Systematic review and meta-analysis of controlled trials assessing spinal cord stimulation for inoperable critical leg ischaemia

Abstract Background Spinal cord stimulation (SCS) may have a place in the treatment of patients with inoperable chronic critical leg ischaemia. Methods A systematic review and meta-analysis was performed of all controlled studies comparing SCS in addition to any form of conservative treatment for inoperable chronic critical leg ischaemia. Main endpoints were limb salvage, pain relief and clinical situation. Systematic methodological appraisal and data extraction were performed by independent reviewers. Results Of the 18 reports found, nine trials, comprising 444 patients, matched the selection criteria. After pooling, limb salvage at 12 months appeared significantly greater in the SCS group (risk difference (RD) − 0·13 (95 per cent confidence interval (c.i.) − 0·04 to − 0·22)). Significant pain relief occurred in both treatment groups, but patients who received SCS required significantly less analgesia and reached Fontaine stage 2 more often than those who did not have SCS (RD 0·33 (95 per cent c.i. 0·19 to 0·47)). Complications of SCS were problems of implantation (8·2 per cent), changes in stimulation requiring reintervention (14·8 per cent) and infection (2·9 per cent). Conclusion The addition of SCS to standard conservative treatment improves limb salvage, ischaemic pain and the general clinical situation in patients with inoperable chronic critical leg ischaemia. These benefits should be weighed against the cost and the (minor) complications associated with the technique.