Explantation of 10 kHz Spinal Cord Stimulation Devices: A Retrospective Review of 744 Patients Followed for at Least 12 Months

Hagedorn, Jonathan M; Lam, Christopher M; D’Souza, Ryan S; Sayed, Dawood; Ha, Chris Thuc; Romero, Joshua; Hall, Morgan; Freeman, Eric D.; Richardson, Brian F; Hoelzer, Bryan C.

doi:10.1111/ner.13359

Cited by 32 publications

(31 citation statements)

References 12 publications

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“…The overall incidence of related SAEs was 8 of 204 (3.9%; Table 3), including six post-surgery infections requiring system removal, all reported during the first four months of follow-up. The permanent system removal rate of 31 of 204 (15.2%) is in line with spinal cord stimulation reports over the same two-year period, 50,51 and the rate of participants requiring surgical intervention, 45 of 204 (20%), is comparable with published incidence data for other neuromodulation therapies for chronic pain. [52][53][54] Lead migration represents the most common AE reported in neurostimulation trials, occurring at the rates of 1.4% to 13.6%.…”

Section: Safetysupporting

confidence: 86%

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial

Gilligan

Volschenk

Russo

et al. 2023

Neuromodulation: Technology at the Neural Interface

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Section: Safetysupporting

confidence: 86%

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial

Gilligan

Volschenk

Russo

et al. 2023

Neuromodulation: Technology at the Neural Interface

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“… 28 , 44 The system removal rate of 19/204 (9.3%) is in line with that reported for spinal cord stimulation over the same period. 42 , 86 In contrast to spinal cord stimulation, leads are placed outside of the spinal canal, thereby avoiding risk of spinal cord injuries. Lead migration represents the most common adverse event reported in neurostimulation trials, occurring at rates of 1.4% to 13.6%.…”

Section: Discussionmentioning

confidence: 99%

An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial

Gilligan

Volschenk

Russo

et al. 2021

Pain

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“…The SCS-implanted cohort will be followed observationally for 24 months in order to corroborate long-term data obtained in a small feasibility study 16 that demonstrated durable efficacy and benefit in this population. Moreover, successful experience with salvaging failed traditional SCS implants by replacing them with 10 kHz implants 41,42 has suggested that 10-kHz SCS may be more effective than traditional SCS in the long term.…”

Section: Limitationsmentioning

confidence: 99%

Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial

Kapural

Jameson

Johnson

et al. 2022

Journal of Neurosurgery: Spine

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OBJECTIVE Spinal cord stimulation (SCS) at 10 kHz (10-kHz SCS) is a safe and effective therapy for treatment of chronic low-back pain. However, it is unclear from existing evidence whether these findings can be generalized to patients with chronic back pain that is refractory to conventional medical management (CMM) and who have no history of spine surgery and are not acceptable candidates for spine surgery. The authors have termed this condition "nonsurgical refractory back pain" (NSRBP) and conducted a multicenter, randomized controlled trial to compare CMM with and without 10-kHz SCS in this population. METHODS Patients with NSRBP, as defined above and with a spine surgeon consultation required for confirmation, were randomized 1:1 to patients undergoing CMM with and without 10-kHz SCS. CMM included nonsurgical treatment for back pain, according to physicians’ best practices and clinical guidelines. Primary and secondary endpoints included the responder rate (≥ 50% pain relief), disability (Oswestry Disability Index [ODI]), global impression of change, quality of life (EQ-5D-5L), and change in daily opioid use and were analyzed 3 and 6 months after randomization. The protocol allowed for an optional crossover at 6 months for both arms, with observational follow-up over 12 months. RESULTS In total, 159 patients were randomized; 76 received CMM, and 69 (83.1%) of the 83 patients who were assigned to the 10-kHz SCS group received a permanent implant. At the 3-month follow-up, 80.9% of patients who received stimulation and 1.3% of those who received CMM were found to be study responders (primary outcome, ≥ 50% pain relief; p < 0.001). There was also a significant difference between the treatment groups in all secondary outcomes at 6 months (p < 0.001). In the 10-kHz SCS arm, outcomes were sustained, including a mean 10-cm visual analog scale score of 2.1 ± 2.3 and 2.1 ± 2.2 and mean ODI score of 24.1 ± 16.1 and 24.0 ± 17.0 at 6 and 12 months, respectively (p = 0.9). In the CMM arm, 74.7% (56/75) of patients met the criteria for crossover and received an implant. The crossover arm obtained a 78.2% responder rate 6 months postimplantation. Five serious adverse events occurred (procedure-related, of 125 total permanent implants), all of which resolved without sequelae. CONCLUSIONS The study results, which included follow-up over 12 months, provide important insights into the durability of 10-kHz SCS therapy with respect to chronic refractory back pain, physical function, quality of life, and opioid use, informing the current clinical practice for pain management in patients with NSRBP.

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Explantation of 10 kHz Spinal Cord Stimulation Devices: A Retrospective Review of 744 Patients Followed for at Least 12 Months

Cited by 32 publications

References 12 publications

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial

An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial

Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial

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