Lead migration and fracture rate in dorsal root ganglion stimulation using anchoring and non-anchoring techniques: A multicenter pooled data analysis
INTRODUCTION/BACKGROUND: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 anchoringÂ >Â anchoring, anchoringÂ >Â 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 (nÂ =Â 565 anchored and nÂ =Â 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 6Â 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 (pÂ <Â 0.01) with decreased survival for unanchored leads (hazard ratio = 5.8, 95% confidence interval [CI] = 2.2-15.5). DISCUSSION/CONCLUSIONS: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.
A Paramedian Approach for Dorsal Root Ganglion Stimulation Placement Developed to Limit Lead Migration and Fracture
INTRODUCTION/BACKGROUND:Dorsal root ganglion stimulation (DRG-S), has demonstrated superiority in the treatment of complex regional pain syndrome and causalgia. Lead migration and fracture impact DRG-S therapeutic stability. Lead anchoring reduces DRG-S lead migration without increasing lead fracture. Lead fracture may be related to lead entrapment in the superficial fascial plane. A novel medialized approach for lead placement and anchoring is presented to address these issues. METHODS:We suggest an alternative technique for implanting percutaneous DRG-S leads at the T10-L5 levels. RESULTS:A novel medialized ipsilateral technique for lead placement and anchoring for single, bilateral, and adjacent segment placement is presented. The Tuohy needle puncture site is medial to the pedicle and adjacent to the spinous process, two vertebral levels caudad to the target foramen. Trajectory is maintained in the sagittal plane, to access the caudad interlaminar space near the midline. This technique allows for ipsilateral or contralateral lead placement. After epidural access, the introducer sheath is rotated toward the targeted foramen and advanced. The guidewire followed by the lead is passed, and once lead position is confirmed, tension 'S' loops are created, followed by anchoring to the deep fascia. CONCLUSION/CONCLUSIONS:We describe a new paramedian technique for DRG-S lead placement. We propose it will decrease DRG-S complication rates through anchoring to reduce migration and by avoiding the fascial planes thought to be responsible for fracture. Long-term outcomes applying our proposed techniques are required for determining the true impact, however, early anecdotal results suggest that these new techniques are favorable.
Dorsal Root Ganglion Stimulation Lead Fracture Within the Superficial Fascial Layers in 4 Cases
We present 4 cases of dorsal root ganglion stimulation lead fracture. In these cases, the surgical technique involved (1) traversing fascial layers for placement of leads via a Tuohy needle in the upper low back, (2) subcutaneous tunneling from the implantable pulse generator site to the lead puncture site without dissecting below the superficial fascial plane at the puncture site, and (3) connection of the lead/extension with the generator. All fractures occurred adjacent to the original lead puncture site. These cases suggest lead entrapment within the membranous fascial plane, with tension on a thin lead, is a mechanism underlying lead fracture.
Lumbar Dorsal Root Ganglion Stimulation Lead Placement Using an Outside-In Technique in 4 Patients With Failed Back Surgery Syndrome: A Case Series
Dorsal root ganglion stimulation (DRG-S) has shown promise as a treatment for low back pain. The traditional anterograde placement of DRG-S leads can be challenging in patients with anatomical changes from prior back surgery. We describe an "outside-in" placement technique of DRG-S leads in 4 patients with histories of multiple lumbar surgeries, which made the traditional anterograde placement not feasible. At long-term follow-up, the patients experienced substantial pain relief and improvement in quality of life, with no complications. The outside-in lead placement technique may be an efficacious alternative to the traditional techniques in patients with anomalous anatomy from prior surgery.
T12 Dorsal Root Ganglion Stimulation to Treat Chronic Low Back Pain: A Case Series [Case Report]
INTRODUCTION/BACKGROUND:Dorsal root ganglion stimulation (DRG-S) is a neuromodulation technique for treating neuropathic pain syndromes. Research has demonstrated DRG-S to be more effective than conventional SCS in treating RSD/CRPS, particularly of the lower extremities. Results from recent case series and prospective studies suggest that DRG-S may be effective in treatment of pain syndromes considered to have non-neuropathic components and characteristics (e.g. nociceptive). There have been multiple, small studies demonstrating efficacy of DRG-S for axial low back pain. There has, however, been no consensus regarding the best location for DRG lead placement in the treatment of low back pain. METHODS:Patients presenting with refractory low back pain in a private pain management practice were considered for DRG-S. Patients were provided a trial stimulator prior to potential implantation. Per standard practice, pain intensity, disability, general health status, and quality of life were followed using the visual analog scale (VAS), Oswestry Disability Index, EQ-5D index, and the SF-36 survey, respectively. Data were collected prior to implantation and at variable follow-ups after DRG-S initiation. RESULTS:Seventeen consecutive patients presented with predominantly axial low back pain with/without a secondary component of lower extremity pain. All were trialed and subsequently implanted for DRG-S. Leads were placed at T12 to target the low back. Stimulation levels were set very low, below that of which patients experienced paresthesias. Last follow-up times averaged 8.3 months. More than half of the patients experienced pain relief â‰¥80%, with an average low back pain relief of 78% at last follow-up. Additionally, substantial improvements in physical and mental functioning, disability, and quality of life were reported. CONCLUSIONS:T12 DRG-S can be an effective treatment for chronic axial low back pain. Stimulation results in reduced pain and disability, while improving quality of life. These outcomes can be achieved without paresthesias.
Prospective observational cohort study on grading the severity of postoperative complications in global surgery research
BACKGROUND:The Clavien-Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien-Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs). METHODS:This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien-Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs. RESULTS:A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16Ã‚Â·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47Ã‚Â·2 per cent) were graded as mild, 4244 (36Ã‚Â·4 per cent) as moderate and 1916 (16Ã‚Â·4 per cent) as severe. Using Clavien-Dindo, 6781 of 11 664 complications (58Ã‚Â·1 per cent) were graded as I or II, 1740 (14Ã‚Â·9 per cent) as III, 2408 (20Ã‚Â·6 per cent) as IV and 735 (6Ã‚Â·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0Ã‚Â·41, 95 per cent c.i. 0Ã‚Â·20 to 0Ã‚Â·55), and in LMICs (ICC 0Ã‚Â·23, 0Ã‚Â·05 to 0Ã‚Â·38) and HICs (ICC 0Ã‚Â·46, 0Ã‚Â·25 to 0Ã‚Â·59). CONCLUSION/CONCLUSIONS:Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.