A Multicentre Propensity Matched Analysis of Clinical Outcomes With the ACURATE Neo2 Transcatheter Aortic Valve.

Abstract

Introduction: Recent data from a large randomized trial suggested less advantageous outcomes following TAVI with the ACURATE Neo2 valve. However, this valve was more appropriately used selectively in patients with smaller annuli and lesser degrees of aortic valve calcification.

Methods: Data from the four highest-volume ACURATE Neo2 implanting sites in the UK were analyzed to compare outcomes between patients treated with the ACURATE Neo2 valve and the Edwards Sapien or Evolut Pro valves. Baseline data was collected at the time of TAVI and outcome obtained from individual patient records. 1-to-1 logit propensity matching with replacement was performed and outcome and survival rates compared. The primary outcome was a composite of death, stroke or cardiac readmission at 1-year.

Results: A total of 1277 patients were included for analysis, 500 of whom received the ACURATE Neo2. Median follow-up was 859 days (95% CI: 441-1062). The ACURATE Neo2 valve was not associated with the composite event (p = 0.56) or its subcomponents. Propensity score matching generated 481 matched pairs which did not differ in terms of the composite end point (15.6% vs. 17.9%, p = 0.34) or the individual subcomponents at 1 year. No difference was seen in survival curves (p = 0.81 for composite end point).

Conclusion: The ACURATE Neo2 valve was a good valve choice for selected patients with severe aortic stenosis. With appropriate patient selection and experienced implanting teams, the ACURATE Neo2 valve led to outcomes equivalent to the other major valve platforms in use today.