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Meta-Analysis
. 2013 Feb 28;2013(2):CD004001.
doi: 10.1002/14651858.CD004001.pub3.

Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia

Dirk T Ubbink  1 , Hester Vermeulen
Affiliations
Meta-Analysis

Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia

Dirk T Ubbink et al. Cochrane Database Syst Rev. .

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: 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.

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Conflict of interest statement

Bakken Research Centre sponsored the principal investigator (DU) as 'quality officer' for the duration of the Spinal Cord Stimulation European Peripheral Artery Disease Outcomes Study (SCS‐EPOS). The Research Centre belongs to the Medtronic Company, which is the worldwide manufacturer of the neurostimulators for SCS treatment. Medtronic did not, however, sponsor the preparation of this review.

Figures

1.1
1.1. Analysis
Comparison 1 Limb survival, Outcome 1 Amputations (12 months).
1.2
1.2. Analysis
Comparison 1 Limb survival, Outcome 2 Amputation rate in non‐hypertensives (18 months).
2.1
2.1. Analysis
Comparison 2 Pain relief, Outcome 1 Change in VAS score (0‐100; where 100 is worst) after 12 months.
2.2
2.2. Analysis
Comparison 2 Pain relief, Outcome 2 Change in Pain Rating Index (overall; where higher is worse) after 12 months.
2.3
2.3. Analysis
Comparison 2 Pain relief, Outcome 3 Change in VAS score (0‐100; where 100 is worst) after 3 months.
3.1
3.1. Analysis
Comparison 3 Clinical improvement, Outcome 1 Reaching Fontaine stage II.
3.2
3.2. Analysis
Comparison 3 Clinical improvement, Outcome 2 Reaching Fontaine stage III.
3.3
3.3. Analysis
Comparison 3 Clinical improvement, Outcome 3 Ulcer healing and hypertension.
4.1
4.1. Analysis
Comparison 4 Ankle/brachial index, Outcome 1 Ankle/brachial pressure index increase after 12 months.
5.1
5.1. Analysis
Comparison 5 Quality of life, Outcome 1 Nottingham Health Profile (0‐100; where 100 is worst) after 12 months.
5.2
5.2. Analysis
Comparison 5 Quality of life, Outcome 2 Euroqol (0‐100; where 100 is worst) after 12 months.
6.1
6.1. Analysis
Comparison 6 TcpO2, Outcome 1 TcpO2 after 12 months.
7.1
7.1. Analysis
Comparison 7 Complications, Outcome 1 Change in stimulation requiring reintervention (within 12 months).
7.2
7.2. Analysis
Comparison 7 Complications, Outcome 2 Infection requiring removal.
7.3
7.3. Analysis
Comparison 7 Complications, Outcome 3 Battery: end of life.
7.4
7.4. Analysis
Comparison 7 Complications, Outcome 4 Overall complications requiring re‐intervention.
7.5
7.5. Analysis
Comparison 7 Complications, Outcome 5 Initial implantation problems (not included in overall complications).
See this image and copyright information in PMC

Update of

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