Safety and efficacy of electrospun polycarbonate-urethane vascular graft for early hemodialysis access: first clinical results in man.

OBJECTIVES: The purpose of this study was to assess the safety and efficacy of an electrospun multilayered, self-sealing polycarbonate-urethane graft for early hemodialysis access in patients.

METHOD: Seventeen eligible consenting patients had a polycarbonate-urethane graft (AVflo™) implanted and followed up prospectively for 12 months or to the end of secondary patency. Performance measures included graft patency, complications, time to first cannulation, and hemostasis times after needle withdrawal.

RESULTS: All patients were of Asian origin (mean age 57 years, range 29-78). Diabetes mellitus was the most common cause of renal failure (52.9%). There were no systemic or local reactions to the graft. Five patients (29.4%) died due to medical complications unrelated to the device. There was 1 pseudoaneurysm, 3 infected grafts that subsequently thrombosed, and 1 primary thrombosis associated with thrombophilia. One venous stenosis needed balloon angioplasty. Primary and secondary patency rates at 6 months were 72.7% and 81.8%, and at 12 months, 54.5% and 72.7%, respectively. Postimplantation vascular access needs were met entirely by the graft in every instance and prevented the need for venous catheters. Fifty-six percent were accessed within 8 days, the earliest being 48 hours. Finally, all arterial punctures and 98% of venous punctures had sealed in less than 5 minutes, with two thirds sealing off within 3 minutes of needle withdrawal.

CONCLUSION: The electrospun polycarbonate-urethane graft is safe in humans, permits early access obviating the need for venous catheters, and has equivalent patency to other prosthetic grafts at 1 year.