Lead Fracture and Other Device-Related Complications With Dorsal Root Ganglion Stimulation: A Subset Analysis From a Study on Sleep and Functional Outcomes.

内容摘要

In this planned analysis of a study on the effects of dorsal root ganglion stimulation (DRGS) on sleep and functional outcomes, we evaluated device-related complications, with a focus on lead fracture. Data were extracted for adult patients treated with DRGS between January 2018 and February 2025 from a clinical registry; patients with ≥1 follow-up were included. Device-related adverse events, including lead fracture and migration, were identified and cross-checked against clinic notes, operative reports, and device interrogation data. Cumulative fracture probability was determined with Kaplan-Meier estimation; multivariable Cox regression was used to identify predictors of fracture. A standardized fascial anchoring technique was implemented in mid-2020 and its influence on events was assessed. A total of 92 patients received 375 leads with a median follow up of 1059 days (interquartile range [IQR]: 529, 1661.5 days). Lead fracture occurred in 37 of 375 leads (9.9%), affecting 21 of 92 patients (22.8%) with an incidence of 3.2% per lead per year. Six patients had multiple fractured leads. Cumulative incidence increased gradually with follow-up, reaching an estimated 15% at 60 months. In multivariable Cox analysis, body mass index (BMI) was the only independent predictor of fracture (HR: 0.943 per kg/m2; 95% CI, 0.893-0.996; p = 0.037); age, sex, lead level, laterality, number of leads, and primary diagnosis were not significant predictors. Crude incidence of fracture was 11.9% in unanchored leads versus 8.6% in anchored leads; however, time-to-event curves were similar, and anchoring was not an independent predictor. Most patients with fractured leads underwent revision (17/21); four experienced a second fracture. Lead migration occurred in four of 375 leads (1.2%) among four patients, mostly before routine anchoring was implemented at our center in June 2020. Five patients (5.4%) underwent explantation. Lead fracture remains a hinderance to long-term durability of DRGS therapy although events were usually manageable with restoration of therapeutic effect. Anchoring did not change fracture risk but coincided with low migration rates. BMI was the only significant predictor of fracture.