Reduced amputation rate with isovolemic hemodilution in critical limb ischemia patients

Aims Critical limb ischemia (CLI) patients are characterized by intractable pain in spite of medication, non-healing ulcers, and gangrene. The objective of this study was to investigate whether or not isovolemic hemodilution treatment can reduce the rate of major amputations in CLI. Methods 28 patients were studied who had tissue loss on Rutherford Grade III, Category 5 or 6. The subjects were divided into two arms: standard-of-care, conventional therapy (CT) (n = 15) as a control group and hemodilution therapy (HT) (n = 13) as a study group. For the HT group, weekly isovolemic hemodilution was performed over 4 consecutive weeks, removing 250 ml of whole blood with the infusion of hydroxyl-ethyl starch solution. Blood viscosity, hematocrit, hemoglobin, ankle-brachial index, VA pain scale, time-to-amputation from admission, and survival time were measured. Results The mean Hct gradually decreased from 36.6 to 35.1, whereas the WBV at a shear rate of 1 s-1 significantly decreased from 18.2 to 10.5 during the same period. Subsequently, tissue oxygen delivery index, defined as the ratio of Hct to WBV at a shear rate of 1 s-1, increased from 24.4 to 37.0 by 51.7%, suggesting improvements in oxygen delivery in the patients. The average rate of lower limb major amputation in the control group was 93% (14/15), whereas that in the study group was 31% (4/13) (p = 0.001). Amputation-free median survival time and amputation-free 5-year survival rate in the control group were 1.2 months and 7%, while those in the study group were 30.2 months and 44% (p = 0.001). There were no adverse effects from repetitive hemodilution in the study group. Conclusions Isovolemic hemodilution treatment of CLI patients was found to be well-tolerated and reduced the rate of major amputation resulting from the deterioration of CLI.