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Broad benefits for Aortic Stenosis from transcatheter heart valve

Edwards Lifesciences Corporation, has 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 shows that they also experienced substantially better quality of life. These results were presented at the American Heart Association’s Scientific Sessions 2010.

with significant benefits seen as early as one month. By one year, patients experienced both cardiovascular and physical health benefits, with the physical improvements roughly comparable to a 10-year reduction in age,” said David J. Cohen, M.D., M.Sc., Director of Cardiovascular Research at St. Luke’s Mid America Heart and Vascular Institute, and principal investigator for the quality of life sub-study that was funded by Edwards. “Quality of life is critically important, particularly for patients like those in this trial — and they are not just surviving, but also thriving.”

The 358 patients were assessed upon enrollment in The PARTNER Trial, and at follow-up intervals of one month, six months and 12 months, on 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 (KCCQ), the SF-12 Health Status Survey and the EQ-5D (EuroQOL).

On a scale from 0 to 100, where a 20-point improvement is considered substantial, the Edwards transcatheter valve patients had a 25-point improvement in quality of life scores compared to the control group at one year, using the KCCQ instrument. Similarly positive results were demonstrated for the other two surveys.

The PARTNER Trial is the first randomized, controlled pivotal trial of a transcatheter aortic heart valve. The Edwards SAPIEN transcatheter valve is an investigational device in the United States.

Published on: December 9, 2010

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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