WASHINGTON — Thousands of older Americans who need new heart valves but are too frail to survive the surgery might soon get a chance at an easier option — a way to thread in an artificial aortic valve without cracking their chests.
The aortic valve is the heart's main doorway, and a major new study found that snaking a new one in through an artery significantly improved the chances that patients with no other treatment options would survive at least a year.
Not yet known is whether easier-to-implant valves might work for the less sick who'd like to try the new technology rather than undergo the open-heart surgery required for standard valve replacements that can last 20 years.
That question still is being studied, but two competing types of these "transcatheter aortic valves" already are sold in Europe — and manufacturer Edwards Lifesciences Corp. hopes to win U.S. Food and Drug Administration approval to sell its version for inoperable patients in about a year.
"This opens the door to a new treatment," said lead researcher Martin Leon of Columbia University Medical Center and New York-Presbyterian Hospital.
He reported the results in today's New England Journal of Medicine and at the annual Transcatheter Cardiovascular Therapeutics conference. Edwards paid for the study at 21 hospitals, and many of the researchers have received fees from that company or competing heart device makers.
The valves aren't a cure-all, they come with a risk of stroke, and no one knows how long they'll last. Still, specialists say they're a step to transforming care for a problem on the rise as the population grays.
Some 300,000 Americans already have a seriously diseased aortic valve, a gate that essentially rusts with age until it can't open properly, forcing the heart to work ever harder to squeeze blood through. More than 50,000 people a year undergo open-heart surgery to replace that valve, and thousands more are turned away, deemed too old or ill to survive the arduous operation.