MAYWOOD, Ill. -- Toni Meyer's heart-valve disease was so severe that she suffered shortness of breath even while sitting in a chair. But Meyer said she is now feeling "100 percent better” after Loyola University Hospital physicians replaced her diseased aortic valve in a catheter procedure as part of a clinical trial. Meyer, 77, of Shorewood, Ill., is among the first patients Loyola has enrolled in the multicenter trial. The study is evaluating an alternative to traditional open-heart surgery for patients who have diseased aortic valves. The catheter-based technology is called transcatheter aortic valve implantation (TAVI). It is being tested on patients with severe aortic stenosis. This condition 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.
Aortic stenosis can lead to heart failure and death. About 100,000 people in the United States have this condition. Currently in the United States, the standard treatment is to replace the aortic valve through 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. Loyola is among a select group of 40 hospitals participating in the Medtronic CoreValve® U.S. Clinical Trial.
Loyola is the only site in the Chicago area and one of the few in the Midwest. 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 at Loyola University Chicago Stritch School of Medicine.
"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 surgeons replace diseased aortic valves routinely with outstanding results. "But many patients are too high-risk for standard open-heart surgery. This new technology has the potential to help many patients who now have no alternative." J. Michael Tuchek, MD, assistant clinical professor in the Department of Thoracic and Cardiovascular Surgery, said if the technology is proven safe and effective, it would offer an alternative to open heart surgery, which can require a few months for full recovery. The device has been implanted in more than 15,000 patients in 40 countries. In the United States, the device is considered investigational and is available only in a clinical trial.
The U.S. clinical trial will enroll more than 1,300 patients. It will be a collaborative effort by cardiac surgeons and interventional cardiologists. Patients will be enrolled in a treatment group based on clinical and surgical risk. Those who can tolerate surgery will be randomly assigned to receive either traditional open-heart valve replacement or valve replacement deployed by a catheter. All patients who are deemed inoperable will be assigned to receive the TAVI catheter procedure. Tuchek considered Meyer too high-risk for open-heart surgery and enrolled her in the trial.
She was among the patients who were assigned to undergo the catheter procedure. She said that before the treatment, she suffered crushing fatigue. Just walking across the room left her exhausted. "I couldn't do anything," she said. She was amazed at how easy her recovery was with the alternative catheter procedure. Her only discomfort was a bit of pain in her groin where the catheter was inserted.
"When my doctors walked in the room afterwards, I couldn't thank them enough," she said. "I felt like I could conquer the world." The procedure was performed in Loyola University Hospital's new hybrid operating room, which combines the imaging capabilities of a cardiac catheterization lab with the sterile environment of a conventional operating room (OR). The hybrid OR is equipped with advanced fluoroscopy equipment, which produces X-ray images of internal organs in motion. The images are displayed on 11 monitors in the operating room.