She discovered she had a PFO and had the device implanted by Dr. Goldberg.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
The RESPECT trial similarly randomized 980 patients to medical therapy or PFO closure.
If approved, physicians worry the PFO closure will become another example of a well-intentioned medical procedure that will be overused.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
He said he believes the study supports the theory of PFO closure, but that concerns about overuse could make regulators cautious.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
Jude's device, called the Amplatzer PFO Occluder, is used to seal a flap-like passageway between the left and right atriums of the heart.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
"If I were 45 years old and I had a prior cryptogenic stroke and a PFO, I'd get my hole closed, " said Frank Callaghan, president of St.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
Then, in its handling of the RESPECT trial of PFO closure, the company transformed the ideals of research and development into research and denial.
Referrals for PFO closure began picking up steam in the 1990s as new imaging techniques showed that a large percentage of patients with cryptogenic strokes had the flap.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
Chertoff designated FEMA Director Mike Brown, the undersecretary for emergency preparedness and response, as the principal federal officer, or PFO, putting him in charge of the relief effort.
Jude trial and believes the study supports the PFO-closure theory.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
Results from a PFO clinical study funded by St.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
Steven Goldberg, a cardiologist at the University of Washington School of Medicine, has performed as many as 60 PFO closures a year and says many patients seek out the procedure out of fear and uncertainty.
WSJ: Doctors Debate Whether Strokes Be Prevented With a Heart-Plug Procedure
The results appear unlikely to resolve the ongoing controversy over the value, or lack of value, of this procedure, but, as an accompanying editorial states, both advocates and critics of PFO closure will find source material for their arguments in these papers.
The PC T rial (Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale Using the Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism) randomized 414 patients with PFO who had had an ischemic stroke, TIA, or a peripheral thromboembolic event to either medical therapy or PFO closure with the Amplatzer PFO Occluder.
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