Medtronic has unveiled new clinical data that shows that patients treated with its self-expanding CoreValve Evolut R transcatheter aortic valve implantation (TAVI) device continued to experience excellent clinical outcomes at one year. Presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA), the Evolut US investigational device exemption (IDE) study showed that 241 patients deemed extreme and high risk with symptomatic severe aortic stenosis had high rates of survival (91.4%) and low rates of disabling stroke (5.1 %) at one year.
Additionally, initial use of the larger, Evolut R 34mm valve resulted in no deaths, no strokes, no vascular complications and two pacemaker implants (13.3%) at 30 days. According to press release, excellent haemodynamic performance was also observed with mean aortic gradients in the single digits (9.0 ± 4.8mmHg) at one year. There were no patients with severe paravalvular leak and low rates of moderate paravalvular leak (3.7%; n=188). Also, no incidents of embolisation or migration, valve dysfunction requiring repeat procedure, endocarditis or valve thrombosis were observed, and the pacemaker rate was 18.3% at one year.
Jeffrey J Popma (director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, USA), who presented the data at TCT, says: “The remarkable one-year results from the Evolut R IDE study, as well as the first outcomes with the 34mm valve size, further strengthens the positive body of evidence that supports the Evolut R system’s clinical performance in a wide range of patient anatomies. It is reassuring to see that patients continued to experience positive clinical outcomes with the Evolut R system at one-year follow-up.”