The influence of blood velocity and vessel geometric parameters on wall shear stress.

Vascular geometry was proposed to be one risk factor of atherosclerosis (AS). When developing this hypothesis, the discussion of geometry-wall shear stress (WSS) has often been included. However, further exploration on how various geometric parameters were affecting WSS was needed. The purpose of this study was to investigate the influence degree of vessel geometric parameters and blood velocity on WSS. A computational fluid dynamics (CFD) analyses of the vertebral and basilar arteries (VA and BA, respectively) was used. Twenty patients with no plaques or vessel wall thickening at the VA and BA were included. CFD analyses using both specific vessel models and flow conditions measured by ultrasound Doppler were performed. Subsequently, CFD results were post-processed with multiple linear regression to investigate numerical correlations between geometrical and flow parameters and WSS. The results of the multiple linear regression analysis further demonstrated that the BA proximal velocity was the most influential factor positively influencing BA WSS. The lower the WSS was, the stronger the influence brought by BA average diameter would be. The regression demonstrated that the contributions brought by average diameter and proximal velocity in lower WSS regions were lower than that in higher WSS regions. Tortuosity was only positively correlated with 97.5th WSS percentile, and vessel length and curvature showed no correlation with WSS. This study quantified the influence degree of BA morphology and flow velocity on WSS, which may have practical implications for predicting hemodynamic risks.

Reproductive Seasonality, Estrous Cycle, Pregnancy, and the Recurrence of Postpartum Estrus Based on Long-Term Profiles of Fecal Sex Steroid Hormone Metabolites regarding Zoo-Housed Female Golden Takins (Budorcas taxicolor bedfordi).

This study investigates the non-invasive monitoring of the endocrine ovarian activities of captive female golden takins (Budorcas taxicolor bedfordi) based on long-term fecal sex steroid hormone metabolite dynamics. Fecal progesterone (P4) metabolite dynamics were monitored in nine females for 0.5-15 years between 2004 and 2022. Fecal estradiol-17ß (E2) and estrone (E1) metabolites were measured during certain estrous cycles, and fecal E1 metabolite concentrations were measured during all gestation periods. The breeding season of the captive animals was mainly between May and December, and they were polyestrous animals whose breeding season begins during the long-day period. The onset of the breeding season occurred slightly earlier as age increased. The mean age (±SD) at puberty based on fecal P4 metabolite dynamics was 4.1 ± 2.9 years. The first conception ages ranged from 2.3-10.2 years. The mean estrous cycle period (±SEM) was 25.4 ± 1.1 days, and mounting and mating occurred in periods of low fecal P4 metabolite levels during the breeding season. The mean gestation period (±SD) from the estimated mating date to the calving date was 253.9 ± 5.7 days, and the fecal P4 metabolite distribution during pregnancy was bimodal. Fecal estrone metabolite levels gradually increased 21 weeks before delivery, peaked during the week of delivery, and then markedly decreased in the first week after delivery. Estrus resumed in the first April-August period after delivery (mean ± SD; 103.5 ± 40.9 days) or in May of the year after delivery (421.0 ± 16.5 days). This study revealed that the estrous cycle and pregnancy of female golden takins can be determined by fecal progesterone metabolite dynamics and that fecal estrone metabolite dynamics increases toward parturition and are useful for predicting the date of delivery. This endocrinological information is important for planned breeding efforts for the golden takins.

Numerical simulation of flow behavior in basilar bifurcation computed tomography angiography.

In this study, a moving boundary deformation model based on four-dimensional computed tomography angiography (4D-CTA) with high temporal resolution is constructed, and blood flow dynamics of cerebral aneurysms are investigated by numerical simulation. A realistic moving boundary deformation model of a cerebral aneurysm was constructed based on 4D-CTA in each phase. Four hemodynamic factors (wall shear stress [WSS], wall shear stress divergence [WSSD], oscillatory shear index [OSI], and residual residence time [RRT]) were obtained from numerical simulations, and these factors were evaluated in basilar artery aneurysms. Comparison of the rigid body condition and the moving boundary condition investigating the relationship between wall displacement and hemodynamic factors clarified that the spatial-averaged WSS and maximum WSSD considering only the aneurysmal dome has a large difference between conditions during the peak systole, and there were also significant differences in OSI and RRT.

Elongation of the proximal descending thoracic aorta and associated hemodynamics increase the risk of acute type B aortic dissection.

BACKGROUND: Acute type B aortic dissection (ATBAD) is a life-threatening aortic disease. However, little information is available on predicting and understanding of ATBAD. OBJECTIVE: The study sought to explore the underlying mechanism of ATBAD by analyzing the morphological and hemodynamic characteristics related to aortic length. METHODS: The length and tortuosity of the segment and the whole aorta in the ATBAD group (n= 163) and control group (n= 120) were measured. A fixed anatomic landmark from the distal of left subclavian artery (LSA) to the superior border of sixth thoracic vertebra was proposed as the proximal descending thoracic aorta (PDTA), and the dimensionless parameter, length ratio, was introduced to eliminate the individual differences. The significant morphological parameters were filtrated and the associations between parameters were investigated using statistical approaches. Furthermore, how aortic morphology influenced ATBAD was explored based on idealized aortic models and hemodynamic-related metrics. RESULTS: The PDTA length was significantly increased in the ATBAD group compared with the control group and had a strong positive correlation with the whole aortic length (r= 0.89). The length ratio (LR2) and tortuosity (T2) of PDTA in the ATBAD group were significantly increased (0.15 ± 0.02 vs 0.12 ± 0.02 and 1.73 ± 0.48 vs 1.50 ± 0.36; P< 0.001), and LR2 was positive correlation with T2 (r= 0.73). In receiver-operating curve analysis, the area under the curve was 0.835 for LR2 and 0.641 for T2. Low and oscillatory shear (LOS) was positive correlation with LR2, and the elevated LOS occurred in the distal of LSA. CONCLUSION: Elongation of PDTA is associated with ATBAD, and the length ratio is a novel predictor. Elongated PDTA induced more aggressive hemodynamic forces, and high LOS regions may correspond to the entry tear location. The synergy of the morphological variation and aggressive hemodynamics creates contributory conditions for ATBAD.

Adult cerebral high-grade glioneuronal tumor with perivascular or pseudopapillary growth co-existing with low-grade tumor: a case report.

An unusual, small cell-predominant, high-grade glioneuronal tumor in the occipital lobe of a 49-year-old man that co-existed with a low-grade tumor is reported. The tumor consisted of two distinct components: the major component was a dense proliferation of primitive small cells showing bidirectional neuronal and glial differentiation; and the minor component consisted of a proliferation of well-differentiated astrocytes intermingled with mature neuronal cells. In the former component, perivascular pseudorosette-like or pseudopapillary growth reminiscent of ependymoma or papillary glioneuronal tumor (PGNT), respectively, was prominent, and hypertrophic astrocytic cells were located just outside the central blood vessels. Small cells were immunoreactive for Olig2, synaptophysin, and, less frequently, for glial fibrillary acidic protein. The low-grade component included Rosenthal fibers, hemosiderin deposition, and perivascular lymphocytic infiltration, thus closely resembling ganglioglioma. Cytogenetic studies did not demonstrate any mutations or rearrangements of the genes IDH1, IDH2, H3F3A, BRAF, FGFR1, or TERT promoter. The tumor recurred and spread along the ventricular surface three years after total removal. The small cell-predominant, high-grade component was considered to have evolved from the ganglioglioma-like, low-grade component. The histopathologic resemblance of the high-grade component to PGNT was a special feature.

Physics-informed neural networks (PINNs) for 4D hemodynamics prediction: An investigation of optimal framework based on vascular morphology.

Hemodynamic parameters are of great significance in the clinical diagnosis and treatment of cardiovascular diseases. However, noninvasive, real-time and accurate acquisition of hemodynamics remains a challenge for current invasive detection and simulation algorithms. Here, we integrate computational fluid dynamics with our customized analysis framework based on a multi-attribute point cloud dataset and physics-informed neural networks (PINNs)-aided deep learning modules. This combination is implemented by our workflow that generates flow field datasets within two types of patient personalized models - aorta with fine coronary branches and abdominal aorta. Deep learning modules with or without an antecedent hierarchical structure model the flow field development and complete the mapping from spatial and temporal dimensions to 4D hemodynamics. 88,000 cases on 4 randomized partitions in 16 controlled trials reveal the hemodynamic landscape of spatio-temporal anisotropy within two types of personalized models, which demonstrates the effectiveness of PINN in predicting the space-time behavior of flow fields and gives the optimal deep learning framework for different blood vessels in terms of balancing the training cost and accuracy dimensions. The proposed framework shows intentional performance in computational cost, accuracy and visualization compared to currently prevalent methods, and has the potential for generalization to model flow fields and corresponding clinical metrics within vessels at different locations. We expect our framework to push the 4D hemodynamic predictions to the real-time level, and in statistically significant fashion, applicable to morphologically variable vessels.

Modeling and hexahedral meshing of cerebral arterial networks from centerlines.

Computational fluid dynamics (CFD) simulation provides valuable information on blood flow from the vascular geometry. However, it requires extracting precise models of arteries from low-resolution medical images, which remains challenging. Centerline-based representation is widely used to model large vascular networks with small vessels, as it encodes both the geometric and topological information and facilitates manual editing. In this work, we propose an automatic method to generate a structured hexahedral mesh suitable for CFD directly from centerlines. We addressed both the modeling and meshing tasks. We proposed a vessel model based on penalized splines to overcome the limitations inherent to the centerline representation, such as noise and sparsity. The bifurcations are reconstructed using a parametric model based on the anatomy that we extended to planar n-furcations. Finally, we developed a method to produce a volume mesh with structured, hexahedral, and flow-oriented cells from the proposed vascular network model. The proposed method offers better robustness to the common defects of centerlines and increases the mesh quality compared to state-of-the-art methods. As it relies on centerlines alone, it can be applied to edit the vascular model effortlessly to study the impact of vascular geometry and topology on hemodynamics. We demonstrate the efficiency of our method by entirely meshing a dataset of 60 cerebral vascular networks. 92% of the vessels and 83% of the bifurcations were meshed without defects needing manual intervention, despite the challenging aspect of the input data. The source code is released publicly.

Effects of helical centerline stent vs. straight stent placement on blood flow velocity.

As an approach to maintain patency in femoropopliteal stenting, a helical stent configuration was proposed, which showed improved patency in clinical trials. However, the effects of helical stent placement on the flow have not been quantitatively analyzed. The purpose of this study was to estimate flow velocities to quantify the influence of helical stent placement. Helical and straight stents were implanted in three healthy pigs, and the flow velocities were estimated using the time-intensity curve (TIC) in the angiography images. The angiographic images indicated thinning of the leading edge of the contrast medium through the helically deformed artery, which was not observed in the straight stent. The slower rise of the TIC peak in the helical stent indicated faster travel of this thinner edge. Arterial expansion due to stenting was observed in all cases, and the expansion rate varied according to location. All cases of helical stent implantation showed that velocity was maintained (55.0%-71.3% velocity retention), unlike for straight stent implantation (43.0%-68.0% velocity retention); however, no significant difference was observed.

Migration of endothelial cells on the surface of anodized Ni-Ti stent strut.

Background: Stent is widely regarded as the main treatment for curing cardiovascular diseases such as stenosis. Previous research has revealed that the damage of endothelial cells (EC), i.e., the components of endothelium, during stent implantation, could lead to severe complications, such as restenosis. To prevent restenosis, enhancements have been made to surface biocompatibility to accelerate the stent endothelialization process. Anodization on the Ni-Ti is a simple and efficient surface modification method to improve the biocompatibility of the Ni-Ti stent surfaces by enhancing the surface hydrophilicity, leading to an increase in the EC activities. The EC activity is known to be affected by the blood flow. Flow change by stent structure may result in EC dysfunctions, thereby leading to restenosis. It is thus essential to investigate the EC activities resulting from the anodization on the Ni-Ti surface under flow conditions. Objective: To study the influence of the endothelialization process on the Ni-Ti stent surface through anodization. The EC attachment and morphology on the anodized stent strut were observed under both with and without the flow conditions. Method: A parallel plate flow chamber was designed to generate a constant wall shear stress (WSS) to study the flow effect on the EC behavior. The hydrophilicity of the Ni-Ti stent strut surface was enhanced by a TiO2 layer fabricated via anodization. The EC distribution on the surface of the anodized nitinol stent strut was observed after 24 h of static (without flow) and flow exposure (with flow) experiment. Results: Under the static condition, the EC density on the surface of the anodized Ni-Ti stent strut was higher compared with the control. Under the flow condition, the enhancement of the EC density on the surface of the stent strut with anodization was reduced. The EC demonstrates a long and thin spindle-shaped morphology under the flow condition. Conclusion: Unlike the static condition, the EC is demonstrating a long and thin morphology in response to the flow under the flow condition. By improving the surface hydrophilicity, the anodization could enhance the EC migration onto the strut surface, and subsequently, accelerate the Ni-Ti stent endothelialization process. The improvement of the surface hydrophilicity is lower under the flow conditions when compared with the static conditions.

Development of Ultrasound Phantom Made of Transparent Material: Feasibility of Optical Particle Image Velocimetry.

OBJECTIVE: The need for ultrasound flow phantoms to validate ultrasound systems requires the development of materials that can clearly visualize the flow inside for measurement purposes. METHODS: A transparent ultrasound flow phantom material composed of poly(vinyl alcohol) hydrogel (PVA-H) with dimethyl sulfoxide (DMSO) and water solution manufactured using the freezing method and mixed with quartz glass powder to exhibit scattering effects is proposed. To achieve transparency of the hydrogel phantom, the refractive index (RI) was changed to match that of the glass by modifying the PVA concentration and the ratio of DMSO to water in the solvent. The feasibility of optical particle image velocimetry (PIV) was verified by comparing an acrylic rectangular cross-section channel with a rigid wall. After the feasibility tests, an ultrasound flow phantom was fabricated to conduct ultrasound B-mode visualization and Doppler-PIV comparison. DISCUSSION: The results revealed that the PIV measured through PVA-H material exhibited 0.8% error in the measured maximum velocity compared with PIV through the acrylic material. B-mode images are similar to real tissue visualization with a limitation of a higher sound velocity, when compared with human tissue, of 1792 m/s. Doppler measurement of the phantom revealed approximately 120% and 19% overestimation of maximum and mean velocities, respectively, compared with those from PIV. CONCLUSION: The proposed material possesses the advantage of the single-phantom ability to improve the ultrasound flow phantom for validation of flow.

Coupled discrete phase model and Eulerian wall film model for numerical simulation of respiratory droplet generation during coughing.

Computational fluid dynamics is widely used to simulate droplet-spreading behavior due to respiratory events. However, droplet generation inside the body, such as the number, mass, and particle size distribution, has not been quantitatively analyzed. The aim of this study was to identify quantitative characteristics of droplet generation during coughing. Airflow simulations were performed by coupling the discrete phase model and Eulerian wall film model to reproduce shear-induced stripping of airway mucosa. An ideal airway model with symmetric bifurcations was constructed, and the wall domain was covered by a mucous liquid film. The results of the transient airflow simulation indicated that the droplets had a wide particle size distribution of 0.1-400 µm, and smaller droplets were generated in larger numbers. In addition, the total mass and number of droplets generated increased with an increasing airflow. The total mass of the droplets also increased with an increasing mucous viscosity, and the largest number and size of droplets were obtained at a viscosity of 8 mPa s. The simulation methods used in this study can be used to quantify the particle size distribution and maximum particle diameter under various conditions.

Reactive hyperplasia of vascular pericytes in meningioma: immunohistochemical and ultrastructural studies of two cases.

An isolated proliferation of pericytes is a unique vascular reaction seen almost exclusively in the stroma of secretory meningioma. We report the results of immunohistochemical and ultrastructural studies of a pericytic proliferation that was found in two cases of meningioma (a secretory meningioma of the sphenoid ridge and a parasagittal atypical meningioma showing predominantly fibroblastic features). Pericytes had hyperchromatic nuclei and scant cytoplasm, and showed stratification or formed small clusters within the walls of small blood vessels. They occasionally showed close contact with pseudopsammoma bodies in secretory meningioma. Pericytes showed immunoreactivity for α-smooth muscle actin but were not immunoreactive for desmin. They also exhibited characteristic ultrastructural features of pericytes, including the presence of microfilaments and abundant pinocytotic vesicles, and investment by the basal lamina. This isolated pericytic proliferation is likely a peculiar response of the vascular wall, probably induced by some cytokines secreted from neoplastic meningothelial cells. The close contact of proliferating pericytes with pseudopsammoma bodies suggests a close pathogenetic association between them. The occurrence of pericytic proliferation that was found in our second case (atypical meningioma with predominantly fibroblastic features) is exceptional and has not been documented to date.

A Software to Visualize, Edit, Model and Mesh Vascular Networks.

Computational fluid dynamics (CFD) is a key tool for a wide range of research areas, beyond the computer science community. In particular, CFD is used in medicine to measure blood flow from patient specific models of arteries. In this field, the creation of accurate meshes remains the most challenging step, as it is based on the segmentation of medical images, a time-consuming task which often requires manual intervention by medical doctors. In this context, user-friendly, interactive softwares are valuable. They enable to spread the new advances in numerical treatment to the medical community and enrich them with the expert knowledge (e.g anatomical knowledge) of clinicians. In this work, we present a user interface dedicated to the meshing of vascular networks from centerlines. It allows for the 3D visualization and edition of input centerlines, which constitute a simplified, easy-to-manipulate representation of vascular networks. The surface of the artery can be reconstructed from the modified centerlines by an editable parametric model and then meshed with high quality hexahedral elements. At every step of the process, the network can be confronted with medical images with enhanced visualization. The software will be released publicly. Clinical relevance- This tool facilitates the manual extraction and editing of vascular networks by medical doctors. It opens the generation of hexahedral meshes for computational fluid dynamics studies to non-expert users.

A Review of Functional Analysis of Endothelial Cells in Flow Chambers.

The vascular endothelial cells constitute the innermost layer. The cells are exposed to mechanical stress by the flow, causing them to express their functions. To elucidate the functions, methods involving seeding endothelial cells as a layer in a chamber were studied. The chambers are known as parallel plate, T-chamber, step, cone plate, and stretch. The stimulated functions or signals from endothelial cells by flows are extensively connected to other outer layers of arteries or organs. The coculture layer was developed in a chamber to investigate the interaction between smooth muscle cells in the middle layer of the blood vessel wall in vascular physiology and pathology. Additionally, the microfabrication technology used to create a chamber for a microfluidic device involves both mechanical and chemical stimulation of cells to show their dynamics in in vivo microenvironments. The purpose of this study is to summarize the blood flow (flow inducing) for the functions connecting to endothelial cells and blood vessels, and to find directions for future chamber and device developments for further understanding and application of vascular functions. The relationship between chamber design flow, cell layers, and microfluidics was studied.

A Parametric Study of Flushing Conditions for Improvement of Angioscopy Visibility.

During an angioscopy operation, a transparent liquid called dextran is sprayed out from a catheter to flush the blood away from the space between the camera and target. Medical doctors usually inject dextran at a constant flow rate. However, they often cannot obtain clear angioscopy visibility because the flushing out of the blood is insufficient. Good flushing conditions producing clear angioscopy visibility will increase the rate of success of angioscopy operations. This study aimed to determine a way to improve the clarity for angioscopy under different values for the parameters of the injection waveform, endoscope position, and catheter angle. We also determined the effect of a stepwise waveform for injecting the dextran only during systole while synchronizing the waveform to the cardiac cycle. To evaluate the visibility of the blood-vessel walls, we performed a computational fluid dynamics (CFD) simulation and calculated the visible area ratio (VAR), representing the ratio of the visible wall area to the total area of the wall at each point in time. Additionally, the normalized integration of the VAR called the area ratio (ARVAR) represents the ratio of the visible wall area as a function of the dextran injection period. The results demonstrate that the ARVAR with a stepped waveform, bottom endoscope, and three-degree-angle catheter results in the highest visibility, around 25 times larger than that under the control conditions: a constant waveform, a center endoscope, and 0 degrees. This set of conditions can improve angioscopy visibility.

Esophageal Intramural Pseudodiverticulosis: A Histopathological and Immunohistochemical Study of 2 Cases.

Esophageal intramural pseudodiverticulosis (EIPD) is a rare disorder characterized by an abnormal, cyst-like dilatation of the excretory ducts of esophageal submucosal glands. We aimed to elucidate the histopathological features and immunohistochemical properties of the epithelial lining of the cyst-like lesions in EIPD. We performed a histopathological and immunohistochemical study of 2 cases (one autopsy and one surgical) of EIPD. The ductal walls consisted of inner ductal cells, which were cytokeratin (CK) 7-positive and CK5/6-negative, and outer basal cells, which were CK7-negative and CK5/6-positive. The ductal epithelium frequently showed squamous metaplasia and rarely simulated a false diverticulum. Immunohistochemistry for CK7 was useful for distinction between the conditions because the surface epithelium was negative for CK7. We also confirmed that myoepithelial cells in the acinar portion of submucosal glands were well-preserved in EIPD, the finding that explained the periodic opening and closing movements of orifices of cyst-like lesions in this disorder. The immunohistochemical properties of the epithelial lining of cyst-like lesions in EIPD were essentially similar to those of the normal ducts of submucosal glands.

Disseminated Cunninghamella bertholletiae mucormycosis with protracted clinical course and formation of a large intra-ventricular mural thrombus.

We report the autopsy findings of a case of disseminated mucormycosis caused by Cunninghamella bertholletiae, a rare pathogenic fungus of the family Mucoraceae. The patient was a 49-year-old woman with B-lymphoblastic leukemia with hyperdiploidy, who died of progressive heart failure 4 months after induction chemotherapy successfully brought about complete remission of the leukemia. Granulocyte colony-stimulating factor (G-CSF) had been administered along with anti-neoplastic drugs, and her blood neutrophil count was markedly elevated. Autopsy revealed disseminated mycotic thromboembolism and abscess formation in the heart, lung, liver, kidney, and spleen. The most marked feature was a large mural thrombus in the left ventricle containing numerous fungal hyphae. In the myocardium and disseminated foci in visceral organs, giant cell-rich, fibrotic reactions to the mycotic infection were observed. Both the formation of a large intra-ventricular mural thrombus and giant cell reactions are rare findings in mucormycosis. We considered that the recovery and marked increase in neutrophil count induced by chemotherapy and G-CSF administration prolonged the clinical course and pathologically elicited an atypical, giant cell reaction to the mycotic infection. The prolonged clinical course also contributed to the formation of an unusually large intra-ventricular mural thrombus.

Efficacy, General Safety, and Joint Safety of Tanezumab in Japanese Patients with Osteoarthritis: Subgroup Analyses from Two Randomized, Phase 3 Studies.

INTRODUCTION: Tanezumab is a monoclonal antibody against nerve growth factor that is under investigation for the treatment of osteoarthritis (OA) pain. We conducted subgroup analyses of two randomized phase 3 studies to summarize efficacy, general safety, and adjudicated joint safety of tanezumab in Japanese patients with moderate-to-severe OA. METHODS: In Study 1 (NCT02528188), patients received subcutaneous tanezumab 2.5 mg or 5 mg every 8 weeks or daily oral nonsteroidal anti-inflammatory drugs (NSAID) for 56 weeks. The co-primary efficacy endpoints were change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score and WOMAC Physical Function subscale score at Week 16 (overall study and Japan-specific endpoints) as well as Patient Global Assessment (PGA)-OA score at Week 16 (overall study endpoint only). In Study 2 (NCT02709486), patients received subcutaneous tanezumab 2.5 mg, 5 mg, or placebo every 8 weeks for 24 weeks. Safety monitoring included adjudicated composite joint safety endpoint (CJSE) including rapidly progressive osteoarthritis type 1 (RPOA1), RPOA2, primary osteonecrosis, pathological fracture, or subchondral insufficiency fracture. RESULTS: For Study 1, Japanese patients (n = 200) treated with tanezumab 2.5 mg and 5 mg showed numerically greater improvements in WOMAC Pain, WOMAC Physical Function, and PGA-OA scores versus NSAID at Week 16. Incidences of treatment-emergent adverse events were generally similar between tanezumab 2.5 mg, 5 mg, and NSAID groups. In the integrated safety analysis (Studies 1 + 2; n = 306), ten patients were adjudicated to have a component of CJSE: RPOA1 [tanezumab 2.5 mg (n = 2), tanezumab 5 mg (n = 5)], RPOA2 [tanezumab 2.5 mg (n = 1), tanezumab 5 mg (n = 1)], or primary osteonecrosis [tanezumab 2.5 mg (n = 1)]. Time-adjusted adjudicated rates of RPOA1 and RPOA2 were higher with tanezumab than NSAID or placebo and increased with dose of tanezumab. CONCLUSION: Observations from the Japanese subgroup were generally consistent with the overall study populations.

Finite element analysis of the mechanical performance of a zinc alloy stent with the tenon-and-mortise structure.

BACKGROUND: Inadequate scaffolding performance hinders the clinical application of the biodegradable zinc alloy stents. OBJECTIVE: In this study we propose a novel stent with the tenon-and-mortise structure to improve its scaffolding performance. METHODS: 3D models of stents were established in Pro/E. Based on the biodegradable zinc alloy material and two numerical simulation experiments were performed in ABAQUS. Firstly, the novel stent could be compressed to a small-closed ring by a crimp shell and can form a tenon-and-mortise structure after expanded by a balloon. Finally, 0.35 MPa was applied to the crimp shell to test the scaffolding performance of the novel stent and meanwhile compare it with an ordinary stent. RESULTS: Results showed that the novel stent decreased the recoiling ratio by 70.7% compared with the ordinary stent, indicating the novel structure improved the scaffolding performance of the biodegradable zinc alloy stent. CONCLUSION: This study proposes a novel design that is expected to improve the scaffolding performance of biodegradable stents.