Long-term results of complex therapy in patients with nonreconstructible chronic lower limb ischemia

Abstract

The aim — to improve the results of surgical treatment of patients with chronic critical lower limb ischemia by developing methods of autologous transplantation of multipotent stem mesenchymal stromal cells, administration of endothelial cells growth factors and therapeutic and diagnostic measures to preserve the lower limb or reduce the level of its amputation, reduce ischemia and the frequency of disability of such patients, improve their quality of life.Materials and methods. The study included 110 patients with a clinical picture of pain at rest, ischemic edema, and trophic changes (IIIA, IIIB, and IV stage of lower limb ischemia according to the classification of the European Association of Angiologists and Vascular Surgeons) caused by nonreconstructible occlusive and obliterating diseases of lower limb arteries. The patients were divided into three groups according to the method of treatment: in the 1st group (n = 48), revascularization osteotrepanation was performed as an operation of indirect revascularization, in the 2nd group (n = 21) a drug of endothelial cells growth factor was administered to stimulate their own angiogenesis, in the 3rd group (n = 41) subcutaneous fat was collected, autologous mesenchymal cells were cultivated and transplanted according to the developed technique. The control group of patients (n = 50) was selected retrospectively according to the case histories in accordance with the criteria of involvement and the results of treatment which could be followed up in a 3‑year observation period.Results and discussion. The safety of the lower limb in the 3rd group was statistically more significant than in the 1st and 2nd groups and remained at the level of 82 % after three years of observation. The smallest number of large amputations was in the 3rd group (2.3 % — above knee‑joint and 7.3 % — below, knee‑joint whereas in the control group the number was 18 % and 24 %, respectively).Conclusions. The level of high amputations directly affects the life expectancy of patients. Only treatment in the 3rd group reduced the risk of large amputation compared with the control group (odds ratio 2.752 (95 % confidence interval — 1.12 — 6.733)). Only treatment in the 3rd group reduced the risk of amputation compared with other types of treatment (odds ratio 0.358 (95 % confidence interval 1.111 — 1.158).