August 29th, 2011
ESC: A Closure Device and a Warfarin Substitute for High-Risk AFib Patients
Stephen Fleet, MD
How can we manage a patient with atrial fibrillation and contraindications to warfarin therapy such as recurrent severe bleeding — a common scenario in clinical practice? Data from the manufacturer-sponsored ASAP study (ASA Plavix Feasibility Study with WATCHMAN Left Atrial Appendage Closure Technology) provides some hope, beyond what we had learned from the Protect AF trial. Annkathrin Braut, of the Frankfurt Cardiovascular Center, presented preliminary results from ASAP.
This feasibility study of Watchman device implantation enrolled 125 high-risk atrial fibrillation patients from the Czech Republic and Germany. All had contraindications to warfarin, so instead they were given clopidogrel (for 6 months) and aspirin (planned as lifelong therapy). The average CHADS2 score was 2.7.
Of the enrollees, 93% had successful device implantation. Complications to date have included 1 episode of cardiac tamponade, 2 episodes of device embolization requiring retrieval, and 1 femoral artery pseudoaneurysm. During about 10 months of follow-up, 4 episodes of device-related thrombus (requiring heparin therapy) occurred, and 3 patients developed ischemic stroke.
The investigators suggest that Watchman device implantation without warfarin overlap is a safe, feasible strategy and that LAA closure is a viable alternative in high-risk atrial fibrillation patients who have contraindications to warfarin.
The ESC audience in Paris raised two main concerns: (1) about giving aspirin and clopidogrel to patients already known to have had a high incidence of bleeding with warfarin; and (2) about the occurrence of 3 ischemic strokes in this relatively small cohort.
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