Real world study of SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Aortic Valve Replacement shows positive outcomes in aortic stenosis – Edwards Lifesciences

Edwards Lifesciences announced the results of a real-world study comparing outcomes for patients with bicuspid aortic stenosis (AS) who were treated with SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Aortic Valve Replacement (TAVR) and at low risk of death from surgery. The data show excellent outcomes at one year, with low rates of death and stroke, and no significant differences in the primary outcomes compared with the overall cohort, or those with tricuspid aortic valve disease. In a propensity-matched, real-world registry analysis of more than 6,000 patients treated with SAPIEN 3 TAVR at low surgical risk, the all-cause mortality rate for bicuspid valves was low and similar at 1 year when compared to those with tricuspid valve disease (4.6% versus 6.6%) as were stroke rates at 1 year (2.0% versus 2.1%).

In addition to the excellent survival and stroke rates, outcomes data from the TVT Registry also demonstrated a low rate of significant paravalvular leak, as well as significant and similar improvements in functional status and quality of life measures. The propensity-matched analysis comparing real-world data of bicuspid and tricuspid AS patients collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry was presented during the EuroPCR 2021 late-breaking clinical trials hotline session by Raj Makkar, M.D., Director, Interventional Cardiology, Associate Director, Smidt Heart Institute at Cedars Sinai Medical Center.