Objective: The objective of this meta-analysis was to approximate the incidence of overall lead migration, clinically significant lead migration, and asymptomatic lead migration in patients who have undergone spinal cord stimulator implantation.
Materials and methods: A comprehensive literature search was performed for studies published before May 31, 2022. Only randomized controlled trials and prospective observational studies with more than ten patients were included. Two reviewers analyzed the articles from the literature search for final inclusion, after which, study characteristics and outcome data were extracted. The primary dichotomous categorical outcome variables were the incidence of overall lead migration, clinically significant lead migration (defined as lead migration resulting in loss of efficacy), and asymptomatic lead migration (defined as lead migration discovered incidentally on follow-up imaging) in patients with spinal cord stimulator implant. Freeman-Tukey arcsine square root transformation for meta-analysis of proportions using random effects (DerSimonian and Laird method) was used to calculate incidence rates for the outcome variables. Pooled incidence rates and 95% CIs were calculated for the outcome variables.
Results: Fifty-three studies met the inclusion criteria, with a total of 2932 patients having received spinal cord stimulator implants. The pooled incidence of overall lead migration was 9.97% (95% CI of 7.62%-12.59%). Only 24 of the included studies commented on the clinical significance of reported lead migrations, of which every lead migration was clinically significant. In these 24 studies, 96% of the reported lead migrations required a revision procedure or explant. Unfortunately, no studies that reported lead migration commented on asymptomatic lead migrations; therefore, the incidence of asymptomatic lead migrations could not be defined.
Conclusions: This meta-analysis found that the rate of lead migration in patients who have received spinal cord stimulator implants is approximately one in ten patients. This likely closely approximates the incidence of clinically significant lead migration owing to the included studies not routinely performing follow-up imaging. Therefore, lead migrations were primarily discovered owing to loss of efficacy, and no included studies clearly reported asymptomatic lead migration. The results of this meta-analysis can be used to inform patients more accurately on the risks and benefits of spinal cord stimulator implantation.
Keywords: Adverse events; lead migration; meta-analysis; procedural complications; spinal cord stimulation.
Copyright © 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.