Survival Analysis of Occipital Nerve Stimulator Leads Placed under Fluoroscopic Guidance with and without Ultrasonography

Abstract

Background: Electrical stimulation of the greater occipital nerves is performed to treat pain secondary to chronic daily headaches and occipital neuralgia. The use of fluoroscopy alone to guide the surgical placement of electrodes near the greater occipital nerves disregards the impact of tissue planes on lead stability and stimulation efficacy. Objective: We hypothesized that occipital neurostimulator (ONS) leads placed with ultrasonography combined with fluoroscopy would demonstrate increased survival rates and times when compared to ONS leads placed with fluoroscopy alone. Study Design: A 2-arm retrospective chart review. Setting: A single academic medical center. Methods: This retrospective chart review analyzed the procedure notes and demographic data of patients who underwent the permanent implant of an ONS lead between July 2012 and August 2015. Patient data included the diagnosis (reason for implant), smoking tobacco use, disability, and age. ONS lead data included the date of permanent implant, the imaging modality used during permanent implant (fluoroscopy with or without ultrasonography), and, if applicable, the date and reason for lead removal. A total of 21 patients (53 leads) were included for the review. Chi-squared tests, Fishers exact tests, 2-sample t-tests, and Wilcoxon rank-sum tests were used to compare fluoroscopy against combined fluoroscopy and ultrasonography as implant methods with respect to patient demographics. These tests were also used to evaluate the primary aim of this study, which was to compare the survival rates and times of ONS leads placed with combined ultrasonography and fluoroscopy versus those placed with fluoroscopy alone. Survival analysis was used to assess the effect of implant method, adjusted for patient demographics (age, smoking tobacco use, and disability), on the risk of lead explant. Results: Data from 21 patients were collected, including a total of 53 ONS leads. There was no statistically significant difference in the lead survival rate or time, disability, or patient age with respect to the implant method with or without ultrasonography. There was a statistically significant negative effect on the risk of explant with regards to lead removal in smoking patients compared to non-smoking patients (hazard ratio 0.36). There was also a statistically significant difference in smoking tobacco use with respect to the implant method, such that a greater number of patients whose leads were placed with combined fluoroscopy and ultrasonography had a history of smoking (P = 0.048). Limitations: This study is a retrospective chart review that had statistically significant differences in the patient groups and a small sample size. Conclusion: This study assessed the survival rates and times of ONS leads placed with ultrasonography and fluoroscopy versus fluoroscopy alone. We did not observe an effect to suggest that the incremental addition of ultrasound guidance to fluoroscopy as the intraoperative imaging modality used during the permanent implant of ONS leads yields statistically significant differences in lead survival rate or time. Medical comorbidities, including age and smoking status, may play a role in determining the risk of surgical revision and should be considered in future studies. Key words: Neuromodulation, peripheral nerve stimulation, occipital nerve stimulation, occipital neuralgia, chronic daily headaches, ultrasonograph