Lead Fractures with Dorsal Root Ganglion Stimulation: A Subanalysis from a Study on Sleep Outcomes

Introduction: We recently published a study on the effects of dorsal root ganglion stimulation (DRGS) on sleep and functional outcomes in patients with chronic pain. In this planned subset analysis of that cohort, we evaluated device-related complications, focusing on lead fracture incidence, predictors of fracture, and management strategies. We hypothesized that mechanical factors and patient characteristics would influence fracture risk, and that standardization of surgical technique would be associated with fewer migration events. Our goal was to characterize hardware durability and to inform best practices to reduce complications and improve long-term device durability.

Methods: A retrospective chart review was conducted for 92 patients treated with DRGS between 01/2018 and 2/2025 with a mean follow-up of 26.8 months at final follow-up (range 3–60 months). Charts were selected according to the inclusion and exclusion criteria from the previously reported sleep cohort. Device-related adverse events, including lead fracture and migration, were identified from institutional quality-review records and cross-checked against clinic notes, operative reports, and device interrogation data. Kaplan–Meier methods were used to estimate cumulative fracture probability, and multivariable Cox regression was used to identify predictors of fracture. A standardized fascial anchoring technique was implemented in mid-2020.

Results: Ninety-two patients received 375 leads. Lead fracture occurred in 37/375 leads (9.9%), affecting 21/92 patients (22.8%); with 6 having multiple fractures. Kaplan–Meier estimated ~15% cumulative fracture at 60 months (Figure 1). In multivariable Cox regression (Table 3), BMI was the only significant predictor (HR 0.943 per kg/m², 95% CI 0.893–0.996; p=0.037), mirroring the inverse BMI–risk pattern in Figure 2 and the BMI-stratified KM curves in Figure 3. Anchoring status showed 11.9% fractures in unanchored vs 8.6% in anchored leads overall, but unanchored had longer exposure (1324 vs 976 days); anchored and unanchored KM curves overlapped (Figure 4), indicating no time-to-fracture difference. Migration requiring surgery occurred in 4 patients (~1.1% of leads); most fractures were revised (17/21), 2 were explanted, and 2 were pending.

Conclusion: DRGS lead fracture was ~10% of leads and ~23% of patients over long follow-up; events were usually manageable. Rates matched real-world series, but cumulative risk rose with implant time, indicating accrual that warrants prevention. Anchoring vs non-anchoring did not change time-to-fracture risk (overlapping curves), though standardization coincided with low migration. In adjusted analyses (Table 3), BMI was the only significant predictor; level, side, age, sex, and diagnosis were not. Design/material refinements, optimized implantation and fixation technique, postoperative activity guidance, and continued surveillance may reduce mechanical stress and enhance long-term durability.