Dorsal root ganglion stimulation device explantation: A multicenter pooled data analysis

Abstract

Introduction Dorsal root ganglion stimulation (DRG‐S) is a relatively new neuromodulation modality. Therefore, data on long‐term device explantation rates is limited. This investigation aimed to assess DRG‐S device explantation rates at long‐term follow‐up. Methods We retrospectively reviewed individuals implanted with DRG‐S in four pain centers from different continuous periods between April 2016 to September 2020. We recorded patient demographics, diagnoses, duration to explantation or last follow‐up, treatment complications, and failure etiologies. Results A total of 249 patients with 756 leads and a mean 27‐month follow‐up were included. The mean age was 55 ± 15 years; 148 (63%) were female. Leading diagnoses were CRPS (n = 106, 43%), followed by FBSS (n = 64, 26%), and non‐surgical low back pain (n = 23, 9%). The explantation rate was ~2% per year (n = 10 total). At explantation, the average time from implantation was 13 ± 10 months. Six patients were explanted for inadequate pain relief. Two patients were explanted due to device‐related complications. One patient was explanted secondary to infection and subsequently reimplanted. Five explanted patients experienced a therapy‐related complication before eventual explantation: one transient post‐procedural neuritis and pocket site pain, one lead fracture, two lead migrations, and one experienced a fracture, a migration, and pocket site pain. Discussion This large retrospective study of DRG‐S revealed a low therapy‐termination rate. The rate of infection leading to explantation was objectively very low at 0.4%. The leading cause of explantation was inadequate pain relief. Explanted patients often had a therapy‐related complication. Therefore, minimizing adverse treatment events may reduce ultimate explantation rates.

Dorsal root ganglion stimulation for the treatment of joint pain with predominantly nociceptive characteristics: A case series

“…Additionally, similar to SCS in its early application stages, 47 technical struggles have been observed with DRG‐S 48 . Improvements in surgical technique, including anchoring leads, appear to decrease migration rates, 49 and low adverse event and explantation rates have been reported in recent publications by our group of authors 50 and others 51 . In the present case series, one of five patients had a therapy‐related complication.…”

Dorsal Root Ganglion Stimulation to Treat Chronic Shoulder Pain: A Case Report

“…A recent pooled data analysis of 249 implants demonstrated migration and fracture rates of 1.4% and 1.9% per anchored lead, an explantation rate of 2% annually, and a 0.4% rate of infection. 9,10 The utility of DRG-S for postjoint replacement pain has been reported in multiple limited studies, primarily under the premise of neuropathic postsurgical pain, or causalgia.…”

“…A recent pooled data analysis of 249 implants demonstrated migration and fracture rates of 1.4% and 1.9% per anchored lead, an explantation rate of 2% annually, and a 0.4% rate of infection. 9,10…”

Best Practices for Dorsal Root Ganglion Stimulation for Chronic Pain: Guidelines from the American Society of Pain and Neuroscience

“…As previously reviewed, loss of efficacy, or habituation, has not yet been demonstrated with DRG-S. 156,157 Given such, if patients implanted with DRG-S present with worsening pain, efforts should be made at reprogramming and, if available, review of recent imaging to evaluate lead location. Device evaluation and reprogramming efforts should be performed prior to alternative options such as medication changes or interventional procedures.…”

“…This concept was supported by a real-world pooled data retrospective analysis of 249 implants which demonstrated only 10 explants over a mean 27-month follow-up, with only 7 explanted for inadequate pain relief. 157 Only one patient underwent explant for infection (0.4%), and there was an overall explant rate of 2% per year. Patients who suffered complications were more likely to undergo explant.…”