FDA approves new artificial heart valve device that does not require major open surgery

An artificial heart valve device that does not require major open surgery has been approved by the Food and Drug Administration.

The heart valve is called the Medtronic CoreValve® System. It 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.

Loyola University Medical Center is the first hospital in Illinois to offer the device.

"It saved me a great deal of pain and suffering from not having to have my chest cracked open," said Loyola patient Martin Rogus. While recovering from the valve placement, he said, "It almost felt like they didn't do anything."

Rogus said that before receiving the new valve, he could not walk a single block without having to stop and catch his breath. Now he can walk a mile slowly, without stopping. "It's been a great gift," he said.

Loyola was the only site in Illinois that participated in a landmark 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.

"This is a major breakthrough," said Fred Leya, MD, co-principal investigator at the Loyola site, along with Mamdouh Bakhos, MD.

The FDA approved the device in January 2014 to treat patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Such patients have a nearly 50 percent risk of death at one year unless they are treated.

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, shortness of breath during activity, heart palpitations and fainting. Aortic stenosis can lead to heart failure and death. About 100,000 people in the United States have aortic stenosis. The traditional treatment is to replace the aortic valve through open-heart surgery.

As part of an ongoing clinical trial, Loyola also is making the device available to high-risk patients who, without treatment, have a one-year mortality risk of between 10 percent and 50 percent. Low-risk patients (one year mortality risk between 4 percent and 10 percent) also can receive the device at Loyola as part of a clinical trial. In this clinical trial, low-risk patients are randomly assigned to receive the device or undergo traditional open chest surgery to replace the heart valve.

Leya is a professor of medicine and director of Interventional Cardiology, and Bakhos is professor and chair of Thoracic and Cardiovascular Surgery at Loyola University Chicago Stritch School of Medicine.

Source: Loyola University Medical Center