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Nonoperative active management of critical limb ischemia: initial experience using a sequential compression biomechanical device for limb salvage.Critical limb ischemia (CLI) patients are at high risk of primary amputation. Using a sequential compression biomechanical device (SCBD) represents a nonoperative option in threatened limbs. We aimed to determine the outcome of using SCBD in amputation-bound nonreconstructable CLI patients regarding limb salvage and 90-day mortality. Thirty-five patients with 39 critically ischemic limbs (rest pain = 12, tissue loss = 27) presented over 24 months. Thirty patients had nonreconstructable arterial outflow vessels, and five were inoperable owing to severe comorbidity scores. All were Rutherford classification 4 or 5 with multilevel disease. All underwent a 12-week treatment protocol and received the best medical treatment. The mean follow-up was 10 months (SD +/- 6 months). There were four amputations, with an 18-month cumulative limb salvage rate of 88% (standard error [SE] +/- 7.62%). Ninety-day mortality was zero. Mean toe pressures increased from 38.2 to 67 mm Hg (SD +/- 33.7, 95% confidence interval [CI] 55-79). Popliteal artery flow velocity increased from 45 to 47.9 cm/s (95% CI 35.9-59.7). Cumulative survival at 12 months was 81.2% (SE +/- 11.1) for SCBD, compared with 69.2% in the control group (SE +/- 12.8%) (p = .4, hazards ratio = 0.58, 95% CI 0.15-2.32). The mean total cost of primary amputation per patient is euro29,815 ($44,000) in comparison with euro13,900 ($20,515) for SCBD patients. SCBD enhances limb salvage and reduces length of hospital stay, nonoperatively, in patients with nonreconstructable vessels.
Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease.Critical limb ischemia (CLI) patients who are unsuitable for intervention face the dire prospect of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. This study assessed the outcome of SCBD in severe CLI patients who otherwise would face an amputation. Primary end points were limb salvage and 30-day mortality. Secondary end points were hemodynamic outcomes (increase in popliteal artery flow and toe pressure), ulcer healing, quality-adjusted time without symptoms of disease or toxicity of treatment (Q-TwiST), and cost-effectiveness.