Process and quality control in use of isolated beating porcine slaughterhouse hearts

Cardiovascular treatments have become complex and require often detailed biological expertise, while the society's expectations are high and regulatory standards stricter in order to ensure patient safety. These circumstances strive the development of more realistic and reliable preclinical test platforms to equally examine safety, design and function. This dissertation resulted from the ambition to improve the experimental use of the PhysioHeart™, an ex-vivo isolated porcine beating heart platform capable of ensuring such realistic preclinical testing. The PhysioHeart™ is a commercially available preclinical test platform able to revive isolated working slaughterhouse pig hearts and therefore comprising more application-related and reliable assessment for preclinical devices compared to in-vitro studies. PhysioHeart™ experiments with slaughterhouse-based hearts encompass easy accessibility, reproducibility, minimal ethical considerations, cost and time efficiency. The cardiac warm oxygenated blood perfusion enables realistic device validation, while the platform can be a medical device itself, for instance in donor heart transportation investigations. The platform can be used up to several hours and replicate or replace acute in-vivo animal models. The aim of this dissertation was to further prepare the PhysioHeart™ for the newest scientific and technological developments in cardiovascular research. This work investigated approaches to minimize the initial pump function variability and to delay the time-dependent pump function degradation which is a common shortcoming of the PhysioHeart™ and other isolated heart platforms. Within this context, we focused on the optimization of process and quality control parameters to preserve cardiac tissue. These findings could be also of potential interest for other cardiac platforms