Performance and Use of the Evolut FX Transcatheter Aortic Valve System: Updated Results from the Evolut FX Limited Market Release Clinical Survey | SCAI

Why is this study important? 

  • Technological improvements in Transcatheter Aortic Valve Replacement (TAVR) delivery systems are ongoing.
  • However, it is important to examine their impact in real- world patient use.

What question was this study supposed to answer? 

  • Next generation supra-annular, self-expanding Evolut FX TAVR system is redesigned to improve deliverability, trackability, and deployment accuracy.
  • The study evaluated the impact of these enhancements in patients undergoing TAVR.
  • Physician feedback on the Evolut FX TAVR system was obtained from June 24 to September 11, 2022, at 69 centers across the USA using a benchmark survey.
  • Survey results compared physician experiences with the Evolut FX system as compared to the older Evolut PRO+ system using descriptive statistics.

What did the study show?

  • The clinical survey results showed that 96% of transfemoral cases achieved commissural alignment on cusp overlap view based on TAV marker orientation and there was no noticeable ventricular movement of the Evolut FX device in 79% of cases. Additionally, 79% of the operators rated the Evolut FX device as having a more predictable deployment.
  • In summary, the next generation supra-annular, self-expanding Evolut FX TAVR system had better deliverability, deployment symmetry and stability, and documented commissural alignment as compared to the older Evolut PRO+ system.
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