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  • Title: Sequential compression biomechanical device versus primary amputation in patients with critical limb ischemia.
    Author: Tawfick WA, Hamada N, Soylu E, Fahy A, Hynes N, Sultan S.
    Journal: Vasc Endovascular Surg; 2013 Oct; 47(7):532-9. PubMed ID: 24052447.
    Abstract:
    INTRODUCTION: Patients with critical limb ischemia (CLI), who are unsuitable for intervention, face the consequence of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. OBJECTIVES: To assess the outcome of SCBD in patients with severe CLI who are unsuitable for revascularization. Primary end points were limb salvage and 30-day mortality. METHODS: From 2005 to 2012, 189 patients with severe CLI were not suitable for revascularization. In all, 171 joined the SCBD program. We match controlled 75 primary amputations. RESULTS: All patients were Rutherford category 4 or higher. Sustained clinical improvement was 68% at 1 year. Mean toe pressure increased from 19.9 to 35.42 mm Hg, P < .0001. Mean popliteal flow increased from 35.44 to 55.91 cm/sec, P < .0001. The 30-day mortality was 0.6%. Limb salvage was 94% at 5 years. Freedom from major adverse clinical events was 62.5%. All-cause survival was 69%. Median cost of managing a primary amputation patient is €29,815 compared to €3,985 for SCBD. We treated 171 patients with artassist at a cost of €681,965. However, primary amputation for 75 patients cost €2,236,125. CONCLUSION: The SCBD therapy is a cost-effective and clinically effective solution in patients with CLI having no option of revascularization. It provides adequate limb salvage while providing relief of rest pain without any intervention.
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