Incidence of infections, explantations and displacements/mechanical complications of Spinal Cord Stimulation during the past 8 years.

Introduction: The overall awareness and potential of real-world data has drastically increased in the medical field, with potential implications for postmarket medical device surveillance. The goal of this study was to evaluate real-world data on incidence of infections, explantations and displacements/mechanical complications of Spinal Cord Stimulation (SCS) during the past 8 years and forecast point estimates for the upcoming 3 years based on the identified patterns.

Methods: Based on electronic health records from 80 healthcare organizations within the TriNetX database in the USA, data of 11,934 patients who received SCS as treatment for Persistent Spinal Pain Syndrome Type 2 (PSPS T2) was extracted. Events of interest were explantations and displacements/mechanical complications of both the lead and implanted pulse generator (IPG), as well as infection rates from 2015 to 2022. Mann-Kendall tests were performed to detect monotonic trends in the time series. Forecasts were made for the upcoming 3 years for every event of interest.

Results: Statistically significant increasing time trends were revealed for the annual incidence of IPG and lead displacements/mechanical complications in patients with PSPS T2 over the past 8 years. These time trends were visible in both males and females as well as in smokers and non-smokers. For annual incidence of explantations and infections, no significant time effect was observed. In 2025, the incidence of displacements/mechanical complications of the lead (3.07%) is predicted to the highest, followed by explantations of the IPG (2.67%) and lead (2.02%).

Conclusion : Based on real world data, device explantation was the most frequent event of interest, with negative peaks in the time series in 2016 and 2020, presumably due to the introduction of rechargeable pulse generators and Covid-19 pandemic, respectively.