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

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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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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Keywords

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