Design: Retrospective chart review

Setting: Multi-center healthcare system

Patients or Participants: Female patients who had undergone a sacral neuromodulation procedure within one healthcare system between January 2018 and December 2021.

Interventions: Charts of patients who underwent a procedure from August 2020, when the MRI compatible lead was released, through December 2021 were reviewed. The same number of charts were reviewed for patients who underwent the procedure prior to August 2020. Demographic characteristics, information regarding the initial procedure and reasons for lead revision or removal were collected. Fishers exact test, t test and a logistic regression model were used to analyze the data.

Measurements and Main Results: A total of 724 patient charts were reviewed. 362 patients underwent procedures after August 1, 2020 and received the new MRI compatible lead. 362 patients underwent procedures completed prior to release of the new lead. Demographic characteristics such as age, BMI, race, tobacco use and medical co-morbidities did not differ between groups. Significantly more patients in the original lead group required a second procedure for revision or removal of the device compared to patients who received the MRI compatible lead, 24.3% and 12.7% respectively (p<0.0001). The most common reasons for a revision procedure in both groups were persistence of symptoms, lead migration, and pain. However, the only factor that differed significantly between groups was pain, which was a more common reason for revision in the MRI compatible lead group, 41.3% vs. 15.9% (p = 0.0027).

Conclusion: The MRI compatible sacral neuromodulation device had a significantly lower revision rate than the original device within one healthcare system. Patients undergoing sacral neuromodulation have several reasons for device revision and removal and further research is needed to better understand these factors.