In vitro and in vivo testing showed a safe and effective function of the ReinHeart-TAH system. This has the potential to become an alternative to transplantation. However, before a first-in-man implant, chronic animal trials still have to be completed.

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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.

At our institute a total artificial heart is being developed. It is directly actuated by a linear drive in between two ventricles, which comprise membranes to separate the drive and blood flow. A compliance chamber (CC) is needed to reduce pressure peaks in the ventricles and to increase the pump capacity. Therefore, the movement of the membrane is supported by applying a negative pressure to the air volume inside the drive unit. This study presents the development of the implantable CC which is connected to the drive unit of the total artificial hearts (TAH). The anatomical fit of the CC is optimized by analyzing CT data and adapting the outer shape to ensure a proper fit. The pressure peaks are reduced by the additional volume and the flexible membrane of the CC. The validation measurements of change in pressure peaks and flow are performed using the complete TAH system connected to a custom mock circulation loop. Using the CC, the pressure peaks could be damped below 5 mm Hg in the operational range. The flow output was increased by up to 14.8% on the systemic side and 18.2% on the pulmonary side. The described implantable device can be used for upcoming chronic animal trials.