Performance characterization and biocompatibility assessment of silicone polyurethanes for polymer heart valve applications.

Silicone polyurethanes have gained widespread application in the biomedical field due to their excellent biocompatibility. This study comprehensively investigates four silicone polyurethane materials suitable for polymer heart valves, each exhibiting distinct chemical compositions and structural characteristics, leading to significant differences, particularly in mechanical performance and biocompatibility. Surface analysis reveals an elevated surface silicon element content in all materials compared to the bulk, indicating a migration of silicon elements towards the surface, providing a structural basis for enhancing biological stability and biocompatibility. However, higher silicon content leads to a decrease in mechanical performance, potentially resulting in mechanical failure and rupture in artificial heart valves. Concerning biocompatibility, an increase in silicone content diminishes the material's adsorption capability for cells and proteins, consequently improving its biocompatibility and biological stability. In summary, while high silicone content leads to a reduction in mechanical performance, the formation of a "silicon protective layer" on the material surface mitigates cell and protein adsorption, thereby enhancing biocompatibility and biological stability. Through comprehensive testing of the four silicone polyurethane materials, this study aims to provide insightful perspectives and methods for selecting materials suitable for polymer heart valves. Additionally, the thorough performance exploration of these materials serves as a crucial reference for the performance assessment and biocompatibility research of polymeric artificial heart valve materials.

A novel method for noninvasive quantification of fractional flow reserve based on the custom function.

Boundary condition settings are key risk factors for the accuracy of noninvasive quantification of fractional flow reserve (FFR) based on computed tomography angiography (i.e., FFRCT). However, transient numerical simulation-based FFRCT often ignores the three-dimensional (3D) model of coronary artery and clinical statistics of hyperemia state set by boundary conditions, resulting in insufficient computational accuracy and high computational cost. Therefore, it is necessary to develop the custom function that combines the 3D model of the coronary artery and clinical statistics of hyperemia state for boundary condition setting, to accurately and quickly quantify FFRCT under steady-state numerical simulations. The 3D model of the coronary artery was reconstructed by patient computed tomography angiography (CTA), and coronary resting flow was determined from the volume and diameter of the 3D model. Then, we developed the custom function that took into account the interaction of stenotic resistance, microcirculation resistance, inlet aortic pressure, and clinical statistics of resting to hyperemia state due to the effect of adenosine on boundary condition settings, to accurately and rapidly identify coronary blood flow for quantification of FFRCT calculation (FFRU). We tested the diagnostic accuracy of FFRU calculation by comparing it with the existing methods (CTA, coronary angiography (QCA), and diameter-flow method for calculating FFR (FFRD)) based on invasive FFR of 86 vessels in 73 patients. The average computational time for FFRU calculation was greatly reduced from 1-4 h for transient numerical simulations to 5 min per simulation, which was 2-fold less than the FFRD method. According to the results of the Bland-Altman analysis, the consistency between FFRU and invasive FFR of 86 vessels was better than that of FFRD. The area under the receiver operating characteristic curve (AUC) for CTA, QCA, FFRD and FFRU at the lesion level were 0.62 (95% CI: 0.51-0.74), 0.67 (95% CI: 0.56-0.79), 0.85 (95% CI: 0.76-0.94), and 0.93 (95% CI: 0.87-0.98), respectively. At the patient level, the AUC was 0.61 (95% CI: 0.48-0.74) for CTA, 0.65 (95% CI: 0.53-0.77) for QCA, 0.83 (95% CI: 0.74-0.92) for FFRD, and 0.92 (95% CI: 0.89-0.96) for FFRU. The proposed novel method might accurately and rapidly identify coronary blood flow, significantly improve the accuracy of FFRCT calculation, and support its wide application as a diagnostic indicator in clinical practice.

Finite Element Analysis of the Non-Uniform Degradation of Biodegradable Vascular Stents.

Most of the studies on the finite element analysis (FEA) of biodegradable vascular stents (BVSs) during the degradation process have limited the accuracy of the simulation results due to the application of the uniform degradation model. This paper aims to establish an FEA model for the non-uniform degradation of BVSs by considering factors such as the dynamic changes of the corrosion properties and material properties of the element, as well as the pitting corrosion and stress corrosion. The results revealed that adjusting the corrosion rate according to the number of exposed surfaces of the element and reducing the stress threshold according to the corrosion status accelerates the degradation time of BVSs by 26% and 25%, respectively, compared with the uniform degradation model. The addition of the pitting model reduces the service life of the BVSs by up to 12%. The effective support of the stent to the vessel could reach at least 60% of the treatment effect before the vessel collapsed. These data indicate that the proposed non-uniform degradation model of BVSs with multiple factors produces different phenomena compared with the commonly used models and make the numerical simulation results more consistent with the real degradation scenario.

A computational analysis of potential aortic dilation induced by the hemodynamic effects of bicuspid aortic valve phenotypes.

BACKGROUND AND OBJECTIVES: The bicuspid aortic valve (BAV) is a major risk factor for the progression of aortic dilation (AD) because of the induced abnormal blood flow environment in aorta. The differences in the development of AD induced by BAV phenotypes remains unclear. Therefore, the objective of this study was to assess the potential locations of AD induced by different phenotypes of BAV. The different effects of opening orifice area and leaflet orientation on ascending aortic hemodynamics in Type-1 BAV was investigated by means of numerical simulation. METHODS: Finite element dynamic analysis was performed on tricuspid aortic valve (TAV) and BAV models to simulate the motion of the leaflets and obtain the geometrical characteristics of AV at peak systole as a reference, which were used for aortic models. Then, four sets of aortic fluid models were designed according to the leaflet fusion types [TAV; BAV (left-right-coronary cusp fusion, LR; right-non-coronary cusp fusion, RN; left-non-coronary cusp fusion, LN)], and the computational fluid dynamics method was applied to compare the hemodynamic differences within the aorta at peak systole. RESULTS: The maximum opening area of BAV was significantly reduced, resulting in alterations in aortic hemodynamics compared with TAV. The velocity streamlines were essentially parallel to the aortic wall in TAV. The average pressure and wall shear stress in aorta tend to be stable. In contrary, the eccentricity of BAV orifice jet resulted in high-velocity flow directed toward the ascending aorta (AA) wall and aortic arch for LR and LN; RN features an asymmetrical velocity distribution toward the outer bend of the middle AA, and eccentric flow tends to impact the distal AA. As the flow angle is associated with distinct flow impingement locations, different degrees of WSS and pressure concentration occur along the aortic wall from the AA to the aortic arch in three BAV types. CONCLUSIONS: The BAV morphotype affects the aortic hemodynamics, and the abnormal blood flow associated with BAV may play a role in AD. The different BAV phenotypes determine the direction of blood flow jet and change the expression of dilation. LR is likely to cause dilation of the tubular AA; RN results in dilation of the middle AA to proximal aortic arch; and LN causes an increased incidence of the tubular AA and the proximal aortic arch.

Research on the Method of Predicting Fractional Flow Reserve Based on Multiple Independent Risk Factors.

The use of diameter stenosis (DS), as revealed by coronary angiography, for predicting fractional flow reserve (FFR) usually results in a high error rate of detection. In this study, we investigated a method for predicting FFR in patients with coronary stenosis based on multiple independent risk factors. The aim of the study was to improve the accuracy of detection. First, we searched the existing literature to identify multiple independent risk factors and then calculated the corresponding odds ratios. The improved analytic hierarchy process (IAHP) was then used to determine the weighted value of each independent risk factor, based on the corresponding odds ratio. Next, we developed a novel method, based on the top seven independent risk factors with the highest weighted values, to predict FFR. This model was then used to predict the FFR of 253 patients with coronary stenosis, and the results were then compared with previous methods (DS alone and a simplified scoring system). In addition to DS, we identified a range of other independent risk factors, with the highest weighted values, for predicting FFR, including gender, body mass index, location of stenosis, type of coronary artery distribution, left ventricular ejection fraction, and left myocardial mass. The area under the receiver-operating characteristic curve (AUC) for the newly developed method was 84.3% (95% CI: 79.2-89.4%), which was larger than 65.3% (95% CI: 61.5-69.1%) of DS alone and 74.8% (95% CI: 68.4-81.2%) of the existing simplified scoring system. The newly developed method, based on multiple independent risk factors, effectively improves the prediction accuracy for FFR.

Effect of Valve Height on the Opening and Closing Performance of the Aortic Valve Under Aortic Root Dilatation.

Patients with aortic valve disease can suffer from valve insufficiency after valve repair surgery due to aortic root dilatation. The paper investigates the effect of valve height (Hv) on the aortic valve opening and closing in order to select the appropriate range of Hv for smoother blood flow through the aortic valve and valve closure completely in the case of continuous aortic root dilatation. A total of 20 parameterized three-dimensional models of the aortic root were constructed following clinical surgical guidance. Aortic annulus diameter (DAA) was separately set to 26, 27, 28, 29, and 30 mm to simulate aortic root dilatation. HV value was separately set to 13.5, 14, 14.5, and 15 mm to simulate aortic valve alterations in surgery. Time-varying pressure loads were applied to the valve, vessel wall of the ascending aorta, and left ventricle. Then, finite element analysis software was employed to simulate the movement and mechanics of the aortic root. The feasible design range of the valve size was evaluated using maximum stress, geometric orifice area (GOA), and leaflet contact force. The results show that the valve was incompletely closed when HV was 13.5 mm and DAA was 29 or 30 mm. The GOA of the valve was small when HV was 15 mm and DAA was 26 or 27 mm. The corresponding values of the other models were within the normal range. Compared with the model with an HV of 14 mm, the model with an HV of 14.5 mm could effectively reduce maximum stress and had relatively larger GOA and less change in contact force. As a result, valve height affects the performance of aortic valve opening and closing. Smaller HV is adapted to smaller DAA and vice versa. When HV is 14.5 mm, the valve is well adapted to the dilatation of the aortic root to enhance repair durability. Therefore, more attention should be paid to HV in surgical planning.

Multiscale Modeling of Vascular Remodeling Induced by Wall Shear Stress.

OBJECTIVE: Hemodynamics-induced low wall shear stress (WSS) is one of the critical reasons leading to vascular remodeling. However, the coupling effects of WSS and cellular kinetics have not been clearly modeled. The aim of this study was to establish a multiscale modeling approach to reveal the vascular remodeling behavior under the interaction between the macroscale of WSS loading and the microscale of cell evolution. METHODS: Computational fluid dynamics (CFD) method and agent-based model (ABM), which have significantly different characteristics in temporal and spatial scales, were adopted to establish the multiscale model. The CFD method is for the second/organ scale, and the ABM is for the month/cell scale. The CFD method was used to simulate blood flow in a vessel and obtain the WSS in a vessel cross-section. The simulations of the smooth muscle cell (SMC) proliferation/apoptosis and extracellular matrix (ECM) generation/degradation in a vessel cross-section were performed by using ABM. During the simulation of the vascular remodeling procedure, the damage index of the SMC and ECM was defined as deviation from the obtained WSS. The damage index decreased gradually to mimic the recovery of WSS-induced vessel damage. RESULTS: (1) The significant wall thickening region was consistent with the low WSS region. (2) There was no evident change of wall thickness in the normal WSS region. (3) When the damage index approached to 0, the amount and distribution of SMCs and ECM achieved a stable state, and the vessel reached vascular homeostasis. CONCLUSION: The established multiscale model can be used to simulate the vascular remodeling behavior over time under various WSS conditions.

[Effect of sinus diameter on the opening and closing performance of aortic valve under the expansion of aortic root].

This study aims to explore the effect of aortic sinus diameter on aortic valve opening and closing performance in the case of no obvious disease of aortic valve and annulus and continuous dilation of aortic root. A total of 25 three-dimensional aortic root models with different aortic sinus and root diameters were constructed according to the size of clinical surgical guidance. The valve sinus diameter DS is set to 32, 36, 40, 44 and 48 mm, respectively, and the aortic root diameter DA is set to 26, 27, 28, 29 and 30 mm, respectively. Through the structural mechanics calculation with the finite element software, the maximum stress, valve orifice area, contact force and other parameters of the model are analyzed to evaluate the valve opening and closing performance under the dilated state. The study found that aortic valve stenosis occurs when the DS = 32 mm, DA = 26, 27 mm and DS = 36 mm, DA = 26 mm. Aortic regurgitation occurs when the DS = 32, 36 and 40 mm, DA = 30 mm and DS = 44, 48 mm, DA = 29, 30 mm. The other 15 models had normal valve movement. The results showed that the size of the aortic sinus affected the opening and closing performance of the aortic valve. The smaller sinus diameter adapted with the larger root diameter and the larger sinus diameter adapted with the smaller root diameter. When the sinus diameter is 40 mm, the mechanical performance of the valve are good and it can well adapt with the relatively large range of aortic root dilation.