Treat Abdominal Aortic Aneurysms
Preventive Surgery May Be Safer, More Effective if Performed Earlier After Diagnosis
The Cleveland Clinic is leading the nation's largest clinical trial to date to determine whether using stents to repair weak spots in the abdominal aorta, the largest artery in the body, is better for patients than waiting for the weak spots to reach a larger size before intervening. The first study patient was implanted with a stent graft this week by Dr. Timur Sarac.
Disease
"Treatment traditionally involved a major open surgical operation with a large incision and a long recovery period. The magnitude of the procedure was such that it has been reserved for patients with larger aneurysms," said vascular surgeon Kenneth Ouriel, M.D., chairman of the Division of Surgery at The Cleveland Clinic and principal investigator of the new clinical trial. "The advent of a minimally invasive approach with stent grafts may offer an option that is reasonable for smaller aneurysms. This contention, however, must be proven with a clinical study."
The clinical trial will be conducted at 70 centers throughout the country and enroll about 1,680 patients. Half of the patients with aneurysms between 4 centimeters and 5 centimeters will be randomly assigned to receive endovascular repair using a stent-delivery system made by Medtronic at the time of their diagnosis. The other half will be monitored with ultrasound every 6 months. Those in the surveillance group who develop symptoms or experience enlargement can be treated with either an open or endovascular repair procedure. The two groups will be observed for five years to track differences in outcomes as they relate to any aneurysm or aneurysm repair.
An aortic aneurysm is a weakening or ballooning of the aorta wall. Aortic aneurysms typically occur when the blood is under high pressure as it travels from the heart to the lower parts of the body. If this pressure continues to build, the aneurysm may burst, creating a dangerous leakage of blood into the abdominal cavity.
Although people of any age can develop an aneurysm, the condition is most prevalent elderly men. Less than half of the people who suffer a ruptured abdominal aortic aneurysm will survive.
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The Cleveland Clinic Foundation, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. The Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News and World Report consistently names The Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,500 full-time salaried physicians at The Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2004, patients came for treatment from every state and 100 countries. The Cleveland Clinic website address is www.clevelandclinic.org