Use of the Viabahn stent graft for the treatment of recurrent cephalic arch stenosis in hemodialysis accesses

Objective: Cephalic arch stenosis (CAS) is a frequent and challenging failure mode of brachiocephalic fistulas. Natural tortuosity of the cephalic arch requires special consideration in selecting a treatment modality. Typical percutaneous angioplasty and bare-metal stent (BMS) treatments provide a short-term treatment solution for CAS without a durable effect. This study assessed Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts (SGs) as a first-line percutaneous option to provide a durable treatment for CAS. Methods: SG data were collected at a free-standing physician office between July 10, 2009, and January 26, 2011. A single-arm, prospective, observational study was conducted of 50 consecutive CAS patients treated with angioplasty followed by deployment of Viabahn SGs. Outcomes included target lesion primary patency and reintervention rates as well as secondary access patency. Results were compared with historic cohorts of percutaneous balloon angioplasty (N = 50) and angioplasty followed by BMS deployment (N = 50). The cohorts were treated between May 5, 2005, and May 20, 2010, and assessed in chronologic order. Results: The SG cohort target lesion primary patency reported at 3, 6, and 12 months was 90% +/- 7%, 74% +/- 12%, and 60% +/- 14% (695% confidence interval), respectively. Compared with historic cohorts, the SG cohort demonstrated statistically superior target lesion primary patency (P <.001), with a reduced reintervention rate per access-year (P <.001). Secondary access patency was statistically superior compared with the percutaneous balloon angioplasty cohort (P = .034) but not statistically different from the BMS cohort when assessed during a 2.5-year period. The secondary access patency for the SG cohort at 5 years was 80% +/- 15%. Conclusions: In treatment of a CAS, the Viabahn SG study group demonstrated superior target lesion primary patency and required fewer subsequent interventions compared with historic cohorts treated with angioplasty or angioplasty followed by BMS placement. Given the significant improvement in target lesion primary patency, future studies should challenge Viabahn SGs as a primary percutaneous treatment modality vs durable surgical alternatives.