Journal of vascular surgery · 2025
Evidence for transcatheter arterialization of deep veins in poor-option chronic limb-threatening ischemia: A systematic review and meta-analysis.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод в очереди
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Boya Mounika Naidu, Cieri Isabella Ferlini, Rodriguez Alvarez Adriana A, Patel Shiv, Schneider Peter A, Clair Daniel, Shishehbor Mehdi H, Dua Anahita
Аннотация
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.
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.