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A Prospective Analysis of Critical Limb Ischemia - Factors Leading to Major Primary Amputation versus Revascularization

Ahmed Abou-Zamzam,Jr., Vascular Surgery, Loma Linda University, Loma Linda, CA; Nephtali Gomez, MD, Loma Linda, CA; Afshin Molkara, MD, Loma Linda, CA; Theodore Teruya, Loma Linda, CA; Christian Bianchi, Loma Linda, CA;

Purpose: In an aging population with significant co-morbidities, primary major amputations (below-knee or above-knee) are frequently performed despite advances in revascularization. A prospective analysis of patients presenting with critical limb ischemia (CLI) was undertaken to determine whether patient-specific factors or health care delivery factors (system-related) influenced treatment with primary amputation (Amp) versus lower extremity revascularization (LER).
Methods: A prospective study of all patients presenting to a university vascular service over a four-year period was undertaken. Patient-specific factors: age, gender, ethnicity, presence of coronary artery disease, cerebrovascular disease, tobacco use, diabetes mellitus (DM), dialysis-dependence (ESRD), hypertension, hyperlipidemia, stage of CLI (rest pain, tissue loss), location of foot lesion (forefoot, hindfoot), history of revascularization, and functional status (living situation and ambulatory status) were recorded. The system-related factors: time from onset of CLI to vascular surgery evaluation; and type of insurance (managed care/other insurance) were also noted. The influence of these patient-specific and system-related factors on the primary treatment modality (Amp versus LER) was determined with univariate and multivariate analysis.
Results: A total of 224 patients presented with CLI between March 1, 2001 and March 1, 2005. Patients were treated with primary major amputation in 97 cases (43%) and revascularization in 127 cases (57%). On univariate analysis, non-white ethnicity/race, DM, ESRD, tissue loss, dependent living situation, and nonambulatory status were all significant predictors of Amp versus LER (all p<0.05). On multivariate analysis, ESRD, DM, dependent living situation, and nonambulatory status remained independent predictors of Amp versus LER(all p<0.01). The system-specific factors including time to vascular surgery evaluation (mean 8.6 weeks, 7.1 vs 9.3 weeks, Amp vs LER, p=n.s.) and type of insurance (managed care, 17% vs 24%, Amp vs LER, p=n.s.) had no influence on treatment.
Conclusions: Patients with CLI who undergo primary lower extremity major amputation have a signifcantly greater incidence of DM and ESRD, and worse functional status than those undergoing revascularization. Treatment of CLI is determined by patient-specific factors and does not appear to be adversely influenced by system-related factors. Efforts towards improving limb salvage may be best directed at early, aggressive treatment of medical comorbidities to prevent the late complications of CLI.