Key result
The computational model of the 26 mm Evolut R TAVR device demonstrated a post-deployment mean systolic transvalvular pressure difference of 6.84 mmHg compared to 41.42 mmHg for the stenotic native valve.
Why the study?
Computer modeling and simulation is a tool to aid in TAVR device design, regulatory approval, and patient-specific care as TAVR use continues to accelerate.
Does a patient-specific immersed finite element-difference model accurately simulate the deployment and hemodynamics of the CoreValve Evolut R TAVR device?
Does a patient-specific immersed finite element-difference model accurately simulate the deployment and hemodynamics of the CoreValve Evolut R TAVR device?
Absolute Event Rate: 6.84% vs 41.42%
The developed computational fluid-structure interaction model successfully simulates TAVR deployment and hemodynamics, providing clinically relevant predictions of transvalvular pressure gradients and effective orifice areas.
May aid TAVR device design and patient-specific planning; leaves open clinical validation before adoption.
Transcatheter aortic valve replacement (TAVR) first received FDA approval for high-risk surgical patients in 2011 and has been approved for low-risk surgical patients since 2019. It is now the most common type of aortic valve replacement, and its use continues to accelerate. Computer modeling and simulation (CM&S) is a tool to aid in TAVR device design, regulatory approval, and indication in patient-specific care. This study introduces a computational fluid-structure interaction (FSI) model of TAVR with Medtronic's CoreValve Evolut R device using the immersed finite element-difference (IFED) method. We perform dynamic simulations of crimping and deployment of the Evolut R, as well as device behavior across the cardiac cycle in a patient-specific aortic root anatomy reconstructed from computed tomography (CT) image data. These IFED simulations, which incorporate biomechanics models fit to experimental tensile test data, automatically capture the contact within the device and between the self-expanding stent and native anatomy. Further, we apply realistic driving and loading conditions based on clinical measurements of human ventricular and aortic pressures and flow rates to demonstrate that our Evolut R model supports a physiological diastolic pressure load and provides informative clinical performance predictions.
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Brown et al. (2022) studied Aortic valve stenosis (n=1). Medtronic CoreValve Evolut R (computational model) vs. Stenotic native valve model was evaluated on Mean systolic transvalvular pressure difference. The computational model of the 26 mm Evolut R TAVR device demonstrated a post-deployment mean systolic transvalvular pressure difference of 6.84 mmHg compared to 41.42 mmHg for the stenotic native valve.
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