05/08/2006

WVU Testing Stroke Prevention Treatment

MORGANTOWN, W.Va – WVU physicians are using a new treatment – in use at only 30 medical centers around the country – that may prevent strokes by implanting a device directly into the brain. Doctors hope that the device, the only one if its kind approved by the FDA, will prevent strokes by maintaining the flow of blood to the brain.

According to Ansaar Rai, M.D., a neuroinerventional radiologist at WVU, the device is similar to the stents used to treat patients with heart disease. “This is the first stent the FDA has approved for treating stroke,” Dr. Rai said. “Stents, whether used in the heart or the brain, are used to hold open a blood vessel after a blockage has been cleared from it.”

Rai explains that coronary stents have been used in the past to maintain blood flow to the brain. “But the blood vessels in the brain are more delicate than those of the heart, and using stents designed for the heart in the brain can cause additional injury to the brain,” he continued.

The Wingspan stent, manufactured by Boston Scientific, is made of wire mesh and  ranges from 3-4 mm in diameter and from 10-15 mm in length. The size of the stent is chosen based on the patient and the blood vessel.

A balloon is inserted through an artery in the leg, and threaded through the body, the stent behind it, until it reaches the blockage. The balloon is then gently inflated to dislodge the plaque buildup. When the plaque has been removed, the balloon is deflated and the stent is guided into place to prevent the artery from collapsing.

Typical patients who could benefit from the stent are those who have the risk factors for heart disease. “Patients who have diabetes, high blood pressure and cholesterol, are overweight and smoke, could benefit from this stent,” he said.

“Many patients don’t realize they have reduced blood flow to their brains,” he added. “But this deficit, caused by a partial blockage, leaves patients with a ‘mist-like’ feeling. One patient, after the stent was implanted, said it was like a fog has been lifted from his mind.”

Up to 10 percent of all ischemic strokes – those caused by the blockage of a blood vessel leading to the brain – are caused by intracranial atherosclerotic disease (ICAD).

The Wingspan stent is used specifically to treat patients with ICAD, the buildup of plaque on the inside walls of the arteries of the brain. This plaque buildup is caused by accumulation of fat, cholesterol and other cells found in the blood. ICAD is currently being treated by blood thinning medications, in an attempt to reduce the plaque buildup and prevent strokes.

The Wingspan stent was approved by the FDA under a humanitarian device exemption, Rai explained, meaning that the device has been found to be safe, and has been approved for use in the United States, but there is no evidence of its effectiveness. “Basically, the exemption means that there is nothing else available, so it can be used,” Rai said. “It allows the company that developed the stent to gather information about its effectiveness, which could lead to it being given full approval by the FDA. In order to use it here, however, the University’s Institutional Review Board (IRB) also had to approve its use.”

- WVU -


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lc:05-08-06

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