Early outcomes of the intraluminal flow guard device for secondary renal access.

PURPOSE: The Flixene Intraluminal Flow Guard (IFG) is a novel arteriovenous graft for use in complex renal access patients. The IFG is a PTFE graft with a covered nitinol stent at the venous end implanted into the axillary vein rather than anastomosed. The purported benefits are improved hemodynamic flow in the vein with reduced neointimal hyperplasia. Our primary aim was to assess its early patency and complications. Our center is the first to publish early outcomes.

METHODS: All patients on whom we would have otherwise performed a standard brachial-axillary graft from April to November 2011 were instead given an IFG graft if they were suitable and consented. The only exclusion criteria was an axillary vein size under 5.5 mm as this would not accommodate the intraluminal stent graft. Data were collected prospectively and follow-up was identical to our usual graft surveillance.

RESULTS: A total of 12 patients (mean age 64, mean follow-up 393 days) had IFG grafts implanted during the study period. There were no exclusions and all patients consented. All patients were having secondary access following previous failed fistulae or grafts and no patient had an autogenous hemodialysis option. On average each patient had already had 1.1 previous ipsilateral access procedures. Mean operating time was 109 minutes. Functional patency at one year was 65.6%, with a mean functional patency of 162 days. There was only one early complication (wound hematoma) and one graft infection requiring explantation.

CONCLUSIONS: The IFG device provides an alternative to standard brachial-axillary grafts and brings similar early patency and complication profile. Continued monitoring of outcomes, however, is required to determine long-term results.