Restoring arteriovenous access: Pilot study using a scoring balloon in 50 patients

Abstract

Background: Arteriovenous access failure is most often due to the development of neointimal hyperplastic stenoses. Balloon angioplasty remains standard of care for endovascular treatment of stenoses obstructing blood flow in hemodialysis fistulas and grafts. Scoring balloon technologies have been developed to disrupt the atheromatous plaque and have shown to be safe and effective for treating stenosis in the hemodialysis access circuit. However, improvement in patency has yet to be established. Methods: This prospective, single-arm study included 50 patients with stenosed hemodialysis fistula/grafts treated with the AngioSculpt® scoring balloon (Philips) and followed for 6 months. The primary endpoint was target lesion primary patency at 2 and 6 months defined as freedom from re-intervention. Results: Treatment with the scoring balloon resulted in a reduction in stenosis from 78% ± 13.36% to 7.2% ± 7.57% (mean ± standard deviation). Scoring balloon inflation pressures averaged 11.4 atm; no slippage/dissections occurred. After 2 months, 10% of patients required re-intervention. At 6 months, 19% of patients required re-intervention. The 6-month freedom from re-intervention rate was higher for patients with stenosed fistulas (83.3%) compared to patients with stenosed grafts (71.4%). Six-month patency rates were highest for patients with no or one previous intervention (91.6% and 90.0%, respectively); patients with two to five preceding interventions had a 6-month patency rate of 80%, and those with more than five previous interventions had a 50% 6-month patency rate. Conclusion: Results from this pilot study suggest that the AngioSculpt scoring balloon may be a viable treatment option for stenosed arteriovenous fistula/graft access.