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Role of Patent Foramen Ovale in Stroke Needs More Study

Last Updated: May 13, 2009.

Greater patient involvement in ongoing trials is needed to guide clinical decisions on the optimal treatment of patent foramen ovale for stroke prevention, according to an advisory published online May 11 in Circulation.

WEDNESDAY, May 13 (HealthDay News) -- Greater patient involvement in ongoing trials is needed to guide clinical decisions on the optimal treatment of patent foramen ovale (PFO) for stroke prevention, according to an advisory published online May 11 in Circulation.

Patrick T. O'Gara, M.D., of the Brigham and Women's Hospital in Boston, and colleagues, on behalf of the American Heart Association/American Stroke Association and the American College of Cardiology Foundation, write that PFO has been strongly associated with cryptogenic stroke, though evidence for causality is lacking in most patients.

Treatment options for PFO include medical therapy, percutaneous device closure, or open surgery. Three U.S. Food and Drug Administration advisory committees in the past decade have called for research to compare medical therapy with percutaneous closure, the authors write. However, slow enrollment in trials has impeded their progress. Three trials are ongoing in the United States regarding PFO closure to prevent recurrent cryptogenic stroke.

"This advisory is a call to action for clinicians to support referral of patients with cryptogenic stroke and PFO to one of these ongoing studies. Practitioners are encouraged to refer patients across the spectrum of perceived risk for recurrent stroke, so as to minimize biased enrollment of relatively healthier patients. Failure to achieve the projected sample sizes in a timely fashion could result in withdrawal of funding, premature study termination, and continued lack of clarity around this vexing management problem," the authors conclude.

Several writing group members and reviewers disclosed potential conflicts of interest.

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