Less-invasive valve approved for U.S. patients too ill for open-heart surgery
In a move that cardiologists say is a "game changer" for cardiovascular surgery, FDA on Wednesday approved a first-of-its-kind artificial heart valve that will offer certain severe aortic stenosis patients a treatment alternative to major surgery.
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According to the AP/New York Times, roughly 300,000 U.S. patients have aortic valve stenosis—a clogged valve in the aorta that impairs the heart's ability to pump blood. FDA statistics show that more than half of these patients die within two years. Approximately 50,000 U.S. patients undergo surgery to replace the valve annually, but thousands of patients are turned away because they are too old or frail to survive the procedure.
The newly approved Sapien valve—manufactured by Edwards Lifesciences—is a bovine valve flap that can be implanted through an artery in the groin or chest using transcatheter aortic valve implantation (TAVI), a procedure similar to balloon angioplasty. In July, an FDA panel recommended that the agency approve the device.
FDA this week approved the valve for patients considered too ill to undergo traditional open-heart surgery to replace the aortic valve. The device is not approved for patients who are deemed eligible for open-heart surgery. The valve already has been on the market for four years in 40 countries, including most of Europe, the AP/Times reports.
According to FDA, the approval was based on Edwards' clinical trial of 365 patients deemed ineligible for the open-heart procedure. Although the trial suggested that TAVI patients suffered more than twice as many strokes and eight times as many vascular and bleeding complications, they experienced better one-year survival rates. After 12 months, 69% of TAVI patients were alive, compared with 50% of patients who did not receive the implant, Reuters reports.
According to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, the valve "is an example of an innovative new device that will provide some people…who can't undergo open-heart surgery with the option of valve replacement."
The valve is expected to cost about $30,000, although surgery fees could increase the price to roughly $70,000, the AP/Times reports. Standard heart valve replacement typically costs more than $50,000. CMS is expected to announce TAVI coverage policies sometime this month, MedPage Today reports (Athvaley, Wall Street Journal, 11/2; Kaiser, MedPage Today, 11/2; Beasley, Reuters, 11/2; AP/Times, 11/2).