One year Rat Study of iBTA-induced "Microbiotube" Microvascular Grafts With an Ultra-Small Diameter of 0.6 mm.

OBJECTIVE: The world's smallest calibre "microbiotube" vascular graft was recently developed, with an inner diameter of 0.6 mm. It was formed using in-body tissue architecture (iBTA) and has a high degree of patency and capacity for regeneration in the acute phase, 1 month after implantation. This consecutive study investigated the compatibility and stability of microbiotubes in the chronic phase of implantation for 12 months for potential application in microsurgery.

METHODS: This was an in vivo experimental study. The microbiotubes were prepared by embedding the mould subcutaneously in rats for 2 months. Allogenic microbiotubes (n = 16) were implanted into the bilateral femoral arteries (inner diameter 0.5 mm) of eight Wistar rats in an end to end anastomosis manner for 12 months. Follow up 7-Tesla magnetic resonance angiograms were performed every 3 months. Histological observation was performed 12 months after implantation.

RESULTS: All patent grafts (n = 12, patency 75%) one month after implantation maintained their patency up to 12 months without any abnormal morphological changes or calcification. Histological observation at 12 months showed that layered α-smooth muscle actin positive cells with a monolayer luminal covering of endothelial cells had formed from the proximal to the distal anastomoses. A thin elastic fibre layer formed in the luminal area. After implantation, all components of the microbiotube were similar to those of a native artery.

CONCLUSIONS: This study suggests that microbiotubes have high compatibility, stability, and durability as replacement grafts over the short to mid-term period.