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30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study.

Hemal Gada1, Ramzi F Khalil2, Stanley J Chetcuti3

  • 1University of Pittsburgh Medical Center Central Pennsylvania Hospitals, Harrisburg, Pennsylvania, USA.

JACC. Cardiovascular Interventions
|June 30, 2025
PubMed
Summary

Transcatheter aortic valve replacement (TAVR) with the Evolut FX device using the cusp overlap technique (COT) showed low permanent pacemaker implantation (PPI) rates and no severe aortic regurgitation (AR) at one year. Post-procedure computed tomography (CT) confirmed good valve alignment.

Keywords:
commissural alignmentcusp overlap techniquedeployment techniquepacemaker implantation

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Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Devices

Background:

  • The Optimize PRO study previously showed transcatheter aortic valve replacement (TAVR) using the cusp overlap technique (COT) yielded low rates of permanent pacemaker implantation (PPI) and no moderate or severe aortic regurgitation (AR).
  • This follow-up study aimed to further assess outcomes with the Evolut FX device and COT.

Purpose of the Study:

  • To evaluate the clinical outcomes of Evolut FX device implantation using the COT in patients with severe aortic stenosis.
  • To assess the accuracy of postprocedural computed tomography (CT) in evaluating transcatheter aortic valve orientation and alignment.

Main Methods:

  • A prospective, multicenter, nonrandomized study involving 151 patients undergoing TAVR with the Evolut FX device and COT.
  • Evaluation of COT adherence, comparison of CT-assessed valve orientation with fluoroscopic guidance, and assessment of commissural and coronary alignment.

Main Results:

  • The refined COT adherence was 86.0%, with a median length of stay of 1 day.
  • At 1 year, the rate of all-cause mortality or stroke was 7.5%, and the PPI rate was 8.8%.
  • No severe AR was observed at 1 year. CT and fluoroscopy showed good agreement for commissural alignment (86.9% vs 91.5%), with CT indicating no severe coronary misalignment in over 92% of patients.

Conclusions:

  • Implantation of the Evolut FX device using a refined COT is associated with favorable clinical outcomes, including low PPI rates and no severe AR at one year.
  • Postprocedural CT is a reliable tool for assessing valve alignment, confirming consistent commissural and coronary positioning.