Lead migration and fracture rate in dorsal root ganglion stimulation using anchoring and non‐anchoring techniques: A multicenter pooled data analysis

Abstract

Introduction: Dorsal root ganglion stimulation (DRG-S) is a neuromodulation technique introduced in the last decade with evolving implant methods. Initial prospective research found low incidences of lead migration and lead fracture with DRG-S. However, several recent studies have highlighted high lead migration and lead fracture rates with DRG-S. We investigated the influence of lead anchoring on migrations and fractures. Methods:We performed a retrospective review between 2016 and 2020 of individuals implanted with DRG-S leads by 4 experienced implanters. The implanters independently changed their standard practice regarding lead anchoring over time, with opposing trends (no anchoring > anchoring, anchoring > no anchoring). We compared lead migration and lead fracture rates between anchored and unanchored DRG-S leads in the entire study cohort. Cox regression was performed on lead migration and fracture distributions. Results:We included 756 leads (n = 565 anchored and n = 191 unanchored) from 249 patients. In unanchored leads, migration occurred in 16 leads (8.4%) from 13 patients (21.0%). In anchored leads, migration occurred in 8 leads (1.4%) from 5 patients (2.7%). Fracture in unanchored leads occurred in 6 leads (3.1%) from 6 patients (9.7%). Fractures in anchored leads occurred in 11 leads (1.9%) from 9 patients (4.8%). The migration survival distributions for the anchored and unanchored leads were statistically significantly different (p < 0.01) with decreased survival for unanchored leads (hazard ratio = 5.8, 95% confidence interval [CI] = 2.2-15.5). Discussion:We found that anchoring DRG-S leads significantly reduces lead migration when compared to leads placed without an anchor. There was no significant difference in fracture rate between anchored and unanchored leads.

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

“…Surgical revision may be complicated by epidural fibrosis 19,20 and lead to suboptimal placement in addition to the increased risk of neurologic sequela after repeated attempts at lead placement 15 . Reducing migration through lead fixation should lessen the risks associated with revision surgery and could potentially decrease explantations 6 . IPG pocket site pain is an often under‐reported adverse event.…”

“…We previously analyzed data from this sample to assess if DRG‐S lead anchoring can prevent lead migration, and these results have been published 6 …”

“…15 Reducing migration through lead fixation should lessen the risks associated with revision surgery and could potentially decrease explantations. 6 IPG pocket site pain is an often under-reported adverse event. In a pooled analysis of 217 patients with permanent DRG-S systems, the investigators detected 26 pocket pain occurrences, and the ACCURATE study reported 11 complaints of pocket a n and % across all levels is greater than total number of patients because leads can be located at multiple levels within the same patient.…”

“…3 Implantable device complications are generally categorized as device-related, biological, and diminished efficacy. 4 Leaning on the prior SCS experience, neuromodulators began to recognize DRG-S lead positional stability, 5 lead fracture, 6 infection, 7 and tolerance prevention as the cornerstones of therapeutic longevity. 8 Compared to the SCS literature, DRG-S evidence maturity is in an early, active development phase.…”

Response to: “Single-Center Retrospective Analysis of Device-Related Complications Related to Dorsal Root Ganglion Stimulation for Pain Relief in 31 Patients”

“…We recently conducted a large (n = 249 patients, n = 756 leads), multicenter, retrospective study with long-term follow-up on the effect of DRG-S lead anchoring on migration and fracture rates. Compared to unanchored leads, migration rates were reduced from 8.4% per lead to 1.4% and lead fracture rates from 3.1% per lead to 1.9% when leads are anchored in a deep fascial plane (2).…”