PARIS /PRNewswire/ - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that the first high-risk European patients to receive the advanced Edwards SAPIEN 3 transcatheter aortic valve via transfemoral delivery had a one-year survival rate of 91.6 percent, as well as low rates of stroke and paravalvular leak. The independently adjudicated data from the CE Mark study were presented at EuroPCR 2015 by John Webb, M.D., director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia.
Among the outcomes reported from the study, transfemoral SAPIEN 3 transcatheter aortic valve replacement (TAVR) was associated with a disabling stroke rate of 1.1 percent. In addition, only 2 percent of patients had moderate paravalvular leaks and there were no reports of severe leaks. There were also no observations of structural valve deterioration.
"The one-year survival rate in the transfemoral cohort is the highest reported in a multicenter, fully adjudicated TAVR study to date. These results set a new standard of care for patients at high risk for surgical aortic valve replacement. The results of the SAPIEN 3 trial via the transfemoral approach also raise the question of whether transcatheter valve replacement should be considered for approval for all elderly patients with severe aortic stenosis," said Webb, who served as a principal investigator in the trial.
The SAPIEN 3 Trial is a prospective, multicenter, non-randomized study. The one-year analysis documented outcomes of the first 150 patients treated with the SAPIEN 3 valve between Jan. 2013 and Nov. 2013 at 16 centers in Europe and Canada*. Access approaches included transfemoral (n=96) and transapical/transaortic (n=54), as determined by the Heart Team. At baseline, the patients in the alternative access group were significantly sicker than the transfemoral group. All-cause mortality in the alternative access group was reported as 24.3 percent in the as-treated population. The SAPIEN 3 Trial is designed to evaluate patients annually for five years.
The SAPIEN 3 valve can be delivered through a low-profile 14 French expandable sheath (eSheath). It also has an outer skirt – a cuff of fabric that provides a seal at the bottom of the frame that is designed to reduce paravalvular aortic regurgitation.
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. 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.
