Redefining Spinal Cord Stimulation “Trials”: A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices

North, Richard B.; Calodney, Aaron; Bolash, Robert; Slavin, Konstantin V.; Creamer, Michael; Rauck, Richard; Vahedifar, Payam; Fox, Ira J.; Özaktay, Cuneyt; Panchal, Sunil J.; Vanquathem, Niek

doi:10.1111/ner.12970

Cited by 26 publications

(22 citation statements)

References 19 publications

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“…With the possibility to change waveforms, we had a positive external trial in 89.4% of the study sample, which is a higher success rate for the trial with external stimulators compared to some other studies 4,7,10,15,16,19,31,32 . Recent studies proposed that there could be considerable savings when adopting an implantation strategy without an external trial 33 .…”

Section: Discussionmentioning

confidence: 95%

Real‐World Analysis: Long‐Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome

Thoai¹,

Smet

Jerjir

et al. 2020

Pain Practice

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Introduction Spinal cord stimulation (SCS) is effective for patients with failed back surgery syndrome (FBSS). SCS improves their pain, as well as their functionality and health‐related quality of life. Different waveforms for SCS have emerged that show improvement in small prospective studies. Analysis of real‐world data shows the clinical implementation and the effect of different waveforms in SCS. Methods A real‐world analysis was performed of 208 patients with FBSS who were treated over 3 years. Stimulators with tonic, burst, high‐density, and 10‐kHz high‐frequency (HF10) waveforms were implanted in patients with FBSS who had predominant pain in the back, legs, or both back and legs. Pain as measured by the VAS, functional disability as measured by the Oswestry Disability Index (ODI), and health‐related quality of life as measured by the 3‐level EuroQol 5‐Dimension (EQ5D‐3L) questionnaire were determined at baseline and for outcome assessment. Results SCS is effective for patients with FBSS. This analysis showed a change in baseline VAS score from 8.0 to 4.7 (P < 0.0001) at 24 months. The EQ5D‐3L score improved from 0.29 to 0.49 (P < 0.0001) at 24 months. The ODI score improved from 54% to 42% (P < 0.0001) at 24 months. The unanticipated explantation rate was only 1.6%. Conclusion This study of SCS showed significant long‐term improvement in pain, disability, and quality of life in a large dataset of patients with FBSS. Strict selection procedures and a strong opioid policy contributed to the high success rate and low unanticipated explantation rate. There was no difference in pain reduction between tonic and HF10 stimulation. Further investigation is necessary to detect any difference between other waveforms of SCS.

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Section: Discussionmentioning

confidence: 95%

Real‐World Analysis: Long‐Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome

Thoai¹,

Smet

Jerjir

et al. 2020

Pain Practice

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“…This health economic rationale has driven the policy of almost all payers ever since, making SCS a two-stage procedure in the U.S. Because an indwelling trial electrode with a percutaneous extension connecting the electrode to an external pulse generator carries a risk of infection, SCS screening trials are limited in duration. In contrast, Wireless SCS technology that has been available since 2015 allows the electrodes, supporting electronics, and a receiver to be placed in a minimally invasive fashion initially, enabling a single-stage, "direct-to-permanent" implantation (19) and offering the opportunity to redefine SCS trials (20). Such single-stage SCS implantation allows the "trial" to continue for a extended period, months if needed, for example, to try a new waveform or combination of waveforms to optimize pain relief.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness Model Shows Superiority of Wireless Spinal Cord Stimulation Implantation Without a Separate Trial

North

Parihar

Spencer

et al. 2021

Neuromodulation: Technology at the Neural Interface

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Objective: We evaluated the cost-effectiveness of wireless spinal cord stimulation (Wireless SCS) with single stage "direct to permanent" implantation vs. screening with temporary electrodes and an external pulse generator followed by implantation of a system for long-term use (IPG SCS). Materials and Methods:We created a cost model that takes a 2019 United States (U.S.) payer perspective and is based on IPG SCS cost models for subjects with chronic back and/or leg pain. Our six-month decision tree includes the screening trial period (success ≥50% relief) and leads to various levels of pain relief with or without complications for IPG SCS and Wireless SCS and without complications for conventional medical management (CMM). Every three months in the follow-on 15-year Markov model (with costs and quality-adjusted life years discounted 3.5% annually), subjects remain stable or transition to deteriorated health or death. Subjects who fail SCS receive CMM. After 60 Markov cycles, a 100,000-sample simulation reveals the impact of maximum willingness-to-pay (WTP) from $10,000 to $100,000 per quality-adjusted life year on net monetary benefit (NMB). Sensitivity analyses considered the impact of the Wireless SCS screening success rate, Wireless SCS device cost, and IPG SCS device longevity.Results: Compared with IPG SCS, Wireless SCS offers higher clinical effectiveness at a lower cost and a higher NMB for our WTP thresholds and is, thus, dominant. Wireless SCS is also cost-effective compared with CMM. Results remain robust with 1) Wireless SCS screening success rates as low as 85% (dominant), 2) the cost of the Wireless SCS devices as high as $55,000 (cost-effective), and 3) IPG SCS devices lasting 12 years (dominant).

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“…The technology demonstrated safety and feasibility in many instances with results comparable to the therapeutic efficacy of traditional SCS. [45][46][47][48] Experience with wireless neuromodulation in a variety of chronic pain syndromes has been published in many reports (►Table 2).…”

Section: Discussionmentioning

confidence: 99%

“…Large-scale multicenter randomized studies are being currently undertaken to establish grounds for routine use of this simple, minimally invasive device. 48 WSCS has the potential to reduce health care costs, hospital stay, and surgical trauma with improved acceptance from patients since the cosmetic result is much superior. Especially in patients with multiple comorbidities and limited life expectancy, this miniature device offers a better option to control chronic pain.…”

Section: Discussionmentioning

confidence: 99%

Minimally Invasive Wireless Spinal Cord Stimulation: A Novel Approach for Refractory Angina in Women

et al. 2019

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Refractory angina (RA) persists even after thorough treatment for coronary artery disease. In such difficult situations, neuromodulation offers effective alternative management. One such minimally invasive procedure is spinal cord stimulation (SCS), a rapidly evolving therapy in the treatment of pain management. SCS has been in use to control RA and in some reports exhibited beneficiary results. However, several equipment-related complications have been reported, mainly attributed to the bulky implant material and the implantable pulse generator.Recent advancements in minimally invasive surgical methods and electronics resulted in implantable electrode coupled with nanotechnology-operated antenna. This is the smallest pulse generator in the field of neuromodulation at present.The equipment in this minimalistic approach involved percutaneous implantation of a single electrode (with embedded microelectronic sensors) at the required anatomical location, operated by means of wireless antenna placed in the vicinity of the implant and moderated by both the patient as well as the clinician. The advantage with the nanoeletrode stimulation include reduced surgical trauma/health care costs/surgical duration and improved cosmetic result, especially in women.This minimalistic wireless neuromodulation (WNM) has been successful in the management of chronic pain in failed back surgery syndrome (FBSS), herpetic neuralgia, complex regional pain syndrome (CRPS), and facial pain. SCS with WNM could increase the indications in RA and possibly improves the outcome of these patients.

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Redefining Spinal Cord Stimulation “Trials”: A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices

Cited by 26 publications

References 19 publications

Real‐World Analysis: Long‐Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome

Real‐World Analysis: Long‐Term Effect of Spinal Cord Stimulation With Different Waveforms for Patients With Failed Back Surgery Syndrome

Cost-Effectiveness Model Shows Superiority of Wireless Spinal Cord Stimulation Implantation Without a Separate Trial

Minimally Invasive Wireless Spinal Cord Stimulation: A Novel Approach for Refractory Angina in Women

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