In silico and in vitro feasibility study of a novel pumping principle for a durable total artificial heart

Total Artificial Hearts (TAH) can be applied to replace the native heart in case of severe biventricular heart failure until a suitable donor heart can be found. Their application as long-term therapy is compromised by limited durability, high complication rates, and low quality of life. To account for the contradictory requirements of adequate long-term heart replacement, different TAH principles emerged, whereas no concept meets all requirements. This thesis gives insights into the design process and explores the early-stage feasibility of an alternative TAH concept, the ShuttlePump, which features an innovative pulsatile pumping principle in both systemic and pulmonary circulation based on a single moving part, intended to overcome the drawbacks of existing TAH concepts by means of pulsatile flow, long-term durability, and small device size. On the basis of risk assessments and results derived from dedicated in silico and in vitro methods, the feasibility of the pumping principle for a durable TAH is evaluated, residual risks are discussed and comparisons to state-of-the-art TAH concepts are drawn. The results point toward the feasibility of the pumping principle with acceptable residual risks in terms of basic hemodynamic performance, anatomical compatibility, and hemocompatible-related parameters. However, the pulsatility metrics fall behind the physiological range, the durability remains an open question, and the quality of life might be impaired due to oscillating reaction forces. To overcome these drawbacks, improvement strategies and risk control measures are discussed, and two alternative pumping principles are proposed that hold promise as durable TAHs for long-term therapy, substantiating further research and development in this direction.