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INTRODUCTION: Atrial fibrillation or flutter (AF) is a well-known risk factor for ischemic stroke. While female sex has been associated with higher stroke risk among AF patients, overall sex-specific real-world burdens of AF-related strokes and hemorrhages are unknown. METHODS: The 2016-2020 National Inpatient Sample was queried for hospitalizations, morbidity, and mortality due to AF-related ischemic strokes and bleeds. Patient demographic information, vascular risk factors, comorbidities, and stroke characteristics were extracted using ICD-10 codes. Overall incidences were calculated using total population estimates provided by the United States Census Bureau, and relative risk was calculated by comparing annual incidences between men and women. RESULTS: 2,420,870 ischemic stroke hospitalizations were identified; 542,635 (22.4%) were associated with AF. Overall, women had similar risk of hospitalization due to AF-related ischemic strokes compared to men; however, women had a higher risk of morbidity and mortality (RR 1.13 and 1.17, respectively; both p<0.001). In contrast, women had lower incidences of hospitalization, morbidity, and mortality due to AF-related bleeds (RR 0.82, 0.94, and 0.74, respectively; all p<0.001). Among patients with AF-related ischemic strokes, women had lower rates of anticoagulation use, higher rates of large vessel occlusion, and higher stroke severity (all p<0.001). These trends persisted among patients 80 years or older (all p<0.001). CONCLUSION: Women in the United States have higher incidences of morbidity and mortality from AF-related ischemic strokes than men. Future studies should investigate strategies to reduce morbidity and mortality due to AF-related strokes in women.
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Pharmacological treatment of gliomas and other brain-infiltrating tumors remains challenging due to limited delivery of most therapeutics across the blood-brain barrier (BBB). Transcranial MRI-guided focused ultrasound (FUS), an emerging technology for noninvasive brain treatments, enables transient opening of the BBB through acoustic activation of circulating microbubbles. Here, we evaluate the safety and utility of transcranial microbubble-enhanced FUS (MB-FUS) for spatially targeted BBB opening in patients with infiltrating gliomas. In this Phase 0 clinical trial (NCT03322813), we conducted comparative and quantitative analyses of FUS exposures (sonications) and their effects on gliomas using MRI, histopathology, microbubble acoustic emissions (harmonic dose [HD]), and fluorescence-guided surgery metrics. Contrast-enhanced MRI and histopathology indicated safe and reproducible BBB opening in all patients. These observations occurred using a power cycling closed feedback loop controller, with the power varying by nearly an order of magnitude on average. This range underscores the need for monitoring and titrating the exposure on a patient-by-patient basis. We found a positive correlation between microbubble acoustic emissions (HD) and MR-evident BBB opening (P = 0.07) and associated interstitial changes (P < 0.01), demonstrating the unique capability to titrate the MB-FUS effects in gliomas. Importantly, we identified a 2.2-fold increase of fluorescein accumulation in MB-FUS-treated compared to untreated nonenhancing tumor tissues (P < 0.01) while accounting for vascular density. Collectively, this study demonstrates the capabilities of MB-FUS for safe, localized, controlled BBB opening and highlights the potential of this technology to improve the surgical and pharmacologic treatment of brain tumors.
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Barreira Hematoencefálica/fisiologia , Sistemas de Liberação de Medicamentos/métodos , Terapia por Ultrassom/métodos , Adulto , Transporte Biológico/fisiologia , Barreira Hematoencefálica/efeitos dos fármacos , Encéfalo/fisiologia , Estudos de Viabilidade , Feminino , Glioma/fisiopatologia , Glioma/terapia , Humanos , Masculino , Microbolhas , Sonicação/métodosRESUMO
BACKGROUND: While endovascular thrombectomy (EVT) is beneficial for patients with acute large vessel occlusion ischemic strokes, a significant portion of patients still do poorly despite successful recanalization. Identifying patients at high risk for poor outcomes can be helpful for future clinical trial design and optimizing acute stroke triage. METHODS: Consecutive EVT patients were identified from 2016 to 2021 at a Comprehensive Stroke Center, and clinical information was recorded. Poor outcome was defined as a 90-day modified Rankin Scale (mRS) of 4 or greater despite achieving a modified thrombolysis in cerebral infarction (mTICI) score of 2b or greater. Multivariable regression analyses were used to identify risk factors for poor outcomes, and a scoring system was constructed. RESULTS: 483 patients with successful recanalization were identified. From a randomly selected training cohort (n = 357), the 10-point BAND score was constructed from independent risk factors for poor outcomes: baseline disability (1 point: baseline mRS ≥ 2), age (1 point: 60-69 years, 2 points: 70-79 years, 3 points: 80-84 years, 4 points: 85 years or older), NIHSS (2 points: 13-17, 3 points: 18-22, and 4 points: ≥ 23), and delay from last known normal (1 point: ≥ 6 h). The BAND score was significantly associated with rates of poor outcomes (p < 0.001), and it achieved an area under the receiver-operating characteristic curve (AUC) of 0.80 (95 %CI 0.76-0.85) in our training cohort and 0.78 (95 %CI 0.70-0.86) in our validation cohort (n = 126). Overall, the BAND score had a significantly higher AUC value than the widely validated THRIVE score and the THRIVE-EVT calculation (p = 0.001 and 0.029, respectively). Among patients with high BAND scores (7 or higher), 88.2 % had poor outcomes. CONCLUSION: The BAND score is a simple tool to predict poor outcomes despite successful recanalization. Future studies are needed to confirm the BAND score's external validity.
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Isquemia Encefálica , Procedimentos Endovasculares , Acidente Vascular Cerebral , Idoso , Humanos , Pessoa de Meia-Idade , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/terapia , Isquemia Encefálica/complicações , Infarto Cerebral/etiologia , Procedimentos Endovasculares/efeitos adversos , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Acidente Vascular Cerebral/etiologia , Trombectomia/efeitos adversos , Resultado do Tratamento , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Osteoarthritis and other musculoskeletal disorders are the leading causes of disability in the United States. While osteoarthritis is not a direct risk factor for stroke, osteoarthritis may impact patient selection for endovascular thrombectomy (EVT) due to prestroke disability. This study investigates associations of osteoarthritis with EVT utilization and outcomes. METHODS: This was a large-scale cross-sectional study of the 2016 to 2019 National Inpatient Sample database. Adult patients with anterior large vessel ischemic strokes were identified. Patient demographics, stroke risk factors, stroke etiology, presence of osteoarthritis, medical comorbidities, EVT, intravenous thrombolysis treatments, and discharge destinations were recorded. Primary outcome was the rate of EVT treatment. Secondary outcomes include rates of discharge to home and in-hospital mortality. Propensity score matching and multivariable logistic regression models were used to account for possible confounders. RESULTS: Two hundred fifty-two thousand five hundred five patients were identified, of whom 8.5% (21 500 patients) had osteoarthritis. After propensity score matching for 32 clinical variables, osteoarthritis patients were found to be 17.3% less likely to receive EVT than non-osteoarthritis patients (14.4% versus 17.3%, respectively; P<0.001). In multivariable logistic regression analysis, osteoarthritis was associated with 22.6% lower odds of receiving EVT (OR, 0.77 [95% CI, 0.70-0.86]; P<0.001), an effect size larger than any medical comorbidity captured in this study other than dementia and nonstroke neurological disease. Among those treated with EVT, multivariable logistic regression models showed that osteoarthritis was not associated with different odds of being discharged home (OR, 0.99 [95% CI, 0.81-1.21]; P=0.93); however, osteoarthritis was marginally associated with lower odds of in-hospital mortality (OR, 0.74 [95% CI, 0.54-1.01]; P=0.054). CONCLUSIONS: Large vessel ischemic stroke patients with osteoarthritis were significantly less likely to receive EVT therapy despite similar post-EVT outcomes. These results warrant further investigation and prompt a critical review of current patient selection practices for stroke EVT therapy, specifically for patients with baseline disability due to musculoskeletal conditions such as osteoarthritis.
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Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Osteoartrite , Acidente Vascular Cerebral , Adulto , Humanos , AVC Isquêmico/etiologia , Isquemia Encefálica/terapia , Estudos Transversais , Resultado do Tratamento , Procedimentos Endovasculares/métodos , Acidente Vascular Cerebral/terapia , Trombectomia/métodosRESUMO
Background Radiology ranks high in terms of specialties implicated in medical malpractice claims. While most radiologists understand the risks of liability for missed findings or lapses of communication, liability for the use of contrast agents in imaging procedures may be underappreciated. Purpose To review the clinical context and outcomes of lawsuits alleging medical malpractice for contrast-related imaging procedures. Materials and Methods Two large U.S. legal databases were queried using the terms "Contrast" and "Radiology OR Radiologist" from database inception to October 31, 2022, to identify cases with published decisions or settlements related to medical malpractice in patients who underwent contrast-related imaging procedures. The search results were screened to include only those cases involving the practice area of health care law where there was at least one claim of medical negligence against a health care institution or provider. Data on the medical complications alleged by patients after contrast agent administration and on the trial were extracted and reported using descriptive statistics. Results A total of 151 published case summaries were included in the analysis. Anaphylactic reaction following contrast agent administration was the most common medical complication observed (30% [45 of 151 cases]), of which failure to diagnose developing anaphylaxis or failure to treat the anaphylactic reaction made up the majority of allegations (93% [42 of 45]). Inappropriate management of contrast media extravasation (27% [41 of 151]) and alleged contrast agent-induced acute kidney injury (13% [19 of 151]) were the next most frequent causes of lawsuits. Of the 11 cases of alleged kidney injury that went to trial, all resulted in a judgment in favor of the defense. Conclusion This study highlights the key reasons for medical malpractice lawsuits associated with use of contrast media and outcomes from these lawsuits. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Trop in this issue.
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Anafilaxia , Radiologia , Humanos , Anafilaxia/induzido quimicamente , Meios de Contraste/efeitos adversos , Comunicação , Bases de Dados FactuaisRESUMO
This technical note describes a novel dual-energy CT (DECT) protocol with iodine map reconstruction that will enable visualization of chronic subdural hematoma (CSDH) membranes. We describe the technique and discuss the potential implications for surgical management. The cohort included 36 patients with 50 hematomas. Enhancing external membrane was demonstrated in all the 50 hematomas, incomplete internal membrane in 13, and complete internal membrane in 23 hematomas. A spandrel sign at the transition zone that indicates partial or complete formation of internal membrane was demonstrated in 36 hematomas. KEY POINTS: ⢠Iodine maps from 5-min delayed post-contrast DECT provide spectral contrast difference and facilitate segregation of chronic subdural hematoma membranes. ⢠The ability to image the membranes helps in assessing the degree of organization of the hematoma by providing the information about the membrane thickness, volume, complexity of the membranes, and the proportion of the liquefied component within the hematoma before surgical procedures are undertaken. ⢠Membrane visualization helps in the localization of the transition zone and extension of the membranes over the cerebral lobes helping in the determination of craniotomy location and size, during membranectomy.
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Hematoma Subdural Crônico , Humanos , Hematoma Subdural Crônico/diagnóstico por imagem , Hematoma Subdural Crônico/cirurgia , Tomografia Computadorizada por Raios X , Craniotomia/métodos , HematomaRESUMO
INTRODUCTION: Endovascular treatment (EVT) is a therapeutic option for cerebral venous thrombosis (CVT); however, its benefit over conservative medical management has not been proven. Whether current patient selection practices are appropriate for EVT is unclear. METHODS: This was a nationwide study of the 2016-2020 National Inpatient Sample database. Adult CVT patients and EVT treatments were identified. Patient demographics, medical comorbidities, CVT risk factors, and CVT manifestations were identified. Presence of radiographic signs of advanced and severe CVT (venous infarction, cerebral edema, and intracranial hemorrhage) were recorded. Primary and secondary outcomes were good discharge outcomes and in-hospital mortality, respectively. RESULTS: 17,130 CVT patients were identified, and 56.7% had good discharge outcomes while 4.6% died during hospitalization. 945 (5.5%) received EVT, and EVT patients were more likely to have cerebral infarction (35.4% vs. 21.8%, p<0.001), edema (35.4% vs. 20.1%, p<0.001), and hemorrhage (37.6% vs. 19.7%, p<0.001). After multivariable adjustments, EVT for patients without infarction, edema, or hemorrhage was moderately associated with higher odds of good outcomes (OR 1.86 [95%CI 0.98 - 3.53], p=0.059) and resulted in zero deaths. However, with increasing burden of radiographic signs of advanced CVT measured by the cumulative presence of infraction, edema, and hemorrhage, EVT was associated with decreasing odds of good outcomes and increasing odds of in-hospital mortality compared to medical management (interaction p=0.046 and 0.029, respectively). CONCLUSIONS: EVT may lead to higher rates of favorable hospitalization outcomes in patients who have not yet developed overt parenchymal manifestations of backpressure changes; presence of infarction, edema, and hemorrhage may diminish the short-term effectiveness of EVT.
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OBJECTIVE: We explore the feasibility to estimate the exudation from chronic subdural hematoma (CSDH) membranes, by using dual-energy computed tomography (DECT) quantification of iodine leak and test if the derived quantitative variables and membrane morphology correlates with hematoma volume, internal architecture (homogeneous, laminar, separated, and trabecular types), and fractional hyperdense hematoma at presentation. METHODS: In this retrospective study, consecutive CSDH patients with postcontrast DECT head images from January 2020 and June 2021 were analyzed. Predictor variables derived from DECT were correlated with outcome variables followed by mixed-effects regression analysis. RESULTS: The study included 36 patients with 50 observations (mean age, 72.6 years; standard deviation, 11.6 years); 31 were men. Dual-energy CT variables that correlated with hematoma volume were external membrane volume (ρ, 0.37; P = 0.008) and iodine concentration (ρ, -0.29; P = 0.04). Variables that correlated with separated type of hematoma were total iodine leak (median [Q 1 , Q 3 ], 68.3 mg [48.5, 88.9] vs 38.8 mg [15.5, 62.9]; P = 0.001) and iodine leak per unit membrane volume (median [Q 1 , Q 3 ], 16.47 mg/mL [10.19, 20.65] vs 8.68 mg/mL [5.72, 11.41]; P = 0.002). Membrane grade was the only variable that correlated with fractional hyperdense hematoma (ρ, 0.28; P = 0.05). Regression analysis showed total iodine leak as the strongest predictor of separated type hematoma (odds ratio [95% confidence interval], 1.06 per mg [1.01, 1.1]). CONCLUSIONS: Dual-energy CT demonstrates iodine leak from CSDH membranes. The variables derived from DECT correlated with hematoma volume, internal architecture, and fractional hyperdense hematoma.
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Hematoma Subdural Crônico , Iodo , Masculino , Humanos , Idoso , Feminino , Tomografia Computadorizada por Raios X/métodos , Estudos de Viabilidade , Estudos Retrospectivos , Hematoma Subdural Crônico/diagnóstico por imagemRESUMO
BACKGROUND: Ischemic lesions on diffusion weighted imaging (DWI) are common after acute spontaneous intracerebral hemorrhage (ICH) but are poorly understood for large ICH volumes (> 30 mL). We hypothesized that large blood pressure drops and effect modification by cerebral small vessel disease markers on magnetic resonance imaging (MRI) are associated with DWI lesions. METHODS: This was an exploratory analysis of participants in the Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation phase 3 trial with protocolized brain MRI scans within 7 days from ICH. Multivariable logistic regression analysis was performed to assess biologically relevant factors associated with DWI lesions, and relationships between DWI lesions and favorable ICH outcomes (modified Rankin Scale 0-3). RESULTS: Of 499 enrolled patients, 300 had MRI at median 7.5 days (interquartile range 7-8), and 178 (59%) had DWI lesions. The incidence of DWI lesions was higher in patients with systolic blood pressure (SBP) reduction ≥ 80 mm Hg in first 24 h (76%). In adjusted models, factors associated with DWI lesions were as follows: admission intraventricular hematoma volume (p = 0.03), decrease in SBP ≥ 80 mm Hg from admission to day 1 (p = 0.03), and moderate-to-severe white matter disease (p = 0.01). Patients with DWI lesions had higher odds of severe disability at 1 month (p = 0.04), 6 months (p = 0.036), and 12 months (p < 0.01). No evidence of effect modification by cerebral small vessel disease on blood pressure was found. CONCLUSIONS: In patients with large hypertensive ICH, white matter disease, intraventricular hemorrhage volume, and large reductions in SBP over the first 24 h were independently associated with DWI lesions. Further investigation of potential hemodynamic mechanisms of ischemic injury after large ICH is warranted.
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Background There have been growing efforts nationally and institutionally toward diversity in radiology. Purpose To analyze sex and racial and ethnic diversity over time (2010-2019) for the various levels of the U.S. academic radiology physician workforce in context of the available pipeline of medical students and trainees. Materials and Methods Data on sex and race and ethnicity were collected among medical school applicants, graduates, radiology residency applicants, residents, and different levels of academic radiology faculty. All trainee data were obtained from two time points, 2010-2011 and 2019-2020. Radiology faculty data were collected from 2010 to 2019. The sex and racial and ethnic composition at each academic level was compared between 2010 and 2019 using the χ2 test and a significance level of P < .05. Results In 2019, the percentage of female faculty among radiology instructors was 38% (251 of 655); assistant professors, 31% (1503 of 4801); associate professors, 28% (600 of 2161); professors, 22% (424 of 1901); and department chairs, 17% (37 of 220). The proportion of female faculty increased from 2010 to 2019, with the greatest relative increase in percentages among the more senior faculty positions. However, the proportion of female department chairs has only increased from 13% (27 of 203) in 2010 to 17% (37 of 220) in 2019. Across training levels, the most abrupt change in composition of female trainees occurred from medical school matriculates (52%, 11 160 of 21 614) to radiology residency applicants (29%, 656 of 2274), which largely stayed unchanged from 2010 to 2019. The proportion of Black or African American department chairs was 5% (10 of 220) in 2019, which was higher compared with that of assistant professor, associate professor, and professor levels for Black or African American faculty (3% [130 of 4949], 2% [41 of 2208], and 2% [35 of 1924], respectively), with proportions of Hispanic faculty at 5% (240 of 4949), 4% (96 of 2208), and 3% (60 of 1924), respectively. These proportions have not changed since 2010. Conclusion Identifying and addressing reasons for the low proportion of female radiology residency applicants despite a highly diverse pool of medical students would be key to increasing female representation in the field. The low representation of African American and Hispanic individuals in academic radiology is seen at all levels and has not changed much over time. Efforts to increase diversity may need to be focused toward the medical school and residency application levels. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Pandharipande and Shah in this issue.
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Radiologia , Estudantes de Medicina , Feminino , Humanos , Docentes de Medicina , Faculdades de Medicina , EtnicidadeRESUMO
OBJECTIVE: The objective of this study was to examine the published cost-effectiveness analyses (CEAs) on endovascular thrombectomy (EVT) in acute stroke patients, with a particular focus on the practice of accounting for costs and utilities. METHODS: We conducted a systematic review of published CEAs on EVT in acute stroke patients from 1/1/2009 to 10/1/2019. Published CEAs were searched in Ovid Embase, Ovid MEDLINE, and Web of Science. Cost or comparative effectiveness analyses were excluded. Risk of bias and quality assessment was based on the Consolidated Health Economic Evaluation Reporting Standard checklist. RESULTS: Twenty-one studies were included in the final analysis, from the USA, Canada, Europe, Asia, and Australia. They all concluded EVT to be cost-effective, but with significant variations in methodology. Fifteen studies employed a long-term horizon (> 20 years), while only 11 incorporated risk of recurrent strokes. The willingness-to-pay (WTP) threshold varied from $10,000/quality-adjusted life year (QALY) to $120,000/QALY, with $50,000/QALY and $100,000/QALY being the most commonly used. Five studies undertook a societal perspective, but only one accounted for indirect costs. Seventeen studies based outcomes on 90-day modified Rankin Scale (mRS) scores, and 9 of these 17 studies grouped outcomes by mRS 0-2 and 3-5. Among these 9 studies, the range of QALY score reported for mRS 0-2 was 0.71-0.85 QALY, and that of mRS 3-5 was 0.21-0.40. CONCLUSIONS: Our study reveals significant heterogeneity in previously published thrombectomy CEAs, highlighting need for better standardization in future CEAs. KEY POINTS: ⢠All included studies concluded thrombectomy to be cost-effective, from both long- and short-term perspectives. ⢠Only 5 out of 22 studies undertook a societal perspective, and only 1 accounted for indirect costs. ⢠The range of value for mRS 0-2 was 0.71-0.85 quality-adjusted life year (QALY) and 0.21-0.40 QALY for mRS 3-5.
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AVC Isquêmico , Acidente Vascular Cerebral , Análise Custo-Benefício , Humanos , AVC Isquêmico/cirurgia , Anos de Vida Ajustados por Qualidade de Vida , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodosRESUMO
As advances in prehospital and early hospital care improve survival of the head-injured patient, radiologists are increasingly charged with understanding the myriad skull base fracture management implications conferred by CT. Successfully parlaying knowledge of skull base anatomy and fracture patterns into precise actionable clinical recommendations is a challenging task. The authors aim to provide a pragmatic overview of CT for skull base fractures within the broader context of diagnostic and treatment planning algorithms. Laterobasal, frontobasal, and posterior basal fracture patterns are emphasized. CT often plays a complementary, supportive, or confirmatory role in management of skull base fractures in conjunction with results of physical examination, laboratory testing, and neurosensory evaluation. CT provides prognostic information about short- and long-term risk of cerebrospinal fluid (CSF) leak, encephalocele, meningitis, facial nerve paralysis, hearing and vision loss, cholesteatoma, vascular injuries, and various cranial nerve palsies and syndromes. The radiologist should leverage understanding of specific strengths and limitations of CT to anticipate next steps in the skull base fracture management plan. Additional imaging is warranted to clarify ambiguity (particularly for potential sources of CSF leak); in other cases, clinical and CT criteria alone are sufficient to determine the need for intervention and the choice of surgical approach. The radiologist should be able to envision stepping into a multidisciplinary planning discussion and engaging neurotologists, neuro-ophthalmologists, neurosurgeons, neurointerventionalists, and facial reconstructive surgeons to help synthesize an optimal management plan after reviewing the skull base CT findings at hand. Online supplemental material is available for this article. ©RSNA, 2021.
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Fraturas Ósseas , Fraturas Cranianas , Vazamento de Líquido Cefalorraquidiano , Humanos , Estudos Retrospectivos , Base do Crânio/diagnóstico por imagem , Fraturas Cranianas/diagnóstico por imagem , Fraturas Cranianas/terapia , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage. METHODS: MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0-3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046. FINDINGS: Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012). INTERPRETATION: For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons. FUNDING: National Institute of Neurological Disorders and Stroke and Genentech.
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Hemorragia Cerebral/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Terapia Trombolítica/efeitos adversos , Terapia Trombolítica/métodos , Idoso , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
Background Minor stroke is common and may represent up to two-thirds of cases of acute ischemic stroke. The cost-effectiveness of CT angiography in patients with minor stroke (National Institutes of Health Stroke Scale [NIHSS] score ≤6) is not well established. Purpose To evaluate cost-effectiveness of CT angiography in the detection of large-vessel occlusion (LVO) in patients with acute minor stroke (NIHSS score ≤6). Materials and Methods A Markov decision-analytic model with a societal perspective was constructed. Three different management strategies were evaluated: (a) no vascular imaging and best medical management, (b) CT angiography for all patients and immediate thrombectomy for LVO after intravenous thrombolysis, and (c) CT angiography for all and best medical management (including intravenous thrombolysis, with rescue thrombectomy for patients with LVO and neurologic deterioration). One-way, two-way, and probabilistic sensitivity analyses were performed. Results Base-case calculation showed that CT angiography followed by immediate thrombectomy had the lowest cost ($346 007) and highest health benefits (9.26 quality-adjusted life-years [QALYs]). CT angiography followed by best medical management with possible rescue thrombectomy for patients with LVO had a slightly higher cost ($346 500) and lower health benefits (9.09 QALYs). No vascular imaging had the highest cost and lowest health benefits. The difference in health benefits compared with the CT angiography and immediate thrombectomy strategy was 0.39 QALY, which corresponds to 142 days in perfect health per patient. The conclusion was robust in a probabilistic sensitivity analysis. CT angiography was cost-effective when the probability of LVO was greater than 0.16% in patients with acute minor stroke. The net monetary benefit of performing CT angiography was higher in younger patients ($68 950 difference between CT angiography followed by immediate thrombectomy and no vascular imaging in 55-year-old patients compared with $20 931 in 85-year-old patients). Conclusion Screening for large-vessel occlusion with CT angiography in patients with acute minor stroke is cost-effective and associated with improved health outcomes. Undetected large-vessel occlusion in the absence of vascular imaging results in worse health outcomes and higher costs. © RSNA, 2020 Online supplemental material is available for this article.
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Angiografia por Tomografia Computadorizada , Acidente Vascular Cerebral , Triagem , Idoso , Idoso de 80 Anos ou mais , Angiografia por Tomografia Computadorizada/economia , Angiografia por Tomografia Computadorizada/estatística & dados numéricos , Análise Custo-Benefício , Humanos , Pessoa de Meia-Idade , Acidente Vascular Cerebral/classificação , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/epidemiologia , Triagem/economia , Triagem/estatística & dados numéricosRESUMO
Background and Purpose- Although computed tomography angiography (CTA) is an excellent, noninvasive imaging modality for surveillance of intracranial aneurysms, radiation concerns have been cited to restrict its use in surveillance imaging. The goal of this study was to estimate distributions of radiation-induced central nervous system cancer incidence from CTA surveillance for intracranial aneurysms, and the impact of frequency and duration of surveillance imaging using follow-up CTAs. Methods- Simulation-modeling approach was performed using data on CTA associated radiation risk. We used the Radiation Risk Assessment Tool, based on the data using the BEIR VII report (BEIR VII). Each CTA was assigned as a separate exposure event. Men and women, respectively, starting surveillance imaging at 30, 40, and 50 years and receiving annual CTAs were considered as separate subgroups. As a comparison, we also calculated the radiation-induced cancer risk in the same groups of patients but receiving CTAs every 2 and 5 years, respectively. Results- CTA-associated excess cancer risk per exposure increases relatively more rapidly with the first 10 exposures and plateaus after the 44th exposure. On average, per CTA incurs ≈0.0026% in excess lifetime cancer risk. Receiving CTA follow-up at a younger age, more frequent follow-up, longer surveillance period, and men are the major factors contributing to an elevated excess lifetime risk. In the highest risk group, male patient receiving annual CTA follow-ups from the age of 30 years, the excess lifetime risk is 0.115% at the age of 81 years. Conclusions- Radiation-induced brain cancer incidence associated with unruptured intracranial aneurysm surveillance strategies using CTA is low relative to the risk for aneurysmal rupture. Further cost-effectiveness/utility analyses might help assess this risk in the context of aneurysmal ruptures prevented by surveillance imaging.
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Background and Purpose- Strokes in patients aged ≥80 years are common, and advanced age is associated with relatively poor poststroke functional outcome. The current guidelines do not recommend an upper age limit for endovascular thrombectomy (EVT). The purpose of this study is to evaluate the effectiveness of EVT in acute stroke because of large vessel occlusion for elderly patients >age 80 years. Methods- A Markov decision analytic model was constructed from a societal perspective to evaluate health outcomes in terms of quality-adjusted life years (QALYs) after EVT for acute ischemic stroke because of large vessel occlusion in patients above age 80 years. Age-specific input parameters were obtained from the most recent/comprehensive literature. Good outcome was defined as a modified Rankin Scale score ≤2. Probabilistic, 1-way, and 2-way sensitivity analyses were performed for both healthy patients and patients with disability at baseline. Results- Base case calculation showed in functionally independent patients at baseline, intravenous thrombolysis (IVT) with tPA (tissue-type plasminogen activator) only to be the better strategy with 3.76 QALYs compared to 2.93 QALYs for patients undergoing EVT. The difference in outcome is 0.83 QALY (equivalent to 303 days of life in perfect health). For patients with baseline disability, IVT only yields a utility of 1.92 QALYs and EVT yields a utility of 1.65 QALYs. The difference is 0.27 QALYs (equivalent to 99 days of life in perfect health). Multiple sensitivity analyses showed that the effectiveness of EVT is significantly determined by the morbidity and mortality after both IVT and EVT strategies, respectively. Conclusions- Our study demonstrates the impact of relevant factors on the effectiveness of EVT in patients above 80 years of age. Morbidity and mortality after both IVT and EVT strategies significantly influence the outcomes in both healthy and disabled patients at baseline. Better identification of patients not benefiting from IVT would optimize the selective use of EVT thereby improving its effectiveness.
Assuntos
Isquemia Encefálica/terapia , Fibrinolíticos/uso terapêutico , Acidente Vascular Cerebral/terapia , Trombectomia , Ativador de Plasminogênio Tecidual/uso terapêutico , Idoso de 80 Anos ou mais , Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/cirurgia , Feminino , Humanos , Masculino , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/cirurgia , Resultado do TratamentoRESUMO
Background and Purpose- Our study aims to evaluate the cost-effectiveness of computed tomography angiography (CTA) for surveillance of tiny unruptured intracranial aneurysms and the impact of CTA radiation-induced brain tumor on the overall effectiveness of CTA. Methods- A Markov decision model was constructed from a societal perspective starting with patients 30-, 40-, or 50-year-old, with incidental detection of unruptured intracranial aneurysm ≤3 mm and no prior history of subarachnoid hemorrhage. Five different management strategies were assessed (1) annual CTA surveillance, (2) biennial CTA, (3) CTA follow-up every 5 years, (4) coiling and subsequent magnetic resonance imaging follow-up, and (5) annual CTA surveillance for the first 2 years, followed by every 5-year CTA follow-up. Probabilistic, 1-way, and 2-way sensitivity analyses were performed. Results- The base case calculation shows every 5-year CTA follow-up to be the most cost-effective strategy, and the conclusion remains robust in probabilistic sensitivity analysis. It remains the dominant strategy when the annual rupture risk of nongrowing unruptured intracranial aneurysms is smaller than 2.66% or the rupture risk in growing aneurysms is <57.4%. The radiation-induced brain cancer risk is relatively low, and sensitivity analysis shows that the radiation-induced cancer risk does not influence the conclusions unless the risk exceeds 663-fold of the base case values. Conclusions- Given the current literature, every 5-year CTA imaging follow-up is the cost-effective strategy in patients with aneurysms ≤3 mm, resulting in better health outcomes and lower healthcare spending. Patients with aneurysms at high risk of rupture might need more aggressive management.
Assuntos
Angiografia por Tomografia Computadorizada/economia , Análise Custo-Benefício/métodos , Gerenciamento Clínico , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/economia , Adulto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologiaRESUMO
Background and Purpose- We investigated the prognostic significance of spontaneous intracerebral hemorrhage location in presence of severe intraventricular hemorrhage. Methods- We analyzed diagnostic computed tomography scans from 467/500 (excluding primary intraventricular hemorrhage) subjects from the CLEAR (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) III trial. We measured intracerebral hemorrhage engagement with specific anatomic regions, and estimated association of each region with blinded assessment of dichotomized poor stroke outcomes: mortality, modified Rankin Scale score of 4 to 6, National Institutes of Health Stroke Scale score of >4, stroke impact scale score of <60, Barthel Index <86, and EuroQol visual analogue scale score of <50 and <70 at days 30 and 180, respectively, using logistic regression models. Results- Frequency of anatomic region involvement consisted of thalamus (332 lesions, 71.1% of subjects), caudate (219, 46.9%), posterior limb internal capsule (188, 40.3%), globus pallidus/putamen (127, 27.2%), anterior limb internal capsule (108, 23.1%), and lobar (29, 6.2%). Thalamic location was independently associated with mortality (days 30 and 180) and with poor outcomes on most stroke scales at day 180 on adjusted analysis. Posterior limb internal capsule and globus pallidus/putamen involvement was associated with increased odds of worse disability at days 30 and 180. Anterior limb internal capsule and caudate locations were associated with decreased mortality on days 30 and 180. Anterior limb internal capsule lesions were associated with decreased long-term morbidity. Conclusions- Acute intracerebral hemorrhage lesion topography provides important insights into anatomic correlates of mortality and functional outcomes even in severe intraventricular hemorrhage causing obstructive hydrocephalus. Models accounting for intracerebral hemorrhage location in addition to volumes may improve outcome prediction and permit stratification of benefit from aggressive acute interventions. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT00784134.
Assuntos
Hemorragia Cerebral/diagnóstico por imagem , Ventrículos Cerebrais/diagnóstico por imagem , Idoso , Gânglios da Base/diagnóstico por imagem , Hemorragia Cerebral/mortalidade , Hemorragia Cerebral/terapia , Estudos de Coortes , Feminino , Escala de Coma de Glasgow , Globo Pálido/diagnóstico por imagem , Humanos , Hidrocefalia/etiologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Tálamo/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
BACKGROUND: Uncontrolled pilot studies have suggested the efficacy of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance for the treatment of essential tremor. METHODS: We enrolled patients with moderate-to-severe essential tremor that had not responded to at least two trials of medical therapy and randomly assigned them in a 3:1 ratio to undergo unilateral focused ultrasound thalamotomy or a sham procedure. The Clinical Rating Scale for Tremor and the Quality of Life in Essential Tremor Questionnaire were administered at baseline and at 1, 3, 6, and 12 months. Tremor assessments were videotaped and rated by an independent group of neurologists who were unaware of the treatment assignments. The primary outcome was the between-group difference in the change from baseline to 3 months in hand tremor, rated on a 32-point scale (with higher scores indicating more severe tremor). After 3 months, patients in the sham-procedure group could cross over to active treatment (the open-label extension cohort). RESULTS: Seventy-six patients were included in the analysis. Hand-tremor scores improved more after focused ultrasound thalamotomy (from 18.1 points at baseline to 9.6 at 3 months) than after the sham procedure (from 16.0 to 15.8 points); the between-group difference in the mean change was 8.3 points (95% confidence interval [CI], 5.9 to 10.7; P<0.001). The improvement in the thalamotomy group was maintained at 12 months (change from baseline, 7.2 points; 95% CI, 6.1 to 8.3). Secondary outcome measures assessing disability and quality of life also improved with active treatment (the blinded thalamotomy cohort)as compared with the sham procedure (P<0.001 for both comparisons). Adverse events in the thalamotomy group included gait disturbance in 36% of patients and paresthesias or numbness in 38%; these adverse events persisted at 12 months in 9% and 14% of patients, respectively. CONCLUSIONS: MRI-guided focused ultrasound thalamotomy reduced hand tremor in patients with essential tremor. Side effects included sensory and gait disturbances. (Funded by InSightec and others; ClinicalTrials.gov number, NCT01827904.).