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

Chapman, Kenneth B; Yang, Ajax; Mogilner, Alon Y; Mandelberg, Nataniel; Patel, Kiran V; Lubenow, Timothy; Deer, Timothy; Kallewaard, Jan Willem; van Helmond, Noud
INTRODUCTION/BACKGROUND: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/CONCLUSIONS: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.
PMID: 35429364
ISSN: 1533-2500
CID: 5204562

Dorsal Root Ganglion Stimulation to Treat Focal Postsurgical and Diffuse Chronic Pain: A Case Report [Case Report]

Akuamoah, Latrice A; Tupper, Connor; Nagrani, Sohan; Chapman, Kenneth B
Dorsal root ganglion stimulation (DRG-S) is widely accepted for treating focal pain syndromes. We present the case of a 46-year-old woman with severe lumbar radiculopathy with an implanted spinal cord stimulator (SCS) that had lost efficacy. She developed an incisional hernia after undergoing a minimally invasive, extreme lateral interbody fusion and SCS explant. After herniorrhaphy, she presented with severe pain at the T10-T11 dermatomes, which we treated with DRG-S. One-year after lumbar fusion, her refractory lumbar and radicular pain returned, which we ultimately treated with bilateral T12+S1 DRG-S. DRG-S was thus used to successfully treat focal postsurgical and diffuse chronic pain.
PMID: 35587521
ISSN: 2575-3126
CID: 5235732

An Anatomy-Informed, Novel Technique for S1 Dorsal Root Ganglion Stimulation Lead Placement

Chapman, Kenneth B; van Helmond, Noud; Kallewaard, Jan Willem; Vissers, Kris C; Patel, Kiran V; Motivala, Soriaya; Hagedorn, Jonathan M; Deer, Timothy R; Dickerson, David M
OBJECTIVE:A heightened and organized understanding of sacral anatomy could potentially lead to a more effective and safe method of dorsal root ganglion stimulation (DRG-S) lead placement. The aim of this technical note is to describe a standardized access method for S1 DRG-S lead placement. DESIGN/METHODS:Technical note. METHODS:The described approach utilizes alignment of the lumbosacral prominence and is measurement- based, allowing for standardized sacral access, even when visualization is suboptimal. The medial-to-lateral needle trajectory is designed to limit interaction with the sensitive neural structures and allows for a more parallel orientation of the lead to the DRG and nerve root. CONCLUSIONS:The described technique potentially improves the safety of S1 DRG-S lead placement. The parallel lead orientation to the DRG may also increase efficacy while lowering energy requirements.
PMID: 35426940
ISSN: 1526-4637
CID: 5204502

Intermittent Dorsal Root Ganglion Stimulation Is as Efficacious as Standard Continuous Dosing in Treating Chronic Pain: Results From a Randomized Controlled Feasibility Trial

Chapman, Kenneth B; Tupper, Connor; Yang, Ajax; van Helmond, Noud; Yousef, Tariq
INTRODUCTION/BACKGROUND:Dorsal root ganglion stimulation (DRG-S) is a form of neuromodulation used to treat chronic pain. A spinal cord stimulation (SCS) method with paresthesia-free waveform used in the dorsal columns, burst-SCS, recently demonstrated efficacy using intermittent stimulation, where stimulation is cycled on and off for set durations. Tonic SCS is a paresthesia-based therapy that is ineffective at sub-perception levels and when delivered in a cycled manner. DRG-S also uses a tonic waveform, yet unlike tonic SCS, it is effective at sub-perception levels. This study aimed to determine whether the cycling of stimulation at the DRG could maintain DRG-S efficacy. MATERIALS AND METHODS/METHODS:This study followed a prospective, randomized, and balanced, double-blinded (assessor) protocol. Twenty DRG-S responders were randomized to a sequence of three programs for consecutive two-week intervals: continuous stimulation; 1 minute on:1 minute off; or 1 minute on:2 minutes off. The primary outcome of this study was change in pain ratings with the cycled programs compared with continuous stimulation. Secondary outcomes included changes in function and scores for quality of life, and stimulation program preference. RESULTS:Mean scores were similar at the end of each two-week stimulation program for Numerical Rating Scale pain (continuous = 2.9 ± 0.8, 1:1 on-off = 2.6 ± 0.7, and 1:2 on-off = 2.7 ± 0.7 cm, p = 0.39), disability (p = 0.72), and general health (p = 0.95). No clinically significant differences were found from the upper boundaries of the 95% confidence intervals of the mean difference in pain, disability, and general health for each intermittent stimulation program vs the continuous program. At the end of the study, the continuous stimulation, 1:1 on-off dosing, and 1:2 on-off dosing programs were preferred by a similar number of patients. CONCLUSIONS:Intermittent DRG-S produces comparable results to continuous stimulation over a two-week period. Intermittent delivery may extend battery life and facilitate a smaller implantable pulse generator.
PMID: 35088752
ISSN: 1525-1403
CID: 5154832

Response to: "Single-Center Retrospective Analysis of Device-Related Complications Related to Dorsal Root Ganglion Stimulation for Pain Relief in 31 Patients" [Letter]

Chapman, Kenneth B; van Helmond, Noud
PMID: 34748680
ISSN: 1525-1403
CID: 5050282

Response to "the Effectiveness of Dorsal Root Ganglion Neurostimulation for the Treatment of Chronic Pelvic Pain and Chronic Neuropathic Pain of the Lower Extremity: A Comprehensive Review of the Published Data"

Chapman, Kenneth B; Kallewaard, Jan Willem
PMID: 33904571
ISSN: 1526-4637
CID: 4889272

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

Chapman, Kenneth B; Mogilner, Alon Y; Yang, Ajax H; Yadav, Abhishek; Patel, Kiran V; Lubenow, Timothy; van Helmond, Noud; Deer, Timothy; Kallewaard, Jan Willem
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 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/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.
PMID: 34145740
ISSN: 1533-2500
CID: 4954652

A Paramedian Approach for Dorsal Root Ganglion Stimulation Placement Developed to Limit Lead Migration and Fracture

Chapman, Kenneth B; Spiegel, Matthew A; Dickerson, David M; Billet, Bart; Patel, Kiran V; Hunter, Corey; Antony, Ajay; van Helmond, Noud; Deer, Timothy; Kallewaard, Jan Willem; Hagedorn, Jonathan M; Yang, Ajax
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.
PMID: 34328256
ISSN: 1533-2500
CID: 4954662

Objective Improvements in Peripheral Arterial Disease from Dorsal Root Ganglion Stimulation: A Case Series [Case Report]

Chapman, Kenneth B; Kloosterman, Jaap; Schor, Jonathan A; Girardi, George E; van Helmond, Noud; Yousef, Tariq A
BACKGROUND:The sympathetic nervous system (SNS) is important in the regulation of perfusion. Dorsal root ganglion stimulation (DRG-S) modulates sympathetic tone and is approved to treat complex regional pain syndrome, a disorder related to SNS dysfunction. We herein present 3 cases of DRG-S therapy to improve blood flow and symptoms of ischemia in peripheral arterial disease (PAD). METHODS:Patient 1 is a 44-year-old female with dry gangrene of the third and fourth digits of her right hand due to Raynaud's syndrome who was scheduled for amputation of the affected digits. DRG-S leads were placed at the right C6, 7, and 8 DRG. Pulse volume recordings (PVR) were measured at baseline and after DRG-S. Patient 2 is a 55-year-old female with a non-healing ulcer of her left foot secondary to PAD scheduled for a below the knee amputation who underwent a DRG-S trial with leads placed at the left L4 and L5 DRG followed by a spinal cord stimulation trial with leads placed at the T9-T10 spinal levels for comparison. Transcutaneous oximetry (TcPO2) was measured at baseline and after 3 days of each therapy. Patient 3 is a 69-year-old female with persistent left foot pain at rest secondary to PAD with DRG-S leads placed at the left L4 and S1 levels. RESULTS:All 3 patients experienced a significant reduction in pain with DRG-S, along with improvements in blood flow of the involved extremities, avoiding or limiting amputation. PVR improved dramatically with DRG-S in patient 1. A greater improvement in TcPO2 was seen with the DRG-S trial compared to spinal cord stimulation trial in patient 2. Patient 3 experienced an increase in walking distance and demonstrated long term efficacy and limb salvage at 32 months postimplantation. CONCLUSIONS:Modulation of SNS output from DRG-S through orthodromic and antidromic autonomic pathways is likely responsible for improving blood flow. DRG-S may be a treatment option for PAD.
PMID: 33549777
ISSN: 1615-5947
CID: 4835442

The Pathways and Processes Underlying Spinal Transmission of Low Back Pain: Observations From Dorsal Root Ganglion Stimulation Treatment

Chapman, Kenneth B; Groenen, Pauline S; Vissers, Kris C; van Helmond, Noud; Stanton-Hicks, Michael D
BACKGROUND:Dorsal root ganglion stimulation (DRG-S) is a novel approach to treat chronic pain. Lead placement at L2 has been reported to be an effective treatment for axial low back pain (LBP) primarily of discogenic etiology. We have recently shown, in a diverse cohort including cases of multilevel instrumentation following extensive prior back surgeries, that DRG-S lead placement at T12 is another promising target. Local effects at the T12 DRG, alone, are insufficient to explain these results. MATERIALS AND METHODS/METHODS:We performed a literature review to explore the mechanisms of LBP relief with T12 DRG-S. FINDINGS/RESULTS:Branches of individual spinal nerve roots innervate facet joints and posterior spinal structures, while the discs and anterior vertebrae are carried via L2, and converge in the dorsal horn (DH) of the spinal cord at T8-T9. The T12 nerve root contains cutaneous afferents from the low back and enters the DH of the spinal cord at T10. Low back Aδ and C-fibers then ascend via Lissauer's tract (LT) to T8-T9, converging with other low back afferents. DRG-S at T12, then, results in inhibition of the converged low back fibers via endorphin-mediated and GABAergic frequency-dependent mechanisms. Therefore, T12 lead placement may be the optimal location for DRG-S to treat LBP.
PMID: 32329155
ISSN: 1525-1403
CID: 4402422