Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia

Background Patients suffering from inoperable chronic critical leg ischaemia (NR-CCLI), face amputation of the leg. Spinal cord stimulation (SCS) has been proposed as a helpful treatment in addition to standard conservative treatment. Objectives To find evidence for an improvement of limb salvage, pain relief and clinical situation using SCS compared to conservative treatment alone. Search strategy We searched the Cochrane Peripheral Vascular Diseases Group's Specialised Register, (last searched May 2005), and the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 2, 2005). Additional data were obtained from research institutes. Selection criteria Controlled studies comparing additional SCS with any form of conservative treatment in patients with NR-CCLI. Data collection and analysis Both authors independently assessed the quality of the studies and extracted data. Main results Six studies comprising nearly 450 patients were included. In general, the quality of the studies was good. None was blinded due to the nature of the intervention. Limb salvage after 12 months was significantly higher in the SCS group (relative risk (RR) 0.71, 95% confidence interval (CI) 0.56 to 0.90; risk difference (RD) -0.11, 95% CI -0.20 to -0.02). Significant pain relief occurred in both treatment groups, but was more prominent in the SCS group, in which the patients required significantly less analgesics. In the SCS group, significantly more patients reached Fontaine stage II than in the conservative group (RR 4.9, 95% CI 2.0 to 11.9; RD 0.33, 95% CI 0.19 to 0.47). Overall, no significantly different effect on ulcer healing was observed between the two treatments. Complications of SCS treatment consisted of implantation problems (9%, 95% CI 4 to 15%) and changes in stimulation requiring re-intervention (15%, 95% CI 10 to 20%). Infections of the lead or pulse generator pocket occurred less frequently (3%, 95% CI 0 to 6%). The overall risk of complications of additional SCS treatment was 17% (95% CI 12 to 22%), indicating a number needed to harm of 6 (95% CI 5 to 8). A cost comparison was made in only one study. The average overall costs at two years were 36,500 Euros, (SCS group) and 28,600 Euros, (conservative group). The difference (7900 Euros) was significant (P <0.009). Authors' conclusions There is evidence to favour SCS over standard conservative treatment to improve limb salvage and clinical situation in patients with NR-CCLI. The bene fits of SCS against the possible harm of relatively mild complications and costs must be considered