Evidence for transcatheter arterialization of deep veins in poor-option chronic limb-threatening ischemia: A
Mounika Naidu Boya1, Isabella Ferlini Cieri1, Adriana A Rodriguez Alvarez1
1Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, MA.
Insights
Transcatheter arterialization of deep veins (TADV) significantly improves limb salvage and amputation-free survival in no-option chronic limb-threatening ischemia (CLTI) patients. This minimally invasive procedure offers a transformative solution for those ineligible for traditional treatments.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Regenerative Medicine
Background:
- Chronic limb-threatening ischemia (CLTI) in no-option patients carries a high risk of major amputation (up to 67% at 1 year).
- Transcatheter arterialization of deep veins (TADV) shows promise, but comparative data against standard-of-care (SoC) is limited.
Purpose of the Study:
- To compare the efficacy of Food and Drug Administration-approved TADV procedures with SoC treatments in no-option CLTI patients.
- To evaluate limb salvage rates, amputation-free survival, and technical success of TADV versus SoC.
Main Methods:
- Systematic literature search (PubMed, Embase, 2015-2025) for TADV studies in Rutherford class 5/6 CLTI patients.
- Comparison with a natural history study cohort (n=180) of no-option CLTI patients managed with conventional strategies (SoC).
- Analysis of primary endpoint: limb salvage rates at 12 months.
Main Results:
- Limb salvage rates were significantly higher in the TADV cohort (79.6%) compared to the SoC cohort (55.1%) at 12 months (P < .001).
- Amputation-free survival was superior in TADV patients (71.0%) versus SoC (37.3%) (P < .001).
- Technical success rate for TADV procedures was high at 97.6%.
Conclusions:
- TADV offers substantially superior limb salvage and amputation-free survival compared to SoC in no-option CLTI patients.
- TADV represents a transformative advancement for managing this high-risk patient population.
- Improved wound healing is also noted with TADV treatment.
Background:
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 deep veins (TADV) has shown promising outcomes, but comparative data with standard-of-care (SoC) treatments are lacking.
Methods:
This evidence summary reviews current data for the only Food and Drug Administration-approved, Conformité Européenne-marked TADV procedure vs SoC treatments. The TADV cohort consisted of studies of Food and Drug Administration-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. The SoC cohort consisted of the natural progression of high-risk chronic limb-threatening ischemia natural history study of 180 no-option CLTI patients treated with conventional strategies.
Results:
Four TADV studies (n = 197) were compared with the natural progression of high-risk chronic limb-threatening ischemia registry (n = 180). The primary end point of limb salvage rates was significantly higher in the TADV cohort: 79.6% [95% confidence interval: 67.6%, 93.9%] vs 55.1% in the SoC cohort (P < .001) at 12 months. Amputation-free survival was superior in TADV patients: 71.0% [56.9%, 88.6%] vs 37.3% in SoC (P < .001). The 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 with SoC in no-option CLTI patients, representing a transformative advancement for this challenging population.
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