Quality of Life and Economic Analyses of Edwards SAPIEN Valve in High-Risk Patients Featured at TCT
SAN FRANCISCO, CA, November 10, 2011 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that data were presented on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) in patients at high risk for traditional open-heart surgery. These data were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The data were based on the clinical outcomes of Cohort A of The PARTNER Trial, a non-inferiority study in which patients with severe aortic stenosis were randomized to receive either TAVR with the Edwards SAPIEN valve (using a transfemoral or transapical approach) or open-heart surgery. Clinical data published earlier this year in The New England Journal of Medicine demonstrated that the study achieved its primary endpoint at one year, concluding that survival of patients treated with the Edwards SAPIEN valve was equivalent to those treated with surgical aortic valve replacement.
The quality of life (QOL) and economic analyses were performed as both a combined and access-site specific analysis for each of the two transcatheter valve delivery approaches. There were 699 patients enrolled in Cohort A: 244 patients received transfemoral TAVR and 104 received transapical TAVR. All remaining patients received surgical valve replacement.