Computational Investigation and Histopathological Validation of Interaction Between Stent Graft and Aorta in Retrograde Type A Dissection After TEVAR in Canine Models.

PURPOSE: Retrograde type A dissection (RTAD) after thoracic endovascular aortic repair (TEVAR) has been a major drawback of endovascular treatment. To our knowledge, no studies have simulated and validated aortic injuries caused by stent grafts (SGs) in animal models. Therefore, the aim of this study was to evaluate and quantify the SG-aorta interaction through computational simulations and to investigate the underlying mechanism through histopathological examinations. METHODS: Two custom-made Fabulous® (DiNovA Meditech, Hang Zhou, China) SGs were implanted in 2 canine aortas with a 5-mm difference in the distance in landing locations. The aortic geometries were extracted from RTAD and non-RTAD cases. A computational SG model was assembled based on the implanted SG using the software Pro-ENGINEER Wildfire 5.0 (PTC Corporation, Needham, Mass). TEVAR simulations were performed 7 times for each canine model using Abaqus software (Providence, RI, USA), and the maximum aortic stress (MAS) was calculated and compared among the groups. Three months after SG implantation, the canine aortas were harvested, and were examined using hematoxylin and eosin staining and Elastica Van Gieson (EVG) staining to evaluate histopathological changes. RESULTS: In the computational models for both canines, MAS was observed at the proximal bare stent (PBS) at aortic greater curve. The PBS generated higher stress toward the aortic wall than other SG parts did. Moreover, the MAS was significantly higher in canine No.1 than in canine No.2 (0.415±0.210 versus 0.200±0.160 MPa) (p<0.01). Notably, in canine No.1, an RTAD developed at the MAS segment, and histopathological examinations of the segment showed an intimal flap, a false lumen, elastin changes, and medial necrosis. RTAD was not observed in canine No.2. In both SG-covered aortas, medial necrosis, elastic fiber stretching, and inflammatory infiltration were seen. CONCLUSION: The characteristic MAS distribution remained at the location where the apex of the PBS interacted with the aortic wall at greater curve. RTAD histopathological examinations showed intimal damage and medial necrosis at the proximal landing zone, at the same MAS location in computational simulations. The in vivo results were consistent with the computational simulations, suggesting the MAS at greater curve may cause RTAD, and the potential application of computational simulation in the mechanism study of RTAD.

Comparison of Balloon-Expandable Valve and Self-Expandable Valve in Transcatheter Aortic Valve Replacement: A Patient-Specific Numerical Study.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive strategy for the treatment of aortic stenosis. The complex postoperative complications of TAVR were related to the type of implanted prosthetic valve, and the deep mechanism of this relationship may guide the clinical pre-operative planning. This technical brief developed a numerical method of TAVR to compare the outcome difference between balloon-expandable valve and self-expandable valve and predict the postoperative results. A complete patient-specific aortic model was reconstructed. Two prosthetic valves (balloon-expandable valve and self-expandable valve) were introduced to simulate the implantation procedure, and postprocedural function was studied with fluid-structure interaction method, respectively. Results showed similar stress distribution for two valves, but higher peak stress for balloon-expandable valve model. The balloon-expandable valve was associated with a better circular cross section and smaller paravalvular gaps area. Hemodynamic parameters like cardiac output, mean transvalvular pressure difference, and effective orifice area (EOA) of the balloon-expandable valve model were better than those of the self-expandable valve model. Significant outcome difference was found for two prosthetic valves. Balloon-expandable valve may effectively decrease the risk and degree of postoperative paravalvular leak, while self-expandable valve was conducive to lower stroke risk due to lower aortic stress. The numerical TAVR simulation process may become an assistant tool for prosthesis selection in pre-operative planning and postoperative prediction.

[The Effect of Torsion of Blood Vessel after Stent Implantation on Mechanical State of Stent].

OBJECTIVE: In daily life, the movement of the neck will cause certain deformation of the blood vessel and the stent. This study explores the quantitative influence of the torsion deformation of the blood vessel on the mechanical properties of the stent. METHODS: In the finite element simulation software Abaqus, the numerical simulation of the crimping and releasing process of the stent, the numerical simulation of the torsion process of the blood vessel with the stent, and the numerical simulation of the pressure loading process of the outer wall of the blood vessel were carried out. RESULTS: After the stent was implanted, when a load was applied to the outer surface of the blood vessel wall, when the applied load did not change, as the torsion angle increased, the smallest cross-sectional area in the blood vessel decreased. CONCLUSIONS: After the stent is placed, when the external load is fixed, the radial support capacity of the stent will decrease as the torsion angle increases.

Discrimination of intracranial aneurysm rupture status: patient-specific inflow boundary may not be a must-have condition in hemodynamic simulations.

BACKGROUND: Computational fluid dynamics (CFD) are important in evaluating the hemodynamics of intracranial aneurysm rupture, and the setting of inflow boundary conditions is critical. We evaluated intracranial aneurysm hemodynamics based on generalized versus patient-specific inflow boundary conditions to examine the effect of different hemodynamic results on the discrimination of intracranial aneurysm rupture status. METHODS: We enrolled 148 patients with 156 intracranial aneurysms. For each included aneurysm, we performed CFD simulation once based on patient-specific and once based on generalized inflow boundary conditions. First, we compared the hemodynamics of intracranial aneurysms based on different inflow boundary conditions. Then, we divided the included aneurysms into a ruptured and unruptured group and compared the hemodynamics between the two groups under patient-specific and generalized inflow boundary conditions. RESULTS: For the hemodynamic parameters using specific inflow boundary conditions, more complex flow (p = 0.002), larger minimum WSS (p = 0.024), lower maximum low WSS area (LSA) (p = 0.038), and oscillatory shear index (p = 0.002) were found. Furthermore, we compared the hemodynamics between ruptured and unruptured groups based on different inflow boundary conditions. We found that the significant hemodynamic parameters associated with rupture status were the same, including the proportion of aneurysms with flow complex and unstable flow and the minimum and maximum of LSA (p = 0.011, p = 0.003, p = 0.001 and p = 0.004, respectively). CONCLUSION: Patient-specific and generalized inflow boundary conditions of aneurysmal hemodynamics resulted in significant differences. However, the significant parameters associated with rupture status were the same in both conditions, indicating that patient-specific inflow boundary conditions may not be necessary for predicting rupture risk.

Numerical modeling and simulations of type B aortic dissection treated by stent-grafts with different oversizing ratios.

Retrograde type A dissection after thoracic endovascular aortic repair has been a major drawback of endovascular treatment. This study investigated the biomechanical mechanism of stent-graft-induced new lesions after implantation and analyzed the relationship between radial force and spring-back force of the stent-graft when it was implanted virtually under different oversizing ratios. Based on the computed tomography angiography images, a three-dimensional geometric model of a patient-specific aortic dissection was established. The stent was designed in CAD software and the stent-graft implantation procedure under different oversizing ratios was simulated in the finite element analysis software. Implantation simulations were performed six times for each stent-graft model under 0%, 3%, 6%, 9%, 12%, and 15% oversizing ratios and the peak stress of the aorta was compared among groups. It was observed that the peak stress of the aorta was located where the proximal bare stent interacted with aortic wall and its value was increased by 62.2% from 0% to 15% oversizing ratio. The conclusions are reached that the long-term higher stress in the aortic wall may lead to the emergence of new lesions in these areas, and the radial force plays a key role in the formation of a new entry in the real aorta model.

[Finite element simulation of stent implantation and its applications in the interventional planning for hemorrhagic cardio-cerebrovascular diseases].

Numerical simulation of stent deployment is very important to the surgical planning and risk assess of the interventional treatment for the cardio-cerebrovascular diseases. Our group developed a framework to deploy the braided stent and the stent graft virtually by finite element simulation. By using the framework, the whole process of the deployment of the flow diverter to treat a cerebral aneurysm was simulated, and the deformation of the parent artery and the distributions of the stress in the parent artery wall were investigated. The results provided some information to improve the intervention of cerebral aneurysm and optimize the design of the flow diverter. Furthermore, the whole process of the deployment of the stent graft to treat an aortic dissection was simulated, and the distributions of the stress in the aortic wall were investigated when the different oversize ratio of the stent graft was selected. The simulation results proved that the maximum stress located at the position where the bare metal ring touched the artery wall. The results also can be applied to improve the intervention of the aortic dissection and the design of the stent graft.

[Clinical Application and Mechanical Analysis of the Treatment of Multiple Rib Fractures and Flail Chest Using Three-wings Rib Plate].

This research evaluated the clinical efficacy of three-wings rib plate in the treatment of multiple rib fractures and flail chest with mechanical analysis and clinical verification. The model of rib and three-wings rib plate was reconstructed. The contact simulation with pretension stress was applied to the plate's fixation, and it was found that the bearable stress of the rib fractures after fixation increased from the result which indicated a good fixation efficacy of the plate. Clinical data of 53 cases of rib fractures and flail chest treated with three-wings rib plate in Shanghai Pudong Hospital of Fudan University were retrospectively analyzed. After the operation, the pain of the patients was relieved. Postoperative CT reconstruction of the chest showed good restoration of the rib fractures, which verified the clinical efficacy of three-wings rib plate. The three-wings rib plate showed a high value in clinical use for treatment of rib fractures.

Computational investigation of interaction between stent graft and aorta in retrograde type A dissection after thoracic endovascular aortic repair for type B aortic dissection.

OBJECTIVE: Retrograde type A dissection (RTAD) after thoracic endovascular aortic repair (TEVAR) has been a major drawback of endovascular treatment. To our knowledge, no studies have evaluated aortic injuries caused by stent grafts (SGs). Therefore, the aim of this study was to evaluate and to quantify the SG-aorta interaction and to analyze the risk factors for injury through computational simulation. METHODS: The aortic geometry was extracted from an RTAD case. Five SG models were assembled based on Valiant and Talent (Medtronic Vascular, Santa Rosa, Calif) SGs, and modifications were made to the original SG design by adding and removing the connecting bar. TEVAR simulations were performed seven times for each SG model with 0% and 15% oversizing ratio (OSR), and the maximum aortic stress (MAS) was calculated and compared within the groups. RESULTS: In all TEVAR models, MAS was seen at the proximal bare stent (PBS). The PBS in the Valiant and Talent SGs generated higher stress toward the aortic wall than other SG parts did. MAS was significantly higher for the 15% OSR (0.54 ± 0.07 MPa) than for the 0% OSR (1.32 ± 0.74 MPa) in 172.5-mm Valiant models. MAS was significantly higher in the Talent with connecting bar SG model (0.73 ± 0.24 MPa) than in the Talent without connecting bar SG model (0.51 ± 0.11 MPa). MAS was significantly higher in the Valiant with connecting bar SG model (0.82 ± 0.29 MPa) than in the Valiant without connecting bar SG model (0.54 ± 0.07 MPa). MAS was not significantly different in models with 172.5-mm and 140-mm Valiant SG implantations with 0% OSR (0.54 ± 0.07 MPa vs 0.60 ± 0.12 MPa) and 15% OSR (1.32 ± 0.74 MPa vs 1.12 ± 0.33 MPa). CONCLUSIONS: The characteristic MAS distribution remained at the location where the apexes of the PBS interacted with the aortic wall at its greater curve. Both higher OSR and the presence of a connecting bar can significantly increase the MAS after SG implantation. Moreover, the chronic MAS at the PBS area may injure the aortic wall, causing RTAD.

[Numerical Investigation of Particle Deposition in Human Nasal Cavity for Different Parameters of Spay Device].

Whether the drug is successfully transported to the focus area is the key to the treatment of the rhinitis disease. The efficiency of drug delivery is dependent on the design of nasal spray device. A three-dimensional model of nasal cavity was constructed from the head CT image data of a healthy human subject. The deposition of drug particles was simulated numerically by Computational Fluid Dynamics technique. The main variables of the study were the size and density of drug particles, the injecting speed of drugs etc. In conclusion, with the increase of particle intensity and injection speed, the deposition of particles in the affected area trends to increase after first slow decrease.

Flow diverter effect of LVIS stent on cerebral aneurysm hemodynamics: a comparison with Enterprise stents and the Pipeline device.

BACKGROUND: The aim of this study was to quantify the effect of the new Low-profile Visualized Intraluminal Support (LVIS®D) device and the difference of fluid diverting effect compared with the Pipeline device and the Enterprise stent using computational fluid dynamics (CFD). METHODS: In this research, we simulated three aneurysms constructed from 3D digital subtraction angiography (DSA). The Enterprise, LVIS and the Pipeline device were virtually conformed to fit into the vessel lumen and placed across the aneurysm orifice. Computational fluid dynamics analysis was performed to compare the hemodynamic differences such as WSS, Velocity and Pressure among these stents. RESULTS: Control referred to the unstented model, the percentage of hemodynamic changes were all compared to Control. A single LVIS stent caused more wall shear stress reduction than double Enterprise stents (39.96 vs. 30.51 %) and velocity (23.13 vs. 18.64 %). Significant reduction in wall shear stress (63.88 %) and velocity (46.05 %) was observed in the double-LVIS stents. A single Pipeline showed less reduction in WSS (51.08 %) and velocity (37.87 %) compared with double-LVIS stent. The double-Pipeline stents resulted in the most reduction in WSS (72.37 %) and velocity (54.26 %). Moreover, the pressure increased with minuscule extent after stenting, compared with the unstented model. CONCLUSIONS: This is the first study analyzing flow modifications associated with LVIS stents. We found that the LVIS stent has certain hemodynamic effects on cerebral aneurysms: a single LVIS stent caused more flow reductions than the double-Enterprise stent but less than a Pipeline device. Nevertheless, the double-LVIS stent resulted in a better flow diverting effect than a Pipeline device.

Phantom-based experimental validation of fast virtual deployment of self-expandable stents for cerebral aneurysms.

BACKGROUND: Endovascular intervention using a stent is a mainstream treatment for cerebral aneurysms. To assess the effect of intervention strategies on aneurysm hemodynamics, we have developed a fast virtual stenting (FVS) technique to simulate stent deployment in patient-specific aneurysms. However, quantitative validation of the FVS against experimental data has not been fully addressed. In this study, we performed in vitro analysis of a patient-specific model to illustrate the realism and usability of this novel FVS technique. METHODS: We selected a patient-specific aneurysm and reproduced it in a manufactured realistic aneurismal phantom. Three numerical simulation models of the aneurysm with an Enterprise stent were constructed. Three models were constructed to obtain the stented aneurysms: a physical phantom scanned by micro-CT, fast virtual stenting technique and finite element method. The flow in the three models was simulated using a computational fluid dynamics software package, and the hemodynamics parameters for the three models were calculated and analyzed. RESULTS: The computational hemodynamics in the patient-specific aneurysm of the three models resembled the very well. A qualitative comparison revealed high similarity in the wall shear stress, streamline, and velocity plane among the three different methods. Quantitative comparisons revealed that the difference ratios of the hemodynamic parameters were less than 10%, with the difference ratios for area average of wall shear stress in the aneurysm being very low. CONCLUSIONS: In conclusion, the results of the computational hemodynamics indicate that FVS is suitable for evaluation of the hemodynamic factors that affect treatment outcomes.

Hemodynamic alterations after stent implantation in 15 cases of intracranial aneurysm.

BACKGROUND: Stent-assisted coiling technology has been widely used in the treatment of intracranial aneurysms. In the current study, we investigated the intra-aneurysmal hemodynamic alterations after stent implantation and their association with the aneurysm location. METHODS: We first retrospectively studied 15 aneurysm cases [8 internal carotid artery-ophthalmic artery (ICA-OphA) aneurysms and 7 posterior communicating artery (PcoA) aneurysms] treated with Enterprise stents and coils. Then, based on the patient-specific geometries before and after stenting, we built virtual stenting computational fluid dynamics (CFD) simulation models. RESULTS: Before and after the stent deployment, the average wall shear stress (WSS) on the aneurysmal sac at systolic peak changed from 7.04 Pa (4.14 Pa, 15.77 Pa) to 6.04 Pa (3.86 Pa, 11.13 Pa), P = 0.001; the spatially averaged flow velocity in the perpendicular plane of the aneurysm dropped from 0.5 m/s (0.28 m/s, 0.7 m/s) to 0.33 m/s (0.25 m/s, 0.49 m/s), P = 0.001, respectively. Post stent implantation, the WSS in ICA-OphA aneurysms and PcoA aneurysms decreased by 14.4 % (P = 0.012) and 16.6 % (P = 0.018), respectively, and the flow velocity also reduced by 10.3 % (P = 0.029) and 10.5 % (P = 0.013), respectively. Changes in the WSS, flow velocity, and pressure were not significantly different between ICA-OphA and PcoA aneurysms (P > 0.05). Stent implantation did not significantly change the peak systolic pressure in either aneurysm type. CONCLUSION: After the stent implantation, both the intra-aneurysmal flow velocity and WSS decreased independently of aneurysm type (ICA-OphA and PcoA). Little change was observed in peak systolic pressure.

[Finite Element Analysis of Effect of Key Dimension of Nitinol Stent on Its Fatigue Behaviour].

To evaluate the fatigue behavior of nitinol stents, we used the finite element method to simulate the manufacture processes of nitinol stents, including expanding, annealing, crimping, and releasing procedure in applications of the clinical treatments. Meanwhile, we also studied the effect of the crown area dimension of stent on strain distribution. We then applied a fatigue diagram to investigate the fatigue characteristics of nitinol stents. The results showed that the maximum strain of all three stent structures, which had different crown area dimensions under vessel loads, located at the transition area between the crown and the strut, but comparable deformation appeared at the inner side of the crown area center. The cause, of these results was that the difference of the area moment of inertia determined by the crown dimension induced the difference of strain distribution in stent structure. Moreover, it can be drawn from the fatigue diagrams that the fatigue performance got the best result when the crown area dimension equaled to the intermediate value. The above results proved that the fatigue property of nitinol stent had a close relationship with the dimension of stent crown area, but there was no positive correlation.

Influence of morphology and hemodynamic factors on rupture of multiple intracranial aneurysms: matched-pairs of ruptured-unruptured aneurysms located unilaterally on the anterior circulation.

BACKGROUND: The authors evaluated the impact of morphological and hemodynamic factors on the rupture of matched-pairs of ruptured-unruptured intracranial aneurysms on one patient's ipsilateral anterior circulation with 3D reconstruction model and computational fluid dynamic method simulation. METHODS: 20 patients with intracranial aneurysms pairs on the same-side of anterior circulation but with different rupture status were retrospectively collected. Each pair was divided into ruptured-unruptured group. Patient-specific models based on their 3D-DSA images were constructed and analyzed. The relative locations, morphologic and hemodynamic factors of these two groups were compared. RESULTS: There was no significant difference in the relative bleeding location. The morphological factors analysis found that the ruptured aneurysms more often had irregular shape and had significantly higher maximum height and aspect ratio. The hemodynamic factors analysis found lower minimum wall shear stress (WSSmin) and more low-wall shear stress-area (LSA) in the ruptured aneurysms than that of the unruptured ones. The ruptured aneurysms more often had WSSmin on the dome. CONCLUSIONS: Intracranial aneurysms pairs with different rupture status on unilateral side of anterior circulation may be a good disease model to investigate possible characteristics linked to rupture independent of patient characteristics. Irregular shape, larger size, higher aspect ratio, lower WSSmin and more LSA may indicate a higher risk for their rupture.

Study on the optimal elastic modulus of flexible blades for right heart assist device supporting patients with single-ventricle physiologies.

Background: Patients with single-ventricle physiologies continue to experience insufficient circulatory power after undergoing palliative surgeries. This paper proposed a right heart assist device equipped with flexible blades to provide circulatory assistance for these patients. The optimal elastic modulus of the flexible blades was investigated through numerical simulation. Methods: A one-way fluid-structure interaction (FSI) simulation was employed to study the deformation of flexible blades during rotation and its impact on device performance. The process began with a computational fluid dynamics (CFD) simulation to calculate the blood pressure rise and the pressure on the blades' surface. Subsequently, these pressure data were exported for finite element analysis (FEA) to compute the deformation of the blades. The fluid domain was then recreated based on the deformed blades' shape. Iterative CFD and FEA simulations were performed until both the blood pressure rise and the blades' shape stabilized. The blood pressure rise, hemolysis risk, and thrombosis risk corresponding to blades with different elastic moduli were exhaustively evaluated to determine the optimal elastic modulus. Results: Except for the case at 8,000 rpm with a blade elastic modulus of 40 MPa, the pressure rise associated with flexible blades within the studied range (rotational speeds of 4,000 rpm and 8,000 rpm, elastic modulus between 10 MPa and 200 MPa) was lower than that of rigid blades. It was observed that the pressure rise corresponding to flexible blades increased as the elastic modulus increased. Additionally, no significant difference was found in the hemolysis risk and thrombus risk between flexible blades of various elastic moduli and rigid blades. Conclusion: Except for one specific case, deformation of the flexible blades within the studied range led to a decrease in the impeller's functionality. Notably, rotational speed had a more significant impact on hemolysis risk and thrombus risk compared to blade deformation. After a comprehensive analysis of blade compressibility, blood pressure rise, hemolysis risk, and thrombus risk, the optimal elastic modulus for the flexible blades was determined to be between 40 MPa and 50 MPa.

Numerical simulation of the distal stent graft-induced new entry after TEVAR.

The study aimed to investigate the mechanical factors for distal stent graft-induced new entry (dSINE) in aortic dissection patients and discussed these factors in conjunction with aortic morphology. Two patients (one dSINE and one non-dSINE), with the same age, gender, and type of implanted stent, were selected, then aortic morphological parameters were calculated. In addition, the stent material parameters used by the patients were also fitted. Simulations were performed based on the patient's aortic model and the stent graft used. The true lumen segment at the distal stent graft was designated as the "dSINE risk zone," and mechanical parameters (maximum principal strain, maximum principal stress) were computed. When approaching the area with higher mechanical parameters in the dSINE risk zone, dSINE patient exhibited higher values and growth rates in mechanical parameters compared to non-dSINE patient. Furthermore, dSINE patient also presented larger aortic taper ratio, stent oversizing ratio, and expansion mismatch ratio of the distal true lumen (EMRDTR). The larger mechanical parameters and growth rates in dSINE patient corresponded to a greater aortic taper ratio, stent oversizing ratio, and EMRDTR. The failure of dSINE prediction by the stent tortuosity index indicated that mechanical parameters were the fundamental reasons for dSINE development.

Preliminary establishment and validation of the inversion method for growth and remodeling parameters of patient-specific abdominal aortic aneurysm.

Traditional medical imaging and biomechanical studies have challenges in analyzing the long-term evolution process of abdominal aortic aneurysm (AAA). The homogenized constrained mixture theory (HCMT) allows for quantitative analysis of the changes in the multidimensional morphology and composition of AAA. However, the accuracy of HCMT still requires further clinical verification. This study aims to establish a patient-specific AAA growth model based on HCMT, simulate the long-term growth and remodeling (G&R) process of AAA, and validate the feasibility and accuracy of the method using two additional AAA cases with five follow-up datasets. The media and adventitia layers of AAA were modeled as mixtures composed of elastin, collagen fibers, and smooth muscle cells (SMCs). The strain energy function was used to describe the continuous deposition and degradation effect of the mixture during the AAA evolution. Multiple sets of growth parameters were applied to finite element simulations, and the simulation results were compared with the follow-up data for gradually selecting the optimal growth parameters. Two additional AAA patients with different growth rates were used for validating this method, the optimal growth parameters were obtained using the first two follow-up imaging data, and the growth model was applied to simulate the subsequent four time points. The differences between the simulated diameters and the follow-up diameters of AAA were compared to validate the accuracy of the mechanistic model. The growth parameters, especially the stress-mediated substance deposition gain factor, are highly related to the AAA G&R process. When setting the optimal growth parameters to simulate AAA growth, the proportion of simulation results within the distance of less than 0.5 mm from the baseline models is above 80%. For the validating cases, the mean difference rates between the simulated diameter and the real-world diameter are within 2.5%, which basically meets the clinical demand for quantitatively predicting the AAA growth in maximum diameters. This study simulated the growth process of AAA, and validated the accuracy of this mechanistic model. This method was proved to be used to predict the G&R process of AAA caused by dynamic changes in the mixtures of the AAA vessel wall during long-term, assisting accurately and quantitatively predicting the multidimensional morphological development and mixtures evolution process of AAA in the clinic.

Electrospun Scaffolds are Not Necessarily Always Made of Nanofibers as Demonstrated by Polymeric Heart Valves for Tissue Engineering.

In the last 30 years, there are ≈60 000 publications about electrospun nanofibers, but it is still unclear whether nanoscale fibers are really necessary for electrospun tissue engineering scaffolds. The present report puts forward this argument and reveals that compared with electrospun nanofibers, microfibers with diameter of ≈3 µm (named as "oligo-micro fiber") are more appropriate for tissue engineering scaffolds owing to their better cell infiltration ability caused by larger pores with available nuclear deformation. To further increase pore sizes, electrospun poly(ε-caprolactone) (PCL) scaffolds are fabricated using latticed collectors with meshes. Fiber orientation leads to sufficient mechanical strength albeit increases porosity. The latticed scaffolds exhibit good biocompatibility and improve cell infiltration. Under aortic conditions in vitro, the performances of latticed scaffolds are satisfactory in terms of the acute systolic hemodynamic functionality, except for the higher regurgitation fraction caused by the enlarged pores. This hierarchical electrospun scaffold with sparse fibers in macropores and oligo-micro fibers in filaments provides new insights into the design of tissue engineering scaffolds, and tissue engineering may provide living heart valves with regenerative capabilities for patients with severe valve disease in the future.

Fish swim bladders as valve leaflets enhance the durability of transcatheter aortic valve replacement devices.

Transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for inoperable patients with severe aortic stenosis (AS). However, calcification-induced limited durability restricts its application. Fish swim bladders (FSB), which are resistant to calcific degeneration, offer a viable solution to this challenge. In this study, we developed a new TAVR device using FSB as the valve leaflet. Furthermore, the in vitro durability, in vivo performance, and size selection of this TAVR device were assessed by an experimental study and finite element analysis. A self-expandable TAVR device was fabricated by suturing the FSB films into a 23 mm nitinol alloy frame. Further, hemodynamic performance, such as effective orifice area, transvalvular pressure difference and regurgitant fraction, the durability was tested by the pulsatile flow test and accelerated fatigue test, according to the ISO 5840-3. The effect of release size on hydrodynamic performance was also investigated. Finally, the in vivo performance of the TAVR device were examined using a porcine implantation model. The results showed that the strength of the FSB films satisfied the requirements for valve leaflets. The hemodynamic performance of the FSB TAVR device met the requirements of ISO 5840-3 standards. After 400 million cycles, the FSB showed no fiber loss, torn, perforation, or other valve failure phenomena. In porcine models, the devices were well-positioned, functioned well with no stenosis immediately after the operation. Collectively, we successfully developed a TAVR device with FSB as valve leaflets that exhibited good fatigue resistance. STATEMENT OF SIGNIFICANCE: The source of material for the leaflets of commercialized biological heart valves (BHVs) is mainly bovine pericardium, but this material suffers the following problems: large and uneven thickness of the material, the presence of α-Gal and Neu5Gc antigens, and the susceptibility to structural valve degradation (SVD). New material for BHVs leaflets is rarely reported. In this study, we prepared a transcatheter aortic valve (TAV) and performed long-term in vitro and short-term in vivo studies using fish swim bladder (FSB) as the leaflets. The study confirmed that FSB TAV device can complete 400 million fatigue tests and maintain the good morphology of the leaflets, and that it still maintains good functionality after a certain amount of compression, indicating that FSB is a promising material for leaflets.

Computational study of transcatheter aortic valve replacement based on patient-specific models-rapid surgical planning for self-expanding valves.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive interventional solution for treating aortic stenosis. The complex post-TAVR complications are associated with the type of valve implanted and the position of the implantation. The study aimed to establish a rapid numerical research method for TAVR to assess the performance differences of self-expanding valves released at various positions. It also aimed to calculate the risks of postoperative paravalvular leak and atrioventricular conduction block, comparing these risks to clinical outcomes to verify the method's effectiveness and accuracy. Based on medical images, six cases were established, including the aortic wall, native valve and calcification; one with a bicuspid aortic valve and five with tricuspid aortic valves. The parameters for the stent materials used by the patients were customized. High strain in the contact area between the stent and the valve annulus may lead to atrioventricular conduction block. Postoperatively, the self-expanding valve maintained a circular cross-section, reducing the risk of paravalvular leak and demonstrating favorable hemodynamic characteristics, consistent with clinical observations. The outcomes of the six simulations showed no significant difference in valve frame morphology or paravalvular leak risk compared to clinical results, thereby validating the numerical simulation process proposed for quickly selecting valve models and optimal release positions, aiding in TAVR preoperative planning based on patients'geometric characteristics.