Sequential Compression Biomechanical Device Versus Primary Amputation in Patients With Critical Limb Ischemia

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 €3985 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.