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 body's 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.

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

In a clinical setting it is necessary to control the speed of rotary blood pumps used as left ventricular assist devices to prevent possible severe complications associated with over- or underpumping. The hypothesis is that by using only the noninvasive measure of instantaneous pump impeller speed to assess flow dynamics, it is possible to detect physiologically significant pumping states (without the need for additional implantable sensors). By varying pump speed in an animal model, five such states were identified: regurgitant pump flow, ventricular ejection (VE), nonopening of the aortic valve over the cardiac cycle (ANO), and partial collapse (intermittent and continuous) of the ventricle wall (PVC-I and PVC-C). These states are described in detail and a strategy for their noninvasive detection has been developed and validated using (n = 6) ex vivo porcine experiments. Employing a classification and regression tree, the strategy was able to detect pumping states with a high degree of sensitivity and specificity: state VE—99.2/100.0% (sensitivity/specificity); state ANO—100.0/100.0%; state PVC-I— 95.7/91.2%; state PVC-C—69.7/98.7%. With a simplified binary scheme differentiating suction (PVC-I, PVC-C) and nonsuction (VE, ANO) states, both such states were detected with 100% sensitivity.

Identification and Classification of Physiologically Significant Pumping States in an Implantable Rotary Blood Pump

Estimation of instantaneous flow in rotary blood pumps (RBPs) is important for monitoring the interaction between heart and pump and eventually the ventricular function. Our group has reported an algorithm to derive ventricular contractility based on the maximum time derivative (dQ/dt(max) as a substitute for ventricular dP/dt(max) ) and pulsatility of measured flow signals. However, in RBPs used clinically, flow is estimated with a bandwidth too low to determine dQ/dt(max) in the case of improving heart function. The aim of this study was to develop a flow estimator for a centrifugal pump with bandwidth sufficient to provide noninvasive cardiac diagnostics. The new estimator is based on both static and dynamic properties of the brushless DC motor. An in vitro setup was employed to identify the performance of pump and motor up to 20 Hz. The algorithm was validated using physiological ventricular and arterial pressure waveforms in a mock loop which simulated different contractilities (dP/dt(max) 600 to 2300 mm Hg/s), pump speeds (2 to 4 krpm), and fluid viscosities (2 to 4 mPa·s). The mathematically estimated pump flow data were then compared to the datasets measured in the mock loop for different variable combinations (flow ranging from 2.5 to 7 L/min, pulsatility from 3.5 to 6 L/min, dQ/dt(max) from 15 to 60 L/min/s). Transfer function analysis showed that the developed algorithm could estimate the flow waveform with a bandwidth up to 15 Hz (±2 dB). The mean difference between the estimated and measured average flows was +0.06 ± 0.31 L/min and for the flow pulsatilities -0.27 ± 0.2 L/min. Detection of dQ/dt(max) was possible up to a dP/dt(max) level of 2300 mm Hg/s. In conclusion, a flow estimator with sufficient frequency bandwidth and accuracy to allow determination of changes in ventricular contractility even in the case of improving heart function was developed.

Development of a pump flow estimator for rotary blood pumps to enhance monitoring of ventricular function.

The effect of blood hematocrit (HCT) on a noninvasive flow estimation algorithm was examined in a centrifugal implantable rotary blood pump (iRBP) used for ventricular assistance. An average flow estimator, based on three parameters, input electrical power, pump speed, and HCT, was developed. Data were collected in a mock loop under steady flow conditions for a variety of pump operating points and for various HCT levels. Analysis was performed using three-dimensional polynomial surfaces to fit the collected data for each different HCT level. The polynomial coefficients of the surfaces were then analyzed as a function of HCT. Linear correlations between estimated and measured pump flow over a flow range from 1.0 to 7.5 L/min resulted in a slope of 1.024 L/min (R2=0.9805). Early patient data tested against the estimator have shown promising consistency, suggesting that consideration of HCT can improve the accuracy of existing flow estimation algorithms.

Noninvasive average flow estimation for an implantable rotary blood pump: a new algorithm incorporating the role of blood viscosity.

The use of long-term mechanical circulatory support (MCS) for heart failure by means of implanted continuous-flow left ventricular assist devices (cf-LVADs) will increase, either to enable recovery or to provide a destination therapy. The effectiveness and user-friendliness of MCS will depend on the development of near-physiologic control strategies for which accurate estimation of pump flow is essential. To provide means for the assessment of pump flow, this study presents pump models, estimating pump flow (Q(lvad)) from pump speed (n) and pressure difference across the LVAD (Delta p(lvad)) or power uptake (P). The models are evaluated for the axial-flow LVADs HeartAssist5 (HA5) and HeartMate II (HMII), and for a centrifugal pump, the HeartWare (HW). For all three pumps, models estimating Q(lvad) from Delta p(lvad) only is capable of describing pump behavior under static conditions. For the axial pumps, flow estimation from power uptake alone was not accurate. When assuming an increase in pump flow with increasing power uptake, low pump flows are overestimated in these pumps. Only for the HW, pump flow increased linearly with power uptake, resulting in a power-based pump model that estimates static pump flow accurately. The addition of pressure head measurements improved accuracy in the axial cf-LVAD estimation models

Pump Flow Estimation From Pressure Head and Power Uptake for the HeartAssist5, HeartMate II, and HeartWare VADs

Non-invasive estimation of flow was investigated in an implantable rotary blood pump (iRBP) with a hydrodynamic bearing. The effects of non-pulsatile and pulsatile flows were studied using in vitro mock loops, and acute (N = 3) and chronic (N = 6) ovine experiments. Using the non-pulsatile and pulsatile mock loops an average flow estimation algorithm was derived from root mean square (RMS) pump impeller speed and RMS input power. These algorithms were programmed into the iRBP controller for subsequent validation in vivo. In the acute experiments, venous return and systemic vascular resistance were adjusted through pharmacological intervention and exsanguination to produce an average range of pump flows from 0.0 to 2.6 l min(-1). Over this range the RMS estimation error was 88 +/- 12 ml, with a linear correlation slope of 0.992 +/- 0.006 (R2 = 0.986 +/- 0.004). In the chronic experiments, animals were monitored daily for up to three months and an average range of flows from 2.8 to 4.8 l min(-1) recorded. A linear correlation between the estimated and measured pump flows yielded a slope of 1.005 +/- 0.006 (R2 = 0.966 +/- 0.004). The RMS estimation error was 120 +/- 11 ml. Using this algorithm it is possible to effectively estimate flow in a rotary blood pump without implanting additional invasive sensors.

https://iopscience.iop.org/article/10.1088/0967-3334/24/1/313/pdf

Non-invasive flow estimation in an implantable rotary blood pump: a study considering non-pulsatile and pulsatile flows.

The VentrAssist implantable rotary blood pump (IRBP) is a centrifugal pump that uses a hydrodynamic bearing to support its impeller. The pump, is to be used as a left ventricular assist device (LVAD). Varying pump speed can control the degree of left ventricular assistance. By increasing impeller speed, it is possible to transition from the normal physiological state of ventricular ejection (VE) to a state where the aortic valve remains closed (AC) throughout the cardiac cycle. Using the non-invasive parameter of instantaneous impeller speed in an ovine experimental model (N=3), we investigated state transitions. The cardiovascular system of the animal was perturbed by pharmacological intervention or by exsanguination. A total of six pump speed set point changes that caused physiological state transitions (VE to AC) were examined. A state transition index (STI) derived originally from data obtained in an in-vitro mock loop setup was found to be directly applicable in the in-vivo studies and showed statistically significant (p<0.0605) reliability in differentiating between no change in state and change in state. These data indicate that the STI may be a valuable mechanism to in optimal LVAD control.

/pdf/identifying-physiologically-significant-pumping-state-qf608edbgr.pdf

Identifying physiologically significant pumping state transitions in implantable rotary blood pumps used as left ventricular assist devices: an in-vivo study

J C Woodard

Papers

Non-invasive flow estimation in an implantable rotary blood pump: a study considering non-pulsatile and pulsatile flows.

Identifying physiologically significant pumping state transitions in implantable rotary blood pumps used as left ventricular assist devices: an in-vivo study