The Medtronic CoreValve System—an artificial heart valve device that doesn’t require major open surgery—received approval from the U.S. Food and Drug Administration last month. Its primary role is in the treatment of patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. These patients face a nearly 50% risk of death at one year unless they receive treatment.

Aortic stenosis 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. Symptoms include fatigue, dizziness, chest pain/pressure, heart murmur and palpitations, and fainting.

Loyola University Medical Center is the first hospital in Illinois to offer the Medtronic CoreValve device. Loyola was the only site in Illinois to participate in a clinical trial of the device. The study found the device substantially improved patients’ quality of life, and had low rates of complications such as stroke and valve leakage.

The Medtronic CoreValve is deployed with a catheter, which is inserted in an artery in the groin and guided up to the heart. Once in place, the artificial valve takes over the function of a diseased valve (see the figure).

As part of an ongoing clinical trial, Loyola also will make the device available to patients who, without treatment, have a one-year mortality risk of between 10% and 50%. In addition, low-risk patients (one-year mortality risk between 4% and 10%) can receive the device at Loyola as part of the trial.

Martin Rogus, a Loyola patient who received the new valve, said he could not walk a single block without having to stop and catch his breath. Now he can walk a mile slowly, without stopping.

Principal investigators for the study are Fred Leya, MD, professor of medicine and director of Interventional Cardiology, and Mamdouh Bakhos, MD, professor and chair of Thoracic and Cardiovascular Surgery at Loyola Univ. Chicago Stritch School of Medicine.

LOYOLA UNIVERSITY MEDICAL CENTER