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Published on: September 22, 2020
Percutaneous deep venous arterialization in patients with critical limb ischemia
Steven Kum1, Eline Huizing2, Michiel A Schreve2
1Vascular Service, Department of Surgery, Changi General Hospital, Singapore, Singapore - steven_kum@cgh.com.sg.
Insights
Deep venous arterialization (DVA) offers a promising alternative for critical limb ischemia (CLI) patients otherwise facing amputation. This novel procedure successfully restored blood flow and achieved wound healing in a majority of patients, improving limb salvage rates.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Regenerative Medicine
Background:
- Critical limb ischemia (CLI) represents end-stage peripheral arterial disease, often leading to amputation despite revascularization efforts.
- A subset of CLI patients are not candidates for traditional revascularization, necessitating novel treatment strategies.
- Deep venous arterialization (DVA) has emerged as a potential limb salvage technique for these 'no-option' CLI patients.
Purpose of the Study:
- To evaluate the safety and feasibility of deep venous arterialization (DVA) in patients with no-option critical limb ischemia (NOP-CLI).
- To assess the efficacy of DVA in achieving wound healing and preventing amputation.
- To determine the technical success and clinical outcomes of DVA in a first-in-man study.
Main Methods:
- A first-in-man study involving 7 NOP-CLI patients undergoing percutaneous DVA using the LimFlow system.
- The procedure aimed to establish arterialized flow to the plantar venous arch, bypassing venous valves.
- Key endpoints included technical success, restoration of plantar arch flow, wound healing, and limb salvage.
Main Results:
- Technical success was achieved in all 7 patients, with plantar arch flow established in 5.
- Complete wound healing was observed in 5 of 7 patients at 12 months, with one patient experiencing pain relief within 48 hours.
- Limb salvage was 71% within 12 months, with 5 patients undergoing minor amputations and 2 major amputations.
Conclusions:
- Deep venous arterialization (DVA) using the LimFlow system is a feasible and promising treatment for NOP-CLI patients.
- The percutaneous approach, including arteriovenous fistula creation and venous disruption, enables delivery of arterialized blood to the foot.
- DVA demonstrates potential for wound healing and amputation prevention in a challenging patient population, though reinterventions may be necessary.
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.
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