Novel Device Prior to Balloon Angioplasty for Dysfunctional Arteriovenous Access: Analysis of a Real-World Registry by Race and Sex Cohorts

Author(s): Omar Davis MD

Introduction Hemodialysis patients often experience arteriovenous (AV) access dysfunction, yet the current standard-of-care, percutaneous transluminal balloon angioplasty (PTA), may introduce risk for vessel damage and long-term complications. Several technologies prepare the stenosed vessel for PTA, however their investigative studies do not consistently represent patient diversity despite inequity of renal care in underrepresented populations such as Blacks and Females. As well, safety concerns and patency limitations are consistently reported among these patient populations. Recently, an all-comers registry reported the safety and effectiveness of vessel preparation by creating longitudinal, controlled-depth micro-incisions prior to PTA in patients with AV access dysfunction. Given the real-world representation of this registry, this sub-analysis assesses clinical outcomes by race and sex. Methods This multicenter, prospective, observational registry (FLEX AV Registry) enrolled hemodialysis patients scheduled to undergo PTA of their AV fistula or graft. Endpoints included anatomic success without adverse event, procedural success, and clinical assessments of target lesion primary patency (TLPP) and freedom from target lesion revascularization (FFTLR) at 6 and 12 months. Data were analyzed by race (Black, Non-Black) and sex (Female, Male) cohorts. Results A total of 114 subjects (65.8% Black; 53.5% Female) were treated at 8 clinical sites with the FLEX Vessel Prep™ System (FLEX VP) prior to PTA. Black (5.4+4.5 vs. Non-Black 3.4+2.4 years) and Female (5.5+6.8 vs Males 3.2+3.7 years) subjects had significantly longer time on hemodialysis. There were no group differences in lesion characteristics. No major complications occurred in any patients, including Blacks and Females. Twelve-month followup showed no difference in TLPP and FFTLR. TLPP and FFTLR for Blacks was 44%/267 days and Non-Blacks was 47%/240 days, and for Females 40%/247 days vs. Male 51%/268 days. In patients with cephalic arch lesions, the Black cohort(n=14) maintained high patency at 69% with 292 days FFTLR. Conclusion This cohort analysis of the multi-center, prospective, observational FLEX AV Registry through 12 months reflects real-world populations most impacted by End-stage Kidney Disease (ESKD) incidence. Results reveal equivalent benefit for Blacks and Females, historically underrepresented populations associated with poorer outcomes.