A Red Blood Cell Model to Estimate the Hemolysis Fingerprint of Cardiovascular Devices.

One of the most relevant and open issues within cardiovascular prosthetic hemodynamic performance is a realistic quantification of the damage sustained by red blood cells (RBCs). Specifically, the optimal design of bileaflet mechanical heart valves (BMHVs) requires both low shear stresses along the leaflets and short particle resident times. This study approaches RBC damage estimation by developing a numerical model of RBCs and computing the damage sustained by a set of passive RBCs immersed within in vitro flows. The RBC is modeled as an ellipsoidal shell with size dependent on age. Mechanically, a viscous hyper-elastic model was adopted to compute the stress-deformation transmitted by the experimental flow field to the RBC layer. The rupture parameters were calibrated using experimental results on real RBCs submitted to Couette flow. Moreover, the integrated hemolysis index (HI) through a BMHV was computed for a set of RBCs injected in a flow field derived from an in vitro study and for multiple RBC passages. The main results are (1) a good capability of the RBC model to replicate in vitro experiments performed with real RBCs, finding realistic rupture parameters; (2) the spatial distribution for the HI, maximal along the leaflet boundary layer and for long resident times; (3) 90% of HI is produced by the less damaging trajectories, which are favored by local flow dynamics; (4) cumulated HI in 8 days is about 0.01% smaller than the clinical warning threshold, the latter being obtained only after a period of time comparable with the RBC lifetime.

Integrated strategy for in vitro characterization of a bileaflet mechanical aortic valve.

BACKGROUND: Haemodynamic performance of heart valve prosthesis can be defined as its ability to fully open and completely close during the cardiac cycle, neither overloading heart work nor damaging blood particles when passing through the valve. In this perspective, global and local flow parameters, valve dynamics and blood damage safety of the prosthesis, as well as their mutual interactions, have all to be accounted for when assessing the device functionality. Even though all these issues have been and continue to be widely investigated, they are not usually studied through an integrated approach yet, i.e. by analyzing them simultaneously and highlighting their connections. RESULTS: An in vitro test campaign of flow through a bileaflet mechanical heart valve (Sorin Slimline 25 mm) was performed in a suitably arranged pulsatile mock loop able to reproduce human systemic pressure and flow curves. The valve was placed in an elastic, transparent, and anatomically accurate model of healthy aorta, and tested under several pulsatile flow conditions. Global and local hydrodynamics measurements and leaflet dynamics were analysed focusing on correlations between flow characteristics and valve motion. The haemolysis index due to the valve was estimated according to a literature power law model and related to hydrodynamic conditions, and a correlation between the spatial distribution of experimental shear stress and pannus/thrombotic deposits on mechanical valves was suggested. As main and general result, this study validates the potential of the integrated strategy for performance assessment of any prosthetic valve thanks to its capability of highlighting the complex interaction between the different physical mechanisms that govern transvalvular haemodynamics. CONCLUSIONS: We have defined an in vitro procedure for a comprehensive analysis of aortic valve prosthesis performance; the rationale for this study was the belief that a proper and overall characterization of the device should be based on the simultaneous measurement of all different quantities of interest for haemodynamic performance and the analysis of their mutual interactions.

In vitro performance investigation of SynCardia™ Freedom® driver via patient simulator mock loop.

PURPOSE: The gold standard therapy for patients with advanced heart failure is heart transplant. The gap between donors and patients in waiting lists promoted the development of circulatory support devices, such as the total artificial heart (TAH). Focusing on in vitro tests performed with CardioWest™ TAH (CW) driven by the SynCardia Freedom® portable driver (FD) the present study goals are: i) prove the reliability of a hydraulic circuit used as patient simulator to replicate a quasi-physiological scenario for various hydrodynamic conditions, ii) investigate the hydrodynamic performance of the CW FD, iii) help clinicians in possible interpretation of clinical cases outcomes. METHODS: In vitro tests were performed using a mechanic-hydraulic patient simulator. Cardiac output (CO), CW ventricles filling, atrial, ventricles, aortic and pulmonary artery pressures were measured for different values of vascular resistance in both systemic (SVR) and pulmonary (PVR) physiological range. RESULTS: After increasing the PVR, the left atrial pressure decreased according to the expected physiological trend, while aortic pressure remained almost stable, proving the ability of the simulator to mimic a physiological scenario. Unexpectedly, the mean pulmonary artery pressure (PPA) was found to increase above 30 mmHg in the range of physiological PVR (2.6 WU) and for constant CO. CONCLUSIONS: The increase in PPA is probably associated with the pre-set driving setup of the FD. The finding suggests a possible explanation of the clinical course of a patient who experienced complications soon after being supported by the FD, with the occurrence of dyspnea and pulmonary edema despite a high cardiac index.

Physiological vortices in the sinuses of Valsalva: An in vitro approach for bio-prosthetic valves.

PURPOSE: The physiological flow dynamics within the Valsalva sinuses, in terms of global and local parameters, are still not fully understood. This study attempts to identify the physiological conditions as closely as possible, and to give an explanation of the different and sometime contradictory results in literature. METHODS: An in vitro approach was implemented for testing porcine bio-prosthetic valves operating within different aortic root configurations. All tests were performed on a pulse duplicator, under physiological pressure and flow conditions. The fluid dynamics established in the various cases were analysed by means of 2D Particle Image Velocimetry, and related with the achieved hydrodynamic performance. RESULTS: Each configuration is associated with substantially different flow dynamics, which significantly affects the valve performance. The configuration most closely replicating healthy native anatomy was characterised by the best hemodynamic performance, and any mismatch in size and position between the valve and the root produced substantial modification of the fluid dynamics downstream of the valve, hindering the hydrodynamic performance of the system. The worst conditions were observed for a configuration characterised by the total absence of the Valsalva sinuses. CONCLUSION: This study provides an explanation for the different vortical structures described in the literature downstream of bioprosthetic valves, enlightening the experimental complications in valve testing. Most importantly, the results clearly identify the fluid mechanisms promoted by the Valsalva sinuses to enhance the ejection and closing phases, and this study exposes the importance of an optimal integration of the valve and root, to operate as a single system.