Longitudinal Micro-Incisions Prior to Balloon Angioplasty for Treatment of Arteriovenous Access Dysfunction in a Real-World Patient Population: 12-Month Cohort Analysis

John Aruny1*, Jeffrey E. Hull MD2, Alexander Yevzlin3, Alejandro C. Alvarez4, Jason D. Beaver5, Robert W. Heidepriem III6, T Michael Serle DMSc, PA-C7

Objective Patients relying on hemodialysis often experience stenotic lesions in their vascular access and require percutaneous transluminal balloon angioplasty (PTA) to restore patency. Recently, an innovative device has become available that creates longitudinal, controlleddepth micro-incisions to prepare the blocked vessel before PTA. This study assessed the 12-month patency rates following this novel vessel preparation and PTA in patients with vascular access dysfunction from a real-world registry. Methods This multicenter, prospective, observational registry (FLEX AV) enrolled hemodialysis patients scheduled to undergo PTA of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities. A primary endpoint was anatomic success, defined as angiographic confirmation of <30% residual stenosis post-procedure without an adverse event. Additional assessments included device technical success, clinical success, target lesion primary patency, freedom from target lesion revascularization, and circuit primary patency at 12 months. Patients receiving PTA with a drug-coated balloon were excluded from clinical outcome analysis. Results One-hundred fourteen patients across 8 clinical sites were treated with the FLEX Vessel Prep™ System (FLEX VP) prior to PTA. Two patients did not complete the 12-month followup evaluation. No serious adverse events were reported. Among the 82 patients who underwent FLEX VP with plain balloon PTA, target lesion primary patency was 44.8% with an average freedom from target lesion revascularization of 256.6 days. Target lesion primary patency and freedom from target lesion revascularization for AVF cases(n=57) were 49% and 267.3 days, respectively. In cases treating AVF cephalic arch stenosis (n=23), 12-month Target lesion primary patency was 59.7% with an average freedom from target lesion revascularization of 267.7 days. Conclusion The FLEX AV Registry demonstrates continued safety and vascular access patency at 12-month s in end-stage renal disease patients with hemodialysis vascular access dysfunction treated with FLEX VP prior to PTA, suggesting the potential benefit of vessel preparation via the creation of longitudinal, controlled-depth micro-incisions.