Deteriorating or clogged heart valves in seriously ill elderly people can be replaced in minimally invasive surgery, researchers said Sunday. Cardiologists compared the significance the new procedure represents with the use of balloon angioplasty to clear blocked arteries.
At least 100,000 Americans develop aortic valve stenosis each year, which impairs the ability of the heart to pump blood. A previous study had showed that the valves can be replaced with prosthetic valves through a catheter inserted in the groin in patients who are too sick for conventional surgery.
New results presented Sunday at a New Orleans meeting of the American College of Cardiology indicate that the procedure is at least as effective as surgery in patients who are not quite so ill, which would extend the procedure to a much larger group of patients. Within a few years, cardiologists expect the procedure to be performed in tens of thousands of patients each year.
“This will be seen as one of the biggest steps in cardiovascular medicine in our lifetime,” trailing only the development of balloon angioplasty and the use of stents to keep cleared arteries open, said Dr. David J. Moliterno, a cardiologist at the University of Kentucky College of Medicine, who was not involved in the research.
“This is a game changer” for cardiovascular surgery, said Dr. Michael J. Mack of the Baylor Health Care System in Dallas, president of the Society of Thoracic Surgeons. “It’s going to change the treatment of the disease.”
Aortic stenosis is a clogged valve in the artery that transports blood from the heart. It affects as much as 9 percent of the U.S. population over age 65, with the incidence increasing with age. The only approved way to treat the condition in the United States is with open chest surgery.
Edwards Lifesciences Corp. of Irvine, Calif., developed a device using valve flaps from cows that can be implanted through a vein in the groin or chest. The device is approved in Europe, but not in this country. A Food and Drug Administration advisory committee is expected to consider it this summer.
Two clinical trials have been conducted, one in patients too sick for conventional surgery and the second in patients at high risk for complications from surgery – effectively those in the top 10 percent of risk.
Results from the first trial, reported last fall, showed that the device increased survival by nearly two years compared with medical therapy alone in those patients, whose median age was 83.