Substantial New Sapien Study Data Presented at STS


New data have been presented on high-risk surgical patients with severe aortic stenosis treated with transapical transcatheter aortic valve replacement (TAVR), compared with patients receiving the valve replacement in traditional open surgical fashion. The data suggest that in an expanded patient treatment group treated after the completion of the PARTNER patient group, there was a trend towards reduced mortality at 30 days and 1 year compared with open surgical valve replacement and a reduced risk of stroke.


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, which took place over the weekend.

Following CE mark approval in 2009, the Edwards SAPIEN transcatheter heart valve received FDA approval in November 2011 for the treatment of certain inoperable patients; it remains an investigational device for the treatment of high-risk patients in the U.S.

The study

In Cohort A of the PARTNER Trial, high-risk surgical patients were randomized to determine whether a less-invasive transcatheter approach could provide equivalent clinical results to traditional open-heart surgery. Patients not randomized to TAVR received valve replacement via traditional open-heart surgery.

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.

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.

After the procedure, early symptom improvement was observed as measured by the New York Heart Association (NYHA) class, measured I through IV. NYHA class I is defined as asymptomatic heart disease; class II is comfortable at rest, with symptoms during normal activity; class III is comfortable at rest, with symptoms during a less than normal level of activity; class IV is symptomatic at rest.

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. In the NRCA group however there was a clear trend towards improved 30 day outcomes with a smaller benefit at 1 year.

Company comments 

“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.

Source: Edwards Lifesciences