Clinical question: Is transcatheter arterialization of lower extremity deep veins safe and effective in preventing above-ankle amputation in patients with advanced chronic limb ischemia (CLI) who are otherwise not candidates for arterial revascularization?
Ms.Sanford
Background: About 20% of patients with CLI are not candidates for arterial revascularization (“no-option”) due to insufficient distal arterial target vessels, and have low amputation-free survival (42%). Transcatheter arterialization of deep veins involves percutaneous creation of an arteriovenous fistula using a stent to connect the tibial artery to an adjacent vein to provide oxygenated blood to the distal lower extremity through reverse flow in pedal veins and may be an option for these patients with CLI.
Study design: Prospective, single-group, multicenter study
Setting: 20 sites in the U.S.
Synopsis: Investigators enrolled 105 participants with no-option CLI who had focal or extensive tissue loss or gangrene, 74% of whom had prior unsuccessful revascularization. They included patients on dialysis with stable AV fistula or peritoneal dialysis. All patients received dual antiplatelet therapy for at least three months.
Following 104 (99%) successful procedures of creating an artery-to-vein connection, 66% of the patients had amputation-free survival at six months, which exceeded the performance goal (54%). At six months, 25% of participants had complete wound healing, and another 51% had wound healing in process. The amputation-free survival differed by dialysis status, 37% and 73% for those requiring and not requiring dialysis, respectively. At six months, 19% experienced stent occlusion, and 37% needed reintervention.
Limitations include few patients dependent on dialysis (19), short-term follow-up (12 months), lack of a control group (randomization for major amputation was deemed unfeasible both ethically and practically), the procedure may require a specialist center, and the study was during the COVID-19 pandemic with 12 reported infections and five deaths that were related to COVID-19.
Bottom line: Transcatheter arterialization for CLI may provide a safe and effective option for patients who may otherwise be relegated to amputation, aside from dialysis-dependent patients, in which further study may be warranted.
Citation: Shishehbor MH, Powell RJ, et al. Transcatheter arterialization of deep veins in chronic limb-threatening ischemia. N Engl J Med. 2023;388(13):1171-80.
Ms. Sanford is an instructor in the division of hospital medicine at the University of Colorado Anshutz Medical Campus in Aurora, Colo