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1.
Neurosurgery ; 2023 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-38059611

RESUMO

BACKGROUND AND OBJECTIVES: Burr hole trepanation to evacuate chronic subdural hematoma (cSDH) results in bony skull defects that can lead to skin depressions. We intend to study the effect of burr hole covers to prevent skin depressions and improve the esthetic result. METHODS: In a randomized trial, we enrolled adult patients with symptomatic cSDH. Patients received burr hole trepanation with (intervention) vs without burr hole covers (control) in a 1:1 ratio. Patients requiring evacuation of bilateral cSDHs served as their internal control. Primary outcome was satisfaction with the esthetic result of the scar, measured from 0 (dissatisfied) to 10 (very satisfied) on the Esthetic Numeric Analog (ANA) scale at 90 days. Secondary outcomes included ANA scale, rates of skin depression, complications, as well as neurological, disability, and health-related quality of life outcomes until 12 months. RESULTS: We included 78 patients (55 with unilateral and 23 with bilateral cSDH; median age 78 years, 83% male) between 03/2019 and 05/2021, 50 trepanations for the intervention and 51 for the control group. In an intention-to-treat analysis, the ANA scale scores were 9.0 (intervention) and 8.5 (control arm) at 90 days (P = .498). At 12 months, the ANA scale scores were 9.0 and 8.0 for the intervention and control groups, respectively (P = .183). Skin depressions over the frontal burr hole were noted by 35% (intervention) and 63% (control) of patients at 90 days (P = .009) and by 35% and 79% (P < .001) at 12 months, respectively. There were no differences in complications, neurological, disability, and health-related quality of life outcomes. CONCLUSION: Satisfaction with the esthetic result of the scar was inherently high. This study does not show evidence for improvement on the ANA scale by applying a burr hole cover. The application of burr hole covers resulted in less skin depressions and did not negatively affect complication rates or outcomes.

2.
Artigo em Inglês | MEDLINE | ID: mdl-38156882

RESUMO

BACKGROUND AND OBJECTIVES: Mixed reality (MxR) benefits neurosurgery by improving anatomic visualization, surgical planning and training. We aim to validate the usability of a dedicated certified system for this purpose. METHODS: All cases prepared with MxR in our center in 2022 were prospectively collected. Holographic rendering was achieved using an incorporated fully automatic algorithm in the MxR application, combined with contrast-based semiautomatic rendering and/or manual segmentation where necessary. Hologram segmentation times were documented. Visualization during surgical preparation (defined as the interval between finalized anesthesiological induction and sterile draping) was performed using MxR glasses and direct streaming to a side screen. Surgical preparation times were compared with a matched historical cohort of 2021. Modifications of the surgical approach after 3-dimensional (3D) visualization were noted. Usability was assessed by evaluating 7 neurosurgeons with more than 3 months of experience with the system using a Usefulness, Satisfaction and Ease of use (USE) questionnaire. RESULTS: One hundred-seven neurosurgical cases prepared with a 3D hologram were collected. Surgical indications were oncologic (63/107, 59%), cerebrovascular (27/107, 25%), and carotid endarterectomy (17/107, 16%). Mean hologram segmentation time was 39.4 ± 20.4 minutes. Average surgical preparation time was 48.0 ± 17.3 minutes for MxR cases vs 52 ± 17 minutes in the matched 2021 cohort without MxR (mean difference 4, 95% CI 1.7527-9.7527). Based on the 3D hologram, the surgical approach was modified in 3 cases. Good usability was found by 57% of the users. CONCLUSION: The perioperative use of 3D holograms improved direct anatomic visualization while not significantly increasing intraoperative surgical preparation time. Usability of the system was adequate. Further technological development is necessary to improve the automatic algorithms and reduce the preparation time by circumventing manual and semiautomatic segmentation. Future studies should focus on quantifying the potential benefits in teaching, training, and the impact on surgical and functional outcomes.

3.
J Clin Med ; 12(20)2023 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-37892774

RESUMO

Bleeding and thromboembolic (TE) complications in neurosurgical diseases have a detrimental impact on clinical outcomes. The aim of this study is to provide a scoping review of the available literature and address challenges and knowledge gaps in the management of coagulation disorders in neurosurgical diseases. Additionally, we introduce a novel research project that seeks to reduce coagulation disorder-associated complications in neurosurgical patients. The risk of bleeding after elective craniotomy is about 3%, and higher (14-33%) in other indications, such as trauma and intracranial hemorrhage. In spinal surgery, the incidence of postoperative clinically relevant bleeding is approximately 0.5-1.4%. The risk for TE complications in intracranial pathologies ranges from 3 to 20%, whereas in spinal surgery it is around 7%. These findings highlight a relevant problem in neurosurgical diseases and current guidelines do not adequately address individual circumstances. The multidisciplinary COagulation MAnagement in Neurosurgical Diseases (COMAND) project has been developed to tackle this challenge by devising an individualized coagulation management strategy for patients with neurosurgical diseases. Importantly, this project is designed to ensure that these management strategies can be readily implemented into healthcare practices of different types and with sustainable integration.

4.
J Neurosurg Pediatr ; 31(4): 313-320, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36738466

RESUMO

OBJECTIVE: The risk of cerebrospinal fluid (CSF) leakage after cranial surgery and its associated complications in children are unclear because of variable definitions and the lack of multicenter studies. In this study, the authors aimed to establish the incidence of CSF leakage after intradural cranial surgery in the pediatric population. In addition, they evaluated potential risk factors and complications related to CSF leakage in the pediatric population. METHODS: The authors performed an international multicenter retrospective cohort study in three tertiary neurosurgical referral centers. Included were all patients aged 18 years or younger who had undergone cranial surgery to reach the subdural space during the period between 2015 and 2021. Patients who died or were lost to follow-up within 6 weeks after surgery were excluded. The primary outcome measure was the incidence of CSF leakage, defined as leakage through the skin, within 6 weeks after surgery. Univariable and multivariable logistic regression analyses were performed to identify risk factors for and complications related to CSF leakage. RESULTS: In total, 759 procedures were identified, performed in 687 individual patients. The incidence of CSF leakage was 7.5% (95% CI 5.7%-9.6%). In the multivariate model, independent risk factors for CSF leakage were hydrocephalus (OR 4.5, 95% CI 2.2-8.9) and craniectomy (OR 7.6, 95% CI 3.0-19.5). Patients with CSF leakage had higher odds of pseudomeningocele (5.7, 95% CI 3.0-10.8), meningitis (21.1, 95% CI 9.5-46.8), and surgical site infection (7.4, 95% CI 2.6-20.8) than patients without leakage. CONCLUSIONS: CSF leakage risk in children after cranial surgery, which is comparable to the risk reported in adults, is an event of major concern and has a serious clinical impact.


Assuntos
Vazamento de Líquido Cefalorraquidiano , Procedimentos Neurocirúrgicos , Adulto , Humanos , Criança , Incidência , Estudos Retrospectivos , Procedimentos Neurocirúrgicos/efeitos adversos , Procedimentos Neurocirúrgicos/métodos , Vazamento de Líquido Cefalorraquidiano/epidemiologia , Vazamento de Líquido Cefalorraquidiano/etiologia , Fatores de Risco , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia
5.
Childs Nerv Syst ; 39(4): 1013-1019, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36790491

RESUMO

PURPOSE: This study aimed to establish the incidence of CSF leakage in children and associated complications after intradural spinal surgery in three tertiary neurosurgical referral centers and to describe the treatment strategies applied. METHODS: Patients of 18 years or younger who underwent intradural spinal surgery between 2015 and 2021 in three tertiary neurosurgical referral centers were included. Patients who died or were lost to follow-up within six weeks after surgery were excluded. The primary outcome measure was CSF leakage within six weeks after surgery, defined as leakage of CSF through the skin. Secondary outcome measures included the presence of pseudomeningocele (PMC), meningitis, and surgical site infection (SSI). RESULTS: We included a total of 75 procedures, representing 66 individual patients. The median age in this cohort was 5 (IQR = 0-13 years. CSF leakage occurred in 2.7% (2/75) of procedures. It occurred on days 3 and 21 after the index procedure, respectively. One patient was treated with a pressure bandage and an external lumbar drain on day 4 after diagnosis of the leak, and the other was treated with wound revision surgery on day 1 after the leak occurred. In total, 1 patient developed a PMC without a CSF leak which was treated with wound revision surgery. SSI occurred in 10.7%, which included both cases of CSF leak. CONCLUSIONS: CSF leakage after intradural spinal surgery in the pediatric population is relatively rare (2.7%). Nevertheless, the clinical consequences with respect to secondary complications such as infection and the necessity for invasive treatment are serious.


Assuntos
Vazamento de Líquido Cefalorraquidiano , Rinorreia de Líquido Cefalorraquidiano , Humanos , Criança , Recém-Nascido , Lactente , Pré-Escolar , Adolescente , Vazamento de Líquido Cefalorraquidiano/etiologia , Vazamento de Líquido Cefalorraquidiano/epidemiologia , Procedimentos Neurocirúrgicos/efeitos adversos , Procedimentos Neurocirúrgicos/métodos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Reoperação , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos
6.
Neurosurgery ; 92(6): 1177-1182, 2023 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-36688661

RESUMO

BACKGROUND: Incisional cerebrospinal fluid (iCSF) leakage is a serious complication after intradural cranial surgery. OBJECTIVE: To determine the incidence and risk factors of iCSF leakage after craniotomy. Secondarily, the complications after iCSF leakage and the success rate of iCSF leakage treatment was studied. METHODS: All patients who underwent an intradural cranial surgery from 2017 to 2018 at 5 neurosurgical centers were retrospectively included. Data were retrieved from medical records with 2 months of follow-up. First, univariate regression analyses were performed. Subsequently, identified risk factors were evaluated in a multivariate regression analysis. RESULTS: In total 2310 consecutive patients were included. Total iCSF leakage rate was 7.1% (n = 165). Younger age, male, higher body mass index, smoking, infratentorial surgery, and use of a dural substitute were associated with increased iCSF leakage risk, and use of a sealant reduced that risk. The odds for developing a wound infection and/or meningitis were 15 times higher in patients with iCSF leakage compared with patients without leakage. Initial conservative iCSF leakage treatment failed in 48% of patients. In 80% of cases, external cerebrospinal fluid drainage ceased the iCSF leakage. A total of 32% of patients with iCSF leakage required wound revision surgery. CONCLUSION: iCSF leakage risk increases by younger age, higher body mass index, smoking, infratentorial craniotomy, and dural substitute use, whereas sealant use reduced the risk for iCSF leakage. The leak increases the risk of postoperative infections. When iCSF leakage occurs, immediate external cerebrospinal fluid drainage or wound revision should be considered.


Assuntos
Vazamento de Líquido Cefalorraquidiano , Procedimentos Neurocirúrgicos , Humanos , Masculino , Estudos Retrospectivos , Procedimentos Neurocirúrgicos/efeitos adversos , Vazamento de Líquido Cefalorraquidiano/epidemiologia , Vazamento de Líquido Cefalorraquidiano/etiologia , Craniotomia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Fatores de Risco
7.
Neurosurg Focus ; 55(6): E11, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-38262007

RESUMO

OBJECTIVE: A central tenet of Enhanced Recovery After Surgery (ERAS) is evidence-based medicine. Survivors of aneurysmal subarachnoid hemorrhage (aSAH) constitute a fragile patient population prone to prolonged hospitalization within neurointensive care units (NICUs), prolonged immobilization, and a range of nosocomial adverse events. Potentially, well-monitored early mobilization (EM) could constitute a beneficial element of ERAS protocols in this population. Therefore, the objective was to summarize the available evidence on EM strategies in patients with aSAH. METHODS: The authors retrieved prospective and retrospective studies that reported efficacy or safety data on EM (defined as EM in the NICU starting ≤ 7 days after ictus) versus delayed mobilization (DM) (any strategy that comparatively delayed mobilization) after aSAH and were published after January 1, 2000, in PubMed/MEDLINE, Embase, and the Cochrane Library. Random-effects meta-analysis was performed. RESULTS: Ten studies analyzing 1292 patients were included for quantitative synthesis, including 1 randomized, 1 prospective nonrandomized, and 8 retrospective studies. Modified Rankin Scale scores at discharge were not different between the EM and DM groups (mean difference [MD] [95% CI] -0.86 [-2.93 to 1.20] points, p = 0.41). Hospital length of stay in days was markedly reduced in the EM group (MD [95% CI] -6.56 [-10.64 to -2.47] days, p = 0.002). Although there was a statistically significant reduction in radiological vasospasms (OR [95% CI] 0.65 [0.44-0.97], p = 0.03), the reduction in clinically relevant vasospasms was nonsignificant (OR [95% CI] 0.63 [0.31-1.26], p = 0.19). The odds of shunting were significantly lower in the EM group (OR [95% CI] 0.61 [0.39-0.95], p = 0.03). The rates of mortality, pneumonia, and thrombosis were similar among groups (p > 0.05). CONCLUSIONS: Due to a lack of high-quality studies, vastly varying protocols, and resulting statistical clinical and statistical heterogeneity, the level of evidence for recommendations regarding EM in patients with aSAH remains low. The currently available data indicated that mobilization within the first 5 days after aneurysm repair was feasible and safe without significant excessive adverse events, that neurological outcome with EM was almost certainly not worse than with prolonged immobilization, and that there was likely at least some reduction in length of hospital stay. Radiological and clinical vasospasms were not more frequent-with signals even trending toward a decrease-in patients who mobilized early. Higher-quality studies and implementation of full ERAS protocols are necessary to evaluate efficacy and safety with a higher level of evidence and to guide practical implementation through increased standardization. Clinical trial registration no.: CRD42023432828 (www.crd.york.ac.uk/prospero).


Assuntos
Hemorragia Subaracnóidea , Humanos , Deambulação Precoce , Estudos Prospectivos , Estudos Retrospectivos
8.
Brain Spine ; 2: 100876, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36248126

RESUMO

Introduction: Hereditary transthyretin amyloidosis (ATTRv) is an autosomal-dominant disorder, where a TTR mutations lead to amyloid fibril deposits in tissues and consecutively alter organ function. ATTRv is a multisystemic disorder with a heterogeneous clinical presentation. Spinal leptomeningeal depositions are described only scarcely in the literature. Research question: We present a rare case of surgically treated intradural, extra-medullary amyloidosis with respective clinical, diagnostic and surgical features to raise awareness of this rare entity. Material and methods: Clinical, radiological and operative characteristics were retrieved from the electronical patient management system. Additionally, a scoping literature review on leptomeningeal spinal manifestations of ATTRv was performed. Results: A 45-year-old man with a known ATTRv presented with gait disturbance and paresis of the lower extremities. He had been treated with the siRNA therapeutical Patisiran for 13 months under which his symptoms worsened. An MRI of the spine revealed spinal cord compression with myelopathy at the level of T2 with anterior dislocation of the spinal cord due to an intradural, extramedullary lesion. A laminectomy and opening of the dura with a complete resection of the lesion was performed. The histological examination of the biopsy showed amyloid deposits. At six-month follow-up the patient showed complete normalization of the paresis, gait, sensory and urinary disturbances and resumed his work. Discussion and conclusion: Spinal leptomeningeal deposition of amyloid is a rare occurrence within the framework of ATTRv. Micro-neurosurgical complete resection of the lesion is feasible in patients with preoperative myelopathic symptoms and resulted in complete symptom relief in this case.

9.
BMJ Open ; 12(9): e061452, 2022 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-36130762

RESUMO

INTRODUCTION: Postoperative imaging after neurosurgical interventions is usually performed in the first 72 hours after surgery to provide an accurate assessment of postoperative resection status. Patient frequently report that early postoperative examination after craniotomy for tumour and vascular procedures is associated with distress, exertion, nausea and pain. Delayed postoperative imaging (between 36 and 72 hours postoperatively) may have an advantage regarding psychological and physical stress compared with early imaging. The goal of this study is to evaluate and determine the optimal time frame for postoperative imaging with MRI and CT in terms of medical and neuroradiological implications and patient's subjective stress level. METHODS AND ANALYSIS: Data will be prospectively collected from all patients aged 18-80 years who receive postoperative MRI or CT imaging following a craniotomy for resection of a cerebral tumour (benign and malignant) or vascular surgery. Participants have to complete questionnaires containing visual analogue scores (VAS) for headache and nausea, Body Part Discomfort score and a single question addressing subjective preference of timing of postoperative imaging after craniotomy. The primary endpoint of the study is the difference in subjective stress due to imaging studies after craniotomy, measured just before and after postoperative MRI or CT with the above-mentioned instruments. Subjective stress is defined as a combination of the scores VAS pain, VAS nausea and 0.5* Body Part Discomfort core.This study determines whether proper timing of postoperative imaging can improve patient satisfaction and reduce pain, stress and discomfort caused by postoperative imaging. Factors causing additional postoperative stress are likely responsible for delayed recovery of neurosurgical patients. ETHICS AND DISSEMINATION: The institutional review board (Kantonale Ethikkommission Zürich) approved this study on 4 August 2020 under case number BASEC 2020-01590. The authors are planning to publish the data of this study in a peer-reviewed paper. After database closure, the data will be exported to the local data repository (Zurich Open Repository and Archive) of the University of Zurich. The sponsor (LR) and the project leader (MR.G) will make the final decision on the publication of the results. The data that support the findings of this study are available on request from the corresponding author LT. The data are not publicly available due to privacy/ethical restrictions. TRIAL REGISTRATION NUMBER: NCT05112575; ClinicalTrials.gov.


Assuntos
Craniotomia , Dor , Craniotomia/efeitos adversos , Humanos , Náusea , Dor Pós-Operatória , Estudos Prospectivos , Suíça
10.
World Neurosurg ; 161: 432-440, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35505564

RESUMO

From a pathophysiological point of view, early neurosurgical treatment seems essential to prevent secondary brain injury and has been stated as the "time-is-brain" concept. However, the question immediately rises: "Is there an optimal time window for acute intracranial neurosurgical interventions?" In neurosurgery, treatment modality has been studied far more extensively than timing to surgery ("time-to-surgery"). The majority of acute intracranial neurosurgical interventions are carried out for traumatic brain injury and hemorrhagic or ischemic stroke. Current guidelines for traumatic brain injury, spontaneous intracerebral hemorrhage, aneurysmal subarachnoid hemorrhage, and middle cerebral artery infarction are reviewed and lessons learned from the randomized controlled trials mentioned are discussed. In acute intracranial neurosurgical interventions, "delayed consent" procedures could play an important role for this field of research. Whether there is an optimal time window for acute intracranial neurosurgical interventions seems difficult to be answered with randomized controlled trials referred to in the current guidelines. Observational designs, such as comparative effectiveness research, and special statistical techniques, may provide a better understanding in the optimal "time-to-surgery."


Assuntos
Lesões Encefálicas Traumáticas , Lesões Encefálicas , Hemorragia Subaracnóidea , Encéfalo/cirurgia , Hemorragia Cerebral , Humanos , Hemorragia Subaracnóidea/cirurgia
11.
World Neurosurg ; 157: 143-151, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34687935

RESUMO

BACKGROUND: The mechanisms of brain arteriovenous malformation (bAVM) development, formation, and progress are still poorly understood. By gaining more knowledge about the molecular signature of bAVM in relation to hemorrhage, we might be able to find biomarkers associated with this serious complication, which can function as a goal for further research and can be a potential target for gene therapy. AIMS: To provide a comprehensive overview of the molecular signature of bAVM-related hemorrhage We conducted a systematic review, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, of articles published in Embase, Medline, Cochrane central, Scopus, and Chinese databases (CNKI, Wanfang). SUMMARY OF REVIEW: Our search identified 3944 articles, of which 3108 remained after removal of duplicates. After title, abstract, and full-text screening, 31 articles were included for analysis. The results show an overview of molecular characteristics. Several genetic polymorphisms are identified that increase the risk of bAVM rupture by increasing the expression of certain inflammatory cytokines (interleukin [IL]-6, IL-17A, IL-1ß, and tumor necrosis factor-α), NOTCH pathways, matrix metalloproteinase-9, and vascular endothelial growth factor-α. CONCLUSIONS: Several molecular factors are associated with the risk of bAVM-related hemorrhage. These factors are associated with increased inflammation on the cellular level and changes in the endothelium leading to instability of the vessel wall. Further investigation of these biomarkers regarding hemorrhage rates, together with their relationship with noninvasive diagnostic methods, should be a goal of future studies to improve the patient specific risk estimation and future treatment options.


Assuntos
Fístula Arteriovenosa/complicações , Fístula Arteriovenosa/genética , Hemorragia Cerebral/genética , Malformações Arteriovenosas Intracranianas/complicações , Malformações Arteriovenosas Intracranianas/genética , Humanos , Polimorfismo Genético
12.
Spine J ; 22(1): 126-135, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34175468

RESUMO

BACKGROUND CONTEXT: Spinal arachnoid web (SAW) is a rare condition characterized by focal thickening of the arachnoid membrane causing displacement and compression of the spinal cord with progressive symptoms and neurological deficits. Recent reports and clinical experience suggest that SAW is a distinct entity with specific radiological findings and treatment strategies distinguishable from other arachnopathies and potential differential diagnoses. PURPOSE: To better define the diagnostic and clinical features, treatment options and outcomes of surgically treated SAW. STUDY DESIGN: Multicentric retrospective cohort study. PATIENT SAMPLE: Twelve cases of SAW surgically treated at three different centers. OUTCOME MEASURES: Self-reported and neurological outcome measurements (pain, sensory-motor deficits, vegetative dysfunctions) were assessed at follow-up timepoints. METHODS: Retrospective review of prospectively collected data on all patients surgically treated for SAW from three participating neurosurgical centers between 2014 and 2020. Clinicopathological data, including neurological presentation, radiological and histological findings and outcome data were analyzed. RESULTS: Twelve radiologically and surgically confirmed cases of SAW were analyzed. Mean patient age was 54.7 [±12.7], 67% were male. All SAWs were located in the posterior thoracic dural sac. On magnetic resonance imaging (MRI), the "scalpel sign" - a characteristic focal dorsal indentation of the spinal cord resembling a scalpel blade - was identified in all patients. A focal intramedullary syrinx was present in 83%. Preoperative clinical symptoms included signs of myelopathy, pain, weakness and sensory loss, most commonly affecting the trunk/upper back or lower extremities. Laminectomy or laminoplasty with intradural excision of the SAW was the surgical treatment of choice in all cases. Intraoperative ultrasound was valuable to visualize the cerebrospinal fluid (CSF) flow obstruction, confirm the SAW location before dura incision and to control adequacy of resection. After surgery, sensory loss and weakness in particular showed significant improvement. CONCLUSIONS: The present study comprises the largest series of surgically treated SAW, underscoring the unique clinical, radiographic, histopathological, and surgical findings. We want to emphasize SAW being a distinct entity of spinal arachnopathy with a favorable long-term outcome if diagnosed correctly and treated surgically. Intraoperative ultrasound aids visualizing the SAW before dural incision, as well as verifying restored CSF flow after resection.


Assuntos
Cistos Aracnóideos , Doenças da Medula Espinal , Siringomielia , Cistos Aracnóideos/cirurgia , Humanos , Laminectomia , Imageamento por Ressonância Magnética , Masculino , Estudos Retrospectivos , Doenças da Medula Espinal/diagnóstico por imagem , Doenças da Medula Espinal/cirurgia , Siringomielia/diagnóstico por imagem , Siringomielia/cirurgia
13.
BMJ Open ; 11(7): e049098, 2021 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-34321304

RESUMO

OBJECTIVE: The dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. DESIGN: First in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up. SETTING: Three large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland. PARTICIPANTS: Forty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations. INTERVENTION: Each patient received one DSP after cranial surgery and closure of the dura mater with sutures. OUTCOME MEASURES: Primary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction. RESULTS: No patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application. CONCLUSIONS: DSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage. TRIAL REGISTRATION NUMBER: NCT03566602.


Assuntos
Vazamento de Líquido Cefalorraquidiano , Procedimentos Cirúrgicos Eletivos , Vazamento de Líquido Cefalorraquidiano/prevenção & controle , Vazamento de Líquido Cefalorraquidiano/cirurgia , Dura-Máter/cirurgia , Humanos , Países Baixos , Procedimentos Neurocirúrgicos/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Suíça
14.
Acta Neurochir (Wien) ; 162(11): 2759-2765, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32358656

RESUMO

BACKGROUND: The decision to treat unruptured intracranial aneurysms (UIAs) or not is complex and requires balancing of risk factors and scores. Machine learning (ML) algorithms have previously been effective at generating highly accurate and comprehensive individualized preoperative predictive analytics in transsphenoidal pituitary and open tumor surgery. In this pilot study, we evaluate whether ML-based prediction of clinical endpoints is feasible for microsurgical management of UIAs. METHODS: Based on data from a prospective registry, we developed and internally validated ML models to predict neurological outcome at discharge, as well as presence of new neurological deficits and any complication at discharge. Favorable neurological outcome was defined as modified Rankin scale (mRS) 0 to 2. According to the Clavien-Dindo grading (CDG), every adverse event during the post-operative course (surgery and not surgery related) is recorded as a complication. Input variables included age; gender; aneurysm complexity, diameter, location, number, and prior treatment; prior subarachnoid hemorrhage (SAH); presence of anticoagulation, antiplatelet therapy, and hypertension; microsurgical technique and approach; and various unruptured aneurysm scoring systems (PHASES, ELAPSS, UIATS). RESULTS: We included 156 patients (26.3% male; mean [SD] age, 51.7 [11.0] years) with UIAs: 37 (24%) of them were treated for multiple aneurysm and 39 (25%) were treated for a complex aneurysm. Poor neurological outcome (mRS ≥ 3) was seen in 12 patients (7.7%) at discharge. New neurological deficits were seen in 10 (6.4%), and any kind of complication occurred in 20 (12.8%) patients. In the internal validation cohort, area under the curve (AUC) and accuracy values of 0.63-0.77 and 0.78-0.91 were observed, respectively. CONCLUSIONS: Application of ML enables prediction of early clinical endpoints after microsurgery for UIAs. Our pilot study lays the groundwork for development of an externally validated multicenter clinical prediction model.


Assuntos
Aneurisma Intracraniano/cirurgia , Aprendizado de Máquina , Procedimentos Neurocirúrgicos/métodos , Adulto , Algoritmos , Estudos de Coortes , Feminino , Humanos , Masculino , Microcirurgia/métodos , Pessoa de Meia-Idade , Projetos Piloto , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
15.
Neurosurgery ; 86(2): E203-E208, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31574157

RESUMO

BACKGROUND: Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery. OBJECTIVE: To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. METHODS: We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP. EXPECTED OUTCOMES: Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy. DISCUSSION: As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.


Assuntos
Vazamento de Líquido Cefalorraquidiano/etiologia , Vazamento de Líquido Cefalorraquidiano/prevenção & controle , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Procedimentos Neurocirúrgicos/efeitos adversos , Resinas Sintéticas/administração & dosagem , Adulto , Dura-Máter/cirurgia , Procedimentos Cirúrgicos Eletivos/tendências , Feminino , Seguimentos , Humanos , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/prevenção & controle , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos/tendências , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controle
16.
BMJ Open ; 9(12): e031375, 2019 12 06.
Artigo em Inglês | MEDLINE | ID: mdl-31811007

RESUMO

INTRODUCTION: Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for the evacuation of cSDH leads to higher patient satisfaction with the aesthetical result at 90 days postoperative, without worsening disability outcomes or increasing the complication rate. METHODS AND ANALYSIS: This is a prospective, single-blinded, randomised, controlled, investigator-initiated clinical trial enrolling 80 adult patients with first-time unilateral or bilateral cSDH in Switzerland. The primary outcome is the difference in satisfaction with the aesthetic result of the scar, comparing patients allocated to the intervention (burr hole cover) and control (no burr hole cover) group, measured on the Aesthetic Numeric Analogue scale at 90 days postoperative. Secondary outcomes include differences in the rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative. ETHICS AND DISSEMINATION: The institutional review board (Kantonale Ethikkommission Zürich) approved this study on 29 January 2019 under case number BASEC 2018-01180. This study determines, whether a relatively minor modification of a standard surgical procedure can improve patient satisfaction, without worsening functional outcomes or increasing the complication rate. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years. TRIAL REGISTRATION NUMBER: NCT03755349.


Assuntos
Estética , Hematoma Subdural Crônico/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Trepanação/métodos , Cicatriz , Humanos , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Próteses e Implantes , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos de Cirurgia Plástica/efeitos adversos , Procedimentos de Cirurgia Plástica/instrumentação , Método Simples-Cego , Suíça , Resultado do Tratamento , Trepanação/efeitos adversos , Trepanação/instrumentação
17.
Neurosurg Focus ; 47(5): E14, 2019 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-31675709

RESUMO

OBJECTIVE: Skin depressions may appear as undesired effects after burr-hole trepanation for the evacuation of chronic subdural hematomas (cSDH). Placement of burr-hole covers to reconstruct skull defects can prevent skin depressions, with the potential to improve the aesthetic result and patient satisfaction. The perception of the relevance of this practice, however, appears to vary substantially among neurosurgeons. The authors aimed to identify current practice variations with regard to the application of burr-hole covers after trepanation for cSDH. METHODS: An electronic survey containing 12 questions was sent to resident and faculty neurosurgeons practicing in different parts of the world, as identified by an Internet search. All responses completed between September 2018 and December 2018 were considered. Descriptive statistics and logistic regression were used to analyze the data. RESULTS: A total of 604 responses were obtained, of which 576 (95.4%) provided complete data. The respondents' mean age was 42.4 years (SD 10.5), and 86.5% were male. The sample consisted of residents, fellows, junior/senior consultants, and department chairs from 79 countries (77.4% Europe, 11.8% Asia, 5.4% America, 3.5% Africa, and 1.9% Australasia). Skin depressions were considered a relevant issue by 31.6%, and 76.0% indicated that patients complain about skin depressions more or less frequently. Burr-hole covers are placed by 28.1% in the context of cSDH evacuation more or less frequently. The most frequent reasons for not placing a burr-hole cover were the lack of proven benefit (34.8%), followed by additional costs (21.9%), technical difficulty (19.9%), and fear of increased complications (4.9%). Most respondents (77.5%) stated that they would consider placing burr-hole covers in the future if there was evidence for superiority of the practice. The use of burr-hole covers varied substantially across countries, but a country's gross domestic product per capita was not associated with their placement. CONCLUSIONS: Only a minority of neurosurgeons place burr-hole covers after trepanation for cSDH on a regular basis, even though the majority of participants reported complaints from patients regarding postoperative skin depressions. There are significant differences in the patterns of care among countries. Class I evidence with regard to patient satisfaction and safety of burr-hole cover placement is likely to have an impact on future cSDH management.


Assuntos
Hematoma Subdural Crônico/cirurgia , Procedimentos de Cirurgia Plástica , Complicações Pós-Operatórias/prevenção & controle , Padrões de Prática Médica/estatística & dados numéricos , Retalhos Cirúrgicos , Trepanação/efeitos adversos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Complicações Pós-Operatórias/etiologia , Inquéritos e Questionários
18.
World Neurosurg ; 131: e508-e513, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31398522

RESUMO

BACKGROUND: Poor-grade subarachnoid hemorrhage (SAH) has been associated with a high case fatality, either in the acute phase or in the later stages. The exact causes of death in these patients are unknown. METHODS: We performed a retrospective study of all consecutive patients with SAH with World Federation of Neurosurgical Societies grade IV or V on admission from 2009 to 2013 at 2 tertiary referral centers in Amsterdam, the Netherlands, and Toronto, Ontario, Canada, who had died during their hospital stay. RESULTS: Of 357 patients, 152 (43%) had died. Of these 152 patients, 87 (24%) had not undergone aneurysm treatment. The median interval to death was 3 days (interquartile range, 1-12 days) after initial hemorrhage. The major cause of death in both centers was withdrawal of life support (107 patients [71%]; 74 of 94 [79%] in Amsterdam and 33 of 58 [58%] in Toronto; P < 0.01), followed by brain death in 23 (15%; 16 of 58 [28%] in Amsterdam vs. 7 of 94 [7%] in Toronto; P < 0.01). The remaining causes of death represented <15%. CONCLUSIONS: The decision to withdraw life support was the major reason for death of patients with poor-grade SAH for an overwhelming majority of the patients. The exact reasons for withdrawal of life support, other than cultural and referral differences, were undetermined. Insight into the reasons of death should be prospectively studied to improve the care and clinical outcomes of patients with poor-grade SAH.


Assuntos
Morte Encefálica , Eutanásia Passiva , Cuidados para Prolongar a Vida , Hemorragia Subaracnóidea/mortalidade , Causas de Morte , Feminino , Parada Cardíaca/mortalidade , Humanos , Hipertensão Intracraniana/mortalidade , Masculino , Isquemia Mesentérica/mortalidade , Pessoa de Meia-Idade , Neoplasias/mortalidade , Países Baixos , Ontário , Pneumonia/mortalidade , Recidiva , Estudos Retrospectivos , Índice de Gravidade de Doença , Choque Séptico/mortalidade , Hemorragia Subaracnóidea/terapia , Suspensão de Tratamento
19.
World Neurosurg ; 122: 43-47, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-31108065

RESUMO

BACKGROUND: The intraoperative use of neurophysiological monitoring (IONM) and indocyanine green video angiography (ICGVA) for aneurysm clipping have evolved during the last years. Both modalities are useful and safe by allowing greater rates of complete aneurysm occlusion with less intraoperative complications and postoperative neurologic deficits. We report a case of attempted aneurysm clipping in which the combined use of ICGVA and IONM was crucial for intraoperative decision-making. CASE DESCRIPTION: A 62-year-old woman was operated for an incidental 6-mm aneurysm at the origin of the right fronto-opercular branch. During aneurysm clipping, IONM amplitudes dropped drastically, despite patency of the parent artery and perforators in ICGVA. Several attempts for clipping were made with recurring drops in IONM amplitudes, which forced us to leave the aneurysm untreated. The patient had a postoperative left-sided hemiparesis that improved on follow-up. Thereafter, the aneurysm was treated with stent-assisted coiling. CONCLUSIONS: The combination of IONM and ICGVA during aneurysm surgery allows for a better assessment of vascular integrity and patient's postoperative outcome than ICGVA alone. Simultaneous evaluation of vessel patency and integrity of the somatosensory and motor pathways illustrates the complementarity of testing different modalities for intraoperative decision-making and for maximizing safeness in aneurysm clipping.


Assuntos
Aneurisma Intracraniano/cirurgia , Angiografia Cerebral/métodos , Corantes , Procedimentos Cirúrgicos Eletivos/métodos , Feminino , Humanos , Verde de Indocianina , Aneurisma Intracraniano/diagnóstico por imagem , Monitorização Neurofisiológica Intraoperatória/métodos , Pessoa de Meia-Idade , Stents , Resultado do Tratamento , Cirurgia Vídeoassistida/métodos
20.
World Neurosurg ; 119: 374-380, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30149166

RESUMO

BACKGROUND: Spontaneous spinal subarachnoid hemorrhage (SAH) is extremely rare and occurs in <1% of all cases of SAH. To the best of our knowledge, only 1 case of spontaneous spinal SAH with later development of a symptomatic spinal arachnoid cyst (SAC) has been described in the literature to date. The objective of the present study was to report the challenging clinical management of SAC based on a literature review. CASE DESCRIPTION: We report the case of a 51-year-old woman with acute onset of back pain, neck pain, and headaches with an angiogram-negative supratentorial SAH. Further magnetic resonance imaging screening of the spine revealed additional subarachnoid blood at the level of the thoracic spine, without evidence of vascular malformations. Several weeks after the hemorrhage, the patient developed progressive numbness in her trunk and lower extremities and weakness in her lower extremities. A follow-up magnetic resonance imaging study revealed a large arachnoid cyst at level T4-T7 with spinal cord compression. The patient underwent left hemilaminectomy at T4-T6 and fenestration of the SAC. In a second surgery, right-sided hemilaminectomy at T7 was performed with complete marsupialization of the larger cyst and placement of an intradural shunt. At the 6-month clinical follow-up examination, she showed improvement of her clinical symptoms. CONCLUSIONS: Treatment of secondary SAC is challenging, and surgery of the SAC with or without placement of a shunt is a possible treatment option.


Assuntos
Cistos Aracnóideos , Laminectomia/métodos , Procedimentos Neurocirúrgicos/métodos , Medula Espinal/diagnóstico por imagem , Medula Espinal/cirurgia , Hemorragia Subaracnóidea , Cistos Aracnóideos/complicações , Cistos Aracnóideos/diagnóstico por imagem , Cistos Aracnóideos/cirurgia , Angiografia por Tomografia Computadorizada , Feminino , Humanos , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Hemorragia Subaracnóidea/complicações , Hemorragia Subaracnóidea/diagnóstico por imagem , Hemorragia Subaracnóidea/cirurgia
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