Abstract
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
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Comment
Article info
Publication history
Published online: May 17, 2023
Accepted:
March 24,
2023
Received in revised form:
March 15,
2023
Received:
January 9,
2023
Publication stage
In Press Corrected ProofFootnotes
Source(s) of financial support: The authors reported no funding sources.
Conflict of Interest: Ryan S. D’Souza has received grant funding from Nevro Corp and Saol Therapeutics. Vwaire Orhurhu is a consultant for Medtronic. The remaining authors reported no conflict of interest.
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© 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
