Personalized Numerical Cardiovascular Model with Weight Growth for Evaluating Pediatric Left Ventricular Assist Devices: Derivation from an Experimental Mock Circulatory Loop.

Pediatric patients with heart failure have limited treatment options because of a shortage of donor hearts and compatible left ventricular assist devices (LVADs). To address this issue, our group is developing an implantable pediatric LVAD for patients weighing 5-20 kg, capable of accommodating different physiological hemodynamic conditions as patients grow. To evaluate LVAD prototypes across a wide range of conditions, we developed a numerical cardiovascular model, using data from a mock circulatory loop (MCL) and patient-specific elastance functions. The numerical MCL was validated against experimental MCL results, showing good agreement, with differences ranging from 0 to 11%. The numerical model was also tested under left heart failure conditions and showed a worst-case difference of 16%. In an MCL study with a pediatric LVAD, a pediatric dataset was obtained from the experimental MCL and used to tune the numerical MCL. Then, the numerical model simulated LVAD flow by using an HQ curve obtained from the LVAD's impeller. When the numerical MCL was validated against the experimental MCL, hemodynamic differences ranged between 0 and 9%. These findings suggest that the numerical model can replicate various physiological conditions and impeller designs, indicating its potential as a tool for developing and optimizing pediatric LVADs.

Hydrogel-polyurethane fiber composites with enhanced microarchitectural control for heart valve replacement.

Polymeric heart valves offer the potential to overcome the limited durability of tissue based bioprosthetic valves and the need for anticoagulant therapy of mechanical valve replacement options. However, developing a single-phase material with requisite biological properties and target mechanical properties remains a challenge. In this study, a composite heart valve material was developed where an electrospun mesh provides tunable mechanical properties and a hydrogel coating confers an antifouling surface for thromboresistance. Key biological responses were evaluated in comparison to glutaraldehyde-fixed pericardium. Platelet and bacterial attachment were reduced by 38% and 98%, respectively, as compared to pericardium that demonstrated the antifouling nature of the hydrogel coating. There was also a notable reduction (59%) in the calcification of the composite material as compared to pericardium. A custom 3D-printed hydrogel coating setup was developed to make valve composites for device-level hemodynamic testing. Regurgitation fraction (9.6 ± 1.8%) and effective orifice area (1.52 ± 0.34 cm2 ) met ISO 5840-2:2021 requirements. Additionally, the mean pressure gradient was comparable to current clinical bioprosthetic heart valves demonstrating preliminary efficacy. Although the hemodynamic properties are promising, it is anticipated that the random microarchitecture will result in suboptimal strain fields and peak stresses that may accelerate leaflet fatigue and degeneration. Previous computational work has demonstrated that bioinspired fiber microarchitectures can improve strain homogeneity of valve materials toward improving durability. To this end, we developed advanced electrospinning methodologies to achieve polyurethane fiber microarchitectures that mimic or exceed the physiological ranges of alignment, tortuosity, and curvilinearity present in the native valve. Control of fiber alignment from a random fiber orientation at a normalized orientation index (NOI) 14.2 ± 6.9% to highly aligned fibers at a NOI of 85.1 ± 1.4%. was achieved through increasing mandrel rotational velocity. Fiber tortuosity and curvilinearity in the range of native valve features were introduced through a post-spinning annealing process and fiber collection on a conical mandrel geometry, respectively. Overall, these studies demonstrate the potential of hydrogel-polyurethane fiber composite as a heart valve material. Future studies will utilize the developed advanced electrospinning methodologies in combination with model-directed fabrication toward optimizing durability as a function of fiber microarchitecture.

Blood-contacting magnetic levitation bearing design using computational fluid dynamics for haemocompatibility.

The Hemocompatibility Assessment Platform (HAP) is a testing rig that will allow for the evaluation of blood trauma caused by individual components of rotary blood pumps including the NeoVAD - a proposed paediatric Left Ventricular Assist Device (LVAD). It is important that the HAP itself is only minimally haemolytic such that the plasma free haemoglobin measured can be assumed to come from the test component. In this study, Computational Fluid Dynamics simulations have been carried out to inform the design of a magnetically levitated motor bearing gap. Simulations show that issues with the original design, namely stagnation regions and large recirculation zones can be mitigated with the introduction of a pipe that introduces blood-flow to the centre of the bearing and disrupts the secondary flow patterns that cause these issues.Clinical relevance- The consequent reduction in shear exposure time will reduce heamolsyis from the HAP. The redesign of the bearing will result in reduced baseline blood trauma from the HAP, thus allowing quantification of test component haemolysis and will therefore aid the design of future paediatric LVADs.

Hemodynamic Effect of a Fontan Assist Device on a Numerical Fontan Circulatory Model under Various Medication Scenarios.

Patients with single-ventricle heart disease and failing Fontan circulation represent the largest and most rapidly growing subgroup of adults with congenital heart disease referred for transplant assessment. Few clinical therapies are available for improving Fontan hemodynamics. Mechanical circulatory support devices have been used successfully in the clinical setting to assist the single ventricle, but no device is currently available to support the subpulmonary circulation. A subpulmonary pump could be used to support patients with failing Fontan circulation by mitigating chronic venous hypertension and restoring normal physiology. Our group designed a Fontan assist device (FAD) to augment right-heart (subpulmonary) flow and decrease venous pressures. To ensure that our FAD could achieve target hemodynamic parameters, we developed a numerical Fontan circulatory model to evaluate the interaction between the cardiovascular system and the FAD. To ensure that the circulatory model can mimic real-world clinical conditions, we investigated the effects of various medications in the FAD loop. Results showed that the FAD can significantly increase cardiac output in Fontan patients and can create a pressure difference between the pulmonary arteries and venae cavae. Further, the systemic venous pressure can be significantly reduced by using the FAD plus diuretic treatment. The downstream pulmonary artery pressure can be increased by augmenting the FAD with vasodilator treatment, diuretic treatment, or both.Clinical Relevance- This work supports FAD development by providing a method for studying human cardiovascular effects under various hemodynamic scenarios.

Dissipated energy and efficiency as objective functions for the design of the NeoVAD rotary blood pump.

Minimising haemolytic blood damage is an important objective when designing rotary blood pumps, however, calculating haemolysis can be computationally expensive and inaccurate. Efficiency and dissipated energy are much more easily calculable hydraulic parameters in the design and analysis of rotary blood pumps and although there is work to suggest that efficiency is not a good indicator of haemocompatibility, i.e. more efficient pumps do not necessarily cause less damage, there is recent speculation that dissipated energy can act as an easily calculable haemolysis analogue.This study shows that for design purposes, optimising for maximum efficiency and minimum dissipated energy are functionally the same as they are inherently and closely linked. Moreover a demonstration of rotary blood pump design has been completed using the NeoVAD paediatric left ventricular assist device optimising for both objective functions. The resulting designs appear similar in rotor blade shape and are similar in hydraulic performance.Clinical relevance- This reinforces the direct link between efficiency and dissipated energy when analysing rotary blood pumps at a given design operating point. This raises questions either of the claim that efficiency cannot be used as an easily calculable analogue for haemolysis or the validity of dissipated energy to act in this same manner.

Machine learning based on computational fluid dynamics enables geometric design optimisation of the NeoVAD blades.

The NeoVAD is a proposed paediatric axial-flow Left Ventricular Assist Device (LVAD), small enough to be implanted in infants. The design of the impeller and diffuser blades is important for hydrodynamic performance and haemocompatibility of the pump. This study aimed to optimise the blades for pump efficiency using Computational Fluid Dynamics (CFD), machine learning and global optimisation. Meshing of each design typically included 6 million hexahedral elements and a Shear Stress Transport turbulence model was used to close the Reynolds Averaged Navier-Stokes equations. CFD models of 32 base geometries, operating at 8 flow rates between 0.5 and 4 L/min, were created to match experimental studies. These were validated by comparison of the pressure-flow and efficiency-flow curves with those experimentally measured for all base prototype pumps. A surrogate model was required to allow the optimisation routine to conduct an efficient search; a multi-linear regression, Gaussian Process Regression and a Bayesian Regularised Artificial Neural Network predicted the optimisation objective at design points not explicitly simulated. A Genetic Algorithm was used to search for an optimal design. The optimised design offered a 5.51% increase in efficiency at design point (a 20.9% performance increase) as compared to the best performing pump from the 32 base designs. An optimisation method for the blade design of LVADs has been shown to work for a single objective function and future work will consider multi-objective optimisation.

Dynamic Evaluation of an Active Axial Magnetic Levitated Bearing System in a Hemocompatibility Assessment Platform.

To evaluate the hemocompatibility of individual components of our pediatric left ventricular assist device (LVAD), we proposed a hemocompatibility assessment platform (HAP) with a magnetic levitated bearing system. The HAP consists of a drive system utilizing a brushless direct current (BLDC) motor, passive magnetic bearings (PMB), and an active magnetically levitated bearing (AMB) to reduce the hemolysis generated by HAP itself. In this study, we designed and evaluated the performance of the AMB by measuring radial and axial displacements of the rotor resulting from radially destabilizing forces as well as the performance of the drive system when rotated at increasing speeds to 1,200 rotations per minute (rpm). The results show that, with radial disturbance, the AMB is capable of maintaining axial stability for the BLDC motor system. The AMB can control up to 1,200 rpm without any contact between the rotor and stator. Future work includes geometry optimization for the AMB structure and increase the capability to control stable high-speed rotation for the entire system. Clinical Relevance- This work furthers the development of the magnetic levitated bearing system for a hemocompatibility assessment platform that will be used to enhance and accelerate the development of adult and pediatric LVADs.

Numerical and Experimental Analysis for a Magnetic Levitation System in a Hemocompatibility Assessment Platform.

Development of pediatric left ventricular assist devices (LVADs) has lagged behind that of adult LVADs, primarily due to the size and hemocompatibility constraints of pediatric anatomy. To quantify sources of blood trauma during LVAD development, we proposed a hemocompatibility assessment platform (HAP) that can evaluate the hemocompatibility of individual components of LVADs. To eliminate the hemolysis induced by the HAP itself, we incorporated passive magnetic (PM) bearings to suspend the rotor radially and an active magnetic bearing (AMB) to control the axial position. In this study, we numerically evaluated AMB forces of 2 geometries and validated the model by comparing its predictions with experimental results. The magnetic forces generated by the AMB were evaluated by increasing the rotor-stator gap from 0.1 mm to 0.5 mm with a 0.1 mm increment and by varying the coil current from -2 A to 2 A with a 1 A increment. The average error of the numerical models was 8.8% and 7.0% for the two geometries, respectively. Higher errors were found at smaller (<0.2mm) rotor-stator gaps. For both biasing ring sizes, the AMB exhibits high magnetic stiffness from -1 A to 1 A, though it saturates for currents of -2 A and 2 A. This region of high current stiffness was identified as the optimal control region. In future work, this function will be used to tune a control algorithm to modulate current supplied to the AMB, ultimately stabilizing the rotor axially. Clinical Relevance- This work furthers the development of a hemocompatibility assessment platform that will enhance and accelerate the development of adult and pediatric LVADs.

Hemocompatibility Assessment Platform Drive System Design: Trade-off between Motor Performance and Hemolysis.

Left ventricular assist devices (LVADs) have long been used to treat adults with heart failure, but LVAD options for pediatric patients with heart failure are lacking. Despite the urgent need for long-term, implantable pediatric LVADs, design challenges such as hemolysis, pump thrombosis, and bleeding persist. We have developed a Hemocompatibility Assessment Platform (HAP) to identify blood trauma from individual LVAD components. A HAP would aid in refining pump components before in vivo testing, thereby preventing unnecessary animal sacrifice and reducing development time and cost. So that the HAP does not confound hemolysis data, the HAP drive system consists of an enlarged air-gap motor coupled to a magnetic levitation system. Although it is known that an enlarged air gap motor will have diminished performance, while the larger gap in the motor will cause less blood damage, the trade-offs are not fully characterized. Therefore, in this study we evaluated these trade-offs to determine an optimal rotor diameter for the HAP drive motor. The motor performance was characterized with an experimental method by determining the torque constant for the HAP drive motor with varied rotor diameters. The torque threshold was set as 10 mNm to achieve a nominal current of 3.5A. Hemolysis in the HAP drive motor gap was estimated by calculating scalar shear stress generated in the HAP motor gap analytically and numerically. A design criterion of 30 Pa was selected for scalar shear stress to achieve minimal hemolysis and platelet activation in the HAP drive system.Clinical Relevance- We evaluated a Hemocompatibility Assessment Platform for developing LVAD prototypes that can best balance motor performance and hemocompatibility. This design method can assist with optimizing the drive system during the research stage and illustrates how motor geometry can be tuned to reduce blood trauma.

Numerical and Experimental Approach to Characterize a BLDC Motor with Different Radial-gap to Improve Hemocompatibility Performance.

Left ventricular assist devices (LVADs) have increasingly been used clinically to treat heart failure patients. However, hemolysis, pump thrombosis, infection and bleeding still persist as major limitations of LVAD technology. Assessing LVAD hemocompatibility using a blood shear stress device (BSSD) has clear advantages, as the BSSD could provide a better experimental platform to develop reliable, quantifiable blood trauma assays to perform iterative testing of LVAD designs. In this study, a BSSD was proposed with short blood exposure time and no seals or contact bearings to reduce blood trauma caused by the test platform. Enlarged air-gap drive motor in BSSD is essential to avoid high shear stress; however, it would significantly reduce the motor torque, which may result in inadequate force to drive the entire system. In order to evaluate and optimize the drive motor air-gap to ensure adequate motor torque as well as acceptable range for blood exposure time and shear stress, a numerical brushless DC (BLDC) motor model was established using finite element method (FEM) in numerical simulation software COMSOL. The model was first validated by the experimental results. Then numerical model with different air-gap was evaluated on the torque and speed constant changes. In the end, two equations were generated based on the curves derived from the torque and speed constant calculations. Determining these relationships between motor performance and motor air-gap will facilitate the development of an appropriate BLDC motor size for the BSSD, considering the design limitations in our future work.