The making of indigenous vascular prosthesis
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Date
2016-06
Journal Title
Journal ISSN
Volume Title
Publisher
THE INDIAN JOURNAL OF MEDICAL RESEARCH
Abstract
Background & objectives: Vascular illnesses are on the rise in India, due to increase in lifestyle diseases
and demographic transition, requiring intervention to save life, organ or limbs using vascular prosthesis.
The aim of this study was to develop indigenous large diameter vascular graft for treatment of patients
with vascular pathologies.
Methods: The South India Textile Research Association, at Coimbatore, Tamil Nadu, India, developed
seamless woven polyester (Polyethylene terephthalate) graft at its research wing. Further characterization
and testing followed by clinical trials were conducted at Sree Chitra Tirunal Institute for Medical
Sciences and Technology, Thiruvananthapuram, Kerala, India. Fifteen in vivo experiments were carried
out in 1992-1994 in pigs as animal model. Controlled (phase I) clinical trial in ten patients was performed
along with control graft. Thereafter, phase II trial involved 22 patients who underwent multi-centre
clinical trial in four centres across India.
Results: Laboratory testing showed that polyester graft was non-toxic, non-leeching and nonhaemolytic
with preserved long-term quality, further confirming in pigs by implanting in thoracic aorta,
comparable to control Dacron grafts. Perigraft incorporation and smooth neointima formation which
are prime features of excellent healing characteristics, were noted at explantation at planned intervals.
Subsequently in the phase I and II clinical trials, all patients had excellent recovery without mortality
or device-related adverse events. Patients receiving the test graft were followed up for 10 and 5 years,
respectively. Serial clinical, duplex scans and CT angiograms performed periodically confirmed excellent
graft performance.
Interpretation & conclusions: Indigenously developed Chitra vascular graft was comparable to
commercially available Dacron graft, ready for clinical use at affordable cost to patients as against costly
imported grafts.
Description
Keywords
Aortic aneurysm - coarctation of aorta - surgical repair - vascular diseases - vascular prosthesis