Evidence for Transcatheter Arterialization of Deep Veins in Poor Option Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis.

Introduction: Patients with chronic limb-threatening ischemia (CLTI) who are ineligible for conventional revascularization ("no-option") face a 1-year major amputation rate of up to 67%. Transcatheter arterialization of the deep veins (TADV) has shown promising outcomes, but comparative data with standard-of-care (SoC) treatments is lacking.

Methods: This evidence summary reviews current data for the only FDA-approved, CE-marked TADV procedure versus SoC treatments. The TADV cohort consisted of studies of FDA-approved TADV procedures, yielded from a systematic search of PUBMED and EMBASE (2015-2025) in no-option CLTI patients with Rutherford class 5 or 6 disease and inadequate conventional revascularization options. SoC cohort consisted of the CLariTI natural history study of 180 no-option CLTI patients treated with conventional strategies.

Results: Four TADV studies (n=197) were compared to CLariTI registry (n=180). The primary endpoint of limb salvage rates was significantly higher in the TADV cohort: 79.6% [67.6%, 93.9%] versus 55.1% in the SoC cohort (p<0.001) at 12 months. Amputation-free survival was superior in TADV patients: 71.0% [56.9, 88.6] versus 37.3% in SoC (p<0.001). Technical success rate was 97.6% [93.8, 99.1] across TADV studies.

Conclusions: TADV demonstrates substantially superior limb salvage, amputation-free survival, and wound healing compared to standard of care in no-option CLTI patients, representing a transformative advancement for this challenging population.