Longevity and Utilization Cost of Rechargeable and Non‐Rechargeable Spinal Cord Stimulation Implants: A Comparative Study

Costandi, Shrif; Mekhail, Nagy; Azer, Gerges; Mehanny, Diana Sue; Hanna, Demiana; Salma, Yustina; Bolash, Robert; Saweris, Youssef

doi:10.1111/papr.12926

Cited by 22 publications

(25 citation statements)

References 21 publications

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“…Another factor to consider is that DRG-S uses a nonrechargeable, primary cell, IPG, and this has been shown to be protective against device explantation. 27,50 We hypothesize that the convenience of not having to charge a device improves therapy success.…”

Section: Explantation Rate To Inadequate Pain Relief Comparison Drg-s...mentioning

confidence: 99%

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

et al. 2022

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Introduction 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 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.

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Section: Explantation Rate To Inadequate Pain Relief Comparison Drg-s...mentioning

confidence: 99%

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

et al. 2022

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“… 4 In the early 1980s, pulse generators became fully implantable with wireless handheld controllers. 5 Improvements such as rechargeable battery technology and computer-controlled programming soon followed, 6 , 7 providing patients with previously impossible options for using high-energy stimulation programs and creating nuanced paresthesia coverage. As compared to open loop (OL) systems where the patient or clinician is responsible for all parameter changes, closed loop (CL) systems were introduced that automatically controlled stimulator settings based on sensor inputs.…”

Section: Spinal Cord Stimulation: Established Intervention and Emerging Innovationsmentioning

confidence: 99%

A New Direction for Closed-Loop Spinal Cord Stimulation: Combining Contemporary Therapy Paradigms with Evoked Compound Action Potential Sensing

Vallejo¹,

Chakravarthy²,

Will³

et al. 2021

JPR

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Spinal cord stimulation (SCS) utilizes the delivery of mild electrical pulses via epidural electrodes placed on the dorsal side of the spinal cord, typically to treat chronic pain. The first clinical use of SCS involved the delivery of paresthesia inducing, low-frequency waveforms to the neural targets corresponding to the painful areas. Contemporary SCS therapies now leverage novel therapeutic pathways to limit paresthesia and deliver superior clinical outcomes. Historically, SCS has largely been delivered with fixed stimulation parameters. This approach, referred to as open-loop (OL) SCS, does not account for the fluctuations in spacing—driven by postural changes and activity—between the electrodes and the cord. These fluctuations result in variability in the delivered dose and the volume of tissue activation (VTA) that manifests with each stimulation pulse. Inconsistent dosing may lead to suboptimal therapeutic efficacy and durability. To address this clinical need, closed-loop (CL) SCS systems have been developed to automatically adjust stimulation parameters to compensate for this variability. The evoked compound action potential (ECAP), a biopotential generated by the synchronous activation of dorsal column fibers, is indicative of the VTA resulting from the stimulation pulse. The ECAP may be utilized as a control signal in CL SCS systems to adjust stimulation parameters to reduce variability in the ECAP, and in turn, variability in the VTA. While investigational CL SCS systems with ECAP sensing have so far focused solely on managing paresthesia-based SCS, such systems must also incorporate the stimulation approaches that now define the contemporary clinical practice of SCS. Accordingly, we describe here a flexible, next-generation framework for neural responsive SCS that blends science-based methodologies for pain management with real-time CL control for biophysical variation. We conclude with a clinical example of such a system and the associated performance characteristics.

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“…Since the first application more than 50 years ago, the technology has been continuously improved 1 , 2 . Currently, conventional systems consist of two components: a pulse generator (PG), which acts as a power source and one or two leads (percutaneous or paddle) that are implanted in the spinal epidural space and transmit stimulation to the dorsal columns of the spinal cord 3 . The first fully implantable pulse generators were non-rechargeable.…”

Section: Introductionmentioning

confidence: 99%

Questionnaire-based approach to evaluate the convenience of rechargeable extracorporeal pulse generators for wireless spinal cord stimulation

Hajiabadi

Jakobs

Vicheva

et al. 2022

Sci Rep

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Spinal cord stimulation (SCS) has been utilized for more than 50 years to treat refractory neuropathic pain. Currently, SCS systems with fully implantable pulse generators (IPGs) represent the standard. New wireless extracorporeal SCS (wSCS) devices without IPGs promise higher levels of comfort and convenience for patients. However, to date there are no studies on how charging and using this wSCS system affects patients and their therapy. This study is the first questionnaire-based survey on this topic focusing on patient experience. The trial was a single arm, open-label and mono-centric phase IV study. Standardized questionnaires were sent to all patients with a wSCS device in use at the time of trial. The primary endpoint was the convenience of the charging and wearing process scored on an ordinal scale from "very hard" (1) to "very easy" (5). Secondary endpoints included time needed for charging, the duration of stimulation per day and complication rates. Questionnaires of 6 out of 9 patients were returned and eligible for data analysis. The mean age of patients was 61.3 ± 6.7 (± SD) years. The duration of therapy was 20.3 ± 15.9 months (mean ± SD). The mean duration of daily stimulation was 17 ± 5.9 h (mean ± SD). n = 5 patients rated the overall convenience as "easy" (4) and n = 3 patients evaluated the effort of the charging process and wearing of the wSCS device as "low" (4). n = 5 patients considered the wearing and charging process as active participation in their therapy. n = 5 patients would choose an extracorporeal device again over a conventional SCS system. Early or late surgical complications did not occur in this patient collective. Overall, patients felt confident using extracorporeal wSCS devices without any complications. Effort to maintain therapy with this system was rated as low.

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Longevity and Utilization Cost of Rechargeable and Non‐Rechargeable Spinal Cord Stimulation Implants: A Comparative Study

Cited by 22 publications

References 21 publications

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

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

A New Direction for Closed-Loop Spinal Cord Stimulation: Combining Contemporary Therapy Paradigms with Evoked Compound Action Potential Sensing

Questionnaire-based approach to evaluate the convenience of rechargeable extracorporeal pulse generators for wireless spinal cord stimulation

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