Balloon angioplasty in chronic critical limb ischemia: Factors affecting clinical and angiographic outcome

Purpose: To assess factors that affect clinical and angiographic outcome in chronic critical limb ischemia (CLI) 12 months after primary, technically successful balloon angioplasty (BA) in infrainguinal arteries. Methods: Sixty consecutive patients (37 women; mean age 75 +/- 10 years, range 53-99) with technically successful BA in 66 limbs were followed for 12 months or until death, for major amputation, or repeat target lesion revascularization (TLR). Assessment at baseline and 1 day and 12 months after BA or at an endpoint event, if feasible, was performed with angiography or duplex ultrasound (above-knee revascularization only). Mortality, limb prognosis, and restenosis rate were correlated with cardiovascular risk factors, hemodynamic measures, and angiographic features. Results: Mortality was 25% at 1 year; compared to survivors, nonsurvivors more often had coronary artery disease (93% versus 44% for survivors, p<0.001), bilateral CLI (60% versus 29%, p=0.033), and higher fibrinogen levels (5.1 g/L versus 4.3 g/L, p=0.049). CLI resolved in more than half (35, 53%) of the limbs without repeat TLR. The major amputation rate was 6%. Limb prognosis correlated with ankle pressures after BA. Restenosis rates were 65% at the femoropopliteal and 56% at the infrapopliteal level (NS); these correlated with the length of the treated arterial segment (8.7 cm with restenosis versus 4.0 cm without, P<0.001). Conclusions: High mortality in CLI was associated with an extensive, clinically manifest arteriosclerotic process and high fibrinogen levels. Limb prognosis and restenosis after BA were primarily influenced by local hemodynamic and technical factors. Despite considerable restenosis, more than 90% of survivors avoided major amputations.