Purpose: Preferred hemodialysis (HD) access is an autologous fistula. Vascular grafts are used in patients with vessels unsuitable to accomplish an arteriovenous fistula (AVF). It is recommended that most current grafts mature in situ for 2-3 weeks before being accessed. Graft complications occur because the structure was not designed for the trauma of repeated cannulation. This study graft has a different structure that enables early use. Its design minimizes weeping through the graft walls and is meant to endure repeated access, thus minimizing the use of HD catheters. The purpose of this study was to show that the Flixene™ graft can be safely placed in patients where fistulas have failed and can be cannulated in 24-72 hr, while maintaining patency rates similar to other polytetrafluoroethylene (PTFE) grafts on the market. Flixene™ configuration should also reduce the incidence of pseudoaneurysms and seromas.
Methods: A prospective two-center study placed 33 grafts in 33 patients; graft efficacy, post-operative complications, and patency were evaluated. Ease of cannulation and dialysis center complications related to early cannulation were documented. Six month follow-up data was analyzed.
Results: Successful access was achieved in all 33 patients within 72 hr (29 patients within 24 hr). Overall primary patency at 6 months was 49%; primary-assisted patency at 6 months was 80%. No pseudoaneurysms or seromas were documented at 6 months. Complications were typical of graft access.
Conclusion: Early cannulation was successful in all patients. Primary and secondary patency rates at 6-months were equivalent to other data reported on PTFE grafts. Flixene™ successfully prevented pseudoaneurysm and seroma formation at 6 months of prospective follow-up. This graft is a better last-resort option for patients who cannot receive a fistula, compared to double-lumen cuffed catheters.