Defining Short- and Long-Term Programming Requirements in Patients Treated With 10-kHz Spinal Cord Stimulation.

OBJECTIVES: High-frequency spinal cord stimulation (10-kHz SCS) has been shown to be an effective treatment for refractory low back pain and neck pain with and without limb pain in clinical trial and real-world studies. However, limited information is available in the literature on the type and frequency of programming parameters required to optimize pain relief. MATERIALS AND METHODS: Retrospective trial and postimplant clinical and system device data were analyzed from consecutive patients with neck pain and low back pain, with and without limb pain, from a single clinical site, including both thoracic and cervical lead placement. Best bipole, stimulation parameters, and outcomes, including pain relief, change in opioid medication use, sleep, and daily function, were analyzed. RESULTS: Of the 92 patients in the trial, 70 received a permanent implant. Of these, the mean duration of follow-up was 1.8 ± 1.3 years. Pain relief of ≥50% at the last follow-up was achieved by 64% of patients implanted; in addition, 65% reduced their opioid medication use; 65% reported improved sleep, and 71% reported improved function. There was some consistency between the "best" bipole at trial and permanent implant, with 82% of patients within one bipole location, including 54% of permanent implants who were using the same best bipole as at trial. After permanent implant, device reprogramming was minimal, with ≤one reprogramming change per patient per quarter required to maintain pain outcomes. CONCLUSIONS: In the study, 10-kHz SCS was an effective therapy for treating chronic pain, whereby a high responder rate (≥50% pain relief) was achieved with short time to pain relief in trial and maintained with limited device programming after permanent implant. The data presented here provide insight into the programming required during the trial and implant stages to obtain and maintain therapeutic efficacy.

Differential Target Multiplexed Spinal Cord Stimulation: A UK Cost-Effectiveness Analysis.

OBJECTIVES: The aim of this economic analysis was to evaluate the cost-effectiveness of differential target multiplexed spinal cord stimulation (DTM-SCS) for treating chronic intractable low back pain, compared with conventional spinal cord stimulation (C-SCS) and conservative medical management (CMM), by updating and expanding the inputs for a previously published cross-industry model. MATERIALS AND METHODS: This model comprised a 12-month decision-tree phase followed by a long-term Markov model. Costs and outcomes were calculated from a UK National Health Service perspective, over a base-case horizon of 15 years and up to a maximum of 40 years. All model inputs were derived from published literature or other deidentified sources and updated to reflect recent clinical trials and costs. Deterministic and one-way sensitivity analyses were performed to calculate costs and quality-adjusted life-years (QALYs) across the 15-year time horizon and to explore the impact of individual parameter variability on the cost-effectiveness results. Probabilistic sensitivity analysis was undertaken to explore the impact of joint parameter uncertainty on the results. RESULTS: DTM-SCS was the most cost-effective option from a payer perspective. Compared with CMM alone, DTM-SCS was associated with an incremental cost-effectiveness ratio (ICER) of £6101 per QALY gained (incremental net benefit [INB] = £21,281). The INB for C-SCS compared with CMM was lower than for DTM-SCS, at £8551. For the comparison of DTM-SCS and C-SCS, an ICER of £897 per QALY gained was calculated, with a 99.5% probability of cost-effectiveness at a £20,000 per QALY threshold. CONCLUSIONS: Among patients with low back pain treated over a 15-year follow-up period, DTM-SCS and C-SCS are cost-effective compared with CMM, from both payer and societal perspectives. DTM-SCS is associated with a lower ICER than that of C-SCS. Wider uptake of DTM-SCS in the UK health care system is warranted to manage chronic low back pain.

Current opinion: optimize radiofrequency ablation through electrophysiological principles, modeling, and clinical recommendations.

PURPOSE OF REVIEW: This article aims to empower the interventional pain physician to utilize RFA effectively by explaining the technical and electrophysiological features of monopolar, bipolar, and internally cooled RFA. Scientific data are used to provide advice on the effective, well tolerated, and rational application of these techniques. Moreover, physicians need to know how to analyze and generalize ex-vivo and in-vivo models to the clinical setting to optimize clinical outcomes. RECENT FINDINGS: Recent studies suggest that there are many ways to enhance the technical effectiveness of interventional pain medicine RFA through adjustments in the equipment selection and settings and the local tissue conditions specific to the targeted anatomical area. These modifications could assist in improving clinical and safety outcomes. SUMMARY: To optimize both the efficacy and safety of RFA, physicians must understand, conceptualize, interpret, and clinically translate the basic science of RFA. This knowledge is crucial for optimizing equipment selection and settings based on target location to enhance clinical outcomes and limit technical failures.

Prevalence of Staphylococcus aureus Colonization in Spinal Cord Stimulator Surgical Procedures.

OBJECTIVES: To determine the prevalence of Staphylococcus aureus (S aureus) colonization for spinal cord stimulation (SCS) surgical patients and to identify specific at-risk patient populations. MATERIALS AND METHODS: Following Institutional Review Board approval, a retrospective review identified 232 SCS surgical patients. Preoperative Saureus nasal swab results were reviewed. Preoperative characteristics that included age at the time of procedure, body mass index, and medical comorbidities including, but not limited to, diabetes, smoking, obesity, and a history of surgical site infections were identified for each patient. The Clopper-Pearson method was used to calculate 95% CIs for proportions, and Fisher exact tests were used to estimate odds ratios (95% CI) for patient characteristics. RESULTS: The 232 SCS surgical patients who were identified underwent 396 unique neuromodulation procedures, with 100% screened for methicillin-resistant Saureus (MRSA) and 98.3% screened for methicillin-sensitive Saureus (MSSA). Overall, 23.3% (n = 54/232, 95% CI: 18.0%-29.3%) of patients were preoperatively colonized with Saureus, according to the following classification: 4.3% (n = 10/232, 95% CI: 2.1%-7.8%) were positive for MRSA and 20.2% (n = 46/228, 95% CI: 15.2%-26.0%) were positive for MSSA. Two patients were colonized with both MRSA and MSSA. Furthermore, 95.7% (n = 44/46, 95% CI: 85.2%-99.5%) of patients that were MSSA colonized were MRSA negative. Analysis of independent patient characteristics revealed anxiety and hypothyroidism as the only conditions associated with significantly increased odds of MRSA and MSSA colonization, respectively. CONCLUSIONS: Staphylococcusaureus colonization was present in >20% of SCS patients, with MSSA carriage occurring at a rate nearly five times that of MRSA. MRSA screening alone would not have identified >90% of Saureus-colonized patients with only MSSA carrier status. Therefore, consideration should be given to preoperative screening for both MRSA and MSSA. Since limited patient characteristics were associated with greater risk for Saureus colonization, all patient populations should be screened.

Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group.

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.

The Use of Contrast Agents in Interventional Pain Procedures: A Multispecialty and Multisociety Practice Advisory on Nephrogenic Systemic Fibrosis, Gadolinium Deposition in the Brain, Encephalopathy After Unintentional Intrathecal Gadolinium Injection, and Hypersensitivity Reactions.

This Practice Advisory presents a comprehensive and evidence-based set of position statements and recommendations for the use of contrast media in interventional pain procedures. The advisory was established by an international panel of experts under the auspices of 11 multinational and multispecialty organizations based on a comprehensive review of the literature up to December 31, 2019. The advisory discusses the risks of using gadolinium-based contrast agents. These include nephrogenic systemic fibrosis, gadolinium brain deposition/retention, and encephalopathy and death after an unintentional intrathecal gadolinium injection. The advisory provides recommendations on the selection of a specific gadolinium-based contrast agent in patients with renal insufficiency, those who had multiple gadolinium-enhanced magnetic resonance imaging examinations, and in cases of paraspinal injections. Additionally, recommendations are made for patients who have a history of mild, moderate, or severe hypersensitivity reactions to contrast medium.

Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study.

BACKGROUND AND OBJECTIVES: Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach. MATERIALS AND METHODS: Vectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months. Secondary endpoints included changes in low back and leg pain, quality of life (European Quality of Life - Five Dimensions, EQ-5D-5L), disability (Oswestry Disability Index, ODI), individual subject goals, and subject satisfaction. RESULTS: There was a significant reduction in overall pain (VAS; 45.4 mm) through the three-month visit, which was sustained through 12 months. At 12 months, 79% of subjects had ≥50% improvement in at least one pain domain (overall, lowback or leg) with 85% of subjects reporting therapy satisfaction. There was a decrease in disability and an improvement in quality of life with 70% of subjects achieving a personal activity goal by the three-month visit. CONCLUSIONS: Long-term pain relief and improvement in quality of life and function were achieved when following a standardized workflow. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03345472.

A Systematic Literature Review of Spine Neurostimulation Therapies for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of spinal cord stimulation (SCS) for pain. DESIGN: Grade the evidence for SCS. METHODS: An international, interdisciplinary work group conducted literature searches, reviewed abstracts, and selected studies for grading. Inclusion/exclusion criteria included randomized controlled trials (RCTs) of patients with intractable pain of greater than one year's duration. Full studies were graded by two independent reviewers. Excluded studies were retrospective, had small numbers of subjects, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: SCS has Level 1 evidence (strong) for axial back/lumbar radiculopathy or neuralgia (five high-quality RCTs) and complex regional pain syndrome (one high-quality RCT). CONCLUSIONS: High-level evidence supports SCS for treating chronic pain and complex regional pain syndrome. For patients with failed back surgery syndrome, SCS was more effective than reoperation or medical management. New stimulation waveforms and frequencies may provide a greater likelihood of pain relief compared with conventional SCS for patients with axial back pain, with or without radicular pain.

A Systematic Literature Review of Dorsal Root Ganglion Neurostimulation for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain. DESIGN: Grade the evidence for DRG stimulation. METHODS: An international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: DRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies. CONCLUSIONS: Moderate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.

Implementation of the North American Neuromodulation Society Mentorship Program: Recommendations and Survey Results of Participants.

INTRODUCTION: Despite Accredited Counsel of Graduate Medical Education (ACGME) guidance and criteria, there remains variability in training both within each specialty and across the specialties involved in the delivery of neuromodulation. NANS advocates for the efficacious and safe the implementation of neuromodulation and therefore an educational mentoring program with a defined educational platform is needed. MATERIALS AND METHODS: This is a structured, patient centered, and evidence-based approach mentorship program performed more than one year. Mentor/Mentee pairs started in 2015 and data collected were more than a five-year period. RESULTS: There was a 70%-86% response rate on each survey administered. All except one respondent reported that the mentorship program met their previously declared expectations. All the respondents self-reported at least a moderate increase in their knowledge in the field of neuromodulation while 54% of the respondents felt their knowledge in the field to have greatly increased. Most respondents reported an increase in the number of spinal cord stimulator trials and permanent implants performed after the mentorship program. The self-reporting of mentees competencies at the conclusion of the program was statistically significant for higher competency scores in all areas assessed. CONCLUSIONS: The NANs mentorship program met expectations and implementation goals by improving neuromodulation education including covering patient care, delivery, and training topics. The mentoring program provides a structured framework for extending formal physician neuromodulation education outside of direct fellowship training.

Spinal Cord Stimulation Infection Rate and Incremental Annual Expenditures: Results From a United States Payer Database.

OBJECTIVES: Surgical site infections (SSIs) result in significant negative clinical and economic outcomes. The objective of this study is to estimate annual health expenditures associated with spinal cord stimulation (SCS)-related infections. MATERIALS AND METHODS: Data from the Truven MarketScan® databases were used to identify patients with an SCS implant (2009-2014) and a continuous health plan enrollment for at least 12-months before and after implant (index date). Annual expenditures were estimated for patients with a device-related infection vs. those without infection since index date. A generalized linear model estimated annual expenditures attributable to device-related infection. Multivariable expenditure models were conducted separately for patients in initial and replacement groups, controlling for demographics, comorbidities, and clinical characteristics. RESULTS: The study included 6615 patients. Multivariable expenditure models revealed that patients with infection have higher annual expenditures than patients without infection. Estimated incremental annual healthcare expenditures for patients with an infection were $59,716 (95% CI: $48,965-$69,480) for initial implanted patients and $64,833 (95% CI: $37,377-$86,519) for replacement patients. Only 26% of patients who were explanted for infection underwent a reimplant. CONCLUSIONS: These results show the substantial expenditure burden associated with an SCS-related infection. Management of SCS-related infection is important from both clinical and economic standpoints. The economic and clinical data presented here reinforce the need for additional research and strategies for healthcare providers to minimize SCS infections. Future economic research is needed to further define the specific economic cost drivers associated with the extensive expenditure burden.

Spinal Cord Stimulation Infection Rate and Risk Factors: Results From a United States Payer Database.

OBJECTIVE: Surgical site infections can cause negative clinical and economic outcomes. A recent international survey on Spinal Cord Stimulation (SCS) infection control practices demonstrated low compliance with evidence-based guidelines. This study defines infection rate for SCS implants and identifies infection risk factors. MATERIALS AND METHODS: A retrospective analysis of the MarketScan® Databases identified patients with SCS implant (2009-2014) and continuous health plan enrollment for ≥12-months (12 m) preimplant. For logistic regression analysis, patients were enrolled for 12 m postimplant. Kaplan-Meier and Cox Proportional Hazard survival analyses assessed time to infection, with infection rate reported at 12 m postimplant. Logistic regression characterized risk factors based on demographics, comorbidities, and clinical characteristics. RESULTS: In the logistic regression (n = 6615), 12 m device-related infection rate was 3.11%. Infection risk factors included peripheral vascular disease (OR, 1.784; 95% CI: 1.011-3.149; p = 0.0457) and infection in 12 m before implant (OR, 1.518; 95% CI: 1.022-2.254; p = 0.0386). The odds of patients experiencing an infection decreased by 3.2% with each additional year of age (OR, 0.968; 95% CI: 0.952-0.984; p < 0.0001). Survival analysis (n = 13,214) identified prior infection (HR, 1.770; 95% CI: 1.342-2.336; p < 0.0001) as a risk factor. Infection was less likely in older patients (HR, 0.974; 95% CI: 0.962-0.986; p < 0.0001). Expected risk factors including obesity, diabetes, and smoking were not identified as risk factors in this analysis. There was no significant difference between infection rate for initial and replacement implants. CONCLUSIONS: The 3.11% SCS-related infection rate within 12 m of implant emphasizes the need for improved infection control practices. Research is needed to limit SCS infections in younger patients and those with infection history.

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment.

BACKGROUND: Lumbar spinal stenosis (LSS) can lead to compression of neural elements and manifest as low back and leg pain. LSS has traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural spinal injections) and invasive (surgical decompression) options. Recently, several minimally invasive procedures have expanded the treatment options. METHODS: The Lumbar Spinal Stenosis Consensus Group convened to evaluate the peer-reviewed literature as the basis for making minimally invasive spine treatment (MIST) recommendations. Eleven consensus points were clearly defined with evidence strength, recommendation grade, and consensus level using U.S. Preventive Services Task Force criteria. The Consensus Group also created a treatment algorithm. Literature searches yielded 9 studies (2 randomized controlled trials [RCTs]; 7 observational studies, 4 prospective and 3 retrospective) of minimally invasive spine treatments, and 1 RCT for spacers. RESULTS: The LSS treatment choice is dependent on the degree of stenosis; spinal or anatomic level; architecture of the stenosis; severity of the symptoms; failed, past, less invasive treatments; previous fusions or other open surgical approaches; and patient comorbidities. There is Level I evidence for percutaneous image-guided lumbar decompression as superior to lumbar epidural steroid injection, and 1 RCT supported spacer use in a noninferiority study comparing 2 spacer products currently available. CONCLUSIONS: MISTs should be used in a judicious and algorithmic fashion to treat LSS, based on the evidence of efficacy and safety in the peer-reviewed literature. The MIST Consensus Group recommend that these procedures be used in a multimodal fashion as part of an evidence-based decision algorithm.

Association of Opioid Usage with Spinal Cord Stimulation Outcomes.

Study Design: Observational study using insurance claims. Objective: To quantify opioid usage leading up to spinal cord stimulation (SCS) and the potential impact on outcomes of SCS. Setting: SCS is an interventional therapy that often follows opioid usage in the care continuum for chronic pain. Methods: This study identified SCS patients using the Truven Health MarketScan databases from January 2010 to December 2014. The index event was the first occurrence of a permanent SCS implant. Indicators of opioid usage at implant were daily morphine equivalent dose (MED), number of unique pain drug classes, and diagnosis code for opioid abuse. System explant was used as a measure of ineffective SCS therapy. Multivariate logistic regression was used to analyze the effect of pre-implant medications on explants. Results: A total of 5,476 patients (56 ± 14 years; 60% female) were included. SCS system removal occurred in 390 patients (7.1%) in the year after implant. Number of drug classes (odds ratio [OR] = 1.11, P = 0.007) and MED level (5-90 vs < 5 mg/d: OR = 1.32, P = 0.043; ≥90 vs < 5 mg/d: OR = 1.57, P = 0.005) were independently predictive of system explant. Over the year before implant, MED increased in 54% (stayed the same in 21%, decreased in 25%) of patients who continued with SCS and increased in 53% (stayed the same in 20%, decreased in 27%) of explant patients (P = 0.772). Over the year after implant, significantly more patients with continued SCS had an MED decrease (47%) or stayed the same (23%) than before (P < 0.001). Conclusions: Chronic pain patients receive escalating opioid dosage prior to SCS implant, and high-dose opioid usage is associated with an increased risk of explant. Neuromodulation can stabilize or decrease opioid usage. Earlier consideration of SCS before escalated opioid usage has the potential to improve outcomes in complex chronic pain.

The Efficacy of High-Density Spinal Cord Stimulation Among Trial, Implant, and Conversion Patients: A Retrospective Case Series.

OBJECTIVES: Methods of energy delivery for traditional spinal cord stimulation (SCS) systems consist of adjusting programming parameters to affect the total charge delivered per unit time. One high electrical charge delivery method being considered is subthreshold high density (HD) programming. To date, there is limited clinical evidence for the efficacy and safety of paresthesia-free HD programming. The aim of this study was to examine the efficacy and safety of HD programming. MATERIALS AND METHODS: A retrospective review was performed on HD-programmed SCS patients with a minimum of one year follow-up. Three HD categories were examined: trial, implant, and conversion (i.e., patients with conventional SCS who were converted to HD settings). High density amplitude settings were below paresthesia threshold. Patients were classified as responders to HD if they preferred the paresthesia-free HD setting to the conventional setting and demonstrated ≥50% pain reduction compared to baseline pain score on delivery and no-stimulation related neurological deficit. Adverse effects were documented. RESULTS: Seventeen patients were identified, including 11 conversion patients and six patients who had positive response to HD programming during the trial and then were implanted. For trial/implant and conversion patients, both HD and conventional programming significantly reduced the numerical pain rating scale (NRPS) compared to baseline (p ≤ 0.026). Pain scores were not significantly different between the HD and traditional programs for the trial (p = 0.060), implant (p = 0.632), and conversion categories (p = 0.658). Through at least 12 months of follow-up, eight (47%) patients continued to be HD responders. CONCLUSIONS: In subpopulations, HD programming may be a viable option to deliver subthreshold pain reduction. Randomized, controlled trials with extended follow-up are needed to further evaluate HD programming.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.

INTRODUCTION: The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce the risk of complications and improve the efficacy of neurostimulation. The first series of papers, published in 2014, focused on the general principles of appropriate practice in the surgical implantation of neurostimulation devices. The NACC was reconvened in 2014 to address specific patient care issues, including bleeding and coagulation. METHODS: The INS strives to improve patient care in an evidence-based fashion. The NACC members were appointed or recruited by the INS leadership for diverse expertise, including international clinical expertise in many areas of neurostimulation, evidence evaluation, and publication. The group developed best practices based on peer-reviewed evidence and, in the absence of specific evidence, on expert opinion. Recommendations were based on international evidence in accordance with guideline creation. CONCLUSIONS: The NACC has recommended specific measures to reduce the risk of bleeding and neurological injury secondary to impairment of coagulation in the setting of implantable neurostimulation devices in the spine, brain, and periphery.

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management.

INTRODUCTION: The use of neurostimulation for pain has been an established therapy for many decades and is a major tool in the arsenal to treat neuropathic pain syndromes. Level I evidence has recently been presented to substantiate the therapy, but this is balanced against the risk of complications of an interventional technique. METHODS: The Neurostimulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society convened an international panel of well published and diverse physicians to examine the best practices for infection mitigation and management in patients undergoing neurostimulation. The NACC recommendations are based on evidence scoring and peer-reviewed literature. Where evidence is lacking the panel added expert opinion to establish recommendations. RESULTS: The NACC has made recommendations to improve care by reducing infection and managing this complication when it occurs. These evidence-based recommendations should be considered best practices in the clinical implantation of neurostimulation devices. CONCLUSION: Adhering to established standards can improve patient care and reduce the morbidity and mortality of infectious complications in patients receiving neurostimulation.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.