David Glen Mason

Response of rotary blood pumps to changes in preload and afterload at a fixed speed setting are unphysiological when compared with the natural heart.

Responses of four rotary blood pumps (Incor, Heartmate II, Heartware, and Duraheart) at a single speed setting to changes in preload and afterload were assessed using the human left ventricle as a benchmark for comparison. Data for the rotary pumps were derived from pressure flow relations reported in the literature while the natural heart was characterized by the Frank-Starling curve adjusted to fit outputs at different afterloads reported in the literature. Preload sensitivity (mean ± SD) for all pumps at all afterloads tested was 0.105 ± 0.092 L/min/mm Hg, while afterload sensitivity was 0.09 ± 0.034 L/min/mm Hg-values that were not significantly different (t-test, P = 0.56). By contrast, preload sensitivity of the natural heart was over twice as high (0.213 ± 0.03 L/min/mm Hg) and afterload sensitivity about one-third (0.03 ± 0.01 L/min/mm Hg) the values recorded for rotary pumps (t-test, P < 0.001). Maximum preload sensitivity and minimum afterload sensitivity allow the right and left ventricles to synchronize outputs without neural or humoral intervention. This theoretical study reinforces the need to provide preload sensitive control mechanisms of sufficient power to enable the pump and left ventricle in combination to adapt to changes in right ventricular output automatically.

Developments in control systems for rotary left ventricular assist devices for heart failure patients: a review

From the moment of creation to the moment of death, the heart works tirelessly to circulate blood, being a critical organ to sustain life. As a non-stopping pumping machine, it operates continuously to pump blood through our bodies to supply all cells with oxygen and necessary nutrients. When the heart fails, the supplement of blood to the bodys organs to meet metabolic demands will deteriorate. The treatment of the participating causes is the ideal approach to treat heart failure (HF). As this often cannot be done effectively, the medical management of HF is a difficult challenge. Implantable rotary blood pumps (IRBPs) have the potential to become a viable long-term treatment option for bridging to heart transplantation or destination therapy. This increases the potential for the patients to leave the hospital and resume normal lives. Control of IRBPs is one of the most important design goals in providing long-term alternative treatment for HF patients. Over the years, many control algorithms including invasive and non-invasive techniques have been developed in the hope of physiologically and adaptively controlling left ventricular assist devices and thus avoiding such undesired pumping states as left ventricular collapse caused by suction. In this paper, we aim to provide a comprehensive review of the developments of control systems and techniques that have been applied to control IRBPs.

Parameter-Optimized Model of Cardiovascular–Rotary Blood Pump Interactions

A lumped parameter model of human cardiovascular-implantable rotary blood pump (iRBP) interaction has been developed based on experimental data recorded in two healthy pigs with the iRBP in situ. The model includes descriptions of the left and right heart, direct ventricular interaction through the septum and pericardium, the systemic and pulmonary circulations, as well as the iRBP. A subset of parameters was optimized in a least squares sense to faithfully reproduce the experimental measurements (pressures, flows and pump variables). Our fitted model compares favorably with our experimental measurements at a range of pump operating points. Furthermore, we have also suggested the importance of various model features, such as the curvilinearity of the end systolic pressure-volume relationship, the Starling resistance, the suction resistance, the effect of respiration, as well as the influence of the pump inflow and outflow cannulae. Alterations of model parameters were done to investigate the circulatory response to rotary blood pump assistance under heart failure conditions. The present model provides a valuable tool for experiment designs, as well as a platform to aid in the development and evaluation of robust physiological pump control algorithms.

Theoretical foundations of a Starling-like controller for rotary blood pumps

A clinically intuitive physiologic controller is desired to improve the interaction between implantable rotary blood pumps and the cardiovascular system. This controller should restore the Starling mechanism of the heart, thus preventing overpumping and underpumping scenarios plaguing their implementation. A linear Starling-like controller for pump flow which emulated the response of the natural left ventricle (LV) to changes in preload was then derived using pump flow pulsatility as the feedback variable. The controller could also adapt the control line gradient to accommodate longer-term changes in cardiovascular parameters, most importantly LV contractility which caused flow pulsatility to move outside predefined limits. To justify the choice of flow pulsatility, four different pulsatility measures (pump flow, speed, current, and pump head pressure) were investigated as possible surrogates for LV stroke work. Simulations using a validated numerical model were used to examine the relationships between LV stroke work and these measures. All were approximately linear (r(2) (mean ± SD) = 0.989 ± 0.013, n = 30) between the limits of ventricular suction and opening of the aortic valve. After aortic valve opening, the four measures differed greatly in sensitivity to further increases in LV stroke work. Pump flow pulsatility showed more correspondence with changes in LV stroke work before and after opening of the aortic valve and was least affected by changes in the LV and right ventricular (RV) contractility, blood volume, peripheral vascular resistance, and heart rate. The system (flow pulsatility) response to primary changes in pump flow was then demonstrated to be appropriate for stable control of the circulation. As medical practitioners have an instinctive understanding of the Starling curve, which is central to the synchronization of LV and RV outputs, the intuitiveness of the proposed Starling-like controller will promote acceptance and enable rational integration into patterns of hemodynamic management.

Biventricular Assist Devices: A Technical Review

The optimal treatment option for end stage heart failure is transplantation; however, the shortage of donor organs necessitates alternative treatment strategies such as mechanical circulatory assistance. Ventricular assist devices (VADs) are employed to support these cases while awaiting cardiac recovery or transplantation, or in some cases as destination therapy. While left ventricular assist device (LVAD) therapy alone is effective in many instances, up to 50% of LVAD recipients demonstrate clinically significant postoperative right ventricular failure and potentially need a biventricular assist device (BiVAD). In these cases, the BiVAD can effectively support both sides of the failing heart. This article presents a technical review of BiVADs, both clinically applied and under development. The BiVADs which have been used clinically are predominantly first generation, pulsatile, and paracorporeal systems that are bulky and prone to device failure, thrombus formation, and infection. While they have saved many lives, they generally necessitate a large external pneumatic driver which inhibits normal movement and quality of life for many patients. In an attempt to alleviate these issues, several smaller, implantable second and third generation devices that use either immersed mechanical blood bearings or hydrodynamic/magnetic levitation systems to support a rotating impeller are under development or in the early stages of clinical use. Although these rotary devices may offer a longer term, completely implantable option for patients with biventricular failure, their control strategies need to be refined to compete with the inherent volume balancing ability of the first generation devices. The BiVAD systems potentially offer an improved quality of life to patients with total heart failure, and thus a viable alternative to heart transplantation is anticipated with continued development.

Noninvasive Activity-based Control of an Implantable Rotary Blood Pump: Comparative Software Simulation Study

A control algorithm for an implantable centrifugal rotary blood pump (RBP) based on a noninvasive indicator of the implant recipients activity level has been proposed and evaluated in a software simulation environment. An activity level index (ALI)-derived from a noninvasive estimate of heart rate and the output of a triaxial accelerometer-forms the noninvasive indicator of metabolic energy expenditure. Pump speed is then varied linearly according to the ALI within a defined range. This ALI-based control module operates within a hierarchical multiobjective framework, which imposes several constraints on the operating region, such as minimum flow and minimum speed amplitude thresholds. Three class IV heart failure (HF) cases of varying severity were simulated under rest and exercise conditions, and a comparison with other popular RBP control strategies was performed. Pump flow increases of 2.54, 1.94, and 1.15 L/min were achieved for the three HF cases, from rest to exercise. Compared with constant speed control, this represents a relative flow change of 30.3, 19.8, and -15.4%, respectively. Simulations of the proposed control algorithm exhibited the effective intervention of each constraint, resulting in an improved flow response and the maintenance of a safe operating condition, compared with other control modes.

Reliable suction detection for patients with rotary blood pumps.

All rotary blood pumps (RBPs) are prone to the harmful effects of ventricular collapse or “suction events” because of over-pumping, because they are inherently preload insensitive devices, yet RBP controllers do not comprise a clinically reliable suction detector. We therefore investigated the clinical performance of seven expertly selected time domain indices of suction based on the observed positive spike induced in the RBP impeller speed waveform. Using expert panel classifications, a balanced set of 404 five-second speed snapshots of normal and suction events was created from the impeller speed 25 Hz data in 12 VentrAssist implant patients. Initially, suction index threshold levels were set differently for each patient, giving best sensitivity 95% and specificity 99%. However, analysis of paired combinations of suction indices with fixed thresholds identified one pair giving an acceptable sensitivity of 99.5% and specificity 97.5%; the low number of high speed data samples relative to the speed snapshot mean and maximum OR the largest increase in successive speed maxima. The additional precondition of RBP speed amplitude exceeding a low threshold level allows its more general application to patients with low cardiac contractility. This gives a suction detector with high clinical utility; requiring three index threshold settings only.

Noninvasive Average Flow and Differential Pressure Estimation for an Implantable Rotary Blood Pump Using Dimensional Analysis

Accurate noninvasive average flow and differential pressure estimation of implantable rotary blood pumps (IRBPs) is an important practical element for their physiological control. While most attempts at developing flow and differential pressure estimate models have involved purely empirical techniques, dimensional analysis utilizes theoretical principles of fluid mechanics that provides valuable insights into parameter relationships. Based on data obtained from a steady flow mock loop under a wide range of pump operating points and fluid viscosities, flow and differential pressure estimate models were thus obtained using dimensional analysis. The algorithm was then validated using data from two other VentrAssist IRBPs. Linear correlations between estimated and measured pump flow over a flow range of 0.5 to 8.0 L/min resulted in a slope of 0.98 (R 2 = 0.9848). The average flow error was 0.20 plusmn 0.14 L/min (mean plusmn standard deviation) and the average percentage error was 5.79%. Similarly, linear correlations between estimated and measured pump differential pressure resulted in a slope of 1.027 (R 2 = 0.997) over a pressure range of 60 to 180 mmHg. The average differential pressure error was 1.84 plusmn 1.54 mmHg and the average percentage error was 1.51%.

NONINVASIVE DETECTION OF SUCTION IN AN IMPLANTABLE ROTARY BLOOD PUMP USING NEURAL NETWORKS

Granting those heart failure patients who are recipients of an implantable rotary blood pump (iRBP) greater functionality in daily activities is a key long-term strategy currently being pursued by many research groups. A reliable technique for noninvasive detection of the various pumping states, most notably that of ventricular collapse or suction, is an essential component of this strategy. Presented in this study is such a technique, whereby various indicators are derived from the noninvasive pump feedback signals, and a suitable computational methodology developed to classify the pumping states of interest. Clinical telemetry data from ten implant recipients was categorized (with the aid of trans-oesophageal echocardiography) into the normal and suction states. These data are used to develop a pumping state classifier based on an artificial neural network (ANN). Nine indices, derived from the noninvasive impeller speed signal, form the inputs to this ANN classifier. During validation, the resulting ANN classifier achieved a maximum sensitivity of 98.54% (609/618 samples of 5 s in length) and specificity of 99.26% (12,123/12,213 samples) for correct detection of the suction state. The ability to detect the suction state with such a high degree of accuracy provides a critical parameter both for control strategy development, and for clinical care of the implant recipient.

A Dynamic Lumped Parameter Model of the Left Ventricular Assisted Circulation

A lumped parameter model of the cardiovascular system (CVS) and its interaction with an implantable rotary blood pump (iRBP) is presented. The CVS model consists of the heart, the systemic and the pulmonary circulations. The pump model is made up of three differential equations, i.e. the motor equation, the torque equation and the hydraulic equation. Qualitative comparison with data from ex vivo porcine experiments suggests that the model is able to simulate different physiologically significant pumping states with varying pump speed set points. The combined CVS- iRBP model is suitable for use as a tool for investigating changes in the circulatory system parameters in the presence of the pump, and for testing control algorithms.