News | Heart Valve Technology | November 07, 2016

Early Quality of Life Improvements Sustained for Intermediate-Risk Patients Treated with Edwards Transcatheter Valves

Quality-of-life study performed alongside PARTNER II trial shows improvements in health status over surgery for transfemoral TAVR; transthoracic TAVR shows equal mortality and quality of life benefits

Edwards, Sapien 3, Sapien XT, quality of life study, PARTNER II Trial, TAVR, intermediate-risk patients, TCT 2016

November 7, 2016 — Edwards Lifesciences Corp. recently 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 28th 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 (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 one- and two-year follow-up, as well. In the transthoracic cohorts, mortality and quality of life benefits were similar to surgery.

Building off the foundational work of the PARTNER II randomized trial, a separate analysis of intermediate-risk patients treated with the Sapien 3 valve in the PARTNER II Trial demonstrated even greater health status improvements than the Sapien XT valve at one month with persistent benefits compared with surgery at one year. These data were presented by Suzanne J. Baron, M.D., M.Sc., assistant professor of medicine at the University of Missouri-Kansas City and a clinical scholar at Saint Luke’s Mid America Heart Institute.

The Sapien XT and Sapien 3 are the only transcatheter aortic valves approved for the treatment of intermediate-risk patients in the United States.

Cohen is a consultant to Edwards Lifesciences.

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