Study shows positive benefits of Sapien 3 transcatheter aortic valve in AVS patients-Edwards Lifesciences

Edwards Lifesciences has announced that 30-day outcomes for intermediate-risk Aortic Valve Stenosis patients treated transfemorally with the Sapien 3 transcatheter aortic valve at centers in Europe and Canada demonstrated very low mortality and stroke rates, and no severe paravalvular leaks. These independently adjudicated data are consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States.

In the multi-center study of 101 intermediate-risk patients, all-cause mortality was 1 percent. The frequency of other important complications was also low: the disabling stroke rate was 2 percent, major vascular complications were 2 percent and the permanent pacemaker rate was 4 percent. The investigators also noted that the Sapien 3 valve had excellent hemodynamic performance, with very low incidence of significant paravalvular regurgitation, as only 2.3 percent of patients had moderate paravalvular leaks and there were no reports of severe leaks. The study was presented at EuroPCR 2015.

Comment: The Sapien 3 valve was approved in Europe in January 2014 for the treatment of high-risk and non-operable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in any country. The valve is an investigational device not yet available commercially in the United States. It is currently being evaluated in the U.S. in The PARTNER II Trial.