Preventing Sudden Cessation of Implantable Pulse Generators in Deep Brain Stimulation: A Systematic Review and Protocol Proposal.

INTRODUCTION: Deep brain stimulation (DBS) requires a consistent electrical supply from the implantable pulse generator (IPG). Patients may struggle to monitor their IPG, risking severe complications in battery failure. This review assesses current literature on DBS IPG battery life management and proposes a protocol for healthcare providers. METHODS: A literature search using four databases identified best practices for DBS IPG management. Studies were appraised for IPG management guidelines, categorized as qualitative, quantitative, or both. RESULTS: Of 408 citations, only seven studies were eligible, none providing clear patient management strategies. Current guidelines lack specificity, relying on clinician suggestions. CONCLUSION: Limited guidelines exist for IPG management. Specificity and adaptability to emerging technology are crucial. The findings highlight the need for specificity in patients' needs and adaptability to emerging technology in future studies. To address this need, we developed a protocol for DBS IPG management that we have implemented at our own institution. Further research is needed for effective DBS IPG battery life management, preventing therapy cessation complications.

Bradycardia risk stratification with implantable loop recorder after unexplained syncope.

BACKGROUND: An implantable loop recorder is an effective tool for diagnosing unexplained syncope. However, after a first episode in non-high-risk patients, the usefulness of implantable loop recorder implantation remains unclear. AIMS: To analyse relevant risk factors for significant bradycardia in order to identify patients who do or do not benefit from implantable loop recorder implantation. Also, to study whether implantable loop recorder implantation with remote monitoring is associated with less recurrence of traumatic syncope. METHODS: This was a retrospective monocentric study including patients with implantable loop recorder implantation after unexplained syncope, using remote monitoring and iterative consultations. RESULTS: Two hundred and thirty-seven patients were implanted for unexplained syncope. Significant bradycardia occurred in 53 patients (22.4%): 23 (43.4%) caused by paroxysmal atrioventricular block and 30 (56.6%) caused by sinus node dysfunction, leading to permanent pacemaker implantation in 48 patients. Compared with younger patients, there was a 3.46-fold increase (95% confidence interval 1.92-6.23; P<0.0001) in the risk of significant bradycardia in patients aged≥60 years. Based on multivariable analysis, only "typical syncope" was associated with significant bradycardia occurrence (hazard ratio 3.14, 95% confidence interval 1.75-5.65; P=0.0001). There was no recurrence of significant bradycardia with traumatic complications among patients implanted for traumatic syncope. CONCLUSIONS: This study shows that: (1) implantable loop recorders identify more significant bradycardia in patients aged≥60 presenting with a first non-high-risk typical syncope, suggesting that an implantable loop recorder should be implanted after a first episode of unexplained syncope in such conditions; and (2) after traumatic syncope, implantable loop recorder implantation is safe, and is associated with little or no recurrence of traumatic syncope.

Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial.

OBJECTIVES: Assess safety and performance of novel quadripolar preshaped left ventricular (LV) leads: NAVIGO 4LV 2D ('S shaped') and NAVIGO 4LV ARC ('U shaped'). METHODS: Patients indicated for cardiac resynchronisation therapy were enrolled in a multicentre, prospective, controlled study (NAVIGATOR, NCT03279484). Patients were implanted with either a NAVIGO 4LV 2D or ARC lead, and assessed at 10 weeks, 6, 12 and 24 months post-implant. Co-primary safety and performance endpoints were assessed at 10 weeks. Safety endpoint was the patients' rate free from lead-related complications. Performance endpoint was the rate of patients with successful lead performance, defined as LV pacing threshold ≤2.5 V at 0.5 ms on at least one pacing vector, and the absence of phrenic nerve stimulation at the final programmed configuration. Lead-related complications and electrical parameters were monitored throughout study. RESULTS: A NAVIGO 4LV lead was successfully implanted in 211 out of 217 patients (97.2%). The safety endpoint was met, with 100% and 96.1% of patients free from complications for NAVIGO 4LV 2D and ARC, respectively. The performance endpoint was met with 98.1% and 98.9% of patients with a successful lead performance for NAVIGO 4LV 2D and ARC, respectively. Over 12 months, the global complication-free rate for both leads was 97.1% (95% CI: 93.71% to 98.70%), with a mean pacing capture threshold of 1.23 V±0.73 V and a mean impedance of 951 Ω±300.1 Ω. CONCLUSION: A high implantation success rate and low complication rate was reported for the novel NAVIGO 4LV 2D and ARC leads, along with successful performance up to 12 months.

[Safety of robot-assisted implantation of deep electrodes for invasive stereo-EEG monitoring]. / Bezopasnost' robot-assistirovannoi implantatsii glubinnykh elektrodov dlya provedeniya invazivnogo stereo-EEG-monitoringa.

Robot-assisted implantation of deep electrodes for stereo-EEG monitoring has become popular in recent years in patients with drug-resistant epilepsy. However, there are still few data on safety of this technique. OBJECTIVE: To assess the incidence of complications in patients with drug-resistant epilepsy undergoing robot-assisted implantation of stereo-EEG electrodes. MATERIAL AND METHODS: We retrospectively studied the results of implantation of stereo-EEG electrodes in 187 patients with drug-resistant epilepsy. All patients underwent non-invasive preoperative examination (video-EEG, MRI, PET, SPECT, MEG). In case of insufficient data, stereo-EEG monitoring was prescribed. We determined electrode insertion trajectory using a robotic station and MR images. Implantation of electrodes was carried out using a Rosa robot (Medtech, France). All patients underwent invasive EEG monitoring after implantation. RESULTS: There were 11.25±3 electrodes per a patient. Implantation of one electrode took 7.5±4.9 min. Postoperative MRI revealed electrode malposition in 2.3% of cases. None was associated with complications. The complication rate per electrode was 0.6%. Complications affected stereo-EEG monitoring only in 3 cases (1.6%). The mortality rate was 0.5%. Bilateral implantation (p=0.005), insular (p=0.040) and occipital (p=0.045) deep electrode implantation were associated with lower incidence of complications. Longer duration of the procedure influenced the incidence of electrode placement in the lateral ventricle (p=0.028), and implantation in the frontal lobe was more often associated with epidural placement of electrodes (p=0.039). CONCLUSION: Robot-assisted implantation of stereo-EEG electrodes is a safe procedure with minimal risk of complications. Rare electrode malposition does not usually affect invasive monitoring.

Intracochlear Trauma and Local Ossification Patterns Differ Between Straight and Precurved Cochlear Implant Electrodes.

HYPOTHESIS: Trauma to the osseous spiral lamina (OSL) or spiral ligament (SL) during cochlear implant (CI) insertion segregates with electrode type and induces localized intracochlear ossification and fibrosis. BACKGROUND: The goal of atraumatic CI insertion is to preserve intracochlear structures, limit reactive intracochlear tissue formation, and preserve residual hearing. Previous qualitative studies hypothesized a localized effect of trauma on intracochlear tissue formation; however, quantitative studies failed to confirm this. METHODS: Insertional trauma beyond the immediate insertion site was histologically assessed in 21 human temporal bones with a CI. Three-dimensional reconstructions were generated and virtually resectioned perpendicular to the cochlear spiral at high resolution. The cochlear volume occupied by ossification or fibrosis was determined at the midpoint of the trauma and compared with regions proximal and distal to this point. RESULTS: Seven cases, all implanted with precurved electrodes, showed an OSL fracture beyond the immediate insertion site. Significantly more intracochlear ossification was observed at the midpoint of the OSL fracture, compared with the -26 to -18 degrees proximal and 28 to 56 degrees distal to the center. No such pattern was observed for fibrosis. In the 12 cases with a perforation of the SL (9 straight and 3 precurved electrodes), no localized pattern of ossification or fibrosis was observed around these perforations. CONCLUSION: OSL fractures were observed exclusively with precurved electrodes in this study and may serve as a nidus for localized intracochlear ossification. Perforation of the SL, in contrast, predominantly occurred with straight electrodes and was not associated with localized ossification.

Brain Shift during Staged Deep Brain Stimulation for Movement Disorders.

INTRODUCTION: Deep brain stimulation (DBS) is a routine neurosurgical procedure utilized to treat various movement disorders including Parkinson's disease (PD), essential tremor (ET), and dystonia. Treatment efficacy is dependent on stereotactic accuracy of lead placement into the deep brain target of interest. However, brain shift attributed to pneumocephalus can introduce unpredictable inaccuracies during DBS lead placement. This study aimed to determine whether intracranial air is associated with brain shift in patients undergoing staged DBS surgery. METHODS: We retrospectively evaluated 46 patients who underwent staged DBS surgery for PD, ET, and dystonia. Due to the staged nature of DBS surgery at our institution, the first electrode placement is used as a concrete fiducial marker for movement in the target location. Postoperative computed tomography (CT) images after the first electrode implantation, as well as preoperative, and postoperative CT images after the second electrode implantation were collected. Images were analyzed in stereotactic targeting software (BrainLab); intracranial air was manually segmented, and electrode shift was measured in the x, y, and z plane, as well as a Euclidian distance on each set of merged CT scans. A Pearson correlation analysis was used to determine the relationship between intracranial air and brain shift, and student's t test was used to compare means between patients with and without radiographic evidence of intracranial air. RESULTS: Thirty-six patients had pneumocephalus after the first electrode implantation, while 35 had pneumocephalus after the second electrode implantation. Accumulation of intracranial air following the first electrode implantation (4.49 ± 6.05 cm3) was significantly correlated with brain shift along the y axis (0.04 ± 0.35 mm; r (34) = 0.36; p = 0.03), as well as the Euclidean distance of deviation (0.57 ± 0.33 mm; r (34) = 0.33; p = 0.05) indicating statistically significant shift on the ipsilateral side. However, there was no significant correlation between intracranial air and brain shift following the second electrode implantation, suggesting contralateral shift is minimal. Furthermore, there was no significant difference in brain shift between patients with and without radiographic evidence of intracranial air following both electrode implantation surgeries. CONCLUSION: Despite observing volumes as high as 22.0 cm3 in patients with radiographic evidence of pneumocephalus, there was no significant difference in brain shift when compared to patients without pneumocephalus. Furthermore, the mean magnitude of brain shift was <1.0 mm regardless of whether pneumocephalus was presenting, suggesting that intracranial air accumulation may not produce clinical significant brain shift in our patients.

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.

Complications of Spinal Cord Stimulators-A Comprehensive Review Article.

PURPOSE OF REVIEW: Spinal cord stimulation has been increasing in influence as an option to regulate pain, especially in the chronic pain patient population. However, even with the numerous changes made to this technology since its inception, it is still prone to various complications such as hardware issues, neurological injury/epidural hematoma, infections, and other biological concerns. The purpose of this article is to thoroughly review and evaluate literature pertaining to the complications associated with percutaneous spinal cord stimulation. RECENT FINDINGS: Lead migration is generally the most common complication of percutaneous spinal cord stimulation; however, recent utilization of various anchoring techniques has been discussed and experienced clinical success in decreasing the prevalence of lead migration and lead fractures. With newer high-frequency systems gaining traction to improve pain management and decrease complications as compared to traditional systems, rechargeable implantable pulse generators have been the preferred power source. However, recent findings may suggest that these rechargeable implantable pulse generators do not significantly increase battery life as much as was proposed. Intraoperative neuromonitoring has seen success in mitigating neurological injury postoperatively and may see more usage in the future through more testing. Though the occurrence of infection and biological complications, including dural puncture and skin erosion, has been less frequent over time, they should still be treated in accordance with established protocols. While many complications can arise following percutaneous spinal cord stimulator implantation, the procedure is less invasive than open implantation and has seen largely positive patient feedback. Hardware complications, the more common issues that can occur, rarely indicate a serious risk and can generally be remedied through reoperation. However, less common cases such as neurological injury, infections, and biological complications require prompt diagnosis to improve the condition of the patient and prevent significant damage.

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

BACKGROUND: 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. OBJECTIVE: This imaging study was undertaken to determine the minimum canal diameter required for safe paddle lead placement. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Multitarget deep brain stimulation for epilepsy.

OBJECTIVE: Deep brain stimulation (DBS) is a rapidly growing surgical option for patients with drug-resistant epilepsy who are not candidates for resective/ablative surgery. Recent randomized controlled trials have demonstrated efficacy of DBS of the anterior nucleus of the thalamus (ANT), particularly in frontal or temporal epilepsy, whereas DBS of the centromedian (CM) nucleus appears to be most suitable in well-defined generalized epilepsy syndromes. At the authors' institution, DBS candidates who did not fit the populations represented in these trials were managed with DBS of multiple distinct targets, which included ANT, CM, and less-studied nuclei-i.e., mediodorsal nucleus, pulvinar, and subthalamic nucleus. The goal of this study was to present the authors' experience with these types of cases, and to motivate future investigations that can determine the long-term efficacy of multitarget DBS. METHODS: This single-center retrospective study of adult patients with drug-resistant epilepsy who underwent multitarget DBS was performed to demonstrate the feasibility and safety of this approach, and to present seizure outcomes. Patients in this cohort had epilepsy with features that were difficult to treat with DBS of the ANT or CM nucleus alone, including multifocal/multilobar, diffuse-onset, and/or posterior-onset seizures; or both generalized and focal seizures. RESULTS: Eight patients underwent DBS of 2-3 distinct thalamic/subthalamic nuclei. DBS was performed with 2 electrodes in each hemisphere. All leads in each patient were implanted with either frontal or parietal trajectories. There were no surgical complications. Among those with > 6 months of follow-up (n = 5; range 7-21 months), all patients were responders in terms of overall seizure frequency and/or convulsive seizure frequency (i.e., ≥ 50% reduction). Two patients had adverse stimulation effects, which resolved with further programming. CONCLUSIONS: Multitarget DBS is a procedurally feasible and safe treatment strategy to maximize outcomes in patients with complex epilepsy. The authors highlight their approach to inform future studies that are sufficiently powered to assess its efficacy.

Upper airway stimulation device failure: A 7-year single center experience.

OBJECTIVE: To identify and report a single center experience with upper airway stimulator device-related failures. STUDY DESIGN: Retrospective case series. SETTING: Single tertiary academic center. METHODS: Retrospective data on 352 patients who underwent UAS surgery with an Inspire device from 2016 to 2023 was collected, including demographics, comorbidities, and nature of device failure requiring revision surgery. RESULTS: Out of the 348 patients included in our analysis, 16 (4.6 %) required revision due to device failure, with an average interval of 772 days (∼2 years) between initial implant and revision. Most failures were attributed to respiratory sensing lead damage (n = 11, 68.8 %), resulting in high system impedance and subsequent device malfunction. Lead fracture causes varied, including idiopathic occurrences and potential trauma. Lead migration was noted in one case (6.3 %), where the hypoglossal electrode detached from the nerve. Two patients (12.3 %) required implantable pulse generator (IPG) replacement, one after experiencing trauma and the other due to unclear source of malfunction. One patient (6.3 %) required complete system replacement following high lead impedance and absent tongue motion. The last patient required replacement of both the IPG and respiratory lead after experiencing high lead impedance (6.3 %). CONCLUSION: Respiratory sensing lead fracture emerged as the leading cause of device failure in this cohort, underscoring the need to address this under-reported issue, potentially linked to the time lapse after device implantation.

Incidence and management of idiopathic peri-lead edema (IPLE) following deep brain stimulation (DBS) surgery: Case series and review of the literature.

OBJECTIVE: Idiopathic peri-lead edema (IPLE) is being increasingly described as a potential complication occurring after DBS surgery. Its incidence and relationship to post-operative symptoms, though, are still poorly defined and its understanding and management yet limited. METHODS: We reviewed delayed (≥ 72 h) post-operative CT imaging of patients who underwent DBS surgery at our Institution. A comparison of clinical and laboratory findings was carried out between patients with IPLE and controls. RESULTS: 61 patients, accounting for 115 electrodes, were included. Incidence of IPLE was 37.7 % per patient and 29.5 % per electrode. Patients with IPLE were significantly older than controls (52.82 ± 15.65 years vs 44.73 ± 18.82 years, p = 0.04). There was no difference in incidence of new-onset neurological symptoms between patients with IPLE and controls. Longer operative time (180.65 ± 34.30 min vs 158.34 ± 49.28 min, p = 0.06) and a greater number of MERs per electrode were associated with IPLE (3.37 ± 1.21 vs 3.00 ± 1.63, p = 0.089), though these comparisons did not meet the statistical significance. None of the patients with IPLE underwent hardware removal, with IPLE vanishing spontaneously over months. CONCLUSIONS: IPLE is an underestimated, benign event that may occur after DBS surgery. Age, longer operative time and MER use may represent risk factors for IPLE formation, but further studies are needed. The presence of post-operative neurological symptoms and fever was not associated with IPLE presence, highlighting its benign nature and suggesting that empiric treatment may not be always justified.

Lack of spontaneous typical seizures during intracranial monitoring with stereo-electroencephalography.

OBJECTIVE: In the presurgical evaluation of patients with drug-resistant epilepsy (DRE), occasionally, patients do not experience spontaneous typical seizures (STS) during a stereo-electroencephalography (SEEG) study, which limits its effectiveness. We sought to identify risk factors for patients who did not have STS during SEEG and to analyze the clinical outcomes for this particular set of patients. METHODS: We conducted a retrospective analysis of all patients with DRE who underwent depth electrode implantation and SEEG recordings between January 2013 and December 2018. RESULTS: SEEG was performed in 155 cases during this period. 11 (7.2%) did not experience any clinical seizures (non-STS group), while 143 experienced at least one patient-typical seizure during admission (STS group). No significant differences were found between STS and non-STS groups in terms of patient demographics, lesional/non-lesional epilepsy ratio, pre-SEEG seizure frequency, number of ASMs used, electrographic seizures or postoperative seizure outcome in those who underwent resective surgery. Statistically significant differences were found in the average number of electrodes implanted (7.0 in the non-STS group vs. 10.2 in STS), days in Epilepsy Monitoring Unit (21.8 vs. 12.8 days) and the number of cases that underwent resective surgery following SEEG (27.3% vs. 60.8%), respectively. The three non-STS patients (30%) who underwent surgery, all had their typical seizures triggered during ECS studies. Three cases were found to have psychogenic non-epileptic seizures. None of the patients in the non-STS group were offered neurostimulation devices. Five of the non-STS patients experienced transient seizure improvement following SEEG. SIGNIFICANCE: We were unable to identify any factors that predicted lack of seizures during SEEG recordings. Resective surgery was only offered in cases where ECS studies replicated patient-typical seizures. Larger datasets are required to be able to identify factors that predict which patients will fail to develop seizures during SEEG.

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases.

BACKGROUND: The number of deep brain stimulation (DBS) procedures is rapidly rising as well as the novel indications. Reporting adverse events related to surgery and to the hardware used is essential to define the risk-to-benefit ratio and develop novel strategies to improve it. OBJECTIVE: To analyze DBS complications (both procedure-related and hardware-related) and further assess potential predictive factors. METHODS: Five hundred seventeen cases of DBS for Parkinson's disease were performed between 2006 and 2021 in a single center (mean follow-up: 4.68 ± 2.86 years). Spearman's Rho coefficient was calculated to search for a correlation between the occurrence of intracerebral hemorrhage (ICH) and the number of recording tracks. Multiple logistic regression analyzed the probability of developing seizures and ICH given potential risk factors. Kaplan-Meier curves were performed to analyze the cumulative proportions of hardware-related complications. RESULTS: Mortality rate was 0.2%, while permanent morbidity 0.6%. 2.5% of cases suffered from ICH which were not influenced by the number of tracks used for recordings. 3.3% reported seizures that were significantly affected by perielectrode brain edema and age. The rate of perielectrode brain edema was significantly higher for Medtronic's leads compared to Boston Scientific's (Χ2(1)= 5.927, P= 0.015). 12.2% of implants reported Hardware-related complications, the most common of which were wound revisions (7.2%). Internal pulse generator models with smaller profiles displayed more favorable hardware-related complication survival curves compared to larger designs (X2(1)= 8.139, P= 0.004). CONCLUSION: Overall DBS has to be considered a safe procedure, but future research is needed to decrease the rate of hardware-related complications which may be related to both the surgical technique and to the specific hardware's design. The increased incidence of perielectrode brain edema associated with certain lead models may likewise deserve future investigation.

The impact of skull thickness on pediatric stereoencephalography electrode implantation and technical considerations.

OBJECTIVE: One consideration in pediatric stereoencephalography (SEEG) is decreased skull thicknesses compared with adults, which may limit traditional bolt-based anchoring of electrodes. The authors aimed to investigate the safety profile, complication rates, and technical adaptations of placing SEEG electrodes in pediatric patients. METHODS: The authors retrospectively reviewed all patients aged 12 years or younger at the time of SEEG implantation at their institution. Postimplantation CT scans were used to measure skull thickness at the entry point of each SEEG lead. Postimplantation lead accuracy was also assessed. RESULTS: Fifty-three patients were reviewed. The median skull thickness was 4.1 (interquartile range [IQR] 3.15-5.2) mm. There were 5 total complications: 1 retained bolt fragment, 3 asymptomatic subdural hematomas, and 1 asymptomatic intracranial hemorrhage. Median radial error from the lead target was 3.5 (IQR 2.24-5.25) mm. Linear regression analysis revealed that increasing skull thickness decreased the deviation from the intended target, implying an improved accuracy to target at thicker skull entry points; this trended towards improved accuracy, but did not achieve statistical significance (p = 0.54). CONCLUSIONS: This study found a 1.9% hardware complication rate and a 9.4% asymptomatic hemorrhage rate. Suturing electrodes to the scalp may represent a reasonable option if there are concerns of young age or a thin skull. These data indicate that invasive SEEG evaluation is safe among patients 12 years old or younger.

Cell-specific alterations in autophagy-lysosomal activity near the chronically implanted microelectrodes.

Intracortical microelectrodes that can record and stimulate brain activity have become a valuable technique for basic science research and clinical applications. However, long-term implantation of these microelectrodes can lead to progressive neurodegeneration in the surrounding microenvironment, characterized by elevation in disease-associated markers. Dysregulation of autophagy-lysosomal degradation, a major intracellular waste removal process, is considered a key factor in the onset and progression of neurodegenerative diseases. It is plausible that similar dysfunctions in autophagy-lysosomal degradation contribute to tissue degeneration following implantation-induced focal brain injury, ultimately impacting recording performance. To understand how the focal, persistent brain injury caused by long-term microelectrode implantation impairs autophagy-lysosomal pathway, we employed two-photon microscopy and immunohistology. This investigation focused on the spatiotemporal characterization of autophagy-lysosomal activity near the chronically implanted microelectrode. We observed an aberrant accumulation of immature autophagy vesicles near the microelectrode over the chronic implantation period. Additionally, we found deficits in autophagy-lysosomal clearance proximal to the chronic implant, which was associated with an accumulation of autophagy cargo and a reduction in lysosomal protease level during the chronic period. Furthermore, our evidence demonstrates reactive astrocytes have myelin-containing lysosomes near the microelectrode, suggesting its role of myelin engulfment during acute implantation period. Together, this study sheds light on the process of brain tissue degeneration caused by long-term microelectrode implantation, with a specific focus on impaired intracellular waste degradation.

Accuracy and Utility of Frameless Stereotactic Placement of Stereoelectroencephalography Electrodes.

BACKGROUND: Successful surgery for epilepsy hinges on identification of the epileptogenic focus. Stereoelectroencephalography (sEEG) is the most effective way to identify most seizure foci. There are multiple methods of inserting depth electrodes, including frame-based, frameless, and robot-assisted techniques. Studies have shown the accuracy of frame-based and robotic-assisted techniques to be statistically similar, while only one study has detailed the frameless sEEG insertion technique. METHODS: Patients underwent placement of sEEG depth electrodes using frameless stereotaxy from September 2019 to September 2021 at Geisinger Medical Center by a single surgeon. Seizure history, electrode placement accuracy relative to the planned trajectories, surgical times, success rate of identifying the epileptogenic focus, and subsequent seizure control rates after surgical treatment were documented. RESULTS: Data were available for 21 patients and 181 electrodes inserted using the VarioGuide frameless stereotactic system. Each insertion took an average of 14.5 minutes per lead. Average entry variance was 2.7 mm with an average target variance of 4.6 mm. The epileptogenic focus was identified in 19 of 21 patients, and further surgical treatment was performed in 18 of 21 patients (85.7%). CONCLUSIONS: VarioGuide frameless stereotaxy for sEEG placement is comparable to frame-based and robotic-assisted techniques with statistically similar rates of epileptic focus identification. Lead placement accuracy is slightly lower and time per lead is slightly higher relative to robot-assisted surgeries. When a robot system is unavailable, surgeons can consider using a frameless stereotactic technique for sEEG insertion, allowing patients to benefit from a similarly high rate of epileptic zone identification.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Safety profile of subdural and depth electrode implantations in invasive EEG exploration of drug-resistant focal epilepsy.

PURPOSE: To analyze the safety profile of subdural and depth electrode implantation in a large monocentric cohort of patients of all ages undergoing intracranial EEG exploration because of drug resistant focal epilepsy diagnosed and implanted by a constant team of epileptologists and neurosurgeons. METHODS: We retrospectively analyzed data from 452 implantations in 420 patients undergoing invasive presurgical evaluation at the Freiburg Epilepsy Center from 1999 to 2019 (n = 160 subdural electrodes, n = 156 depth electrodes and n = 136 combination of both approaches). Complications were classified as hemorrhage with or without clinical manifestations, infection-associated and other complications. Furthermore, possible risk factors (age, duration of invasive monitoring, number of electrode contacts used) and changes in complication rates during the study period were analyzed. RESULTS: The most frequent complications in both implantation groups were hemorrhages. Subdural electrode explorations caused significantly more symptomatic hemorrhages and required more operative interventions (SDE 9.9%, DE 0.3%, p < 0.05). Hemorrhage risk was higher for grids with 64 contacts than for smaller grids (p < 0.05). The infection rate was very low (0,2%). A transient neurological deficit occurred in 8.8% of all implantations and persisted for at least 3 months in 1.3%. Transient, but not persistent neurological deficits were more common in patients with implanted subdural electrodes than in the depth electrode group. CONCLUSION: The use of subdural electrodes was associated with a higher risk of hemorrhage and transient neurological symptoms. However persistent deficits were rare with either approach, demonstrating that intracranial investigations using either subdural electrodes or depth electrodes carry acceptable risks in patients with drug-resistant focal epilepsy.