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