10 kHz stimulation as rescue therapy for spinal cord stimulation trial failure or loss of efficacy: A retrospective study.

INTRODUCTION: Spinal cord stimulation (SCS) is currently used for the management of pain of different origin, and since its inception, many waveforms have been developed. Some patients experience no pain relief already during SCS trial, while other patients go through a loss of efficacy due to habituation after a variable period of satisfying pain control. Our retrospective study represents the first report exploring the potential role of 10 kHz stimulation as rescue therapy for patients who did not benefit not only from conventional stimulation but even from other waveforms during SCS trial or follow-up. METHODS: This study was conducted in Germany; we retrospectively enrolled patients with no pain relief during SCS trial or with loss of efficacy of other waveforms over time; and we recorded visual analogic scale (VAS), Oswestry Disability Index (ODI), and daily opioid consumption expressed as morphine milligram equivalents (MME), right before and 12 months after the switching to 10 kHz simulation. RESULTS: The rate of successful switching to 10 kHz stimulation was comparable in patients enrolled during the SCS trial and during the follow-up (43% vs. 40%, respectively); notably, the highest rate of failed rescue was recorded in case of persistent spinal pain syndrome (PSPS) II. Patients who responded to the switching showed a significant improvement in VAS and ODI after 12 months of treatment compared to baseline (3.6 ± 1.0 vs. 8.2 ± 0.9, p < 0.00001 and 34.0 ± 7.8 vs. 64.3 ± 8.7, p < 0.0001, respectively), whereas there was no reduction in the consumption of opioids in terms of MME (3 (0-16) vs. 5 (0-8.75), p = 0.1003). CONCLUSIONS: Rescue therapy with 10 kHz stimulation could be an important strategy to avoid SCS explant in both patients non-responsive during trial or experiencing a loss of efficacy during the years with other waveforms.

Improved Outcomes and Therapy Longevity after Salvage Using a Novel Spinal Cord Stimulation System for Chronic Pain: Multicenter, Observational, European Case Series.

Spinal cord stimulation (SCS) is proven to effectively relieve chronic neuropathic pain. However, some implanted patients may face loss of efficacy (LoE) over time, and conversion to more recent devices may rescue SCS therapy. Recent SCS systems offer novel stimulation capabilities, such as temporal modulation and spatial neural targeting, and can be used to replace previous neurostimulators without changing existing leads. Our multicenter, observational, consecutive case series investigated real-world clinical outcomes in previously implanted SCS patients who were converted to a new implantable pulse generator. Data from 58 patients in seven European centers were analyzed (total follow-up 7.0 years, including 1.4 years after conversion). In the Rescue (LoE) subgroup (n = 51), the responder rate was 58.5% at the last follow-up, and overall pain scores (numerical rating scale) had decreased from 7.3 ± 1.7 with the previous SCS system to 3.5 ± 2.5 (p < 0.0001). Patients who converted for improved battery longevity (n = 7) had their pain scores sustained below 3/10 with their new neurostimulator. Waveform preferences were diverse and patient dependent (34.4% standard rate; 44.8% sub-perception modalities; 20.7% combination therapy). Our results suggest that patients who experience LoE over time may benefit from upgrading to a more versatile SCS system.

Incidence and Management of Hardware-Related Wound Infections in Spinal Cord, Peripheral Nerve Field, and Deep Brain Stimulation Surgery: A Single-Center Study.

INTRODUCTION: Neuromodulation using deep brain stimulation (DBS), spinal cord stimulation (SCS), and peripheral nerve field stimulation (PNFS) to treat neurological, psychiatric, and pain disorders is a rapidly growing field. Infections related to the implanted hardware are among the most common complications and result in health-related and economic burden. Unfortunately, conservative medical therapy is less likely to be successful. In this retrospective study, we aimed to identify characteristics of the infections and investigated surgical and antimicrobial treatments. METHODS: A retrospective analysis was performed of patients with an infection related to DBS, SCS, and/or PNFS hardware over an 8-year period at our institution. Data were analyzed for type of neurostimulator, time of onset of infection following the neurosurgical procedure, location, and surgical treatment strategy. Surgical treatment of infections consisted of either a surgical wound revision without hardware removal or a surgical wound revision with partial or complete hardware removal. Data were further analyzed for the microorganisms involved, antimicrobial treatment and its duration, and clinical outcome. RESULTS: Over an 8-year period, a total of 1,250 DBS, 1,835 SCS, and 731 PNFS surgeries were performed including de novo system implantations, implanted pulse generator (IPG) replacements, and revisions. We identified 82 patients with infections related to the neurostimulator hardware, representing an incidence of 3.09% of the procedures. Seventy-one percent of the patients had undergone multiple surgeries related to the neurostimulator prior to the infection. The infections occurred after a mean of 12.2 months after the initial surgery. The site of infection was most commonly around the IPG, especially in DBS and SCS. The majority (62.2%) was treated by surgical wound revision with simultaneous partial or complete removal of hardware. Microbiological specimens predominantly yielded Staphylococcus epidermidis (39.0%) and Staphylococcus aureus (35.4%). After surgery, antimicrobials were given for a mean of 3.4 weeks. The antimicrobial regime was significantly shorter in patients with hardware removal in comparison to those who only had undergone surgical wound revision. One intracranial abscess occurred. No cases of infection-related death, sepsis, bacteremia, or intraspinal abscesses were found. CONCLUSION: Our data did show the predominance of S. epidermidis and S. aureus as etiologic organisms in hardware-related infections. Infections associated with S. aureus most likely required (partial) hardware removal. Aggressive surgical treatment including hardware removal shortens the duration of antimicrobial treatment. Clear strategies should be developed to treat hardware-related infections to optimize patient management and reduce health- and economic-related burden.

Dose escalation in intrathecal baclofen therapy based on disease etiology: Can an a priori target dose be established? A ten-year follow-up study.

CONTEXT: Intrathecal baclofen (ITB) therapy is administered for severe, persistent spasticity that cannot be addressed by oral medication or other treatments. OBJECTIVE: We aimed to evaluate the target dose of ITB for severe, persistent spasticity based on disease etiology. METHODS: Data at baseline (discharge), 1, and 10 years from 102 patients who received ITB therapy between 1985 and 2011 were retrospectively collected. Patients were divided based on disease etiology (cerebral, spinal, or multiple sclerosis [MS]) to evaluate differences in dose requirements. A comprehensive literature review of the dose trends in ITB therapy was conducted. RESULTS: Patients with cerebral spasticity (n = 62) required the highest dose after discharge (102.66 ± 30.9 µg), 1 (402.29 ± 300.2 µg), and 10 years (578.74 ± 421.2 µg). Patients with spinal spasticity (n = 19) required an average of 82.89 ± 30.7 µg baclofen at discharge, 296.3 ± 224.6 µg after 1 year, and 522.63 ± 425.97 µg after 10 years. Patients with MS-related spasticity (n = 21) had a dose of 82.73 ± 39.3 µg baclofen at discharge, 226.95 ± 193.3 µg after 1 year, and 320.6 ± 261.4 µg after 10 years. The differences among the categories were significant after 1 and 10 years of therapy. CONCLUSIONS: The largest dose escalation occurs within the first year of ITB therapy. Our work provides a guideline for the initial dose setting during the inpatient stay after implantation and potentially expected dosage over the years thereafter, although this must always be adjusted individually.

Spinal cord stimulation as a treatment option for complex regional pain syndrome: a narrative review.

Objectives: This review aims to analyze the last years' experience of applying spinal cord stimulation (SCS) in complex regional pain syndrome (CRPS) patients with persistent or refractory chronic pain. Methods: This is a narrative review which was executed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and was carried out through the following databases: PUBMED and Cochrane Library. Also, a search for trials in the metaRegister of controlled trials (www.clinicaltrials.gov) was performed. Results: SCS provides pain reduction and improves sensory, vasomotor and sudomotor symptoms. It can reduce opioid using, offering better life quality for the patients. Conclusions: SCS found to be an excellent therapeutic alternative for patients with CRPS. It offers immediate pain relief and allows patients to regain functionality and have a better quality of life.

[Burnout and dependence among medical personnel timeless and during the COVID-19 pandemic, using surgery and anesthesia as examples]. / Burnout und Abhängigkeit bei ärztlichem Personal zeitlos und während der COVID-19-Pandemie am Beispiel der Chirurgie und Anästhesie.

BACKGROUND: The COVID-19 pandemic affects the mental health and professional behavior of surgeons and anesthesiologists and seems to have an impact on substance dependence. QUESTION: What are the reasons for the occurrence of substance dependence and burnout in surgeons and anesthesiologists timelessly and during the COVID-19 pandemic and what improvement measures could help in the clinical practice? MATERIAL AND METHODS: A literature search was conducted in the form of a systematic review of studies and review articles relevant to the topic. RESULTS: Over the years it has been shown that surgeons and anesthesiologists are prone to drug dependence due to their direct access to medications in the clinical field and work-related stress. In particular, surgeons and anesthesiologists appeared to have an increased propensity for addictive diseases and an increased risk of burnout in the pandemic. CONCLUSION: Preventive measures in favor of better working conditions in surgery and anesthesia and better drug control (not only for dispensing but also for correct drug testing), as well as more treatment and reintegration programs under psychiatric supervision and in collaboration with a multidisciplinary team are meaningful.

Epidural electrical spinal cord stimulation of the thoracic segments (T2-T5) facilitates respiratory function in patients with complete spinal cord injury.

INTRODUCTION: Patients with high cervical Spinal Cord Injury (SCI) usually require mechanical ventilation support. Phrenic Nerve Stimulation (PNS) both direct and indirect is the main alternative for these patients to wean off ventilator although PNS has several limitations and phrenic nerve could be also damaged after cervical spinal cord injury. OBJECTIVE: In this study, we assessed if the spinal cord Epidural Electrical Stimulation (EES) at the segments T2-T5, related to intercostal muscles, can facilitate respiratory function and particularly inspired tidal volume during mechanic ventilation. METHODS: Two patients with a high cervical injury were selected for this study with ethical committee permission and under review board supervision. A phrenic nerve conduction study with diaphragm electromyography (DEMG) was performed before and after trial of EES. RESULTS: Results demonstrate that EES at T2-T5 substantially increase the inspired volume. The results of this study also demonstrate that EES at spinal segments T2-T5 can bring patients dependent from mechanical ventilation to pressure support (on CPAP), preventing Baro-trauma and other complications related to mechanical ventilation. CONCLUSION: These findings suggest that tested approach applied alone or in combination with the phrenic nerve stimulation could help to reduce time on mechanical ventilation and related complications.

Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review - revival of a promising therapeutic option?

INTRODUCTION: Peripheral vascular disease (PVD) is caused by a blood circulation disorder of the arteries and Critical Limb Ischemia (CLI) is the advanced state of PVD. For patients with surgically non-reconstructable CLI, Spinal Cord Stimulation (SCS) appears to be an alternative therapeutic option. OBJECTIVE: The aim of our study was to investigate the efficacy of SCS in non-reconstructable CLI compared with the conservative treatment and re-appraise the existing literature in light of the recent advances in neuromodulation. METHODS: We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, using electronic databases and reference lists for article retrieval. RESULTS: A total of 404 records were identified and finally 6 randomised controlled trials (RCTs), a Cochrane review and a meta-analysis were included in our systematic review. The studies assessed the efficacy of tonic SCS in the treatment of patients with non-reconstructable CLI compared with the conservative treatment. There is moderate to high quality evidence suggesting, that tonic SCS has beneficial effects for patients suffering from non-reconstructable CLI in terms of limb salvage, pain relief, clinical improvement and quality of life. The contradictory conclusions of the two meta-analyses regarding the efficacy of SCS for limb salvage at 12 months refer rather to the magnitude of the beneficial effect than to the effect itself. So far, the current literature provides evidence about the traditional tonic SCS but there is a lack of studies investigating the efficacy of new waveforms in the treatment of non-reconstructable CLI. CONCLUSION: SCS represents an alternative for PVD patients with non-reconstructable CLI and the existing literature provides encouraging clinical results, that should not be neglected. Instead, they should be re-appraised in light of the recent advances in neuromodulation with the emergence of novel waveform technologies and neuromodulation targets.

A Retrospective Analysis of Intrathecal Catheter Tip Position in Plain Radiography: How Much Do We Agree?

AIM: To assess interrater and intrarater reliability of postoperative plain radiographs, which are routinely performed to confirm the correct placement of the catheter tip after intrathecal drug delivery systems (IDDS) implantation. MATERIAL AND METHODS: This was a retrospective analysis of plain radiographs obtained from patients implanted with intrathecal catheters and morphine pumps. Each plain radiograph was assessed independently by three raters with varying expertise, at three different time points, to confirm the position of the intrathecal catheter tip. Krippendorff?s alpha coefficient was used to calculate both the interrater and intrarater reliability. RESULTS: There was a high level of agreement among the three raters and the three reviews of each rater separately when assessing the location of intrathecal catheter tips in plain radiographs from 126 patients. This was evidenced by the Krippendorff?s alpha value being > 0.99 in all cases, which was greater than the cutoff threshold value of 0.8. CONCLUSION: The interrater and intrarater reliability of plain radiographs for determination of catheter tip position after IDDS implantation was high. The experience and expertise of the raters did not significantly affect the assessments.

Surgical Management for Dystonia: Efficacy of Deep Brain Stimulation in the Long Term.

INTRODUCTION: Dystonia is a movement disorder substantially affecting the quality of life. Botulinum Neurotoxin (BoNT) is used intramuscularly as a treatment for dystonia; however, not all dystonia patients respond to this treatment. Deep brain stimulation (DBS) is an established treatment for Parkinson's disease (PD) and essential tremor, but it can help in dystonia as well. OBJECTIVES: We studied a total of 67 dystonia patients who were treated with DBS over a period of 7 years to find out the long-term efficacy of DBS in those patients. First, we calculated patient improvement in post-surgery follow-up programs using the Global Dystonia Severity scale (GDS) and Burke-Fahn-Marsden dystonia rating scale (BFMDRS). Secondly, we analyzed the scales scores to see if there was any statistical significance. METHODS: In our study we analyzed patients with ages from 38 to 78 years with dystonia who underwent DBS surgery between January 2014 and December 2020 in four different centers (India, Kuwait, Egypt, and Turkey). The motor response to DBS surgery was retrospectively measured for each patient during every follow-up visit using the GDS and the BFMDRS scales. RESULTS: Five to 7 years post-DBS, the mean reduction in the GDS score was 30 ± 1.0 and for the BFMDRS score 26 ± 1.0. The longitudinal change in scores at 12 and 24 months post-op was also significant with mean reductions in GDS and BFMDRS scores of 68 ± 1.0 and 56 ± 1.0, respectively. The p-values were <0.05 for our post-DBS dystonia patients. CONCLUSIONS: This study illustrates DBS is an established, effective treatment option for patients with different dystonias, such as generalized, cervical, and various brain pathology-induced dystonias. Although symptoms are not completely eliminated, continuous improvements are noticed throughout the post-stimulation time frame.

Intrathecal pain management with ziconotide: Time for consensus?

This article summarizes recommendations made by six pain specialists who discussed the rationale for ziconotide intrathecal analgesia (ITA) and the requirement for evidence-based guidance on its use, from a European perspective. Riemser Pharma GmbH (Greifswald, Germany), which holds the European marketing authorization for ziconotide, hosted the meeting. The group agreed that ITA is under-used in Europe, adding that ziconotide ITA has potential to be a first-line alternative to morphine; both are already first-line options in the USA. Ziconotide ITA (initiated using a low-dose, slow-titration approach) is suitable for many patients with noncancer- or cancer-related chronic refractory pain and no history of psychosis. Adopting ziconotide as first-line ITA could reduce opioid usage in these patient populations. The group advocated a risk-reduction strategy for all candidate patients, including compulsory prescreening for neuropsychosis, and requested US-European alignment of the licensed starting dose for ziconotide: the low-and-slow approach practiced in the USA has a better tolerability profile than the fixed high starting dose licensed in Europe. Of note, an update to the European Summary of Product Characteristics is anticipated in early 2021. The group acknowledged that the Polyanalgesic Consensus Conference (PACC) treatment algorithms for ziconotide ITA provide useful guidance, but recommendations tailored specifically for European settings are required. Before a consensus process can formally begin, the group called for additional European prospective studies to investigate ziconotide in low-and-slow dosing strategies, in different patient settings. Such data would enable European guidance to have the most appropriate evidence at its core.

1.2 kHz High-Frequency Stimulation as a Rescue Therapy in Patients With Chronic Pain Refractory to Conventional Spinal Cord Stimulation.

OBJECTIVES: We aimed to investigate the efficacy of new subperception stimulation paradigms including 1.2 kHz-high-frequency stimulation (HFS) and advanced-HFS field-shaping algorithm (dorsal horn HFS [DHHFS]) in refractory cases which initially benefited from conventional spinal cord stimulation (SCS) and lost the effect throughout time. MATERIALS AND METHODS: In the context of a rescue-therapy, patients underwent externalization of the implanted SCS-leads and were tested with multiple combinations of new SCS paradigms. Pain intensity was analyzed using the numeric rating scale (NRS), and data were collected preoperatively and at multiple postoperative follow-ups. RESULTS: Thirty-seven patients underwent externalization of the leads. Mean preoperative NRS-score was 8.1/10 points (SD ± 0.9) for the ON-stimulation period. Patients received a combination of either tonic, burst and 1.2 kHz-HFS, or burst and 1.2 kHz-HFS, DHHFS, or 1.2 kHz-HFS and DHHFS, or 1.2 kHz-HFS alone. The mean postoperative NRS-score after the testing-phase was 3.8/10 points (SD ± 2.5), showing a 48.0% mean reduction (p < 0.001). In total, 29 patients reported a significant reduction above 50% in NRS-scores and therefore were reimplanted with new generators that could deliver the new paradigms. Eight patients underwent full SCS-system explantation. The patients who continued with the new paradigms (n = 29) reported mean NRS-scores of 3.5/10 points (SD ± 1.7) 12 months postoperatively, still showing a significant reduction of 43.3% when compared to preoperative scores (p < 0.001). CONCLUSION: Rescue-therapy with combination of multiple waveforms, including tonic, burst, 1.2 kHz-HFS, and DHHFS, was associated with a significant pain relief in patients with failed conventional SCS. This approach is a safe and efficient and should be considered before explantation of the SCS-system.

Prediction of Lumbar Disc Herniation Patients' Satisfaction with the Aid of an Artificial Neural Network.

AIM: To identify key determinants of lumbar disc herniation (LDH) patients' satisfaction and to evaluate the efficiency of an artificial neural network (ANN) model to prognosticate satisfaction derived from the hospital stay in this specific patient group. MATERIAL AND METHODS: A single item question was used to assess patient satisfaction. Principal component analysis evaluated several aspects of care (15 items). An ANN encompassed all variables and its prediction ability was tested. The ANN performance was correlated to a binary logistic regression (BLR) model. RESULTS: Higher levels of satisfaction were reported by females, older patients, Greeks, and patients with elementary education staying in not rural areas. A history of a single previous hospitalisation was correlated with more satisfaction. The accuracy of ANN was 96% for satisfaction prediction outperforming the BLR model. CONCLUSION: Satisfactory health services are influenced by sex, age, nationality, and number of prior admissions. The self-perceived health state plays also a crucial role. The current study is the first one reporting on the capability of an ANN to accurately predict the satisfaction levels of LDH patients.

An atypical meningioma demystified and advanced magnetic resonance imaging techniques.

A 40-year-old male presented with visuospatial processing disturbances. Family history was free. Conventional and advanced magnetic resonance imaging (MRI) studies were performed. On T2 and fluid attenuation inversion recovery images, an increased signal intensity extra-axial lesion was demonstrated. Post-contrast scans depicted homogeneous intense contrast medium enhancement. T2* star sequence was negative for hemorrhagic or calcification foci. Diffusion-weighted imaging findings were indicative of malignant behavior and magnetic resonance venography confirmed superior sagittal sinus infiltration. Increased cerebral blood volume values were observed and peri-lesional oedema on perfusion-weighted imaging was also demonstrated. The signal intensity-time curve depicted the characteristic meningioma pattern. Spectroscopy showed increased choline and alanine levels, but decreased N-acetyl-aspartate levels. Conventional MRI is adequate for typical types of meningiomas. However, the more atypical ones, in which even the histopathologic specimen may demonstrate characteristics of typical meningioma, could be easier diagnosed with advanced MRI techniques.

Spinal arteriovenous fistula with progressive paraplegia after spinal anaesthesia.

A case of an iatrogenic spinal arteriovenous fistula with progressive paraplegia in a young woman is reported. The fistula was eventually created after repetitive lumbar punctures performed in the process of spinal anaesthesia. Her symptoms were progressed to paraplegia over a period of 2 years. The digital subtraction angiography demonstrated a single-hole fistula, involving the anterior spinal artery and vein. The lesion was occluded by embolization with immediate improvement. The potential mechanism is discussed.

Silicone models as basic training and research aid in endovascular neurointervention--a single-center experience and review of the literature.

The rapid development and wider use of neurointerventional procedures have increased the demand for a comprehensive training program for the trainees, in order to safely and efficiently perform these procedures. Artificial vascular models are one of the dynamic ways to train the new generation of neurointerventionists to acquire the basic skills of material handling, tool manipulation through the vasculature, and development of hand-eye coordination. Herein, the authors present their experience regarding a long-established training program and review the available literature on the advantages and disadvantages of vascular silicone model training. Additionally, they present the current research applications of silicone replicas in the neurointerventional arena.

Organizational issues in stroke treatment: The Swiss paradigm - Stroke units.

Stroke represents the leading cause of acquired disability in adults and poses a tremendous socioeconomic burden both on patients and the society. In this sense, prompt diagnosis and urgent treatment are needed in order to radically reduce the devastating consequences of this disease. Herein the authors present the new guidelines recently adopted by the Swiss Stroke Society concerning the establishment of stroke units. Standardized treatment and allocation protocols along with an acute rehabilitation concept seem to be the core of the Swiss stroke management system. Coordinated multidisciplinary care provided by specialized medical, nursing and therapy staff is of utmost importance for achieving a significant dependency and death reduction. It is believed that the implementation of these guidelines in the stroke care system would be beneficial not only for the stroke patients, but also for the health system.