Edwards Sapien Valve Demonstrates Improved Quality of Life in Inoperable Patients

November 15, 2010—Edwards Lifesciences Corporation (Irvine, CA) announced that in addition to the improved survival seen in inoperable aortic stenosis patients treated with the Edwards Sapien transcatheter heart valve in the PARTNER trial, a newly released analysis of the same patients showed that they also experienced substantially better quality of life. The results were presented at the American Heart Association's Scientific Sessions 2010 in Chicago.

The PARTNER trial is a randomized, controlled pivotal trial of the Edwards Sapien transcatheter aortic heart valve. The trial successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization. The trial's Cohort B results were presented on September 23 at the Transcatheter Cardiovascular Therapies scientific symposium in Washington, DC and were published in the New England Journal of Medicine (2010; 363:1597–1607). This was reported at that time in Cardiac Interventions Today.

According to the company, the 358 patients in this substudy analysis were assessed upon enrollment in the PARTNER trial and at follow-up intervals of 1, 6, and 12 months for a broad range of factors, such as their symptoms, physical and social limitations, and heart failure-related quality of life. Several scientifically validated surveys were used to collect information from the patient's own perspective, including the Kansas City Cardiomyopathy Questionnaire, the SF-12 Health Status Survey, and the EQ-5D.

The investigators found that on a scale from 0 to 100, in which a 20-point improvement is considered substantial, the Edwards Sapien transcatheter valve patients had a 25-point improvement in quality-of-life scores compared to the control group at 1 year, as scored by the Kansas City Cardiomyopathy Questionnaire. Similarly positive results were shown with the other two surveys.

“The degree and immediacy of the quality-of-life improvement was striking, with significant benefits seen as early as 1 month,” commented David J. Cohen, MD, principal investigator for the quality-of-life substudy. “By 1 year, patients experienced both cardiovascular and physical health benefits, with the physical improvements roughly comparable to a 10-year reduction in age. Quality of life is critically important, particularly for patients like those in this trial—and they are not just surviving, but also thriving.”

In the United States, the Edwards Sapien transcatheter aortic valve is an investigational device and is not yet commercially available, the company advised.