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.

Pulmonary Valve Opening With Two Rotary Left Ventricular Assist Devices for Biventricular Support.

Right ventricular failure is a common complication associated with rotary left ventricular assist device (LVAD) support. Currently, there is no clinically approved long-term rotary right ventricular assist device (RVAD). Instead, clinicians have implanted a second rotary LVAD as RVAD in biventricular support. To prevent pulmonary hypertension, the RVAD must be operated by either reducing pump speed or banding the outflow graft. These modes differ in hydraulic performance, which may affect the pulmonary valve opening (PVO) and subsequently cause fusion, valvular insufficiency, and thrombus formation. This study aimed to compare PVO with the RVAD operated at reduced speed or with a banded outflow graft. Baseline conditions of systemic normal, hypo, and hypertension with severe biventricular failure were simulated in a mock circulation loop. Biventricular support was provided with two rotary VentrAssist LVADs with cardiac output restored to 5 L/min in banded outflow and reduced speed conditions, and systemic and pulmonary vascular resistances (PVR) were manipulated to determine the range of conditions that allowed PVO without causing left ventricular suction. Finally, RVAD sine wave speed modulation (±550 rpm) strategies (co- and counter-pulsation) were implemented to observe the effect on PVO. For each condition, outflow banding had higher PVR (97 ± 20 dyne/s/cm5 higher) for when the pulmonary valve closed compared to reduced speed. In addition, counter-pulsation demonstrated greater PVO than co-pulsation and constant speed. For the purpose of reducing the risks of pulmonary valve insufficiency, fusion, and thrombotic event, this study recommends a RVAD with a steeper H-Q gradient by banding and further exploration of RVAD speed modulation.

In Vitro Evaluation of an Immediate Response Starling-Like Controller for Dual Rotary Blood Pumps.

Rotary ventricular assist devices (VADs) are used to provide mechanical circulatory support. However, their lack of preload sensitivity in constant speed control mode (CSC) may result in ventricular suction or venous congestion. This is particularly true of biventricular support, where the native flow-balancing Starling response of both ventricles is diminished. It is possible to model the Starling response of the ventricles using cardiac output and venous return curves. With this model, we can create a Starling-like physiological controller (SLC) for VADs which can automatically balance cardiac output in the presence of perturbations to the circulation. The comparison between CSC and SLC of dual HeartWare HVADs using a mock circulation loop to simulate biventricular heart failure has been reported. Four changes in cardiovascular state were simulated to test the controller, including a 700 mL reduction in circulating fluid volume, a total loss of left and right ventricular contractility, reduction in systemic vascular resistance ( SVR) from 1300 to 600 dyne  s/cm5, and an elevation in pulmonary vascular resistance ( PVR) from 100 to 300 dyne  s/cm5. SLC maintained the left and right ventricular volumes between 69-214 mL and 29-182 mL, respectively, for all tests, preventing ventricular suction (ventricular volume = 0 mL) and venous congestion (atrial pressures > 20 mm Hg). Cardiac output was maintained at sufficient levels by the SLC, with systemic and pulmonary flow rates maintained above 3.14 L/min for all tests. With the CSC, left ventricular suction occurred during reductions in SVR, elevations in PVR, and reduction in circulating fluid simulations. These results demonstrate a need for a physiological control system and provide adequate in vitro validation of the immediate response of a SLC for biventricular support.

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.

Pulsatile operation of a continuous-flow right ventricular assist device (RVAD) to improve vascular pulsatility.

Despite the widespread acceptance of rotary blood pump (RBP) in clinical use over the past decades, the diminished flow pulsatility generated by a fixed speed RBP has been regarded as a potential factor that may lead to adverse events such as vasculature stiffening and hemorrhagic strokes. In this study, we investigate the feasibility of generating physiological pulse pressure in the pulmonary circulation by modulating the speed of a right ventricular assist device (RVAD) in a mock circulation loop. A rectangular pulse profile with predetermined pulse width has been implemented as the pump speed pattern with two different phase shifts (0% and 50%) with respect to the ventricular contraction. In addition, the performance of the speed modulation strategy has been assessed under different cardiovascular states, including variation in ventricular contractility and pulmonary arterial compliance. Our results indicated that the proposed pulse profile with optimised parameters (Apulse = 10000 rpm and ωmin = 3000 rpm) was able to generate pulmonary arterial pulse pressure within the physiological range (9-15 mmHg) while avoiding undesirable pump backflow under both co- and counter-pulsation modes. As compared to co-pulsation, stroke work was reduced by over 44% under counter-pulsation, suggesting that mechanical workload of the right ventricle can be efficiently mitigated through counter-pulsing the pump speed. Furthermore, our results showed that improved ventricular contractility could potentially lead to higher risk of ventricular suction and pump backflow, while stiffening of the pulmonary artery resulted in increased pulse pressure. In conclusion, the proposed speed modulation strategy produces pulsatile hemodynamics, which is more physiologic than continuous blood flow. The findings also provide valuable insight into the interaction between RVAD speed modulation and the pulmonary circulation under various cardiovascular states.

Mitral Valve Regurgitation with a Rotary Left Ventricular Assist Device: The Haemodynamic Effect of Inlet Cannulation Site and Speed Modulation.

Mitral valve regurgitation (MVR) is common in patients receiving left ventricular assist device (LVAD) support, however the haemodynamic effect of MVR is not entirely clear. This study evaluated the haemodynamic effect of MVR with LVAD support and the influence of inflow cannulation site and LVAD speed modulation. Left atrial (LAC) and ventricular (LVC) cannulation was evaluated in a mock circulation loop with no, mild, moderate and severe MVR with constant speed and speed modulation (±600 RPM) modes. The use of an LVAD relieved pulmonary congestion during severe MVR, by reducing left atrial pressure from 20.5 to 10.8 (LAC) and 11.5 (LVC) mmHg. However, LAC resulted in decreased left ventricular stroke work (-0.08 J), ejection fraction (-7.9%) and higher MVR volume (+12.7 mL) and pump speed (+100 RPM) compared to LVC. This suggests that LVC, in addition to reducing MVR severity, also improves ventricular washout over LAC. LVAD speed modulation in synchrony with ventricular systole reduced MVR volume and increased ejection fraction with LAC and LVC, thus demonstrating the potential benefits of this mode, despite a reduction in cardiac output.

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.