An immediate access dialysis graft designed to prevent needle-related complications: Results from the initial pre-clinical studies

Abstract

Introduction: No technology has been specifically developed with the intent to reduce needle-related vascular access injuries; a significant source of complications and abandonment. We present the initial pre-clinical study results of a novel, self-sealing, immediate cannulation dialysis graft that aims to prevent needle-related complications; to promote safe, reliable needle access; to reduce catheter use; and could facilitate home hemodialyisis. Methods: The innovative graft design consists of two cannulation chambers with self-sealing properties and materials that prevent side and back wall needle puncture. Study and control grafts (expanded polytetrafluoroethylene) were implanted in one pig and 10 sheep in two studies over the course of 1 year. First cannulation occurred immediately post implant for all study grafts. Post-cannulation time to hemostasis, hematoma and seroma formation, infection, and patency were recorded. Results: The two studies account for nearly 60 weeks (average 6.4 weeks/graft) of study graft follow-up. In the ovine study, average study graft time to hemostasis was 27.3 s (standard deviation = 26.3, range = 0–120), and the control averaged 177.2 s (standard deviation = 113.4, range = 60–600), p < 0.0001. Secondary patency was 75% and 67% for the study and control grafts, respectively. Neither study nor control groups experienced seroma, graft infections, or deaths. Discussion: All novel grafts in the studies were implanted successfully and functioned as intended. There were no complications related to tunneling of the study graft and the chamber prevented back/side wall needle injury. This novel technology may help to mitigate these needle-related complications, while allowing for early/immediate cannulation which could also reduce catheter contact time.