Cost-utility Analysis of Evoke Closed-loop Spinal Cord Stimulation for Chronic Back and Leg Pain.

OBJECTIVES: The effectiveness of Evoke closed-loop spinal cord stimulation (CL-SCS), a novel modality of neurostimulation, has been demonstrated in a randomized controlled trial (RCT). The objective of this cost-utility analysis was to develop a de novo economic model to estimate the cost-effectiveness of Evoke CL-SCS when compared with open-loop SCS (OL-SCS) for the management of chronic back and leg pain. METHODS: A decision tree followed by a Markov model was used to estimate the costs and outcomes of Evoke CL-SCS versus OL-SCS over a 15-year time horizon from the UK National Health Service perspective. A "high-responder" health state was included to reflect improved levels of SCS pain reduction recently reported. Results are expressed as incremental cost per quality-adjusted life year (QALY). Deterministic and probabilistic sensitivity analysis (PSA) was conducted to assess uncertainty in the model inputs. RESULTS: Evoke CL-SCS was estimated to be the dominant treatment strategy at ~5 years postimplant (ie, it generates more QALYs while cost saving compared with OL-SCS). Probabilistic sensitivity analysis showed that Evoke CL-SCS has a 92% likelihood of being cost-effective at a willingness to pay threshold of £20,000/QALY. Results were robust across a wide range of scenario and sensitivity analyses. DISCUSSION: The results indicate a strong economic case for the use of Evoke CL-SCS in the management of chronic back and leg pain with or without prior spinal surgery with dominance observed at ~5 years.

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

INTRODUCTION: Lumbar degenerative disease and the accompanying pain and dysfunction affect a significant number of patients in the USA and around the world. As surgery and innovation are moving towards minimally invasive treatments, this study looks to explore interspinous fixation as a standalone posterior approach to treat lumbar degenerative disc disease in the presence of neurogenic claudication and spinal stenosis. METHODS: This study was approved by an institutional review board (IRB) and is actively enrolling in a single-arm, multicenter, prospective, open-label fashion. Patients are followed with reporting at 3 months, and 12 months for primary endpoint analysis of efficacy and safety based on improved composite endpoints relative to baseline, with success defined as greater than 20 mm back pain reduction in Visual Analog Scale 100 mm (VAS) while standing or walking, greater than 20 mm leg pain reduction in VAS while standing or walking, Zurich Claudication Questionnaire (ZCQ) improvement of 0.5 or greater in two or three domains, Oswestry Disability Index (ODI) improvement of a least 10 points and no reoperations or revisions at the index level(s). Secondary endpoints included a multidimensional assessment in the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 and Patient Global Impression of Change (PGIC). RESULTS: In this interim 3-month analysis, 82% of patients reported they were improved from the procedure, while 65% of patients demonstrated clinical meaningful improvement in their pain and function, as defined by the VAS, ODI, and ZCQ. There was only one adverse event and no complications were identified at last clinic research follow-up visit. CONCLUSIONS: This interim analysis of the first 20% of the enrolled patients out to 3 months was to determine safety of the procedure and report on adverse events, acknowledging the heterogeneity of surgical specialty. Further follow-up and greater numbers are needed as the study is ongoing. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05504499.

Transfixation of the Sacroiliac Joint: Biomechanical Stability of a Dual-Implant Minimally Invasive Procedure.

BACKGROUND: Despite minimally invasive techniques for sacroiliac joint fixation, clinical challenges remain. The investigators hypothesized the studied technique will transfix the sacroiliac joint to a level comparable to the intact sacroiliac joint. OBJECTIVES: The study objective was to determine the dynamic stability of a square inter-joint implant using a triangular notch in opposing bone segments spanning the joint space. STUDY DESIGN: Stability was assessed by measuring micromotion using contralaterally placed transducers spanning the sacroiliac joint of a specimen during cyclic loading. SETTING: A porcine in-vitro model was equipped with micromotion transducers on the intact and surgically implanted sacroiliac joint. Cyclic loading was applied on the L4 vertebra and the recorded micromotion data at each sacroiliac joint was analyzed. METHODS: Porcine specimens from L3 to the sacrum including the pelvic ring were used to biomechanically evaluate the implantation technique. A novel technique consisting of a square inter-joint implant was placed so as to create a triangular stabilization notch within adjacent boney components of the sacroiliac joint. Displacement transducers were placed across implanted and contralateral porcine sacroiliac joint. Specimens were subjected to compressive loading between -10N and -100N followed by bending/rotation between 0.4Nm and 4.0Nm. Tests were conducted at 0.5Hz for 200 cycles. For each loading mode, transducer deflections (or rotations) were averaged at five-cycle intervals. Student's t-tests were used to compare fitted parameters between implanted and intact sacroiliac joint. RESULTS: In compression, implanted SIJ displayed reduced deflection compared to intact sacroiliac joint (P < 0.0001). In bending/rotation, initial rotation for the intact sacroiliac joint was increased compared to implanted sacroiliac joint (P < 0.0001). The computed Half-Life parameter represents the number of cycles at which the initial rotation decreases by 50% and was found to be statistically reduced for implanted sacroiliac joint as compared to intact sacroiliac joint. LIMITATIONS: The use of porcine specimens resulted in uniform and good quality bone purchase. Further study may be required to evaluate the technique in older patients where bone quality is reduced. CONCLUSIONS: Compared to the intact sacroiliac joint, the implant and procedure in this study demonstrated decreased motion under cyclic compression. Under rotation, the implanted sacroiliac joint displayed increased initial stability that subsequently normalized to intact sacroiliac joint values.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on Neuroablative Procedures for Patients With Cancer Pain.

BACKGROUND: Managing cancer pain once it is refractory to conventional treatment continues to challenge caregivers committed to serving those who are suffering from a malignancy. Although neuromodulation has a role in the treatment of cancer pain for some patients, these therapies may not be suitable for all patients. Therefore, neuroablative procedures, which were once a mainstay in treating intractable cancer pain, are again on the rise. This guideline serves as a systematic review of the literature of the outcomes following neuroablative procedures. OBJECTIVE: To establish clinical practice guidelines for the use of neuroablative procedures to treat patients with cancer pain. METHODS: A systematic review of neuroablative procedures used to treat patients with cancer pain from 1980 to April 2019 was performed using the United States National Library of Medicine PubMed database, EMBASE, and Cochrane CENTRAL. After inclusion criteria were established, full text articles that met the inclusion criteria were reviewed by 2 members of the task force and the quality of the evidence was graded. RESULTS: In total, 14 646 relevant abstracts were identified by the literature search, from which 189 met initial screening criteria. After full text review, 58 of the 189 articles were included and subdivided into 4 different clinical scenarios. These include unilateral somatic nociceptive/neuropathic body cancer pain, craniofacial cancer pain, midline subdiaphragmatic visceral cancer pain, and disseminated cancer pain. Class II and III evidence was available for these 4 clinical scenarios. Level III recommendations were developed for the use of neuroablative procedures to treat patients with cancer pain. CONCLUSION: Neuroablative procedures may be an option for treating patients with refractory cancer pain. Serious adverse events were reported in some studies, but were relatively uncommon. Improved imaging, refinements in technique and the availability of new lesioning modalities may minimize the risks of neuroablation even further.The full guidelines can be accessed at https://www.cns.org/guidelines/browse-guidelines-detail/guidelines-on-neuroablative-procedures-patients-wi.

Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.

BACKGROUND: Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain. METHODS: This multicentre, double-blind, parallel-arm, randomised controlled trial was done at 13 specialist clinics, academic centres, and hospitals in the USA. Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm; Oswestry Disability Index [ODI] score 41-80) who were refractory to conservative therapy, on stable pain medications, had no previous experience with spinal cord stimulation, and were appropriate candidates for a spinal cord stimulation trial were screened. Eligible patients were randomly assigned (1:1) to receive ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group). The randomisation sequence was computer generated with permuted blocks of size 4 and 6 and stratified by site. Patients, investigators, and site staff were masked to the treatment assignment. The primary outcome was the proportion of patients with a reduction of 50% or more in overall back and leg pain with no increase in pain medications. Non-inferiority (δ=10%) followed by superiority were tested in the intention-to-treat population at 3 months (primary analysis) and 12 months (additional prespecified analysis) after the permanent implant. This study is registered with ClinicalTrials.gov, NCT02924129, and is ongoing. FINDINGS: Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned (67 to each treatment group). The intention-to-treat analysis comprised 125 patients at 3 months (62 in the closed-loop group and 63 in the open-loop group) and 118 patients at 12 months (59 in the closed-loop group and 59 in the open-loop group). The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060). We observed no differences in safety profiles between the two groups. The most frequently reported study-related adverse events in both groups were lead migration (nine [7%] patients), implantable pulse generator pocket pain (five [4%]), and muscle spasm or cramp (three [2%]). INTERPRETATION: ECAP-controlled closed-loop stimulation provided significantly greater and more clinically meaningful pain relief up to 12 months than open-loop spinal cord stimulation. Greater spinal cord activation seen in the closed-loop group suggests a mechanistic explanation for the superior results, which aligns with the putative mechanism of action for spinal cord stimulation and warrants further investigation. FUNDING: Saluda Medical.

Nonawake vs Awake Placement of Spinal Cord Stimulators: A Prospective, Multicenter Study Comparing Safety and Efficacy.

BACKGROUND: Spinal cord stimulation (SCS) is a common intervention for managing intractable pain. Generally, leads are implanted in a minimally invasive procedure with verbal feedback regarding the location and nature of generated paresthesias by active stimulation; in this way their optimal location can be confirmed. However, lead placement under general anesthesia can have additional benefits. OBJECTIVE: To investigate the outcomes of awake vs asleep lead placement procedures. METHODS: In this prospective multicenter open label trial, subjects were assigned to undergo asleep (n = 19) or awake (n = 11) SCS implantations in a nonrandomized fashion. Subjects received paddle leads following laminotomy. The process for intraoperative programming differed between the groups: awake subjects participated by verbally reporting on pain-paresthesia overlap, while for asleep subjects, paresthesia location was inferred based on electromyographic monitoring. RESULTS: Operative time was shorter for the asleep group compared to the awake group (88.9 ± 51.2 min vs 125.2 ± 37.9, respectively; P = .018), as well as 27% less total time spent in the operating room (95.4 ± 48.6 min vs 130.6 ± 39.9; P = .014). At 6 wk postimplant, subjects in the asleep group had better pain-paresthesia overlap than the awake group (83.5% ± 19.8 coverage vs 46.6% ± 44.5, respectively; P = .05) and fewer extraneous paresthesia (16.7% ± 23.1 vs 71.2% ± 30.3; P < .001). Both groups had equivalent levels of pain relief (more than 50%) after 6 and 24 wk of treatment. There were 2 adverse events in the asleep group compared to 6 in the awake group. CONCLUSION: Electrophysiological monitoring during asleep SCS implantation is a robust tool becoming more frequently used. This comparative prospective series demonstrates that asleep placement allows for shorter procedure and operating room times with superior paresthesia coverage profiles, while maintaining lower adverse events and equal clinical outcomes for pain relief.

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.

Evaluation of Patient Perspectives Toward Awake, Frame-Based Deep-Brain Stimulation Surgery.

BACKGROUND: Deep brain stimulation (DBS) is an effective therapeutic modality; however, only a percentage of eligible patients undergo the procedure. OBJECTIVES: To study patients' perspectives toward DBS surgery. METHODS: A survey was sent to 95 consecutive adult patients who underwent DBS surgery for Parkinson disease, essential tremor, or dystonia; the response rate was 73% (69 patients). Post-hoc analyses were performed to evaluate factors that led to favorable outcomes. The average time between surgical procedure to survey completion was 16 months. RESULTS: Awake surgery, use of a rigid head frame, and having hair clipped were seldom reported as major deterrents to surgery. Patients retrospectively reported an average comfort level of 8.3 ± 1.8 during surgery. The average comfort level with head frame placement was reported as 5.2 ± 3.15, and patients reporting discomfort with the frame nonetheless reported overall comfort with the procedure (8.7 ± 1.8). An analysis of satisfaction revealed that 90% of patients would recommend the procedure to a family member or friend and that 78% of patients would undergo the procedure again. A post-hoc analysis of patients who were not satisfied with the procedure revealed that this subset reported significantly less overall comfort (6.9 ± 1.7, P = 0.0003) and were less likely to report that the goals and expectations of surgery were clearly discussed before surgery (P = 0.0004). CONCLUSIONS: Frame placement, awake surgery, and head shaving did not appear to play a significant role in most patients' decision-making process to undergo DBS, as analyzed in this retrospective cohort. The majority of patients were satisfied with the procedure and reported being comfortable. Managing goals and expectations preoperatively played a significant role in ultimate overall satisfaction.

Spinal Cord Stimulator Implant Infection Rates and Risk Factors: A Multicenter Retrospective Study.

OBJECTIVES: Spinal cord stimulation is an evidence-based treatment for a number of chronic pain conditions. While this therapy offers improvement in pain and function it is not without potential complications. These complications include device failure, migration, loss of therapeutic paresthesia, and infection. This article looked to establish a modern infection rate for spinal cord stimulators, assess the impact of known risk factors for surgical site infections and to determine the impact of certain preventative measures on the rate of infection. METHODS: After institutional review board approval, a multisite, retrospective review was conducted on 2737 unique implants or revisions of SCS systems. Patient demographics, risk factors including diabetes, tobacco use, obesity, revision surgery, trial length, implant location, implant type, surgeon background, prophylactic antibiotic use, utilization of a occlusive dressing, and post-operative antibiotic use were recorded and analyzed. RESULTS: The overall infection rate was 2.45% (n = 67). Diabetes, tobacco use, and obesity did not independently increase the rate of infection. Revision surgeries had a trend toward higher infection rate; however, this did not meet statistical significance. There was no difference in the rate of infection between implants performed by physicians of different base specialties, cylinder leads vs. paddle leads, or between different prophylactic antibiotics. Implants performed at academic centers had a higher rate of infection when compared to implants performed in nonacademic settings. When patients received an occlusive dressing or post-operative antibiotics they had a lower rate of infection. CONCLUSIONS: The infection rate (2.45%) reported in this study is lower than the previously reported rates (3-6%) and are on par with other surgical specialties. This study did not show an increased rate of infection for patients that used tobacco, had diabetes or were obese. It's possible that given the low overall infection rate a larger study is needed to establish the true impact of these factors on infection. In addition, this study did not address the impact of poorly controlled diabetes mellitus (elevated hemoglobin A1c) vs. well-controlled diabetes. It can be concluded from this study that utilizing an occlusive dressing over the incision in the post-operative period decreases the rate of infection and should become the standard of care. This study also demonstrated the positive impact of post-operative antibiotics in decreasing the rate of infection. Studies in other surgical specialties have not shown this impact which would suggest that further research is needed.

The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines.

INTRODUCTION: Pain treatment is best performed when a patient-centric, safety-based philosophy is used to determine an algorithmic process to guide care. Since 2007, the International Neuromodulation Society has organized a group of experts to evaluate evidence and create a Polyanalgesic Consensus Conference (PACC) to guide practice. METHODS: The current PACC update was designed to address the deficiencies and innovations emerging since the previous PACC publication of 2012. An extensive literature search identified publications between January 15, 2007 and November 22, 2015 and authors contributed additional relevant sources. After reviewing the literature, the panel convened to determine evidence levels and degrees of recommendations for intrathecal therapy. This meeting served as the basis for consensus development, which was ranked as strong, moderate or weak. Algorithms were developed for intrathecal medication choices to treat nociceptive and neuropathic pain for patients with cancer, terminal illness, and noncancer pain, with either localized or diffuse pain. RESULTS: The PACC has developed an algorithmic process for several aspects of intrathecal drug delivery to promote safe and efficacious evidence-based care. Consensus opinion, based on expertise, was used to fill gaps in evidence. Thirty-one consensus points emerged from the panel considerations. CONCLUSION: New algorithms and guidance have been established to improve care with the use of intrathecal drug delivery.

Revision Surgery of Deep Brain Stimulation Leads.

INTRODUCTION: Deep brain stimulation (DBS) is widely used for various movement disorders. DBS lead revisions are becoming more common as the indications and number of cases increases. METHODS: Patients undergoing DBS lead revisions at a single institution were retrospectively analyzed based on diagnosis, reason for revision, where the lead was relocated, and surgical technique. RESULTS: We reviewed 497 consecutive DBS lead placements and found that there was need for 25 DBS lead revisions with at least six months of follow-up. Loss of efficacy and development of adverse effects over time were the most common reasons for lead revision across all diagnosis. Lead malfunction was the least common. Ten patients requiring 19 DBS lead revisions that underwent their original surgery at another institution were also analyzed. Surgical technique dictated replacing with a new lead while maintaining brain position and tract with the old lead until final placement. Methods to seal exposed wire were developed. CONCLUSION: Surgical technique, as well as variable options are important in lead revision and can be dictated based on reason for revision. Over time patients who have had adequate relief with DBS placement may experience loss of efficacy and development of adverse effects requiring revision of the DBS lead to maintain its effects.

Deep Brain Stimulation for Chronic Pain.

Deep brain stimulation (DBS) is a commonly performed procedure and has been used for the treatment of chronic pain since the early 1970s. A review of the literature was performed utilizing the PubMed database evaluating the use of DBS in the treatment of various pain syndromes. Literature over the last 30 years was included with a focus on those articles in the last 10 years dealing with pain conditions with the highest success as well as the targets utilized for treatment. DBS carries favorable results for the treatment of chronic pain, especially when other methods have not been successful such as medications, conservative measures, and extracranial procedures. Various chronic pain conditions reported in the literature respond to DBS including failed back surgery syndrome (FBSS), phantom limb pain, and peripheral neuropathic pain with a higher response rate for those with nociceptive pain compared to neuropathic pain. Cephaligias have promising results, with cluster headaches carrying the best success rates. DBS plays a role in the treatment of chronic pain conditions. Although considered investigational in the USA, it carries promising success rates in a recalcitrant patient population.

Optimizations and Nuances in Neurosurgical Technique for the Minimization of Complications in Subdural Electrode Placement for Epilepsy Surgery.

BACKGROUND: Surgical intervention is an important therapeutic option for patients with intractable epilepsy and a well-characterized epileptogenic focus. Invasive monitoring with subdural electrodes is an effective technique for localizing epileptogenic foci. Previous studies reported varying complication rates, and these may deter more widespread adoption. We present potentially valuable technical nuances that may be associated with low complication rates. We assess the potential contribution of specific aspects of surgical technique to the reduction of complication rates. METHODS: We retrospectively reviewed patients from the Rush University Surgical Epilepsy database who underwent craniotomies for invasive electroencephalography monitoring for medically intractable epilepsy using our technique. We analyzed and compared complication rates and techniques with those reported elsewhere. RESULTS: The sample group comprised 127 consecutive patients who underwent electrode implantation. The average monitoring period was 6 days. There were 5 complications (3.9%), including 1 subdural hematoma requiring surgery (0.8%), 1 infection (0.8%), 2 pulmonary emboli (1.6%), and 1 deep vein thrombosis (0.8%). There were no symptomatic cerebrospinal fluid leaks or permanent neurologic complications. These results compare favorably with published results. Analysis and comparison of our technique anecdotally suggest the importance of use of a subgaleal drain throughout the monitoring period, postoperative antibiotic coverage for 1 week, meticulous hemostasis, and secure suturing of the electrodes to the dura mater to minimize trauma to superficial vessels as potential contributors to improved complication rates. CONCLUSIONS: A very low incidence of major morbidity can be achieved in invasive electroencephalography monitoring with this protocol.

Radiosurgery for the treatment of dominant hemisphere periventricular heterotopia and intractable epilepsy in a series of three patients.

Periventricular heterotopia (PVH) is a neuronal migration disorder characterized by masses of gray matter located along the lateral ventricles that commonly cause epilepsy. The benefit of surgical resection of the PVH has been demonstrated in case reports to date; however, the location of the PVH in the paratrigonal region of the lateral ventricles can present significant surgical challenges. Noninvasive modalities of ablating this epileptogenic focus must therefore be considered. We present a small series of three patients who underwent stereotactic radiosurgery (SRS) for inoperable unilateral dominant hemisphere PVHs in order to illustrate the potential benefits and risks of this treatment modality. A total dose of 37.5-65 Gy resulted in seizure freedom for at least 14 months at the time of their last follow-up, even in patients harboring a second independent epileptic focus. Whether intracranial electrode recording truly offers added value is therefore uncertain. The two patients who received higher radiation doses suffered from symptomatic radiation necrosis and associated cerebral edema, requiring further medical intervention, and persistent monocular visual loss in one patient. While a longer interval prior to re-treatment may have been attempted, neither patient demonstrated radiographic findings typically associated with seizure remission. Refractory epilepsy due to PVH may be successfully treated with radiation therapy; but further work is needed to define the optimal dosing parameters in order to lower toxicity to normal tissue.

Awake vs. asleep placement of spinal cord stimulators: a cohort analysis of complications associated with placement.

INTRODUCTION: Patients will typically undergo awake surgery for permanent implantation of spinal cord stimulation (SCS) in an attempt to optimize electrode placement using patient feedback about the distribution of stimulation-induced paresthesia. The present study compared efficacy of first-time electrode placement under awake conditions with that of neurophysiologically guided placement under general anesthesia. METHODS: A retrospective review was performed of 387 SCS surgeries among 259 patients which included 167 new stimulator implantation to determine whether first time awake surgery for placement of spinal cord stimulators is preferable to non-awake placement. RESULTS: The incidence of device failure for patients implanted using neurophysiologically guided placement under general anesthesia was one-half that for patients implanted awake (14.94% vs. 29.7%). CONCLUSION: Non-awake surgery is associated with fewer failure rates and therefore fewer re-operations, making it a viable alternative. Any benefits of awake implantation should carefully be considered in the future.