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.
R. Shahverdyan, Daniel G Clair, Jordan Knepper· Journal of Vascular Access· 0 citations
OBJECTIVE
Transcatheter arterialization of the deep veins (TADV) is a novel therapy for no-option chronic limb-threatening ischemia (CLTI) that delivers oxygenated blood to the foot via the venous system and has demonstrated favorable limb salvage outcomes in several studies, including the PROMISE II trial. The present study characterizes circuit maturation in the PROMISE II cohort by examining its longitudinal hemodynamic development and associated wound healing, with the goal of better defining the mechanism of action of TADV.
METHODS
PROMISE II (NCT03970538) was a prospective, multicenter study on TADV in patients with no-option CLTI due to "desert foot" arterial anatomy. The objective was to evaluate longitudinal changes following TADV including hemodynamics from duplex ultrasound, distal perfusion, and wound healing over time. Clinical outcomes, perfusion metrics, and serial duplex ultrasound data were collected through 1 year using standardized protocols. Duplex studies evaluated volume flow and spectral Doppler parameters across the TADV circuit. Distal perfusion was assessed using toe-brachial index (TBI) and toe pressures. Duplex-derived waveforms were categorized as low- or high-resistance, and longitudinal hemodynamic changes were analyzed. Circuit maturation was assessed using characteristics such as waveform achieving high-resistance configuration and decreased acceleration time indicating vascular remodeling.
RESULTS
A total of 105 patients from PROMISE II were included in the analysis. Limb salvage was 68.7% at 1 year. Among patients with adjudicated wound data, 75.5% were healed/healing at 1 year; patients with worsening status decreased from 52.6% to 14.3%, while complete healing increased to 46.9%. Circuits transitioned from low- to high-resistance waveforms (7.9% at baseline, 24.6% at 3 months, 37.7% at 6 months, 81.1% at 1 year, p<0.0001). At 1 year, in patients with high-resistance circuits, healed/healing wound status was 86.7%, TBI ≥0.3 was 57.1%, and toe pressure ≥40 mmHg was 78.3% indicating greater distal perfusion.
CONCLUSIONS
TADV promotes limb salvage through staged hemodynamic maturation demonstrated with duplex, microvascular remodeling, sustaining perfusion, and supporting its durable benefit in no-option CLTI.
Peter A. Schneider, Anahita Dua, Richard J. Powell et al.· Journal of Vascular Surgery· 0 citations
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