Aortic stenosis: Interventional vs. surgical approach being compared in new trial
A national clinical trial to offer patients a less invasive approach to replacing diseased aortic valves has begun, and is now recruiting up to 1,200 patients at 40 sites including the University of Michigan Cardiovascular Center, a leader in heart valve replacement.
The study, called the Medtronic CoreValve U.S. Pivotal trial, will examine an investigational alternative to open heart surgery for patients with severe aortic stenosis.
About 100,000 Americans, are diagnosed with severe aortic stenosis each year, but one-third of patients, due to age or frail health, are considered too high-risk for traditional surgery.
"Through this trial we are investigating a minimally invasive procedure for the thousands of patients diagnosed each year with severe aortic stenosis," says U-M cardiac surgeon G. Michael Deeb, the Herbert Sloan Collegiate professor of surgery. "There is a tremendous unmet need for a safe and effective treatment that will help them live longer and feel better."
It's not uncommon for patients to experience chest pain, dizziness, shortness of breath, feel faint with activity, and suffer heart palpitations. As the population ages, more Americans will be susceptible to aortic stenosis, he says.
Severe aortic stenosis is often unpreventable and may be related to age, buildup of calcium deposits causing narrowing, radiation therapy, medications, history of rheumatic fever or high cholesterol.
The U-M study team is led by Stanley J. Chetcuti, M.D., associate professor of internal medicine, Paul Michael Grossman, M.D., associate professor of internal medicine, Deeb, and Himanshu J. Patel, M.D., associate professor of surgery.
All are part of the U-M aortic program that performs over 500 surgical valve procedures a year -- more than any other Michigan program.
In the CoreValve trial, surgeons and interventional cardiologists work together to perform the procedure called transcatheter aortic valve implantation. It allows access to the diseased aortic valve percutaneously, usually an artery in the leg, rather than through open surgery.
"There can be many advantages to that," says Grossman, study co-principal investigator and director of the cardiac catheterization laboratory at the Veterans Administration Ann Arbor Healthcare System. "Open surgical procedures are often associated with long recovery times and there are many patients who are too sick to tolerate and recover from major surgery."
Dr. Chetcuti, the study co-principal investigator, director of the cardiac catheterization laboratory at the Cardiovascular Center and the Eric J. Topol professor of cardiovascular medicine, says: "The critical part of the study is to make sure it is done well and that we answer the questions: Is this technology safe and does it make a difference to our patients."
The trial adds to the U-M Cardiovascular Center's tradition of research expertise. In the past five years alone, its physicians and scientists have participated in more than 700 cardiovascular clinical trials.
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