A Novel Hybrid Membrane VAD as First Step Toward Hemocompatible Blood Propulsion.

Heart failure is a raising cause of mortality. Heart transplantation and ventricular assist device (VAD) support represent the only available lifelines for end stage disease. In the context of donor organ shortage, the future role of VAD as destination therapy is emerging. Yet, major drawbacks are connected to the long-term implantation of current devices. Poor VAD hemocompatibility exposes the patient to life-threatening events, including haemorrhagic syndromes and thrombosis. Here, we introduce a new concept of artificial support, the Hybrid Membrane VAD, as a first-of-its-kind pump prototype enabling physiological blood propulsion through the cyclic actuation of a hyperelastic membrane, enabling the protection from the thrombogenic interaction between blood and the implant materials. The centre of the luminal membrane surface displays a rationally-developed surface topography interfering with flow to support a living endothelium. The precast cell layer survives to a range of dynamically changing pump actuating conditions i.e., actuation frequency from 1 to 4 Hz, stroke volume from 12 to 30 mL, and support duration up to 313 min, which are tested both in vitro and in vivo, ensuring the full retention of tissue integrity and connectivity under challenging conditions. In summary, the presented results constitute a proof of principle for the Hybrid Membrane VAD concept and represent the basis for its future development towards clinical validation.

Control of ventricular unloading using an electrocardiogram-synchronized pulsatile ventricular assist device under high stroke ratios.

Pulsatile ventricular assist devices (pVADs) yield a blood flow that imitates the pulsatile flow of the heart and, therefore, could diminish the adverse events related to the continuous flow provided by the ventricular assist devices that are commonly used. However, their intrinsic characteristics of larger size and higher weight set a burden to their implantation, that along with the frequent mechanical failures and thrombosis events, reduce the usage of pVADs in the clinical environment. In this study, we investigated the possibility to reduce the pump size by using high pump stroke ratios while maintaining the ability to control the hemodynamics of the cardiovascular system (CVS). In vitro and in vivo experiments were conducted with a custom pVAD implemented on a hybrid mock circulation system and in five sheep, respectively. The actuation of the pVAD was synchronized with the heartbeat. Variations of the pump stroke ratio, time delay between the pump stroke and the heart stroke, as well as duration of the pump systole in respect to the total cardiac cycle duration were used to evaluate the effects of various pump settings on the hemodynamics of the CVS. The results suggest that by varying the operating settings of the pVAD, a pulsatile flow that provides physiological hemodynamic parameters, as well as a control over the hemodynamic parameters, can be achieved. Additionally, by employing high pump stroke ratios, the size of the pVAD can be significantly reduced; however, at those high pump stroke ratios, the effect of the other pump parameters diminishes.

High-frequency operation of pulsatile ventricular assist devices: A computational study on circular and elliptically shaped pumps.

Pulsatile positive displacement pumps as ventricular assist devices were gradually replaced by rotary devices due to their large volume and high adverse event rates. Nevertheless, pulsatile ventricular assist devices might be beneficial with regard to gastrointestinal bleeding and cardiac recovery. Therefore, aim of this study was to investigate the flow field in new pulsatile ventricular assist devices concepts with an increased pump frequency, which would allow lower stroke volumes to reduce the pump size. We developed a novel elliptically shaped pulsatile ventricular assist devices, which we compared to a design based on a circular shape. The pump size was adjusted to deliver similar flow rates at pump frequencies of 80, 160, and 240 bpm. Through a computational fluid dynamics study, we investigated flow patterns, residence times, and wall shear stresses for different frequencies and pump sizes. A pump size reduction by almost 50% is possible when using a threefold pump frequency. We show that flow patterns inside the circular pump are frequency dependent, while they remain similar for the elliptic pump. With slightly increased wall shear stresses for higher frequencies, maximum wall shear stresses on the pump housing are higher for the circular design (42.2 Pa vs 18.4 Pa). The calculated blood residence times within the pump decrease significantly with increasing pump rates. A smaller pump size leads to a slight increase of wall shear stresses and a significant improvement of residence times. Hence, high-frequency operation of pulsatile ventricular assist devices, especially in combination with an elliptical shape, might be a feasible mean to reduce the size, without any expectable disadvantages in terms of hemocompatibility.

Short-term physiological response to high-frequency-actuated pVAD support.

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.

High-frequency operation of a pulsatile VAD - a simulation study.

Ventricular assist devices (VADs) are mechanical blood pumps that are clinically used to treat severe heart failure. Pulsatile VADs (pVADs) were initially used, but are today in most cases replaced by turbodynamic VADs (tVADs). The major concern with the pVADs is their size, which prohibits full pump body implantation for a majority of patients. A reduction of the necessary stroke volume can be achieved by increasing the stroke frequency, while maintaining the same level of support capability. This reduction in stroke volume in turn offers the possibility to reduce the pump's overall dimensions. We simulated a human cardiovascular system (CVS) supported by a pVAD with three different stroke rates that were equal, two- or threefold the heart rate (HR). The pVAD was additionally synchronized to the HR for better control over the hemodynamics and the ventricular unloading. The simulation results with a HR of 90 bpm showed that a pVAD stroke volume can be reduced by 71%, while maintaining an aortic pulse pressure (PP) of 30 mm Hg, avoiding suction events, reducing the ventricular stroke work (SW) and allowing the aortic valve to open. A reduction by 67% offers the additional possibility to tune the interaction between the pVAD and the CVS. These findings allow a major reduction of the pVAD's body size, while allowing the physician to tune the pVAD according to the patient's needs.

A Physiological Controller for Turbodynamic Ventricular Assist Devices Based on Left Ventricular Systolic Pressure.

The current article presents a novel physiological feedback controller for turbodynamic ventricular assist devices (tVADs). This controller is based on the recording of the left ventricular (LV) pressure measured at the inlet cannula of a tVAD thus requiring only one pressure sensor. The LV systolic pressure (SP) is proposed as an indicator to determine the varying perfusion requirements. The algorithm to extract the SP from the pump inlet pressure signal used for the controller to adjust the speed of the tVAD shows robust behavior. Its performance was evaluated on a hybrid mock circulation. The experiments with changing perfusion requirements were compared with a physiological circulation and a pathological one assisted with a tVAD operated at constant speed. A sensitivity analysis of the controller parameters was conducted to identify their limits and their influence on a circulation. The performance of the proposed SP controller was evaluated for various values of LV contractility, as well as for a simulated pressure sensor drift. The response of a pathological circulation assisted by a tVAD controlled by the introduced SP controller matched the physiological circulation well, while over- and underpumping events were eliminated. The controller presented a robust performance during experiments with simulated pressure sensor drift.