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 Sapien.
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.