WASHINGTON, Nov. 1, 2016 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating dramatic and sustained improvements in quality of life for severe aortic stenosis (AS) patients at intermediate surgical risk treated with Edwards transcatheter heart valves. Study results were presented at the 28 th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, D.C.
The new data, involving more than 3,000 patients enrolled in The PARTNER II Trial, showed dramatic improvements in cardiovascular health status as well as overall physical and mental well-being after transcatheter aortic valve replacement, or TAVR, with the Edwards SAPIEN XT and SAPIEN 3 valves. The health benefits with TAVR were early and sustained. "Because AS patients are generally elderly and often have multiple comorbid conditions, many of them care more about maintaining or improving their quality of life rather than simply achieving a longer life," said David J. Cohen, M.D., Professor of Medicine at the University of Missouri-Kansas City and Director of Cardiovascular Research at Saint Luke's Mid America Heart Institute, who presented the late-breaking data from the PARTNER II randomized trial at TCT. "Taken together with previous data demonstrating very low mortality and disabling stroke rates with transfemoral TAVR among patients at intermediate surgical risk, these findings demonstrate that, for such patients, TAVR provides both early and late benefits that are important from the patient's perspective." In the quality-of-life study performed alongside the PARTNER II Trial comparing TAVR with surgical aortic valve replacement, patients treated via transfemoral TAVR with the SAPIEN XT valve saw substantially greater health status improvements at one month than patients treated with surgery. Overall, 71.1 percent of patients treated with transfemoral TAVR experienced health status improvements at one month compared with just 44.7 percent of patients treated surgically. Moreover, when mortality and the extent of quality of life improvement were evaluated together, transfemoral TAVR with the SAPIEN XT valve was superior to surgery at the 1- and 2-year follow-up, as well. In the transthoracic cohorts, mortality and quality of life benefits were similar to surgery.