Ubbink DT, Vermeulen H, et al.
The Cochrane database of systematic reviews. Date of publication 2013 Feb 28;volume (2):CD004001.
1. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD004001. doi:
10.1002/14651858.CD004001.pub3.
Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia.
Ubbink DT(1), Vermeulen H.
Author information:
(1)Quality Assurance & Process Innovation, and Department of Surgery, Academic
Medical Centre, University of Amsterdam,
Amsterdam,Netherlands.d.ubbink@amc.uva.nl.
Update of
Cochrane Database Syst Rev. 2005;(3):CD004001.
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: For this update the Cochrane Peripheral Vascular Diseases Group
Trials Search Co-ordinator searched the Specialised Register (last searched
January 2013) and CENTRAL (2012, Issue 12).
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.
DOI: 10.1002/14651858.CD004001.pub3
PMCID: PMC7163280
PMID: 23450547 [Indexed for MEDLINE]
