First Carotid Stent Placement Utilizing Current FDA Approved Embolic Protection Device Performed
Posted on 7/12/2007
New Carotid Stent System Offers Minimally Invasive Alternative to Open Surgery
Jose M. Wiley, M.D., Interventional Cardiologist at St. Alexius Medical Center performed the first Carotid Stent procedure in Bismarck, ND utilizing the current FDA approved Embolic Protection System on June 15, 2007.
Carotid Stent System and Embolic Protection System provide a minimally invasive treatment alternative to conventional open carotid artery surgery to patients who are at high surgical risk.
“St. Alexius Medical Center is committed to reducing the risk of stroke, which has serious health and economic consequences for over 700,000 Americans who suffer a stroke each year,” says Michael R. Brown, M.D.,PhD, cardiothoracic surgeon at St. Alexius Medical Center. “Stenting is an established therapy that has been used successfully for years to treat heart and peripheral vascular disease. “The approval of a carotid stent represents a minimally invasive breakthrough therapy for patients at risk of stroke who are ineligible or at high risk for traditional surgery,” said Robert G. Oatfield, MD, interventional cardiologist at St. Alexius Medical Center.
Carotid artery disease involves the buildup of plaque in one or both carotid arteries in the neck. The carotid arteries supply vital oxygen and glucose-rich blood to the parts of the brain where thinking, speech, personality, and sensory and motor functions reside. The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient’s neck and artery to remove plaque from inside the vessel wall.
In contrast, during a carotid stenting procedure, the embolic protection system is positioned and a stent is deployed using a catheter inserted into a small puncture in the patient’s groin. The patient usually remains conscious while the stent is implanted at the site of the blockage. The embolic protection system is designed to capture and remove particles of plaque that might be dislodged during the procedure, which could potentially lead to stroke and other complications. High-risk patients indicated for carotid stenting include those with significant heart, kidney or lung disease, recurrence of a blockage following a prior carotid surgery, or with difficult-to-access neck anatomy.
Clinical trials of carotid stent and embolic protection system showed the therapy to be safe and effective. The risk of combined complications of death, stroke and heart attack at 30 days and/or any stroke in the area of the blockage at one year was about 10 percent for high-risk patients, compared to approximately 15 percent for complications seen in the literature from high-risk patients undergoing surgery. In addition, results for patients followed beyond one year demonstrated continued effectiveness of the stent procedure, with a low rate of repeat procedures due to re-narrowing.
“Results from the clinical trials demonstrated that high surgical-risk patients benefited from being treated with carotid artery stenting, and current technology gives physicians an easy-to-use platform for treating these patients,” said John Windsor, D.O., interventional cardiologist & director of the Cardiac Catheterization Laboratory at St. Alexius Medical Center.
About Carotid Artery Disease and Stroke
Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Approximately 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. An ischemic stroke can occur when carotid arteries become narrowed and when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the bloodstream and block vessels in the brain. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die. The lifetime cost of stroke exceeds $90,000 per patient in the United States.