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.