A spun elastomeric graft for dialysis access.
A new composite vascular graft was developed using electrostatic spinning technology. The graft is primarily microfibrous polydimethylsiloxane spun onto a mandrel; a small diameter polyester yarn provides additional strength while minimizing wall thickness, and a helical bead provides crush and kink resistance. Eighteen grafts were implanted in a mongrel canine arteriovenous shunt model for 12 months. The grafts were implanted in femoral artery to femoral vein loops and were cannulated using three pairs of 16 gauge dialysis needles per week. Grafts were evaluated during each puncture session, and also followed using angiography. Histologic study of explanted grafts, regional lymph nodes, and lungs was performed. The grafts provided excellent handling and puncture characteristics, with no bleeding through the graft wall at puncture sites. Cumulative patency of these punctured grafts was 88% at 6 months and 80% at 1 year. Histologic study showed external fibroconnective tissue encapsulation of the grafts, with tissue growth through the interstices of the graft consisting of a microvascular network surrounded predominantly by histiocytes, many multinucleated foreign body giant cells, with some fibroblasts and collagen formation also present. Little luminal thrombus was seen at puncture sites in the patent grafts, and there was no evidence of pulmonary thromboemboli. This new elastomeric graft shows excellent promise for dialysis access; similar grafts under development may also find application for small diameter peripheral vascular reconstruction.