4.4 Article

Preclinical evaluation of hydrogel sealed fluropassivated indigenous vascular prosthesis

Journal

INDIAN JOURNAL OF MEDICAL RESEARCH
Volume 146, Issue -, Pages 646-653

Publisher

MEDKNOW PUBLICATIONS & MEDIA PVT LTD
DOI: 10.4103/ijmr.IJMR_1933_15

Keywords

Aortic reconstruction; flouropassivated polyester graft; hydrogel sealing; in vivo large animal trial; polyethylene terephthalate vascular prosthesis

Funding

  1. Technology Development Fund, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala

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Background objectives: Polyethylene terephthalate (PET) graft, designed and developed at our institute for vascular reconstruction, is porous to promote optimal incorporation and neointima formation, requiring pre-clotting or biomodification by sealing the pores before implantation. The objective of this study was to characterize, test and perform preclinical evaluation of hydrogel (alginate dialdehyde cross-linked gelatin) sealed fluoropassivated PET vascular prosthesis in pig model, so as to avoid pre-clotting, for its safety and efficacy before employing the indigenous and less expensive graft for clinical use. Methods: Hydrogel sealed, fluoropassivated PET vascular prosthesis were tested for haemocompatibility and toxicity followed by small animal toxicology tests and in vivo experiments in pigs receiving implantation at thoracic aorta. All 33 animals received test as well as control grafts with a plan for phased explantation at 2, 12 and 26 weeks. All animals underwent completion angiogram at the end of procedure as well as before graft explantation. Results: Haemocompatibility tests for haemolysis and toxicity tests showed no adverse events in tested mice and rabbits. Completion angiogram showed intact anastamosis and patent graft in each animal in post-operative period and at explantation. Gross and histopathological examination showed well-encapsulated grafts, clean glistening neointima and no evidence of thrombus in both test and control grafts. Interpretation & conclusions: Hydrogel sealed, fluoropassivated PET vascular prosthesis was found non-toxic, haemocompatible and remained patent in in vivo studies at planned intervals.

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