ACURATE neo™ Aortic Valve System shows safety & efficacy results comparable to SAPIEN 3

Sponsored by Boston Scientific

Multi-centre propensity-matched comparison study1 between ACURATE neo Aortic Valve System and Edwards SAPIEN 3 Transcatheter Heart Valve, published in October’s edition of the Journal of the American College of Cardiology (JACC) shows comparable procedural outcomes.

List of outcomes:

  • Observational, propensity-matched multicenter comparison of ACURATE neo and SAPIEN 3 from 3 high volume centers in Germany (DHZ Munich, UK Regensburg, Kerckhoff Klinikum Bad Nauheim)
  • 1,121 consecutive patients between Jan. 2014 and Jan. 2016 with symptomatic, severe stenosis of the native aortic valve treated with transfemoral TAVI using ACURATE neo (n = 311) or SAPIEN 3 (n = 810)
  • To increase statistical power, a 1-to-2 nearest neighbor matching was used to identify 2 control cases treated with SAPIEN 3 (n = 622) for each case treated with ACURATE neo (n = 311)
  • Endpoints: device failure and early safety composite endpoint at 30 days according to VARC-2 criteria

View full JACC publication

Key facts highlighted in the study:

Comparable performance for ACURATE neo and SAPIEN 3 with no significant differences at 30 days in safety outcomes, including the VARC-2 early safety and device failure composite endpoints.*

Morena - Publication summary: ACURATE neo vs. SAPIEN 3

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Key facts highlighted in the study

 

See interview with Won-Keun Kim, Germany - Learnings from MORENA comparitive analysis - PCR London Valves 2017

© Europa Group – Original recording at PCR London Valves 2017

References

* Comparable VARC-2 device failure composite endpoint with ACURATE neo versus SAPIEN 3 (10.9% vs. 9.6%, p=n.s.) and early safety composite endpoint (15.8% vs. 15.6%, p=n.s.).
** According to VARC-2, elevated gradients >20 mmHg are defined as mild stenosis, are assessed as Device Failure and may indicate prosthetic valve dysfunction.

  1. Husser O, et al. Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2078-2087.

SH-512201-AA NOV2017

Page published on December 2017

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With an unrestricted educational grant from Boston Scientific

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This case report does not reflect the opinion of PCR or PCRonline, nor does it engage their responsibility.