Guidance
3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 6 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (described in 2 publications), 1 case series (described in 2 publications) and another 2 case series. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: patient-reported outcome measures including reduction in back pain, improved quality of life and improved activities of daily living.
3.3 The professional experts and the committee considered the key safety outcomes to be: lead fracture, lead migration, infection, pain, pulse generator failure and need for early removal.
3.4 Twenty-two commentaries from patients who have had this procedure were discussed by the committee.
Committee comments
3.5 The committee was informed that there have been changes in the leads used in the device and in the surgical technique used to implant them, which have reduced the risk of lead fractures and migration. The majority of the adverse events came from earlier devices.
3.6 The devices are not MRI compatible, but research is ongoing to make them safe in some scanners (MRI conditional).
3.7 The committee noted that the majority of the research is in younger patients with a body mass index below 35.
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