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1.
World Neurosurg ; 2024 Aug 02.
Article in English | MEDLINE | ID: mdl-39098504

ABSTRACT

OBJECTIVES: Surgical intervention for unstable thoracolumbar spine fractures is common, but delayed management and complications can impact outcomes. This study compares perioperative outcomes between patients directly admitted and those transferred from another facility for thoracolumbar spine surgery, aiming to identify predictors of complications and mortality. METHODS: A multicenter retrospective cohort study used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database from 2011 to 2021 identified 61,626 patients undergoing fusion surgeries for thoracolumbar spine fractures, excluding spinal cord injury or pathological fractures. Patients were categorized as Direct (admitted from the emergency department) and Transfer (transferred from another facility). Perioperative outcomes, including operative time, length of stay (LOS), 30-day mortality, and complications were compared. RESULTS: Our patient population (54.3% female, mean age 62.4 ± 12.9 years) comprised 12.2% Transfer and 87.8% Direct patients. Following propensity score matching, Transfer patients had a longer hospital LOS (5.1±5.7 days vs 4.5±4.6 days, p<0.001). Transfer exhibited higher rates of superficial incisional surgical site infection (1.7% vs 1.1%, p=0.003), sepsis (1.7% vs 1.3%, p=0.038), pneumonia (1.7% vs 1.2%, p=0.019), postoperative reintubation (0.9% vs 0.6%, p=0.036), and failure to wean off ventilator >48 hours post-surgery (0.7% vs 0.3%, p=0.005) compared to Direct admissions. Direct group had higher rate of perioperative transfusion (16.5% vs 13.4%, p<0.001). Transfer patients also had higher 30-day mortality rate compared to Direct admissions (1.1% vs 0.6%, p=0.002). CONCLUSIONS: Interhospital transfers significantly affect hospital LOS, postoperative morbidity, and mortality in thoracolumbar spine surgery. Enhancing postoperative monitoring for transfer patients is crucial.

2.
J Neurosurg Case Lessons ; 8(5)2024 Jul 29.
Article in English | MEDLINE | ID: mdl-39074401

ABSTRACT

BACKGROUND: Traumatic high cervical spinal cord injury (SCI) can result in a devastating loss of functional respiration, leaving patients permanently dependent on mechanical ventilation. Nerve transfer is a promising reinnervation strategy that has the potential to restore connectivity in paralyzed distal muscles. The spinal accessory nerve (SAN) remains functional in most cases after high cervical SCI and can serve as a donor to reinnervate the phrenic nerve (PN), thereby improving diaphragmatic function. OBSERVATIONS: Information regarding thorough physical, electrodiagnostic, and pulmonary assessments to establish candidacy for nerve transfer, as well as the surgical procedure, was summarized with an illustrative case. The patient demonstrated improvement in pulmonary function testing but did not achieve independent respiration. A systematic literature review identified 3 studies with 9 additional patients who had undergone SAN-to-PN transfer. The nerve transfer meaningfully restored diaphragmatic function, improving pulmonary function tests and reducing ventilator dependency. LESSONS: Respiratory dependency significantly impacts the quality of life of patients with a high cervical SCI. The use of the lower SAN motor branch for PN transfer is safe and does not result in a meaningful downgrade in trapezius function. Outcomes following this procedure are promising but heterogeneous, indicating a need for significant innovation and improvement for future therapies. https://thejns.org/doi/10.3171/CASE24236.

3.
Clin Neurophysiol ; 165: 166-179, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39033698

ABSTRACT

OBJECTIVE: The objective of this narrative review was to locate and assess recent articles employing a combinatorial approach of transcutaneous spinal cord stimulation or epidural spinal cord stimulation with additional modalities. We sought to provide relevant knowledge of recent literature and advance understanding on outcomes reported, to better equip those working in neurorehabilitation and neuromodulation. METHODS: Articles were selected and analyzed based on study approach, stimulation parameters, outcome measures, and presence of neurophysiological data to support findings. RESULTS: This narrative review analyzed 44 recent articles employing a combinatorial approach of transcutaneous spinal cord stimulation or epidural spinal cord stimulation with additional modalities. Our findings showed that limited research exists regarding such combinatorial approaches, particularly when considering modalities beyond activity-based training. There is also limited consistency in neurophysiological and quality of life outcomes. CONCLUSION: Articles involving transcutaneous spinal cord stimulation or epidural spinal cord stimulation with other modalities are limited in the current body of literature. Authors noted variety in approach, sample size, and use of participant perspective. Opportunities are present to add high quality research to this body of literature. SIGNIFICANCE: Transcutaneous spinal cord stimulation and epidural spinal cord stimulation are emerging in research as viable avenues for targeting improvement of function after traumatic spinal cord injury, particularly when combined with activity-based training. This body of literature demonstrates viable areas for growth from both neurophysiological and functional perspectives. Further, exploration of novel combinatorial approaches holds potential to offer enhanced contributions to clinical and neurophysiological rehabilitation and research.


Subject(s)
Spinal Cord Injuries , Spinal Cord Stimulation , Humans , Spinal Cord Injuries/rehabilitation , Spinal Cord Injuries/physiopathology , Spinal Cord Stimulation/methods , Treatment Outcome , Neurological Rehabilitation/methods
4.
Commun Biol ; 7(1): 869, 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39020197

ABSTRACT

Electrokinetic convection-enhanced delivery (ECED) utilizes an external electric field to drive the delivery of molecules and bioactive substances to local regions of the brain through electroosmosis and electrophoresis, without the need for an applied pressure. We characterize the implementation of ECED to direct a neutrally charged fluorophore (3 kDa) from a doped biocompatible acrylic acid/acrylamide hydrogel placed on the cortical surface. We compare fluorophore infusion profiles using ECED (time = 30 min, current = 50 µA) and diffusion-only control trials, for ex vivo (N = 18) and in vivo (N = 12) experiments. The linear intensity profile of infusion to the brain is significantly higher in ECED compared to control trials, both for in vivo and ex vivo. The linear distance of infusion, area of infusion, and the displacement of peak fluorescence intensity along the direction of infusion in ECED trials compared to control trials are significantly larger for in vivo trials, but not for ex vivo trials. These results demonstrate the effectiveness of ECED to direct a solute from a surface hydrogel towards inside the brain parenchyma based predominantly on the electroosmotic vector.


Subject(s)
Brain , Convection , Drug Delivery Systems , Hydrogels , Hydrogels/chemistry , Brain/metabolism , Animals , Drug Delivery Systems/instrumentation , Drug Delivery Systems/methods , Fluorescent Dyes/chemistry , Fluorescent Dyes/administration & dosage , Male , Rats
5.
World Neurosurg ; 188: e34-e40, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38710406

ABSTRACT

OBJECTIVE: This study aims to assess race as an independent risk factor for postoperative complications after surgical fixation of traumatic thoracolumbar fractures for African American and Asian American patients compared with White patients. METHODS: The 2011-2021 American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP) dataset was used to identify patients undergoing fusion surgeries for thoracolumbar spine fractures. Patient comorbidity burden was assessed using a modified 5-item frailty index score (mFI-5). Chi-squared and ANOVA tests were used to compare baseline clinical characteristics between groups. Multivariate analysis was performed to compare African American and Asian American patients with White patients controlling for age, BMI, and American Society of Anesthesiologists (ASA) score. RESULTS: African American patients experienced longer operative times compared to Asian American and White patients (3.74 ± 1.87 hours vs. 3.04 ± 1.71 hours and 3.48 ± 1.81 hours, P < 0.001). African American and Asian American patients demonstrated higher comorbidity burden with mFI-5>2 compared to White patients (30.7% and 25.6% vs. 19.9%, P < 0.001). African American and Asian American patients had a higher risk of postoperative complications than White patients (22.4% and 20% vs. 19.7%, P < 0.001). African American race was an independent risk factor of postoperative 30-day morbidity (OR 1.19, CI 1.11-1.28, P < 0.001). CONCLUSIONS: African American and Asian American patients undergoing thoracolumbar fusion surgeries exhibit disproportionate comorbidity burden, longer LOS, and greater postoperative complications compared with White patients. Furthermore, the African American race was associated with an increased rate of 30-day postoperative complications.


Subject(s)
Lumbar Vertebrae , Postoperative Complications , Spinal Fractures , Thoracic Vertebrae , Adult , Aged , Female , Humans , Male , Middle Aged , Asian , Black or African American , Databases, Factual , Healthcare Disparities/ethnology , Lumbar Vertebrae/surgery , Lumbar Vertebrae/injuries , Operative Time , Postoperative Complications/epidemiology , Postoperative Complications/ethnology , Risk Factors , Spinal Fractures/surgery , Spinal Fractures/ethnology , Spinal Fusion , Thoracic Vertebrae/surgery , Thoracic Vertebrae/injuries , Treatment Outcome , United States/epidemiology , White
6.
World Neurosurg ; 187: e1062-e1071, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38744375

ABSTRACT

OBJECTIVES: The modified 5-item frailty index (mFI-5) is a comorbidity-based risk stratification tool to predict adverse events following various neurologic surgeries. This study aims to quantify the association between increased mFI-5 and postoperative complications and mortality following surgical fixation of traumatic thoracolumbar fractures. METHODS: The 2011-2021 American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP) dataset was used to identify patients undergoing fusion surgeries for thoracolumbar spine fractures. The mFI-5 score was calculated based on the presence of 5 major comorbidities: congestive heart failure within 30 days before surgery, insulin-dependent or noninsulin-dependent diabetes mellitus, chronic obstructive pulmonary disease, partially dependent or totally dependent functional health status at the time of surgery, and hypertension requiring medication. Multivariate analysis assessed the independent impact of increasing mFI-5 scores on postoperative 30-day morbidity and mortality while controlling for baseline clinical characteristics. RESULTS: A total of 66,904 patients were included in our analysis (54.2% female, mean age 62.27 ± 12.93 years). On univariate analysis, higher mFI-5 score was significantly associated with increased risks of superficial surgical site infection, deep surgical site infection, wound dehiscence, unplanned reoperation, pneumonia, unplanned intubation, postoperative ventilator use, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke, myocardial infarction, cardiac arrest, pulmonary embolism, deep vein thrombosis, bleeding requiring transfusion, sepsis, septic shock, and longer hospital length of stay (LOS). On multivariate logistic regression, increasing mFI-5 score versus a mFI-5 score of zero was associated with higher odds of overall complications (mFI-5 ≥2: odds ratio [OR] 1.38 CI: 1.24-1.54, P < 0.001; mFI-5 = 1: OR 1.18 CI: 1.11-1.24, P < 0.001) and 30-day mortality (mFI-5 ≥2: OR 2.33 CI: 1.60-3.38, P < 0.001). CONCLUSION: This study demonstrates that frailty, when measured using the mFI-5, independently predicts postoperative complications, hospital LOS, and 30-day mortality after surgical repair of thoracolumbar fractures. These findings are important for risk stratification in patients undergoing thoracolumbar fusion surgery and for standardization in reporting outcomes after those procedures.


Subject(s)
Frailty , Lumbar Vertebrae , Postoperative Complications , Spinal Fractures , Thoracic Vertebrae , Humans , Female , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Thoracic Vertebrae/surgery , Thoracic Vertebrae/injuries , Spinal Fractures/surgery , Spinal Fractures/mortality , Aged , Lumbar Vertebrae/surgery , Frailty/complications , Spinal Fusion/adverse effects , Spinal Fusion/methods
7.
Spine J ; 2024 Apr 27.
Article in English | MEDLINE | ID: mdl-38685276

ABSTRACT

BACKGROUND CONTEXT: Transcranial Motor Evoked Potentials (TcMEPs) can improve intraoperative detection of femoral plexus and nerve root injury during lumbosacral spine surgery. However, even under ideal conditions, TcMEPs are not completely free of false-positive alerts due to the immobilizing effect of general anesthetics, especially in the proximal musculature. The application of transcutaneous stimulation to activate ventral nerve roots directly at the level of the conus medularis (bypassing the brain and spinal cord) has emerged as a method to potentially monitor the motor component of the femoral plexus and lumbosacral nerves free from the blunting effects of general anesthesia. PURPOSE: To evaluate the reliability and efficacy of transabdominal motor evoked potentials (TaMEPs) compared to TcMEPs during lumbosacral spine procedures. DESIGN: We present the findings of a single-center 12-month retrospective experience of all lumbosacral spine surgeries utilizing multimodality intraoperative neuromonitoring (IONM) consisting of TcMEPs, TaMEPs, somatosensory evoked potentials (SSEPs), electromyography (EMG), and electroencephalography. PATIENT SAMPLE: Two hundred and twenty patients having one, or a combination of lumbosacral spine procedures, including anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion (LLIF), posterior spinal fusion (PSF), and/or transforaminal lumbar interbody fusion (TLIF). OUTCOME MEASURES: Intraoperative neuromonitoring data was correlated to immediate post-operative neurologic examinations and chart review. METHODS: Baseline reliability, false positive rate, true positive rate, false negative rate, area under the curve at baseline and at alerts, and detection of pre-operative deficits of TcMEPs and TaMEPs were compared and analyzed for statistical significance. The relationship between transcutaneous stimulation voltage level and patient BMI was also examined. RESULTS: TaMEPs were significantly more reliable than TcMEPs in all muscles except abductor hallucis. Of the 27 false positive alerts, 24 were TcMEPs alone, and 3 were TaMEPs alone. Of the 19 true positives, none were detected by TcMEPs alone, 3 were detected by TaMEPs alone (TcMEPs were not present), and the remaining 16 true positives involved TaMEPs and TcMEPs. TaMEPs had a significantly larger area under the curve (AUC) at baseline than TcMEPs in all muscles except abductor hallucis. The percent decrease in TcMEP and TaMEP AUC during LLIF alerts was not significantly different. Both TcMEPs and TaMEPs reflected three pre-existing motor deficits. Patient BMI and TaMEP stimulation intensity were found to be moderately positively correlated. CONCLUSIONS: These findings demonstrate the high reliability and predictability of TaMEPs and the potential added value when TaMEPs are incorporated into multimodality IONM during lumbosacral spine surgery.

8.
J Neural Eng ; 21(1)2024 02 01.
Article in English | MEDLINE | ID: mdl-38237175

ABSTRACT

Peripheral nerve interfaces (PNIs) are electrical systems designed to integrate with peripheral nerves in patients, such as following central nervous system (CNS) injuries to augment or replace CNS control and restore function. We review the literature for clinical trials and studies containing clinical outcome measures to explore the utility of human applications of PNIs. We discuss the various types of electrodes currently used for PNI systems and their functionalities and limitations. We discuss important design characteristics of PNI systems, including biocompatibility, resolution and specificity, efficacy, and longevity, to highlight their importance in the current and future development of PNIs. The clinical outcomes of PNI systems are also discussed. Finally, we review relevant PNI clinical trials that were conducted, up to the present date, to restore the sensory and motor function of upper or lower limbs in amputees, spinal cord injury patients, or intact individuals and describe their significant findings. This review highlights the current progress in the field of PNIs and serves as a foundation for future development and application of PNI systems.


Subject(s)
Amputees , Peripheral Nerves , Humans , Amputation, Surgical , Electrodes , Paralysis/surgery
9.
Global Spine J ; 14(3): 1098-1099, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37070613

ABSTRACT

We thank the authors for their interest in and commentary on "Preoperative Serum Albumin Level Predicts Length of Stay and Perioperative Adverse Events Following Vertebral Corpectomy and Posterior Stabilization for Metastatic Spine Disease." We appreciate the opportunity to respond to their comments herein.

10.
Oper Neurosurg (Hagerstown) ; 26(3): 309-313, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-37890096

ABSTRACT

BACKGROUND AND OBJECTIVES: Intrathecal drug therapy is a common treatment for dystonia, pain, and spasticity using implanted pump and catheter systems. Standardized management of intrathecal drug pump (ITDP) migration and flipping has not been well established in the literature. This study reports the use of soft tissue to address less common pump complications such as pump flipping, migration, and difficulty in medication refill. METHODS: A retrospective chart review of intrathecal pump cases performed by two surgeons between February 2020 and August 2022 was conducted. Patients with complications such as pump flipping, migration, or challenges in medication refill treated with soft tissue flaps were included. Patient demographics, comorbidities, and perioperative data were collected. RESULTS: A total of five patients with ITDP complicated by pump flipping, migration, malposition, or difficulty in medication refill that were treated using fascial flaps were included in the study. Three technical considerations when revising ITDP complications are secure pump anchoring, reliable wound closure, and ease of pump medication refill. Cases 1 and 2 demonstrate the technique of secure pump anchoring with a rectus fascial flap. Cases 3 and 4 show a technique to achieve reliable vascularized wound closure, and case 5 describes a technique to solve an uncommon problem of a thick subcutaneous abdominal tissue preventing the refill of the ITDP medication. CONCLUSION: Soft tissue flaps may serve as a treatment option for patients with uncommon ITDP complications. De-epithelialized dermal fasciocutaneous or fascial flaps may be developed to anchor the pump more securely. Cross-discipline collaboration may further delineate the technique, benefits, and outcomes of this approach.


Subject(s)
Infusion Pumps, Implantable , Surgical Flaps , Humans , Retrospective Studies , Infusion Pumps, Implantable/adverse effects , Muscle Spasticity/drug therapy , Muscle Spasticity/surgery , Muscle Spasticity/etiology , Abdomen
11.
J Neurotrauma ; 2024 Apr 05.
Article in English | MEDLINE | ID: mdl-38062795

ABSTRACT

Cervical spinal cord injury (SCI) causes devastating loss of upper limb function and independence. Restoration of upper limb function can have a profound impact on independence and quality of life. In low-cervical SCI (level C5-C8), upper limb function can be restored via reinnervation strategies such as nerve transfer surgery. The translation of recovered upper limb motor function into functional independence in activities of daily living (ADLs), however, remains unknown in low cervical SCI (i.e., tetraplegia). The objective of this study was to evaluate the association of patterns in upper limb motor recovery with functional independence in ADLs. This will then inform prioritization of reinnervation strategies focused to maximize function in patients with tetraplegia. This retrospective study performed a secondary analysis of patients with low cervical (C5-C8) enrolled in the SCI Model Systems (SCIMS) database. Baseline neurological examinations and their association with functional independence in major ADLs-i.e., eating, bladder management, and transfers (bed/wheelchair/chair)-were evaluated. Motor functional recovery was defined as achieving motor strength, in modified research council (MRC) grade, of ≥ 3 /5 at one year from ≤ 2/5 at baseline. The association of motor function recovery with functional independence at one-year follow-up was compared in patients with recovered elbow flexion (C5), wrist extension (C6), elbow extension (C7), and finger flexion (C8). A multi-variable logistic regression analysis, adjusting for known factors influencing recovery after SCI, was performed to evaluate the impact of motor function at one year on a composite outcome of functional independence in major ADLs. Composite outcome was defined as functional independence measure score of 6 or higher (complete independence) in at least two domains among eating, bladder management, and transfers. Between 1992 and 2016, 1090 patients with low cervical SCI and complete neurological/functional measures were included. At baseline, 67% of patients had complete SCI and 33% had incomplete SCI. The majority of patients were dependent in eating, bladder management, and transfers. At one-year follow-up, the largest proportion of patients who recovered motor function in finger flexion (C8) and elbow extension (C7) gained independence in eating, bladder management, and transfers. In multi-variable analysis, patients who had recovered finger flexion (C8) or elbow extension (C7) had higher odds of gaining independence in a composite of major ADLs (odds ratio [OR] = 3.13 and OR = 2.87, respectively, p < 0.001). Age 60 years (OR = 0.44, p = 0.01), and complete SCI (OR = 0.43, p = 0.002) were associated with reduced odds of gaining independence in ADLs. After cervical SCI, finger flexion (C8) and elbow extension (C7) recovery translate into greater independence in eating, bladder management, and transfers. These results can be used to design individualized reinnervation plans to reanimate upper limb function and maximize independence in patients with low cervical SCI.

12.
J Neural Eng ; 20(6)2024 01 04.
Article in English | MEDLINE | ID: mdl-38118169

ABSTRACT

Objective. Currently, few non-invasive measures exist for directly measuring spinal sensorimotor networks. Electrospinography (ESG) is one non-invasive method but is primarily used to measure evoked responses or for monitoring the spinal cord during surgery. Our objectives were to evaluate the feasibility of ESG to measure spinal sensorimotor networks by determining spatiotemporal and functional connectivity changes during single-joint movements at the spinal and cortical levels.Approach. We synchronously recorded electroencephalography (EEG), electromyography, and ESG in ten neurologically intact adults while performing one of three lower-limb tasks (no movement, plantar-flexion and knee flexion) in the prone position. A multi-pronged approach was applied for removing artifacts usingH∞filtering, artifact subspace reconstruction and independent component (IC) analysis. Next, data were segmented by task and ICs of EEG were clustered across participants. Within-participant analysis of ICs and ESG data was conducted, and ESG was characterized in the time and frequency domains. Generalized partial directed coherence analysis was performed within ICs and between ICs and ESG data by participant and task.Results.K-means clustering resulted in five clusters of ICs at Brodmann areas (BAs) 9, BA 8, BA 39, BA 4, and BA 22. Areas associated with motor planning, working memory, visual processing, movement, and attention, respectively. Time-frequency analysis of ESG data found localized changes during movement execution when compared to no movement. Lastly, we found bi-directional changes in functional connectivity (p < 0.05, adjusted for multiple comparisons) within IC's and between IC's and ESG sensors during movement when compared to the no movement condition.Significance. To our knowledge this is the first report using high density ESG for characterizing single joint lower limb movements. Our findings provide support that ESG contains information about efferent and afferent signaling in neurologically intact adults and suggests that we can utilize ESG to directly study the spinal cord.


Subject(s)
Electroencephalography , Spinal Cord , Adult , Humans , Electroencephalography/methods , Movement/physiology , Visual Perception , Memory, Short-Term
13.
J Neurosurg Case Lessons ; 6(26)2023 Dec 25.
Article in English | MEDLINE | ID: mdl-38145561

ABSTRACT

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

14.
J Neurointerv Surg ; 2023 Nov 03.
Article in English | MEDLINE | ID: mdl-37923383

ABSTRACT

BACKGROUND: The evolution of neuroendovascular technologies has progressed substantially. Over the last two decades, the introduction of new endovascular devices has facilitated treatment for more patients, and as a result, the regulatory environment concerning neuroendovascular devices has evolved rapidly in response. OBJECTIVE: To examine trends in the approval of neuroendovascular devices by the United States Food and Drug Administration (FDA) over the last 20 years. METHODS: Open-access US FDA databases were queried between January 2000 and December 2022 for all devices approved by the Neurological Devices Advisory Committee. Neuroendovascular devices were manually classified and grouped by category. Device approval data, including approval times, approval pathway, and presence of predicate devices, were examined. RESULTS: A total of 3186 neurological devices were approved via various US FDA pathways during the study period. 320 (10.0%) corresponded to neuroendovascular devices, of which 301 (94.1%) were approved via the 510(k) pathway. The percentage of 510(k) pathway neuroendovascular devices increased from 6.9% to 14.3% of all neuro devices before and after 2015, respectively. There was an increase in approval times for neuroendovascular devices cleared after 2015. CONCLUSION: Over the last two decades, the neuroendovascular device armamentarium has rapidly expanded, especially after positive stroke trials in 2015. Regulatory approval times are significantly affected by device category, generation, company size, and company location, and a vast majority are approved by the 510(k) pathway. These results can guide further innovation in the endovascular device space and may act as a roadmap for future regulatory planning.

15.
Oper Neurosurg (Hagerstown) ; 25(3): 242-250, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37441801

ABSTRACT

BACKGROUND: Chronic entrapment neuropathy results in a clinical syndrome ranging from mild pain to debilitating atrophy. There remains a lack of objective metrics that quantify nerve dysfunction and guide surgical decision-making. Mechanomyography (MMG) reflects mechanical motor activity after stimulation of neuromuscular tissue and may indicate underlying nerve dysfunction. OBJECTIVE: To evaluate the role of MMG as a surgical adjunct in treating chronic entrapment neuropathies. METHODS: Patients 18 years or older with cubital tunnel syndrome (n = 8) and common peroneal neuropathy (n = 15) were enrolled. Surgical decompression of entrapped nerves was performed with intraoperative MMG of the hypothenar and tibialis anterior muscles. MMG stimulus thresholds (MMG-st) were correlated with compound muscle action potential (CMAP), motor nerve conduction velocity, baseline functional status, and clinical outcomes. RESULTS: After nerve decompression, MMG-st significantly reduced, the mean reduction of 0.5 mA (95% CI: 0.3-0.7, P < .001). On bivariate analysis, MMG-st exhibited significant negative correlation with common peroneal nerve CMAP ( P < .05), but no association with ulnar nerve CMAP and motor nerve conduction velocity. On preoperative electrodiagnosis, 60% of nerves had axonal loss and 40% had conduction block. The MMG-st was higher in the nerves with axonal loss as compared with the nerves with conduction block. MMG-st was negatively correlated with preoperative hand strength (grip/pinch) and foot-dorsiflexion/toe-extension strength ( P < .05). At the final visit, MMG-st significantly correlated with pain, PROMIS-10 physical function, and Oswestry Disability Index ( P < .05). CONCLUSION: MMG-st may serve as a surgical adjunct indicating axonal integrity in chronic entrapment neuropathies which may aid in clinical decision-making and prognostication of functional outcomes.


Subject(s)
Cubital Tunnel Syndrome , Neural Conduction , Humans , Neural Conduction/physiology , Ulnar Nerve/surgery , Cubital Tunnel Syndrome/diagnosis , Cubital Tunnel Syndrome/surgery , Muscle, Skeletal , Pain
16.
J Neurosurg Case Lessons ; 5(26)2023 Jun 26.
Article in English | MEDLINE | ID: mdl-37399140

ABSTRACT

BACKGROUND: Schwannomas are common peripheral nerve sheath tumors. Imaging techniques such as magnetic resonance imaging (MRI) and computed tomography (CT) can help to distinguish schwannomas from other types of lesions. However, there have been several reported cases describing the misdiagnosis of aneurysms as schwannomas. OBSERVATIONS: A 70-year-old male with ongoing pain despite spinal fusion surgery underwent MRI. A lesion was noted along the left sciatic nerve, which was believed to be a sciatic nerve schwannoma. During the surgery for planned neurolysis and tumor resection, the lesion was noted to be pulsatile. Electromyography mapping and intraoperative ultrasound confirmed vascular pulsations and turbulent flow within the aneurysm, so the surgery was aborted. A formal CT angiogram revealed the lesion to be an internal iliac artery (IIA) branch aneurysm. The patient underwent coil embolization with complete obliteration of the aneurysm. LESSONS: The authors report the first case of an IIA aneurysm misdiagnosed as a sciatic nerve schwannoma. Surgeons should be aware of this potential misdiagnosis and potentially use other imaging modalities to confirm the lesion before proceeding with surgery.

17.
J Vis Exp ; (196)2023 06 09.
Article in English | MEDLINE | ID: mdl-37358293

ABSTRACT

The SEEG methodology has gained favor in North America over the last decade as a means of localizing the epileptogenic zone (EZ) prior to epilepsy surgery. Recently, the application of a robotic stereotactic guidance system for implantation of SEEG electrodes has become more popular in many epilepsy centers. The technique for the use of the robot requires extreme precision in the pre-surgical planning phase and then the technique is streamlined during the operative portion of the methodology, as the robot and surgeon work in concert to implant the electrodes. Herein is detailed precise operative methodology of using the robot to guide implantation of SEEG electrodes. A major limitation of the procedure, namely its heavy reliance on the ability to register the patient to a preoperative volumetric magnetic resonance image (MRI), is also discussed. Overall, this procedure has been shown to have a low morbidity rate and an extremely low mortality rate. The use of a robotic stereotactic guidance system for the implantation of SEEG electrodes is an efficient, fast, safe, and accurate alternative to conventional manual implantation strategies.


Subject(s)
Epilepsy , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Electrodes, Implanted , Stereotaxic Techniques , Epilepsy/surgery , Imaging, Three-Dimensional , Electroencephalography/methods
18.
J Neurosurg Spine ; 39(3): 355-362, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37243549

ABSTRACT

OBJECTIVE: High cervical spinal cord injury (SCI) results in complete loss of upper-limb function, resulting in debilitating tetraplegia and permanent disability. Spontaneous motor recovery occurs to varying degrees in some patients, particularly in the 1st year postinjury. However, the impact of this upper-limb motor recovery on long-term functional outcomes remains unknown. The objective of this study was to characterize the impact of upper-limb motor recovery on the degree of long-term functional outcomes in order to inform priorities for research interventions that restore upper-limb function in patients with high cervical SCI. METHODS: A prospective cohort of high cervical SCI (C1-4) patients with American Spinal Injury Association Impairment Scale (AIS) grade A-D injury and enrolled in the Spinal Cord Injury Model Systems Database was included. Baseline neurological examinations and functional independence measures (FIMs) in feeding, bladder management, and transfers (bed/wheelchair/chair) were evaluated. Independence was defined as score ≥ 4 in each of the FIM domains at 1-year follow-up. At 1-year follow-up, functional independence was compared among patients who gained recovery (motor grade ≥ 3) in elbow flexors (C5), wrist extensors (C6), elbow extensors (C7), and finger flexors (C8). Multivariable logistic regression evaluated the impact of motor recovery on functional independence in feeding, bladder management, and transfers. RESULTS: Between 1992 and 2016, 405 high cervical SCI patients were included. At baseline, 97% of patients had impaired upper-limb function with total dependence in eating, bladder management, and transfers. At 1 year of follow-up, the largest proportion of patients who gained independence in eating, bladder management, and transfers had recovery in finger flexion (C8) and wrist extension (C6). Elbow flexion (C5) recovery had the lowest translation to functional independence. Patients who achieved elbow extension (C7) were able to transfer independently. On multivariable analysis, patients who gained elbow extension (C7) and finger flexion (C8) were 11 times more likely to gain functional independence (OR 11, 95% CI 2.8-47, p < 0.001) and patients who gained wrist extension (C6) were 7 times more likely to gain functional independence (OR 7.1, 95% CI 1.2-56, p = 0.04). Older age (≥ 60 years) and motor complete SCI (AIS grade A-B) reduced the likelihood of gaining independence. CONCLUSIONS: After high cervical SCI, patients who gained elbow extension (C7) and finger flexion (C8) had significantly greater independence in feeding, bladder management, and transfers than those with recovery in elbow flexion (C5) and wrist extension (C6). Recovery of elbow extension (C7) also increased the capability for independent transfers. This information can be used to set patient expectations and prioritize interventions that restore these upper-limb functions in patients with high cervical SCI.


Subject(s)
Cervical Cord , Spinal Cord Injuries , Humans , Prospective Studies , Upper Extremity , Spinal Cord Injuries/complications , Quadriplegia/complications , Recovery of Function
19.
J Neurosurg ; 139(6): 1598-1603, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37243553

ABSTRACT

OBJECTIVE: The stereoelectroencephalography (SEEG) procedure provides a unique 3D overview of the seizure-onset zone. Although the success of SEEG relies on the accuracy of depth electrode implantation, few studies have investigated how different implantation techniques and operative variables affect accuracy. This study examined the effect of two different electrode implantation techniques (external vs internal stylet) on implantation accuracy while controlling for other operative variables. METHODS: The implantation accuracy of 508 depth electrodes from 39 SEEG cases was measured after coregistration of postimplantation CT or MR images with planned trajectories. Two different implantation techniques were compared: preset length with internal stylet use and measured length with external stylet use. Correlations between implantation accuracy and technique type, entry angle, intended implantation depth, and other operative variables were determined statistically using multiple regression analysis. RESULTS: Multiple regression analysis showed that the internal stylet technique exhibited a larger target radial error (p = 0.046) and angular deviation (p = 0.039) with a smaller depth error (p < 0.001) than the external stylet technique. Entry angle and implantation depth were positively correlated with target radial error (p = 0.007 and < 0.001, respectively) only for the internal stylet technique. CONCLUSIONS: Better target radial accuracy was achieved when an external stylet was used to open the intraparenchymal pathway for the depth electrode. In addition, more oblique trajectories were equally accurate to orthogonal ones with the usage of an external stylet, while more oblique trajectories were associated with larger target radial errors with the usage of an internal stylet (without an external stylet).


Subject(s)
Drug Resistant Epilepsy , Robotics , Humans , Electroencephalography/methods , Stereotaxic Techniques , Electrodes, Implanted , Drug Resistant Epilepsy/diagnostic imaging , Drug Resistant Epilepsy/surgery
20.
J Vis Exp ; (193)2023 03 31.
Article in English | MEDLINE | ID: mdl-37067267

ABSTRACT

The overall goal of this procedure is to perform stereotaxy in the pig brain with real-time magnetic resonance (MR) visualization guidance to provide precise infusions. The subject was positioned prone in the MR bore for optimal access to the top of the skull with the torso raised, the neck flexed, and the head inclined downward. Two anchor pins anchored on the bilateral zygoma held the head steady using the head holder. A magnetic resonance imaging (MRI) flex-coil was placed rostrally across the head holder so that the skull was accessible for the intervention procedure. A planning grid placed on the scalp was used to determine the appropriate entry point of the cannula. The stereotactic frame was secured and aligned iteratively through software projection until the projected radial error was less than 0.5 mm. A hand drill was used to create a burr hole for insertion of the cannula. A gadolinium-enhanced co-infusion was used to visualize the infusion of a cell suspension. Repeated T1-weighted MRI scans were registered in real time during the agent delivery process to visualize the volume of gadolinium distribution. MRI-guided stereotaxy allows for precise and controlled infusion into the pig brain, with concurrent monitoring of cannula insertion accuracy and determination of the agent volume of distribution.


Subject(s)
Brain , Gadolinium , Animals , Swine , Brain/diagnostic imaging , Brain/surgery , Brain/pathology , Magnetic Resonance Imaging/methods , Stereotaxic Techniques , Magnetic Resonance Spectroscopy
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