21 research outputs found

    Experimental measurement and numerical modelling of dye washout for investigation of blood residence time in ventricular assist devices

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    Ventricular assist devices have become the standard therapy for end-stage heart failure. However, their use is still associated with severe adverse events related to the damage done to the blood by fluid dynamic stresses. This damage relates to both the stress magnitude and the length of time the blood is exposed to that stress. We created a dye washout technique which combines experimental and numerical approaches to measure the washout times of ventricular assist devices. The technique was used to investigate washout characteristics of three commercially available and clinically used ventricular assist devices: the CentriMag, HVAD and HeartMate II. The time taken to reach 5% dye concentration at the outlet (T05) was used as an indicator of the total residence time. At a typical level of cardiac support, 5 L/min and 100 mmHg, T05 was 0.93, 0.28 and 0.16 s for CentriMag, HVAD and HeartMate II, respectively, and increased to 5.06, 1.64 and 0.96 s for reduced cardiac support of 1 L/min. Regional variations in washout characteristics are described in this article. While the volume of the flow domain plays a large role in the differences in T05 between the ventricular assist devices, after standardising for ventricular assist device volume, the secondary flow path was found to increase T05 by 35%. The results explain quantitatively, for the first time, why the CentriMag, which exerts low shear stress magnitude, has still been found to cause acquired von Willebrand Syndrome in patients

    An evaluation of continuous-flow left ventricular assist devices and the incidence of stroke in patients awaiting heart transplantation

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    Continuous-flow left ventricular assist devices provide mechanical circulatory assistance for patients suffering from end-stage heart failure that are awaiting or ineligible for heart transplantation. Although actuarial survival and quality of life with these devices is comparable to allograft transplant, they are associated with severe adverse events, including cerebrovascular accidents. Recent advances in continuous-flow technology aim to mitigate the risk of stroke by including design features that minimize flow stasis, turbulence and endothelial dysfunction, as well as promote near-normal pulse pressures. The proposed study is a multicenter, prospective, randomized clinical trial that aims to compare the stroke-free survival and associated incidence and risk of cerebrovascular accidents between three continuous-flow left ventricular assist devices in patients with refractory, end-stage heart failure planning to undergo bridge-to-transplant or destination therapy. Patients will be randomized to receive one of three devices (HeartMate II, Thoratec Corporation, Pleasanton, CA; HeartWare HVAD, HeartWare International Inc., Framingham, MA; HeartMate III, Thoratec Corporation, Pleasanton, CA). Patients will be monitored for stroke-free survival and incidence of cerebrovascular accident for 24 months post-implantation. Investigators will compare stroke-free survival with Kaplan-Meier survival curves and log-rank testing; in addition, investigators will examine each device’s level of risk for causing a cerebrovascular accident with chi square and odds ratio analysis. The data from this study will be used to guide treatment paradigms, device assignment and future development of technologies that mitigate stroke risk in this high-risk population

    Doctor of Philosophy

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    dissertationHeart disease is the leading cause of death in the United States. Mechanical circulatory support by ventricular assist devices (VADs) is a means by which deteriorating heart function can be supplemented, and is a leading therapy for latestage heart failure patients. The devices are commonly connected to the apex of the left ventricle (LV) to move oxygenated blood to the body via the aorta. Recent developments have made continuous-flow pumps commonplace in the clinical environment when compared to their pulsatile-flow predecessors. Typically, continuous-flow VADs are designed with axial- or centrifugal- (radial) configurations. The pressures and flow rates vary dramatically in the native heart as blood is moved from the LV to the aorta. This dissertation presents pressure-flow characteristics for both axial- and centrifugal-flow VADs within a wide range of pressure differential values under uniform conditions, by means of a novel, open-loop flow system. Current techniques employ a closed-loop system to determine pump performance. A closed-loop system does not allow pressure differentials less than or equal to zero to be achieved. The native heart experiences pressure gradients near zero across the aortic valve during systole, which is essentially where the VAD is placed. Thus, an open-loop flow system with independently adjustable preload and afterload pressures is required to reach physiologically-relevant pressure differential regions that approximate the pressure gradient across the aortic valve during systole. Additional modifications made to the open-loop flow system generate pulsatile flow type conditions, which mimic those of the native LV. With this type of in vitro test system, not only can general hydrodynamic performance and hydraulic efficiency of VADs be measured, but also off-design operational performance under dynamic flow conditions can be characterized. This research explores hydrodynamic performance characteristics of axial- and centrifugal-flow VADs to determine design advantages that each have. Device characteristics include pressure-flow performance curves, pressure sensitivity, pulsatility index, and pulsatility ratio. Performance curves and other relevant attributes are investigated at previously unreported pressure-flow regions. Performance is evaluated theoretically, computationally, and experimentally under both steady-state, continuous-flow and pulsatile-flow circumstances

    Blood Damage in Mechanical Circulatory Support Systems:-

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    Development of Mechanical Cardiovascular Assist Devices for Fontan Patients: Two Novel Approaches

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    Few therapeutic alternatives exist for patients with a failing single ventricle physiology. To address this need, this thesis project investigated two new therapeutic alternatives, which sought to positively augment the Fontan hemodynamics. The first modality introduced a non-invasive method of external pressure application to the lower extremities. A clinical study (n=2) was conducted, and results indicated an increase in flow as a consequence to an increase in transmural pressure in the lower extremities. The second modality investigated a minimally invasive blood pump. Numerical analyses of the pump were performed to examine hydraulic performance under physiologic conditions. The pump produced pressure rises of 1 to 25 mmHg over flows of 1 to 4 LPM, has a blood damage index less than 1% and was also found to successfully augment the hydraulic energy of the Fontan physiology. This work resulted in substantial progress to develop both modalities and address a significant human health problem

    Preclinical Biocompatibility Assessment of Pediatric Ventricular Assist Devices

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    A number of heart assist devices including the PediaFlowTM ventricular assist device (VAD), a magnetically levitated mixed flow rotary blood pump, and the Levitronix® PediVAS™, an extracorporeal magnetically levitated centrifugal blood pump are under development to address the urgent need for mechanical circulatory support suitable for children in heart failure. VADs are associated with a host of biological complications including bleeding, thromboembolism, and infection. The biocompatibility of these new devices must be characterized in a preclinical model (juvenile ovines) to ensure their safety and efficacy in children. However, biocompatibility studies in ovines are limited due to a lack of available assays. Flow cytometric assays were developed to detect ovine platelet activation and function. These assays were applied during in vitro assessment of potential biomimetic coatings for the blood contacting surfaces of pediatric VADs. These assays were then applied in vivo in 5 lambs undergoing a VAD sham surgical procedure for 30 days duration, in 20 lambs implanted with the Levitronix PediVAS for 30 days duration, and in 8 lambs implanted with the three design iterations of the PediaFlow VAD ranging from 6 - 72 days duration. The sham surgical procedure enabled characterization of the effects of the implant surgery on platelet activation. Platelet activation was reduced on surfaces that received a biomimetic coating compared to uncoated surfaces which was in agreement with platelet deposition results. Platelet activation levels rose post-operatively in the sham animals and returned to pre-operative levels at approximately two weeks. In PediaFlow and Levitronix implanted animals platelet activation also rose post-operatively and typically returned to baseline levels. In these implants platelet activation consistently rose following pump or animal complications. In a subset of studies platelet activation was elevated for the duration of the study and this high level of activation generally coincided with increased kidney infarcts or thrombus deposition in the cannulae at necropsy. Overall, the blood biocompatibility of the Levitronix PediVAS and the PediaFlow VAD as represented by a low level of platelet activation observed in the majority of studies is encouraging for the potential clinical use of these devices. The ability of the developed platelet activation assays to differentiate between surface coatings, and to discern trends with respect to pump complications and kidney infarcts following VAD implant demonstrate its utility in assessing the blood biocompatibility of pediatric heart assist devices

    Optimization of Geometric Characteristics of Axial and Centrifugal Pumps For Mechanical Circulatory Support Devices

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    PhDThe physiological and clinical considerations of centrifugal and axial pumps as ven- tricular assist devices (VADs) demands limitations on the power, size and geometry of the impellers. A typical pump design method is to rely on the characteristics of previously designed pumps with known performance using empirical equations and nondimensional parameters based on uid dynamics similarity law. Such data are widely available for industrial pumps operating in Reynolds number region of 108. VADs operate in Re<106 and therefore the similarity concept does not apply between the industrial diagrams and the medical application of small pumps. The present dissertation employs a parametric approached analytical model to in- vestigate more than 150 axial and centrifugal pumps. The design parameters are optimised using the response surface methodology. The effect of different design parameters on the performance, force analysis and hemocompatibility of the pumps is thoroughly investigated by modelling the haemolysis through a power-law equation. The results show an explicit and consistent relationship between the number of blades, outlet width, outlet angle and the hemocompatibility of the device. Centrifu- gal pumps showed signi cantly lower probability of blood complications compared to axial pumps. The evaluation of the design characteristics helps pump designers to select their parameters accordingly for a low probability of blood complications. Furthermore, experimental techniques are employed to test more than 70 pumps in different conditions of flow, pressure and rotational speed. The experimental results validate the numerical simulations and create a database of empirical equations and data points for small axial and centrifugal pumps. The specifi c speed and speci fic diameters of the pumps are plotted on an ns − ds diagram to enable preliminary design of small pumps for VADs suitable for different stages of congestive heart failure (CHF)
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