| CHICAGO, March 26
CHICAGO, March 26 Elderly patients who received
a replacement heart valve through Edwards LifeSciences Corp's
less-invasive technique had similar death rates and risk
of stroke at two years as those who got a new valve during
open-heart surgery, a study showed.
Two years after implantation with Edwards' heart valve, 33.9
percent of patients died compared with the 35 percent who
underwent open-heart surgery in the study of very old and ill
patients. The difference was not statistically significant.
The Edwards valve, called Sapien, is implanted via a
catheter threaded to the heart through a leg artery or through a
small incision between the ribs.
Patients who received the Edwards valve had nearly twice as
many strokes within the first 30 days than those who had
open-heart surgery for valve replacement.
But between the first and second year after the procedure,
the risk of stroke diminished to 1.7 percent for both groups,
said Dr. Susheel Kodali, co-director of the Heart Valve Center
at Columbia University Medical Center/New York Presbyterian
"There is clearly no late hazard with the transcatheter
valve for stroke," Kodali said in an interview.
The study, called Partner, which was funded by Edwards,
looked at 699 patients who were at high risk for surgery and
whose average age was 84 years. About 5 percent of people 75 and
older have aortic stenosis, a narrowing of the valve that
controls blood flow to the heart.
The U.S. Food and Drug Administration in November approved
Edwards' Sapien valve for patients deemed too sick to have
open-heart surgery. The company is seeking a wider indication
for the device.
The company's Sapien valve competes with Medtronic Inc's
CoreValve device in Europe.