Deep vein arterialization for chronic limb-threatening ischemia: from PROMISE to practice.

A subset of patients with chronic limb-threatening ischemia (CLTI) lack viable options for traditional arterial revascularization - often termed "no-option" patients - and have historically faced primary major amputation as the default treatment. Deep venous arterialization (DVA) has emerged as a potential limb salvage strategy for this challenging population, involving the creation of an arteriovenous fistula to deliver oxygenated blood via the venous system to the ischemic foot. The approval of the LimFlow System by the United States Food and Drug Administration (FDA) in 2023, following the PROMISE II trial, has generated considerable interest in this approach. Prospective studies report 6-month amputation-free survival of 66% and limb salvage of 76% after percutaneous DVA. However, real-world Medicare data demonstrate substantially inferior outcomes, with 6-month amputation-free survival of only 42% and 1-year amputation-free survival of 33%. This discrepancy likely reflects differences in patient selection, operator experience, and institutional resources between clinical trials and routine practice. Outcomes are particularly poor in dialysis-dependent patients. Critical evidence gaps remain, including the absence of randomized controlled trials comparing DVA to intensive wound care alone, limited patient-reported outcome data, and undefined cost-effectiveness. Despite an evolving evidence base, DVA represents a promising treatment for carefully selected no-option patients at centers capable of providing comprehensive wound care, close surveillance, and timely reintervention.