RESUMEN
BACKGROUND: No standard has been established regarding timing and choice of strategy for discontinuation of external ventricular drainage (EVD) in patients with aneurysmal subarachnoid haemorrhage (aSAH), and little is known about the importance of clinical variables. A proportion of the patients who initially pass their discontinuation attempt return with delayed hydrocephalus and the need of a permanent shunt. Early differentiation between patients who need a shunt and those who do not would facilitate care. We conducted a retrospective analysis on patients with aSAH and an EVD to search significant differences in treatment and clinical variables between patients who received a permanent shunt during initial hospitalization or after readmission, and those who never received a shunt. METHODS: We included 183 patients with aSAH who received an EVD over a 4-year period between 2015 and 2018 and divided them into three groups: those who received a shunt during primary admission, those who were readmitted for delayed hydrocephalus and received a shunt, and those who never needed a shunt. Between these groups, we compared selected clinical variables as well as outcome at discharge and after 6 months. Additionally, we assessed the ability of a shunt dependency score (SDASH) to predict the need for permanent drainage in the patients. RESULTS: Of 183 included patients, 108 (59%) ultimately received a ventriculoperitoneal (VP) shunt. Of these, 89 (82%) failed discontinuation during the primary admission and received a permanent shunt before discharge from the neurosurgical department. The remaining 19 (18%) were discharged after successful discontinuation, but subsequently developed delayed hydrocephalus and were admitted for shunt placement a median of 39 (range: 18-235) days after ictus. Ninety-four patients were discharged after successful discontinuation of the EVD, consisting of those who never developed the need for a permanent shunt and the 19 who were readmitted with delayed hydrocephalus, corresponding to a 20% (19/94) readmittance rate. Clinical variables such as drainage volume or discontinuation strategy did not differ across the three groups of patients. The SDASH score failed to provide any clinically useful information regarding prediction of shunt placement. CONCLUSION: In this study, clinical variables including use of the predictive score SDASH predicted neither the overall need for nor the timing of shunt placement after aSAH. The homogeneous distribution of data between the three different groups renders strong independent clinical predictive factors unlikely. Thus, attempts to predict a permanent shunt requirement from these variables may be futile in these patients.
Asunto(s)
Hidrocefalia , Hemorragia Subaracnoidea , Humanos , Hidrocefalia/etiología , Hidrocefalia/cirugía , Estudios Retrospectivos , Hemorragia Subaracnoidea/cirugía , Derivación VentriculoperitonealRESUMEN
BACKGROUND: Aneurysmal subarachnoid haemorrhage (aSAH) is a life-threatening disease caused by rupture of an intracranial aneurysm. A common complication following aSAH is hydrocephalus, for which placement of an external ventricular drain (EVD) is an important first-line treatment. Once the patient is clinically stable, the EVD is either removed or replaced by a ventriculoperitoneal shunt. The optimal strategy for cessation of EVD treatment is, however, unknown. Gradual weaning may increase the risk of EVD-related infection, whereas prompt closure carries a risk of acute hydrocephalus and redundant shunt implantations. We designed a randomised clinical trial comparing the two commonly used strategies for cessation of EVD treatment in patients with aSAH. METHODS: DRAIN is an international multi-centre randomised clinical trial with a parallel group design comparing gradual weaning versus prompt closure of EVD treatment in patients with aSAH. Participants are randomised to either gradual weaning which comprises a multi-step increase of resistance over days, or prompt closure of the EVD. The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, or ventriculostomy-related infection. Secondary outcomes are serious adverse events excluding mortality, functional outcome (modified Rankin scale), health-related quality of life (EQ-5D) and Fatigue Severity Scale (FSS). Outcome assessment will be performed 6 months after ictus. Based on the sample size calculation (event proportion 80% in the gradual weaning group, relative risk reduction 20%, type I error 5%, power 80%), 122 patients are needed in each intervention group. Outcome assessment for the primary outcome, statistical analyses and conclusion drawing will be blinded. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03948256.
Asunto(s)
Hidrocefalia , Hemorragia Subaracnoidea , Humanos , Hemorragia Subaracnoidea/complicaciones , Hemorragia Subaracnoidea/terapia , Calidad de Vida , Destete , Hidrocefalia/etiología , Hidrocefalia/cirugía , Drenaje/efectos adversos , Drenaje/métodos , Estudios Retrospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVE: Decompressive hinge craniotomy (DHC) is an alternative treatment option to decompressive craniectomy (DC) for elevated intracranial pressure (ICP). The aim of this study was to characterize the difference in pressure-volume relationship between DHC and DC. METHODS: We compared the intracranial pressure-volume relationship in a human cadaver model following either DHC, DC, or fixing of the bone plate by titanium clamps. We inserted an intracranial expandable device in two human cadaver specimens, performed either DHC, DC, or bone plate fixation, and gradually increased the intracranial volume while measuring ICP. Following DHC, we also performed CT-scans at pre-defined intervals. RESULTS: Before ICP exceeded a threshold of 20 mmHg, a fixed bone plate tolerated an increase of 130 ml of intracranial volume, while DHC and DC allowed an increase of 190 ml and 290 ml, respectively. CT-derived calculations following DHC determined that the increase in intracranial volume at ICP 22 mmHg was 65 ml, the maximal increase of intracranial volume was 84 ml, the maximal bone displacement was 21 mm, and the bone plate volume to be 82 ml. Manual stress test of the hinged bone plate did not allow misalignment or intracranial displacement of the bone plate. CONCLUSION: DHC increases the intracranial volume by up to 84 ml and allows for approximately 60 ml increase of intracranial volume before ICP exceeds 20 mmHg. This indicates, when comparing with results from previous studies of herniation volumes, that DHC will be sufficient in many patients with head injury or cerebral infarction with treatment refractory intracranial hypertension.
Asunto(s)
Craniectomía Descompresiva , Hipertensión Intracraneal , Humanos , Presión Intracraneal , Craniectomía Descompresiva/métodos , Craneotomía/métodos , Hipertensión Intracraneal/etiología , Hipertensión Intracraneal/cirugía , Infarto Cerebral , Cadáver , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
BACKGROUND: Available nomograms to predict aortic root (AoR) diameter for body surface area have limitations. The purpose of this study was to evaluate the use of a new multivariate predictive model to identify AoR dilatation in hypertensive patients with left ventricular hypertrophy. METHODS: 943 of 961 patients in the Losartan Intervention For Endpoint reduction in hypertension (LIFE) echocardiographic sub-study had the necessary baseline characteristics and echocardiographic 2D measurements of AoR size to be included. RESULTS: Predicted AoR (Sinus of Valsalva) diameter was 1.519 + (age [years] × 0.010) + (height [cm] × 0.010) - (gender [1 = M, 2 = F] × 0.247), and a measured AoR diameter exceeding the 97.5-percentile of this estimate was considered dilated. Measured AoR diameter was larger in men than in women (3.75 vs. 3.48 cm, p < 0.001) and AoR diameter predicted by the model was larger than predicted by nomogram (3.52 vs. 3.28 cm, p < 0.001). Using the multivariate model to identify patients with AoR dilatation, the prevalence was 13.7% in men and 12.3% in women (p = 0.537). There was consensus of AoR phenotype (normal/dilated) between model and nomogram in 92.8% of the patients. In multivariate logistic regression, AoR dilatation by model definition was predicted by presence of aortic regurgitation (OR 2.67, p < 0.001) and SD increase in age (OR 0.75, p = 0.023), pulse pressure (OR 0.64, p < 0.001), left ventricular mass index (OR 1.36, p = 0.08) and stroke volume (OR 1.45, p = 0.002), but not by body weight. CONCLUSIONS: Using the proposed model the prevalence of AoR dilatation was equal in men and women and the model seems to address the effects of gender, age and body size on AoR size. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00338260.
Asunto(s)
Hipertensión , Hipertrofia Ventricular Izquierda , Presión Sanguínea , Dilatación , Dilatación Patológica , Ecocardiografía , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Hipertrofia Ventricular Izquierda/diagnóstico por imagen , Hipertrofia Ventricular Izquierda/epidemiología , MasculinoRESUMEN
Intracranial pressure (ICP)-derived indices of cerebrovascular reactivity (e.g., PRx, PAx, and RAC) have been developed to improve understanding of brain status from available neuromonitoring variables. These indices are moving correlation coefficients between slow-wave vasogenic fluctuations in ICP and arterial blood pressure. In this retrospective analysis of neuromonitoring data from 200 patients admitted with moderate/severe traumatic brain injury (TBI), we evaluate the predictive value of CPPopt based on these ICP-derived indices of cerebrovascular reactivity. Valid CPPopt values were obtained in 92.3% (PRx), 86.7% (PAX), and 84.6% (RAC) of the monitoring periods, respectively. In multivariate logistic analysis, a baseline model that includes age, sex, and admission Glasgow Coma Score had an area under the receiver operating curve of 0.762 (P < 0.0001) for dichotomous outcome prediction (dead vs. good recovery). When adding time/dose of CPP below CPPopt, all multivariate models (based on PRx, PAx, and RAC) predicted the dichotomous outcome measure, but additional value of the prediction was only significantly added by the PRx-based calculations of time spent with CPP below CPPopt and dose of CPP below CPPopt.
Asunto(s)
Lesiones Traumáticas del Encéfalo , Presión Intracraneal , Presión Arterial , Circulación Cerebrovascular , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: The standard lumbar puncture position involves maximum flexion of both lumbar and cervical spine. The cerebrospinal fluid opening pressure (CSFop) is measured in a horizontal position. This study investigated if flexion of hip and neck both separately and simultaneously influence intracranial pressure (ICP) to a clinically relevant extent. METHODS: Thirty-nine patients, undergoing invasive ICP monitoring as part of diagnostic work-up, were included. The patients underwent either a vertical postural examination (n = 24) or a horizontal postural examination (n = 15) to examine a varying degree of spine flexion. RESULTS: The vertical examination showed that ICP decreased by 15.2 mmHg when straightening the neck in a sitting lumbar puncture position (n = 24, IQR - 20.1 to - 9.7). In the horizontal examination, ICP increased in all but one patient when changing from supine position to lateral recumbent position (n = 15, median increase of 6.9 mmHg, IQR 3.1 to 9.9). Straightening the hips alone decreased ICP with 0.2 mmHg (n = 15, IQR - 0.5 to 2.0), while straightening the neck alone decreased ICP by 4.0 mmHg (n = 15, IQR - 5.9 to - 1.7). However, when straightening the hip and neck simultaneously ICP decreased by 6.4 mmHg (n = 6, IQR - 9.5 to - 4.4). CONCLUSIONS: Neck flexion alone, and neck flexion and hip flexion in combination, has significant confounding influence on ICP. This may cause patients to shift from a normal ICP range to a pathological ICP range, which will potentially affect treatment decisions. Consensus on guidelines for body position including neck and hip flexion measuring CSFop may be needed.
Asunto(s)
Presión Intracraneal , Humanos , Hipertensión Intracraneal , Postura , Rango del Movimiento Articular , Sedestación , Punción EspinalRESUMEN
PURPOSE: Repeated intracranial pressure (ICP) measurements are essential in treatment of patients with complex cerebrospinal fluid (CSF) disorders. These patients often have a long surgical history with numerous invasive lumbar or intracranial pressure monitoring sessions and/or ventriculoperitoneal (VP) shunt revisions. Telemetric ICP monitoring might be an advantageous tool in treatment of these patients. In this paper, we evaluate our experience with this technology in paediatric patients. METHODS: During a 4-year period, we implanted telemetric ICP sensors (Raumedic NEUROVENT-P-tel) in 20 paediatric patients to minimise the number of future invasive procedures. Patients were diagnosed with hydrocephalus, idiopathic intracranial hypertension (IIH) or an arachnoid cyst. Most patients (85%) had a VP shunt at the time of sensor implantation. RESULTS: In total, 32 sensors were inserted in the 20 patients; the cause of re-implantation was technical malfunction of the implant. One sensor was explanted due to wound infection and one due to skin erosion. We experienced no complications directly related to the implantation/explantation procedures. A total of 149 recording sessions were conducted, including 68 home monitoring sessions. The median implantation period was 523 days with a median duration of clinical use at 202 days. The most likely consequence of a recording session was non-surgical treatment alteration (shunt valve adjustment or acetazolamide dose adjustment). CONCLUSION: Telemetric ICP monitoring in children is safe and potentially decreases the number of invasive procedures. We find that telemetric ICP monitoring aids the clinical management of patients with complex CSF disorders and improves everyday life for both patient and parents. It allows continuous ICP measurement in the patient's home and thereby potentially reducing hospitalisations, leading to significant cost savings.
Asunto(s)
Hidrocefalia , Hipertensión Intracraneal , Niño , Humanos , Hidrocefalia/cirugía , Presión Intracraneal , Monitoreo Fisiológico , Telemetría , Derivación VentriculoperitonealRESUMEN
BACKGROUND: Infusion tests, which measure resistance to outflow (Rout), are used in selecting patients suspected for idiopathic normal pressure hydrocephalus (iNPH) for shunt surgery. Infusion tests can be performed through an external ventricular drain (EVD). A 24-hour time gap from EVD insertion to an infusion test is a routine practice at our department due to concerns that the surgical procedure might influence the test results in the immediate postoperative period. The objective of the study was to investigate if timing of an intraventricular infusion test influences the results of the test in patients suspected for iNPH. METHODS: Ten patients scheduled for an intraventricular infusion test were included. Measurements of baseline intracranial pressure (ICP) and plateau ICP were obtained during constant rate intraventricular infusion test performed at two time points (1 and 24 h after EVD insertion) and Rout was calculated from these measures and compared within patients. RESULTS: Eight patients completed both infusion tests. In one of the 18 infusion tests performed, it was not possible to define an ICP plateau and this infusion test was excluded, leaving 7 paired infusion tests. Median Rout was 12.9 mmHg/ml/min (range 7.0-22.0) 1 h after EVD insertion and 11.3 mmHg/ml/min (range 7.8-18.1) after 24 h. Overall, there were no statistically significant differences in Rout (P = 0.83), baseline ICP (P = 0.70), or plateau ICP (P = 0.81) between the recordings performed 1 h and 24 h after EVD insertion. For two of the seven patients with paired infusion tests, there was poor agreement between Rout values at 1 and 24 h. CONCLUSION: Overall, Rout estimates do not change significantly between 1 and 24 h after EVD insertion. We therefore propose that infusion tests can be performed shortly after surgery to reduce the period of indwelling EVD and duration of hospitalization.
Asunto(s)
Hidrocéfalo Normotenso/diagnóstico , Presión Intracraneal/fisiología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Hidrocéfalo Normotenso/fisiopatología , Infusiones Intraventriculares , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Hydrocephalus requiring external ventricular drainage is common following aneurysmal subarachnoid hemorrhage (aSAH). Timing and strategy for the discontinuation of the external ventricular drain (EVD) are, however, controversial as guidelines are based on limited scientific evidence. A recent similar survey showed that guidelines and recommendations are not being followed. We conducted a questionnaire survey regarding the management of EVD treatment in patients with aSAH and investigated current treatment practice, consensus, and adherence to guidelines within the neurosurgical departments in Scandinavia. METHODS: A questionnaire concerning the management of EVD discontinuation in patients with hydrocephalus following aSAH was distributed to all 14 neurosurgical departments in Scandinavia (Norway, Sweden, and Denmark). Neurosurgeons and neurosurgical trainees at all levels were asked to complete the questionnaire individually. A total of 175 completed questionnaires were received between May 2018 and April 2019, resulting in a response rate of 64 %. RESULTS: Eighty-five percent of respondents reported no knowledge of international guidelines regarding EVD discontinuation in patients with hydrocephalus following aSAH. Within every department, respondents disagreed on whether a common discontinuation strategy was followed or not. Seventy-four percent decided upon the EVD discontinuation strategy mainly determined by patients' clinical condition and drainage volume. Forty-five percent considered Glasgow Coma Score (GCS) the most important clinical variable when assessing the timing of EVD discontinuation. There was general agreement towards the initiation of EVD discontinuation 4-7 days after ictus of aSAH in a stable patient with a drainage volume of < 150 ml/day and intracranial pressure (ICP) < 15 mmHg. CONCLUSION: Awareness of and adherence to international guidelines regarding EVD discontinuation in patients with hydrocephalus following aSAH were limited in Scandinavia. Internal consensus at department level was absent. Initiation of the discontinuation process appeared to be case dependent and mainly influenced by the patients' clinical condition and drainage volume. GCS was the clinical variable considered most important when deciding on the initiation of EVD discontinuation.
Asunto(s)
Drenaje/métodos , Hidrocefalia/cirugía , Complicaciones Posoperatorias/epidemiología , Hemorragia Subaracnoidea/cirugía , Ventriculostomía/métodos , Adulto , Anciano , Drenaje/efectos adversos , Drenaje/normas , Femenino , Adhesión a Directriz/estadística & datos numéricos , Humanos , Presión Intracraneal , Masculino , Persona de Mediana Edad , Noruega , Suecia , Ventriculostomía/efectos adversos , Ventriculostomía/normasRESUMEN
KEY POINTS: During long-term missions, some astronauts experience structural and functional changes of the eyes and brain which resemble signs/symptoms experienced by patients with intracranial hypertension. Weightlessness prevents the normal cerebral volume and pressure 'unloading' associated with upright postures on Earth, which may be part of the cerebral and ocular pathophysiology. By placing the lower body in a negative pressure device (LBNP) that pulls fluid away from cranial compartments, we simulated effects of gravity and significantly lowered pressure within the brain parenchyma and ventricle compartments. Application of incremental LBNP demonstrated a non-linear dose-response curve, suggesting 20 mmHg LBNP as the optimal level for reducing pressure in the brain without impairing cerebral perfusion pressure. This non-invasive method of reducing pressure in the brain holds potential as a countermeasure in space as well as having treatment potential for patients on Earth with traumatic brain injury or other pathology leading to intracranial hypertension. ABSTRACT: Patients with elevated intracranial pressure (ICP) exhibit neuro-ocular symptoms including headache, papilloedema and loss of vision. Some of these symptoms are also present in astronauts during and after prolonged space-flight where lack of gravitational stress prevents daily lowering of ICP associated with upright posture. Lower body negative pressure (LBNP) simulates the effects of gravity by displacing fluid caudally and we hypothesized that LBNP would lower ICP without compromising cerebral perfusion. Ten cerebrally intact volunteers were included: six ambulatory neurosurgical patients with parenchymal ICP-sensors and four former cancer patients with Ommaya-reservoirs to the frontal horn of a lateral ventricle. We applied LBNP while recording ICP and blood pressure while supine, and during simulated intracranial hypertension by 15° head-down tilt. LBNP from 0 to 50 mmHg at increments of 10 mmHg lowered ICP in a non-linear dose-dependent fashion; when supine (n = 10), ICP was decreased from 15 ± 2 mmHg to 14 ± 4, 12 ± 5, 11 ± 4, 10 ± 3 and 9 ± 4 mmHg, respectively (P < 0.0001). Cerebral perfusion pressure (CPP), calculated as mean arterial blood pressure at midbrain level minus ICP, was unchanged (from 70 ± 12 mmHg to 67 ± 9, 69 ± 10, 70 ± 12, 72 ± 13 and 74 ± 15 mmHg; P = 0.02). A 15° head-down tilt (n = 6) increased ICP to 26 ± 4 mmHg, while application of LBNP lowered ICP (to 21 ± 4, 20 ± 4, 18 ± 4, 17 ± 4 and 17 ± 4 mmHg; P < 0.0001) and increased CPP (P < 0.01). An LBNP of 20 mmHg may be the optimal level to lower ICP without impairing CPP to counteract spaceflight-associated neuro-ocular syndrome in astronauts. Furthermore, LBNP holds clinical potential as a safe, non-invasive method for lowering ICP and improving CPP for patients with pathologically elevated ICP on Earth.
Asunto(s)
Presión Intracraneal , Presión Negativa de la Región Corporal Inferior , Adulto , Anciano , Encéfalo , Femenino , Gravitación , Humanos , Masculino , Persona de Mediana Edad , Postura , Vuelo Espacial , Resultado del Tratamiento , Ingravidez , Adulto JovenRESUMEN
BACKGROUND: Telemetric intracranial pressure (ICP) monitoring enable long-term ICP monitoring on patients during normal day activities and may accordingly be of use during evaluation and treatment of complicated ICP disorders. However, the benefits of such equipment depend strongly on the validity of the recordings and how often the telemetric sensor needs to be re-implanted. This study investigates the clinical and technical sensor survival time and drift of the telemetric ICP sensor: Raumedic Neurovent-P-tel. METHODS: Implanted telemetric ICP sensors in the period from January 2011 to December 2017 were identified, and medical records reviewed for complications, explantation reasons, and parameters relevant for determining clinical and technical sensor survival time. Explanted sensors were tested in an experimental setup to study baseline drift. RESULTS: In total, implantation of 119 sensors were identified. Five sensors (4.2%) were explanted due to skin damage, three (2.5%) due to wound infection, and two (1.7%) due to ethylene oxide allergy. No other complications were observed. The median clinical sensor survival time was 208 days (95% CI 150-382). The median technical sensor survival time was 556 days (95% CI 382-605). Explanted sensors had a median baseline drift of 2.5 mmHg (IQR 2.0-5.5). CONCLUSION: In most cases, the ICP sensor provides reliable measurements beyond the approved implantation time of 90 days. Thus, the sensor should not be routinely removed after this period, if ICP monitoring is still indicated. However, some sensors showed technical malfunction prior to the CE-approval, underlining that caution should always be taken when analyzing telemetric ICP curves.
Asunto(s)
Presión Intracraneal , Monitoreo Fisiológico/instrumentación , Prótesis e Implantes/efectos adversos , Falla de Prótesis , Telemetría/métodos , Adulto , Remoción de Dispositivos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/efectos adversos , Reimplantación/estadística & datos numéricos , Telemetría/instrumentación , Infección de Heridas/epidemiologíaRESUMEN
OBJECTIVE: Optimizing the treatment of several neurosurgical and neurological disorders relies on knowledge of the intracranial pressure (ICP). However, exploration of normal ICP and intracranial pressure pulse wave amplitude (PWA) values in healthy individuals poses ethical challenges, and thus the current documentation remains scarce. This study explores ICP and PWA values for healthy adults without intracranial pathology expected to influence ICP. METHODS: Adult patients (age > 18 years) undergoing surgery for an unruptured intracranial aneurysm without any other neurological co-morbidities were included. Patients had a telemetric ICP sensor inserted, and ICP was measured in four different positions: supine, lateral recumbent, standing upright, and 45-degree sitting, at day 1, 14, 30, and 90 following the surgery. RESULTS: ICP in each position did not change with time after surgery. Median ICP was 6.7 mmHg and median PWA 2.1 mmHg in the supine position, while in the upright standing position median ICP was - 3.4 mmHg and median PWA was 1.9 mmHg. After standardization of the measurements from the transducer site to the external acoustic meatus, the median ICPmidbrain was 8.3 mmHg in the supine position and 1.2 mmHg in the upright standing position. CONCLUSION: Our study provides insights into normal ICP dynamics in healthy adults following a uncomplicated surgery for an unruptured aneurysm. These results suggest a slightly wider normal reference range for invasive intracranial pressure than previously suggested, and present the first normal values for PWA in different positions. Further studies are, however, essential to enhance our understanding of normal ICP. Trial registration The study was preregistered at www. CLINICALTRIALS: gov (NCT03594136) (11 July 2018).
Asunto(s)
Aneurisma Intracraneal , Presión Intracraneal , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Aneurisma Intracraneal/cirugía , Aneurisma Intracraneal/fisiopatología , Presión Intracraneal/fisiología , Procedimientos Neuroquirúrgicos , Postura/fisiología , Análisis de la Onda del Pulso , Estudios ProspectivosRESUMEN
BACKGROUND: Insertion of an external ventricular drain (EVD) is a first-line treatment of acute hydrocephalus caused by aneurysmal subarachnoid haemorrhage (aSAH). Once the patient is clinically stable, the EVD is either removed or replaced by a permanent internal shunt. The optimal strategy for cessation of the EVD is unknown. Prompt closure carries a risk of acute hydrocephalus or redundant shunt implantations, whereas gradual weaning may increase the risk of EVD-related infections. METHODS: DRAIN (Danish RAndomised Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage) is an international multicentre randomised clinical trial comparing prompt closure versus gradual weaning of the EVD after aSAH. The primary outcome is a composite of VP-shunt implantation, all-cause mortality, or EVD-related infection. Secondary outcomes are serious adverse events excluding mortality and health-related quality of life (EQ-5D-5L). Exploratory outcomes are modified Rankin Scale, Fatigue Severity Scale, Glasgow Outcome Scale Extended, and length of stay in the neurointensive care unit and hospital. Outcome assessment will be performed 6 months after ictus. Based on the sample size calculation (event proportion 80% in the gradual weaning group, relative risk reduction 20%, alpha 5%, power 80%), 122 participants are required in each intervention group. Outcome assessment for the primary outcome, statistical analyses, and conclusion drawing will be blinded. Two independent statistical analyses and reports will be tracked using a version control system, and both will be published. Based on the final statistical report, the blinded steering group will formulate two abstracts. CONCLUSION: We present a pre-defined statistical analysis plan for the randomised DRAIN trial, which limits bias, p-hacking, and data-driven interpretations. This statistical analysis plan is accompanied by tables with simulated data, which increases transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03948256. Registered on May 13, 2019.
Asunto(s)
Drenaje , Hidrocefalia , Ensayos Clínicos Controlados Aleatorios como Asunto , Hemorragia Subaracnoidea , Humanos , Hemorragia Subaracnoidea/complicaciones , Hemorragia Subaracnoidea/cirugía , Hemorragia Subaracnoidea/terapia , Hidrocefalia/etiología , Hidrocefalia/cirugía , Drenaje/efectos adversos , Drenaje/métodos , Resultado del Tratamiento , Factores de Tiempo , Estudios Multicéntricos como Asunto , Interpretación Estadística de Datos , Calidad de Vida , Dinamarca , Derivación Ventriculoperitoneal/efectos adversosRESUMEN
INTRODUCTION: Endoscopic third ventriculostomy (ETV) is becoming an increasingly widespread treatment for hydrocephalus, but research is primarily based on paediatric populations. In 2009, Kulkarni et al created the ETV Success score to predict the outcome of ETV in children. The purpose of this study is to create a prognostic model to predict the success of ETV for adult patients with hydrocephalus. The ability to predict who will benefit from an ETV will allow better primary patient selection both for ETV and shunting. This would reduce additional second procedures due to primary treatment failure. A success score specific for adults could also be used as a communication tool to provide better information and guidance to patients. METHODS AND ANALYSIS: The study will adhere to the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis reporting guidelines and conducted as a retrospective chart review of all patients≥18 years of age treated with ETV at the participating centres between 1 January 2010 and 31 December 2018. Data collection is conducted locally in a standardised database. Univariate analysis will be used to identify several strong predictors to be included in a multivariate logistic regression model. The model will be validated using K-fold cross validation. Discrimination will be assessed using area under the receiver operating characteristic curve (AUROC) and calibration with calibration belt plots. ETHICS AND DISSEMINATION: The study is approved by appropriate ethics or patient safety boards in all participating countries. TRIAL REGISTRATION NUMBER: NCT04773938; Pre-results.
Asunto(s)
Hidrocefalia , Tercer Ventrículo , Adulto , Niño , Humanos , Hidrocefalia/cirugía , Lactante , Estudios Multicéntricos como Asunto , Pronóstico , Estudios Retrospectivos , Tercer Ventrículo/cirugía , Resultado del Tratamiento , Ventriculostomía/métodosRESUMEN
INTRODUCTION: Non-vitamin K-antagonist oral anticoagulants (NOAC) have become first choice oral anticoagulant (OAC) with decreasing use of vitamin K antagonists (VKA), partly due to lower risk of intracerebral hemorrhage (ICH). Aim: to identify trends in sale of OACs and relate them to trends in OAC-related ICH (OAC-ICH). PATIENTS AND METHODS: Study was based on the population in the Capital Region of Denmark (1.8 million inhabitants). We identified all patients admitted with a non-traumatic OAC-ICH in 2010-2017 and ascertained diagnosis and drug use through medical charts. We used information available in the public domain on sale of defined daily doses (DDD) of OAC in the Capital Region of Denmark. RESULTS: 453 patients with OAC-ICH out of a total of 2877 ICH-events were identified. From 2010 to 2017 sale of NOAC rose from 0.1 to 11.8 DDD/1000 inhabitants/day (p < 0.001); while VKA sale decreased from 7.6 to 5.2 DDD/1000 inhabitants/day (p < 0.001). The total number of ICH events was stable between 2010 and 2017, but the proportion of OAC-ICH events increased from 13% in 2010 to 22% in 2017 (p < 0.001). The proportion of ICH events related to NOAC had a significant increasing trend (p < 0.001), whereas a decreasing trend was observed for VKA (p = 0.04). DISCUSSION: In Denmark, the population on OACs has increased; resulting from increased use of NOACs. Parallel to this development, the proportion of OAC-ICH overall has increased based on an increasing trend in NOAC-related ICH. CONCLUSION: Our findings document a need for further research on prevention and treatment of this complication.
RESUMEN
OBJECTIVES: To summarise the evidence on benefits and harms of prompt closure versus gradual weaning of external ventricular drainage (EVD) in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage (aSAH) based on randomised clinical trials (RCTs) in humans. SETTING: RCTs comparing prompt closure versus gradual weaning of EVD in adult patients with hydrocephalus following aSAH were included. PARTICIPANTS: Patients aged equal to or greater than 18 years with an EVD due to hydrocephalus following aSAH were eligible for inclusion. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes were all-cause mortality, any serious adverse event, rate of ventriculoperitoneal (VP) shunt placement and quality of life. Secondary outcomes were patients with shunt failure, hospital and neuro intensive care unit (NICU) length of stay (LOS) and complications related to treatment with an EVD. Data permitted report of rate of VP shunt placement, and hospital and NICU LOS. RESULTS: Six studies were assessed in full text. One RCT with 81 patients was included. Rate of VP shunt placement was 63.4% in the rapid weaning group (ie, prompt closure of the EVD; 41 patients) and 62.5% in the gradual weaning group (40 patients; p=0.932). LOS in hospital and NICU was significantly shorter in the rapidly weaned group compared with the gradually weaned group (mean 19.1 vs 21.5 days in hospital (p=0.03); and mean 14.1 vs 16.9 days in NICU (p=0.0002)). Data were insufficient to conduct meta-analysis, trial sequential analysis or subgroup analysis of heterogeneity and sensitivity. One RCT is currently ongoing. CONCLUSIONS: We found insufficient evidence to favour any of the two strategies for EVD discontinuation in patients with hydrocephalus following aSAH. PROSPERO REGISTRATION NUMBER: CRD42018108801.
Asunto(s)
Hidrocefalia , Hemorragia Subaracnoidea , Adulto , Drenaje , Humanos , Hidrocefalia/etiología , Hidrocefalia/cirugía , Calidad de Vida , Estudios Retrospectivos , Hemorragia Subaracnoidea/complicaciones , DesteteRESUMEN
BACKGROUND: Decompressive craniectomy (DC) is used in cases of severe intracranial hypertension or impending intracranial herniation. DC effectively lowers intracranial pressure (ICP) but carries a risk of severe complications related to abnormal ICP and/or cerebrospinal fluid (CSF) circulation, eg, hygroma formation, hydrocephalus, and "syndrome of the trephined." OBJECTIVE: To study the long-term effect of DC on ICP, postural ICP regulation, and intracranial pulse wave amplitude (PWA). METHODS: Prospective observational study including patients undergoing DC during a 12-mo period. Telemetric ICP sensors (Neurovent-P-tel; Raumedic, Helmbrechts, Germany) were implanted in all patients. Following discharge from the neuro intensive care unit (NICU), scheduled weekly ICP monitoring sessions were performed during the rehabilitation phase. RESULTS: A total of 16 patients (traumatic brain injury: 7, stroke: 9) were included (median age: 55 yr, range: 19-71 yr). Median time from NICU discharge to cranioplasty was 48 d (range: 16-98 d) and during this period, mean ICP gradually decreased from 7.8 ± 2.0 mm Hg to -1.8 ± 3.3 mm Hg (P = .02). The most pronounced decrease occurred during the first month. Normal postural ICP change was abolished after DC for the entire follow-up period, ie, there was no difference between ICP in supine and sitting position (P = .67). PWA was markedly reduced and decreased from initially 1.2 ± 0.7 mm Hg to 0.4 ± 0.3 mm Hg (P = .05). CONCLUSION: Following NICU discharge, ICP decreases to negative values within 4 wk, normal postural ICP regulation is lost and intracranial PWA is diminished significantly. These abnormalities might have implications for intracranial fluid movements (eg, CSF and/or glymphatic flow) following DC and warrants further investigations.
Asunto(s)
Lesiones Traumáticas del Encéfalo/cirugía , Craniectomía Descompresiva/tendencias , Hipertensión Intracraneal/cirugía , Presión Intracraneal/fisiología , Monitoreo Fisiológico/tendencias , Accidente Cerebrovascular/cirugía , Adulto , Anciano , Lesiones Traumáticas del Encéfalo/epidemiología , Lesiones Traumáticas del Encéfalo/fisiopatología , Craniectomía Descompresiva/efectos adversos , Femenino , Estudios de Seguimiento , Alemania/epidemiología , Humanos , Unidades de Cuidados Intensivos/tendencias , Hipertensión Intracraneal/epidemiología , Hipertensión Intracraneal/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Prótesis e Implantes/efectos adversos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/fisiopatologíaRESUMEN
OBJECTIVES: Suboccipital decompressive craniectomy (SDC) is considered the best treatment option in patients with space-occupying cerebellar infarction and clinical signs of deterioration. The primary purpose of this study was to evaluate long-term functional outcome in patients one year after SDC for space-occupying cerebellar infarction, and secondly, to determine factors associated with outcome. PATIENTS AND METHODS: All patients treated with SDC due to space-occupying cerebellar infarction between January 2009 and October 2015 were included in the study. Data was retrospectively collected from patient records, CT/MRI scans and surgical protocols. Long-term functional outcome was determined by the modified Rankin Scale (mRS) and mRS ≥ 4 was defined as unfavorable outcome. RESULTS: Twenty-two patients (16 male, 6 female) were included in the study. Median age was 53 years. Nine patients were treated with external ventricular drainage as an initial treatment attempt prior to SDC. Median time from symptom onset (stroke ictus) to initiation of the SDC surgery was 48 h (IQR 28-99 hours) and median GCS before SDC was 8 (IQR 5-10). At follow up, median mRS was 3 (IQR 2-6). Outcome was favorable (mRS 0-3) in 12 patients and unfavorable in 10 (3 with major disability, 7 dead). Brainstem infarction and bilateral cerebellar infarction were associated with unfavorable outcome. CONCLUSIONS: In this small study, functional long-term outcome in patients with space-occupying cerebellar infarction treated by SDC was acceptable and comparable to previously published results (favorable outcome in 54% of patients). Brainstem infarction and bilateral cerebellar infarction were associated with unfavorable outcome.
Asunto(s)
Lesiones Encefálicas/cirugía , Craniectomía Descompresiva , Accidente Cerebrovascular/cirugía , Tiempo , Adulto , Anciano , Infartos del Tronco Encefálico , Enfermedades Cerebelosas/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Purpose of Review: Monitoring of intracranial pressure (ICP) is an important and integrated part of the treatment algorithm for children with severe traumatic brain injury (TBI). Guidelines often recommend ICP monitoring with a treatment threshold of 20 mmHg. This focused review discusses; (1) different ICP technologies and how ICP should be monitored in pediatric patients with severe TBI, (2) existing evidence behind guideline recommendations, and (3) how we could move forward to increase knowledge about normal ICP in children to support treatment decisions. Summary: Current reference values for normal ICP in adults lie between 7 and 15 mmHg. Recent studies conducted in "pseudonormal" adults, however, suggest a normal range below this level where ICP is highly dependent on body posture and decreases to negative values in sitting and standing position. Despite obvious physiological differences between children and adults, no age or body size related reference values exist for normal ICP in children. Recent guidelines for treatment of severe TBI in pediatric patients recommend ICP monitoring to guide treatment of intracranial hypertension. Decision on ICP monitoring modalities are based on local standards, the individual case, and the clinician's choice. The recommended treatment threshold is 20 mmHg for a duration of 5 min. Both prospective and retrospective observational studies applying different thresholds and treatment strategies for intracranial hypertension were included to support this recommendation. While some studies suggest improved outcome related to ICP monitoring (lower rate of mortality and severe disability), most studies identify high ICP as a marker of worse outcome. Only one study applied age-differentiated thresholds, but this study did not evaluate the effect of these different thresholds on outcome. The quality of evidence behind ICP monitoring and treatment thresholds in severe pediatric TBI is low and treatment can potentially be improved by knowledge about normal ICP from observational studies in healthy children and cohorts of pediatric "pseudonormal" patients expected to have normal ICP. Acceptable levels of ICP - and thus also treatment thresholds-probably vary with age, disease and whether the patient has intact cerebral autoregulation. Future treatment algorithms should reflect these differences and be more personalized and dynamic.