Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis.

Objective: More than 85% of patients with end-stage renal disease start dialysis through a tunneled dialysis catheter (TDC) for long periods while their arteriovenous fistula or vascular access graft (arteriovenous graft [AVG]) matures. Because TDCs are associated with a high risk of complications, including death and infection, use of an AVG that can be cannulated safely immediately after implantation may reduce morbidity in these patients by allowing earlier TDC removal. We report a prospective multicenter study of a new early-cannulation AVG (Gore ACUSEAL Vascular Graft; W. L. Gore & Associates, Flagstaff, Ariz).

Methods: Patients requiring creation of a prosthetic vascular access for hemodialysis were enrolled between July 2010 and February 2012 and observed for 12 months. Data were collected on the patients' baseline characteristics; location, position, loss of patency, and revisions of prior AVGs; dialysis sessions using the AVG; and major adverse events related to graft implantation or cannulation. Cumulative and primary unassisted graft patency rates were calculated. A subgroup analysis compared outcomes in patients in whom the AVG was first cannulated within 72 hours after implantation with outcomes in patients in whom the initial cannulation was performed >21 days postoperatively.

Results: The population of this study was formed by 138 patients who received an ACUSEAL graft. During follow-up, 17 patients died and the AVG was abandoned in 27. The median value for follow-up was 360 days for all patients (variance 15,387). The overall mean time to initial cannulation was 15 days, with 54 grafts (40%) first cannulated within 72 hours after graft implantation and 33 grafts first cannulated >21 days afterward. The reason for late cannulation in some patients was dependent on the implanting surgeon's decision and the surgeon's personal experience with early cannulating grafts. The 1-year overall cumulative patency rate was 79% (95% confidence interval, 71%-85%); the primary unassisted patency rate was 35% (95% confidence interval, 27%-44%). Adverse events included 6 hematomas (two of which were related to cannulation and occurred 107 and 169 days, respectively, after AVG implantation), 15 graft infections, and 15 cases of steal syndrome requiring intervention. Patients in the early- and later-cannulation groups had similar characteristics and no significant differences in rates of cumulative or primary unassisted patency or adverse events.

Conclusions: This study demonstrated that the new, early-cannulation AVG graft can be cannulated soon after implantation without a significant difference in patency and complication rates compared with rates associated with standard cannulation of expanded polytetrafluoroethylene grafts in the literature. This new AVG may allow early removal or avoidance of TDC use in patients undergoing hemodialysis, potentially reducing or eliminating the number of days of catheter-dependent dialysis, but further studies will be needed to demonstrate this potential.