Initial United States experience with Medtronic Stealth Autoguide cranial robotic guidance platform.

OBJECTIVE: Stereotactic techniques play an important role in neurosurgery. The development of a miniaturized cranial robot with an efficient workflow and accurate surgical execution is an important step in a broader application of these techniques. Herein, the authors describe their experience with the Medtronic Stealth Autoguide miniaturized cranial robot. METHODS: A retrospective review of 75 cases from 2020 to 2022 was performed. The patients who had undergone surgery utilizing the Stealth Autoguide robot were analyzed for surgical indication and accuracy, operative time, and clinical outcome. The outcomes were defined as follows: for stereoelectroencephalography (SEEG), the electrode placement pattern that identified the seizure focus and did not require any revision or additional leads; for biopsy, the percentage of cases in which diagnostic tissue was obtained; and for laser interstitial thermal therapy (LITT), the percentage of cases in which laser fiber placement was adequate for ablation. Surgical complications were defined as any asymptomatic or symptomatic intracerebral hemorrhage, new neurological deficit, or need for electrode, laser fiber, or biopsy needle repositioning or revision. RESULTS: The Stealth Autoguide robot was utilized in 75 on-label cases, including 40 SEEG cases for seizure focus localization, 19 LITT cases, and 16 stereotactic biopsy cases. The mean real target error (RTE) at the entry was 1.48 ± 0.84 mm for biopsy, 1.36 ± 0.89 mm for Visualase laser fiber placement, and 1.24 ± 0.72 mm for SEEG. The mean RTE at the target was 1.56 ± 0.95 mm for biopsy needle placement, 1.42 ± 0.93 mm for Visualase laser fiber placement, and 1.31 ± 0.87 mm for SEEG electrode placement. The surgical time for unilateral SEEG cases took an average 52 minutes (average 6.5 mins/lead, average 8 electrodes). Bilateral SEEG cases took an average 105 minutes (average 7.5 mins/lead, average 14 electrodes). In the SEEG population, there were no revised or unsuccessful seizure localizations. For biopsy, diagnostic tissue was obtained in 100% of cases. For LITT, fiber placement was adequate for ablation in 100% of cases. There were no cases of symptomatic or asymptomatic intracerebral hemorrhage, and no cases required repositioning or replacement of the laser fiber, electrode, or biopsy needle. One patient experienced transient cranial nerve III palsy following laser ablation that resolved in 10 weeks. A failure of communication between the robotic platform and the Stealth Autoguide as a station required the cancellation of 1 procedure. CONCLUSIONS: The Medtronic Stealth Autoguide robot system is versatile across biopsy, SEEG, and laser ablation indications. Setup and surgical execution are efficient with a high degree of accuracy and consistency.

Descriptive cross-sectional study to evaluate perception, attitude, and practice of parents regarding COVID-19 vaccination in children 10-12 years of age-A step toward prevention of future COVID-19 outbreaks in India.

Purpose: COVID-19 was declared a global pandemic and all age groups were equally affected. Coronavirus had devastating effects worldwide due to the emergence of new variants till vaccination was adopted to eradicate the transmission of the virus and restore normalcy. However, children were not included in the initial phase of vaccination. The purpose of the study was to assess the level of perception, attitude, and practice among parents toward the COVID-19 vaccination drive in children 10-12 years of age. Design and Study: The present research is a cross-sectional questionnaire-based survey including parents of children aged 10-12 years as participants. The survey was conducted between May 2022 and July 2022 with a sample size of 320. Results: A high willingness (80%) among parents was found for getting their children vaccinated. COVID-19 vaccines were perceived to be safe by the parents (59%) and efficacious (75%) for their children. Parents (67%) felt that the benefits of getting their children vaccinated against COVID-19 prevail over the risks of the vaccine. Parents 214 (67%) feel the need of getting their child vaccinated for sending them to school followed by availing of daycare facilities after school 54 (17%) among working parents. A significant association (P < 0.05) was seen between the variables of practice being followed by parents and their children as per COVID-19 norms. Parent's negative attitude toward COVID-19 vaccination was associated with availability of no/unclear safety information (36%), fear of adverse effects of vaccine (3%), and false belief of having long-term immunity due to natural infection (32%). The positive attitude of parents was due to trust in positive information/news about the vaccine (42%), belief in the safety and efficacy of the vaccine (5%), acceptability for mild adverse effects (1%), and the necessity of vaccine to send children to schools (1%). Conclusion and Recommendations: The awareness of parents regarding COVID-19 vaccination for children was limited, high level of acceptance for vaccination was seen in our study. We recommend to continuing educational programs through mass campaigns to increase increasing awareness among parents for getting COVID-19 vaccination for their children. Vaccine hesitancy including vaccine safety concerns of parents should be addressed by presenting myths and facts related to COVID-19 vaccine using television, radio, and social media platforms.

Differential Target Multiplexed Spinal Cord Stimulation: A UK Cost-Effectiveness Analysis.

OBJECTIVES: The aim of this economic analysis was to evaluate the cost-effectiveness of differential target multiplexed spinal cord stimulation (DTM-SCS) for treating chronic intractable low back pain, compared with conventional spinal cord stimulation (C-SCS) and conservative medical management (CMM), by updating and expanding the inputs for a previously published cross-industry model. MATERIALS AND METHODS: This model comprised a 12-month decision-tree phase followed by a long-term Markov model. Costs and outcomes were calculated from a UK National Health Service perspective, over a base-case horizon of 15 years and up to a maximum of 40 years. All model inputs were derived from published literature or other deidentified sources and updated to reflect recent clinical trials and costs. Deterministic and one-way sensitivity analyses were performed to calculate costs and quality-adjusted life-years (QALYs) across the 15-year time horizon and to explore the impact of individual parameter variability on the cost-effectiveness results. Probabilistic sensitivity analysis was undertaken to explore the impact of joint parameter uncertainty on the results. RESULTS: DTM-SCS was the most cost-effective option from a payer perspective. Compared with CMM alone, DTM-SCS was associated with an incremental cost-effectiveness ratio (ICER) of £6101 per QALY gained (incremental net benefit [INB] = £21,281). The INB for C-SCS compared with CMM was lower than for DTM-SCS, at £8551. For the comparison of DTM-SCS and C-SCS, an ICER of £897 per QALY gained was calculated, with a 99.5% probability of cost-effectiveness at a £20,000 per QALY threshold. CONCLUSIONS: Among patients with low back pain treated over a 15-year follow-up period, DTM-SCS and C-SCS are cost-effective compared with CMM, from both payer and societal perspectives. DTM-SCS is associated with a lower ICER than that of C-SCS. Wider uptake of DTM-SCS in the UK health care system is warranted to manage chronic low back pain.

Precision Rehabilitation After Neurostimulation Implantation for Multifidus Dysfunction in Nociceptive Mechanical Chronic Low Back Pain.

Chronic low back pain (CLBP) is a debilitating, painful, and costly condition. Implantable neuromuscular electrical stimulation targeting the multifidus musculature is growing as a non-pharmacologic option for patients with recalcitrant nociceptive mechanical CLBP who have failed conservative treatments (including medications and physical therapy) and for whom surgery is not indicated. Properly selecting patients who meet specific criteria (based on historical results from randomized controlled trials), who diligently adhere to implant usage and precisely implement neuromuscular rehabilitation, improve success of significant functional recovery, as well as pain medication reductions. Patients with nociceptive mechanical CLBP who underwent implanted multifidus neurostimulation have been treated by physicians and rehabilitation specialists who have honed their experience working with multifidus neurostimulation. They have collaborated on consensus and evidence-driven guidelines to improve quality outcomes and to assist providers when encountering patients with this device. Physicians and physical therapists together provide precision patient-centric medical management with quality neuromuscular rehabilitation to encourage patients to be experts of both their implants and quality spine motion to help override long-standing multifidus dysfunction related to their CLBP.

Cerebral Protection in Trans-Catheter Aortic Valve Replacement: Review and Contemporary Assessment of Randomized Trial Data.

As the population has aged and as aortic valve therapies have evolved, the use of trans-catheter aortic valve replacement (TAVR) has grown dramatically over the past decade. A well-known complication of percutaneous cardiac intervention is embolic phenomena, and TAVR is among the highest risk procedures for clinical and subclinical stroke. As indications for TAVR expand to lower-risk and ultimately younger patients, the long-term consequences of stroke are amplified. Cerebral embolic protection (CEP) devices have taken a on unique preventative role following the Food and Drug Administration approval of the SentinelTM Cerebral Protection System (CPS). More recently, the PROTECTED TAVR study has spurred extensive debate in the neuro-cardiac community. In this review we describe the contemporary literature regarding stroke risk associated with TAVR, the history and role of CEP devices, a PROTECTED TAVR sub-group analysis, and implications for next steps in the field. Lastly, we explore the unique need for CEP in a younger TAVR population, as well as directions for future research.

Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

National multicentered retrospective review of clinical and intraoperative factors associated with the development of cerebellar mutism after pediatric posterior fossa tumor resection.

BACKGROUND: Cerebellar mutism (CM) is characterized by a significant loss of speech in children following posterior fossa (PF) surgery. The biological origin of CM remains unclear and is the subject of ongoing debate. Significant recovery from CM is less likely than previously described despite rigorous multidisciplinary neuro-rehabilitational efforts. METHODS: A national multi-centered retrospective review of all children undergoing PF resection in four midsized Canadian academic pediatric institutions was undertaken. Patient, tumor and surgical factors associated with the post-operative development of CM were reviewed. Retrospective identification of PF surgery patients including those developing and those that did not (internal control). RESULTS: The study identified 258 patients across the 4 centers between 2010 and 2020 (mean age 6.73 years; 42.2% female). Overall, CM was experienced in 19.5% of patients (N = 50). Amongst children who developed CM histopathology included medulloblastoma (35.7%), pilocytic astrocytoma (32.6%) and ependymoma (17.1%). Intraoperative impression of adherence to the floor of the 4th ventricle was positive in 36.8%. Intraoperative abrupt changes in blood pressure and/or heart rate were identified in 19.4% and 17.8% of cases. The clinical resolution of CM was rated to be complete, significant resolution, slight improvement, no improvement and deterioration in 56.0%, 8.0%, 20.0%, 14.0% and 2.0%, respectively. In the cohort of children who experienced post-operative CM as compared to their no-CM counterpart, proportionally more tumors were felt to be adherent to the floor of the 4th ventricle (56.0% vs 49.5%), intraoperative extent of resection was a GTR (74% vs 68.8%) and changes in heart rate were noted (≥ 20% from baseline) (26.0% vs 15.9%). However, a multiple regression analysis identified only abrupt changes in HR (OR 5.97, CI (1.53, 23.1), p = 0.01) to be significantly associated with the development of post-operative CM. CONCLUSION: As a devastating surgical complication after posterior fossa tumor surgery with variable clinical course, identifying and understanding the operative cues and revising intraoperative plans that optimizes the child's neurooncological and clinical outcome are essential.

Identification and management of foreign body in the primary teeth.

Paediatric dentists encounter many emergencies in child patients and entrapment of foreign bodies in teeth is a commonly anticipated complication. It is more frequently seen in children with chronic carious lesions or due to teeth with wide open pulp chambers and pulp canals affected with caries or traumatic dental injuries. Here, we report a case of successful management of foreign body lodgement in the primary teeth of a middle childhood female patient along with a literature review of various foreign bodies identified in the past and some practical recommendations for the prevention of such incidents in the future.

HSF-1 enhances cardioprotective potential of stem cells via exosome biogenesis and their miRNA cargo enrichment.

Stem cell therapy provides a hope to no option heart disease patient group. Stem cells work via different mechanisms of which paracrine mechanism is reported to justify most of the effects. Therefore, identifying the control arms for paracrine cocktail production is necessary to tailor stem cell functions in disease contextual manner. In this study, we describe a novel paracrine cocktail regulatory axis, in stem cells, to enhance their cardioprotective abilities. We identified that HSF1 knockout resulted in reduced cardiac regenerative abilities of mesenchymal stem cells (MSCs) while its overexpression had opposite effects. Altered exosome biognesis and their miRNA cargo enrichment were found to be underlying these altered regenerative abilities. Decreased production of exosomes by MSCs accompanied their loss of HSF1 and vice versa. Moreover, the exosomes derived from HSF1 depleted MSCs showed significantly reduced candidate miRNA expression (miR-145, miR-146, 199-3p, 199b and miR-590) compared to those obtained from HSF1 overexpressing MSCs. We further discovered that HSF1 mediates miRNAs' enrichment into exosomes via Y binding protein 1 (YBX1) and showed, by loss and gain of function strategies, that miRNAs' enrichment in mesenchymal stem cell derived exosomes is deregulated with altered YBX1 expression. It was finally demonstrated that absence of YBX1 in MSCs, with normal HSF1 expression, resulted in significant accumulation of candidate miRNAs into the cells. Together, our data shows that HSF1 plays a critical role in determining the regenerative potential of stem cells. HSF1 does that by affecting exosome biogenesis and miRNA cargo sorting via regulation of YBX1 gene expression.

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

Spinal ectopic recurrence of craniopharyngioma in a pediatric patient.

Craniopharyngiomas are rare, benign lesions that can be treated with surgery, radiation therapy, or a combination of these modalities. They have a propensity for local recurrence, but there have also been rare cases reported of ectopic recurrence. Here, we present the case of a 15-year-old girl with a recurrence of craniopharyngioma in the spine, which is the second-ever reported case of recurrence outside of the brain in a pediatric patient, and review the 19 reported cases of ectopic recurrence in pediatric patients due to cerebrospinal fluid dissemination.

A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain.

OBJECTIVES: The aim of this article is to discuss the possible mechanisms of action (MOAs) and results of a pilot study of a novel, anatomically placed, and paresthesia-independent, neurostimulation waveform for the management of chronic intractable pain. MATERIALS AND METHODS: A novel, multilayered pulsed stimulation pattern (PSP) that comprises three temporal layers, a Pulse Pattern layer, Train layer, and Dosage layer, was developed for the treatment of chronic intractable pain. During preliminary development, the utility was evaluated of anatomical PSP (aPSP) in human subjects with chronic intractable pain of the leg(s) and/or low back, compared with that of traditional spinal cord stimulation (T-SCS) and physiological PSP. The scientific theory and testing presented in this article provide the preliminary justification for the potential MOAs by which PSP may operate. RESULTS: During the pilot study, aPSP (n = 31) yielded a greater decrease in both back and leg pain than did T-SCS (back: -60% vs -46%; legs: -63% vs -43%). In addition, aPSP yielded higher responder rates for both back and leg pain than did T-SCS (61% vs 48% and 78% vs 50%, respectively). DISCUSSION: The novel, multilayered approach of PSP may provide multimechanistic therapeutic relief through preferential fiber activation in the dorsal column, optimization of the neural onset response, and use of both the medial and lateral pathway through the thalamic nuclei. The results of the pilot study presented here suggest a robust responder rate, with several subjects (five subjects with back pain and three subjects with leg pain) achieving complete relief from PSP during the acute follow-up period. These clinical findings suggest PSP may provide a multimechanistic, anatomical, and clinically effective management for intractable chronic pain. Because of the limited sample size of clinical data, further testing and long-term clinical assessments are warranted to confirm these preliminary findings.

Dynamic Brain Imaging Response to Spinal Cord Stimulation Differential Frequencies DiFY SCS-PET Clinical Trial.

OBJECTIVES: This study with sequential 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)-computed tomography (CT) scanning was designed to investigate any objective measurable effect of differential frequency stimulation (40 Hz, 4000 Hz, and 10,000 Hz) on specific pain matrix areas in patients who underwent spinal cord stimulation (SCS) for intractable lumbar neuropathic pain. MATERIALS AND METHODS: In this single-center, randomized, blinded study, four brain 18F-FDG PET scans were performed for each patient-at baseline before SCS implant and after 40-Hz, 4000-Hz, and 10,000-Hz stimulation. After 40-Hz stimulation for four weeks, patients were randomized 1:1 (4000 Hz/10,000 Hz), crossing over at another four weeks. 18F-FDG PET-CT brain scans acquired on the GE-Discovery 710 PET system (GE Healthcare, Chicago, IL) with 128-slice CT (250-MBq dose) were analyzed using the PMOD software (PMOD Technologies Ltd, Zurich, Switzerland). A total of 18 pain regions, the right and left prefrontal cortex (PFC), insula, anterior cingulate cortex (ACC), hippocampus, amygdala, primary somatosensory cortices, secondary somatosensory cortices (SSCII), thalami, parabrachial, and periaqueductal gray (PAG), were analyzed. RESULTS: A total of 14 patients received 40 Hz for four weeks before crossing over to 10,000 Hz/4000 Hz. A total of 57 PET-CT scans (15 for baseline and 14 each for 40 Hz, 4000 Hz, and 10,000 Hz) were analyzed for maximum standardized uptake value (SUVmax), with a statistically significant difference in SUVmax between 40 Hz and baseline (p = 0.002) and 4000 Hz and baseline (p = 0.001) when pooled across 18 pain matrices. There was no statistical difference in SUVmax between 10,000 Hz and baseline. The pooled analysis showed a proportionately higher thalamic region reduction (59.5%) in metabolic activity than other pain matrices, PFC (52%), insula (50%), ACC (52%), SSCII (49%), and PAG (52%). CONCLUSION: This large cohort of brain PET scans (n = 57) shows statistically significant differences in brain metabolic activity at 40 Hz and 4000 Hz from baseline, with effect on both nociceptive and affect-cognitive pathways (proportionately higher reduction in the thalamus), highlighting the possible mechanism of SCS. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03716557.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

BACKGROUND: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. OBJECTIVE: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. RESULTS: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. CONCLUSION: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354.

Lupus Nephritis Associated With Renal Cell Carcinoma.

A 43-year-old man was found to have hematuria and proteinuria during a regular checkup. Workup revealed a renal mass on a CT scan. He continued to have worsening proteinuria and hematuria, with declining renal function, so a renal biopsy was performed, which revealed lupus nephritis class IV. He underwent partial nephrectomy, which confirmed the diagnosis of renal cell carcinoma on pathology. He was started on glucocorticoids, hydroxychloroquine, and cyclophosphamide for lupus nephritis.

Scleroderma Renal Crisis With Thrombotic Microangiopathy Treated With Eculizumab.

We herein report the unusual case of a 52-year-old female with systemic scleroderma who was admitted to the emergency department (ED) with renal dysfunction and hypertension. Following a decline in hemoglobin (Hb) and platelet (Plt) count, the diagnosis of scleroderma renal crisis (SRC) with associated microangiopathic hemolytic anemia was made. Renal replacement therapy using hemodialysis was required. Systemic scleroderma is a chronic autoimmune multisystem vasculopathy affecting several vessel beds, including distal extremities, kidneys, and lungs. Microangiopathic hemolytic anemia occurs in almost half of patients who develop scleroderma renal crisis. This association is thought to be related to the activation of the complement system via the classical pathway. Based on that, we administered a C5 blocker (eculizumab) to our patient and reported an unprecedented positive outcome.

Opioid sparing strategies for perioperative pain management other than regional anaesthesia: A narrative review.

Opioids play a crucial role in pain management in spite of causing increased hospital morbidity and related costs. It may also cause significant risks such as postoperative nausea and vomiting (PONV), sedation, sleep disturbances, urinary retention and respiratory depression (commonly referred to as opioid related adverse effects) in postoperative patients. In order to evade these opioid related side effects and also improve pain management, multimodal analgesia i.e., combination of different analgesics, was introduced more than a decade ago. Both pharmacological and non-pharmacological techniques are available as opioid sparing analgesia. Research from around the world have proved pharmacological techniques ranging from acetaminophen, NSAIDs (non-steroidal anti-inflammatory drugs), N-methyl-D-aspartate receptor antagonists (NDMA), alpha-2 agonists, anticonvulsants such as gamma aminobutyric acid analogues, beta-blockers, capsaicin, lignocaine infusion to glucocorticoids to be effective. On the other hand, non-pharmacological methods include techniques such as cognitive behavioral therapy, transcutaneous electrical nerve stimulation (TENS), electroanalgesia, acupuncture and hypnosis. However, research regarding the effect of these non-pharmacological techniques on pain management is still needed.