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Objectives: Spinal cord stimulation (SCS) has become a mainstay in the continuum of care for patients suffering from chronic neuropathic pain of the trunk and limbs. Options for placing these devices have included a percutaneous method of using an epidural needle to place a cylindrical (percutaneous) lead to stimulate the spinal cord, or an open laminotomy method for placing a paddle lead at the location of the surgical decompression of the laminae. Both of these methods have been successful in a high percentage of patients, but neither have been ideal. Limitations of the percutaneous leads have been inefficiency of power delivery, inability to achieve desired depth of stimulation in the spinal cord, occasional lead migration and difficulty covering complex pain patterns. Limitations of the paddle lead have been the need for surgical laminotomy, inability to steer the lead once placed, limits on placement in the vicinity of the surgical decompression, and a perceived risk of increased bleeding and trauma to the tissue. These factors have led many minimally invasive spine specialists to seek new options for SCS. This paper presents the initial US experience with a newly approved device to place both paddle leads, and multi-lead arrays into the epidural space via a percutaneous Seldinger-guided approach through a single needle placement. We will both describe the technique and review the outcomes of some of the early cases. Materials and Methods: After Investigational Review Board clearance, patients consented to data collection in a prospective fashion regarding the use of a new percutaneous epidural introducer (Epiducer, St. Jude Neurological, Minneapolis, MN, USA) to place paddle leads and complex lead arrays. The patients underwent education regarding expectations and risks of the procedure consistent with our normal preoperative period. Patients underwent preoperative anesthesia screening and proper testing as outlined by the Joint Commission on Hospital Accreditation, and were given the opportunity to ask questions concerning the procedure. Once the patient wished to move forward, they were consented using the approved case reporting form and followed during the course of their care. The initial cases were performed in West Virginia with subsequent cases following at the other centers involved in this analysis. The outcomes of this analysis focused on three areas: 1 The technical success in placing the percutaneous sheath. This included the ability to successfully complete: • epidural access with a 14-gauge Tuohy needle • ability to place a styleted guidewire • ability to introduce the introduction system over the wire into the epidural space • ability to remove the guidewire and introduction tip leaving the 10-gauge sheath intact 2 The ability to place the desired lead or leads into the epidural space via the percutaneous introduction sheath. 3 The presence of any major adverse event which were defined as: • nerve injury • paraplegia • worsening of baseline pain • epidural hematoma • epidural infection • dural tear • dural rent • retained device that could not be removed This information was carefully recorded for each implant, and summarized in this communication. Results: During the initial 30 days of the evaluation period, 43 epidural introduction systems were attempted in 38 patients. In patients in whom more than one paddle lead was placed, the system required the reinsertion of the guidewire through the Epiducer, removal of the Epiducer, and rewiring over the guidewire. This is necessary because the diameter of a paddle lead does not allow two or three leads to be placed without rewiring the system. The success of placement was 42/43, with inability to access the epidural space in one patient in whom ligamentum flavum hypertrophy was present on the preoperative imaging study. In all patients, the system was placed at the L1–L2 level, or lower, based on the Food and Drug Administration labeling. The total numbers of leads placed were 75, with both paddle and percutaneous arrays implanted successfully. There were no adverse events during this prospective surveillance evaluation. Ten patients complained of soreness at the entry site and post-procedure stiffness. These complaints were treated with ice, rest, and analgesics and resolved without incident. Conclusion: This paper describes the initial US cases of the placement of a paddle lead via a minimally invasive percutaneous method, as well as complex cylindrical arrays with a single needle entry to the epidural space. The device functioned successfully and presented a safe option for placing paddle leads and complex arrays.

The use of epidural steroids has been a cornerstone of interventional pain medicine as it has evolved as a specialty over the past few decades. These injections, which have been documented in the literature for more than 50 years, have been used for both radicular and axial pain throughout the neuroaxis. Studies have been performed that both support and distract from the evidence for these interventions. Many of the studies that have shown little or no support for the therapies have been flawed, by poor methodologies, lack of fluoroscopic guidance, and use of proceduralists with minimal training. Some clinicians have used these injections in excessive numbers in inappropriate patients. It is the goal of this paper to give guidelines for the proper use of this important therapy. Recommendations have been made on the frequency, route of administration, use of fluoroscopy, and type and dose of steroid but there does not currently exist a specific set of guidelines to address these issues. An extensive review of the available literature was performed, and evidence-based guidelines are established for the first time in an attempt to provide the interventional pain physician with specific guidelines concerning the administration of epidural steroids in patients with axial and radicular pain of spinal origin.

Symptomatic lumbar spinal stenosis (LSS) patients often suffer from multiple etiologies, and patient symptoms must be differentiated and identified as either neurogenic claudication, radicular pain, or both. The most common symptom associated with LSS is neurogenic claudication, which has been reported to occur in 91% to 100% of the LSS patient population. Neurogenic claudication symptoms are described as pain radiating to the lower extremities that begins and worsens as the patient ambulates. Neurogenic claudication symptoms worsen over time and can eventually result in significant life-altering functional limitations. Symptomatic LSS patients may also suffer from radicular pain, which is a persistent pain transmitted through neural pathways, and is associated with inflammation of the exiting nerve root.To assess patient safety, pain reduction, and functional status of patients treated with percutaneous lumbar decompression.Single-center, prospective clinical study of 46 consecutive patients with neurogenic claudication symptoms related to lumbar spinal stenosis.US interventional pain management practice.From March 2010 to January 2011, 46 LSS patients suffering from neurogenic claudication underwent mild percutaneous lumbar decompression. Of these, 12-week, 6-month and one-year follow-up was available for 35 patients.Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Outcomes were assessed at baseline, 12-week, 6-month and one-year follow-ups.One-year follow-up patients in this study experienced statistically and clinically significant improvement in physical function, as well as reduction of pain intensity. The initial improvement in these patients, which was significant, was sustained through one year, with no significant differences among the interim follow-up visit periods. These results demonstrate early improvement following treatment with a high degree of durability over time. There were no serious device or procedure-related complications reported in this study.Single-center study with no control group.In this study, the mild procedure was shown to be safe. In addition, patients experienced significant improvement in mobility and reduction of pain one year after the procedure. One-year outcomes were not significantly different from interim results, indicating that the significant improvement following treatment, occurring as early as 12 weeks, was maintained through one year. This high degree of consistency over time indicates the durability of percutaneous lumbar decompression in the treatment of neurogenic claudication in symptomatic LSS.

The use of epidural injections has become a common procedure for the treatment of spinal diseases causing pain. In some settings, such as that of acute lumbar radiculitis, the uses of these techniques have substantial benefits. In other clinical scenarios, such as chronic axial spinal pain, the utility of these procedures is debatable. Epidural steroids are an option in the broad algorithm of pain treatment, but they are a more conservative option than many more permanent techniques.1, 2, 3 This chapter will review the proper use of epidural injections with a focus on patient selection, technical aspects of the procedure, risk and complication management, and outcomes.

Publisher Summary This chapter reviews the important procedural steps for entering the spinal space desired for implant, and also reviews critical anatomical components that are important in the outcome of accessing the anatomical region. The placement of the device is determined by the choice of device, proper technique in placing the device, and the anatomical variations in the spine that may affect the success of obtaining access. The majority of pumps are placed in the lateral decubitus position as this position allows for access of the spine and abdominal wall without the need for repositioning and redraping. In this position it is important to align the shoulders, minimize lordosis, flex the hips, and properly expose the abdominal wall to assure a sterile field. Once the patient has been adequately positioned, widely prepped and draped, and prepared for the procedure, the fluoroscopic imaging device should be used to perform an initial scout film. The use of laser-guided imagery may improve the ability to correct needle direction and make changes with the catheter as it is advanced. Once spinal access is confirmed, a purse string suture is secured around the needle and the needle is removed. Placement of the purse string suture may prevent CSF leakage and formation of a hygroma. Several factors may also affect the distribution of agents when infused into the spinal fluid which include total dosage, lipophilicity, baricity, and patient position.