What is the role of self-expanding transcatheter aortic-valve bioprosthesis (CoreValve) for the treatment of aortic stenosis (AS)?

Updated: May 07, 2019
  • Author: Xiushui (Mike) Ren, MD; Chief Editor: Terrence X O'Brien, MD, MS, FACC  more...
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Answer

In June 2014, the FDA widened the indication for the self-expanding transcatheter aortic-valve bioprosthesis CoreValve to include patients with symptomatic severe aortic stenosis who are at high risk for surgery. [41, 42] The original indication approved in January 2014 was for patients considered at extreme risk and thus not surgical candidates. [41]

Approval for the expanded indication was based on data from the head-to-head High-Risk Study of the CoreValve US Pivotal Trial, in which patients who underwent TAVR with CoreValve had a significantly higher 1-year survival rate (85.8%) compared with those who underwent surgical valve replacement (80.9%). [41, 42] The rates of stroke were low and similar between the groups; however, relative to those who received a surgical valve, rates of major adverse cardiovascular/cerebral events were significantly better at 1 year and overall hemodynamic performance was better at all time points in those who underwent TAVR with CoreValve. [42]


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