Raffael Amacher

A Novel Interface for Hybrid Mock Circulations to Evaluate Ventricular Assist Devices

This paper presents a novel mock circulation for the evaluation of ventricular assist devices (VADs), which is based on a hardware-in-the-loop concept. A numerical model of the human blood circulation runs in real time and computes instantaneous pressure, volume, and flow rate values. The VAD to be tested is connected to a numerical-hydraulic interface, which allows the interaction between the VAD and the numerical model of the circulation. The numerical-hydraulic interface consists of two pressure-controlled reservoirs, which apply the computed pressure values from the model to the VAD, and a flow probe to feed the resulting VAD flow rate back to the model. Experimental results are provided to show the proper interaction between a numerical model of the circulation and a mixed-flow blood pump.

A Physiological Controller for Turbodynamic Ventricular Assist Devices Based on a Measurement of the Left Ventricular Volume

The current article presents a novel physiological control algorithm for ventricular assist devices (VADs), which is inspired by the preload recruitable stroke work. This controller adapts the hydraulic power output of the VAD to the end-diastolic volume of the left ventricle. We tested this controller on a hybrid mock circulation where the left ventricular volume (LVV) is known, i.e., the problem of measuring the LVV is not addressed in the current article. Experiments were conducted to compare the response of the controller with the physiological and with the pathological circulation, with and without VAD support. A sensitivity analysis was performed to analyze the influence of the controller parameters and the influence of the quality of the LVV signal on the performance of the control algorithm. The results show that the controller induces a response similar to the physiological circulation and effectively prevents over- and underpumping, i.e., ventricular suction and backflow from the aorta to the left ventricle, respectively. The same results are obtained in the case of a disturbed LVV signal. The results presented in the current article motivate the development of a robust, long-term stable sensor to measure the LVV.

Synchronized Pulsatile Speed Control of Turbodynamic Left Ventricular Assist Devices: Review and Prospects

Turbodynamic blood pumps are used clinically as ventricular assist devices (VADs). They are mostly operated at a constant rotational speed, which results in a reduced pulsatility. Previous research has analyzed pulsing pump speeds (speed modulation) to alter the interaction between the cardiovascular system and the blood pump. In those studies, sine- or square-wave speed profiles that were synchronized to the natural cardiac cycle were analyzed in silico, in vitro and in vivo. The definitions of these profiles with respect to both timing and speed levels vary among different research groups. The current paper provides a definition of the timing of these speed profiles such that the resulting hemodynamic effects become comparable. The results published in the literature are summarized and compared using this definition. Further, applied to a turbodynamic VAD, a series of measurements is conducted on a hybrid mock circulation using a constant speed as well as different types of square-wave speed profiles and a sine-wave speed profile. When a consistent definition of the timing of the speed profiles is used, the hemodynamic effects observed in previous work are in agreement with the measurement data obtained for the current paper. These findings allow the conclusion that the speed modulation of turbodynamic VADs represents a consistent tool to systematically change the ventricular load and the pulsatility in the arterial tree. The timing that yields the minimal left ventricular load also yields the minimal arterial pulse pressure.

Control of ventricular unloading using an electrocardiogram-synchronized Thoratec paracorporeal ventricular assist device

OBJECTIVE Current pulsatile ventricular assist devices operate asynchronous with the left ventricle in fixed-rate or fill-to-empty modes because electrocardiogram-triggered modes have been abandoned. We hypothesize that varying the ejection delay in the synchronized mode yields more precise control of hemodynamics and left ventricular loading. This allows for a refined management that may be clinically beneficial. METHODS Eight sheep received a Thoratec paracorporeal ventricular assist device (Thoratec Corp, Pleasanton, Calif) via ventriculo-aortic cannulation. Left ventricular pressure and volume, aortic pressure, pulmonary flow, pump chamber pressure, and pump inflow and outflow were recorded. The pump was driven by a clinical pneumatic drive unit (Medos Medizintechnik AG, Stolberg, Germany) synchronously with the native R-wave. The start of pump ejection was delayed between 0% and 100% of the cardiac period in 10% increments. For each of these delays, hemodynamic variables were compared with baseline data using paired t tests. RESULTS The location of the minimum of stroke work was observed at a delay of 10% (soon after aortic valve opening), resulting in a median of 43% reduction in stroke work compared with baseline. Maximum stroke work occurred at a median delay of 70% with a median stroke work increase of 11% above baseline. Left ventricular volume unloading expressed by end-diastolic volume was most pronounced for copulsation (delay 0%). CONCLUSIONS The timing of pump ejection in synchronized mode yields control over left ventricular energetics and can be a method to achieve gradual reloading of a recoverable left ventricle. The traditionally suggested counterpulsation is not optimal in ventriculo-aortic cannulation when maximum unloading is desired.

A Robust Reference Signal Generator for Synchronized Ventricular Assist Devices

Ventricular assist devices (VADs) are blood pumps that offer an option to support the circulation of patients with severe heart failure. Since a failing heart has a remaining pump function, its interaction with the VAD influences the hemodynamics. Ideally, the hearts action is taken into account for actuating the device such that the device is synchronized to the natural cardiac cycle. To realize this in practice, a reliable real-time algorithm for the automatic synchronization of the VAD to the heart rate is required. This paper defines the tasks such an algorithm needs to fulfill: the automatic detection of irregular heart beats and the feedback control of the phase shift between the systolic phases of the heart and the assist device. We demonstrate a possible solution to these problems and analyze its performance in two steps. First, the algorithm is tested using the MIT-BIH arrhythmia database. Second, the algorithm is implemented in a controller for a pulsatile and a continuous-flow VAD. These devices are connected to a hybrid mock circulation where three test scenarios are evaluated. The proposed algorithm ensures a reliable synchronization of the VAD to the heart cycle, while being insensitive to irregularities in the heart rate.

Analysis of Pressure Head-Flow Loops of Pulsatile Rotodynamic Blood Pumps

The clinical importance of pulsatility is a recurring topic of debate in mechanical circulatory support. Lack of pulsatility has been identified as a possible factor responsible for adverse events and has also demonstrated a role in myocardial perfusion and cardiac recovery. A commonly used method for restoring pulsatility with rotodynamic blood pumps (RBPs) is to modulate the speed profile, synchronized to the cardiac cycle. This introduces additional parameters that influence the (un)loading of the heart, including the timing (phase shift) between the native cardiac cycle and the pump pulses, and the amplitude of speed modulation. In this study, the impact of these parameters upon the heart-RBP interaction was examined in terms of the pressure head-flow (HQ) diagram. The measurements were conducted using a rotodynamic Deltastream DP2 pump in a validated hybrid mock circulation with baroreflex function. The pump was operated with a sinusoidal speed profile, synchronized to the native cardiac cycle. The simulated ventriculo-aortic cannulation showed that the level of (un)loading and the shape of the HQ loops strongly depend on the phase shift. The HQ loops displayed characteristic shapes depending on the phase shift. Increased contribution of native contraction (increased ventricular stroke work [WS ]) resulted in a broadening of the loops. It was found that the previously described linear relationship between WS and the area of the HQ loop for constant pump speeds becomes a family of linear relationships, whose slope depends on the phase shift.

Minimizing left ventricular stroke work with iterative learning flow profile control of rotary blood pumps

Abstract Rotary blood pumps are gaining importance in the successful treatment of advanced heart failure. However, the application of fixed pump speeds is discussed controversially. Since the natural heart delivers pulsatile flow, many physicians presume that pulsatile pumping provides therapeutical advantages. To address this, we combine the technical advantages of continuous flow devices with the supposed physiological advantages of pulsatile flow. We present an iterative learning control (ILC) strategy for continuous flow ventricular assist devices that minimizes the left ventricular stroke work (LVSW). For that, a comprehensive nonlinear model for rotary blood pumps that is used for simulation and controller design is introduced. The controller is tested using a hardware-in-the-loop cardiovascular system simulator with a Medos deltastream DP1 blood pump. The tracking performance of the proposed ILC approach is compared to a benchmark controller that uses additional sensor information, both controllers significantly reduce the residual LVSW compared to the fixed speed case. In addition to decreasing ventricular load, the proposed ILC strategy can be used as an inner control loop to any physiological controller that sets reference flow profiles. The introduced controller might be useful for the investigation of effects of various pulsatile flow patterns independent from the type of VAD in future in vivo studies. The targeted manipulation of physiological quantities such as the residual cardiac work has the potential to considerably improve ventricular assist device therapy.

In Vivo Evaluation of Physiologic Control Algorithms for Left Ventricular Assist Devices Based on Left Ventricular Volume or Pressure

Turbodynamic left ventricular assist devices (LVADs) provide a continuous flow depending on the speed at which the pump is set, and do not adapt to the changing requirements of the patient. The limited adaptation of the pump flow to the amount of venous return can lead to ventricular suction or overload. Physiological control may compensate such situations by an automatic adaptation of the pump flow to the volume status of the left ventricle. We evaluated two physiological control algorithms in an acute study with eight healthy pigs. Both controllers imitate the Frank-Starling law of the heart and are based on a measurement of the left ventricular volume or pressure, respectively. After implantation of a modified Deltastream DP2 blood pump as an LVAD, we tested the responses of the physiological controllers to hemodynamic changes and compared them with the response of the constant speed mode. Both physiological controllers adapted the pump speed such that the flow was more sensitive to preload and less sensitive to afterload, as compared to the constant speed mode. As a result, the risk for suction was strongly reduced. Five suction events were observed in the constant speed mode, one with the volume-based controller, and none with the pressure-based controller. The results suggest that both physiological controllers have the potential to reduce the number of adverse events when used in the clinical setting.Turbodynamic left ventricular assist devices (LVADs) provide a continuous flow depending on the speed at which the pump is set, and do not adapt to the changing requirements of the patient. The limited adaptation of the pump flow (PF) to the amount of venous return can lead to ventricular suction or overload. Physiologic control may compensate such situations by an automatic adaptation of the PF to the volume status of the left ventricle. We evaluated two physiologic control algorithms in an acute study with eight healthy pigs. Both controllers imitate the Frank–Starling law of the heart and are based on a measurement of the left ventricular volume (LVV) or pressure (LVP), respectively. After implantation of a modified Deltastream DP2 blood pump as an LVAD, we tested the responses of the physiologic controllers to hemodynamic changes and compared them with the response of the constant speed (CS) mode. Both physiologic controllers adapted the pump speed (PS) such that the flow was more sensitive to preload and less sensitive to afterload, as compared with the CS mode. As a result, the risk for suction was strongly reduced. Five suction events were observed in the CS mode, one with the volume-based controller and none with the pressure-based controller. The results suggest that both physiologic controllers have the potential to reduce the number of adverse events when used in the clinical setting.

Left Ventricular Assist Devices: Challenges Toward Sustaining Long-Term Patient Care

Over the last few decades, the left ventricular assist device (LVAD) technology has been tremendously improved transitioning from large and noisy paracorporeal volume displacement pumps to small implantable turbodynamic devices with only a single transcutaneous element, the driveline. Nevertheless, there remains a great demand for further improvements to meet the challenge of having a robust and safe device for long-term therapy. Here, we review the state of the art and highlight four key areas of needed improvement targeting long-term, sustainable LVAD function: (1) LVADs available today still have a high risk of thromboembolic and bleeding events that could be addressed by the rational fabrication of novel surface structures and endothelialization approaches aiming at improving the device hemocompatibility. (2) Novel, fluid dynamically optimized pump designs will further reduce blood damage. (3) Infection due to the paracorporeal driveline can be avoided with a transcutaneous energy transmission system that additionally allows for increased freedom of movement. (4) Finally, the lack of pump flow adaptation needs to be encountered with physiological control systems, working collaboratively with biocompatible sensor devices, targeting the adaptation of the LVAD flow to the perfusion requirements of the patient. The interdisciplinary Zurich Heart project investigates these technology gaps paving the way toward LVADs for long-term, sustainable therapy.

Control of the fluid viscosity in a mock circulation

A mock circulation allows the in vitro investigation, development, and testing of ventricular assist devices. An aqueous-glycerol solution is commonly used to mimic the viscosity of blood. Due to evaporation and temperature changes, the viscosity of the solution drifts from its initial value and therefore, deviates substantially from the targeted viscosity of blood. Additionally, the solution needs to be exchanged to account for changing viscosities when mimicking different hematocrits. This article presents a method to control the viscosity in a mock circulation. This method makes use of the relationship between temperature and viscosity of aqueous-glycerol solutions and employs the automatic control of the viscosity of the fluid. To that end, an existing mock circulation was extended with an industrial viscometer, temperature probes, and a heating nozzle band. The results obtained with different fluid viscosities show that a viscosity controller is vital for repeatable experimental conditions on mock circulations. With a mixture ratio of 49 mass percent of aqueous-glycerol solution, the controller can mimic a viscosity range corresponding to a hematocrit between 29 and 42% in a temperature range of 30-42°C. The control response has no overshoot and the settling time is 8.4 min for a viscosity step of 0.3 cP, equivalent to a hematocrit step of 3.6%. Two rotary blood pumps that are in clinical use are tested at different viscosities. At a flow rate of 5 L/min, both show a deviation of roughly 15 and 10% in motor current for high rotor speeds. The influence of different viscosities on the measured head pressure is negligible. Viscosity control for a mock circulation thus plays an important role for assessing the required motor current of ventricular assist devices. For the investigation of the power consumption of rotary blood pumps and the development of flow estimators where the motor current is a model input, an integrated viscosity controller is a valuable contribution to an accurate testing environment.