November 14, 2011 — Edwards Lifesciences Corp. announced data were presented on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The data focused on patients at high risk for traditional open-heart surgery. TCT was 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 involving patients with severe aortic stenosis. Patients 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 the study achieved its primary endpoint at one year. It concluded that survival of patients treated with the 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.
Patients were assessed with a variety of validated methods upon enrollment in the PARTNER trial and at one-, six- and 12-month intervals. A broad range of factors were utilized, such as their symptoms and physical and social limitations.
In comparing transfemoral TAVR with surgery, the transfemoral patients felt better at one month, and had comparable results at one year to surgical aortic valve replacement, the current gold standard. With transapical TAVR, patients did not demonstrate a quality of life benefit at one month; however, the transapical and surgical groups showed comparable results at one year.
An economic analysis of Cohort A was performed to determine the relative value of TAVR versus surgery in high-risk patients. The transfemoral TAVR procedure was 87 minutes faster and the length of the hospital stay was more than six days shorter than surgery. The index admission costs were also $2,500 lower in TAVR patients.
In comparing transapical TAVR with surgery, the transapical procedure was 130 minutes shorter and the length of hospital stay was one-and-a-half days less than surgery. However, index admission costs were $11,000 higher in transapical TAVR patients.
The Sapien valve received U.S. Food and Drug Administration (FDA) approval for the treatment of inoperable patients; it is currently an investigational device for the treatment of high-risk patients in the United States.
For more information: www.edwards.com