In vitro and in vivo studies of a polyester arterial prosthesis with a warp-knitted sharkskin structure

The present study was undertaken to assess the performance of a new knitted and gelatin-sealed polyester vascular graft that is believed to have greater dimensional stability than current commercial devices. Samples of the uncrimped, crimped, and sealed prosthesis were submitted to a series of in vitro and in vivo trials. Four commercial polyester knitted devices were included as controls for the in vitro tests, which included measurements of the textile and yarn structure and physical, chemical, and thermal properties of the graft, such as water permeability, dilatation, suture retention strength, melting point, and crystallinity index. The in vivo evaluation involved implanting the prototype device as a canine thoraco-abdominal bypass for periods ranging from 4 h to 1 year and assessing the biocompatibility, biofunctionality, and biostability of the explanted specimens. The warp-knitted structure of the prototype device has a unique sharkskin stitch that confers a superior dilatation resistance and suture retention strength to the prosthesis. The animal trial demonstrated that the gelatin ensures initial hemostasis without preclotting. The gelatin is bioresorbed during the first 2 weeks of implantation, which generates a temporary, moderate, acute inflammatory response. An external capsule of granulomatous tissue and an internal collagen capsule are formed between the first and third month. Analysis of the textile and physical properties of the explanted prostheses confirmed there was neither dilatation nor significant changes in structure or mechanical performance during implantation, thus confirming the biostability of this new prototype device and opening the way for clinical trials.