Study of Nonsurgical Heart Valve Replacement

Loyola University Hospital is enrolling patients in a clinical trial that offers an alternative to traditional open-heart surgery for patients who need new aortic heart valves.

Loyola is among a select group of 40 hospitals participating in the Medtronic CoreValve® U.S. Clinical Trial. Loyola is one of the few study sites in the Midwest, and the only site in the Chicago area.

The device is being tested on patients with severe aortic stenosis, which occurs when the heart's aortic valve is narrowed, restricting blood flow from the heart to the body. The valve doesn't open properly, forcing the heart to work harder to pump blood. The condition can lead to heart failure and death. About 100,000 people in the United States suffer from severe aortic stenosis.

The most common treatment is to replace the aortic valve in a traditional open-heart surgery. The clinical trial will evaluate an alternative procedure, in which an artificial valve is delivered and deployed with a catheter (thin tube). The catheter is inserted into an artery in the groin and guided up to the heart. Once in place, the artificial valve takes over the function of the diseased valve, ensuring that oxygen-rich blood flows into the aorta, the body's main artery.

Principal investigators for the Loyola site are Ferdinand Leya, MD, professor of medicine and director of interventional cardiology, and Mamdouh Bakhos, MD, professor and chair of thoracic and cardiovascular surgery.

"If proven safe and effective, this technology could be the next great advance in minimally invasive treatment of patients with heart disease," Leya said.

Bakhos said the technology "has the potential to help many patients, for whom, at this point, there is no alternative."

The device has been approved in more than 40 countries, but is considered an investigational device in the United States.

The U.S. clinical trial will enroll more than 1,300 patients. It will be a collaborative effort by cardiac surgeons and interventional cardiologists. Most patients will be enrolled in a treatment group based on clinical and surgical risk. They will be randomly assigned to receive either traditional open-heart valve replacement or valve replacement deployed by a catheter. Patients who have extreme or prohibitive surgical risks will be considered as candidates for the catheter procedure.

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Source: Loyola University Health System