Introduction The publication of explant rates has established risk factors and a definitive objective outcome of failure for spinal cord stimulation (SCS) treating neuropathic pain. We present a UK study analyzing explants of electrical neuromodulation devices for different conditions over 11 years in a single center specializing in neuromodulation.
Methods A retrospective analysis was performed using a departmental database between 2008 and 2019. Explants were analyzed according to condition, mode of stimulation and other demographics using logistic regression and Kaplan-Meier graphs with log-rank (Mantel-Cox) test.
Results Out of a total of 1177 patients, the explant rate was 17.8% at 5 years and 25.2% at 10 years. Loss of efficacy was the most frequent reason for explant 119/181 (65%). Multivariant regression analysis indicated patients with back pain without prior surgery had a reduced risk of explant (p=0.03). Patients with SCS systems that had 10 kHz, options of multiple waveforms, and rechargeable batteries also had a decreased risk of explant (p<0.001). None of these findings were confirmed when comparing Kaplan-Meier graphs, however. Contrary to other studies, we found gender and age were not independent variables for explant.
Conclusion These data contribute to a growing list of explant data in the scientific literature and give indications of what factors contribute to long-term utilization of electrical neuromodulation devices.
- spinal cord stimulation
- chronic pain
- back pain
- postoperative complications
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Contributors JR conceptualized the study and design with input from AA-K, OA-K and SH. AA-K, TS, SP, DP and NP performed the cases. OA-K, SH, JR and SW were involved in acquisition of data. JR and OA-K analyzed and interpreted the data. JR and SW performed statistical analysis. JR drafted the manuscript with input from TLY. All authors read, contributed and approved the final version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests AA-K is an investigator with Nevro, Boston Scientific, Abbott and Medtronic and has stock in Micron. SP is and investigator with Saluda Medical. TLY is a consultant with Boston Scientific, an investigator with Nevro, Abbott and Boston Scientific and chief medical officer of Meghan Medical.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. The deidentified data are available on request from Jonathan Royds (firstname.lastname@example.org)