SUNDAY, April 3 (HealthDay News) -- An experimental, minimally
invasive procedure to place a new valve in a damaged heart is as
good as conventional open-heart surgery, although it comes with a
higher risk of stroke, researchers reported Sunday.
Transcatheter aortic valve implantation (TAVI) involves snaking
a valve into position in the heart via an artery in the leg or
directly through a tiny incision into the left ventricle of the
heart, similar to a balloon angioplasty procedure to clear clogged
The collapsible heart valve, called the Edwards SAPIEN valve, is
made by Edwards Lifesciences Corp., which sponsored the study.
According to Dr. Paul Teirstein, an interventional cardiologist
with Scripps Health in San Diego and a study author, the full
procedure could cost up to $50,000 -- about the same as traditional
aortic valve replacement surgery.
The device is not yet approved by the U.S. Food and Drug
Administration, although the new study results will no doubt be
taken into account when the agency makes its decision.
The findings were presented at the annual meeting of the
American College of Cardiology, in New Orleans.
Of the 200,000 people in the United States who need an aortic
valve replacement, some 100,000 can't get one because their health
is too frail to withstand traditional surgery, according to the
Previous results from the same study showed that TAVI actually
bested standard medical therapy among patients who were too sick to
undergo open-heart surgery. After one year, death rates went down
45 percent among those who underwent TAVI. Rates of patients
needing to be hospitalized again also went down (22.3 percent in
the TAVI group, vs. 44.1 percent in the open-heart surgery
In this new trial, TAVI went head-to-head with traditional
surgical valve replacement. Nearly 700 patients with aortic
stenosis (when the aortic valve, which opens to allow the aorta to
transport blood out of the heart and into the rest of the body,
does not fully open) were randomly chosen for one of the two
After one year, 24 percent of the patients undergoing TAVI had
died, compared to 27 percent in the surgery group. Eight percent
and 4 percent had strokes, respectively. The median age of the
patients was 84.
Another portion of the trial was also presented Sunday at the
cardiology conference. This found that among 358 patients, TAVI was
more cost-effective at the end of one year than traditional
Findings presented at medical meetings should be viewed as
preliminary because they typically do not undergo the same scrutiny
as research published in peer-reviewed medical journals, scientists
"The buzz here is that this is a promising new approach," said Dr. Louis Teichholz, medical director of cardiac service at Hackensack University Medical Center in New Jersey. But it's not ready yet for widespread use, he added.
Teichholz pointed out a number of considerations, even beyond
the stroke issue. Namely, this study involved very high-risk
"They had bad valves, a lot of symptoms, poor function in the heart," he said. "In the future, they [doctors] will be doing lower-risk patients so if this is going to have wide acceptance, it would have to be successful in less than the highest-risk patients."
The device is also quite large compared to second-generation
devices already being developed in Europe, he said.
Another big question: When will the FDA actually approve the
device. And the answer to that question, no one knows.
The U.S. National Institutes of Health has more on
traditional valve replacement surgery.