In vivo evaluation of an elastomeric small-diameter vascular graft reinforced with a highly flexible Nitinol mesh

Highly porous small-diameter vascular grafts (SDVGs) prepared with elastomeric materials such as poly(ether urethane) (PEtU)-polydimethylsiloxane (PEtU-PDMS) are capable to biodegrade but may develop aneurismal dilatation. Through a compliance/patency assessment with ultrasound techniques, the current study investigated the functionality, in terms of patency and endothelialization, of a highly flexible and porous Nitinol mesh incorporated into PEtU-PDMS SDVGs in a sheep carotid model. Nitinol-PEtU-PDMS grafts with an internal diameter (ID) of 4 mm were manufactured by spray, phase-inversion technique. Compliance tests were performed by ultrasound (US) imaging using a high-resolution ultrasound diagnostic system. Ten adult sheep were implanted with 7 cm long grafts. The results of this study demonstrated an almost complete neointima luminal coverage in transmurally porous grafts reinforced with the Nitinol meshes after 6 months of implantation. Additionally, ultrasound has been used to quantitatively assess and monitor hemodynamic variables in an experimental model of synthetic vascular graft replacement. The use of reinforced PEtU-PDMS grafts may accelerate the endothelialization process of relatively long grafts, such as those needed for aortocoronary bypass. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 951-964, 2019.