Virtual stenting workflow with vessel-specific initialization and adaptive expansion for neurovascular stents and flow diverters

Endovascular intervention using traditional neurovascular stents and densely braided flow diverters (FDs) have become the preferred treatment strategies for traditionally challenging intracranial aneurysms. Modeling stent and FD deployment in patient-specific aneurysms and its flow modification results prior to the actual intervention can potentially predict the patient outcome and treatment optimization. We present a clinically focused, streamlined virtual stenting workflow that efficiently simulates stent and FD treatment in patient-specific aneurysms based on expanding a simplex mesh structure. The simplex mesh is generated using an innovative vessel-specific initialization technique, which uses the patient’s parent artery diameter to identify the initial position of the simplex mesh inside the artery. A novel adaptive expansion algorithm enables the acceleration of deployment process by adjusting the expansion forces based on the distance of the simplex mesh from the parent vessel. The virtual stenting workflow was tested by modeling the treatment of two patient-specific aneurysms using the Enterprise stent and the Pipeline Embolization Device (commercial FD). Both devices were deployed in the aneurysm models in a few seconds. Computational fluid dynamics analyses of pre- and post-treatment aneurysmal hemodynamics show flow reduction in the aneurysmal sac in treated aneurysms, with the FD diverting more flow than the Enterprise stent. The test results show that this workflow can rapidly simulate clinical deployment of stents and FDs, hence paving the way for its future clinical implementation.     

Prediction of stenting related adverse events through patient-specific finite element modelling

Right ventricular outflow tract (RVOT) calcific obstruction is frequent after homograft conduit implantation to treat congenital heart disease. Stenting and percutaneous pulmonary valve implantation (PPVI) can relieve the obstruction and prolong the conduit lifespan, but require accurate pre-procedural evaluation to minimize the risk of coronary artery (CA) compression, stent fracture, conduit injury or arterial distortion.Herein, we test patient-specific finite element (FE) modeling as a tool to assess stenting feasibility and investigate clinically relevant risks associated to the percutaneous intervention.Three patients undergoing attempted PPVI due to calcific RVOT conduit failure were enrolled; the calcific RVOT, the aortic root and the proximal CA were segmented on CT scans for each patient. We numerically reproduced RVOT balloon angioplasty to test procedure feasibility and the subsequent RVOT pre-stenting expanding the stent through a balloon-in-balloon delivery system.Our FE framework predicted the occurrence of CA compression in the patient excluded from the real procedure. In the two patients undergoing RVOT stenting, numerical results were consistent with intraprocedural in-vivo fluoroscopic evidences. Furthermore, it quantified the stresses on the stent and on the relevant native structures, highlighting their marked dependence on the extent, shape and location of the calcific deposits. Stent deployment induced displacement and mechanical loading of the calcific deposits, also impacting on the adjacent anatomical structures.This novel workflow has the potential to tackle the analysis of complex RVOT clinical scenarios, pinpointing the procedure impact on the dysfunctional anatomy and elucidating potential periprocedural complications.     

An in silico biomechanical analysis of the stent–esophagus interaction

Despite all technological innovations in esophageal stent design over the past 20 years, the association between the stent design’s mechanical behavior and its effect on the clinical outcome has not yet been thoroughly explored. A parametric numerical model of a commercially available esophageal bioresorbable polymeric braided wire stent is set up, accounting for stent design aspects such as braiding angle, strut material, wire thickness, degradation and friction between the wires comprising a predictive tool on the device’s mechanical behavior. Combining this tool with complex multilayered numerical models of the pathological in vivo stressed, actively contracting and buckling esophagus could provide clinicians and engineers with a patient-specific window into the mechanical aspects of stent-based esophageal intervention. This study integrates device and soft tissue mechanics in one computational framework to potentially aid in the understanding of the occurrence of specific symptoms and complications after stent placement.     

Development of an integrated CAD–FEA system for patient-specific design of spinal cages

Spinal cages are used to create a suitable mechanical environment for interbody fusion in cases of degenerative spinal instability. Due to individual variations in bone structures and pathological conditions, patient-specific cages can provide optimal biomechanical conditions for fusion, strengthening patient recovery. Finite element analysis (FEA) is a valuable tool in the biomechanical evaluation of patient-specific cage designs, but the time- and labor-intensive process of modeling limits its clinical application. In an effort to facilitate the design and analysis of patient-specific spinal cages, an integrated CAD–FEA system (CASCaDeS, comprehensive analytical spinal cage design system) was developed. This system produces a biomechanical-based patient-specific design of spinal cages and is capable of rapid implementation of finite element modeling. By comparison with commercial software, this system was validated and proven to be both accurate and efficient. CASCaDeS can be used to design patient-specific cages with a superior biomechanical performance to commercial spinal cages.     

Hemodynamic Changes Caused by Flow Diverters in Rabbit Aneurysm Models: Comparison of Virtual and Realistic FD Deployments Based on Micro-CT Reconstruction

Adjusting hemodynamics via flow diverter (FD) implantation is emerging as a novel method of treating cerebral aneurysms. However, most previous FD-related hemodynamic studies were based on virtual FD deployment, which may produce different hemodynamic outcomes than realistic (in vivo) FD deployment. We compared hemodynamics between virtual FD and realistic FD deployments in rabbit aneurysm models using computational fluid dynamics (CFD) simulations. FDs were implanted for aneurysms in 14 rabbits. Vascular models based on rabbit-specific angiograms were reconstructed for CFD studies. Real FD configurations were reconstructed based on micro-CT scans after sacrifice, while virtual FD configurations were constructed with SolidWorks software. Hemodynamic parameters before and after FD deployment were analyzed. According to the metal coverage (MC) of implanted FDs calculated based on micro-CT reconstruction, 14 rabbits were divided into two groups (A, MC >35%; B, MC <35%). Normalized mean wall shear stress (WSS), relative residence time (RRT), inflow velocity, and inflow volume in Group A were significantly different (P<0.05) from virtual FD deployment, but pressure was not (P>0.05). The normalized mean WSS in Group A after realistic FD implantation was significantly lower than that of Group B. All parameters in Group B exhibited no significant difference between realistic and virtual FDs. This study confirmed MC-correlated differences in hemodynamic parameters between realistic and virtual FD deployment.     

Simulation of mechanical behavior of temperature-responsive braided stents made of shape memory polyurethanes

Polymeric stents can be considered as an alternative to metallic stents thanks to their lessened incidence of restenosis and controlled deployment. The purpose of this study was to investigate the feasibility of developing a temperature-responsive braided stent using shape memory polyurethane (SMPU) through finite element analysis. It was assumed that braided stents were manufactured using SMPU fibers. The mechanical behavior of SMPU fibers was modeled using a constitutive equation describing their one-dimensional thermal-induced shape memory behavior. Then, the braided stents were analyzed to investigate their mechanical behavior using finite element analysis software, in which the constitutive equation was implemented through a user material subroutine. The diameter of the SMPU fibers and braiding angle were chosen as the design parameters and their values were adjusted to ensure that the mechanical properties of the braided polymer stents match those of metallic stents. Finally, the deployment process of the braided stents inside narrowed vessels was simulated, showing that the SMPU stents can be comfortably implanted while minimizing the overpressure onto the vessel walls, due to their thermo-responsive shape memory behavior.     

Influence of overlapping pattern of multiple overlapping uncovered stents on the local mechanical environment: A patient-specific parameter study

BackgroundMultiple overlapping uncovered stents (MOUS) system has shown potentials in managing complex aortic aneurysms with side branches involvement. It promotes the development of thrombus by modulating local flow pattern that reduces the wall tension, while maintaining patency of side branches. However the modulation of local hemodynamic parameters depends on various factors that have not been assessed comprehensively.MethodsAneurysm 3D geometry was reconstructed based on CT images. One-way fluid-structure interaction analysis was performed to quantify structural stress concentration in the wall, and changes of blood velocity, wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RRT) and pressure in the sac due to the stent deployment.ResultsHigh structural stress concentration due to stent deployment was found in the landing zone and it increased linearly with the number of stents deployed. The wall tension in the sac was unaffected by the stent deployment. Stress within the wall was insensitive to the different overlapping pattern. After one stent was deployed, the mean flow velocity in the sac reduced by 36.4%. The deployment of the 2nd stent further reduced the mean sac velocity by 10%. WSS decreased while both OSI and RRT increased after stent deployment, however pressure in the sac remained nearly unchanged. Except for the cases with complete stents struts alignment, different overlapping pattern had little effect on flow parameters.ConclusionsMechanical parameters modulated by the MOUS are insensitive to different overlapping pattern suggesting that endovascular procedure can be performed with less attention to the overlapping pattern.     

Anomalous hemodynamic effects of a self-expanding intracranial stent: Comparing in-vitro and ex-vivo models using ultra-high resolution MicroCT based CFD

Previous research on the effects of intracranial stents on arterial hemodynamics has involved computational hemodynamics (CHD) simulations applied to artificially generated stent models. In this study, accurate geometric reconstructions of in-vitro (PTFE tube) and ex-vivo (canine artery) deployed stents based on ultra-high resolution MicroCT imaging were used. The primary goal was to compare the hemodynamic effects of deployment in these two different models and to identify flow perturbations due to deployment anomalies such as stent malapposition and strut prolapse, important adverse mechanics occurring in clinical practice, but not considered in studies using idealized stent models.Ultra-high resolution MicroCT data provided detailed visualization of deployment characteristics allowing for accurate in-stent flow simulation. For stent cells that are regularly and symmetrically deployed, the near wall flow velocities and wall shear stresses were similar to previously published results derived from idealized models. In-stent hemodynamics were significantly altered by misaligned or malapposed stent cells, important effects not realistically captured in previous models. This research shows the feasibility and value of an ex-vivo stent model for MicroCT based CHD studies. It validates previous in-vitro studies and further contributes to the understanding of in-stent hemodynamics associated with adverse mechanics of self-expanding intracranial stents.     

Haemodynamic effects of stent diameter and compaction ratio on flow-diversion treatment of intracranial aneurysms: A numerical study of a successful and an unsuccessful case

Background: Compacting a flow-diverting (FD) stent is an emerging technique to create a denser configuration of wires across the aneurysm ostium. However, quantitative analyses of post-stenting haemodynamics affected by the compaction level of different stent sizes remain inconclusive.Objective: To compare the aneurysmal haemodynamic alterations after virtual FD treatments with different device diameters at different compaction ratios.Methods: We virtually implanted three sizes of FD stent, with each size deployed at four compaction ratios, into two patient aneurysms previously treated with the Silk + FD—one successful case and the other unsuccessful. Wire configurations of the FD in the 24 treatment scenarios were examined, and aneurysmal haemodynamic alterations were resolved by computational fluid dynamics (CFD) simulations. We investigated the aneurysmal flow patterns, aneurysmal average velocity (AAV), mass flowrate (MF), and energy loss (EL) in each scenario.Results: Compactions of the stent in the successful case resulted in a greater metal coverage rate than that achieved in the unsuccessful one. A 25% increment in compaction ratio further decreased the AAV (12%), MF (11%), and EL (9%) in both cases (average values). The averaged maximum differences attributable to device size were 10% (AAV), 8% (MF), and 9% (EL).Conclusions: Both stent size and compaction level could markedly affect the FD treatment outcomes. It is therefore important to individualise the treatment plan by selecting the optimal stent size and deployment procedure. CFD simulation can be used to investigate the treatment outcomes, thereby assisting doctors in choosing a favourable treatment plan.     

Mechanical modeling of self-expandable stent fabricated using braiding technology

The mechanical behavior of a stent is one of the important factors involved in ensuring its opening within arterial conduits. This study aimed to develop a mechanical model for designing self-expandable stents fabricated using braiding technology. For this purpose, a finite element model was constructed by developing a preprocessing program for the three-dimensional geometrical modeling of the braiding structure inside stents, and validated for various stents with different braiding structures. The constituent wires (Nitinol) in the braided stents were assumed to be superelastic material and their mechanical behavior was incorporated into the finite element software through a user material subroutine (VUMAT in ABAQUS) employing a one-dimensional superelastic model. For the verification of the model, several braided stents were manufactured using an automated braiding machine and characterized focusing on their compressive behavior. It was observed that the braided stents showed a hysteresis between their loading and unloading behavior when a compressive load was applied to the braided tube. Through the finite element analysis, it was concluded that the current mechanical model can appropriately predict the mechanical behavior of braided stents including such hysteretic behavior, and that the hysteresis was caused by the slippage between the constituent wires and their superelastic property.     

Model reduction methodology for computational simulations of endovascular repair

Endovascular aneurysm repair (EVAR) is a current alternative treatment for thoracic and abdominal aortic aneurysms, but is still sometimes compromised by possible complications such as device migration or endoleaks. In order to assist clinicians in preventing these complications, finite element analysis (FEA) is a promising tool. However, the strong material and geometrical nonlinearities added to the complex multiple contacts result in costly finite-element models. To reduce this computational cost, we establish here an alternative and systematic methodology to simplify the computational simulations of stent-grafts (SG) based on FEA. The model reduction methodology relies on equivalent shell models with appropriate geometrical and mechanical parameters. It simplifies significantly the contact interactions but still shows very good agreement with a complete reference finite-element model. Finally, the computational time for EVAR simulations is reduced of a factor 6–10. An application is shown for the deployment of a SG during thoracic endovascular repair, showing that the developed methodology is both effective and accurate to determine the final position of the deployed SG inside the aneurysm.     

Our capricious vessels: The influence of stent design and vessel geometry on the mechanics of intracranial aneurysm stent deployment

There is a growing interest in virtual tools to assist clinicians in evaluating different procedures and devices for endovascular treatment. In the present study we use finite element analysis to investigate the influence of stent design and vessel geometry for stent assisted coiling of intracranial aneurysms. Nine virtual stenting procedures were performed: three nitinol stent designs ((i) an open cell stent resembling the Neuroform, (ii) a generic stiff and (iii) a more flexible closed cell design), were deployed in three patient-specific cerebral aneurysmatic vessels. We investigated the percentage of strut area covering the aneurysm neck, the straightening induced on the cerebrovasculature by the stent placement (quantified by the reduction in tortuosity), and stent apposition to the wall (quantified as the percentage of struts within 0.2mm of the vessel). The results suggest that the open cell design better covers the aneurysm neck (11.0±1.1%) compared to both the stiff (7.8±1.6%) and flexible (8.7±1.6%) closed cell stents, and induces less straightening of the vessel (-5.1±1.6% vs. -42.9±9.8% and -26.9±11.9% ). The open cell design has, however, less struts apposing well to the vessel wall (56.0±6.4%) compared to the flexible (73.4±4.6%) and stiff (70.4±5.1%) closed cell design. With the presented study, we hope to contribute to and improve aneurysm treatment, using a novel patient specific environment as a possible pre-operative tool to evaluate mechanical stent behavior in different vascular geometries.     

Mechanical properties of coronary stents determined by using finite element analysis.

The mechanical function of a stent deployed in a damaged artery is to provide a metallic tubular mesh structure. The purpose of this study was to determine the exact mechanical characteristics of stents. In order to achieve this, we have used finite-element analysis to model two different type of stents: tubular stents (TS) and coil stents (CS). The two stents chosen for this modeling present the most extreme mechanical characteristics of the respective types. Seven mechanical properties were studied by mathematical modeling with determination of: (1) stent deployment pressure, (2) the intrinsic elastic recoil of the material used, (3) the resistance of the stent to external compressive forces, (4) the stent foreshortening, (5) the stent coverage area, (6) the stent flexibility, and (7) the stress maps. The pressure required for deployment of CS was significantly lower than that required for TS, over 2.8 times greater pressure was required for the tubular model. The elastic recoil of TS is higher than CS (5.4% and 2.6%, respectively). TS could be deformed by 10% at compressive pressures of between 0.7 and 1.3 atm whereas CS was only deformed at 0.2 and 0.7 atm. The degree of shortening observed increases with deployment diameter for TS. CS lengthen during deployment. The metal coverage area is two times greater for TS than for CS. The ratio between the stiffness of TS and that of CS varies from 2060 to 2858 depending on the direction in which the force is applied. TS are very rigid and CS are significantly more flexible. Stress mapping shows stress to be localized at link nodes. This series of finite-element analyses illustrates and quantifies the main mechanical characteristics of two different commonly used stents. In interventional cardiology, we need to understand their mechanisms of implantation and action.     

Patient-specific simulation of stent-graft deployment in type B aortic dissection: model development and validation

Thoracic endovascular aortic repair (TEVAR) has been accepted as the mainstream treatment for type B aortic dissection, but post-TEVAR biomechanical-related complications are still a major drawback. Unfortunately, the stent-graft (SG) configuration after implantation and biomechanical interactions between the SG and local aorta are usually unknown prior to a TEVAR procedure. The ability to obtain such information via personalised computational simulation would greatly assist clinicians in pre-surgical planning. In this study, a virtual SG deployment simulation framework was developed for the treatment for a complicated aortic dissection case. It incorporates patient-specific anatomical information based on pre-TEVAR CT angiographic images, details of the SG design and the mechanical properties of the stent wire, graft and dissected aorta. Hyperelastic material parameters for the aortic wall were determined based on uniaxial tensile testing performed on aortic tissue samples taken from type B aortic dissection patients. Pre-stress conditions of the aortic wall and the action of blood pressure were also accounted for. The simulated post-TEVAR configuration was compared with follow-up CT scans, demonstrating good agreement with mean deviations of 5.8% in local open area and 4.6 mm in stent strut position. Deployment of the SG increased the maximum principal stress by 24.30 kPa in the narrowed true lumen but reduced the stress by 31.38 kPa in the entry tear region where there was an aneurysmal expansion. Comparisons of simulation results with different levels of model complexity suggested that pre-stress of the aortic wall and blood pressure inside the SG should be included in order to accurately predict the deformation of the deployed SG.

     

Numerical investigations of the mechanical properties of a braided non-vascular stent design using finite element method

This paper discusses various issues relating to the mechanical properties of a braided non-vascular stent made of a Ni–Ti alloy. The design of the stent is a major factor which determines its reliability after implantation into a stenosed non-vascular cavity. This paper presents the effect of the main structural parameters on the mechanical properties of braided stents. A parametric analysis of a commercial stent model is developed using the commercial finite element code ANSYS. As a consequence of the analytical results that the pitch of wire has a greater effect than other structural parameters, a new design of a variable pitch stent is presented to improve mechanical properties of these braided stents. The effect of structural parameters on mechanical properties is compared for both stent models: constant and variable pitches. When the pitches of the left and right quarters of the stent are 50% larger and 100% larger than that of the central portion, respectively, the radial stiffness in the central portion increases by 10% and 38.8%, while the radial stiffness at the end portions decreases by 128% and 164.7%, the axial elongation by 25.6% and 56.6% and the bending deflection by 3.96% and 10.15%. It has been demonstrated by finite element analysis that the variable pitch stent can better meet the clinical requirements.     

Hemodynamic study of overlapping bare-metal stents intervention to aortic aneurysm

To investigate the hemodynamic performance of overlapping bare-metal stents intervention treatment to thoracic aortic aneurysms (TAA), three simplified TAA models, representing, no stent, with a single stent and 2 overlapped stents deployed in the aneurismal sac, were studied and compared in terms of flow velocity, wall shear stress (WSS) and pressure distributions by means of computational fluid dynamics. The results showed that overlapping stents intervention induced a flow field of slow velocity near the aneurismal wall. Single stent deployment in the sac reduced the jet-like flow formed prior to the proximal neck of the aneurysm, which impinged on the internal wall of the aneurysm. This jet-like flow vanished completely in the overlapping double stents case. Overlapping stents intervention led to an evident decrease in WSS; meanwhile, the pressure acting on the wall of the aneurysm was reduced slightly and presented more uniform distribution. The results therefore indicated that overlapping stents intervention may effectively isolate the thoracic aortic aneurysm, protecting it from rupture. In conclusion, overlapping bare-metal stents may serve a purpose similar to that of the multilayer aneurysm repair system (MARS) manufactured by Cardiatis SA (Isnes, Belgium).     

Numerical simulation of aneurysmal haemodynamics with calibrated porous-medium models of flow-diverting stents

Modelling flow-diverting (FD) stents as porous media (PM) markedly improves the efficiency of computational fluid dynamics (CFD) simulations in the study of intracranial aneurysm treatment. Nonetheless, the parameters of PM models adopted for simulations up until now were rarely calibrated to match the represented FD structure. We therefore sought to evaluate the PM parameters for a representative variety of commercially available stents, so characterising the flow-diversion behaviours of different FD devices on the market.We generated fully-resolved geometries for treatments using PED, Silk+, FRED, and dual PED stents. We then correspondingly derived the calibrated PM parameters—permeability (k) and inertial resistance factor (C₂)—for each stent design from CFD simulations, to ensure the calibrated PM model has identical flow resistance to the FD stent it represents. With each of the calibrated PM models respectively deployed in two aneurysms, we studied the flow-diversion effects of these stent configurations.This work for the first time reported several sets of parameters for PM models, which is vital to address the current knowledge gap and rectify the errors in PM model simulations, thereby setting right the modelling protocol for future studies using PM models. The flow resistance parameters were strongly affected by porosity and effective thickness of the commercial stents, and thus accounted for in the PM models. Flow simulations using the PM stent models revealed differences in aneurysmal mass flowrate (MFR) and energy loss (EL) between various stent designs.This study improves the practicability of FD simulation by using calibrated PM models, providing an individualised method with improved simulation efficiency and accuracy.     

Modeling of stents exhibiting negative Poisson's ratio effect

Intravascular stents are metallic scaffolding structures deployed in the stenotic arteries to restore the lumen for the blood flow to the down stream tissues. Most stents are balloon expandable and are deployed from its crimped state through a balloon catheter. The efficacy of the stenting procedure mainly depends on the way the stent is deployed. Both numerical and experimental evaluations show that almost all the present day stents undergo the most undesirable effects namely: (i) longitudinal foreshortening: the axial contraction in the length, and (ii) dogboning: flaring of the distal edges, during the radial expansion of the stents. Due to the foreshortening effect, clinicians are forced to select stents longer than the plaque. Still, the final length of the stent depends on the amount of radial expansion, which is subjective during the procedure. This paper introduces a new stent model called “Murugan”, which exhibits negative Poisson's ratio effect. That is, the stent may have zero axial contraction or can have extension when under radial expansion. The presence of hyperelastic balloon and the stent–balloon friction is also considered to study their effects in mechanical properties of the stents under consideration. Free expansion analysis is done using finite element method (FEM) to compare the new stent model with the present day stent geometries.     

Modeling of stents exhibiting negative Poisson's ratio effect

Intravascular stents are metallic scaffolding structures deployed in the stenotic arteries to restore the lumen for the blood flow to the down stream tissues. Most stents are balloon expandable and are deployed from its crimped state through a balloon catheter. The efficacy of the stenting procedure mainly depends on the way the stent is deployed. Both numerical and experimental evaluations show that almost all the present day stents undergo the most undesirable effects namely: (i) longitudinal foreshortening: the axial contraction in the length, and (ii) dogboning: flaring of the distal edges, during the radial expansion of the stents. Due to the foreshortening effect, clinicians are forced to select stents longer than the plaque. Still, the final length of the stent depends on the amount of radial expansion, which is subjective during the procedure. This paper introduces a new stent model called "Murugan", which exhibits negative Poisson's ratio effect. That is, the stent may have zero axial contraction or can have extension when under radial expansion. The presence of hyperelastic balloon and the stent-balloon friction is also considered to study their effects in mechanical properties of the stents under consideration. Free expansion analysis is done using finite element method (FEM) to compare the new stent model with the present day stent geometries.     

Finite element comparison of performance related characteristics of balloon expandable stents

Cardiovascular stents are commonly made from 316L stainless steel and are deployed within stenosed arterial lesions using balloon expansion. Deployment involves inflating the balloon and plastically deforming the stent until the required diameter is obtained. This plastic deformation induces static stresses in the stent, which will remain for the lifetime of the device. In order to determine these stresses, finite element models of the unit cells of geometrically different, commercially available balloon expandable stents have been created, and deployment and elastic recoil have been simulated. In this work the residual stresses associated with deployment and recoil are compared for the various stent geometries, with a view to establishing appropriate initial stress states for fatigue loading for the stents. The maximum, minimum, and mean stresses induced in the stent due to systolic/diastolic pressure are evaluated, as are performance measures such as radial and longitudinal recoil.