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Watching, but not waiting: vascular neurology perspective on the disparate regulatory pathways for stroke
  1. Sunil A Sheth1,
  2. Raul G Nogueira2,
  3. Ali Reza Noorian1,
  4. David S Liebeskind1
  1. 1Department of Neurology, University of California Los Angeles, Los Angeles, California, USA
  2. 2Department of Neurology, Emory University, Atlanta, Georgia, USA
  1. Correspondence to Dr David S Liebeskind, UCLA Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095, USA; davidliebeskind{at}yahoo.com

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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 …

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