In-Silico Development- and Clinical-Trial-Platform for Testing In-Situ Tissue Engineered Heart Valves (SimInSitu)

Unknown Transcatheter aortic valve implantation (TAVI) device. Image from Serruys et al. (2017).

Unknown Xeltis scaffold material is a unique material composition, which consists of a supramolecular polymer raw material together with a sophisticated and controlled electrospinning process, which leads to a highly porous 'single-fiber' material. Image from Bockeria et al. (2017).

SimInSitu is aiming to develop a sophisticated in-silico method to predict the short- and long-term behavior of in-situ tissue engineered heart valves (TEHV) by combing advanced tissue remodeling algorithms with a personalized virtual heart modeling approach. The method will be specifically developed to predict the complex transformation process of biodegradable heart valves from the initially synthetic scaffold into a fully remodeled and functional valve.

Though, significant progress was made during the past years in developing TEHV-based devices, it remains very challenging, costly, time-consuming, and rich with obstacles. New knowledge can only be generated through a tedious trial and error process (requiring preclinical and clinical studies), since the restorative process cannot be replicated in an in-vitro environment.

Advanced computer modeling and simulation technologies have the potential to overcome this limitation by allowing to test new designs, modified scaffold compositions, or other applications in a virtual patient-specific environment – in-silico. In particular, the availability of this computer model could significantly accelerate the development of endogenous tissue repair devices and accelerate translation to the clinic and to the marketplace.

Briefly, in this project, we (TU Graz, Institute of Biomechanics) are responsible for the material characterization of the scaffold material by performing mechanical investigations such as uniaxial and biaxial extension tests. The experimental results are then used to develop constitutive models, which describe the (short-term) behavior of the scaffold material. The developed constitutive models are subsequently implemented in the commercial finite element software Abaqus to perform computational investigations both with an implicit and an explicit solver. In the further, the implemented constitutive models are verified and validated to obtain accurate results.

Funding: European Union