The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for Spinal Cord Stimulation Long-term Outcome Optimization and Salvage Therapy.

INTRODUCTION: The International Neuromodulation Society (INS) has recognized a need to establish best practices for optimizing implantable devices and salvage when ideal outcomes are not realized. This group has established the Neurostimulation Appropriateness Consensus Committee (NACC)® to offer guidance on matters needed for both our members and the broader community of those affected by neuromodulation devices. MATERIALS AND METHODS: The executive committee of the INS nominated faculty for this NACC® publication on the basis of expertise, publications, and career work on the issue. In addition, the faculty was chosen in consideration of diversity and inclusion of different career paths and demographic categories. Once chosen, the faculty was asked to grade current evidence and along with expert opinion create consensus recommendations to address the lapses in information on this topic. RESULTS: The NACC® group established informative and authoritative recommendations on the salvage and optimization of care for those with indwelling devices. The recommendations are based on evidence and expert opinion and will be expected to evolve as new data are generated for each topic. CONCLUSIONS: NACC® guidance should be considered for any patient with less-than-optimal outcomes with a stimulation device implanted for treating chronic pain. Consideration should be given to these consensus points to salvage a potentially failed device before explant.

Conscious Sedation Using Dexmedetomidine During Surgical Paddle Lead Placement Improves Outcome in Spinal Cord Stimulation: A Case Series of 25 Consecutive Patients.

OBJECTIVES: Different anesthesia techniques are used for surgical implantation of paddle lead electrodes for neurostimulation through a laminectomy. We wanted to evaluate the use of dexmedetomidine as sedative for this procedure in a series of patients. Second, we wanted to verify whether the stimulation pattern and position of the electrode had to be changed during the procedure guided by the patient's feedback. MATERIAL AND METHODS: Twenty-five consecutive patients received surgical implantation of a spinal cord stimulation electrode under conscious sedation using dexmedetomidine and local anesthesia. We evaluated the effects of the administered drug, the patient comfort, and the adequacy of the stimulation pattern. RESULTS: Twenty-four patients completed the procedure with only dexmedetomidine and local anesthetic. Infusion was started on average 55 minutes (sd 29) prior to incision. The mean dose of lidocaine was 430 mg (sd 95). There were no significant hemodynamic changes. Median time to reach Modified Aldrete's score postoperative was 67 minutes (sd 38). In 46% of the patients, the position of the electrode was changed guided by the feedback of the patient. More than half of the patients remember most details of the procedure. Only four patients mentioned substantial discomfort and only three would definitely not want to undergo this procedure again. CONCLUSIONS: Implantation of spinal cord stimulation electrodes through a surgical laminectomy using dexmedetomidine is a safe and feasible procedure with adequate comfort for patient and surgeon. This way of working increases the optimal position of the electrode resulting in the most convenient stimulation pattern and avoiding revisions.

A new minimally invasive technique for lead revision of perc-paddle leads.

To report on a less-invasive technique for replacing a broken lead in a spinal cord stimulation (SCS) device that makes use of St. Jude Medical's "Epiducer" device. A 53-year-old woman suffered a loss of stimulation on her internal pulse generator (IPG), which was found to have a broken lead. The broken lead was withdrawn using the Epiducer device with minimal invasiveness and without pain. A new lead was put in place, and successful stimulation using the IPG resumed. Follow-up 3 weeks later showed a well-functioning SCS system. An Epiducer can be used to revise the SCS system in a minimal invasive way without a new puncture. Follow-up study of this technique as well as others for revising an SCS system should be encouraged and used in comparison study.

Large-scale real-world data on a multidisciplinary approach to spinal cord stimulation for persistent spinal pain syndromes: first evaluation of the Neuro-Pain® nationwide screening and follow-up interactive register.

Introduction: Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data. Methods: In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed. Results: Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term. Discussion: Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process.

Technological innovation in spinal cord stimulation: use of a newly developed delivery device for introduction of spinal cord stimulation leads.

OBJECTIVE: The use of multiple cylindrical leads and multicolumn and single column paddle leads in spinal cord stimulation offers many advantages over the use of a single cylindrical lead. Despite these advantages, placement of multiple cylindrical leads or a paddle lead requires a more invasive surgical procedure. Thus, the ideal situation for lead delivery would be percutaneous insertion of a paddle lead or multiple cylindrical leads. This study evaluated the feasibility and safety of percutaneous delivery of S-Series paddle leads using a new delivery device called the Epiducer lead delivery system (all St. Jude Medical Neuromodulation Division, Plano, TX, USA). MATERIALS AND METHODS: This uncontrolled, open-label, prospective, two-center study approved by the AZ St. Lucas (Ghent) Ethics Committee evaluated procedural aspects of implantation of an S-Series paddle lead using the Epiducer lead delivery system and any adverse events relating to the device. Efficacy data during the patent's 30-day trial also were collected. RESULTS: Data from 34 patients were collected from two investigational sites. There were no adverse events related to the Epiducer lead delivery system. The device was inserted at an angle of either 20°-30° or 30°-40° and was entered into the epidural space at T12/L1 in most patients. The S-Series paddle lead was advanced four vertebral segments in more than 50% of patients. The average (±standard deviation [SD]) time it took to place the Epiducer lead delivery system was 8.7 (±5.0) min. The average (+SD) patient-reported pain relief was 78.8% (+24.1%). CONCLUSIONS: This study suggests the safe use of the Epiducer lead delivery system for percutaneous implantation and advancement of the S-Series paddle lead in 34 patients.

High-frequency (10 kHz) spinal cord stimulation for the treatment of focal, chronic postsurgical neuropathic pain: results from a prospective study in Belgium.

Aim: Chronic postsurgical pain (CPSP) is a common complication of surgery. This study was conducted to evaluate the efficacy and safety of paresthesia-free, 10-kHz spinal cord stimulation (SCS) as a treatment for CPSP. Patients & methods: Subjects in this prospective, single-arm study had an average pain intensity of ≥5 cm on a 10-cm visual analog scale. The subjects who had pain relief of ≥50% (response) with temporary trial stimulation were permanently implanted with 10-kHz SCS and assessed for 1 year. Results: At 12 months, 94% of subjects were responders to 10-kHz SCS, and 88% had pain remission (visual analog scale ≤2.5 cm). Conclusion: The pain relief was durable in CPSP subjects and the safety profile of 10-kHz SCS was as expected. Clinical Trial registration number: VT005076953 (Privacy Commission of Belgium).

Identification of the cerebral effects of paracetamol in healthy subjects: an fMRI study.

INTRODUCTION: Paracetamol is commonly used for its antipyretic properties and analgesic effects, but the central mechanism remains elusive. We designed a study in healthy volunteers to detect the central functional working mechanism of paracetamol. SUBJECTS MATERIAL AND METHODS: A total of 20 subjects had a baseline functional magnetic resonance imaging (fMRI) before the intake of 1000 mg paracetamol orally; 60 minutes later, a second fMRI was made aiming detection of regional blood flow differences. RESULTS: A decreased connectivity was observed in the ventral volume of interest (VOI), with the posterior cingulate (with both the left anterior cingulate cortex (ACC) and right ACC: respectively, Ke = 576; t = -6.8894 and Ke = 185; t = -4.8178) and the inferior temporal left (Ke = 103; t = -5.0993); in the combined ventral and dorsal VOIs, the posterior cingulate (with the left ACC; Ke = 149; t = -4.5658) and, both with the right ACC, the inferior temporal left (Ke = 88; t = -3.8456) and the inferior frontal gyrus (Ke = 86; t = -4.3937) had a decrease in connectivity. An increase was seen in other regions, including, among others, the middle frontal and temporal gyri (respectively, Ke = 85; t = 4.4256 and Ke = 85; t = 5.6851), the inferior frontal (with the left ACC: Ke = 165; t = 4.4998) and the superior frontal gyrus (with the right ACC; Ke = 281; t = 4.5992), and the post/precentral gyrus (with the right ACC, respectively, Ke = 102; t = 6.0582 and Ke = 105; t = 4.0776). CONCLUSIONS: On fMRIs in healthy volunteers, the ingestion of paracetamol affects connections with the ACC. This suggests a central effect of paracetamol in cerebral areas known to be associated with pain. Further studies are needed to demonstrate the same effects in acute and chronic pain states.

The epidural fibrous sheath: a guide for the replacement of a spinal cord stimulation electrode.

BACKGROUND AND OBJECTIVE: During spinal cord stimulation there is sometimes a need to replace defective leads. Percutaneous lead replacement by recannulating the epidural space and "steering" the new lead to the prior location is sometimes very difficult, resulting in diminished analgesia. Since fibrous deposits are known to form around epidural catheters and epidural obstructions have been noted with other techniques, we have inserted the new lead through the well-dissected opening in the interspinal ligament. We will report the results of our case series. METHODS: In 11 patients with lead malfunction we reinserted a new electrode into the epidural space by first withdrawing the lead with one hand and inserting the new one through the interspinal ligament with the other. In using this method, we found we could position the new electrode almost identically to the first. In only 3 patients did we experience difficulty in identifying the opening for the insertion. In the successfully cannulated patients identical stimulation parameters and paresthesia areas were obtained. By experimentally injecting contrast dye through an epidural catheter inserted into the interspinal opening and epidural pathway, we could visualize a thin dense line representing the fibrous sheath. CONCLUSION: Foreign bodies in the epidural space lead to fibrous deposits. Spinal cord stimulation, when those deposits form a sheath, the sheath is useful for lead revision. The procedure, if meticulously performed, has a high success rate.

Quality of life and efficacy of nebivolol in an open-label study in hypertensive patients. the QoLaN study.

BACKGROUND: Nebivolol is a highly selective beta-adrenoreceptor antagonist with vasodilating properties. This study investigated its effect on quality of life (QoL) and blood pressure (BP) in real life conditions. In total, 1468 patients were enrolled, 12% diabetics. Nebivolol was prescribed as monotherapy, add-on or switch medication. METHODS: In this open-label, prospective study, the JNC-VII BP target values were used: < 140/90 and < 130/80 mmHg for diabetics. The responder rate and the QoL was determined at baseline and after 4 and 8 weeks. RESULTS: After 4 weeks, 27% of subjects reached target BP, 45% after 8 weeks. The responder rates were 92, 90 and 83% for the monotherapy, add-on and switch groups. Compared with baseline, all showed statistical significance at 8 weeks. Similarly to results for the QoL after 8 weeks, the mean improvement in QoL for all three groups was 9-10 points (total range: 0-88). CONCLUSIONS: The study demonstrates that nebivolol in mild to moderate hypertension is associated with overall improvements in QoL, with a marked BP-lowering effect, in monotherapy, add-on or switch, irrespective of the glucose tolerance status. It may be hypothesized that its dual mode of action explains its BP-lowering effect as well as the tolerability.