1. In this single-group multicenter study, transcatheter arterialization of the deep veins was safe and successful in patients with chronic limb-threatening ischemia and no conventional treatment options.
2. Transcatheter arterialization of the deep veins led to increased amputation-free survival and limb salvage.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Arterial revascularization is the standard of care for patients with chronic limb-threatening ischemia. However, up to 20% of patients with this disease are not candidates for revascularization due to a lack of an arterial target or an appropriate conduit for surgical bypass. Therefore, in these patients, major amputation is the last option. Transcatheter arterialization of the deep veins has been proposed as an endovascular revascularization procedure for treating no-option chronic limb-threatening ischemia. An arteriovenous fistula is created proximal to the diseased tibial arteries using a covered stent. The oxygenated blood is then diverted from the tibial arteries to the tibial veins to bypass the severely diseased arterial vasculature. The venous system is leveraged to deliver oxygenated arterial blood to the foot through the pedal veins, which potentially averts major amputation and promotes wound healing. However, there is a gap in knowledge as to understanding the effect of the procedure on amputation-free survival and limb salvage. Overall, this study found that transcatheter arterialization of the deep veins was safe and could be performed with a high degree of procedural success in patients with chronic limb-threatening ischemia and no other treatment options. This study was limited by the lack of a control group and follow-up being limited to 12 months. Nevertheless, these study’s findings are significant, demonstrating that transcatheter arterialization of the deep veins is effective in patients with chronic limb-threatening ischemia.
Click to read the study in NEJM
Relevant Reading: Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia
In-Depth [single-group multicenter study]: This prospective, single-group, multicenter study was conducted to evaluate the effectiveness of transcatheter arterialization of the deep veins. Patients with Rutherford class five (tissue loss or focal gangrene) or six (extensive gangrene) chronic limb-threatening ischemia were eligible for the study. Patients with systemic infection, rapidly deteriorating wounds, or advanced heart failure were excluded from the study. The primary outcome measured was amputation-free survival, defined as a composite of freedom from above-ankle amputation or death from any cause at six months. Outcomes in the primary analysis were assessed via a Bayesian Goldilocks adaptive design with Kaplan-Meier estimates. Based on the primary analysis, transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%), with 66.1% of the patients reporting amputation-free survival at six months. Based on the Bayesian analysis, the posterior probability that amputation-free survival at six months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan–Meier analysis). Wounds were completely healed in 25% of patients or in the process of healing in 51% of patients. In summary, this study demonstrates that transcatheter arterialization of the deep veins is safe and successful in preventing amputation in patients with chronic limb-threatening ischemia without any other conventional treatment options.
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