Sep 22, 2010 4:59 PM
WASHINGTON (AP) - 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
Dr. Martin Leon of Columbia University Medical Center and New
He reported the results in Thursday'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.
The less invasive option will "possibly be a game-changer,"
said Dr. Robert Bonow of Northwestern University's Feinberg School
in Medicine in Chicago, who monitors the valves' development for
the American Heart Association and has consulted for Edwards. "In
the future, this may be the way many patients get their valves
Patients marvel at how quickly they can bounce back.
"It's like they jacked me up and put a new motor in," said
Herbert Rose, 81, of New York City. He couldn't climb a few stairs
without pain and shortness of breath before his April implant, but
said now he swims 11 to 14 laps in the local pool every other day.
Traditionally, surgeons saw a person's breastbone in half, stop
the heart, cut out the old, hardened valve and sew in a new one.
Even the best patients spend a week in the hospital and require a
few months to recuperate, but people can live well with these
valves for decades.
Transcatheter valves, made by Edwards and competitor Medtronic,
are threaded through a leg artery up to the heart - and don't
require removing the old valve. Instead, it's propped open and the
new valve is wedged into that doorway.
In the new study, 358 patients deemed inoperable were randomly
assigned to receive either the Edwards transcatheter valve or
essentially comfort care. In the first month, 5 percent of the
valve recipients died, compared with 2.8 percent of the control
group, showing the risk of any procedure in these
But a year later, half of the patients who didn't get a new
valve had died of various causes, compared with just 30 percent of
the valve recipients. Columbia's Leon said doctors saved a life for
every five patients treated - and most patients felt better and
moved better, enjoying more quality of life.
That's a meaningful survival difference, said Dr. Andrew Wang of
Duke University, who called the results exciting. Duke is among the
centers soon to begin testing Medtronic's valve.
However, 5 percent of valve recipients suffered strokes,
compared with 1 percent of the control group.
While the results are promising, the strokes are a worry, said
Dr. James McClurken of Temple University in Philadelphia: "We
don't want to have people stop having heart failure and be
debilitated by having strokes."
Doctors had seen similar stroke rates in Europe and are working
on smaller valves and better techniques to lower that risk.
Study patients will be tracked for five years, but how long
these wedged-in valves will last is a huge question if they're ever
to be used by lower-risk patients, cautioned Dr. John Conte of
Johns Hopkins University, a spokesman for the Society of Thoracic
Surgeons. He said potential patients should be evaluated by both an
interventional cardiologist and a cardiac surgeon to decide if the
new method or the old is the best option.
Standard heart valve replacement costs upward of $50,000, most
from surgical and hospitalization fees. Transcatheter valves are
anticipated to cost $20,000 to $30,000 but to bring lower hospital