Speaking at PCR London Valves (9–11 September, London, UK) Didier Tchétché (Clinique Pasteur, Toulouse, France) reported that the one-year results of the VIVA (valve-in-valve) trial support previous 30-day findings that transcatheter valve-in-valve procedures with the CoreValve/CoreValve Evolut R device (Medtronic) are safe and effective for patients with failing bioprosthetic valves who were unable to undergo redo surgery.
According to Tchétché, VIVA was an observational, single-arm, postmarket multicentre study that evaluated valve-in-valve procedures with CoreValve/CoreValve Evolut R. The primary safety endpoint was the rate of cardiovascular death at 30 days and the primary efficacy endpoint was the lack of significant stenosis or insufficiency at one year. Given the 30-day results have already indicated that valve-in-valve procedures with the CoreValve devices are safe and effective, the aim of the present analysis was to see if the one-year results confirmed these findings and to assess the incidence of the primary efficacy endpoint.
At one year, follow-up data were available for 173 patients of 202 initially enrolled (most of whom had received the CoreValve Evolut R device: 183 vs. 19 who received CoreValve). The rate of all-cause mortality was 8.8% and the rate of cardiovascular mortality was 5.6% (at 30 days, the rates of these endpoints were 2.5% and 2.5%, respectively). The rate of all stroke was 6.2% and the rate of disabling stroke was 0.6%. There were no significant differences in mortality in between patients who had received a smaller valve (≤21mm) and those who had received a larger valve: 8.5% vs. 9% respectively (p=0.98).
At one year, 98.9% of patients met the primary efficacy endpoint (lack of significant aortic stenosis/insufficiency). Of these patients, 99% met the criteria for lack of significant aortic stenosis (mean gradient >40mmHg) and all met the criteria for lack of aortic insufficiency (> moderate severity). Furthermore, the proportion of patients with New York Heart Association (NYHA) Class IV reduced from 16.2% at baseline to 1.3% at one year. The proportion of patients in NYHA Class I increased from 3.5% at baseline to 46.5% at 12 months.
Concluding, Tchétché said: “The one-year results from the VIVA trial confirm consistent safety and efficacy results for valve-in-valve interventions using a self-expanding CoreValve/Evolut R for failed surgical bioprosthesis. Excellent haemodynamics were observed in various types of degenerated surgical bioprosthesis.”