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In vitro cardiovascular simulators (namely mock circulatory loops (MCLs)) refer to fully physical systems which can be connected or used with medical devices (MDs). They usually adopt their design from a lumped parameters model dedicated to the simulation of the hemodynamics of the human cardiovascular system. 1,2

For those suffering from end-stage biventricular heart failure, and where a heart transplantation is not a viable option, a Total Artificial Heart (TAH) can be used as a bridge to transplant device. The Realheart TAH is a four-chamber artificial heart that uses a positive-displacement pumping technique mimicking the native heart to produce pulsatile flow governed by a pair of bileaflet mechanical heart valves. The aim of this work was to create a method for simulating haemodynamics in positive-displacement blood pumps, using computational fluid dynamics with fluid–structure interaction to eliminate the need for pre-existing in vitro valve motion data, and then use it to investigate the performance of the Realheart TAH across a range of operating conditions. The device was simulated in Ansys Fluent for five cycles at pumping rates of 60, 80, 100 and 120 bpm and at stroke lengths of 19, 21, 23 and 25 mm. The moving components of the device were discretised using an overset meshing approach, a novel blended weak–strong coupling algorithm was used between fluid and structural solvers, and a custom variable time stepping scheme was used to maximise computational efficiency and accuracy. A two-element Windkessel model approximated a physiological pressure response at the outlet. The transient outflow volume flow rate and pressure results were compared against in vitro experiments using a hybrid cardiovascular simulator and showed good agreement, with maximum root mean square errors of 15% and 5% for the flow rates and pressures respectively. Ventricular washout was simulated and showed an increase as cardiac output increased, with a maximum value of 89% after four cycles at 120 bpm 25 mm. Shear stress distribution over time was also measured, showing that no more than $$4.5\times 10^{-4}$$ 4.5 × 10 - 4 % of the total volume exceeded 150 Pa at a cardiac output of 7 L/min. This study showed this model to be both accurate and robust across a wide range of operating points, and will enable fast and effective future studies to be undertaken on current and future generations of the Realheart TAH.

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Simulators are expected to assume a prominent role in the process of design—development and testing of cardiovascular medical devices. For this purpose, simulators should capture the complexity of human cardiorespiratory physiology in a realistic way. High fidelity simulations of pathophysiology do not only allow to test the medical device itself, but also to advance practically relevant monitoring and control features while the device acts under realistic conditions. We propose a physiologically controlled cardiorespiratory simulator developed in a mixed in silico-in vitro simulation environment. As inherent to this approach, most of the physiological model complexity is implemented in silico while the in vitro system acts as an interface to connect a medical device. As case scenarios, severe heart failure was modeled, at rest and at exercise and as medical device a left ventricular assist device (LVAD) was connected to the simulator. As initial validation, the simulator output was compared against clinical data from chronic heart failure patients supported by an LVAD, that underwent different levels of exercise tests with concomitant increase in LVAD speed. Simulations were conducted reproducing the same protocol as applied in patients, in terms of exercise intensity and related LVAD speed titration. Results show that the simulator allows to capture the principal parameters of the main adaptative cardiovascular and respiratory processes within the human body occurring from rest to exercise. The simulated functional interaction with the LVAD is comparable to the one clinically observed concerning ventricular unloading, cardiac output, and pump flow. Overall, the proposed simulation system offers a high fidelity in silico-in vitro representation of the human cardiorespiratory pathophysiology. It can be used as a test bench to comprehensively analyze the performance of physically connected medical devices simulating clinically realistic, critical scenarios, thus aiding in the future the development of physiologically responding, patient-adjustable medical devices. Further validation studies will be conducted to assess the performance of the simulator in other pathophysiological conditions.

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Prognostic modelling techniques have rapidly evolved over the past decade and may greatly benefit patients supported with ExtraCorporeal Membrane Oxygenation (ECMO). Epidemiological and computational physiological approaches aim to provide more accurate predictive assessments of ECMO-related risks and benefits. Implementation of these approaches may produce predictive tools that can improve complex clinical decisions surrounding ECMO allocation and management. This Review describes current applications of prognostic models and elaborates on upcoming directions for their clinical applicability in decision support tools directed at improved allocation and management of ECMO patients. The discussion of these new developments in the field will culminate in a futuristic perspective leaving ourselves and the readers wondering whether we may “ fly ECMO by wire” someday.