Article Title: Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia (PROMISE II Trial)
Authors: Shishehbor MH, et al.
The reason I chose this article is because during my long-term care rotation, I cared for a 75-year-old male with insulin-dependent diabetes mellitus, peripheral vascular disease, prior right 1st and 2nd toe amputations, left below-knee amputation, and a persistent non-healing right 3rd toe wound associated with chronic pain. He recently underwent a right lower extremity angiogram that demonstrated occlusion of the anterior tibial and posterior tibial arteries at the ankle with no distal targets for bypass. Vascular surgery documented possible consideration of a LimFlow procedure. I was interested in learning more about this procedure because patients like him often have very limited treatment options and are at high risk for further amputation.
This study evaluated the safety and effectiveness of transcatheter arterialization of deep veins (TADV) using the LimFlow system in patients with chronic limb-threatening ischemia (CLTI) who had no remaining surgical or endovascular revascularization options. This was a prospective, multicenter, single-group study involving 105 patients across 20 centers in the United States. The median patient age was 70 years, 77.1% had diabetes, 91.4% had hypertension, and nearly three-fourths had undergone prior interventions on the affected limb. All patients had advanced disease with non-healing ulcers, tissue loss, or gangrene and were classified as Rutherford class 5 or 6, representing severe limb-threatening ischemia.
The LimFlow procedure creates an artery-to-vein connection in the lower leg and redirects oxygenated arterial blood through the deep venous system to perfuse the ischemic foot. The goal is to improve blood flow, promote wound healing, and avoid major amputation in patients who otherwise have no conventional revascularization options.
Key findings demonstrated a technical success rate of 99%. At six months, 66.1% of patients achieved amputation-free survival, meaning they were alive and had avoided above-ankle amputation. The limb salvage rate was 76%, and overall survival was 87.1%. In addition, 25% of target wounds completely healed and another 51% were actively healing. The study also found that patients with dialysis-dependent chronic kidney disease experienced worse outcomes and lower amputation-free survival.
Overall, this article demonstrates that transcatheter arterialization of deep veins may provide a promising limb-salvage option for patients with no-option chronic limb-threatening ischemia who previously had very limited alternatives other than major amputation. This article was particularly relevant to my patient because he closely fits the population studied, with diabetes, prior amputations, a chronic non-healing toe wound, and poor distal arterial targets. The study highlights how emerging endovascular therapies may offer another opportunity for wound healing and limb preservation in high-risk patients who would otherwise face a significant likelihood of additional amputation.
