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ORIGINAL ARTICLE
Year : 2017  |  Volume : 146  |  Issue : 5  |  Page : 646-653

Preclinical evaluation of hydrogel sealed fluropassivated indigenous vascular prosthesis


1 Division of Vascular Surgery, Department of Cardiovascular & Thoracic Surgery, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India
2 Division of In Vivo Models & Testing, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India
3 Polymer Processing Laboratory, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India
4 Division of Artificial Organs, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India
5 Thrombosis Research Unit, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India
6 Division of Toxicology, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India
7 Division of Implant Biology, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India

Correspondence Address:
Dr. Madathipat Unnikrishnan
Department of Cardiovascular & Thoracic Surgery, Division of Vascular Surgery, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram 695 011, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijmr.IJMR_1933_15

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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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