Edwards Sapien Valve Equivalent To Traditional Open-Heart Surgery In Severe Stenosis Patients

“…even though seriously ill patients with aortic stenosis face dismal outcomes, many do not receive life-saving surgery because of other medical risks, age or preference. This underscores the value of an alternative therapeutic option for these high-risk patients.”

In short

Edwards Lifesciences Corporation, the self-styled global leader in the science of heart valves and hemodynamic monitoring, reported that longer-term results from the high-risk Cohort A of The PARTNER Trial have now been published in The New England Journal of Medicine and concurrently presented at the American College of Cardiology’s (ACC) 61st Annual Scientific Session in Chicago.

Background

The PARTNER Trial is the first randomized, controlled trial of a transcatheter aortic valve and the only trial that has follow-up data on all patients for at least two years. Cohort A of the trial enrolled between May 2007 and Sept. 2009 and studied 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery.

Patients were evaluated by a multi-disciplinary heart team and were evenly randomized to receive either traditional open-heart surgery or the Edwards SAPIEN valve with transfemoral or transapical delivery. The study represented the initial experience with TAVR at most sites, and the use of first-generation delivery systems. The PARTNER Trial achieved its primary endpoint, concluding that survival of patients treated with the Edwards SAPIEN valve at one year was equivalent to those treated with surgery.

At two years, all-cause mortality for patients treated with Edwards’ SAPIEN transcatheter aortic valve replacement (TAVR) was 33.9 percent, which is statistically equivalent to open-heart surgical aortic valve replacement (AVR) at 35.0 percent.

Investigator comments

The authors concluded: “[T]his 2-year follow-up of patients in the PARTNER trial supports the use of TAVR as an alternative to surgery in selected high-risk patients with aortic stenosis. The two treatments were similar with respect to mortality, reduction in cardiac symptoms and improved valve hemodynamics.”

The authors noted that earlier results raised concerns that TAVR was responsible for increased early and, possibly, late strokes. However, over the reported follow-up period from The PARTNER Trial, the available data published today showed there was no significant difference in the risk of stroke between TAVR and surgery patients.

The study authors noted that there was a new and important observation of an association of paravalvular regurgitation after TAVR with late mortality, possibly related to factors including the ratio of the transcatheter-valve size to the patient’s native valve size. According to the authors, “Recently, the routine use of three-dimensional imaging techniques has improved annulus sizing, resulting in better selection of properly sized valves.”

Company comments

“We are pleased that the growing body of longer-term evidence supports the Edwards SAPIEN transcatheter valve as an important therapy for high-risk patients,” said Michael A. Mussallem, Edwards’ chairman and CEO. “Consistent with previous studies, The PARTNER Trial also demonstrated that, even though seriously ill patients with aortic stenosis face dismal outcomes, many do not receive life-saving surgery because of other medical risks, age or preference. This underscores the value of an alternative therapeutic option for these high-risk patients.”

Source: Edwards Lifesciences