Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia

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 of limb salvage, pain relief and clinical situation by means of SCS over conservative treatment alone.

Search strategy: The reviewers searched the Cochrane Peripheral Vascular Diseases Group Specialised Register, (last searched November 2002), the Cochrane Central Register of Controlled Trials (CENTRAL) (last searched Issue 4, 2002). 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: Two reviewers (DU, HV), independently assessed the quality of the studies and extracted the data.

Main results: Six studies comprising nearly 450 patients were included. In general the quality of the studies was good, although none of them was blinded due to the nature of the intervention. Limb salvage after 12 months was significantly higher in the SCS group (RR 0.71, 95%CI: 0.56 to 0.90; RD -0.13, 95%CI: -0.22 to -0.04). 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 reintervention, (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 six (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, in the SCS group and 28,600 euros, in the conservative group. The difference (7,900 euros) was significant (p<0.009).

Reviewer's conclusions: There is evidence to favour SCS over standard conservative treatment to improve limb salvage and clinical situation in patients with NR-CCLI. The benefits of SCS against the possible harm of relatively mild complications, and costs must be considered.