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Peripheral vascular disease (PVD) is caused by a blood circulation disorder of the arteries and Critical Limb Ischemia (CLI) is the advanced state of PVD. For patients with surgically non-reconstructable CLI, Spinal Cord Stimulation (SCS) appears to be an alternative therapeutic option. The aim of our study was to investigate the efficacy of SCS in non-reconstructable CLI compared with the conservative treatment and re-appraise the existing literature in light of the recent advances in neuromodulation. We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, using electronic databases and reference lists for article retrieval. A total of 404 records were identified and finally 6 randomised controlled trials (RCTs), a Cochrane review and a meta-analysis were included in our systematic review. The studies assessed the efficacy of tonic SCS in the treatment of patients with non-reconstructable CLI compared with the conservative treatment. There is moderate to high quality evidence suggesting, that tonic SCS has beneficial effects for patients suffering from non-reconstructable CLI in terms of limb salvage, pain relief, clinical improvement and quality of life. The contradictory conclusions of the two meta-analyses regarding the efficacy of SCS for limb salvage at 12 months refer rather to the magnitude of the beneficial effect than to the effect itself. So far, the current literature provides evidence about the traditional tonic SCS but there is a lack of studies investigating the efficacy of new waveforms in the treatment of non-reconstructable CLI. SCS represents an alternative for PVD patients with non-reconstructable CLI and the existing literature provides encouraging clinical results, that should not be neglected. Instead, they should be re-appraised in light of the recent advances in neuromodulation with the emergence of novel waveform technologies and neuromodulation targets.

Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review – revival of a promising therapeutic option?