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Patent Foramen Ovale Closure Devices
Moving Beyond Equipoise
William H. Maisel, MD, MPH;
Warren K. Laskey, MD
JAMA. 2005;294:366-369.
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The off-label use of patent foraman ovale (PFO) closure devices in patients with a PFO and a first cryptogenic stroke has increased despite a remarkable paucity of supporting clinical data and a lack of US Food and Drug Administration (FDA) approval. Because more than 500 000 patients annually may be candidates for these devices worldwide,1 it is imperative that randomized controlled clinical trials be performed to evaluate the safety and effectiveness of PFO closure devices. An understanding of the relationship between stroke and PFO, the regulatory status of PFO closure devices, the factors hampering enrollment into ongoing randomized trials, and the implications of extensive off-label device use are crucial to the evaluation process for this potentially important therapy.
Scope of the Problem
Approximately 700 000 strokes occur annually in the United States, and in more than one third of these cases, the etiology is unknown or cryptogenic.1-3 . . . [Full Text of this Article]
Author Affiliations: Department of Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (Dr Maisel); and Department of Medicine, Division of Cardiology, University of New Mexico School of Medicine, Albuquerque, NM (Dr Laskey).
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