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. 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 [Formula: see text]% 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.

In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood.

BACKGROUND: Hemolysis testing of new devices to treat heart failure is a regulatory requirement. The ASTM F1841-97 standard for hemolysis testing was developed for continuous flow pumps and does not specify test rig design. When research groups use different methodologies, results are difficult to compare. Pulsatile flow pump rigs require compliance chambers, and thus, the Aachen rig (Gräf et al) was developed for the pulsatile Reinheart TAH. The study objective was to use this rig to test the early Realheart TAH prototype V11C hemolysis performance compared to literature. METHODS: The experimental control was the continuous flow pump BPX-80 (Medtronic) and pooled heparinized porcine blood was used. RESULTS: The mgNIH of BPX-80 and V11C was 5.42 ± 1.47 and 25.20 ± 5.46 mg/100 L, respectively. The NIH ratio of V11C over BPX-80 was 5.5. CONCLUSION: The absolute and the relative hemolysis of the V11C are lower compared to both the large and small Reinheart TAH devices published values. Pulsatile pumps create more hemolysis in the Aachen rig, and it is not known if this is because how the rig handles pulsatile flow or due to the devices. Future studies will, therefore, use a pulsatile pump such as the SynCardia as clinical comparator and human blood to test the performance of future Realheart TAH prototypes.

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. METHODS: The Realheart® TAH was connected to a hybrid cardiovascular simulator with inflow connections at the left/right atrium, and outflow connections at the ascending aorta/pulmonary artery. The Realheart® TAH was tested at different pumping rates and stroke volumes. Different systemic resistances (20.0-16.7-13.3-10.0 Wood units), pulmonary resistances (6.7-3.3-1.7 Wood units), and pulmonary/systemic arterial compliances (1.4-0.6 ml/mm Hg) were simulated. Tests were also conducted in static conditions, by imposing predefined values of preload-afterload across the artificial ventricle. RESULTS: The Realheart® TAH allows the operator to finely tune the delivered flow by regulating the pumping rate and stroke volume of the artificial ventricles. For a systemic resistance of 16.7 Wood units, the TAH flow ranges from 2.7 ± 0.1 to 6.9 ± 0.1 L/min. For a pulmonary resistance of 3.3 Wood units, the TAH flow ranges from 3.1 ± 0.0 to 8.2 ± 0.3 L/min. The Realheart® TAH delivered a pulse pressure ranging between ~25 mm Hg and ~50 mm Hg for the tested conditions. CONCLUSIONS: The Realheart® TAH offers great flexibility to adjust the output flow and delivers good pressure pulsatility in the vessels. Low sensitivity of device flow to the pressure drop across it was identified and a new version is under development to counteract this.

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. METHODS: The accuracies of four different computational methods for simulating fluid-structure interaction of the prosthetic valves were assessed by comparison of chamber pressures and flow rates with experimental measurements. The four strategies were: prescribed motion of valves opening and closing at the atrioventricular plane extrema; simulation of fluid-structure interaction of both valves; prescribed motion of the mitral valve with simulation of fluid-structure interaction of the aortic valve; motion of both valves prescribed from video analysis of experiments. RESULTS: The most accurate strategy (error in ventricular pressure of 6%, error in flow rate of 5%) used video-prescribed motion. With the Realheart operating at 80 bpm, the power consumption was 1.03 W, maximum shear stress was 15 Pa, and washout of the ventricle chamber after 4 cycles was 87%. CONCLUSIONS: This study, the first CFD analysis of this novel TAH, demonstrates that good agreement between computational and experimental data can be achieved. This method will therefore enable future optimisation of the geometry and motion of the Realheart®.

Preclinical Device Thrombogenicity Assessments: Key Messages From the 2018 FDA, Industry, and Academia Forum.

Device-related thrombosis and thromboembolic complications remain a major clinical concern and often impact patient morbidity and mortality. Thus, improved preclinical thrombogenicity assessment methods that better predict clinical outcomes and enhance patient safety are needed. However, there are several challenges and limitations associated with developing and performing preclinical thrombogenicity assessments on the bench and in animals (e.g., the clinical relevance of most in vitro tests has not been established, animal studies may not accurately predict clinical thrombotic events). To facilitate a discussion on how to overcome some of these challenges and to promote collaboration between the Food and Drug Administration (FDA), industry, and academia for the development of more reliable test methods, a scientific forum was organized by FDA and held in Washington, DC, on June 15, 2018 at the ASAIO 64th Annual Conference. Three subject matter experts from the medical device industry and FDA presented their perspectives at this forum, and several audience experts provided input during the open dialogue session. This article summarizes the key messages from the forum regarding the current status and challenges of preclinical thrombogenicity testing, important areas of needed research, and mechanisms for working with FDA to further improve thrombogenicity evaluations of medical devices.

Hemodilution Increases the Susceptibility of Red Blood Cells to Mechanical Shear Stress During In Vitro Hemolysis Testing.

The American Society for Testing and Materials (ASTM) F1841 standard for the assessment of hemolysis in blood pumps recommends using phosphate-buffered saline (PBS) for hemodilution to standardize hematocrit (HCT). However, PBS increases red blood cell mechanical fragility and hemolysis. Herein, we investigated diluents and dilutions during in vitro testing to reduce hemodilution bias when assessing hemolysis. Bovine blood was diluted with either PBS or PBS + 4/6 g% bovine serum albumin (BSA) to a 70/90% blood dilution, or to an HCT of 30% ± 2%, and pumped with the CentriMag or RotaFlow under hemodynamic conditions. Separately, bovine and human blood were subjected to ventricular assist device-like shear stress using a vortex. Plasma-free hemoglobin levels, normalized milligram index of hemolysis (mgNIH), and protein concentrations were analyzed. Hemolysis depended on the diluent and final blood concentration. Seventy percent of blood diluted with PBS alone caused significantly greater hemolysis than PBS + 4/6 g% BSA. However, at 90% blood, PBS + 4/6 g% BSA caused significantly greater hemolysis than PBS alone. Hence, a positive correlation between mgNIH and hemodilution was observed with PBS and a negative correlation with PBS + 4g% BSA. PBS alone significantly reduced the total protein concentration. Hemodilution with BSA maintains protein concentration within a physiologic range and reduces bias during hemolysis testing at high blood dilutions. Thus, American Society for Testing and Materials standards could consider including BSA as a diluent, when and as required: where large dilution is required (<83%) use PBS + 4 g% BSA, otherwise use PBS alone.