Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia

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Abstract
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 on limb salvage, pain relief, and the clinical situation using SCS compared to conservative treatment alone. Search methods The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched September 2008), and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 3). Additional data were obtained from research institutes. Selection criteria Controlled studies comparing the addition of SCS with any form of conservative treatment to conservative treatment alone 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. No study was blinded due to the type of intervention. Limb salvage after 12 months was significantly higher in the SCS group (risk ratio (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 where 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 with 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%). Overall risk of complications with additional SCS treatment was 17% (95% CI 12 to 22%), indicating a number needed to harm of 6 (95% CI 5 to 8). Average overall costs (one study) at two years were EUR 36,500 (SCS group) and EUR 28,600 (conservative group). The difference (EUR 7900) was significant (P < 0.009). Authors' conclusions There is evidence to favour SCS over standard conservative treatment alone to improve limb salvage and clinical situations in patients with NR‐CCLI. The benefits of SCS must be considered against the possible harm of relatively mild complications and the costs.