Substantial New Transcatheter Patient Data Presented at STS

Edwards Lifesciences has announced that a recent clinical trial studying its Sapien transcatheter heart valve found reduced mortality rates in high-risk patients with severe aortic stenosis.

A recent press release explains that patients in the trial were treated with transapical transcatheter aortic valve replacement (TAVR) during the continued access period of Cohort A of The PARTNER Trial

From the announcement:

After the randomized enrollment of 104 transapical patients in The PARTNER Trial, another 822 patients were treated transapically during the non-randomized continued access (NRCA) program that enrolled between Sept. 2009 and Sept. 2011. The average predicted risk of operative mortality at 30 days, according to the STS Adult Cardiac Database, was 12.2 percent. During continued access, mortality at 30 days was 8.2 percent and, at one year, it was 23.6 percent. (See tables below for additional details.)

The randomized portion of The PARTNER Trial had previously demonstrated that, for the patients treated with transapical TAVR, mortality at 30 days and one year was 8.7 percent and 29.1 percent, respectively. The STS score of average predicted risk of operative mortality at 30 days in this group of patients was 12.1 percent. Patients not randomized to TAVR received valve replacement via traditional open-heart surgery.

After the procedure, early symptom improvement was observed as measured by the New York Heart Association (NYHA) class, measured I through IV. At baseline, 5 percent of continued access patients were assessed as NYHA class I or II, and at 30 days, this number increased to 77 percent. At one year, the benefits of aortic valve replacement were evident in all groups, as measured by improvements in NYHA class.

Substantial New Transcatheter Patient Data Presented at STS

FT. LAUDERDALE, FL, January 30, 2012 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that new data were presented on high-risk surgical patients with severe aortic stenosis treated with transapical transcatheter aortic valve replacement (TAVR) during the continued access period of Cohort A of The PARTNER Trial. The data on the Edwards SAPIEN transcatheter heart valve were presented by Todd M. Dewey, M.D., surgical director of structural heart disease and cardiac transplantation at Medical City Dallas Hospital, during the late-breaking clinical trial abstracts at The Society of Thoracic Surgeons’ (STS) annual meeting in Ft. Lauderdale, Fla.

“It is encouraging that, in this much larger group of patients treated with transapical valve replacement, investigators observed a trend toward patients feeling better faster and having improved outcomes. We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery,” said Michael A. Mussallem, Edwards’ chairman and CEO.

After the randomized enrollment of 104 transapical patients in The PARTNER Trial, another 822 patients were treated transapically during the non-randomized continued access (NRCA) program that enrolled between Sept. 2009 and Sept. 2011. The average predicted risk of operative mortality at 30 days, according to the STS Adult Cardiac Database, was 12.2 percent. During continued access, mortality at 30 days was 8.2 percent and, at one year, it was 23.6 percent. (See tables below for additional details.)

The randomized portion of The PARTNER Trial had previously demonstrated that, for the patients treated with transapical TAVR, mortality at 30 days and one year was 8.7 percent and 29.1 percent, respectively. The STS score of average predicted risk of operative mortality at 30 days in this group of patients was 12.1 percent. Patients not randomized to TAVR received valve replacement via traditional open-heart surgery.

After the procedure, early symptom improvement was observed as measured by the New York Heart Association (NYHA) class, measured I through IV. At baseline, 5 percent of continued access patients were assessed as NYHA class I or II, and at 30 days, this number increased to 77 percent. At one year, the benefits of aortic valve replacement were evident in all groups, as measured by improvements in NYHA class.

Source:http://www.edwards.com/eu/newsroom/pages/ShowPR.aspx?PageGuid={aeae66f7-7cc8-44db-bb7b-08721aa956ca}

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