A multi-constituent model for assessing the effect of impeller shroud on the thrombosis potential of a centrifugal blood pump.

Centrifugal blood pumps can be used for treating heart failure patients. However, pump thrombosis has remained one of the complications that trouble clinical treatment. This study analyzed the effect of impeller shroud on the thrombosis risk of the blood pump, and predicted areas prone to thrombosis. Multi-constituent transport equations were presented, considering mechanical activation and biochemical activation. It was found that activated platelets concentration can increase with shear stress and adenosine diphosphate(ADP) concentration increasing, and the highest risk of thrombosis inside the blood pump was under extracorporeal membrane oxygenation (ECMO) mode. Under the same condition, ADP concentration and thrombosis index of semi-shroud impeller can increase by 7.3% and 7.2% compared to the closed-shroud impeller. The main reason for the increase in thrombosis risk was owing to elevated scalar shear stress and more coagulation promoting factor-ADP released. The regions with higher thrombosis potential were in the center hole, top and bottom clearance. As a novelty, the findings revealed that impeller shroud can influence mechanical and biochemical activation factors. It is useful for identifying potential risk regions of thrombus formation based on relative comparisons.

Numerical investigation on the effect of impeller axial position on hemodynamics of an extracorporeal centrifugal blood pump.

Extracorporeal centrifugal blood pumps are used to treat cardiogenic shock. Owing to the imbalanced excitation or initial assembly configurations, the variation in the impeller axial position has the potential to affect the blood pump performance. This study compared the hydrodynamics and hemolysis outcomes at different impeller axial positions via numerical simulations. The result shows that pressure difference of the blood pump decreased with increasing impeller axial position, with decreasing by 4.5% at a flow rate of 2 L/min. Under axial impeller motion close to the top pump casing, average wall shear stress and scalar shear stress reached their maximum values (64.2 and 29.1 Pa, respectively). The residence time in the impeller center hole and bottom clearance were extended to 0.5 s by increasing impeller axial position. Compared to the baseline blood pump, hemolysis index increased by 12.3% and 24.3% when impeller axial position is 2.5 and 4.0 mm, respectively. As a novelty, the findings reveal that the impeller axial position adversely affects hemolysis performance when the impeller is close to the pump casing. Therefore, in the development process of centrifugal blood pumps, the optimal axial position of the impeller must be defined to ensure hemodynamic performance.

The hemodynamics and blood trauma in axial blood pump under different operating models.

BACKGROUND: Speed modulation of blood pumps has been proved to help restore vascular pulsatility and implemented clinically during treatment for cardiac failure. However, its effect on blood trauma has not been studied thoroughly. METHODS: In this paper, we study the flow field of an axial pump FW-X under the modes of co-pulse, counter pulse, and constant speed to evaluate the blood trauma. Based on the coupling model of cardiovascular systems and axial blood pump, aortic pressure and the pump flow were obtained and applied as the boundary conditions at the pump outlet and inlet. The level of shear stress and hemolysis index were derived from computational fluid dynamics (CFD) simulation. RESULTS: Results showed that the constant speed mode had the lowest shear stress level and hemolytic index at the expense of diminished pulsatility. Compared with the constant speed mode, the hemolysis index of co-pulse and counter pulse mode was higher, but it was helpful to restore vascular pulsatility. CONCLUSIONS: This method can be easily incorporated in the in vitro testing phase to analyze and decrease a pump's trauma before animal experimentation, thereby reducing the cost of blood pump development.

Intraventricular flow visualization in different heart failure stages with blood pump support in a mock circulatory loop.

The intraventricular blood flow changed by blood pump flow dynamics may correlate with thrombosis and ventricular suction. The flow velocity, distribution of streamlines, vorticity, and standard deviation of velocity inside a left ventricle failing to different extents throughout the cardiac cycle when supported by an axial blood pump were measured by particle image velocimetry (PIV) in this study. The results show slower and static flow velocities existed in the central region of the left ventricle near the mitral valve and aortic valve and that were not sensitive to left ventricular (LV) failure degree or LV pressure. Strong vorticity located near the inner LV wall around the LV apex and the blood pump inlet was not sensitive to LV failure degree or LV pressure. Higher standard deviation of the blood velocity at the blood pump inlet decreased with increasing LV failure degree, whereas the standard deviation of the velocity near the atrium increased with increasing intraventricular pressure. The experimental results demonstrated that the risk of thrombosis inside the failing left ventricle is not related to heart failure degree. The "washout" performance of the strong vorticity near the inner LV wall could reduce the thrombotic potential inside the left ventricle and was not related to heart failure degree. The vorticity near the aortic valve was sensitive to LV failure degree but not to LV pressure. We concluded that the risk of blood damage caused by adverse flow inside the left ventricle decreased with increasing LV pressure.

Experimental investigation of the influence of the hydraulic performance of an axial blood pump on intraventricular blood flow.

Blood flow inside the left ventricle (LV) is a concern for blood pump use and contributes to ventricle suction and thromboembolic events. However, few studies have examined blood flow inside the LV after a blood pump was implanted. In this study, in vitro experiments were conducted to emulate the intraventricular blood flow, such as blood flow velocity, the distribution of streamlines, vorticity and the standard deviation of velocity inside the LV during axial blood pump support. A silicone LV reconstructed from computerized tomography (CT) data of a heart failure patient was incorporated into a mock circulatory loop (MCL) to simulate human systemic circulation. Then, the blood flow inside the ventricle was examined by particle image velocimetry (PIV) equipment. The results showed that the operating conditions of the axial blood pump influenced flow patterns within the LV and areas of potential blood stasis, and the intraventricular swirling flow was altered with blood pump support. The presence of vorticity in the LV from the thoracic aorta to the heart apex can provide thorough washing of the LV cavity. The gradually extending stasis region in the central LV with increasing blood pump support is necessary to reduce the thrombosis potential in the LV.

A 3-dimensional-printed left ventricle model incorporated into a mock circulatory loop to investigate hemodynamics inside a severely failing ventricle supported by a blood pump.

Intraventricular blood stasis is a design consideration for continuous flow blood pumps and might contribute to adverse events such as thrombosis and ventricular suction. However, the blood flow inside left ventricles (LVs) supported by blood pumps is still unclear. In vitro experiments were conducted to imitate how the hydraulic performance of an axial blood pump affects the intraventricular blood flow of a severe heart failure patient, such as velocity distribution, vorticity, and standard deviation of velocity. In this study, a silicone model of the LV was constructed from the computed tomography data of one patient with heart failure and was 3D printed. Then, intraventricular flow was visualized by particle image velocimetry equipment within a mock circulation loop. The results showed that the axial blood pump suctions most of the blood in a severely failing LV, there was an altered flow status within the LV, and blood stasis appeared in the central region of the LV. Some blood may be suctioned from the aortic valve to the blood pump because the patient's native heart was severely failing. Blood stasis at the LV center may cause thrombosis in the LV. The vortex flow near the inner wall of the LV can thoroughly wash the left ventricular cavity.

A two-phase flow approach for modeling blood stasis and estimating the thrombosis potential of a ventricular assist device.

Thrombosis and its related events have become a major concern during the development and optimization of ventricular assist devices (VADs, also called blood pumps), and limit their clinical use and economic benefits. Attempts have been made to model the thrombosis formation, considering hemodynamic and biochemical processes. However, the complexities and computational expenses are prohibitive. Blood stasis is one of the key factors which may lead to the formation of thrombosis and excessive thromboembolic risks for patients. This study proposed a novel approach for modeling blood stasis, based on a two-phase flow principle. The locations of blood residual can be tracked over time, so that regions of blood stasis can be identified. The blood stasis in an axial blood pump is simulated under various working conditions, the results agree well with the experimental results. In contrast, conventional hemodynamic metrics such as velocity, time-averaged wall shear stress (TAWSS), and relative residence time (RRT), were contradictory in judging risk of blood stasis and thrombosis, and inconsistent with experimental results. We also found that the pump operating at the designed rotational speed is less prone to blood stasis. The model provides an efficient and fast alternative for evaluating blood stasis and thrombosis potential in blood pumps, and will be a valuable addition to the tools to support the design and improvement of VADs.

Platelet deposition estimation: A novel method for emulating the pump thrombosis potential of blood pumps.

Pump thrombosis potential exists in most blood pumps and limits their clinical use. To improve the pump thrombosis performance of blood pumps, a method for emulating the platelet deposition on the flow passage component surfaces inside blood pumps was presented and tested. The method emulates the blood platelet deposition, employing laser-induced fluorescence tracing technology. The blood pump was rotated in a mock circulation loop with deionized water filled with fluorescent particles. The component surfaces were then explored via laser. The fluorescent particles were induced by laser and imaged in a charge-coupled device (CCD) camera to show the distribution of fluorescent particles gathering on the blood pump component surfaces. The activated platelet deposition was emulated by fluorescent particle gathering. The experiment showed obvious particle gathering on the interface surfaces and cross-sectional surface (perpendicular to the flow). This platelet deposition estimation (PDE) method can be easily incorporated in the in vitro testing phase to analyze and decrease a pump's thrombosis potential before animal experimentation, thereby reducing the cost of blood pump development. This methodology of emulating blood platelet deposition indicates its potential for improving flow passage component structure and reducing device thrombosis of blood pumps.

Platelet adhesion emulation: A novel method for estimating the device thrombosis potential of a ventricular assist device.

Device thrombosis inside ventricular assist devices remains a limitation to their long-term clinical use. Thrombosis potential exists in almost all ventricular assist devices because the device-induced high shear stress and vortices can activate platelets, which then aggregate and adhere to the surfaces inside the ventricular assist device. To decrease the device thrombosis potential of long-term use of ventricular assist devices, a methodology entitled platelet adhesion emulation for predicting the thrombosis potential and thrombosis position inside the ventricular assist devices is developed. The platelet adhesion emulation methodology combines numerical simulations with in vitro experiments by correlating the structure of the flow passage components within the ventricular assist device with the platelet adhesion to estimate the thrombosis potential and location, with the goal of developing ventricular assist devices with optimized antithrombotic performance. Platelet adhesion emulation is aimed at decreasing the device thrombus potential of ventricular assist devices. The platelet adhesion emulation effectiveness is validated by simulating and testing an axial left ventricular assist device. The blood velocity relative to the surfaces of the flow passage components is calculated to estimate the platelet adhesion potential, indicating the probability of thrombus formation on the surfaces. Platelet adhesion emulation experiments conducted in a mock circulation loop with pump prototypes show the distribution of platelet adhesion on the surfaces. This methodology of emulating the device thrombosis distribution indicates the potential for improving the component structure and reducing the device thrombosis of ventricular assist devices.

Numerical investigation of the influence of a bearing/shaft structure in an axial blood pump on the potential for device thrombosis.

Adverse events caused by flow-induced thrombus formation around the bearing/shaft of an axial blood pump remain a serious problem for axial blood pumps. Moreover, excessive anticoagulation with thrombosis around the bearing potentially increases the risk of postoperative gastrointestinal bleeding. The purpose of this study is to analyze the influence of the bearing structure on the thrombosis potential of an axial blood pump. The bearing/shaft structure was embedded into an axial blood pump numerical model. The numerical simulation and analysis are focused on the low wall shear stresses, recirculation, and residence time close to the bearing region to evaluate the potential for thrombosis around the bearing. Then, the flow field near the blood pump bearing was tested via in vitro particle image velocimetry experiments to verify the numerical results. The simulation results showed that after embedding the bearing/shaft structure a recirculation zone appeared in the outlet guide vane bearing/shaft region, the residence time increased 11-fold in comparison to the pump without the bearing/shaft structure, the scalar shear stress in the shaft surface was less than 7.8 Pa, and the stress accumulation was less than 0.10 Pa s. The numerical results showed that platelets that flow through the bearing region are exposed to significantly lower wall shear stress and a longer residence time, leading to activated platelet adhesion. The reduced stress accumulation and increased time in the bearing region lead to increased platelet activation.

Numerical Investigation of the Influence of Blade Radial Gap Flow on Axial Blood Pump Performance.

The gaps between the blades and the shroud (or hub) of an axial blood pump affect the hydraulics, efficiency, and hemolytic performance. These gaps are critical parameters when a blood pump is manufactured. To evaluate the influence of blade gaps on axial blood pump performance, the flow characteristics inside an axial blood pump with different radial blade gaps were numerically simulated and analyzed with special attention paid to the hydraulic characteristics, gap flow, hydraulic efficiency, and hemolysis index (HI). In vitro hydraulic testing and particle image velocimetry testing were conducted to verify the numerical results. The simulation results showed that the efficiency and pressure rise decreased when the gap increased. The efficiency of the axial blood pump at design point decreased from 37.1% to 27.1% and the pressure rise decreased from 127.4 to 71.2 mm Hg when the gap increased from 0.1 to 0.3 mm. Return and vortex flows were present in the outlet guide vane channels when the gap was larger than 0.2 mm. The HI of the blood pump with a 0.1 mm gap was 1.5-fold greater than that with a 0.3 mm gap. The results illustrated poor hydraulic characteristics when the gap was larger than 0.15 mm and rapidly deteriorated hemolysis when the gap was larger than 0.1 mm. The numerical and experimental results demonstrated that the pressure rise, pump efficiency, and scalar shear stress decreased when the gap increased. The HI did not strictly decrease with gap increases. The preliminary results encourage the improvement of axial blood pump designs.

Design and numerical evaluation of an axial partial-assist blood pump for Chinese and other heart failure patients.

A fully implantable axial left ventricular assist device LAP31 was developed for Chinese or other heart failure patients who need partial support. Based on the 5-Lpm total cardiac blood output of Chinese without heart failure disease, the design point of LAP31 was set to a flow rate of 3 Lpm with 100-mmHg pressure head. To achieve the required pressure head and good hemolytic performance, a structure that includes a spindly rotor hub and a diffuser with splitter and cantilevered main blades was developed. Computational fluid dynamics (CFD) was used to analyze the hydraulic and hemodynamic performance of LAP31. Then in vitro hydraulics experiments were conducted. The numerical simulation results show that LAP31 could generate a 1 to 8 Lpm flow rate with a 60.9 to 182.7 mmHg pressure head when the pump was rotating between 9,000 and 12,000 rpm. The average scalar shear stress of the blood pump was 21.7 Pa, and the average exposure time was 71.0 milliseconds. The mean hemolysis index of LAP31 obtained using Heuser's hemolysis model and Giersiepen's model was 0.220% and 3.89 × 10-5% respectively. After adding the splitter blades, the flow separation at the suction surface of the diffuser was reduced. The cantilever structure reduced the tangential velocity from 6.1 to 4.7-1.4 m/s within the blade gap by changing the blade gap from shroud to hub. Subsequently, the blood damage caused by shear stress was reduced. In conclusion, the hydraulic and hemolytic characteristics of the LAP31 are acceptable for partial support.

Numerical and In Vitro Experimental Investigation of the Hemolytic Performance at the Off-Design Point of an Axial Ventricular Assist Pump.

The ventricular assist pumps do not always function at the design point; instead, these pumps may operate at unfavorable off-design points. For example, the axial ventricular assist pump FW-2, in which the design point is 5 L/min flow rate against 100 mm Hg pressure increase at 8,000 rpm, sometimes works at off-design flow rates of 1 to 4 L/min. The hemolytic performance of the FW-2 at both the design point and at off-design points was estimated numerically and tested in vitro. Flow characteristics in the pump were numerically simulated and analyzed with special attention paid to the scalar sheer stress and exposure time. An in vitro hemolysis test was conducted to verify the numerical results. The simulation results showed that the scalar shear stress in the rotor region at the 1 L/min off-design point was 70% greater than at the 5 L/min design point. The hemolysis index at the 1 L/min off-design point was 3.6 times greater than at the 5 L/min design point. The in vitro results showed that the normalized index of hemolysis increased from 0.017 g/100 L at the 5 L/min design point to 0.162 g/100 L at the 1 L/min off-design point. The hemolysis comparison between the different blood pump flow rates will be helpful for future pump design point selection and will guide the usage of ventricular assist pumps. The hemolytic performance of the blood pump at the working point in the clinic should receive more focus.

Short-term effect analysis of radiofrequency ablation combined chemotherapy on middle and late period non-small cell lung cancer.

In this study, we investigated the effect of radiofrequency ablation (RFA) combined chemotherapy on middle and late period non-small cell lung cancer (NSCLC). In total, 85 cases of middle and late period NSCLC patients were selected, and were randomly divided into the RFA combined chemotherapy group, RFA treatment group and chemotherapy group. After treatment, the three groups were followed up for computed tomography (CT) scan, and were analyzed for the effect of RFA combined chemotherapy on middle and late period NSCLC. It was found that CT value of RFA combined chemotherapy group decreased significantly compared to before surgery (P<0.05). The CT value of the RFA group decreased significantly compared to before surgery (P<0.05). The CT value of chemotherapy group was not significantly changed compared to before surgery (P>0.05). The postoperative CT value of the RFA combined chemotherapy group and RFA group was smaller compared to that of the chemotherapy group (P<0.05). Effective rate [complete response (CR) + partial response (PR)] of RFA combined chemotherapy group was significantly higher than that of the EFA and chemotherapy groups (P<0.05). Effective rate (CR+PR) of the RFA group was significantly higher than that of the chemotherapy group (P<0.05). By contrast, the progressive rate (P) of RFA combined chemotherapy group was significantly lower than that of the RFA and chemotherapy groups (P<0.05). In conclusion, RFA combined chemotherapy has obvious effect on middle and late period NSCLC, and is safe and feasible.

Off-pump pulmonary valve implantation of a valved stent with an anchoring mechanism.

PURPOSE: The purpose of this study was to evaluate the longitudinal performance and anti-migration effect of a bovine valved stent equipped with an anchoring mechanism implanted off-pump in the pulmonary position. DESCRIPTION: Through a delivery system, the bell-shaped pulmonary valved stents were implanted off-pump in the pulmonary valve position into six sheep by the transventricular approach. Hemodynamic, angiographic, and echocardiographic evaluations were carried out before, immediately after, and 2 months after implantation. Macroscopic and radiographic examination were performed for evaluation. EVALUATION: The valved stents were all successfully implanted off-pump in the pulmonary position on six sheep. Early and late angiographic, echocardiographic, hemodynamic, and macroscopic studies confirmed firm anchoring and good positions of the stents. All valved stents were potent, except one mild stenosis with a 24 mm Hg transvalvular pressure gradient that developed and one mild insufficiency that were discovered at the end of the study. CONCLUSIONS: Transventricular implantation of the bell-shaped pulmonary valved stents was evaluated during a 2-month period in the sheep in the present study and showed a good structural and functional outcome with no migration.