Kinetic endovascular micro-incision creation (KEMIC) in arteriovenous access: A U.S. and European experience...

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.

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.

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%).

KEMIC is a reproducible, low-risk, stent-sparing approach that improves access durability while potentially delivering substantial savings to payers and systems.