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Edwards Lifesciences' SAPIEN Improves Life Quality In High Risk Heart Patients

Edwards Lifesciences Corp. (EW: Quote) Thursday announced the presentation of data on the quality of life impact and cost effectiveness of transcatheter aortic valve replacement or TAVR in patients at high risk for traditional open-heart surgery.

The Edwards SAPIEN valve received FDA approval for the treatment of inoperable patients; it is currently an investigational device for the treatment of high-risk patients in the U.S.

Separately, Edwards said two-year data of inoperable patients with severe aortic stenosis treated with the SAPIEN transcatheter heart valve demonstrated a mortality difference of 24.3 percent over standard therapy. The mortality advantage had been 20 percent at one year.

Edwards reported data from clinical outcomes of Cohort A of The PARTNER Trial, demonstrating superior quality of life impact and cost effectiveness of TAVR in patients at high risk for traditional open-heart surgery.

In Cohort A, 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.

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 and at one-, six- and 12-month intervals, on a broad range of factors, 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, which is the current gold standard. With transapical TAVR which is performed via a small incision between the ribs, patients did not demonstrate a quality of life benefit at one month; however, the transapical and surgical groups showed comparable results at one year.

Michael Mussallem, Edwards' chairman and CEO, said," Even with first-generation technology, transfemoral SAPIEN improved the quality of life for patients in a meaningful way and was cost-effective. These results are better than we expected at this early stage."

An 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 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.

Clinical data published earlier this year demonstrated that the study achieved its primary endpoint at one year, concluding that survival of patients treated with the Edwards SAPIEN valve was equivalent to those treated with surgical aortic valve replacement.

Earlier Thursday, Edwards reported data from the clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve, which was approved last week by the United States Food and Drug Administration.

The data from The PARTNER Trial (Cohort B) demonstrated a widening survival benefit for SAPIEN valve patients at two years, including significantly less time spent in the hospital.

At two years, mortality for patients treated with TAVR remained superior to standard therapy, with the mortality curves diverging further to demonstrate rates of 43.3 percent versus 67.6 percent, respectively.

At one year, all-cause mortality was 30.7 percent for TAVR and 50.7 percent for standard therapy as published last year in The New England Journal of Medicine.

The company said there was a higher neurologic event rate in the transcatheter group as compared to standard therapy.

Raj Makkar, M.D., associate director of the Cedars-Sinai Heart Institute, said," Remarkably, the median days alive outside of the hospital was 699 days in TAVR patients and 355 days for standard therapy patients -- a difference of nearly one year. This demonstrates that without the SAPIEN valve, patients that survived spent significantly more time in the hospital."

In addition to the clinical advantages, the new data demonstrated that the improvement in hemodynamic performance was sustained at two years.

This trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery. Patients were evenly randomized to receive either the Edwards SAPIEN valve or standard therapy.

The new results were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

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by RTT Staff Writer

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