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Vascular neurologists have keenly watched the Watchman device (Atritech, Plymouth, Minnesota, USA) regulatory approval process. We are, as always, searching for additional options in the prevention and treatment of stroke to better care for our patients, and new approaches to the management of atrial fibrillation play a large part in this effort. Recently, a Food and Drug Administration (FDA) panel voted 13:1 in favor of the Watchman device for the prevention of ischemic stroke in non-valvular atrial fibrillation.1 The panelists came to this decision after reviewing data from large randomized trials that compared anticoagulation with warfarin, the standard of care at the time, with antiplatelet therapy plus occlusion of the left atrial appendage with the Watchman device.2 ,3 The studies found that the approach incorporating the Watchman device was non-inferior to warfarin in the prevention of stroke or systemic embolism, with an acceptable periprocedural safety profile. Therefore, the panel, mostly without stroke experience, gave near unanimous support for the device. Although the device offers an intriguing new approach to stroke prevention in this high-risk group of patients, the decision also underscores the seemingly disparate process for development of stroke therapies and the disengagement of the stroke community from recent cardiology-driven stroke trials.
While designed as cardiology device trials to treat complications of a cardiac arrhythmia, studies examining thromboembolism from atrial fibrillation are, in fact, stroke prevention studies. The most relevant endpoint in these trials is the prevention of stroke, and it will be predominantly vascular neurologists, not cardiologists, who will ultimately manage, treat, and …
Contributors SAS contributed substantially to the conception and design of the work, drafting and critically revising it and giving final approval. RGN, ARN, and DSL conceived the work, revised the article, and gave final approval. All the authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The data discussed in this article are taken from the clinical studies referenced within the work. We provide no new additional data.
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