The increasing global prevalence of congestive heart failure is a major healthcare concern, accounting for a high morbidity rate worldwide. In particular, isolated right heart dysfunction after cardiotomy has a poor prognosis and is associated with a high mortality rate. The occurrence of postoperative right heart failure may develop in more than 40% of patients undergoing implantation of a left ventricular assist device (LVAD) and cardiac transplantation. To date, mechanical cardiac assistance in the form of VADs has become accepted as a therapeutic solution for end-stage patients when a donor heart is not available. However, right ventricular (RV) assistance is still in the early phase of development when compared with LVAD technology. State-of-the-art RVADs, both in clinical use and under development, are reviewed in this manuscript. Clinical RVADs include the extracorporeal pulsatile Abiomed BVS 5000 and AB5000, Thoratec PVAD, MEDOS VAD, BerlinHeart Excor, the percutaneous continuous flow CentriMag and TandemHeart systems, and the implantable Thoratec IVAD. Devices on the horizon, including the wear-free implantable DexAide and the minimally invasive Impella RD, are additionally reviewed. In addition to the current status of RV assistance, as well as the device categorization, the outlook and considerations for successful development of future RVADs were discussed.

Acquired von Willebrand Syndrome (AvWS) is known as a frequent bleeding complication in patients on ventricular assist device (VAD) support. Clinicians demand that the requirements for VADs with regard to hemocompatibility should also include low susceptibility for AvWS. Clinical AvWS diagnosis is known to be a complex, high-price, and time-consuming analysis. This article investigates an easy-to-handle, time-efficient, and inexpensive method for comparative AvWS investigations in vitro. Von Willebrand Factor activity level (vWF:Ac) and von Willebrand Factor antigen level (vWF:Ag) were chosen from the complete set of clinically established parameters. Blood plasma (human and porcine) was exposed to an inhomogeneous shear field in a shear-inducing test set up for up to 4 h. Plasma samples were drawn after different load periods and analyzed for vWF:Ac and vWF:Ag. vWF multimer analysis of selected samples were used as reference for determination of high molecular weight multimer (HMWM) loss. AvWS was detected after 20 min of shear load via vWF:Ac/vWF:Ag ratio and multimer analysis. A good correlation between the vWF:Ac/vWF:Ag ratio and HMWM loss (multimer analysis) was found for human plasma. AvWS characteristics of human and porcine plasma for analyzed samples were comparable. A correlation between vWF:Ac/vWF:Ag ratio and HMWM in porcine plasma could not be found. Results gained in this study indicate that vWF:Ac/vWF:Ag ratio is sensitive enough for comparative AvWS investigations in vitro with human blood. The applicability of the method suggested in this article for AvWS characterization in porcine blood needs to be investigated in further studies. The selection of analysis kits promises a less cost- and labor-intensive, time-consuming, and complex method for comparative AvWS investigations in vitro compared with AvWS diagnosis in patients.

BackgroundGood anatomical compatibility is an important aspect in the development of cardiovascular implants. This work analyzes the interaction of the pump unit of an electrically driven pulsatile Total Artificial Heart (TAH) and the mediastinum. For an adequate compliance, both overall dimensions and alignment of inlets and outlets must be matched.MethodsCross-sectional medical image data of 27 individuals, including male and female patients suffering from end stage heart failure, was segmented and reconstructed to three dimensional (3D) surface models. Dimensions and orientations of relevant structures were identified and analyzed. The TAH surface model was virtually placed in orthotopic position and aligned with atrioventricular valves and big vessels. Additionally seven conventional cadaver studies were performed to validate different pump chamber designs based on virtual findings. Thereby 3D-coordinates were captured and introduced to the virtual environment to allow quantitative comparison between different individuals.ResultsSpatial parameters varied more in male patients with higher values if heart failure persists. Good correlation of the virtual analysis both to literature data and conventional cadaver studies could be shown. The full data of the 27 individuals as well as the summarized values found in literature are enclosed in the appendix. By superimposing the TAH-volume model to the anatomy, various misalignments were found and the TAH-design was adjusted.ConclusionsVirtual fitting allows implant design adjustments in realistic anatomy which has not been influenced by thoracotomy. Higher numbers of relevant individuals can be reasonably investigated in the virtual environment and quantitatively correlated. Using this approach, conventional cadaver studies can be significantly reduced but not obviated, due to the unavailable haptic feedback and immobility of potentially compressed structures.

Assuming that blood has a constant viscosity is a common practice when designing rotary blood pumps (RBPs), where shear stresses are generally higher than in the human body. This eases the design and allows numerical simulations and bench top experiments to be performed with Newtonian fluids. However, specific flow conditions may cause a change in cell distribution leading to an apparent lower blood viscosity. It has been observed that decreasing the vessel diameters and increasing flow velocities contribute to this effect. Because a hydrodynamic bearing operates under flow conditions following this pattern, it is important to verify whether this effect also takes place when this type of bearing is applied to a RBP. Because the operation of a hydrodynamic bearing depends directly on the fluid viscosity, a local change in cell distribution in the bearing gap can be reflected in changes in the bearing performance. In this work, a spiral groove hydrodynamic bearing was tested with porcine blood in a specially built test rig. The generated suspension force, cross flow, and bearing torque were recorded and compared with the reference response when using a solution of water and glycerol. Experiments with porcine blood yielded lower suspension forces, lower flows, and lower bearing torques than when using the glycerol solution. An explanation could be a lower apparent viscosity due to inhomogeneity of blood cell concentrations. Therefore, it is crucial to consider the effective blood viscosity when designing hydrodynamic bearings for RBPs and performing experiments.

The feasibility of RV unloading by a selective decrease in RV afterload was proved in principle. By alternation of the pump speed, gradual reloading in sense of a myocardial training may be achieved. The results will be validated by future animal trials where the relationship between the level of support and pulmonary vascular pressure can be investigated in vivo. Further device design concerning foldable impeller leaflets will be carried out. At a final stage, the crimped version is supposed to reach a size below 1 cm to facilitate minimally invasive insertion.

The rapid evolution of rotary blood pump (RBP) technology in the last few decades was shaped by devices with increased durability, frequently employing magnetic or hydrodynamic suspension techniques. However, the potential for low flow in small gaps between the rotor and pump casing is still a problem for hemocompatibility. In this study, a spiral groove hydrodynamic bearing (SGB) is applied with two distinct objectives: first, as a mechanism to enhance the washout in the secondary flow path of a centrifugal RBP, lowering the exposure to high shear stresses and avoiding thrombus formation; and second, as a way to allow smaller gaps without compromising the washout, enhancing the overall pump efficiency. Computational fluid dynamics was applied and verified via bench-top experiments. An optimization of selected geometric parameters (groove angle, width and depth) focusing on the washout in the gap rather than generating suspension force was conducted. An optimized SGB geometry reduced the residence time of the cells in the gap from 31 to 27 ms, an improvement of 14% compared with the baseline geometry of 200 μm without grooves. When optimizing for pump performance, a 15% smaller gap yielded a slightly better rate of fluid exchange compared with the baseline, followed by a 22% reduction in the volumetric loss from the primary pathway. Finally, an improved washout can be achieved in a pulsatile environment due to the SGB ability to pump inwardly, even in the absence of a pressure head.

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