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September 7, 2004
Emory a training center for FDA-approved stent procedure

BY sherry baker

The U.S. Food and Drug Administration (FDA) has approved a new technique for treating potentially life-threatening blockages in the arteries of the neck that lead to the brain. The carotid stenting procedure offers a minimally invasive alternative to carotid endarterectomy (surgical removal of arterial plaque) in patients with carotid artery disease who are at risk for stroke.

In addition to the approval, the FDA recommended that physicians who use the carotid stenting device undergo special training, and the Emory Heart Center is one of 30 training sites for carotid stenting across the nation.

Just as stents (tiny mesh tubes) often are used following coronary angioplasty (a minimally invasive procedure that uses a balloon-tipped catheter to enlarge a narrowing caused by atherosclerosis to keep arteries open), they also can be used to prop open carotid arteries in the neck.

The FDA’s approval will allow treatment for patients with blocked carotid arteries who have been unable to undergo the rigors of surgery due to lung disease, heart disease or other illnesses.

“Carotid stenting is a very exciting new technology that certainly offers high-risk patients a less invasive option to carotid endarterectomy,” said cardiologist Christopher Cates, director of vascular intervention at Emory and Crawford Long hospitals. “This procedure also has significantly fewer bad outcomes—heart attack, stroke and death—when compared to carotid endarterectomy. It is also the first catheter-based technology to show a major benefit versus a surgical procedure.”

The Society for Cardiovascular Angiography and Interventions (SCAI) predicts demand for the carotid stenting procedure will mushroom following FDA approval, and the SCAI is working with industry partners to help develop training programs on virtual reality simulators to train physicians.

Cates and Anthony Gallagher, associate professor of surgery (research) and research director of the Emory Endosurgery Unit, have designed one of the first of these programs to train physicians in carotid stenting. Using simulators that look like human mannequins, physicians thread a catheter through an artificial circulatory system and view angiograms of the “patient.” Emory already has trained more than 100 physicians using the simulator.

“For the first time, physicians are able to practice on simulators, much like airline pilots who learn to fly first using a simulator, prior to performing carotid artery stenting on patients. Doctors learn on the simulator until they are proficient, working in lifelike settings,” said Cates, who chairs SCAI’s Board of Governors.

According to Cates, stents placed in carotid arteries following angioplasty can reduce the risk of stroke in many people. Carotid artery disease—a buildup of atherosclerotic plaque (fatty material) in major vessels of the neck that supply blood to the brain—is an important risk factor for stroke. Stroke is the nation’s third leading cause of death and a major cause of serious, long-term disability. According to the American Stroke Association, someone in America has a stroke every 45 seconds. Roughly 700,000 Americans suffer from stroke each year.

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