Kinetic endovascular micro-incision creation (KEMIC) in arteriovenous access: A U.S. and European experience demonstrating economic benefit.
PURPOSE Repeated interventions for arteriovenous (AV) access dysfunction in hemodialysis patients are costly, burdensome, and detrimental to quality of life. The FLEX Vessel Preparation (VP) system utilizes a technique termed kinetic endovascular micro-incision creation (KEMIC) to improve vessel compliance and durability prior to angioplasty. This study compares real-world procedural and specifically the economic outcomes from matched U.S. and European cohorts. MATERIALS AND METHODS This is a retrospective, quality-improvement (QI)-exempt comparative study from two high-volume centers. Twelve FLEX patients managed by a single U.S. vascular surgeon were compared to 60 matched PTA controls via propensity matching. The European cohort included 74 patients treated with FLEX at a single center and compared to 80 matched PTA controls in Germany. FLEX-VP was performed using three to eight passes with a balloon-free, microblade catheter, typically via a 6 F sheath and followed by low-pressure angioplasty and/or drug-coated balloon. RESULTS U.S. FLEX patients underwent 1.5 fewer interventions per patient-year than PTA controls (0.7 vs 2.2, p < 0.01). In Germany, FLEX reduced reinterventions by 0.4 per patient-year compared to PTA (0.6 vs 1.0, p < 0.001). Depending on local procedure costs, these reductions translate to estimated per-patient annual savings of $1451-$2902 in the U.S. and €426-€767 in Germany. Kaplan-Meier analyses demonstrated superior reintervention-free survival at 12 months in both cohorts (U.S.: 70.7% vs 46.1%; Germany: 67.4% vs 44.3%). CONCLUSIONS KEMIC is a reproducible, low-risk, stent-sparing approach that improves access durability while potentially delivering substantial savings to payers and systems.