Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia

This prospective, single-group, multicenter PROMISE II trial evaluated the safety and efficacy of transcatheter arterialization of deep veins in 105 patients with chronic limb-threatening ischemia (CLTI) who lacked revascularization options. The procedure redirects oxygenated blood into the venous system via an arteriovenous fistula, using covered stents and valvulotomes to bypass occluded arteries. At 6 months, amputation-free survival was 66.1% (posterior probability vs. performance goal of 54%: 0.993). Technical success was 99.0%, limb salvage was 76.0%, and wound healing was complete in 25% and progressing in 51%. Subgroup analysis showed lower outcomes in dialysis-dependent patients. The technique was well-tolerated with no unexpected device-related adverse events. Findings support transcatheter arterialization as a viable treatment in no-option CLTI, potentially reducing major amputation and its downstream effects.

This prospective, single-group, multicenter PROMISE II trial evaluated the safety and efficacy of transcatheter arterialization of deep veins in 105 patients with chronic limb-threatening ischemia (CLTI) who lacked revascularization options. The procedure redirects oxygenated blood into the venous system via an arteriovenous fistula, using covered stents and valvulotomes to bypass occluded arteries. At 6 months, amputation-free survival was 66.1% (posterior probability vs. performance goal of 54%: 0.993). Technical success was 99.0%, limb salvage was 76.0%, and wound healing was complete in 25% and progressing in 51%. Subgroup analysis showed lower outcomes in dialysis-dependent patients. The technique was well-tolerated with no unexpected device-related adverse events. Findings support transcatheter arterialization as a viable treatment in no-option CLTI, potentially reducing major amputation and its downstream effects.