Spinal Cord Stimulator Explantation: Motives for Removal of Surgically Placed Paddle Systems

Dupré, Derrick A.; Tomycz, Nestor D.; Whiting, Donald; Oh, Michael

doi:10.1111/papr.12639

Cited by 46 publications

(48 citation statements)

References 26 publications

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“…2 Despite the level of success of these systems, the rate of failure to accomplish long-term pain coverage still remains as high as 30%. 3 Loss or lack of efficacy represents the most frequent reason for neurostimulator explant. 4 The more commonly reported side effects documented amongst patients with these conventional low-frequency (40-1200 Hz) devices (LF-SCS) are unpleasant paresthesia or dysesthesia.…”

Section: Introductionmentioning

confidence: 99%

“…4 The more commonly reported side effects documented amongst patients with these conventional low-frequency (40-1200 Hz) devices (LF-SCS) are unpleasant paresthesia or dysesthesia. [2][3][4] High frequency SCS at 10 kHz (10 kHz SCS) is known to produce no paresthesias and provides superior pain relief with a favorable safety and efficacy profile. [5][6][7][8] This therapy, therefore, may be considered a viable salvage option to conventional SCS systems.…”

Section: Introductionmentioning

confidence: 99%

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<p>Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study</p>

Kapural¹,

Sayed²,

Kim³

et al. 2020

JPR

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Background and Objectives A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails. Methods We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS. Results Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66±3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30±1.4 (median of 8) cm to 3.32±2.0 (median of 3) cm at 12 months and 3.36±2.0 (median of 3) cm at the most recent clinic visit (p<0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy. Conclusion Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved >50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

<p>Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study</p>

Kapural¹,

Sayed²,

Kim³

et al. 2020

JPR

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show abstract

“…The loss of analgesic efficacy is currently the most important factor contributing to SCS explantation. Retrospective analyses performed by multiple investigators identified inadequate pain relief as a significant etiology of t‐SCS device surgical removals in the range of 19% to 73% 19–22 . Patients undergoing explantation of their t‐SCS devices is not uncommon; up to 30% of patients undergo explantation over the course of over a decade 23 .…”

Section: Discussionmentioning

confidence: 99%

The Evolving Role of High‐Frequency Spinal Cord Stimulation as Salvage Therapy in Neurostimulation

2020

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Background High‐frequency 10‐kHz spinal cord stimulation (10‐kHz SCS) has shown promise in multicenter prospective trials for the management of chronic back and leg pain. Traditional spinal cord stimulation (t‐SCS) has a long history of effectiveness in chronic neuropathic syndromes but not uncommonly can fail to provide long‐term relief, leaving a significant group of patients with unsatisfactory outcomes. There is mounting evidence that 10‐kHz SCS may offer relief in this subset of patients. Methods The purpose of this retrospective analysis was to report a single‐institution long‐term experience of 10‐kHz SCS in patients who did not get adequate pain relief with prior t‐SCS devices. A temporary trial of 10‐kHz SCS was carried out for 7 days, and those experiencing an average of 50% reduction in pain intensity underwent implantation. Patients were classified as moderate responders if relief was 31% to 50% and excellent responders if pain relief exceeded 50%. Results Thirty‐one patients who had experienced failed t‐SCS primarily from poor paresthesia coverage underwent a trial of 10‐kHz SCS and 29 underwent implantation. Twenty‐eight patients were available for analysis, with 57.1% experiencing 30% response and 46.4% experiencing excellent response at a median follow‐up of 21.2 (±8.4) months. Conclusions This small single‐institution study suggests that a significant proportion of patients with previously failed t‐SCS may achieve clinically meaningful and durable pain relief with 10‐kHz SCS.

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“…A technical example of successful longterm paddle lead removal with replacement by percutaneous cylindrical leads resulting in improved pain control and decreased opioid use CASE Traditionally, spinal cord neuromodulation included paddle lead placement; however, recent technological innovations have led to less invasive techniques [1,2]. There is debate on how to proceed with treatment in patients with previous paddle lead spinal cord stimulation (SCS) who are no longer reporting adequate pain relief, thought to be due to extensive scar tissue that can form over the paddle [3,4].…”

Section: Key Findingsmentioning

confidence: 99%

Images in Practice: Replacement of an 18-Year-Old Spinal Cord Stimulator Paddle Lead with Cylindrical Leads Under Direct Visualization

et al. 2020

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Spinal Cord Stimulator Explantation: Motives for Removal of Surgically Placed Paddle Systems

Cited by 46 publications

References 26 publications

<p>Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study</p>

<p>Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study</p>

The Evolving Role of High‐Frequency Spinal Cord Stimulation as Salvage Therapy in Neurostimulation

Images in Practice: Replacement of an 18-Year-Old Spinal Cord Stimulator Paddle Lead with Cylindrical Leads Under Direct Visualization

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