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A mechanistic investigation of the EDWARDS INTUITY Elite valve’s hemodynamic performance

General Thoracic and Cardiovascular Surgery volume 68, pages 9–17 (2020)Cite this article

Abstract

Objective

Rapid deployment surgical aortic valve replacement has emerged as an alternative to the contemporary sutured valve technique. A difference in transvalvular pressure has been observed clinically between RD-SAVR and contemporary SAVR. A mechanistic inquiry into the impact of the rapid deployment valve inflow frame design on the left ventricular outflow tract and valve hemodynamics is needed.

Methods

A 23 mm EDWARDS INTUITY Elite rapid deployment valve and a control contemporary, sutured valve, a 23 mm Magna Ease valve, were implanted in an explanted human heart by an experienced cardiac surgeon. Per convention, the rapid deployment valve was implanted with three non-pledgeted, simple guiding sutures, while fifteen pledgeted, mattress sutures were used to implant the contemporary surgical valve. In vitro flow models were created from micro-computed tomography scans of the implanted valves and surrounding cardiac anatomy. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated pulsatile flow loop system.

Results

The rapid deployment and control valves were found to have mean transvalvular pressure gradients of 7.92 ± 0.37 and 10.13 ± 0.48 mmHg, respectively. The inflow frame of the rapid deployment valve formed a larger, more circular, left ventricular outflow tract compared to the control valve. Furthermore, it was found that the presence of the control valve’s sub-annular pledgets compromised its velocity distribution and consequently its pressure gradient.

Conclusions

The rapid deployment valve’s intra-annular inflow frame provides for a larger, left ventricular outflow tract, thus reducing the transvalvular pressure gradient and improving overall hemodynamic performance.

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Funding

This study was funded by a research grant from Edwards Lifesciences.

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Authors and Affiliations

  1. Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA, USA

    Vahid Sadri, Charles H. Bloodworth IV & Ajit P. Yoganathan

  2. George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USA

    Immanuel David Madukauwa-David & Prem A. Midha

  3. Department of Aerospace Engineering, Auburn University, Auburn, AL, USA

    Vrishank Raghav

Authors
  1. Vahid Sadri
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  2. Charles H. Bloodworth IV
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  3. Immanuel David Madukauwa-David
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  4. Prem A. Midha
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  5. Vrishank Raghav
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  6. Ajit P. Yoganathan
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Corresponding author

Correspondence to Ajit P. Yoganathan.

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Georgia Tech Research Corporation received a grant from Edwards Lifesciences to carry out this research.

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Sadri, V., Bloodworth, C.H., Madukauwa-David, I.D. et al. A mechanistic investigation of the EDWARDS INTUITY Elite valve’s hemodynamic performance. Gen Thorac Cardiovasc Surg 68, 9–17 (2020). https://doi.org/10.1007/s11748-019-01154-y

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  • DOI: https://doi.org/10.1007/s11748-019-01154-y

Keywords

  • Aortic valve replacement
  • Cardiac surgery
  • Minimal invasive
  • Rapid deployment valves
  • Sutureless valves