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STROKE PFO IMPLANT STUDY

A year ago, Orhan Sarki’s incapacitating migraines started. And just a few weeks ago, he blacked out at work.
“I am 36 years old, married, three children. Health-wise, medical history-wise, I’ve had a fairly healthy life so far,” says Orhan. “The next thing I know I was in the hospital with a nurse poking me, Mr. Sarki can you hear me?” recalls Orhan.

Tests turned up a hole in his heart wall known as a patent foramen ovale- or PFO. It’s present in 12 to 25 percent of adults in the United States. The foramen ovale is a normal opening in unborn babies that detours blood away from the lungs because the baby is not breathing yet. It gets the oxygen instead from the mother. The blood thus travels directly from the right side of the heart to the left. But after birth, the foramen ovale is supposed to close, and blood then goes to the lung. When it doesn’t, it becomes a patent foramen ovale, leaving a pathway from the right side of the heart to the left through which a blood clot can pass, travel to the brain, and obstruct a blood vessel.
It can cause a stroke, or as in Orhan’s case, a mini-stroke, when a clot only temporarily obstructs a blood vessel. Orhan had the option to get either a blood thinner to prevent the clots, open heart surgery to repair the PFO, or a new experimental procedure called the starflex septal closure system, where a device is placed in the heart to seal the flap.
The implant is threaded through a leg vein using a catheter up to the right side of the heart and then placed in the PFO, sealing it. It is done under local anesthesia and takes only a half hour. The device has been used safely in Europe and now here in the United States doctors across the country are in trials right now to determine whether this works as well, or better than long-term blood thinner use. It’s an important study since patients with a PFO carry between a 2 to 12% risk each year for a stroke.
According to cardiologist, Dr. Robert Sommer, “most people don’t associate strokes with young people and it may well be that as many as 100,000 patients in the United States are affected by stroke with no other definable cause.”
Ten days after the procedure Orhan is migraine and blackout free.
“I’m looking forward to not having them. Looking forward to not blacking out again, says Orhan. “I’m back to my normal life. I’m ripping my deck out.”
The PFO study is being done at 80 centers nationwide. Either the patient will get the implant or be given a blood thinner like Coumadin or aspirin. It’s not yet approved by the FDA.
For more information on the trials and other National Stroke Association programs, click here:
www.stroke.org
For more information about PFO, click here:
http://www.clevelandclinic.org/heartcenter/pub/guide/disease/congenital/pfo.htm

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