U-M's CoreValve trial to offer less invasive approach for patients with aortic stenosis

The University of Michigan Cardiovascular Center, a leader in heart valve replacement, will participate in a national clinical trial to offer patients a less invasive approach to replacing diseased aortic valves.

The nationally ranked U-M is among 40 sites in the nation selected for the Medtronic CoreValve U.S. Pivotal trial, a study that will examine an investigational alternative to open heart surgery for patients with severe aortic stenosis.

About 100,000 Americans, most of them over the age of 70, are diagnosed with severe aortic stenosis each year, but one-third of patients, because of 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.

Aortic stenosis is a condition where the aortic valve narrows, thereby limiting blood flow from the aorta to the rest of the body. Left untreated, aortic valve stenosis can lead to serious heart problems, including heart failure and even death.

The U-M study team will be lead by Stanley J. Chetcuti, M.D., associate professor of internal medicine, Paul Michael Grossman, M.D., associate professor of internal medicine, G. Michael Deeb, M.D., Herbert Sloan Collegiate professor of surgery, and Himanshu J. Patel, M.D., associate professor of surgery.

They are among the experts in the U-M aortic program that performs over 500 surgical valve procedures a year, which is more than any other Michigan program.

High volume and excellent patient outcomes contribute to the University of Michigan's heart and heart surgery programs ranking as one of the nation's best and tops in the state, according to U.S. News and World Report.

"A unique aspect of the Cardiovascular Center is that there are multiple disciplines housed in one building," says Patel, a U-M cardiac surgeon. "This collaborative atmosphere has existed for many years and raises the level of expertise we can offer patients."

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, meaning through the skin, 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."

The CoreValve trial will involve up to 1,200 patients nationwide who are randomly assigned to one of two treatment options: the CoreValve system or open heart surgical aortic valve replacement surgery.

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.

Dr. Chetcuti, the study co-principal investigator and director of the cardiac catheterization laboratory at the Cardiovascular Center 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.