Arteriovenous fistula construction with the VasQ™ external support device: a pilot study.

BACKGROUND AND OBJECTIVE: Arteriovenous fistulas (AVF) are currently the gold standard for access, exhibiting the best combination of a low complication profile with a long patency period and attractive pricing. Despite a steady increase in the use of autogenous AVF in recent years, there is still a high rate of non-maturation of native fistulas. VasQ™ (Laminate Medical Technologies, Israel) is an external support device for AVFs designed to improve flow and reduce neointimal hyperplasia at the anastomotic site. Preliminary data are presented of its use, assessing its safety and efficacy for brachiocephalic AVFs in haemodialysis patients.

DESIGN, SETTING, PARTICIPANTS AND MEASUREMENTS: A single institution study of VasQ™ use was conducted with placement of the device in patients undergoing a brachiocephalic fistula, followed for 6 months. The VasQ™ was available in three sizes and was deployed externally over the fistula. Patients were assessed for flow, maturation and patency at 1, 3 and 6 months by Doppler ultrasonography.

RESULTS: Twenty patients were implanted. Mean venous flow at 1, 3 and 6 months was 1130, 1426 and 1304 mL/min, respectively. Primary patency rates for these time periods were 95%, 79% and 79%, respectively, with unassisted maturation rates of 80%, 79% and 74%, respectively. There were no device-related serious adverse events. At the end of the follow-up period, 14/15 patients requiring dialysis were able to use the AVF.

CONCLUSIONS: VasQ™ is safe with high unassisted maturation and patency rates. The device may prevent perianastomotic stenosis, the leading cause of AVF failure.