Optimization of a Transcatheter Heart Valve Frame Using Patient-Specific Computer Simulation
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This study proposes a new framework to optimize the design of a transcatheter aortic valve through patient-specific finite element and fluid dynamics simulation.
Two geometrical parameters of the frame, the diameter at ventricular inflow and the height of the first row of cells, were examined using the central composite design. The effect of those parameters on postoperative complications was investigated by response surface methodology, and a Nonlinear Programming by Quadratic Lagrangian algorithm was used in the optimization. Optimal and initial devices were then compared in 12 patients. The comparison was made in terms of device performance [i.e., reduced contact pressure on the atrioventricular conduction system and paravalvular aortic regurgitation (AR)].
Results suggest that large diameters and high cells favor higher anchoring of the device within the aortic root reducing the contact pressure and favor a better apposition of the device to the aortic root preventing AR. Compared to the initial device, the optimal device resulted in almost threefold lower predicted contact pressure and limited AR in all patients.
In conclusion, patient-specific modelling and simulation could help to evaluate device performance prior to the actual first-in-human clinical study and, combined with device optimization, could help to develop better devices in a shorter period.
KeywordsComputer simulation Design of experiment Optimization Patient-specific Transcatheter aortic valve
G. Rocatello is supported by the European Commission within the Horizon 2020 Framework through the Marie Sklodowska-Curie Action-International Training Network (MSCA-ITN) European Training Networks (Project Number 642458). Computer modeling and simulation was performed using the TAVIguide framework developed at FEops NV.
Conflict of Interest
Matthieu De Beule and Peter Mortier are shareholders of FEops. Sander De Bock and Gianluca de Santis are employees of FEops.
For this retrospective study, formal consent is not required. This article does not contain any studies with animals performed by any of the authors.
Informed consent was obtained from all individual participants included in the study.
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