Mechanical thrombectomy is cost-effective versus medical management alone around Europe in patients with low ASPECTS.

OBJECTIVE: To demonstrate, by a cost-effectiveness analysis, the efficiency of mechanical thrombectomy (MT) versus medical management (MM) in patients with a low Alberta Stroke Program Early CT Score (ASPECTS) from the RESCUE Study. METHODS: A cost-effectiveness model was designed to project both direct medical costs and quality-adjusted life-years (QALYs) of MT versus MM in eight European countries (Spain, UK, France, Italy, Belgium, Germany, Sweden, and the Netherlands). Our model was created based on previously published health-economic data in those countries. Procedure costs, acute, mid-term, and long-term care costs were projected based on expected modified Rankin Scale (mRS) scores as reported in the RESCUE-Japan LIMIT trial. RESULTS: MT was found to be a cost-effective option in eight different countries across Europe (Spain, Italy, UK, France, Belgium, Germany, the Netherlands, and Sweden). with a lifetime incremental cost-effectiveness ratio varying from US$2 875 to US$11 202/QALY depending on the country. A cost-effectiveness acceptability curve showed 100% acceptability of MT at the willingness to pay (WTP) of US$40 000 for the eight countries. CONCLUSIONS: MT is efficient versus MM alone for patients with low ASPECTS in eight countries across Europe. Patients with a large ischemic core could be treated with MT because it is both clinically beneficial and economically sustainable.

Safety and Outcomes of Thrombectomy in Ischemic Stroke With vs Without IV Thrombolysis.

OBJECTIVE: To test the hypothesis that IV thrombolysis (IVT) treatment before endovascular thrombectomy (EVT) is associated with better outcomes in patients with anterior circulation large artery occlusion (LAO) stroke, we examined a large real-world database, the Safe Implementation of Treatment in Stroke-International Stroke Thrombectomy Register (SITS-ISTR). METHODS: We identified centers recording ≥10 consecutive patients in the SITS-ISTR, with at least 70% available modified Rankin Scale (mRS) scores at 3 months during 2014 to 2019. We defined LAO as intracranial internal carotid artery, first and second segment of middle cerebral artery, and first segment of anterior cerebral artery. Main outcomes were functional independence (mRS score 0-2) and death at 3 months and symptomatic intracranial hemorrhage (SICH) per modified SITS-Monitoring Study. We performed propensity score-matched (PSM) and multivariable logistic regression analyses. RESULTS: Of 6,350 patients from 42 centers, 3,944 (62.1%) received IVT. IVT + EVT-treated patients had less frequent atrial fibrillation, ongoing anticoagulation, previous stroke, heart failure, and prestroke disability. PSM analysis showed that IVT + EVT-treated patients had a higher rate of functional independence than patients treated with EVT alone (46.4% vs 40.3%, p < 0.001) and a lower rate of death at 3 months (20.3% vs 23.3%, p = 0.035). SICH rates (3.5% vs 3.0%, p = 0.42) were similar in both groups. Multivariate adjustment yielded results consistent with PSM. CONCLUSION: Pretreatment with IVT was associated with favorable outcomes in EVT-treated LAO stroke in the SITS-ISTR. These findings, while indicative of international routine clinical practice, are limited by observational design, unmeasured confounding, and possible residual confounding by indication. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that IVT before EVT increases the probability of functional independence at 3 months compared to EVT alone.

Stroke Acute Management and Outcomes During the COVID-19 Outbreak: A Cohort Study From the Madrid Stroke Network.

BACKGROUND AND PURPOSE: The coronavirus disease 2019 (COVID-19) outbreak has added challenges to providing quality acute stroke care due to the reallocation of stroke resources to COVID-19. Case series suggest that patients with COVID-19 have more severe strokes; however, no large series have compared stroke outcomes with contemporary non-COVID-19 patients. Purpose was to analyze the impact of COVID-19 pandemic in stroke care and to evaluate stroke outcomes according to the diagnosis of COVID-19. METHODS: Retrospective multicenter cohort study including consecutive acute stroke patients admitted to 7 stroke centers from February 25 to April 25, 2020 (first 2 months of the COVID-19 outbreak in Madrid). The quality of stroke care was measured by the number of admissions, recanalization treatments, and time metrics. The primary outcome was death or dependence at discharge. RESULTS: A total of 550 acute stroke patients were admitted. A significant reduction in the number of admissions and secondary interhospital transfers was found. COVID-19 was confirmed in 105 (19.1%) patients, and a further 19 patients were managed as suspected COVID-19 (3.5%). No differences were found in the rates of reperfusion therapies in ischemic strokes (45.5% non-COVID-19, 35.7% confirmed COVID-19, and 40% suspected COVID-19; P=0.265). However, the COVID-19 group had longer median door-to-puncture time (110 versus 80 minutes), which was associated with the performance of chest computed tomography. Multivariate analysis confirmed poorer outcomes for confirmed or suspected COVID-19 (adjusted odds ratios, 2.05 [95% CI, 1.12-3.76] and 3.56 [95% CI, 1.15-11.05], respectively). CONCLUSIONS: This study confirms that patients with COVID-19 have more severe strokes and poorer outcomes despite similar acute management. A well-established stroke care network helps to diminish the impact of such an outbreak in stroke care, reducing secondary transfers and allowing maintenance of reperfusion therapies, with a minor impact on door-to-puncture times, which were longer in patients who underwent chest computed tomography.

Predictors for Cerebral Edema in Acute Ischemic Stroke Treated With Intravenous Thrombolysis.

BACKGROUND AND PURPOSE: Cerebral edema (CED) is a severe complication of acute ischemic stroke. There is uncertainty regarding the predictors for the development of CED after cerebral infarction. We aimed to determine which baseline clinical and radiological parameters predict development of CED in patients treated with intravenous thrombolysis. METHODS: We used an image-based classification of CED with 3 degrees of severity (less severe CED 1 and most severe CED 3) on postintravenous thrombolysis imaging scans. We extracted data from 42 187 patients recorded in the SITS International Register (Safe Implementation of Treatments in Stroke) during 2002 to 2011. We did univariate comparisons of baseline data between patients with or without CED. We used backward logistic regression to select a set of predictors for each CED severity. RESULTS: CED was detected in 9579/42 187 patients (22.7%: 12.5% CED 1, 4.9% CED 2, 5.3% CED 3). In patients with CED versus no CED, the baseline National Institutes of Health Stroke Scale score was higher (17 versus 10; P<0.001), signs of acute infarct was more common (27.9% versus 19.2%; P<0.001), hyperdense artery sign was more common (37.6% versus 14.6%; P<0.001), and blood glucose was higher (6.8 versus 6.4 mmol/L; P<0.001). Baseline National Institutes of Health Stroke Scale, hyperdense artery sign, blood glucose, impaired consciousness, and signs of acute infarct on imaging were independent predictors for all edema types. CONCLUSIONS: The most important baseline predictors for early CED are National Institutes of Health Stroke Scale, hyperdense artery sign, higher blood glucose, decreased level of consciousness, and signs of infarct at baseline. The findings can be used to improve selection and monitoring of patients for drug or surgical treatment.

Impact of clinical training on supra-aortic duplex and transcranial doppler examination concordance.

Sonographic tests are observer-dependent. With 1,527 consecutive patients, 22 trainees were assessed at baseline and after a hands-on 1:1 program, with a pre-examination median of 76 studies/trainee. We evaluated the required number of supervised examinations to reach a 0.80 kappa index (ki). Statistics included linear and exponential generalized estimating equation models. In the exponential model, 76 studies for carotid-duplex and >102 for vertebral-duplex and transcranial Doppler were needed for a 0.80 ki. "Relevant-categories" after-training ki was 0.80 in carotid-duplex and transcranial Doppler but 0.60 in vertebral-duplex. A fixed training does not guarantee a high ki. Measuring the acquired skills of every trainee would improve quality. © 2016 Wiley Periodicals, Inc. J Clin Ultrasound 44:571-579, 2016.

El ictus en pacientes muy ancianos y deontología en la investigación clínica / Stroke in very old patients and ethics in clinical research

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Questionable reversal of anticoagulation in the therapeutic management of cerebral haemorrhage associated with vitamin K antagonists.

Reversal of anticoagulation is recommended to correct the international normalised ratio (INR) for patients with intracranial haemorrhage (ICH) associated with vitamin K antagonists (VKA). However, the validity of such treatment is debated. We sought to identify, prospectively, the prognostic effect of VKA-ICH treatment in a cohort of patients (n=71; median age 78 years, range 20-89; 52% males). Data collated were: baseline characteristics, treatments, baseline and post-treatment INR, haematoma volume, and haematoma enlargement. Treatment effects and prognostic factor assessment were in relation to mortality and functional outcomes. On admission, the patients had a median score of 9 [p25; p75 of 5; 20] on the National Institute of Health Stroke Scale (NIHSS) and a mean INR of 2.7 (range: 0.9 - 10.8). Haematoma volume (34.6 cm³; SD: 24.9) correlated with NIHSS (r = 0.55; p<0.001) but not with INR. Anticoagulation reversal treatment was administered in 83% of patients. INR <1.5 was achieved in 60.7% of cases. Death or dependency at three months was 76%. Neither baseline INR, anticoagulation reversal nor haematoma enlargement were related to mortality or functional outcome. The only independent prognostic factor was clinical severity on admission. Baseline NIHSS predicted mortality (OR: 1.18; 95%CI: 1.09-1.27), independence (OR: 0.83; 95%CI: 0.74-0.94) and neurological recovery (NIHSS 0-1) (OR: 0.83; 95%CI: 0.73-0.95). The data indicate that VKA-ICH had a poor prognosis. Treatment and INR correction did not appear to affect outcomes.

Endovascular treatment of distal internal carotid artery occlusions with retrievable stents.

BACKGROUND: Acute stroke due to distal intracranial internal carotid artery (ICA) occlusion has a poor natural history. Outcome in patients who receive intravenous tissue plasminogen activator (tPA) is also unsatisfactory. The objective of this study is to evaluate the effectiveness and safety of endovascular treatment with retrievable stents in these patients. METHODS: Data from a prospective register of patients with acute stroke treated with an endovascular procedure in a single centre were analysed. RESULTS: A total of 20 patients with distal ICA occlusion were collected. Mean baseline National Institutes of Health Stroke Scale score was 18. Eight cases (40%) had received previous intravenous tPA. Mean time from stroke to recanalization was 393 min. Retrievable stents with proximal occlusion and aspiration were used in all cases. In 3 patients, 2 retrievable stents were used simultaneously. Complete recanalization (thrombolysis in cerebral infarction 2b/3) was accomplished in 85% of cases. A favourable clinical outcome (modified Rankin Scale score 0-2) was achieved in 13 patients (65%). Mortality occurred in 2 cases (10%). CONCLUSIONS: Endovascular treatment of patients with distal ICA occlusion seems safe and effective. Retrievable stents may be the treatment of choice, although randomized clinical trials are necessary. The use of 2 retrievable stents at the same time could be an alternative technique useful in thrombi of larger size.

Importance of cerebral artery recanalization in patients with stroke with and without neurological improvement after intravenous thrombolysis.

BACKGROUND AND PURPOSE: Recanalization status after intravenous thrombolysis (IVT) in patients with ischemic stroke is a reference point to proceed with a rescue reperfusion intervention, although early neurological improvement (NI) may preclude endovascular procedures. We aimed to evaluate the importance of restoration of blood flow at the arterial occlusion site in subgroups of patients with stroke stratified by early NI after IVT. METHODS: The following patients were recruited from the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Register: (1) with baseline vessel occlusion documented by computed tomographic (CT) or magnetic resonance (MR) angiography and follow-up angioimaging between 22 and 36 hours after IVT available; and (2) with dense cerebral artery sign on admission CT scan and results of follow-up CT reported. Recanalization at 24 hours was defined as absence of vessel occlusion or as resolution of dense cerebral artery sign on follow-up 22- to 36-hour imaging. NI was assessed at 2 hours and 24 hours after IVT and was defined as improvement by 20% from baseline National Institute of Health Stroke scale score. Primary outcome measure was independence, defined as modified Rankin scale score 0 to 2 after 3 months. RESULTS: Of 28136 cases registered between December 2003 and November 2009, 5324 cases (19%) met the inclusion criteria. Patients with both NI at 2 hours post-treatment and vessel recanalization had the best chances to achieve independence at 3 months (adjusted odds ratio, 15.8; 95% confidence interval, 12.5-20.0), followed by those who had NI despite persistent occlusion (adjusted odds ratio, 4.7; 95% confidence interval, 3.6-6.1); and those without NI despite recanalization (adjusted odds ratio, 2.7; 95% confidence interval, 2.2-3.3). CONCLUSIONS: Recanalization of an occluded artery in acute stroke is associated with favorable functional outcome both in patients with and without NI after IVT. In future evaluations of mechanical thrombectomy and other additional strategies, recanalization should be considered in patients with persisting occlusion after IVT even after significant NI.

Stroke and transient ischemic attack incidence rate in Spain: the IBERICTUS study.

BACKGROUND: In Spain, stroke is a major public health concern, but large population-based studies are scarce and date from the 1990s. We estimated the incidence and in-hospital mortality of stroke through a multicentered population-based stroke register in 5 geographical areas of Spain, i.e. Lugo, Almería, Segovia, Talavera de la Reina and Mallorca, representing north, south, central (×2) and Mediterranean areas of Spain, respectively, the aim and novelty being that all methodologies were standardized, and diagnoses were verified by a neurologist using neuroimaging techniques. METHODS: The register identified subjects >17 years of age who suffered a first-ever stroke or transient ischemic attack (TIA) between 1 January and 31 December 2006. Stroke and TIA were defined according to the WHO criteria. The Lausanne Stroke Registry definitions were used to classify ischemic stroke subtypes, as follows: (1) large-artery atherosclerosis (LAA); (2) cardioembolism (CE); (3) lacunar stroke or small-artery occlusion (SAO); (4) stroke of other infrequent cause (SIC), and (5) stroke of undetermined cause (UND). We used several complementary data sources such as hospital discharge registers, emergency room registers and primary care surveillance systems. RESULTS: In the 1-year study period, we identified 2,700 first-ever cerebrovascular episodes (53% men; 2,257 strokes + 443 TIA episodes). Brain CT in the acute stage was performed in 99% of cases. Of a total of 2,257 stroke patients, 1,817 (81%) had cerebral infarction, 350 (16%) had intracerebral hemorrhage, 59 (3%) had subarachnoid hemorrhage (SAH) and 31 (1%) had unclassifiable stroke. The overall unadjusted annual incidence for all cerebrovascular events was 187 per 100,000 [95% confidence interval (CI) 180-194; incidence for men: 202, 95% CI 189-210; incidence for women: 187, 95% CI 180-194]. The subtype of ischemic stroke could be determined in 1,779 patients and was classified as LAA in 624 (35%), CE in 352 (20%), SAO in 316 (18%), SIC in 56 (3%) and UND in 431 (24%). The incidence rates per 100,000 (95% CI) standardized to the 2006 European population were as follows: all cerebrovascular events, 176 (169-182); all stroke (non-TIA), 147 (140-153); TIA, 29 (26-32); ischemic stroke, 118 (112-123); intracerebral hemorrhage, 23 (21-26), and SAH, 4.2 (3.1-5.2). Incidence rates clearly increased with age in both genders, with a peak at or above 85 years of age. The in-hospital mortality was 14%. CONCLUSIONS: Our results show that the incidence of stroke and TIA in Spain is moderate compared to other Western and European countries. However, it is expected that these figures will change due to progressively aging populations.

Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe Implementation of Treatments in Stroke (SITS) symptomatic intracerebral hemorrhage risk score.

BACKGROUND AND PURPOSE: Symptomatic intracerebral hemorrhage (SICH) is a serious complication in patients with acute ischemic stroke treated with intravenous thrombolysis. We aimed to develop a clinical score that can easily be applied to predict the risk of SICH. METHODS: We analyzed data from 31 627 patients treated with intravenous alteplase enrolled in the Safe Implementation of Treatments in Stroke (SITS) International Stroke Thrombolysis Register. The outcome measure was SICH per the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition: a Type 2 parenchymal hemorrhage with deterioration in National Institutes of Health Stroke Scale score of ≥ 4 points or death. Univariate risk factors associated with the outcome were entered into a logistic regression model after stratification of continuous variables. Adjusted ORs for the independent risk factors were converted into points, which were summated to produce a risk score. RESULTS: We identified 9 independent risk factors for SICH: baseline National Institutes of Health Stroke Scale, serum glucose, systolic blood pressure, age, body weight, stroke onset to treatment time, aspirin or combined aspirin and clopidogrel, and history of hypertension. The overall rate of SICH was 1.8%. The risk score ranged from 0 to 12 points and showed a >70-fold graded increase in the rate of SICH for patients with a score ≥ 10 points (14.3%) compared with a score of 0 point (0.2%). The prognostic discriminating capability by C statistic was 0.70. CONCLUSIONS: The SITS SICH risk score predicts large cerebral parenchymal hemorrhages associated with severe clinical deterioration. The score could aid clinicians to identify patients at high as well as low risk of SICH after intravenous alteplase.

Agreement between information provided by stroke patients and their relatives on psychophysical and vascular risk factors.

BACKGROUND: In studies examining vascular risk factors and the effects of stress in stroke patients, information sometimes has to be provided by a close relative. OBJECTIVES: The present study was designed to assess agreement between the information provided by a stroke patient and his/her next-of-kin or other close relative on prior vascular risk factors and situations of psychophysical stress based on a standardized interview within 72 h after stroke. DESIGN: Case-control observational study. PARTICIPANTS AND SETTINGS: All patients with incident stroke aged 18-65 years admitted to our centre were enrolled as cases, and their coinhabiting relatives as controls. The study was conducted from January to June 2008. METHODS: A structured questionnaire about vascular risk factors and psychophysical stress factors were obtained from the participants within 72 h after stroke. Subjects were required to grade themselves or their relatives using validated Spanish versions of the Life Events Stress Scale of Holmes and Rahe, Goldberg's General Health Questionnaire GHQ-28 and the SF-12 Health Survey, as well as the Spanish Type A Behaviour Scale. The questionnaires were self-administered. Cases and controls completed the same questionnaires and which were administered with a time difference of no longer than 24 h between the two groups of subjects. Risk factors were analyzed by determining kappa statistics and interclass correlation coefficients (ICC). Bland-Altman plots were used to examine the scores obtained in graded scales. RESULTS: 25 patients and 25 relatives were recruited. Agreement between cases and controls was good for reported atrial fibrillation, diabetes, alcohol consumption and smoking (range 0.83-1.0). ICC were low for the questionnaires Holmes-Rahe Life Events (0.26; 95%CI: 0.08-0.57), General Health GHQ-28 (0.39; 95%CI: 0.03-0.67) and SF12 Health Survey (0.52; 95%CI: 0.16-0.76 and 0.35; 95%CI: 0.06-0.66), and good for the Type A Behaviour Scale ERCTA (0.62; 95%CI: 0.32-0.81). CONCLUSIONS: The information obtained from family members on patient risk factors could be considered reliable, while that related to psychophysical aspects was not sufficiently reliable for research purposes. Agreement assessments could be useful to avoid misclassification biases.

Thrombolysis in very elderly people: controlled comparison of SITS International Stroke Thrombolysis Registry and Virtual International Stroke Trials Archive.

OBJECTIVE: To assess effect of age on response to alteplase in acute ischaemic stroke. DESIGN: Adjusted controlled comparison of outcomes between non-randomised patients who did or did not undergo thrombolysis. Analysis used Cochran-Mantel-Haenszel test and proportional odds logistic regression analysis. SETTING: Collaboration between International Stroke Thrombolysis Registry (SITS-ISTR) and Virtual International Stroke Trials Archive (VISTA). PARTICIPANTS: 23 334 patients from SITS-ISTR (December 2002 to November 2009) who underwent thrombolysis and 6166 from VISTA neuroprotection trials (1998-2007) who did not undergo thrombolysis (as controls). Of the 29 500 patients (3472 aged >80 ("elderly," mean 84.6), data on 272 patients were missing for baseline National Institutes of Health stroke severity score, leaving 29 228 patients for analysis adjusted for age and baseline severity. MAIN OUTCOME MEASURES: Functional outcomes at 90 days measured by score on modified Rankin scale. RESULTS: Median severity at baseline was the same for patients who underwent thrombolysis and controls (median baseline stroke scale score: 12 for each group, P=0.14; n=29 228). The distribution of scores on the modified Rankin scale was better among all thrombolysis patients than controls (odds ratio 1.6, 95% confidence interval 1.5 to 1.7; Cochran-Mantel-Haenszel P<0.001). The association occurred independently among patients aged ≤80 (1.6, 1.5 to 1.7; P<0.001; n=25 789) and in those aged >80 (1.4, 1.3 to 1.6; P<0.001; n=3439). Odds ratios were consistent across all 10 year age ranges above 30, and benefit was significant from age 41 to 90; dichotomised outcomes (score on modified Rankin scale 0-1 v 2-6; 0-2 v 3-6; and 6 (death) v rest) were consistent with the results of the ordinal analysis. CONCLUSIONS: Outcome in patients with acute ischaemic stroke is significantly better in those who undergo thrombolysis compared with those who do not. Increasing age is associated with poorer outcome but the association between thrombolysis treatment and improved outcome is maintained in very elderly people. Age alone should not be a barrier to treatment.

Mother tongue lost while second language intact: insights into aphasia.

Cortical representations of the native language and a second language may have different anatomical distribution. The relationships between the phonologic and orthographic forms of words continue to be debated. We present a bilingual patient whose competence in his mother tongue was disrupted following brain ischaemia. Semantic units were accessible only as isolated letters in written as well as oral language presentation. His second language appeared completely unaffected. Whole word system disturbance of both orthography and phonology pathways of the native language could explain this presentation. It is a great opportunity to learn about the language neural network when a bilingual subject presents with brain ischaemia.

Thrombolysis for ischaemic stroke and glioblastoma multiforme: a case report.

OBJECTIVE: To report the uncomplicated use of systemic thrombolysis for stroke in a patient with a misdiagnosed glioblastoma multiforme mimicking brain ischaemia and to suggest that new clinical situations question the stated exclusion criteria for intravenous thrombolysis. PATIENT: A 57-year-old male presented at the emergency room with a sudden aphasia. MEASUREMENT AND MAIN RESULTS: After Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) exclusion criteria were ruled out, intravenous alteplase was administered. The patient presented with tonic-clonic seizures 17 min after perfusion completion, requiring phenytoine administration. Additional computed tomography scan did not show haemorrhagic transformation or brain oedema. A left temporal lobe glioblastoma multiforme was diagnosed after magnetic resonance imaging and neurosurgery. The patient became asymptomatic on the seventh day. CONCLUSION: Any history of central nervous system neoplasm is considered a contraindication to thrombolysis, but the true risk of systemic thrombolysis-precipitated intracranial bleeding is unknown. Further data are needed to establish real haemorrhage risk in this clinical condition.

Benefits of modifying the predictive factors of stroke recurrence.

The risk of stroke recurrence is high. With annual rates of around 4%, accumulative rates of 40% are reached within 10 years. Despite being underestimated, the risk is highest in the early stages; around 12% in the first year. The most important etiological subtypes have different levels of risk; the highest being for atherothrombotic infarction and the lowest for lacunar infarction. Each etiology has its own risk factors. For example, in carotid stenosis, the grade of stenosis, ulceration, and plaque morphology, silent infarction on neuroimaging, coexistence of intracranial disease, or microemboli detected on transcranial Doppler, all have predictive value for stroke recurrence. There is a paucity of data on the risk factors for intracranial stenosis. In cardioembolism due to atrial fibrillation age, coexistence of hypertension or diabetes, and echocardiographic data predict recurrence. Risk factors for recurrence do not parallel those for first stroke. Diabetes is the most consistent risk factor for recurrence in different studies, while control of hypertension has been shown to be effective in the prevention of recurrences. Among the inflammatory markers, C-reactive protein is the most effective in prediction of recurrence. Elevated levels of homocysteine also predict recurrence, but attempts to improve risk by the modification of these levels have, to date, been unsuccessful. To be effective, the modification of predictive factors needs to be multifactorial and should be taken into account corresponding to each etiological type. More research is needed on biological markers to establish their clinical relevance and the benefit of targeting them for therapeutic modification.