reported pooled analysis. Potential improvement in the device delivery technology can reduce the risk of periprocedural bleeding further, and lead to improved bleeding profile of the WATCHMAN device compared with warfarin therapy.
Please note: Dr. Khalili has reported that he has no relationships relevant to the contents of this paper to disclose. Dr. Hanzel has served on the scientific advisory board for Boston Scientific and Watchman Scientific; and has received honoraria paid to Beaumont hospital for travel for the Watchman Scientific Advisory Board.
- American College of Cardiology Foundation
- Price M.J.,
- Reddy V.Y.,
- Valderrabano M.,
- et al.
- ↵Food and Drug Administration. Class 2 device recall WATCHMAN access system access sheath with dilator. November 2015. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139706. Accessed January 5, 2016.