Comparative analysis of novel esophageal pressure monitoring catheters versus commercially available alternatives in a biomechanical model of the thoracic cavity.

Transpulmonary pressure can be estimated using esophageal balloon (EB) catheters, which come in a variety of manufacturing configurations. We assessed the performance of novel polyurethane EB designs, Aspisafe NG and NG+, against existing alternatives. We created a biomechanical model of the chest cavity using a plastic chamber and an ex-vivo porcine esophagus. The chamber was pressurized (- 20 and + 20 cmH2O) to simulate pleural pressures. We conducted tests with various EB inflation volumes and measured transesophageal pressure (TEP). TEP measurement was defined as accurate when the difference between pressure within the EB and chamber was 0 ± 1 cmH2O. We computed the minimal (Vaccuracy-min) and maximal (Vaccuracy-max) EB inflation volumes of accuracy. Inflation volumes were further validated using a surrogate method derived by the clinically validated positive pressure occlusion test (PPOT). When the esophageal balloons were filled with inflation volumes within the range provided by the manufacturers, the accuracy of TEP measurements was marginal. Our tests found median Vaccuracy-min across EB of 0.00-0.50 mL (p = 0.130), whereas Vaccuracy-max ranged 0.50-2.25 mL (p = 0.002). Post PPOT validation, median TEP was - 0.4 cmH2O (- 1.5 to 0.3) (p < 0.001 among catheters). The Aspisafe NG and NG+ were accurate in 81.7% and 77.8% of the measurements, respectively. We characterized two new EBs, which demonstrated good benchtop accuracy in TEP measurements. However, accuracy was notably influenced by the precise selection of EB inflation volumes.

A comprehensive evaluation of hemodynamic energy production and circuit loss using four different ECMO arterial cannulae.

OBJECTIVE: Pulsatile-flow veno-arterial extracorporeal membrane oxygenation (V-A ECMO) has shown encouraging results for microcirculation resuscitation and left ventricle unloading in patients with refractory cardiogenic shock. We aimed to comprehensively assess different V-A ECMO parameters and their contribution to hemodynamic energy production and transfer through the device circuit. METHODS: We used the i-cor® ECMO circuit, which composed of Deltastream DP3 diagonal pump and i-cor® console (Xenios AG), the Hilite 7000 membrane oxygenator (Xenios AG), venous and arterial tubing and a 1 L soft venous pseudo-patient reservoir. Four different arterial cannulae (Biomedicus 15 and 17 Fr, Maquet 15 and 17 Fr) were used. For each cannula, 192 different pulsatile modes were investigated by adjusting flow rate, systole/diastole ratio, pulsatile amplitudes and frequency, yielding 784 unique conditions. A dSpace data acquisition system was used to collect flow and pressure data. RESULTS: Increasing flow rates and pulsatile amplitudes were associated with significantly higher hemodynamic energy production (both p < 0.001), while no significant associations were seen while adjusting systole-to-diastole ratio (p = 0.73) or pulsing frequency (p = 0.99). Arterial cannula represents the highest resistance to hemodynamic energy transfer with 32%-59% of total hemodynamic energy generated being lost within, depending on pulsatile flow settings used. CONCLUSIONS: Herein, we presented the first study to compare hemodynamic energy production with all pulsatile ECLS pump settings and their combinations and widely used yet previously unexamined four different arterial ECMO cannula. Only increased flow rate and amplitude increase hemodynamic energy production as single factors, whilst other factors are relevant when combined.

Preclinical Studies on Pulsatile Veno-Arterial Extracorporeal Membrane Oxygenation: A Systematic Review.

Refractory cardiogenic shock is increasingly being treated with veno-arterial extracorporeal membrane oxygenation (V-A ECMO), without definitive proof of improved clinical outcomes. Recently, pulsatile V-A ECMO has been developed to address some of the shortcomings of contemporary continuous-flow devices. To describe current pulsatile V-A ECMO studies, we conducted a systematic review of all preclinical studies in this area. We adhered to PRISMA and Cochrane guidelines for conducting systematic reviews. The literature search was performed using Science Direct, Web of Science, Scopus, and PubMed databases. All preclinical experimental studies investigating pulsatile V-A ECMO and published before July 26, 2022 were included. We extracted data relating to the 1) ECMO circuits, 2) pulsatile blood flow conditions, 3) key study outcomes, and 4) other relevant experimental conditions. Forty-five manuscripts of pulsatile V-A ECMO were included in this review detailing 26 in vitro , two in silico , and 17 in vivo experiments. Hemodynamic energy production was the most investigated outcome (69%). A total of 53% of studies used a diagonal pump to achieve pulsatile flow. Most literature on pulsatile V-A ECMO focuses on hemodynamic energy production, whereas its potential clinical effects such as favorable heart and brain function, end-organ microcirculation, and decreased inflammation remain inconclusive and limited.

Ventricular Flow Dynamics With an Intra-Ventricular Balloon Pump: An In Vitro Analysis.

Due to the high treatment costs associated with durable ventricular assist devices, an intra-ventricular balloon pump (IVBP) was developed to provide low-cost, short-term support for patients suffering from severe heart failure. It is imperative that intraventricular flow dynamics are evaluated with an IVBP to ensure stagnation points, and potential regions for thrombus formation, are avoided. This study used particle image velocimetry to evaluate flow patterns within the left ventricle of a simulated severe heart failure patient with IVBP support to assess left ventricle pulsatility as an indicator of the likelihood of flow stasis. Two inflation timings were evaluated against the baseline severe heart failure condition: IVBP co-pulsation and IVBP counter-pulsation with respect to ventricular systole. IVBP co-pulsation was found to have a reduced velocity range compared to the severe heart failure condition (0.44 m/s compared to 0.54 m/s). IVBP co-pulsation demonstrated an increase in peak velocities (0.25 m/s directed toward the aortic valve during systole, as opposed to 0.2 m/s in severe heart failure), indicating constructive energy in systole and cardiac output (1.7 L/min increase with respect to severe heart failure baseline - 3.5 L/min) throughout the cardiac cycle. IVBP counter-pulsation, while exhibiting the greatest peak systolic velocity directed to the aortic valve (0.4 m/s) was found to counterasct the natural vortex flow pattern during ventricular filling, as well as inducing a secondary ventricular pulse during diastole and a 23% increase in left ventricle end-diastolic volume (indicative of dilation). Ideal IVBP actuation timing did not result in reduced intraventricular pulsatility, indicating promising blood washout.

Improving Trendelenburg position effectiveness by varying cardiopulmonary bypass flow.

INTRODUCTION: Trendelenburg position (TP) is used to transport gaseous emboli away from the cerebral region during cardiac surgery. However, TP effectiveness has not been fully considered when combined with varying the cardiopulmonary bypass (CPB) flow. This study simulated the supine and TP at different pump flows and assessed the trapped emboli and embolic load entering the aortic arch branch arteries (AABA). METHODS: A computational fluid dynamics (CFD) approach used a centrally cannulated adult patient-specific aorta model replicating a CPB circuit. Air emboli of 0.1 mm, 0.5 mm, and 1.0 mm (n = 700 each) were injected into the aorta placed in the supine position (0°) and the TP (-20°) at 2 L/min and 5 L/min. The number of emboli entering the AABA were compared. An aortic phantom flow experiment was performed to validate air bubble behaviour. RESULTS: TP at 5 L/min had the lowest 0.1 mm mean (±SD) embolic load compared to the supine 2 L/min (55.3 ± 30.8 vs 64.3 ± 35.4). For both the supine and TP, the lower flow of 2 L/min had the highest number of simulated trapped emboli in higher elevated regions than at 5 L/min (541 ± 185 and 548 ± 191 vs 520 ± 159 and 512 ± 174), respectively. The flow experiment demonstrated that 2 L/min promoted bubble coalescence and high amounts of trapped emboli and 5 L/min transported air emboli away from the AABA. CONCLUSIONS: TP effectiveness was improved by using CPB flow to manage air emboli. These results provide insights for predicting emboli behaviour and improving emboli de-airing procedures.

Effect of aortic cannulation depth on air emboli transport during cardiopulmonary bypass: A computational study.

INTRODUCTION: Varying the insertion depth of the aortic cannula during cardiopulmonary bypass (CPB) has been investigated as a strategy to mitigate cerebral emboli, yet its effectiveness associated with CPB flow is not fully understood. We compared different arterial cannula insertion depths and pump flow influencing air microemboli entering the aortic arch branch arteries (AABA). METHODS: A computational approach used a patient-specific aorta model to evaluate four cannula locations at (1) proximal arch, (2) mid arch, (3) distal arch, and (4) descending aorta. We injected 0.1 mm microemboli (N=720) at 2 and 5 L/min and assessed the embolic load and the particle averaged transit times ( entering the AABA. RESULTS: Location 4 had the lowest embolic load (2 L/min: N= 63) and (5 L/min: N= 54) compared to locations 1 to 3 in the range of (N= 118 to 116 at 2 L/min:) and (N= 92 to 146 at 5 L/min). There was no significant difference between 2 L/min and 5 L/min (p = 0.31), despite 5 L/min attaining a lower mean (±standard deviation) than 2 L/min (38.0±23.4 vs 44.5±21.1), respectively. Progressing from location 1 to 4, increased 3.11s -7.40 s at 2 L/min and 1.81s -4.18s at 5 L/min. CONCLUSION: It was demonstrated that the elongated cannula insertion length resulted in lower embolic loads, particularly at a higher flow rate. The numerical results suggest that CPB management could combine active flow variation with improving cannula performance and provide a foundation for a future experimental and clinical investigation to reduce surgical cerebral air microemboli.

Diamond-like carbon films prepared by a low temperature periodic process for application in ventricular assist devices.

Due to the poor tribological properties of titanium (Ti) and its alloy Ti6Al4V (commonly used for ventricular assist devices manufacturing), diamond-like carbon (DLC) films with excellent anti-wear properties are pursued to improve the wear resistance of Ti and its alloys. Considering the effect of temperature on magnets inside pump impellers and workpiece deformation, DLC films are preferred to be prepared under low temperature. In this study, DLC films were prepared on Ti6Al4V alloys by periodic and continuous processes, and the corresponding maximum deposition temperature was 85 and 154°C, respectively. The periodic DLC films exhibited the feature of columnar structure, and the surface hillocks were less uniform than that of continuous DLC films. The periodic DLC films possessed more sp3 -bonded structures, and the accessorial sp3 -bonding mainly existed in the form of CH. Compared to continuous DLC films, the periodic DLC films had lower residual stress and better adhesion with Ti6Al4V substrates. Both DLC films could effectively reduce the friction coefficient and wear rate of Ti6Al4V alloys both in air and fetal bovine serum (FBS), and the periodic DLC films exhibited superior anti-wear properties to that of continuous DLC films in FBS. Haemocompatibility evaluation revealed that both DLC films presented similar levels of more human platelet adhesion and activation as compared with that of bare Ti6Al4V. However, both DLC films significantly prolonged plasma clotting time in comparison to bare Ti6Al4V. This study demonstrates the potential of low-temperature DLC films as wear-resistant surface modification for VADs.

Initial clinical validation of a hybrid in silico-in vitro cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems.

Simulators are expected to assume a prominent role in the process of design-development and testing of cardiovascular medical devices. For this purpose, simulators should capture the complexity of human cardiorespiratory physiology in a realistic way. High fidelity simulations of pathophysiology do not only allow to test the medical device itself, but also to advance practically relevant monitoring and control features while the device acts under realistic conditions. We propose a physiologically controlled cardiorespiratory simulator developed in a mixed in silico-in vitro simulation environment. As inherent to this approach, most of the physiological model complexity is implemented in silico while the in vitro system acts as an interface to connect a medical device. As case scenarios, severe heart failure was modeled, at rest and at exercise and as medical device a left ventricular assist device (LVAD) was connected to the simulator. As initial validation, the simulator output was compared against clinical data from chronic heart failure patients supported by an LVAD, that underwent different levels of exercise tests with concomitant increase in LVAD speed. Simulations were conducted reproducing the same protocol as applied in patients, in terms of exercise intensity and related LVAD speed titration. Results show that the simulator allows to capture the principal parameters of the main adaptative cardiovascular and respiratory processes within the human body occurring from rest to exercise. The simulated functional interaction with the LVAD is comparable to the one clinically observed concerning ventricular unloading, cardiac output, and pump flow. Overall, the proposed simulation system offers a high fidelity in silico-in vitro representation of the human cardiorespiratory pathophysiology. It can be used as a test bench to comprehensively analyze the performance of physically connected medical devices simulating clinically realistic, critical scenarios, thus aiding in the future the development of physiologically responding, patient-adjustable medical devices. Further validation studies will be conducted to assess the performance of the simulator in other pathophysiological conditions.

Investigation of heparin-loaded poly(ethylene glycol)-based hydrogels as anti-thrombogenic surface coatings for extracorporeal membrane oxygenation.

Extracorporeal membrane oxygenation (ECMO), a critical life-sustaining tool, faces significant challenges for the maintenance of normal haemostasis due to the large volume of circulating blood continuously in contact with artificial surfaces, hyperoxia and excessive shear stresses of the extracorporeal circuit. From a biomaterials perspective, it has been hypothesised that drug eluting coatings composed of haemocompatible hydrogels loaded with an anticoagulant drug could potentially enhance the haemocompatibility of the circuit. Poly(ethylene glycol) (PEG) has been well established as a biocompatible and anti-fouling material with wide biomedical application. Unfractionated heparin is the most commonly used anticoagulant for ECMO. In the present study, the feasibility of using heparin-loaded PEG-based hydrogels as anti-thrombogenic surface coatings for ECMO was investigated. The hydrogels were synthesised by photopolymerisation using poly(ethylene glycol) diacrylate (PEGDA) as the crosslinking monomer and poly(ethylene glycol) methacrylate (PEGMA) as the hydrophilic monomer, with heparin loaded into the pre-gel solution. Factors which could affect the release of heparin were investigated, including the ratio of PEGDA/PEGMA, water content, loading level of heparin and the flow of fluid past the hydrogel. Our results showed that increased crosslinker content and decreased water content led to slower heparin release. The hydrogels with water contents of 60 wt% and 70 wt% could achieve a sustained heparin release by adjusting the ratio of PEGDA/PEGMA. The anticoagulation efficacy of the released heparin was evaluated by measuring the activated clotting time of whole blood. The hydrogels with desirable heparin release profiles were prepared onto poly(4-methyl-1-pentene) (PMP) films with the same chemical composition as the PMP ECMO membranes. The coatings showed sustained heparin release with a cumulative release of 70-80% after 7 days. Haemocompatibility tests demonstrated that PEG hydrogel coatings significantly reduced platelet adhesion and prolonged plasma recalcification time. These results suggest that heparin-loaded PEG hydrogels are potential anti-thrombogenic coatings for ECMO.

A mock circulation loop to evaluate differential hypoxemia during peripheral venoarterial extracorporeal membrane oxygenation.

INTRODUCTION: Peripheral veno-arterial extracorporeal membrane oxygenation (VA ECMO) creates a retrograde flow along the aorta competing with the left ventricle (LV) in the so-called 'mixing zone' (MZ). Detecting it is essential to understand which of the LV or the ECMO flow perfuses the upper body - particularly the brain and the coronary arteries - in case of differential hypoxemia (DH). METHODS: We described a mock circulation loop (MCL) that enabled experimental research on DH. We recreated the three clinical situations relevant to clinicians: where the brain is either totally perfused by the ECMO or the LV or both. In a second step, we used this model to investigate two scenarios to diagnose DH: (i) pulse pressure and (ii) thermodilution via injection of cold saline in the ECMO circuit. RESULTS: The presented MCL was able to reproduce the three relevant mixing zones within the aortic arch, thus allowing to study DH. Pulse pressure was unable to detect location of the MZ. However, the thermodilution method was able to detect whether the brain was totally perfused by the ECMO or not. CONCLUSION: We validated an in-vitro differential hypoxemia model of cardiogenic shock supported by VA ECMO. This MCL could be used as an alternative to animal studies for research scenarios.

Surface Coatings for Rotary Ventricular Assist Devices: A Systematic Review.

Rotary ventricular assist devices (VADs) are frequently used to provide mechanical circulatory support to patients suffering from end-stage heart failure. Therefore, these devices and especially their pump impeller and housing components have stringent requirements on wear resistance and hemocompatibility. Various surface coatings have been investigated to improve the wear resistance or hemocompatibility of these devices. The aim of the present systematic review was to build a comprehensive understanding of these coatings and provide potential future research directions. A Boolean search for peer-reviewed studies was conducted in online databases (Web of Science, Scopus, PubMed, and ScienceDirect), and a preferred reporting items for systematic reviews and meta-analyses (PRISMA) process was followed for selecting relevant papers for analysis. A total of 45 of 527 publications were included for analysis. Eighteen coatings were reported to improve wear resistance or hemocompatibility of rotary VADs with the most common coatings being diamond-like carbon (DLC), 2-methacryloyloxyethyl phosphorylcholine (MPC), and heparin. Ninety-three percent of studies focused on hemocompatibility, whereas only 4% of studies focused on wear properties. Thirteen percent of studies investigated durability. This review provides readers with a systematic catalogue and critical review of surface coatings for rotary VADs. The review has identified that more comprehensive studies especially investigations on wear properties and durability are needed in future work.

A Compliant Model of the Ventricular Apex to Study Suction in Ventricular Assist Devices.

Ventricular suction is a frequent adverse event in patients with a ventricular assist device (VAD). This study presents a suction module (SM) embedded in a hybrid (hydraulic-computational) cardiovascular simulator suitable for the testing of VADs and related suction events. The SM consists of a compliant latex tube reproducing a simplified ventricular apex. The SM is connected on one side to a hydraulic chamber of the simulator reproducing the left ventricle, and on the other side to a HeartWare HVAD system. The SM is immersed in a hydraulic chamber with a controllable pressure to occlude the compliant tube and activate suction. Two patient profiles were simulated (dilated cardiomyopathy and heart failure with preserved ejection fraction), and the circulating blood volume was reduced stepwise to obtain different preload levels. For each simulated step, the following data were collected: HVAD flow, ventricular pressure and volume, and pressure at the inflow cannula. Data collected for the two profiles and for decreasing preload levels evidenced suction profiles differing in terms of frequency (intermittent vs. every heart beat), amplitude (partial or complete stoppage of the HVAD flow), and shape. Indeed different HVAD flow patterns were observed for the two patient profiles because of the different mechanical properties of the simulated ventricles. Overall, the HVAD flow patterns showed typical indicators of suctions observed in clinics. Results confirmed that the SM can reproduce suction phenomena with VAD under different pathophysiological conditions. As such, the SM can be used in the future to test VADs and control algorithms aimed at preventing suction phenomena.

Anti-thrombogenic Surface Coatings for Extracorporeal Membrane Oxygenation: A Narrative Review.

Extracorporeal membrane oxygenation (ECMO) is used in critical care to manage patients with severe respiratory and cardiac failure. ECMO brings blood from a critically ill patient into contact with a non-endothelialized circuit which can cause clotting and bleeding simultaneously in this population. Continuous systemic anticoagulation is needed during ECMO. The membrane oxygenator, which is a critical component of the extracorporeal circuit, is prone to significant thrombus formation due to its large surface area and areas of low, turbulent, and stagnant flow. Various surface coatings, including but not limited to heparin, albumin, poly(ethylene glycol), phosphorylcholine, and poly(2-methoxyethyl acrylate), have been developed to reduce thrombus formation during ECMO. The present work provides an up-to-date overview of anti-thrombogenic surface coatings for ECMO, including both commercial coatings and those under development. The focus is placed on the coatings being developed for oxygenators. Overall, zwitterionic polymer coatings, nitric oxide (NO)-releasing coatings, and lubricant-infused coatings have attracted more attention than other coatings and showed some improvement in in vitro and in vivo anti-thrombogenic effects. However, most studies lacked standard hemocompatibility assessment and comparison studies with current clinically used coatings, either heparin coatings or nonheparin coatings. Moreover, this review identifies that further investigation on the thrombo-resistance, stability and durability of coatings under rated flow conditions and the effects of coatings on the function of oxygenators (pressure drop and gas transfer) are needed. Therefore, extensive further development is required before these new coatings can be used in the clinic.

Extracorporeal Membrane Oxygenation-Induced Hemolysis: An In Vitro Study to Appraise Causative Factors.

In vitro hemolysis testing is commonly used to determine hemocompatibility of ExtraCorporeal Membrane Oxygenation (ECMO). However, poor reproducibility remains a challenging problem, due to several unidentified influencing factors. The present study investigated potential factors, such as flow rates, the use of anticoagulants, and gender of blood donors, which could play a role in hemolysis. Fresh human whole blood was anticoagulated with either citrate (n = 6) or heparin (n = 12; 6 female and 6 male blood donors). Blood was then circulated for 360 min at 4 L/min or 1.5 L/min. Regardless of flow rate conditions, hemolysis remained unchanged over time in citrated blood, but significantly increased after 240 min circulation in heparinized blood (p ≤ 0.01). The ratio of the normalized index of hemolysis (NIH) of heparinized blood to citrated blood was 11.7-fold higher at 4 L/min and 16.5-fold higher at 1.5 L/min. The difference in hemolysis between 1.5 L/min and 4 L/min concurred with findings of previous literature. In addition, the ratio of NIH of male heparinized blood to female was 1.7-fold higher at 4 L/min and 2.2-fold higher at 1.5 L/min. Our preliminary results suggested that the choice of anticoagulant and blood donor gender could be critical factors in hemolysis studies, and should be taken into account to improve testing reliability during ECMO.

In vitro Hemocompatibility Evaluation of the HeartWare Ventricular Assist Device Under Systemic, Pediatric and Pulmonary Support Conditions.

The development of adult use right ventricular assist devices (RVADs) and pediatric left ventricular assist devices (pediatric LVADs) have significantly lagged behind compared to adult use left ventricular assist devices (LVADs). The HeartWare ventricular assist device (HVAD) intended to be used for adult's systemic support, is increasingly used off-label for adult pulmonary and pediatric systemic support. Due to different hemodynamics and physiology, however, the HVAD's hemocompatibility profiles can be drastically different when used in adult pulmonary circulation or in children, compared to its intended usage state, which could have a direct clinical and developmental relevance. Taking these considerations in mind, we sought to conduct in vitro hemocompatibility testing of HVAD in adult systemic, pediatric systemic and adult pulmonary support conditions. Two HVADs coupled to custom-built blood circulation loops were tested for 6 hours using bovine blood at 37°C under adult systemic, pediatric systemic, and adult pulmonary flow conditions (flow rate = 5.0, 2.5, and 4.5 L/min; differential pressure = 100, 69, and 20 mm Hg, respectively). Normalized index of hemolysis for adult systemic, pediatric systemic, and adult pulmonary conditions were 0.0083, 0.0039, and 0.0017 g/100 L, respectively. No significant difference was seen in platelet activation for these given conditions. High molecular weight von Willebrand factor multimer degradation was evident in all conditions (p < 0.05). In conclusion, alterations in the usage mode produce substantial differences in hemocompatibility of the HVAD. These findings would not only have clinical relevance but will also facilitate future adult use RVAD and pediatric LVAD development.

Assessing potential for aortoiliac vascular injury from venoarterial extracorporeal membrane oxygenation cannulae: An in vitro particle image velocimetry study.

Limb ischemia is a major complication associated with peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO). The high velocity jet from arterial cannulae can cause "sandblasting" injuries to the arterial endothelium, with the potential risk of distal embolization and end organ damage. The aim of this study was to identify, for a range of clinically relevant VA-ECMO cannulae and flow rates, any regions of peak flow velocity on the aortic wall which may predispose to vascular injury, and any regions of low-velocity flow which may predispose to thrombus formation. A silicone model of the aortic and iliac vessels was sourced and the right external iliac artery was cannulated. Cannulae ranged from 15 to 21 Fr in size. Simulated steady state ECMO flow rates were instituted using a magnetically levitated pump (CentriMag pump). Adaptive particle image velocimetry was performed for each cannula at 3, 3.5, 4, and 4.5 L/min. For all cannulae, in both horizontal and vertical side hole orientations, the peak velocity on the aortic wall ranged from 0.3 to 0.45 m/s, and the regions of lowest velocity flow were 0.05 m/s. The magnitude of peak velocity flow on the aortic wall was not different between a single pair versus multiple pairs of side holes. Maximum velocity flow on the aortic wall occurred earlier at a lower pump flow rate in the vertical orientation of distal side holes compared to a horizontal position. The presence of multiple paired side holes was associated with fewer low-velocity flow regions, and some retrograde flow, in the distal abdominal aorta compared to cannulae with a single pair of side holes. From this in vitro visualization study, the selection of a cannula design with multiple versus single pairs of side holes did not change the magnitude of peak velocity flow delivered to the vessel wall. Cannulae with multiple side holes were associated with fewer regions of low-velocity flow in the distal abdominal aorta. Further in vivo studies, and ideally clinical data would be required to assess any correlation of peak velocity flows with incidence of vascular injury, and any low-velocity flow regions with incidence of thrombosis.

Influence of Powder Loading Fraction on Properties of Bonded Permanent Magnets Prepared By Selective Laser Sintering.

Production of bonded permanent magnets (PMs) by processing a mixture of neodymium-iron-boron (Nd-Fe-B) (spherical and flake) and polyamide-12 powders using selective laser sintering (SLS) has focused on increasing the magnetic powder loading fraction to improve the magnetic performance of PMs. However, when using SLS to produce PMs from mixed feedstock, the likelihood of the areas between the magnetic particles being infiltrated by the liquefied binder inducing particle bonding is reduced as binder content is reduced. This decreases mechanical strength and introduces upper limits to the attainable loading fraction of the magnetic powder. The present study investigated the mechanical properties and provided an insight into the residual induction, of loading fractions between 10% and 90% of spherical and flake powders when producing PMs using SLS. The maximum attainable loading fractions were 80%/vol and 70%/vol for the flake and spherical powders, respectively. The PMs produced from the flakes reached a maximum density and residual induction at 50%/vol loading fraction. The PMs produced from spherical powder reached maximum density and residual induction at 70%/vol loading fraction; however, a knee point at 30%/vol loading fraction demonstrated only minor improvements to density (8.8%) and residual induction (13.4%) with further increases in loading fraction. Although PMs produced from flakes demonstrated superior mechanical properties, the elastic modulus and strain limit rapidly decreased with increases in powder loading fraction for both powder types. This study demonstrated the application-specific balance between mechanical and magnetic strength that must be considered when producing PMs by using SLS.

Ex vivo assessment of erythrocyte tolerance to the HeartWare ventricular assist device operated in three discrete configurations.

Despite technological advances in ventricular assist devices (VADs) to treat end-stage heart failure, hemocompatibility remains a constant concern, with supraphysiological shear stresses an unavoidable reality with clinical use. Given that impeller rotational speed is related to the instantaneous shear within the pump housing, it is plausible that the modulation of pump speed may regulate peak mechanical shear stresses and thus ameliorate blood damage. The present study investigated the hemocompatibility of the HeartWare HVAD in three configurations typical of clinical applications: standard systemic support left VAD (LVAD), pediatric support LVAD, and pulmonary support right VAD (RVAD) conditions. Two ex vivo mock circulation blood loops were constructed using explanted HVADs, in which pump speed and external loop resistance were manipulated to reflect the flow rates and differential pressures reported in configurations for standard adult LVAD (at 3150 rev⸱min-1 ), pediatric LVAD (at 2400 rev⸱min-1 ), and adult RVAD (at 1900 rev⸱min-1 ). Using bovine blood, the mock circulation blood loops were tested at 37°C over a period of 6 hours (consistent with ASTM F1841-97) and compared with static control. Hemocompatibility assessments were conducted for each test condition, examining hematology, hemolysis (absolute and normalized index), osmotic fragility, and blood viscosity. Regardless of configuration, continuous exposure of blood to the VAD over the 6-hour period significantly altered hematological and rheological blood parameters, and induced increased hemolysis when compared with a static control sample. Comparison of the three operational VAD configurations identified that the adult LVAD condition-associated with the highest pump speed, flow rate, and differential pressure across the pump-resulted in increased normalized hemolysis index (NIH; 0.07) when compared with the lower pump speed "off-label" counterparts (NIH of 0.04 in pediatric LVAD and 0.01 in adult RVAD configurations). After normalizing blood residence times between configurations, pump speed was identified as the primary determinant of accumulated blood damage; plausibly, blood damage could be limited by restricting pump speed to the minimum required to support matched cardiac output, but not beyond.

An advanced mock circulation loop for in vitro cardiovascular device evaluation.

Controlled and repeatable in vitro evaluation of cardiovascular devices using a mock circulation loop (MCL) is essential prior to in vivo or clinical trials. MCLs often consist of only a systemic circulation with no autoregulatory responses and limited validation. This study aimed to develop, and validate against human data, an advanced MCL with systemic, pulmonary, cerebral, and coronary circulations with autoregulatory responses. The biventricular MCL was constructed with pneumatically controlled hydraulic circulations with Starling responsive ventricles and autoregulatory cerebral and coronary circulations. Hemodynamic repeatability was assessed and complemented by validation using impedance cardiography data from 50 healthy humans. The MCL successfully simulated patient scenarios including rest, exercise, and left heart failure with and without cardiovascular device support. End-systolic pressure-volume relationships for respective healthy and heart failure conditions had slopes of 1.27 and 0.54 mm Hg mL-1 (left ventricle), and 0.18 and 0.10 mm Hg mL-1 (right ventricle), aligning with the literature. Coronary and cerebral autoregulation showed a strong correlation (R2 : .99) between theoretical and experimentally derived circuit flow. MCL repeatability was demonstrated with correlation coefficients being statistically significant (P < .05) for all simulated conditions while MCL hemodynamics aligned well with human data. This advanced MCL is a valuable tool for inexpensive and controlled evaluation of cardiovascular devices.

Development and validation of a low-cost polymer selective laser sintering machine.

Due to manufacturer implemented processing parameter restrictions and the cost prohibitive nature of selective laser sintering (SLS) machines, researchers have limited opportunities to explore the processing of new materials using this additive manufacturing (3D printing) process. Accordingly, this article aimed to overcome these limitations by describing the build and operation of a customizable low-cost polymer SLS machine. The machine boasts a three piston powder bed with the center build piston heated by PID controlled ceramic heaters. Thermal energy for powder consolidation was provided via a 2.44 W solid state diode laser which was mechanically traversed using stepper motor driven belt drives. New layers of powder were deposited by a counter-rotating roller system. The SLS machine was controlled by executing G-code in Mach3 allowing full customization of processing parameters. The machine demonstrated the production of parts from polyamide-12 reaching densities of 918 ± 9 kg/m3 while achieving an elastic modulus of 358.36 ± 3.04 MPa and elongation at break of 11.13 ± 0.02%. With part properties similar to those achievable with a commercial machine, this low-cost SLS machine could be a vital tool in assisting researchers to explore the processing of new materials.