Transcatheter aortic valve replacement (TAVR) represents an established recent technology in a high risk patient base. To better understand TAVR performance, a fluid-structure interaction (FSI) model of a self-expandable transcatheter aortic valve was proposed. After an in vitro durability experiment was done to test the valve, the FSI model was built to reproduce the experimental test. Lastly, the FSI model was used to simulate the virtual implant and performance in a patient-specific case. Results showed that the leaflet opening area during the cycle was similar to that of the in vitro test and the difference of the maximum leaflet opening between the two methodologies was of 0.42%. Furthermore, the FSI simulation quantified the pressure and velocity fields. The computed strain amplitudes in the stent frame showed that this distribution in the patient-specific case is highly affected by the aortic root anatomy, suggesting that the in vitro tests that follow standards might not be representative of the real behavior of the percutaneous valve. The patient-specific case also compared in vivo literature data on fast opening and closing characteristics of the aortic valve during systolic ejection. FSI simulations represent useful tools in determining design errors or optimization potentials before the fabrication of aortic valve prototypes and the performance of tests.
Nitinol stents are nowadays widely used for the treatment of occlusions in peripheral arteries. However, the expansion of this indication has also highlighted some complications. In particular, the patient daily activities expose the peripheral arteries to large and cyclic deformations which may cause long-term failure of the device and consequently re-occlusion of the artery. Accordingly, the assessment of the stent fatigue rupture is of primary importance to assure the effectiveness of stenting procedure. However the fatigue behavior characterization of Nitinol for peripheral stent is a quite difficult problem because of the complexity of the in vivo solicitations the stent is subjected to and the strong nonlinearity in the material response. In this paper we approached the problem in two steps: (i) in the first step the study of the stent solicitations under realistic (physiological) conditions was performed through the use of numerical simulations which allowed sophisticated patient-specific models of the stenting procedure; (ii) in the second step, the previous results were used for the design of an experimental campaign and the following execution of the tests for the material mechanical characterization and fatigue life study. The tests were performed on Nitinol specimens derived from the same tubes used for producing a commercial peripheral stent and created following the same procedure employed for the device. As a consequence of the small dimension of the specimens, a preliminary design of the experimental test set-up was also required. The obtained results allowed a sufficiently accurate characterization of the stent material fatigue behavior in the range of interest
Nickel-Titanium (NiTi) peripheral stents are commonly used for the treatment of diseased femoropopliteal arteries (FPA). However, cyclic deformations of the vessel, induced by limb movements affect device performance and fatigue failure may occur. Stent strut fracture has been described in the literature, and is implicated as a potential causative factor in vessel re-occlusion. In this paper, a numerical approach is proposed to predict the fatigue behaviour of peripheral NiTi stents within patient-specific arterial geometries, as additional information to aid clinician intervention planning. The procedure needs some patient-specific vessel features derived from routine clinical images but, when this information is not available, reference data from the literature may be used, obviously increasing the uncertainties of the results. In addition, specific stent material data are required and can be obtained from experimental tests. Several 3D finite element models resembling stented vessel segments are built and used for fatigue analyses. For each model, axial cyclic boundary conditions are obtained from a patient-specific lumped parameter model representing the entire artery as a series of suitable springs. This allows the simplification of stiffness changes along the vessel due to plaque and stent that affect local axial deformations. Imposed local cyclic bending values depend on the stent location along the FPA. The procedure is exemplified by its application to an actual clinical case that showed two strut fractures at 18 months follow-up. Interestingly, despite the lack of some of patient-specific information and the use of data from the literature to inform the model, the numerical approach was able to interpret the in vivo fractures.
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