Real-world multicenter retrospective study of outcomes following transcatheter arterialization of the deep veins for no-option chronic limb-threatening ischemia.

Abstract

The purpose of this study was to report on the outcomes of patients treated with the LimFlow System for transcatheter arterialization of the deep veins (TADV) in a real-world setting, after its approval from the U.S. Food and Drug Administration and subsequent commercialization. This multicenter, observational, retrospective analysis included patients who were treated with the LimFlow System for TADV from October 2023 to August 2025. Study outcomes included amputation-free survival (AFS) (a composite of freedom from both major above-ankle amputation and all-cause mortality), limb salvage (freedom from major above-ankle amputation), survival (freedom from all-cause mortality), wound healing status (worsening, stable, improving, or healed), and patency of the stent graft through follow-up. A total of 80 patients were included in the analysis. Technical success of the TADV procedure was 100%. The median follow-up after TADV was 184 days (interquartile range, 78-357 days). The AFS rate was 74.2% at 6 months and 63.6% at 1 year. The limb salvage rate was 76.1% at 6 months and 71.7% at 1 year. The overall survival rate was 93.1% at 6 months and 84.7% at 1 year. Wounds were healed, stable, or improving in 94.3% of patients at follow-up. Graft patency was maintained in 75.4% of patients at 3 months and 60.3% at 6 months. In this first real-world, multicenter, retrospective study, TADV with the LimFlow System demonstrated favorable AFS and limb salvage outcomes.