Study shows benefits of Sapien TAVR device in Aortic Valve Stenosis-Edwards Lifesciences

March 2015-Edwards Lifesciences has announced that the final five-year clinical data for high-risk Aortic Valve Stenosis patients treated with the first-generation Sapien transcatheter aortic valve in The PARTNER Trial demonstrated equivalent outcomes to traditional open-heart surgery, and no structural valve deterioration requiring intervention. Data from the world's first prospective randomized trial for transcatheter aortic valve replacement (TAVR) in patients at high risk for surgery were presented as part of the late-breaking clinical trials at the American College of Cardiology's 64th Annual Scientific Session and published in The Lancet.

This five-year data report shows equivalency between what was then a brand new procedure with a first-generation TAVR device and surgery. The high-risk patients also had durable valve performance. These data show that TAVR is an effective treatment for these patients. The authors noted no significant differences in all-cause mortality, cardiovascular mortality, stroke or need for repeat hospitalization.

See: "5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial." Michael J Mack et al. The Lancet, 15 March 2015 http://dx.doi.org/10.1016/S0140-6736(15)60308-7