Left ventricular assist device mode: Co-pulse left ventricular unloading in a working mode of ex vivo heart perfusion.

BACKGROUND: For normothermic ex vivo heart perfusion (EVHP), a resting mode and working mode have been proposed. We newly developed a left ventricular assist device (LVAD) mode that supports heart contraction by co-pulse synchronized LVAD. METHODS: Following resting mode during time 0 to 1 hour, pig hearts (n = 18) were perfused in either resting, working, or LVAD mode during time 1 to 5 hour, and then myocardial function was evaluated in working mode at 6 hour. The preservation ratio was defined as the myocardial mechanical function at 330 minute divided by the function at 75 minute. In LVAD mode, LVAD unloaded the pressure and the volume in the left ventricle in the systolic phase. RESULTS: The LVAD group was significantly associated with higher preservation ratios in cardiac output (resting, 33 ± 3; working, 35 ± 5; LVAD, 76% ± 5%; p < 0.001), stroke work, dP/dt maximum, and dP/dt minimum compared with the other groups. Glucose consumption was significantly reduced in the resting group. The LVAD group was significantly associated with higher myocardial oxygen consumption (resting, 2.2 ± 0.3; working; 4.6 ± 0.5; LVAD, 6.1 ± 0.5 mL O2/min/100 g, p < 0.001) and higher adenosine triphosphate (ATP) levels (resting, 1.1 ± 0.1; working, 0.7 ± 0.1; LVAD, 1.6 ± 0.2 µmol/g, p = 0.001) compared with the others. CONCLUSION: These data suggest that myocardial mechanical function was better preserved in LVAD mode than in resting and working modes. Although our data suggested similar glycolysis activity in the LVAD and working groups, the higher final ATP in the LVAD group might be explained by reduced external work in LVAD.

Real-time Lung Weight Measurement During Cellular Ex Vivo Lung Perfusion: An Early Predictor of Transplant Suitability.

BACKGROUND: Increased extravascular lung water during ex vivo lung perfusion (EVLP) is associated with ischemia reperfusion injury and poor pulmonary function. A non-invasive technique for evaluating extravascular lung water during EVLP is desired to assess the transplant suitability of lungs. We investigated real-time lung weight measurements as a reliable method for assessing pulmonary functions in cellular EVLP using a porcine lung model. METHODS: Fifteen pigs were randomly divided into 3 groups: control (no warm ischemia) or donation after circulatory death groups with 60 or 90 min of warm ischemia (n = 5, each). Real-time lung weight gain was measured by load cells positioned at the bottom of the organ chamber. RESULTS: Real-time lung weight gain at 2 h was significantly correlated with lung weight gain as measured on a back table ( R = 0.979, P < 0.01). Lung weight gain in non-suitable cases (n = 6) was significantly higher than in suitable cases (n = 9) at 40 min (51.6 ± 46.0 versus -8.8 ± 25.7 g; P < 0.01, cutoff = +12 g, area under the curve = 0.907). Lung weight gain at 40 min was significantly correlated with PaO 2 /FiO 2 , peak inspiratory pressure, shunt ratio, wet/dry ratio, and transplant suitability at 2 h ( P < 0.05, each). In non-suitable cases, lung weight gain at 66% and 100% of cardiac output was significantly higher than at 33% ( P < 0.05). CONCLUSIONS: Real-time lung weight measurement could potentially be an early predictor of pulmonary function in cellular EVLP.

Lung thermography during the initial reperfusion period to assess pulmonary function in cellular ex vivo lung perfusion.

BACKGROUND: Thermography is a noninvasive technology to detect low temperatures in poorly circulated areas. In ex vivo lung perfusion (EVLP), lungs are rewarmed to body temperature during the initial 1 h. Currently, the effect of graft thermal changes during the rewarming phase on pulmonary function is unknown. In this study, we evaluated the correlation of lung surface temperature with physiological parameters, wet/dry ratio, and transplant suitability in Lund-type EVLP. METHODS: Fifteen pigs were divided into three groups: control group (no warm ischemia) or donation after circulatory death groups with 60 or 90 min of warm ischemia (n = 5, each). Thermal images of the lower lobes were continuously collected from the bottom of an organ chamber using infrared thermography throughout EVLP. RESULTS: At 8 min, lung surface temperatures of nonsuitable cases were significantly lower than in suitable cases (25.1 ± 0.6 vs. 27.8 ± 1.2°C, p < 0.001), while there was no difference in lung surface temperatures between the two groups at 0-4 min and 12-120 min. There was a significant negative correlation between lung surface temperatures at 8 min and wet/dry ratio at 2 h in the lower lobes (R = -0.769, p < 0.001, cutoff = 26°C, area under the curve = 1.0). A lung surface temperature of <26°C was significantly correlated with poor pulmonary function and transplant nonsuitability. CONCLUSION: A lung surface temperature of ≥26°C at 8 min is a good early predictor of transplant suitability in cellular EVLP and might be applicable in clinical EVLP.

Optical oxygen saturation imaging in cellular ex vivo lung perfusion to assess lobular pulmonary function.

Ex vivo lung perfusion (EVLP) is an emerging tool to evaluate marginal lungs in lung transplantation. However, there is no objective metric to monitor lobular regional oxygenation during EVLP. In this study, we developed oxygen saturation (SaO2) imaging to quantitatively assess the regional gas exchange potential of the lower lobes. Ten porcine lungs were randomly divided into control and donation after circulatory death (DCD) groups (n = 5, each). Lungs were perfused in cellular EVLP for 2 h, and multispectral images were continuously collected from the dorsal sides of the lower lobes. We examined whether lower lobe SaO2 correlated with PaO2/FiO2 (P/F) ratios in lower pulmonary veins (PV). The wet/dry ratio in lower lobes was measured and Monte Carlo simulations were performed to investigate the method's feasibility. There was a significant correlation between lower lobe SaO2 and the P/F ratio in lower PV (r = 0.855, P < 0.001). The DCD group was associated with lower SaO2 and higher wet/dry ratio than the control group (P < 0.001). The error of estimated SaO2 was limited according to Monte Carlo simulations. The developed technology provides a noninvasive and regional evaluative tool of quantitative lobular function in EVLP.

Impact of gap size and groove design of hydrodynamic bearing on plasma skimming effect for use in rotary blood pump.

Plasma skimming can exclude red blood cells from high shear regions in the gaps formed by hydrodynamic bearings in rotary blood pumps. We investigated the effect of the gap size and groove design on the plasma skimming efficiency. Spiral groove bearings (SGBs) were installed into a specially designed test rig for in vitro experiments performed using human blood. The measured gap between the ridges of the bearing and the rotor surface was 17-26 µm at a flow rate of 150 ml/min and a rotor speed of 2400 rpm. Three different patterns of SGBs were designed (SGB-0, SGB-30, and SGB-60) with various degrees of the circumferential component. The hematocrit measured by a high-speed camera was compared with the hematocrit in the circuit, and the plasma skimming efficiency for the three bearing patterns was evaluated at hematocrits of 20%, 25%, and 30%. SGB-60, which had the strongest circumferential component, provided the best plasma skimming efficiency. When the gap size was less than 20 µm, the red blood cells in the gaps between the ridges of the bearing and rotor surface reduced significantly and the efficiency became higher than 90%. The gap size had the strongest effect on producing a significant plasma skimming. The plasma skimming efficiency can be significantly improved by optimizing the bearing gap size and groove design, which facilitates the further development of SGBs for use in applications such as rotary blood pumps.

In vitro hemocompatibility investigation for the development of low-flow centrifugal blood pumps with less platelet clogging.

Low-flow blood pumps rated under 1 L/min are emerging for new medical applications, such as hemofiltration in acute use. In those pumps, platelet adhesion and aggregation have to be carefully considered because of clogging risk in the filter part. To find an acceptable hemocompatibility that can be applied to low-flow centrifugal blood pump design, the platelet aggregation index, clogging on a micromesh filter, and the hemolysis index were investigated using a low-flow blood pump designed for hemofiltration use. We conducted circulation testing in vitro using fresh porcine blood and two centrifugal pumps with different impeller inlet shapes. The Negative Log Platelet Aggregation Threshold Index (NL-PATI), which reflects the ability of residual platelets to aggregate, and flow rate were measured during reflux for 60 min, and the Normalized Index of Hemolysis (NIH (g/20 min)) was calculated. In addition, blood cell clogging after reflux was observed on the micromesh filter by SEM, and the adhesion rate was calculated. Our results showed that the platelet clogging on the micromesh filter occurred when the average NL-PATI was greater than 0.28 and the average NIH (g/20 min) was greater than 0.01. In contrast, platelet clogging on the micromesh was suppressed when NL-PATI was less than 0.17 and the NIH (g/20 min) was less than 0.003. These values might be used as acceptable hemocompatibility of low-flow centrifugal blood pumps with suppressed platelet clogging for hemofiltration pumps.

Quantitative investigation of platelet aggregation under high shear force for anti-platelet aggregation in vitro tests.

Blood pumps are often used for hemofiltration in patients with renal failure. To design effective centrifugal blood pumps for hemofiltration, it is important to suppress clogging caused by platelet aggregation. However, the optimal conditions for conducting anti-platelet aggregation tests in vitro have not yet been established. This study aimed to quantify the effect of the shear loading value and shear loading time on platelet aggregation and determine the optimal conditions for anti-platelet aggregation testing in vitro. To quantitatively evaluate platelet aggregation in terms of the negative logarithm-platelet aggregation threshold index (NL-PATI), which reflects the propensity of residual platelets to aggregate after shear loading, the following parameters were examined: blood collection method (collected from porcine vein using a syringe or collected from a slaughterhouse), type of anticoagulant (sodium citrate or heparin), shear rate, and shear time. The results showed that platelet aggregation in porcine blood increased under a high shear load applied at shear rates of approximately 20,000 s-1 or higher for 30 s. Platelet aggregation propensity was 2-3 times higher in heparin-anticoagulated blood than in sodium citrate-anticoagulated blood. Moreover, platelet aggregation was 1.5-2 times more in blood collected from the slaughterhouse than in syringe-collected blood. Testing with an integrated shear time of 30 s or less in relation to the total blood volume may be effective for conducting in vitro circulation experiments using hemofiltration blood pumps. The conditions established in this study may be useful for hemocompatibility testing of cardiovascular devices based on NL-PATI.

Investigating the cause of hemolysis in patients supported by a pulsatile ventricular assist device.

A survey conducted by Abiomed, Inc. revealed that 10 of 60 patients who received ventricular assistance via the AB5000 ventricular assist device (VAD) experienced hemolysis. The present study was conducted to investigate which factors influence hemolysis under pulsatile-flow VADs such as the AB5000. We compared the specificity of the AB5000 and its driving console with those of the NIPRO-VAD and VCT50χ under severe heart failure conditions using a mock circulatory system with a glycerol water solution. We used the mock circuit with bovine blood to confirm which pump conditions were most likely to cause hemolysis. In addition, we measured the shear velocity using particle image velocimetry by analyzing the seeding particle motion for both the AB5000 and NIPRO-VAD under the same conditions as those indicated in the initial experiment. Finally, we analyzed the correlation between negative pressure, exposure time, and hemolysis by continuously exposing fixed vacuum pressures for fixed times in a sealed device injected with bovine blood. Applying higher vacuum pressure to the AB5000 pump yielded a larger minimum inlet pressure and a longer exposure time when the negative pressure was under - 10 mmHg. The plasma-free hemoglobin increased as more negative pressure was driven into the AB5000 pump. Moreover, the negative pressure interacted with the exposure time, inducing hemolysis. This study revealed that negative pressure and exposure time were both associated with hemolysis.

Improvement of hemolysis performance in a hydrodynamically levitated centrifugal blood pump by optimizing a shroud size.

We have developed a hydrodynamically levitated centrifugal blood pump. In the blood pump having hydrodynamic bearings, the narrow bearing gap has a potential for high hemolysis. The purpose of the this study is to improve hemolysis performance in a hydrodynamically levitated centrifugal blood pump by optimizing a shroud size. The impeller was levitated passively at the position where the thrust forces acting on the impeller were balanced. We focused on a size of a bottom shroud with a hydrodynamic bearing that could change the bottom hydrodynamic force to balance the thrust force at the wide bearing gap for reducing hemolysis. Five test models with various shroud size were compared: 989 mm2 (HH-10.5), 962 mm2 (HH-12), 932 mm2 (HH-13.5), 874 mm2 (HH-16), and 821 mm2 (HH-18). A numerical analysis was first performed to estimate the bearing gaps in the test model. The bearing gaps were then measured to validate the numerical analysis. Finally, an in vitro hemolysis test was performed. The numerical analysis revealed that the HH-13.5 model had the widest bearing gap of 129 µm. In the measurement test, the estimation error for the bearing gap was less than 10%. In the hemolysis test, the HH-13.5 model achieved the lowest hemolysis level among the five models. The present study demonstrated that the numerical analysis was found to be effective for determining the optimal should size, and the HH-13.5 model had the optimal shroud size in the developed hydrodynamically levitated centrifugal blood pump to reduce hemolysis.

Real-time, non-invasive thrombus detection in an extracorporeal circuit using micro-optical thrombus sensors.

INTRODUCTION: Real-time, non-invasive monitoring of thrombus formation in extracorporeal circuits has yet to be achieved. To address the challenges of conventional optical thrombus detection methods requiring large devices that limit detection capacity, we developed a micro-optical thrombus sensor. METHODS: The proposed micro-optical thrombus sensor can detect the intensity of light scattered by blood at wavelengths of 660 and 855 nm. Two thrombus sensors were installed on in vitro circuit: one at the rotary blood pump and one at a flow channel. To evaluate the variation in the ratio of incident light intensity at each wavelength of the two sensors, Rfluct (for 660 nm) and Ifluct (for 855 nm) were defined. Using fresh porcine blood as a working fluid, we performed in vitro tests of haematocrit (Hct) and oxygen saturation (SaO2) variation and thrombus detection. Thrombus tests were terminated after Rfluct or Ifluct showed a larger change than the maximum range of those in the Hct and SaO2 variation test. RESULTS: In all three thrombus detection tests, Ifluct showed a larger change than the maximum range of those in the Hct and SaO2 variation test. After the tests, thrombus formation was confirmed in the pump, and there was no thrombus in the flow channel. The results indicate that Ifluct is an effective parameter for identifying the presence of a thrombus. CONCLUSION: Thrombus detection in an extracorporeal circuit using the developed micro-optical sensors was successfully demonstrated in an in vitro test.

Suitable hemolysis index for low-flow rotary blood pumps.

A suitable index is needed for hemolysis tests that use low-flow pumps, such as pediatric blood pumps or blood purification pumps. To create such an index, the present study investigates the change of plasma-free hemoglobin in the pump circuit with time and the change of the hemolysis rate with flow rate and impeller rotational speed. The results show that the hemolysis rate or the increase rate of the total free hemoglobin are suitable measures for hemolysis evaluation for low-flow pumps.

Plasma skimming efficiency of human blood in the spiral groove bearing of a centrifugal blood pump.

This work investigates the plasma skimming effect in a spiral groove bearing within a hydrodynamically levitated centrifugal blood pump when working with human blood having a hematocrit value from 0 to 40%. The present study assessed the evaluation based on a method that clarified the limitations associated with such assessments. Human blood was circulated in a closed-loop circuit via a pump operating at 4000 rpm at a flow rate of 5 L/min. Red blood cells flowing through a ridge area of the bearing were directly observed using a high-speed microscope. The hematocrit value in the ridge area was calculated using the mean corpuscular volume, the bearing gap, the cross-sectional area of a red blood cell, and the occupancy of red blood cells. The latter value was obtained from photographic images by dividing the number of pixels showing red blood cells in the evaluation area by the total number of pixels in this area. The plasma skimming efficiency was calculated as the extent to which the hematocrit of the working blood was reduced in the ridge area. For the hematocrit in the circuit from 0 to 40%, the plasma skimming efficiency was approximately 90%, meaning that the hematocrit in the ridge area became 10% as compared to that in the circuit. For a hematocrit of 20% and over, red blood cells almost completely occupied the ridge. Thus, a valid assessment of plasma skimming was only possible when the hematocrit was less than 20%.

Development of a real-time and quantitative thrombus sensor for an extracorporeal centrifugal blood pump by near-infrared light.

We developed an optical thrombus sensor for a monopivot extracorporeal centrifugal blood pump. In this study, we investigated its quantitative performance for thrombus detection in acute animal experiments of left ventricular assist using the pump on pathogen-free pigs. Optical fibers were set in the driver unit of the pump. The incident light at the near-infrared wavelength of 810 nm was aimed at the pivot bearing, and the resulting scattered light was guided to the optical fibers. The detected signal was analyzed to obtain the thrombus formation level. As a result, real-time and quantitative monitoring of the thrombus surface area on the pivot bearing was achieved with an accuracy of 3.6 ± 2.3 mm2. In addition, the sensing method using the near-infrared light was not influenced by changes in the oxygen saturation and the hematocrit. It is expected that the developed sensor will be useful for optimal anticoagulation management for long-term extracorporeal circulation therapies.

Optical Dynamic Analysis of Thrombus Inside a Centrifugal Blood Pump During Extracorporeal Mechanical Circulatory Support in a Porcine Model.

Complications due to pump thrombus remain the weak point of mechanical circulatory support (MCS), such as the use of a left ventricular assist device (LVAD) or extracorporeal membrane oxygenation, leading to poor outcomes. Hyperspectral imaging (HSI) is an effective imaging method using a hyperspectral (HS) camera, which comprises a spectrophotometer and a charge-coupled device camera to discriminate thrombus from whole blood. Animal experiments were conducted to analyze dynamic imaging of thrombus inside a prototype of a hydrodynamically levitated centrifugal blood pump using an HSI system. Six pigs were divided into a venous circulation group (n = 3) and an arterial circulation group (n = 3). Inflow and outflow cannulae were inserted into the jugular veins in the venous circulation group. The latter simulated an LVAD application. To create thrombogenic conditions, pump flow was maintained at 1 L/min without anticoagulation. An image of the bottom surface of the pump was captured by the HS camera every 4 nm over the wavelength range of 608-752 nm. Real-time dynamic images of the inside of the pump were displayed on the monitor. Appearance of an area displaying thrombus was detected within 24 h after the start of the circulation in every experiment. This imaging system also succeeded in determining the origins of pump thrombus: from inside the pump in two cases, and from outside in four cases. Two main possible sources of pump thrombus originating outside the pump were identified on autopsy: wedge thrombus around the inflow cannula; and string-like thrombus at the junction between the pump inlet and circuit tube. The results of this study from close observation of the changing appearance of pump thrombus may contribute to improvements in the safety of extracorporeal MCS.

Long-term durability test of axial-flow ventricular assist device under pulsatile flow.

A long-term durability test was conducted on a newly developed axial-flow ventricular assist device (VAD) with hydrodynamic bearings. The mock circulatory loop consisted of a diaphragm pump with a mechanical heart valve, a reservoir, a compliance tank, a resistance valve, and flow paths made of polymer or titanium. The VAD was installed behind the diaphragm pump. The blood analog fluid was a saline solution with added glycerin at a temperature of 37 °C. A pulsatile flow was introduced into the VAD over a range of flow rates to realize a positive flow rate and a positive pressure head at a given impeller rotational speed, yielding a flow rate of 5 L/min and a pressure of 100 mmHg. Pulsatile flow conditions were achieved with the diastolic and systolic flow rates of ~0 and 9.5 L/min, respectively, and an average flow rate of ~5 L/min at a pulse rate of 72 bpm. The VAD operation was judged by not only the rotational speed of the impeller, but also the diastolic, systolic, and average flow rates and the average pressure head of the VAD. The conditions of the mock circulatory loop, including the pulse rate of the diaphragm pump, the fluid temperature, and the fluid viscosity were maintained. Eight VADs were tested with testing periods of 2 years, during which they were continuously in operation. The VAD performance factors, including the power consumption and the vibration characteristics, were kept almost constant. The long-term durability of the developed VAD was successfully demonstrated.

Plasma Skimming in a Spiral Groove Bearing of a Centrifugal Blood Pump.

Plasma skimming is a phenomenon in which discharge hematocrit is lower than feed hematocrit in microvessels. Plasma skimming has been investigated at a bearing gap in a spiral groove bearing (SGB), as this has the potential to prevent hemolysis in the SGB of a blood pump. However, it is not clear whether plasma skimming occurs in a blood pump with the SGB, because the hematocrit has not been obtained. The purpose of this study is to verify plasma skimming in an SGB of a centrifugal blood pump by developing a hematocrit measurement method in an SGB. Erythrocyte observation using a high-speed microscope and a bearing gap measurement using a laser confocal displacement meter was performed five times. In these tests, bovine blood as a working fluid was diluted with autologous plasma to adjust the hematocrit to 1.0%. A resistor was adjusted to achieve a pressure head of 100 mm Hg and a flow rate of 5.0 L/min at a rotational speed of 2800 rpm. Hematocrit on the ridge region in the SGB was measured using an image analysis based on motion image of erythrocytes, mean corpuscular volume, the measured bearing gap, and a cross-sectional area of erythrocyte. Mean hematocrit on the ridge region in the SGB was linearly reduced from 0.97 to 0.07% with the decreasing mean bearing gap from 38 to 21 µm when the rotational speed was changed from 2250 to 3000 rpm. A maximum plasma skimming efficiency of 93% was obtained with a gap of 21 µm. In conclusion, we succeeded in measuring the hematocrit on the ridge region in the SGB of the blood pump. Hematocrit decreased on the ridge region in the SGB and plasma skimming occurred with a bearing gap of less than 30 µm in the hydrodynamically levitated centrifugal blood pump.

Properties of a monopivot centrifugal blood pump manufactured by 3D printing.

An impeller the same geometry as the impeller of a commercial monopivot cardiopulmonary bypass pump was manufactured using 3D printing. The 3D-printed impeller was integrated into the pump casing of the commercially available pump to form a 3D-printed pump model. The surface roughness of the impeller, the hydraulic performance, the axial displacement of the rotating impeller, and the hemolytic properties of the 3D-printed model were measured and compared with those of the commercially available model. Although the surface roughness of the 3D-printed model was significantly larger than that of the commercially available model, the hydraulic performance of the two models almost coincided. The hemolysis level of the 3D-printed model roughly coincided with that of the commercially available model under low-pressure head conditions, but increased greatly under high-pressure head conditions, as a result of the narrow gap between the rotating impeller and the pump casing. The gap became narrow under high-pressure head conditions, because the axial thrust applied to the impeller increased with increasing impeller rotational speed. Moreover, the axial displacement of the rotating impeller was twice that of the commercially available model, confirming that the elastic deformation of the 3D-printed impeller was larger than that of the commercially available impeller. These results suggest that trial models manufactured by 3D printing can reproduce the hydraulic performance of the commercial product. However, both the surface roughness and the deformation of the trial models must be considered to precisely evaluate the hemolytic properties of the model.

In vitro thrombogenesis resulting from decreased shear rate and blood coagulability.

In vitro antithrombogenic testing with mock circulation is a useful type of pre-evaluation in ex vivo testing of mechanical assist devices. For effective in vitro testing, we have been developing a clear quantitative thrombogenesis model based on shear stress and blood coagulability. Bovine blood was used as the test medium. The activating clotting time (ACT) was adjusted with trisodium citrate and calcium chloride from 200 to 1,000 seconds. The blood was then applied to a rheometer and subjected to shear at 50 to 2,880 s-1. Blood coagulation time and degree of thrombogenesis were measured by the torque sensor of the rheometer. Prothrombin time (PT) and activated partial thromboplastin time (APTT) of the test blood were also measured after the application of shear. Blood coagulation time increased, and the degree of thrombogenesis decreased, with increases in shear rate to between 50 and 2,880 s-1. for test bloods with ACTs of 200 to 250 seconds. An ACT of 200 to 250 seconds is thus appropriate for in vitro antithrombogenic testing under a shear rate of 2,880 s-1. APTT was prolonged, whereas PT did not change, with increasing shear rate: that is, increasing the shear rate reduced thrombogenesis related to the intrinsic clotting pathway. An ACT of 200 to 250 seconds was suitable for in vitro antithrombogenic testing, and increasing the shear stress generated in the mechanical assist device reduced thrombogenesis via the intrinsic clotting pathway.

Effect of Impeller Geometry on Lift-Off Characteristics and Rotational Attitude in a Monopivot Centrifugal Blood Pump.

The effect of the flow path geometry of the impeller on the lift-off and tilt of the rotational axis of the impeller against the hydrodynamic force was investigated in a centrifugal blood pump with an impeller supported by a single-contact pivot bearing. Four types of impeller were compared: the FR model with the flow path having both front and rear cutouts on the tip, the F model with the flow path having only a front cutout, the R model with only a rear cutout, and the N model with a straight flow path. First, the axial thrust and the movement about the pivot point, which was loaded on the surface of the impeller, were calculated using computational fluid dynamics (CFD) analysis. Next, the lift-off point and the tilt of the rotational axis of the impeller were measured experimentally. The CFD analysis showed that the axial thrust increased gently in the FR and R models as the flow rate increased, whereas it increased drastically in the F and N models. This difference in axial thrust was likely from the higher pressure caused by the smaller circumferential velocity in the gap between the top surface of the impeller and the casing in the FR and R models than in the F and N models, which was caused by the rear cutout. These results corresponded with the experimental results showing that the impellers lifted off in the F and N models as the flow rate increased, whereas it did not in the FR and R models. Conversely, the movement about the pivot point increased in the direction opposite the side with the pump outlet as the flow rate increased. However, the tilt of the rotational axis of the impeller, which oriented away from the pump outlet, was less than 0.8° in any model under any conditions, and was considered to negligibly affect the rotational attitude of the impeller. These results confirm that a rear cutout prevents lift-off of the impeller caused by a decrease in the axial thrust.

Optical aggregometry of red blood cells associated with the blood-clotting reaction in extracorporeal circulation support.

The aggregability of red blood cell (RBCs) is associated with the contribution of plasma proteins, such as fibrinogen and lipoproteids, to blood-clotting. Hence, we hypothesized that RBC aggregability reflects the blood-clotting reaction. A noninvasive optical monitoring method to measure RBC aggregability for the assessment of blood-clotting stage during mechanical circulatory support was developed. An in vitro thrombogenic test was conducted with a rotary blood pump using heparinized fresh porcine blood. Near-infrared laser light at a wavelength of 785 nm was guided by an optical fiber. The fibers for detecting incident, forward-, and backward-scattered light were fixed on the circuit tubing with an inner diameter of 1/4 inch. Because there is substantial RBC aggregation at low shear flow rates, a pulsatile flow was generated by controlling the pump rotational speed. The flow rate was changed from 0 to 8.5 L/min at a period of 40 s. The intensities of forward- and backward-scattered light changed dramatically when the flow stopped. The aggregability was evaluated by the increase ratio of the transmitted light intensity from the flow stopping in the low-flow condition. The experiment started when the anticoagulation was stopped by the addition of protamine into the circulating blood. Reduction in RBC aggregability was associated with a decrease in the amount of fibrinogen and the number of platelets. Continuous, noninvasive monitoring of thrombosis risk is possible using optical measurements combining pulsatile flow control of a rotary blood pump. RBC aggregometry is a potential label-free method for evaluating blood-clotting risk.