Quality-of-Life and Economic Analyses of Edwards Sapien Valve in High-Risk Patients Presented at TCT

November 10, 2011—Edwards Lifesciences (Irvine, CA) announced data on the quality-of-life (QOL) impact and cost effectiveness of transcatheter aortic valve replacement (TAVR) in patients who are at high risk for surgery. These data were presented at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

The data were based on the clinical outcomes of cohort A of the PARTNER trial, a noninferiority study in which high-risk surgical patients with severe aortic stenosis were randomized to receive either TAVR with the Edwards Sapien valve, using a transfemoral or transapical approach, or open heart surgery.

As reported in Cardiac Interventions Today in June 2011, the 1-year clinical data from cohort A was published in The New England Journal of Medicine (2011;364:2187–2198). The PARTNER investigators found that the study achieved its primary endpoint at 1 year and concluded that the survival rate of patients who were treated with the Edwards Sapien valve was equivalent to those treated with surgical aortic valve replacement.

The QOL and economic analyses were performed as both a combined and access-site-specific analysis for each of the two delivery approaches for the transcatheter valve. There were 699 patients enrolled in cohort A: 244 patients underwent transfemoral TAVR, and 104 underwent transapical TAVR. The remaining 351 patients underwent surgical valve replacement.

To determine QOL data, patients were assessed with a variety of validated methods in the PARTNER trial upon enrollment and at 1-, 6- and, 12-month intervals on a broad range of factors, such as their symptoms and physical and social limitations.

The data showed that the transfemoral TAVR patients felt better at 1 month than the surgical patients. At 1 year, they had comparable results to surgical patients. The transapical TAVR patients did not demonstrate a QOL benefit at 1 month; however, the transapical and surgical groups showed comparable results at 1 year.

The economic analysis of cohort A of the PARTNER trial 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 hospital stay was > 6 days shorter than with surgery. The index admission costs were also $2,500 lower for TAVR patients. In comparing transapical TAVR with surgery, the transapical procedure was 130 minutes shorter, and the length of hospital stay was 1.5 days shorter than surgery; however, index admission costs were $11,000 higher for transapical TAVR patients.

The company stated that the benefits of transfemoral delivery with the Sapien valve are very compelling and that these results are better than expected at this early stage for the first-generation device. The company further observed that although the transapical QOL and cost-effectiveness results were not superior to surgery, these data reflect a limited number of patients at each site, and the transapical experience occurred earlier in the trial's learning curve. European experience has shown that transapical clinical results have continued to improve and provide an important alternative to surgery for high-risk patients. With continued experience and next-generation device enhancements, the QOL and cost-effectiveness results for TAVR will continue to improve, Edwards stated.

The Edwards Sapien valve received US Food and Drug Administration approval for the treatment of inoperable patients on November 2, and it is currently an investigational device for the treatment of high-risk patients in the United States.