Various physiological controllers for left ventricular assist devices (LVADs) have been developed to prevent flow conditions that may lead to left ventricular (LV) suction and overload. In the current study, we selected and implemented six of the most promising physiological controllers presented in literature. We tuned the controllers for the same objectives by using the loop-shaping method from control theory. The in vitro experiments were derived from literature and included different preload, afterload, and contractility variations. All experiments were repeated with an increased or decreased contractility from the baseline pathological circulation and with simulated sensor drift. The controller performances were compared with an LVAD operated at constant speed (CS) and a physiological circulation. During preload variations, all controllers resulted in a pump flow change that resembled the cardiac output response of the physiological circulation. For afterload variations, the response varied among the controllers, whereas some of them presented a high sensitivity to contractility or sensor drift, leading to LV suction and overload. In such cases, the need for recalibration of the controllers or the sensor is indicated. Preload-based physiological controllers showed their clinical significance by outperforming the CS operation and promise many benefits for the LVAD therapy. However, their clinical implementation in the near future for long-term use is highly dependent on the sensor technology and its reliability.

Cardiothoracic open-heart surgery has revolutionized the treatment of cardiovascular disease, the leading cause of death worldwide. After the surgery, hemodynamic and volume management can be complicated, for example in case of vasoplegia after endocarditis. Timely treatment is crucial for outcomes. Currently, treatment decisions are made based on heart volume, which needs to be measured manually by the clinician each time using ultrasound. Alternatively, implantable sensors offer a real-time window into the dynamic function of our body. Here it is shown that a soft flexible sensor, made with biocompatible materials, implanted on the surface of the heart, can provide continuous information of the heart volume after surgery. The sensor works robustly for a period of two days on a tensile machine. The accuracy of measuring heart volume is improved compared to the clinical gold standard in vivo, with an error of 7.1 mL for the strain sensor versus impedance and 14.0 mL versus ultrasound. Implanting such a sensor would provide essential, continuous information on heart volume in the critical time following the surgery, allowing early identification of complications, facilitating treatment, and hence potentially improving patient outcome.

SummarySyringe infusion pumps are used for the administration of short‐acting drugs in anaesthesia and critical care medicine, but are prone to flow irregularities at low flow rates. A flow‐controlled syringe infusion pump using an integrated flow sensor for feedback control represents a new approach to overcoming these limitations. This study compares the performance of a prototype flow‐controlled syringe pump both at start‐up, and during vertical displacement manoeuvres, with that of a standard infusion syringe pump. The novel pump almost completely eliminated delays at start‐up and flow irregularities during hydrostatic pressure changes. Related fluctuations in plasma drug concentration were minimised and the known disadvantages of standard syringe infusion pumps currently used in clinical practice were reduced. Besides providing fast start‐up to steady‐state flow and precise continuous drug delivery at low flow rates during hydrostatic pressure changes, the new pump offers the potential for the development of target‐controlled infusion algorithms for short‐acting cardiovascular and other drugs.

Aortic wall stiffening is a predictive marker for morbidity in hypertensive patients. Arterial pulse wave velocity (PWV) correlates with the level of stiffness and can be derived using non-invasive 4D-flow magnetic resonance imaging (MRI). The objectives of this study were twofold: to develop subject-specific thoracic aorta models embedded into an MRI-compatible flow circuit operating under controlled physiological conditions; and to evaluate how a range of aortic wall stiffness impacts 4D-flow-based quantification of hemodynamics, particularly PWV. Three aorta models were 3D-printed using a novel photopolymer material at two compliant and one nearly rigid stiffnesses and characterized via tensile testing. Luminal pressure and 4D-flow MRI data were acquired for each model and cross-sectional net flow, peak velocities, and PWV were measured. In addition, the confounding effect of temporal resolution on all metrics was evaluated. Stiffer models resulted in increased systolic pressures (112, 116, and 133 mmHg), variations in velocity patterns, and increased peak velocities, peak flow rate, and PWV (5.8–7.3 m/s). Lower temporal resolution (20 ms down to 62.5 ms per image frame) impacted estimates of peak velocity and PWV (7.31 down to 4.77 m/s). Using compliant aorta models is essential to produce realistic flow dynamics and conditions that recapitulated in vivo hemodynamics.

Future left ventricular assist devices (LVADs) are expected to respond to the physiologic need of patients; however, they still lack reliable pressure or volume sensors for feedback control. In the clinic, echocardiography systems are routinely used to measure left ventricular (LV) volume. Until now, echocardiography in this form was never integrated in LVADs due to its computational complexity. The aim of this study was to demonstrate the applicability of a simplified ultrasonic sensor to fit an LVAD cannula and to show the achievable accuracy in vitro. Our approach requires only two ultrasonic transducers because we estimated the LV volume with the LV end-diastolic diameter commonly used in clinical assessments. In order to optimize the accuracy, we assessed the optimal design parameters considering over 50 orientations of the two ultrasonic transducers. A test bench was equipped with five talcuminfused silicone heart phantoms, in which the intra-ventricular surface replicated papillary muscles and trabeculae carnae. The end-diastolic LV filling volumes of the five heart phantoms ranged from 180 to 480 mL. This reference volume was altered by ±40 mL with a syringe pump. Based on the calibrated measurements acquired by the two ultrasonic transducers, the LV volume was estimated well. However, the accuracies obtained are strongly dependent on the choice of the design parameters.Orientations toward the septum perform better, as they interfere less with the papillary muscles. The optimized design is valid for all hearts. Considering this, the Bland-Altman analysis reports the LV volume accuracy as a bias of ±10% and limits of agreement of 0%-40% in all but the smallest heart. The simplicity of traditional echocardiography systems was reduced by two orders of magnitude in technical complexity, while achieving a comparable accuracy to 2D echocardiography requiring a calibration of absolute volume only. Hence, our approach exploits the established benefits of echocardiography and makes them applicable as an LV volume sensor for LVADs. K E Y W O R D Scardiac phantom, 3D printing, trabeculae, volume sensor, ultrasound, implantable, intra-cardiac echocardiography, ventricular assist device, hemodynamic monitoring 468 | DUAL et al.

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Ventricular assist devices (VADs) are an established treatment option for heart failure (HF). However, the devices are often plagued by material‐related hemocompatibility issues. In contrast to continuous flow VADs with high shear stresses, pulsatile VADs (pVADs) offer the potential for an endothelial cell coating that promises to prevent many adverse events caused by an insufficient hemocompatibility. However, their size and weight often precludes their intracorporeal implantation. A reduction of the pump body size and weight of the pump could be achieved by an increase in the stroke frequency while maintaining a similar cardiac output. We present a new pVAD system consisting of a pump and an actuator specifically designed for actuation frequencies of up to 240 bpm. In vitro and in vivo results of the short‐term reaction of the cardiovascular system show no significant changes in left ventricular and aortic pressure between actuation frequencies from 60 to 240 bpm. The aortic pulsatility increases when the actuation frequency is raised while the heart rate remains unaffected in vivo. These results lead us to the conclusion that the cardiovascular system tolerates short‐term increases of the pVAD stroke frequencies.