Background: Critical limb ischemia (CLI) is the presentation of end stage peripheral arterial disease and typically presents with rest pain, ulceration and gangrene. The outcome of conservative treatment is poor and often leads to amputations. Arterial revascularization plays an important role in amputation prevention. Unfortunately, a significant percentage of CLI patients cannot be revascularized and subsequently end up with a palliative amputation. This has led to the need and exploration of new treatment options in this no option subgroup of CLI. Deep venous arterialization (DVA) is one of them and has been reported as a save and feasible novel and promising alternative to amputation. The goal of DVA is to provide arterialized blood in significant volumes and pressure to the plantar venous arch and ischemic tissue to enable wound healing. Selecting the right patients is critical for successful DVA and requires that extra attention is paid to the wounds as well as arterial and venous vascular status.
Methods: The procedure was previously described in our initial experience in the first-in-man study performed on 7 patients with NOP-CLI. The angiographic goal of the procedure is to deliver arterialized blood to the plantar venous arch in significant volumes and pressure, circumventing the numerous valves in the process. The clinical goal is to achieve wound healing.
Results: Technical success was achieved in all patients. Flow in the plantar arch was achieved in 5 of the 7 patients. One patient with chronic rest pain became pain free within 48 hours after the procedure. Complete wound healing was achieved at 12 months in 5 of the 7 patients. Reinterventions were performed in 5 of 7 patients to maintain patency. Of the 7 study patients, five underwent minor amputation of one or more toes, and two underwent major amputations within 12 months (limb salvage, 71%).
Conclusions: The LimFlow system is currently the only registered device a total percutaneous DVA can be performed with. In addition to the percutaneous creation of an arteriovenous fistula (AVF), it also allows disruption of the veins with a dedicated valvulotome.