Geometric adaption of biodegradable magnesium alloy scaffolds to stabilise biological myocardial grafts. Part I.

Synthetic patch materials currently in use have major limitations, such as high susceptibility to infections and lack of contractility. Biological grafts are a novel approach to overcome these limitations, but do not always offer sufficient mechanical durability in early stages after implantation. Therefore, a stabilising structure based on resorbable magnesium alloys could support the biological graft until its physiologic remodelling. To prevent early breakage in vivo due to stress of non-determined forming, these scaffolds should be preformed according to the geometry of the targeted myocardial region. Thus, the left ventricular geometry of 28 patients was assessed via standard cardiac magnetic resonance imaging (MRI). The resulting data served as a basis for a finite element simulation (FEM). Calculated stresses and strains of flat and preformed scaffolds were evaluated. Afterwards, the structures were manufactured by abrasive waterjet cutting and preformed according to the MRI data. Finally, the mechanical durability of the preformed and flat structures was compared in an in vitro test rig. The FEM predicted higher durability of the preformed scaffolds, which was proven in the in vitro test. In conclusion, preformed scaffolds provide extended durability and will facilitate more widespread use of regenerative biological grafts for surgical left ventricular reconstruction.