Spinal Cord Stimulator Paddle Research Articles

ID: 332465 A Prospective Evaluation of Selectivity in a High-Resolution Spinal Cord Stimulation Paddle

ID: 332465 A Prospective Evaluation of Selectivity in a High-Resolution Spinal Cord Stimulation Paddle

ID: 330220 Follow My Lead: Migration of Spinal Cord Stimulator Paddle

ID: 330220 Follow My Lead: Migration of Spinal Cord Stimulator Paddle

Spinal Cord Stimulator Paddle Lead Revision and Replacement for Misplaced or Displaced Electrodes

ObjectivesSpinal cord stimulators (SCS) are commonly implanted via a laminotomy or laminectomy. Revision surgery may be necessary in instances of hardware failure or loss of efficacy. It is uncommon for leads to have been initially misplaced in a suboptimal position, and revision in these cases necessitates additional dissection for appropriate repositioning. Accordingly, there is concern with a more extensive revision for a potentially higher risk of associated complications. This study aims to describe a series of patients with failed paddle SCS electrodes due to misplacement who underwent revision and replacement. MethodsPatients who underwent SCS paddle replacement for misplaced paddles between 2021 and 2023 were identified. Medical charts were reviewed for demographic data, operative details, and incidence of complications. ResultsSixteen patients underwent thoracic SCS paddle revision and replacement. The mean age was 59.6±12.6 years, with 11 females and 5 males. Misplaced paddles were too lateral (n=12), too high (n=2), or incompletely within the epidural space (n=2). The mean duration from initial implantation to revision surgery was 44.8±47.5 months. The mean operative duration was 126.1±26.9 minutes, and all patients required a “skip” laminectomy or laminotomy. No complications were encountered. The mean length of follow-up was 18.4±7.3 months. Mean preoperative pain intensity was 7.9±1.5, and at last follow-up was 3.6±1.7 (p<0.001). All but one patient continued to use their device in follow-up. ConclusionThe revision and replacement of misplaced paddle SCS electrodes is a feasible and durable revision strategy, even in long-term implants with extensive scarring.

Spinal cord stimulation for chronic pain treatment following sacral chordoma resection: illustrative case.

Cancer-related or postoperative pain can occur following sacral chordoma resection. Despite a lack of current recommendations for cancer pain treatment, spinal cord stimulation (SCS) has demonstrated effectiveness in addressing cancer-related pain. A 76-year-old female with a sacral chordoma underwent anterior osteotomies and partial en bloc sacrectomy. She subsequently presented with chronic pain affecting both buttocks and posterior thighs and legs, significantly impeding her daily activities. She underwent a staged epidural SCS paddle trial and permanent system placement using intraoperative neuromonitoring. The utilization of percutaneous leads was not viable because of her history of spinal fluid leakage, multiple lumbosacral surgeries, and previous complex plastic surgery closure. The patient reported a 62.5% improvement in her lower-extremity pain per the modified Quadruple Visual Analog Scale and a 50% improvement in the modified Pain and Sleep Questionnaire 3-item index during the SCS trial. Following permanent SCS system placement and removal of her externalized lead extenders, she had an uncomplicated postoperative course and reported notable improvements in her pain symptoms. This case provides a compelling illustration of the successful treatment of chronic pain using SCS following radical sacral chordoma resection. Surgeons may consider this treatment approach in patients presenting with refractory pain following spinal tumor resection.

Interlaminar endoscopic uniportal approach for implantation of a paddle lead larger than 10 mm for spinal cord stimulation: illustrative case.

The authors aim to describe a new technique for implantation of a spinal cord stimulation paddle lead sized over 10 mm through an endoscopic uniportal approach. A new endoscopic cannula was developed for the passage of a paddle lead width between 10 and 13 mm. The distal portion of the cannula was designed with a larger opening, providing better visibility of the anterior portion of the adjacent structures, thus allowing a panoramic view of the electrode passage. An electrode was implanted in an 11-mm paddle. After searching PubMed, Cochrane, and Lilacs databases, the authors found no mention of the implantation of a paddle electrode with a width greater than 10 mm. The implantation of a paddle electrode less than 10 mm wide is possible via endoscopic access using 10-mm working channels. However, for electrodes with a width greater than 10 mm, access via endoscopy is impossible, since the working channel is only 10 mm. The authors concluded that it is possible to pass electrodes safely and effectively with a paddle width between 10 and 13 mm using spinal endoscopy via uniportal interlaminar access. However, it is necessary to expand studies to elucidate this technique of endoscopic implantation of electrodes for neurostimulation.

Explantation and Simultaneous Explantation-Reimplantation of Spinal Cord Stimulation Paddle Electrodes: Complication Rate and Predisposing Factors

BACKGROUND AND OBJECTIVES: Spinal cord stimulation (SCS) is an effective treatment for chronic pain that does not respond to conservative treatment. Nonetheless, up to 38% of all implanted SCS electrodes are explanted, and while the risks involved in the surgical implantation of SCS paddle electrodes are well documented, there is scarce information about SCS explantations and their associated complications. We aimed to document the complication rate and identify their predisposing factors in SCS paddle electrode explantations and simultaneous explantation-reimplantations. METHODS: We retrospectively reviewed the outcomes and the characteristics of all patients who underwent explantation of surgically implanted SCS paddle electrodes at the Helsinki University Hospital Department of Neurosurgery between February 2005 and October 2020. RESULTS: One hundred thirty-one explantations were performed on 106 patients. The complication rate was 18.3% (24 operations). Major complications occurred during 5 operations (3.8%). No permanent neurological deficits were recorded. Smoking predisposed patients to postoperative complications (P = .023). On average, patients who suffered complications required a day longer hospitalization (2.22 vs 2.92, P = .011). Patients who had repeated explantations (3 or more) suffered significantly more complications than patients who had only 1 or 2 operations (62.5% vs 15.4%, P = .005). CONCLUSION: Our results suggest that the explantation of the SCS paddle electrode is a relatively safe surgical procedure. Although severe complications occurred, they were successfully managed. Repeated explantations should be treated cautiously as they seem to increase the complication rate considerably.

Analysis of spinal canal diameter in the placement of thoracic spinal cord stimulator paddle leads.

Neurologic deficit is known as a rare complication of thoracic spinal cord stimulator (SCS) paddle lead implantation, but many believe its incidence after SCS paddle lead placement is under-reported. It is possible that imaging characteristics may be used to help predict safe paddle lead placement. This imaging study was undertaken to determine the minimum canal diameter required for safe paddle lead placement. Patients who underwent thoracic laminotomy for new SCS paddle lead placement from January 2018 to March 2023 were identified retrospectively. Preoperative thoracic canal diameter was measured in the sagittal plane perpendicular to the disc space from T5/6 to T11/12. These thoracic levels were chosen because they span the most common levels targeted for SCS placement. Patients with and without new neurologic deficits were compared using a Mann-Whitney U-test. Of 185 patients initially identified, 180 had thoracic imaging available for review. One (0.5%) and 2 (1.1%) of 185 patients complained of permanent and transient neurologic deficit after thoracic SCS placement, respectively. Patients with neurologic deficits had average canal diameters of <11 mm. The average canal diameter of patients with and without neurologic deficits was 10.2 mm (range 6.1-12.9 mm) and 13.0 mm (range 5.9-20.2), respectively (p < 0.0001). Postoperative neurologic deficit is an uncommon complication after thoracic laminotomy for SCS paddle lead placement. The authors recommend ensuring a starting thoracic canal diameter of at least 12 mm to accommodate a SCS paddle lead measuring 2 mm thick to ensure a final diameter of >10 mm. If canal diameter is <12 mm, aggressive undercutting of the lamina, a second laminotomy, or placement of smaller SCS wire leads should be considered.

Predictors of Skip Laminotomy for Placement of Paddle Leads for Spinal Cord Stimulation

ObjectivesPlacement of a standard paddle lead for spinal cord stimulation (SCS) requires a laminotomy for positioning of the lead within the epidural space. During initial placement, an additional laminotomy or laminectomy, termed a “skip” laminotomy, may be necessary at a higher level to pass the lead to the appropriate midline position. Patient and radiographic factors that predict the need for a skip laminotomy have yet to be identified. Materials and MethodsParticipants who underwent SCS paddle placement at Albany Medical Center between 2016 and 2017 were identified. Operative reports were reviewed to identify the paddle type, level of initial laminotomy, target level, and skip laminotomy level. Preoperative thoracic magnetic resonance images (MRIs) were reviewed, and spinal canal diameter, interpedicular distance, and dorsal cerebral spinal fluid thickness were measured for each participant when available. ResultsA total of 106 participants underwent thoracic SCS placement. Of these, 97 had thoracic MRIs available for review. Thirty-eight participants required a skip laminotomy for placement of the paddle compared with 68 participants who did not. There was no significant difference in demographic features including age, sex, body mass index, and surgical history. Univariate analyses that suggested trends were selected for further analysis using binary logistic regression. Level of initial laminotomy (odds ratio [OR] = 1.51, p = 0.028), spinal canal diameter (OR = 0.71, p = 0.015), and dorsal cerebrospinal fluid thickness (OR = 0.61, p = 0.011) were correlated with skip laminotomy. Target level (OR = 1.27, p = 0.138) and time from trial (1.01, p = 0.117) suggested potential association. The multivariate regression was statistically significant, X2(10) = 28.02, p = 0.002. The model explained 38.3% of the variance (Nagelkerke R2) and predicted skip laminectomy correctly in 73.3% of cases. However, for the multivariate regression, only a decrease in spinal canal diameter (OR = 0.59, p = 0.041) was associated with a greater odds of skip laminotomy. ConclusionsThis study aims to characterize the patient and radiographic factors that may predict the need to perform a skip laminotomy during the initial placement of SCS paddles. Here, we show that radiographic and anatomic variables, primarily spinal canal diameter, play an important role in predicting the need for a skip laminotomy. Furthermore, we suggest that target level for placement and level of initial laminotomy also may contribute. Further investigation of the predictive factors for performing a skip laminotomy would help optimize surgical planning and preoperative patient selection and counseling.

Investigation of the intraoperative cortical responses to spinal motor mapping in a patient with chronic pain.

Intraoperative neurophysiological monitoring (IONM) in spinal cord stimulation (SCS) surgery for chronic pain is shown to provide effective guidance during device placement. Electromyography (EMG) is used to determine the laterality of the paddle. In some SCS cases, laterality cannot be obtained via EMG due to patient physiology. Electroencephalography (EEG) is already used in IONM to monitor cortical responses. Here, we show proof-of-concept of assessing the responses of epidurally evoked EMGs simultaneously with EEGs to determine laterality during IONM using a high-resolution (HR) SCS paddle. An 8-column HR-SCS paddle was acutely placed at T9-T10 interspace in patients with failed back surgery syndrome. EMG signals from 18 muscle groups were recorded simultaneously with 60-channel EEG signals at various stimulation amplitudes (0-10 mA). Particular attention was paid to regions associated with pain including the somatosensory cortex (S1), prefrontal cortex (PFC), and motor cortex (M1). When left and right lateral contacts were stimulated at low amplitudes (1-2 mA), significant changes were seen in θ, α, and β powers in the contralateral PFC but not in M1 or S1. There was a significant correlation between M1 and contralateral contacts in α power. At higher currents (7-8 mA), right-sided contacts resulted in α power change. We found significant differences in α, θ, and β powers in PFC for contralateral stimulation of the lateral SCS contacts at low amplitudes and in α power at higher amplitudes. The changes in PFC suggest the potential of EEG for understanding a cortical mechanism of action of SCS and provide insight into the pathophysiology of chronic pain.NEW & NOTEWORTHY Here, we present proof of concept of assessing the responses of epidurally evoked electromyography simultaneously with scalp electroencephalography to determine whether both laterality and insights into pain mechanisms can be elucidated. With stimulation, significant changes were seen in θ, α, and β band power in the contralateral prefrontal cortex and in α power in the motor cortex. We provide insight into the mechanism of action of SCS in preventing pain in this patient.

ID: 209037 Retrograde Paddle Implant for Spinal Cord Stimulation in Complex Failed Back Surgery Syndrome Cases

Complex spine arthrodesis can challenge the approach for spinal cord stimulation (SCS). Percutaneous SCS placement is limited by epidural fibrosis and bone grafts over the puncture sites (1) making traditional techniques prone to higher complication rates and suboptimal lead placement (2). Placing retrograde SCS paddle can overcome these technical issues and promote effective SCS therapy in select patients.

Paddle-Lead Spinal-Cord Stimulation Surgeries for Chronic Neuropathic Pain: A Single Surgeon Case-Series Outcome Analysis in Indian Population.

Background Spinal-cord stimulation (SCS) for relief of chronic neuropathic pain is well established. Objective The inherent limitations with conventional percutaneous lead SCS are lead migration, positional variations in stimulation, as well as possible nonreplication of benefits after permanent SCS implantation, which were experienced during a positive trial period. To circumvent these limitations, we analyzed five consecutive cases of chronic intractable neuropathic pain who underwent direct SCS paddle lead placement during the trial period for pain relief. In addition, during the process of placing a permanent paddle lead, the impediment created by prior epidural scarring in such chronic patients can be obviated mechanically thereby increasing the efficacy of the procedure. Material and Methods The demographic details, diagnosis, preoperative visual analogue scale score (VAS), and follow-up VAS were recorded. Surgical procedure consisted of a standard dorsal laminotomy followed by placement of permanent paddle leads. Results All patients reported significant improvement in their VAS scores. Mean duration of follow-up was 23.6 months (9-35 months). Mean preoperative VAS was 9.4 and 1.4 at the last follow-up. No major complications were found. Conclusion With careful patient selection and appropriate surgical strategy, it was possible to implant permanent paddle leads during SCS trial itself in our five patients thereby replicating and sustaining the trial period pain relief. We argue that this can be a new cost-effective and reliable technique for the placement of SCS leads achieving excellent and sustained pain relief.

Animal Feasibility Study of a Novel Spinal Cord Stimulation Multicolumn Lead (Heron Lead).

Currently available spinal cord stimulation paddle leads require a laminectomy, limiting the types of clinicians who can implant and increasing the risk of complications. Recently, WISE S.r.l. designed a prototype multicolumn lead named the Heron® lead that can be implanted percutaneously. The purpose of the study was to examine the efficiency of placing a paddle lead percutaneously. Ten sheep were assigned to either the Heron lead group (n = 7) or the control group (n = 3). The sheep were observed for 13 weeks after implantation. Neurological and clinical examinations were conducted prior to surgery and then during the follow-up period. The implantation sites were evaluated through macroscopic observations during the article explantation and the lead migration was evaluated by comparing the article positioning at the surgery, four weeks after the surgery and at the explantation day through fluoroscope images. A qualitative comparison was made between the results collected with the test article and the control article. Observations at the surgical sites indicate that test animals appeared to have less swelling around the surgical wound than control ones in the first 14 days, but no impact on wound healing was noticed. Additionally, no clear difference was observed in pain scores between the two groups, with observations tending to show that the maximum pain was occurring later in the test group with respect to the control group. General clinical observations showed no major difference between the two groups, and determined clinical abnormalities were not directly related to the procedure. Lastly, neurological deficits frequency decreased from the first to last animal operated, regardless of their test or control status. Our study concluded that the Heron lead is safe to implant, with a safety profile similar to the control article. Additionally, we conclude that the Heron lead is effective in reducing lead migration events.

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads.

Spinal cord stimulation (SCS) is a safe neuromodulatory treatment used to treat failed back surgery syndrome, chronic neuropathic pain, and complex regional pain syndrome. Despite its efficacy, some patients fail to achieve pain relief and elect to undergo removal of SCS paddle leads. The safety and best practices of these procedures have not been defined. In this article, we describe our technique and complication rate in a series of SCS paddle removals. All patients who underwent SCS paddle removal at the Albany Medical Center between 2011 and 2020 were identified. Medical charts were reviewed for demographic data, operative technique, and incidence of complications within 30 days of the procedure. Thirty-two (91%) patients underwent a thoracic paddle removal, whereas 3 (9%) underwent a cervical paddle removal. All cases underwent preoperative imaging with computed tomography or MRI, and all cases were performed with neuromonitoring and fluoroscopy. The technique required for paddle removal depended on the extent of local scar formation and ranged from soft tissue dissection to additional laminectomy at an adjacent level. Cases took on average 2 ± 0.09 hours with 23.21 ± 4.29 cc blood loss. Two patients had superficial infections, which were cleared with 1 week of oral antibiotics. There were no other adverse events. Thirty-five patients successfully underwent paddle removal with the minor complications reported. In this article, we show that by using neuromonitoring, fluoroscopy, and the techniques described, SCS paddle removal can be performed with minimal risk.

Revision and Replacement of Spinal Cord Stimulator Paddle Leads

ObjectivesPaddle leads for spinal cord stimulation (SCS) offer more efficient energy delivery and advantages in some patients. However, there is concern for how safely SCS paddles can be replaced once previously implanted because of scar tissue and the relative vulnerability of the thoracic cord. In this study, we share our experience on SCS paddle replacement. Materials and MethodsParticipants who underwent SCS replacement at Albany Medical Center between 2011 and 2020 were identified. The medical records were reviewed for demographic data and information regarding initial complications, reason for removal or revision, subsequent complications of replacement surgery and its timing, and whether the implant was ultimately removed. Percutaneous lead replacement cases performed over the same period were used as a comparison group. ResultsA total of 1265 patients were identified to have had an SCS-related procedure based on billing codes. Of these, 73 involved replacement of epidural leads (51 paddles, 22 percutaneous). Most paddles (48/51) were replaced at the time of removal. A total of 30 of the 51 paddle replacements required additional lamina removal. Re-operations that occurred more than one year after initial implant were significantly more likely to require additional bone removal (p < 0.001). Paddle re-operations lasted in general 1.7 ± 0.2 hours and had 35 ± 5 mL of blood loss, whereas percutaneous operations lasted 1.3 ± 0.2 hours and had 12.5 ± 2 mL of blood loss. Despite the invasive nature of paddle replacement, there was no difference in complications (p = 0.23) compared with that in percutaneous leads. ConclusionsThis study characterizes the safety profile of SCS paddle replacement surgeries. Here, we demonstrate that the replacement of paddle leads at the time of removal, with additional lamina removal if needed because of scar, is associated with low rates of complications. This validates the feasibility and low-risk profile of replacing paddle leads when clinically indicated for experienced surgeons with specialization in SCS.

Images in Practice: Replacement of an 18-Year-Old Spinal Cord Stimulator Paddle Lead with Cylindrical Leads Under Direct Visualization.

Images in Practice: Replacement of an 18-Year-Old Spinal Cord Stimulator Paddle Lead with Cylindrical Leads Under Direct Visualization.

Awake Implantation of Thoracic Spinal Cord Stimulator Paddle Electrode and Generator: 2-Dimensional Operative Video.

In this surgical video, the operative technique is presented for awake implantation of a thoracic paddle electrode for spinal cord stimulation. In the first stage, a laminotomy is performed with the patient under conscious sedation. Once the paddle is in optimal position, the patient is tested intraoperatively to confirm adequate coverage and absence of untoward side effects. This paddle electrode is used for the trial period. If the patient derives satisfactory pain relief during the trial, they are returned for the second stage implantation of pulse generator, without moving the initial paddle electrode now already placed in an optimal location. Particular attention in this video is provided toward the optimal positioning and technique for the awake laminotomy to ensure patient comfort and reliability during testing, the use of extension leads tunneled opposite the planned pulse generator site, and the method of removing extension leads to preserve the placement of the initial paddle electrode.

Commentary: Implantation of a Thoracic Spinal Cord Stimulator Paddle Electrode and Generator Under General Anesthesia With Intraoperative Neuromonitoring: 2-Dimensional Operative Video.

Commentary: Implantation of a Thoracic Spinal Cord Stimulator Paddle Electrode and Generator Under General Anesthesia With Intraoperative Neuromonitoring: 2-Dimensional Operative Video.

Immediate Abdominal Pain after Placement of Thoracic Paddle Leads for Spinal Cord Stimulation: A Case Series

Background: Spinal cord stimulation (SCS) is a well-established treatment modality for chronic pain. Thoracic radiculopathy has been reported as a complication of SCS paddle lead implantation by several authors and commonly presents as abdominal pain. Methods: We performed a search of all patients who underwent either placement of a new epidural paddle lead electrode or revision of an epidural paddle lead electrode for SCS in the thoracic region from January 2017 to January 2018. We then investigated all cases of immediate postoperative abdominal pain. Results: We identified 7 patients who had immediate postoperative abdominal pain among 86 cases of epidural SCS procedures. Most patients were discharged on postoperative days 1–3. No patients required revisions or removals of their SCS for any reason. Conclusions: We conclude that the etiology of immediate postoperative abdominal pain after thoracic paddle lead implantation for SCS is most likely thoracic radiculopathy. We hypothesize that small, transient epidural hematomas could be the cause of this thoracic radiculopathy. We argue that all patients with immediate postoperative abdominal pain and no other neurologic deficits after thoracic paddle lead implantation for SCS should first be treated conservatively with observation and pain management.

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal

Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature. We retrospectively reviewed the outcomes of all patients at the Cleveland Clinic who underwent removal of SCS paddle electrodes between 2009 and 2016. We identified 68 patients during this interval who had a paddle electrode removed. The most common reason for removal was loss of coverage or effect (75%), followed by infection (13.24%), and the need for magnetic resonance imaging for diagnostic purposes (8.82%). Postoperative complications occurred in eight patients (11.75%), two of which were classified as major (2.94%). One of these patients developed a postoperative cerebrospinal fluid leak, and another suffered a large suprafascial hematoma. Both patients underwent reoperation. Minor complications were reported in six patients (8.82%) and included wound dehiscence, infection, and prolonged ileus in one case. On average, patients who developed complications lost 20 mL more blood during surgery than those who did not develop complications (p = 0.006). One of the benefits of SCS therapy is the reversibility of the procedure. However, removal is not without some risk though the overall risk of minor or major complication is low. Patients who are considering removal should be counseled appropriately. Prophylactic removal is not recommended. However, when removal is needed, surgeons and pain specialists must be familiar with these complications and their management.

Minimally Invasive Placement of Spinal Cord Stimulator Paddle Electrodes Is Associated With Improved Perioperative and Long-Term Experience Among Neuropathic Pain Patients.

Prospective, observational cohort study. This study compared in-hospital and long-term outcomes among spinal cord stimulation (SCS) patients undergoing paddle insertion by open or minimally invasive surgery (MIS) approaches. Patients with treatment-refractory extremity neuropathic pain may benefit from SCS. Conventional placement of surgical paddles for an external neurostimulation trial is through open laminectomy, but MIS techniques may offer advantages. Twenty SCS patients were prospectively assessed. Open patients underwent caudal thoracic laminectomy for multicolumnar electrode paddle placement. MIS patients underwent paddle placement through interlaminar flavectomy using tubular retractors. Demographic data included age, sex, underlying diagnosis, and preoperative visual analog scale (VAS) extremity scores. Intraoperative data included operative duration, blood loss, and number of device passages to achieve final position. Perioperative data included VAS back pain scores; trial data included time-to-trial and time-to-decision. Postoperative data included 1 month VAS back pain scores and 1 year follow-up device complications. No demographic differences were observed among surgical cohorts. MIS procedures had shorter operative duration (P = 0.03), less blood loss (P < 0.001), and similar median number of device passages (2 vs 1.5, P = 0.71). MIS patients reported less perioperative surgical back pain (P < 0.05). External neurostimulation trials began sooner among MIS patients who also made sooner decision whether to implant the SCS device (2.8 ± 1.4 vs 4.3 ± 1.0 days, P = 0.013). Similar 1 month back pain scores were reported between surgical cohorts (P = 0.08). MIS techniques for SCS surgical paddle implantation is associated with less perioperative morbidity and surgical site back pain, shorter external neurostimulator trial duration, and long-term device stability benefits. 2.