A systemic review and meta-analysis found transcatheter arterialization of deep veins (TADV) produces higher rates of limb salvage, amputation-free survival (AFS), and wound healing than standard-of-care (SoC) in no-option chronic limb-threatening ischemia (CLTI) patients. The findings appear in the Journal of Vascular Surgery (JVS).
The research group, led by Anahita Dua, MD, of the Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and Harvard Medical School, aimed to systematically evaluate outcomes of TADV versus SoC in patients with no-option CLTI using the LimFlow system (Inari Medical).
A systematic literature search of PubMed and Embase was conducted from January 2015 to March 2025. Studies were eligible if they included patients treated with an FDA-approved TADV device, enrolled a minimum of 20 patients, reported at least one year of follow-up data, and captured primary outcomes including technical success, limb salvage, AFS, and wound healing.
Four multicenter studies met the inclusion criteria — PROMISE I, PROMISE II, PROMISE-UK, and the ALPS study — comprising 197 patients in the TADV cohort. The SoC cohort consisted of 180 no-option CLTI patients from the prospective CLariTI registry. Both cohorts were closely matched at baseline, with mean ages of 68.7 and 68.9 years and diabetes prevalence of 74.2% and 76.1% in the TADV and SoC groups, respectively.
The technical success rate across TADV studies was 97.6%. Limb salvage at 12 months was 79.6% in the TADV cohort versus 55.1% in SoC. AFS at 12 months favored TADV at 71% against 37.3% in SoC, and 12-month survival was 90.2% with TADV compared with 66.8% in SoC.
The PROMISE-UK trial reported 100% complete or near-complete wound healing at 12 months in remaining limbs, while the ALPS study recorded 85.7%. In contrast, the SoC cohort reached full wound healing in only 53.2% of patients.
“This evidence summary highlights the substantial clinical benefit of TADV over SoC in no-option CLTI patients,” the authors concluded. “With significantly higher limb salvage, AFS, and wound healing rates, TADV represents a transformative advancement in the treatment of this challenging patient population.”
