Investigation of the inherent left-right flow balancing of rotary total artificial hearts by means of a resistance box.

With the incidence of end-stage heart failure steadily increasing, the need for a practical total artificial heart (TAH) has never been greater. Continuous flow TAHs (CFTAH) are being developed using rotary blood pumps (RBPs), leveraging their small size, mechanical simplicity, and excellent durability. To completely replace the heart with currently available RBPs, two are required; one for providing pulmonary flow and one for providing systemic flow. To prevent hazardous states, it is essential to maintain balance between the pulmonary and systemic circulation at a wide variety of physiologic states. In this study, we investigated factors determining a CFTAH's inherent ability to balance systemic and pulmonary flow passively, without active management of pump rotational speed. Four different RBPs (ReliantHeart HA5, Thoratec HMII, HeartWare HVAD, and Ventracor VentrAssist) were used in various combinations to construct CFTAHs. Each CFTAH's ability to autonomously maintain pressures and flows within defined ranges was evaluated in a hybrid mock loop as systemic and pulmonary vascular resistance (PVR) were changed. The resistance box, a method to quantify the range of vascular resistances that can be safely supported by a CFTAH, was used to compare different CFTAH configurations in an efficient and predictive way. To reduce the need for future in vitro tests and to aid in their analysis, a novel analytical evaluation to predict the resistance box of various CFTAH configurations was also performed. None of the investigated CFTAH configurations fully satisfied the predefined benchmarks for inherent flow balancing, with the VentrAssist (left) and HeartAssist 5 (right) offering the best combination. The extent to which each CFTAH was able to autonomously maintain balance was determined by the pressure sensitivity of each RPB: the sensitivity of outflow to changes in the pressure head. The analytical model showed that by matching left and right pressure sensitivity the inherent balancing performance can be improved. These findings may ultimately lead to a reduced need for manual speed changes or active control systems.

In Vitro Evaluation of the Dual-Diffuser Design for a Reversible Rotary Intra-Aortic Ventricular Assist Device.

The intra-aortic ventricular assist device (IntraVAD) is a miniature intra-aortic axial-flow ventricular assist device (VAD) that works in series with the left ventricle (LV) to assist the compromised heart. Previous in vitro results have shown that the IntraVAD can successfully increase coronary perfusion and offload ventricular volume by operating in reverse-rotation control (RRc) mode. The RRc mode includes forward rotation in systole and reverse rotation (RR) in diastole. It is necessary to derive a new diffuser design that can be used for the bi-directional rotation of the IntraVAD. In this work, a dual-diffuser set (DDS) was proposed to replace the conventional inducer and diffuser upstream and downstream of the pump. The DDS comprised two diffusers, located on both sides of the impeller, omitting the conventional inducer and diffuser. Different configurations of the DDS were designed and manufactured with various combinations of curved and straight blades. All configurations were initially tested in continuous flow, then in a pulsatile mock circulatory loop. A weighted normalized scalar (WNS) was proposed to comprehensively evaluate the hemodynamic effect of the DDS with different configurations. The results show that the maximum of WNS occurred when the upstream diffuser had equal numbers of curved and straight blades and the downstream diffuser had only curved blades. This indicates such a dual-diffuser design for the IntraVAD can give an optimal cardiac assistance potentially improving ventricular contractility, thereby restoring heart function.

Rapid Speed Modulation of a Rotary Total Artificial Heart Impeller.

Unlike the earlier reciprocating volume displacement-type pumps, rotary blood pumps (RBPs) typically operate at a constant rotational speed and produce continuous outflow. When RBP technology is used in constructing a total artificial heart (TAH), the pressure waveform that the TAH produces is flat, without the rise and fall associated with a normal arterial pulse. Several studies have suggested that pulseless circulation may impair microcirculatory perfusion and the autoregulatory response and may contribute to adverse events such as gastrointestinal bleeding, arteriovenous malformations, and pump thrombosis. It may therefore be beneficial to attempt to reproduce pulsatile output, similar to that generated by the native heart, by rapidly modulating the speed of an RBP impeller. The choice of an appropriate speed profile and control strategy to generate physiologic waveforms while minimizing power consumption and blood trauma becomes a challenge. In this study, pump operation modes with six different speed profiles using the BiVACOR TAH were evaluated in vitro. These modes were compared with respect to: hemodynamic pulsatility, which was quantified as surplus hemodynamic energy (SHE); maximum rate of change of pressure (dP/dt); pulse power index; and motor power consumption as a function of pulse pressure. The results showed that the evaluated variables underwent different trends in response to changes in the speed profile shape. The findings indicated a possible trade-off between SHE levels and flow rate pulsatility related to the relative systolic duration in the speed profile. Furthermore, none of the evaluated measures was sufficient to fully characterize hemodynamic pulsatility.

Hemodynamic response to exercise and head-up tilt of patients implanted with a rotary blood pump: a computational modeling study.

The present study investigates the response of implantable rotary blood pump (IRBP)-assisted patients to exercise and head-up tilt (HUT), as well as the effect of alterations in the model parameter values on this response, using validated numerical models. Furthermore, we comparatively evaluate the performance of a number of previously proposed physiologically responsive controllers, including constant speed, constant flow pulsatility index (PI), constant average pressure difference between the aorta and the left atrium, constant average differential pump pressure, constant ratio between mean pump flow and pump flow pulsatility (ratioP I or linear Starling-like control), as well as constant left atrial pressure ( P l a ¯ ) control, with regard to their ability to increase cardiac output during exercise while maintaining circulatory stability upon HUT. Although native cardiac output increases automatically during exercise, increasing pump speed was able to further improve total cardiac output and reduce elevated filling pressures. At the same time, reduced venous return associated with upright posture was not shown to induce left ventricular (LV) suction. Although P l a ¯ control outperformed other control modes in its ability to increase cardiac output during exercise, it caused a fall in the mean arterial pressure upon HUT, which may cause postural hypotension or patient discomfort. To the contrary, maintaining constant average pressure difference between the aorta and the left atrium demonstrated superior performance in both exercise and HUT scenarios. Due to their strong dependence on the pump operating point, PI and ratioPI control performed poorly during exercise and HUT. Our simulation results also highlighted the importance of the baroreflex mechanism in determining the response of the IRBP-assisted patients to exercise and postural changes, where desensitized reflex response attenuated the percentage increase in cardiac output during exercise and substantially reduced the arterial pressure upon HUT.

Modeling of a rotary blood pump.

The accurate representation of rotary blood pumps in a numerical environment is important for meaningful investigation of pump-cardiovascular system interactions. Although numerous models for ventricular assist devices (VADs) have been developed, modeling methods for rotary total artificial hearts (rTAHs) are still required. Therefore, an rTAH prototype was characterized in a steady flow, hydraulic test bench over a wide operational range for pump and hydraulic parameters. In order to develop a generic modeling method, a data-driven modeling approach was chosen. k-Nearest-neighbors, artificial neural networks, and support vector machines (SVMs) were the machine learning approaches evaluated. The best performing parameters for each algorithm were determined via optimization. The resulting multiple-input-multiple-output models were subsequently assessed under identical conditions, and a SVM with a radial basis function kernel was identified as the best performing. The achieved root mean squared errors were 0.03 L/min, 0.06 L/min, and 0.18 W for left and right flow and motor power consumption, respectively. In comparison with existing models for VADs, the flow errors are more than 70% lower. Further advantages of the SVM model are the robustness to measurement noise and the capability to operate outside of the trained parameter range. This proposed modeling method will accelerate further device refinements by providing a more appropriate numerical environment in which to evaluate the pump-cardiovascular system interaction.

A hybrid mock circulation loop for a total artificial heart.

Rotary blood pumps are emerging as a viable technology for total artificial hearts, and the development of physiological control algorithms is accelerated with new evaluation environments. In this article, we present a novel hybrid mock circulation loop (HMCL) designed specifically for evaluation of rotary total artificial hearts (rTAH). The rTAH is operated in the physical domain while all vasculature elements are embedded in the numerical domain, thus combining the strengths of both approaches: fast and easy exchange of the vasculature model together with improved controllability of the pump. Parameters, such as vascular resistance, compliance, and blood volume, can be varied dynamically in silico during operation. A hydraulic-numeric interface creates a real-time feedback loop between the physical and numerical domains. The HMCL uses computer-controlled resistance valves as actuators, thereby reducing the size and number of hydraulic elements. Experimental results demonstrate a stable interaction over a wide operational range and a high degree of flexibility. Therefore, we demonstrate that the newly created design environment can play an integral part in the hydraulic design, control development, and durability testing of rTAHs.

Effects of biventricular shunt on pump characteristics in a maglev total artificial heart.

Severe left ventricular failure can progress to right ventricular failure, necessitating alternatives to heart transplantation, such as total artificial heart (TAH) treatment. Conventional TAHs encounter challenges associated with miniaturization and hemocompatibility owing to their reliance on mechanical valves and bearings. A magnetically levitated TAH (IB-Heart) was developed, utilizing a magnetic bearing. The IB-Heart features a distinctive biventricular shunt channel situated between the flow paths of the left and right centrifugal blood pumps, simplifying and miniaturizing its control system. However, the impact of these shunt channels remains underexplored. This study aimed to investigate the effects of shunt flow on pump characteristics and assess the IB-Heart's potential to regulate flow balance between systemic and pulmonary circulation. At a rotational speed of 2000 rpm and flow rate range of 0-10 L/min, shunt flow exhibited a minor impact, with a 1.4 mmHg (1.3%) effect on pump characteristics. Shunt flow variation of about 0.13 L/min correlated with a 10 mmHg pressure difference between the pumps' afterload and preload conditions. This variance was linked to changes in the inlet flow rates of the left and right pumps, signifying the ventricular shunt structure's capacity to mirror the function of an atrial shunt in alleviating pulmonary congestion. The IB-Heart's ventricular shunt structure enables passive regulation of left-right flow balance. The findings establish a fundamental technical groundwork for the development of IB-Hearts and TAHs with similar shunt structures. The innovative coupling of centrifugal pumps and the resultant effects on flow dynamics contribute to the advancement of TAH technology.

A low-volume tester for the thrombogenic potential of mechanical heart valve prostheses.

BACKGROUND AND AIM OF THE STUDY: During the development of a mechanical heart valve prosthesis, many studies are conducted to guarantee its correct function. Currently, investigations into the thrombogenic potential of a valve after its replacement are conducted with expensive and time-consuming chronic animal trials. Hence, the study aim was to develop and test an alternative system to resolve such thrombogenic issues. METHODS: The Thrombosis Tester of the Helmholtz Institute Aachen (THIA II) has a reasonably small priming volume (220-270 ml) that allows analysis of the thrombogenic potential of two valves, using one human blood bottle. RESULTS: Hydrodynamic evaluation demonstrated an absolutely stable physiological pressure and flow progression at the aortic and pulmonary positions. A sinus geometry of the human aortic root is implemented downstream of the valve in order to guarantee physiological leaflet motion. The tester remained absolutely thrombus-free during several tests carried out with minimally anticoagulated porcine blood, while the valves showed reproducible thrombus formation in reasonable locations. Tests with fully heparinized porcine blood showed that a soft silicon fixture for the valve could reduce hemolysis in the THIA II. CONCLUSION: This in-vitro test protocol can enable the optimization of a valve design during the early stages of its research and development. The system can provide a unique and suitable supplement to animal trials for testing thrombogenic performance, under constant and reproducible boundary conditions, including considerable physiological and pathological circumstances such as the influence of valve position (aortic, pulmonic), and a comparison of different valve types.

A compact mock circulation loop for the in vitro testing of cardiovascular devices.

In vitro cardiovascular device performance evaluation in a mock circulation loop (MCL) is a necessary step prior to in vivo testing. A MCL that accurately represents the physiology of the cardiovascular system accelerates the assessment of the device's ability to treat pathological conditions. To serve this purpose, a compact MCL measuring 600 × 600 × 600 mm (L × W × H) was constructed in conjunction with a computer mathematical simulation. This approach allowed the effective selection of physical loop characteristics, such as pneumatic drive parameters, to create pressure and flow, and pipe dimensions to replicate the resistance, compliance, and fluid inertia of the native cardiovascular system. The resulting five-element MCL reproduced the physiological hemodynamics of a healthy and failing heart by altering ventricle contractility, vascular resistance/compliance, heart rate, and vascular volume. The effects of interpatient anatomical variability, such as septal defects and valvular disease, were also assessed. Cardiovascular hemodynamic pressures (arterial, venous, atrial, ventricular), flows (systemic, bronchial, pulmonary), and volumes (ventricular, stroke) were analyzed in real time. The objective of this study is to describe the developmental stages of the compact MCL and demonstrate its value as a research tool for the accelerated development of cardiovascular devices.

Evaluation of hydraulic radial forces on the impeller by the volute in a centrifugal rotary blood pump.

In many state-of-the-art rotary blood pumps for long-term ventricular assistance, the impeller is suspended within the casing by magnetic or hydrodynamic means. For the design of such suspension systems, profound knowledge of the acting forces on the impeller is crucial. Hydrodynamic bearings running at low clearance gaps can yield increased blood damage and magnetic bearings counteracting high forces consume excessive power. Most current rotary blood pump devices with contactless bearings are centrifugal pumps that incorporate a radial diffuser volute where hydraulic forces on the impeller develop. The yielding radial forces are highly dependent on impeller design, operating point and volute design. There are three basic types of volute design--singular, circular, and double volute. In this study, the hydraulic radial forces on the impeller created by the volute in an investigational centrifugal blood pump are evaluated and discussed with regard to the choice of contactless suspension systems. Each volute type was tested experimentally in a centrifugal pump test setup at various rotational speeds and flow rates. For the pump's design point at 5 L/min and 2500 rpm, the single volute had the lowest radial force (∼0 N), the circular volute yielded the highest force (∼2 N), and the double volute possessed a force of approx. 0.5 N. Results of radial force magnitude and direction were obtained and compared with a previously performed computational fluid dynamics (CFD) study.

A method for control of an implantable rotary blood pump for heart failure patients using noninvasive measurements.

We propose a deadbeat controller for the control of pulsatile pump flow (Q(p) ) in an implantable rotary blood pump (IRBP). Noninvasive measurements of pump speed and current are used as inputs to a dynamical model of Q(p) estimation, previously developed and verified in our laboratory. The controller was tested using a lumped parameter model of the cardiovascular system (CVS), in combination with the stable dynamical models of Q(p) and differential pressure (head) estimation for the IRBP. The control algorithm was tested with both constant and sinusoidal reference Q(p) as input to the CVS model. Results showed that the controller was able to track the reference input with minimal error in the presence of model uncertainty. Furthermore, Q(p) was shown to settle to the desired reference value within a finite number of sampling periods. Our results also indicated that counterpulsation yields the minimum left ventricular stroke work, left ventricular end diastolic volume, and aortic pulse pressure, without significantly affecting mean cardiac output and aortic pressure.

Optimizing the response from a passively controlled biventricular assist device.

Recent studies into rotary biventricular support have indicated that inadequate left/right flow balancing may lead to vascular congestion and/or ventricular suckdown. The implementation of a passive controller that automatically adjusts left/right flow during total and partial cardiac support would improve physiological interaction. This has encouraged the development of a biventricular assist device (BiVAD) prototype that achieves passive control of the two rotary pumps' hydraulic output by way of a nonrotating double pressure plate configuration, the hub, suspended between the ventricular assist device (VAD) impellers. Fluctuations in either the VAD's inlet or outlet pressure will cause the hub to translate, and in doing so, affect each pump's hydraulic outputs. In order to achieve partial support, the floating assembly needed to respond to pathologic blood pressure signals while being insensitive to residual ventricular function. An incorporated mechanical spring-mass-damper assembly affects the passive response to optimize the dynamic interaction between the prototype and the supported cardiovascular system. It was found that increasing the damping from a medium to a high level was effective in filtering out the higher frequency ventricular pressure signals, reducing a modified amplitude ratio by up to 72%. A spring response was also identified as being inherent in the passive response and was characterized as being highly nonlinear at the extremes of the floating assembly's translation range. The results from this study introduce a new means of BiVAD control as well as the characterization of a fully passive mechanical physiological controller.

Flow distribution during cardiopulmonary bypass in dependency on the outflow cannula positioning.

Oxygen deficiency in the right brain is a common problem during cardiopulmonary bypass (CPB). This is linked to an insufficient perfusion of the carotid and vertebral artery. The flow to these vessels is strongly influenced by the outflow cannula position, which is traditionally located in the ascending aorta. Another approach however is to return blood via the right subclavian artery. A computational fluid dynamics (CFD) study was performed for both methods and validated by particle image velocimetry (PIV). A 3-dimensional computer aided design model of the cardiovascular (CV) system was generated from realtime computed tomography and magnetic resonance imaging data. Mesh generation (CFD) and rapid prototyping (PIV) were used for the further model creation. The simulations were performed assuming usual CPB conditions, and the same boundary conditions were applied for the PIV validation. The flow distribution was analyzed for 55 cannula positions inside the aorta and in relation to the distance between the cannula tip and the vertebral artery branch for subclavian cannulation. The study reveals that the Venturi effect due to the cannula jet appears to be the main reason for the loss in cerebral perfusion seen clinically. It provides a PIV-validated CFD method of analyzing the flow distribution in the CV system and can be transferred to other applications.

The impact of aortic/subclavian outflow cannulation for cardiopulmonary bypass and cardiac support: a computational fluid dynamics study.

Approximately 100 000 cases of oxygen deficiency in the brain occur during cardiopulmonary bypass (CPB) procedures each year. In particular, perfusion of the carotid and vertebral arteries is affected. The position of the outflow cannula influences the blood flow to the cardiovascular system and thus end organ perfusion. Traditionally, the cannula returns blood into the ascending aorta. But some surgeons prefer cannulation to the right subclavian artery. A computational fluid dynamics study was initially undertaken for both approaches. The vessel model was created from real computed tomography/magnetic resonance imaging data of young healthy patients. The simulations were run with usual CPB conditions. The flow distribution for different cannula positions in the aorta was studied, as well as the impact of the cannula tip distance to vertebral artery for the subclavian position. The study presents a fast method of analyzing the flow distribution in the cardiovascular system, and can be adapted for other applications such as ventricular assist device support. It revealed that two effects cause the loss of perfusion seen clinically: a vortex under the brachiocephalic trunk and low pressure regions near the cannula jet. The results suggest that cannulation to the subclavian artery is preferred if the cannula tip is sufficiently far away from the branch of the vertebral artery. For the aortic positions, however, the cannula should be injected from the left body side.

Preliminary design of the internal geometry in a minimally invasive left ventricular assist device under pulsatile-flow conditions.

PURPOSE: A minimally invasive, partial-assist, intra-atrial blood pump has been proposed, which would unload the left ventricle with a flow path from the left atrium to the arterial system. Flow modulation is a common strategy for ensuring washout in the pump, but it can increase power consumption because it is typically achieved through motor-speed variation. However, if a pump's performance curve had the proper gradient, flow modulation could be realized passively. To achieve this goal, we propose a pump performance operating curve as an alternative to the more standard operating point. METHODS AND RESULTS: Mean-line theory was employed to generate an initial set of geometries that were then tested on a hydraulic test rig at ~20,000 r/min. Experimental results show that the intra-atrial blood pump performed below the operating region; however, it was determined that smaller hub diameter and longer chord length bring the performance of the intra-atrial blood pump device closer to the operating curve. CONCLUSION: We found that it is possible to shape the pump performance curve for specifically targeted gradients over the operating region through geometric variations inside the pump.

Hemodynamic effects of synchronizing an intra-aortic VAD in reverse-rotation control with left ventricle: a mock loop study.

The IntraVAD is an intra-aortic left ventricular assist device (LVAD) to be located in the ascending aorta. In order to enhance unloading and promote coronary flow for the left ventricle (LV), an operating mechanism, reverse-rotation control (RRc) mode, has been developed for the IntraVAD and tested in vitro in a mock circulation loop (MCL). The RRc mode consists of forward rotation (FR) and reverse rotation (RR). The synchronization between the IntraVAD and the LV was studied to offload the ventricle more effectively and to improve myocardial perfusion. The percentage time length of the FR period in the cardiac cycle (Tlf) and time offset between the central-lines of the FR period and the LV systole (Toc) are two parameters of the RRc mode that were varied to adjust the synchronization between the IntraVAD and the LV. The ejection fraction (EF), coronary perfusion pressure (CPP), and arterial pulsatility index (API) were measured at different Tlf and Toc values. These hemodynamic results closely correlated to the LV unloading, coronary perfusion, and peripheral arterial pulsatility. The EF, CPP and API were fed into a weighted normalized scalar (WNS) which was implemented to comprehensively evaluate the hemodynamic influence. The WNS result shows that the overall hemodynamic response is more sensitive to the changes in Toc value than Tlf value. The result shows a significant reduction in LV afterload by starting the FR before LV contraction, then switching to RR at the onset of ventricular dilation. The optimal phase shift of -π/5 was found to precede LV contraction, indicating that changes in LV afterload are more sensitive to the phase shift at the start of the ventricular systole than at the end. Thus, a phase advance between intra-aortic pumps and the LV is critical to unload the ventricle and promote myocardial recovery.

In vitro study of an intra-aortic VAD: Effect of reverse-rotating mode on ventricular recovery.

Cardiac recovery has been observed in end-stage heart failure patients with mechanical circulatory support. An intra-aortic ventricular assist device (IntraVAD) is a novel rotary blood pump designed to operate in the ascending aorta behind the aortic valve, working in series with the compromised left ventricle (LV). Such a device requires optimal motion control in order to enhance the myocardial perfusion and thus promote cardiac recovery. Therefore, a reverse-rotating control (RRc) mode has been proposed to increase the mean arterial pressure (MAP) in diastole where the most coronary flow occurs. The RRc mode consists of two motions - forward rotating speed (FS) and reversely rotating speed (RS). The capability of cardiac recovery of three control modes, including `continuous', `on/off ' and `RRc' modes, was evaluated in vitro. Stroke work (SW), ventricular volume, coronary perfusion pressure (CPP), and arterial pulsatility index (API) were used to evaluate LV unloading, myocardial perfusion and arterial pulsatility. The results show that, all three modes increased the LV stroke work (0.98W vs 1.00W vs 1.01W for continuous, on/off and RRc, respectively; baseline 0.9W) and decreased both end-diastolic volume (EDV) and end-systolic volume (ESV). The "RRc" mode improved CPP significantly (78.4 mm Hg compared to 66.4 mmHg and 70.9 mm Hg for continuous and on/off modes; baseline 71 mm Hg). The arterial pulsatility was higher in `RRc' mode (0.84 compared to 0.43 and 0.59; baseline 0.48). In summary, the IntraVAD operating in the RRc mode can successfully unload the LV, enhance the myocardial perfusion, and restore the arterial pulsatility; therefore, it could be a promising therapeutic option to bridge heart failure patients to recovery.

Total artificial hearts: past, present, and future.

A practical artificial heart has been sought for >50 years. An increasing number of people succumb to heart disease each year, but the number of hearts available for transplantation remains small. Early total artificial hearts mimicked the pumping action of the native heart. These positive-displacement pumps could provide adequate haemodynamic support and maintain the human circulation for short periods, but large size and limited durability adversely affected recipients' quality of life. Subsequent research into left ventricular assist devices led to the use of continuous-flow blood pumps with rotating impellers. Researchers have attempted to integrate this technology into modern total artificial hearts with moderate clinical success. The importance of pulsatile circulation remains unclear. Future research is, therefore, needed into positive-displacement and rotary total artificial hearts.

Pulsatile operation of the BiVACOR TAH - Motor design, control and hemodynamics.

Although there is limited consensus about the strict requirement to deliver pulsatile perfusion to the human circulatory system, speed modulation of rotary blood pumps is an approach that may capture the benefits of both positive displacement and continuous flow blood pumps. In the current stage of development of the BiVACOR Total Artificial Heart emphasis is placed on providing pulsatile outflow from the pump. Multiple pulsatile speed profiles have been applied in preliminary in-vivo operation in order to assess the capability of the TAH to recreate a physiologic pulse. This paper provides an overview about recent research towards pulsatile BiVACOR operation with special emphasis on motor and control requirements and developments.

A mock circulatory loop for designing and evaluating total artificial hearts.

A mock circulatory loop was constructed to facilitate total artificial heart development. The loop includes many novel features such as a pressure-regulated tank to simulate exercise conditions, controllable systemic and pulmonary vascular resistance to create left-right flow imbalances as seen in postural change and breathing, and a left atrial suction valve. Dual HeartMate II pumps and the BiVACOR® rotary total artificial heart were used to generate pressure and flow data characterizing the flow loop.