SAN FRANCISCO, March 11 Patients who received
the original version of Edwards Lifesciences Corp's
non-invasive heart valve replacement system had a nearly
identical death rate after three years as those who had
open-heart surgery, with no increased risk of stroke, according
to results from a clinical trial.
The data, presented on Monday at the American College of
Cardiology scientific meeting in San Francisco, should provide
doctors with some reassurance about the durability of the
Edwards transcatheter aortic valve replacement (TAVR), known as
Three years after implantation, the death rates for any
reason in high-risk patients deemed eligible for surgery was
nearly identical at 44.2 percent for Sapien and 44.8 percent for
those who got new valves via standard open-heart surgery.
Heart related death rates also mirrored each other at three
years - 30.1 percent for Sapien versus 30.2 percent for surgery.
"It gives me a level of comfort that ... the late mortality
is largely associated not with the device implanted, but with
the intrinsic patient co-morbidities," said Dr. Martin Leon, a
co-lead investigator of the trial.