Six years after rejecting the approval of the Watchman device, the FDA finally cleared it in March. The Watchman (Boston Scientific) became the first and only minimally invasive device to exclude the left atrial appendage and help prevent strokes in patients with atrial fibrillation.
Still, although the device is intended as an alternative to warfarin, some wondered if doctors may prescribe novel oral anticoagulants before they turn to the Watchman, at least in part due to cost considerations.
A recent study suggests, though, that the Watchman may save money and be more cost-effective in the long-run. Researchers developed a Markov model that found the Watchman device was less expensive and more effective than novel anticoagulants from year 5 onward and provided an estimated additional 0.298 life-years and 0.349 quality-adjusted life-years.
As of now, the standard of care to prevent strokes in patients with atrial fibrillation remains warfarin or the novel oral anticoagulants based on evidence from large, randomized trials. However, N.A. Mark Estes III, MD, noted in a Journal of the American College of Cardiology editorial that the medications are associated with issues such as underutilization, compliance and bleeding.
The Watchman is intended for patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism and failed on or were deemed unsuitable for warfarin therapy.
Estes wrote that the analysis based on a cost-effectiveness model “represents an important analytic approach for evaluating stroke prevention strategies” in patients with atrial fibrillation. Still, he noted a few limitations, including that the researchers used an indirect comparison methodology with warfarin as the common control, only had data from clinical trials and the model’s inputs assumed the operators were experienced with the device.
Further analysis should include head-to-head comparisons of the Watchman device and novel oral anticoagulants and prospective trials of the Watchman to provide an evidence-based analysis of cost-effectiveness over a patient’s lifetime, according to Estes.
“Despite these unanswered questions, the evidence from the Watchman clinical trials and this analysis represent meaningful progress in the quest for [left atrial appendage] closure as a clinical strategy for stroke prevention in [atrial fibrillation] patients,” Estes wrote.