Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management

Walsh, Kevin M.; Machado, André G.; Krishnaney, Ajit A.

doi:10.1016/j.spinee.2015.04.043

Cited by 33 publications

(27 citation statements)

References 46 publications

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“…MRI compatible stimulation technology is evolving, and functional MRI (fMRI) for investigational research might be feasible as part of the study design, pending appropriate regulatory approvals. The current commercially available spinal stimulators are still contraindicated for MRI, as the artifacts may be problematic and risks of tissue heating in this application are still unknown [27]. Thus, careful imaging of the spinal cord should be completed before implantation of a stimulator.…”

Section: Section III Clinical Testing and Trainingmentioning

confidence: 99%

Epidural Spinal Stimulation to Improve Bladder, Bowel, and Sexual Function in Individuals With Spinal Cord Injuries: A Framework for Clinical Research

Pettigrew

Heetderks

Kelley

et al. 2017

IEEE Trans. Biomed. Eng.

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While some recent studies that apply epidural spinal cord stimulation (SCS) have demonstrated a breakthrough in improvement of the health and quality of the life of persons with spinal cord injury (SCI), the numbers of people who have received SCS are small. This is in sharp contrast to the thousands of persons worldwide living with SCI who have no practical recourse or hope of recovery of lost functions. Thus, the vision is to understand the full potential of this new intervention and to determine if it is safe and effective in a larger cohort, and if it is scalable so that it can be made available to all those who might benefit. To achieve this vision, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) called for and organized a consortium of multiple stakeholder groups: foundations addressing paralysis, Federal and public agencies, industrial partners, academicians and researchers, all interested in the same goal. Based on input from consortium participants, we have reasoned that a first step is to define a scalable SCS approach that is effective in restoring lost autonomic physiology, specifically bladder, bowel and sexual function. These functions are most critical for improving the quality of life of persons living with SCI. This report outlines a framework for conducting the research needed to define such an effective SCS procedure that might seek FDA approval and be implemented at the population level.

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Section: Section III Clinical Testing and Trainingmentioning

confidence: 99%

Epidural Spinal Stimulation to Improve Bladder, Bowel, and Sexual Function in Individuals With Spinal Cord Injuries: A Framework for Clinical Research

Pettigrew

Heetderks

Kelley

et al. 2017

IEEE Trans. Biomed. Eng.

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“…A patient, implanted with deep brain stimulator, reported a shocking sensation, described as "lancinating" when exposed to monopolar cautery during a dermatologic procedure (26). Therefore, all 5 SCS companies recommend avoidance of monopolar electrocautery in a patient with SCS (18-22) Bipolar electrocautery is recommended if electrocautery is required (2). Different from the monopolar mode, bipolar does not require a grounding pad; the active and return electrodes are on opposite ends of the forceps, limiting energy dispersion (27).…”

Section: Electrocauterymentioning

confidence: 99%

“…Current operating room recommendations, including turning the device to the lowest setting and then powering off, should be followed. Finally, the SCS must be interrogated after the procedure to ensure proper setting and working order (2,19,21).…”

Section: Electrocauterymentioning

confidence: 99%

“…www.painphysicianjournal.com S pinal cord stimulation (SCS) has become increasingly important in the management of chronic pain conditions including chronic back and leg pain, complex regional pain syndrome, refractory cardiovascular conditions, and painful peripheral neuropathy (1). As a result, it will become increasingly common for the anesthesia care team (ACT) to provide care for patients with implanted neuromodulation devices (2). Moreover, chronic pain patients are known to have increased rates of medical service utilization (3).…”

mentioning

confidence: 99%

“…With the increasing complexity of current and future SCS and the potential for adverse device and patient outcomes, the ACT is required to have more than just a superficial "turn it off and forget about it" understanding. Recently, 2 references on perioperative management of SCS have been published; however, the first one is written for surgeons addressing the surgical management and the second does not address the myriad anesthetizing locations and the specific implications found in those unique environments (2,5).…”

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confidence: 99%

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Anesthetic Considerations and Perioperative Management of Spinal Cord Stimulators: Literature Review and Initial Recommendations

et al. 2017

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Background: Patients with implanted spinal cord stimulators (SCS) present to the anesthesia care team for management at many different points along the care continuum. Currently, the literature is sparse on the perioperative management. What is available is confusing; monopolar electrocautery is contraindicated but often used, full body magnetic resonance imaging (MRI) is safe with particular systems but with other manufactures only head and specific extremities exams are safe. Moreover, there are anesthetizing locations outside of the operating room where implanted SCS can interact with surrounding medical equipment and pose significant risk to patient and device. Objectives: The objective of this review is to present relevant known literature about the safe management of SCS in the perioperative period and to begin to develop recommendations. Study Design: A review of current literature and each manufacturers’ labeling was performed to assess risk of interference and patient harm between SCS and technology used in and around typical anesthetizing locations. Methods: A systematic search of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. A computerized search was conducted for English articles in print up to April 2016 via PubMed www.ncbi.nlm.nih.gov/pubmed; EMBASE www.embase. com; and Cochrane Library www.thecochranelibrary.com. Search terms included “spinal cord stimulator AND MRI,” “spinal cord stimulator AND ECG,” “spinal cord stimulator AND implanted cardiac device,” “spinal cord stimulator AND electrocautery,” and “spinal cord stimulator AND obstetrics.” In addition, a search of Google and Google Scholar was performed. Websites of SCS manufactures were reviewed. Results: Generalized recommendations include turning the amplitude of the SCS to the lowest possible setting and turning off prior to any procedure. Monopolar electrocautery is contraindicated but is still often utilized; placing grounding pads as far away from the device can reduce the risk to device and patient. Bipolar cautery is favored. Implanted cardiac devices can interfere with SCS, but risks can be minimized. Neuraxial anesthesia can be attempted in a patient with implanted SCS, provided the device is not in the expected path. MRI labeling differences present the biggest difference among SCS manufactures. Medtronic’s SureScan SCS, Boston Scientific’s Precision system, St. Jude’s Proclaim, and Stimwave’s Freedome SCS are full body MRI compatible under specific conditions, while other manufacturers have labeling that restricts exams of the trunk and certain extremities. Limitations: This review was intended to be a comprehensive, cumulative review of recommendations for perioperative SCS management; however, the limitations of a review of this nature is the complete reliance on previously published research and the availability of these studies using the methods outlined. Conclusions: SCS is being used earlier in the treatment algorithm for patients with chronic pain. The anesthesia care team needs working knowledge of where the device resides in the neuraxial space and what risks different medical technologies pose to the patient and device. This understanding will lead to appropriate perioperative management which can reduce risk and improve patient outcomes. Key words: Spinal cord stimulation, perioperative management, MRI, anesthetic considerations, CT scan, interventional pain management

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Patient with a Spinal Cord Stimulator

Karri

Lee

Sun

et al. 2020

Guide to the Inpatient Pain Consult

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Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management

Cited by 33 publications

References 46 publications

Epidural Spinal Stimulation to Improve Bladder, Bowel, and Sexual Function in Individuals With Spinal Cord Injuries: A Framework for Clinical Research

Epidural Spinal Stimulation to Improve Bladder, Bowel, and Sexual Function in Individuals With Spinal Cord Injuries: A Framework for Clinical Research

Anesthetic Considerations and Perioperative Management of Spinal Cord Stimulators: Literature Review and Initial Recommendations

Patient with a Spinal Cord Stimulator

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