Loyola University Medical Center is the first hospital in Illinois to implant a newly approved aortic heart valve device that does not require open surgery.
The device, recently approved by the Food and Drug Administration, is called the Medtronic CoreValve® System. On March 28, Loyola became the first Illinois hospital to implant the device in a patient who was not part of a clinical trial. Prior to the FDA approval, the device was available only to patients enrolled in a clinical trial.
The new device 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. The system is much less invasive than traditional open-heart surgery.
Loyola physicians also have implanted the device in patients participating in clinical trials, including a landmark trial published March 29 in the New England Journal of Medicine. The study found that patients who received the device had significantly lower mortality than heart valve patients who underwent open-heart surgery.
"This is a major breakthrough," said Fred Leya, MD, co-principal investigator at the Loyola site, along with Mamdouh Bakhos, MD.
The study published in the New England Journal of Medicine included 795 seriously ill heart-valve patients who were randomly assigned to receive the new device or to undergo open-heart surgery. After one year, the mortality rate was 19.1 percent in the group that underwent open-heart surgery, but only 14.2 percent in the group that received the new device.
After 30 days, quality-of-life scores improved 19 points for patients who received the new device, compared with 3.7 points for open-surgery patients. At one year, quality-of-life scores increased 23.2 points in the device group and 21.9 points in the open-surgery group. Quality of life is measured on a 100-point scale, in which 5 points is considered important and 20 points is considered a very large improvement.
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.
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 open-heart surgery. Such patients have a nearly 50 percent risk of death at one year unless they are treated.
As part of an ongoing clinical trial, Loyola also is making the device available to patients who have a one-year mortality risk of between 10 percent and 50 percent without treatment.
Low-risk patients (one-year mortality risk of between 4 percent and 10 percent) also can receive the device at Loyola as part of a clinical trial. These low-risk patients are randomly assigned to receive the device or to undergo traditional open-heart surgery to replace the heart valve.
Loyola University Health System