A helical PTFE arteriovenous access graft to swirl flow across the distal anastomosis: results of a preliminary clinical study.

Intimal hyperplasia develops preferentially in regions where the blood flow is stagnant and wall shear stress low. The small amplitude helical geometry of the SwirlGraft was designed to ensure physiological-type swirling flow, and thus suppress the triggers. We report the first conceptual testing of the SwirlGraft. Primary, assisted primary and secondary patency rates at 6 months in 20 patients were 57.9+/-11.4%, 84.4+/-8.3% and 100+/-0.0%. There was angiographic evidence of reduction of helical geometry in a proportion of the grafts. The helical graft is associated with high assisted primary and secondary patency. Elaboration of the surgical implantation techniques and an improved SwirlGraft design can be expected to exploit the advantages of the helical concept.