Activation of a Soft Robotic Left Ventricular Phantom Embedded in a Closed-Loop Cardiovascular Simulator: A Computational and Experimental Analysis.

Purpose: Cardiovascular simulators are used in the preclinical testing phase of medical devices. Their reliability increases the more they resemble clinically relevant scenarios. In this study, a physiologically actuated soft robotic left ventricle (SRLV) embedded in a hybrid (in silico- in vitro) simulator of the cardiovascular system is presented, along with its experimental and computational analysis.

Physiological control for left ventricular assist devices based on deep reinforcement learning.

Background: The improvement of controllers of left ventricular assist device (LVAD) technology supporting heart failure (HF) patients has enormous impact, given the high prevalence and mortality of HF in the population. The use of reinforcement learning for control applications in LVAD remains minimally explored. This work introduces a preload-based deep reinforcement learning control for LVAD based on the proximal policy optimization algorithm.

A patient-specific echogenic soft robotic left ventricle embedded into a closed-loop cardiovascular simulator for advanced device testing.

Cardiovascular medical devices undergo a large number of pre- and post-market tests before their approval for clinical practice use. Sophisticated cardiovascular simulators can significantly expedite the evaluation process by providing a safe and controlled environment and representing clinically relevant case scenarios. The complex nature of the cardiovascular system affected by severe pathologies and the inherently intricate patient-device interaction creates a need for high-fidelity test benches able to reproduce intra- and inter-patient variability of disease states.

Left Ventricular Unloading in Extracorporeal Membrane Oxygenation: A Clinical Perspective Derived from Basic Cardiovascular Physiology.

Purpose Of Review: To present an abridged overview of the literature and pathophysiological background of adjunct interventional left ventricular unloading strategies during veno-arterial extracorporeal membrane oxygenation (V-A ECMO). From a clinical perspective, the mechanistic complexity of such combined mechanical circulatory support often requires in-depth physiological reasoning at the bedside, which remains a cornerstone of daily practice for optimal patient-specific V-A ECMO care.

Recent Findings: Recent conventional clinical trials have not convincingly shown the superiority of V-A ECMO in acute myocardial infarction complicated by cardiogenic shock as compared with medical therapy alone.

The physiology of venoarterial extracorporeal membrane oxygenation - A comprehensive clinical perspective.

Venoarterial extracorporeal membrane oxygenation (VA ECMO) has become a standard of care for severe cardiogenic shock, refractory cardiac arrest and related impending multiorgan failure. The widespread clinical use of this complex temporary circulatory support modality is still contrasted by a lack of formal scientific evidence in the current literature. This might at least in part be attributable to VA ECMO related complications, which may significantly impact on clinical outcome.

Hypotension Prediction Index Is Equally Effective in Predicting Intraoperative Hypotension during Noncardiac Surgery Compared to a Mean Arterial Pressure Threshold: A Prospective Observational Study.

Background: The Hypotension Prediction Index is designed to predict intraoperative hypotension in a timely manner and is based on arterial waveform analysis using machine learning. It has recently been suggested that this algorithm is highly correlated with the mean arterial pressure itself. Therefore, the aim of this study was to compare the index with mean arterial pressure-based prediction methods, and it is hypothesized that their ability to predict hypotension is comparable.

Circadian rhythms in pump parameters of patients on contemporary left ventricular assist device support.

Background: Algorithms to monitor pump parameters are needed to further improve outcomes after left ventricular assist device (LVAD) implantation. Previous research showed a restored circadian rhythm in pump parameters in patients on HeartWare (HVAD) support. Circadian patterns in HeartMate3 (HM3) were not studied before, but this is important for the development of LVAD monitoring algorithms.

An model to study suction events by a ventricular assist device: validation with clinical data.

Ventricular assist devices (LVADs) are a valuable therapy for end-stage heart failure patients. However, some adverse events still persist, such as suction that can trigger thrombus formation and cardiac rhythm disorders. The aim of this study is to validate a suction module (SM) as a test bench for LVAD suction detection and speed control algorithms.

Clinical decision support for ExtraCorporeal Membrane Oxygenation: Will we fly by wire?

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.

Fluid-structure interaction modelling of a positive-displacement Total Artificial Heart.

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.

Use of 3D anatomical models in mock circulatory loops for cardiac medical device testing.

Introduction: Mock circulatory loops (MCLs) are mechanical representations of the cardiovascular system largely used to test the hemodynamic performance of cardiovascular medical devices (MD). Thanks to 3 dimensional (3D) printing technologies, MCLs can nowadays also incorporate anatomical models so to offer enhanced testing capabilities. The aim of this review is to provide an overview on MCLs and to discuss the recent developments of 3D anatomical models for cardiovascular MD testing.

Initial clinical validation of a hybrid - cardiorespiratory simulator for comprehensive testing of mechanical circulatory support systems.

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.

Hemodynamic characterization of the Realheart® total artificial heart with a hybrid cardiovascular simulator.

Background: Heart failure is a growing health problem worldwide. Due to the lack of donor hearts there is a need for alternative therapies, such as total artificial hearts (TAHs). The aim of this study is to evaluate the hemodynamic performance of the Realheart® TAH, a new 4-chamber cardiac prosthesis device.

Long-term evolution of N-terminal pro-brain natriuretic peptide levels and exercise capacity in 132 left ventricular assist device recipients.

Objectives: N-terminal pro-brain natriuretic peptide (NT-proBNP) is a widely used biomarker in clinical practice in the context of heart failure. Little is known about the long-term evolution of NT-proBNP levels in left ventricular assist device (LVAD) recipients. Besides this, the potential correlation of NT-proBNP with exercise capacity on the long term after LVAD implantation has not been previously studied.

A Compliant Model of the Ventricular Apex to Study Suction in Ventricular Assist Devices.

Ventricular suction is a frequent adverse event in patients with a ventricular assist device (VAD). This study presents a suction module (SM) embedded in a hybrid (hydraulic-computational) cardiovascular simulator suitable for the testing of VADs and related suction events. The SM consists of a compliant latex tube reproducing a simplified ventricular apex.

Potential of Medical Management to Mitigate Suction Events in Ventricular Assist Device Patients.

Ventricular suction is a common adverse event in ventricular assist device (VAD) patients and can be due to multiple underlying causes. The aim of this study is to analyze the potential of different therapeutic interventions to mitigate suction events induced by different pathophysiological conditions. To do so, a suction module was embedded in a cardiovascular hybrid (hydraulic-computational) simulator reproducing the entire cardiovascular system.

Video-based valve motion combined with computational fluid dynamics gives stable and accurate simulations of blood flow in the Realheart total artificial heart.

Background: Patients with end-stage, biventricular heart failure, and for whom heart transplantation is not an option, may be given a Total Artificial Heart (TAH). The Realheart® is a novel TAH which pumps blood by mimicking the native heart with translation of an atrioventricular plane. The aim of this work was to create a strategy for using Computational Fluid Dynamics (CFD) to simulate haemodynamics in the Realheart®, including motion of the atrioventricular plane and valves.

Exercise physiology in left ventricular assist device patients: insights from hemodynamic simulations.

Left ventricular assist devices (LVADs) assure longer survival to patients, but exercise capacity is limited compared to normal values. Overall, LVAD patients show high wedge pressure and low cardiac output during maximal exercise, a phenomenon hinting at the need for increased LVAD support. Clinical studies investigating the hemodynamic benefits of an LVAD speed increase during exercise, ended in inhomogeneous and sometimes contradictory results.

Development of a computational simulator of the extracorporeal membrane oxygenation and its validation with in vitro measurements.

In the recent years, the use of extracorporeal membrane oxygenation (ECMO) has grown substantially, posing the need of having specialized medical and paramedical personnel dedicated to it. Optimization of the therapy, definition of new therapeutic strategies, and ECMO interaction with the cardiorespiratory system require numerous specific skills and preclinical models for patient successful management. The aim of the present work is to develop and validate a computational model of ECMO and connect it to an already existing lumped parameter model of the cardiorespiratory system.