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

Gen Thorac Cardiovasc Surg. 2020 Jan;68(1):9-17. doi: 10.1007/s11748-019-01154-y. Epub 2019 Jun 27.

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.

Keywords: Aortic valve replacement; Cardiac surgery; Minimal invasive; Rapid deployment valves; Sutureless valves.

MeSH terms

  • Aortic Valve / surgery
  • Aortic Valve Stenosis / surgery
  • Bioprosthesis
  • Heart Valve Prosthesis Implantation / methods
  • Heart Valve Prosthesis*
  • Hemodynamics / physiology*
  • Humans
  • Prosthesis Design
  • X-Ray Microtomography