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Continued: Blind trials: Tried and tested
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Before closing a hole in a heart
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As Poulose explained, a PFO is more like a door without a latch that swings open and shut between the upper chambers of the heart. The opening is normal in fetuses, and usually closes shortly after birth.
But in about 20 percent of adults, the hole never closes, allowing blood to bypass the normal filtering systems of the lungs. Most people never know if they have the defect. Some doctors — though not all — believe that substances such as small blood clots or chemicals in the unfiltered blood that travel directly to the brain may trigger severe migraines.
More than 30 million Americans suffer from migraine, roughly 10 percent of the U.S. population, according to the Migraine Research Foundation. About 15 to 20 percent of sufferers have migraine with “aura” — symptoms such as flashes of light, blind spots or tingling in the arms or legs.
There is no cure for the debilitating condition, which is usually treated with drugs. And the cause of migraines has confounded doctors.
“We know what happens with migraine, but no one has ever been able to explain why it happens,’’ said Dr. Ronald Tarrel, a neurologist with the Noran Neurological Clinic in Minneapolis, who is an investigator in the AGA Medical clinical trial and Sable’s doctor.
In the 1990s, an association between PFO and migraines was noticed by doctors who treated PFOs in young stroke patients and scuba divers suffering from decompression illness. But that was purely anecdotal.
“Enough of these people came in with PFOs who said they had migraines,’’ said Tarrel. “And then, anecdotally, they’d come in after having their PFO closed and say, 'Hey, I haven’t had a migraine since.’”
The first serious study probing the connection was conducted between 2005 and 2006 in the United Kingdom by Massachusetts-based NMT Medical Inc. It enrolled 147 patients with PFO who were suffering from migraines with aura.
Though the study did not meet its primary endpoint, patients whose PFO was closed with the company’s device experienced at least a 50 percent reduction in the number of migraine headache days, compared with a 23 percent reduction in the arm of trial where patients did not get the device, according to the company.
At least three companies, including Little Canada-based St. Jude Medical Inc., have launched clinical trials enrolling about 1,500 patients that test different kinds of devices to fix a PFO in migraine patients. (AGA Medical officials declined to be interviewed for this story.)
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