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BACKGROUND: Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. METHODS: TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. FINDINGS: We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99]). INTERPRETATION: In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients. FUNDING: European Union Horizon 2020 Research and Innovation Programme.
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Procedimentos Endovasculares , AVC Isquêmico , Trombectomia , Humanos , Trombectomia/métodos , Masculino , Feminino , Procedimentos Endovasculares/métodos , Idoso , AVC Isquêmico/cirurgia , AVC Isquêmico/terapia , Pessoa de Meia-Idade , Resultado do Tratamento , Qualidade de Vida , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715. FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. FUNDING: EU Horizon 2020.
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Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/cirurgia , Estudos Prospectivos , Trombectomia/métodos , Hemorragias Intracranianas/etiologia , AVC Isquêmico/diagnóstico por imagem , AVC Isquêmico/cirurgia , Procedimentos Endovasculares/métodos , Infarto/complicações , Alberta , Resultado do TratamentoRESUMO
The present-day situation is associated with less optimistic economic development. At the turn of 2019/2020, the world was struck by a coronavirus pandemic that affected both the economy of the entire country represented mainly by industries and the social level of the population. More than ever, corporate management adhered to the established business rules which include certain fiscal policy rules. These fiscal rules are theoretically referred to as the Golden Rules of Fiscal Policy [1] [2] [3]. These Golden Rules of Fiscal Policy include 4 rules related to assets, sources of asset coverage, their longevity and the investment growth rate. The Golden Rules of Fiscal Policy apply in general to any business subject. However, this paper focuses solely on the construction industry. The aim of the paper is to find out, on a sample of construction companies operating in the Czech Republic, whether they comply with the Golden Rules of Fiscal Policy within their operation and compare these values to the national average. The sample of construction companies was chosen on the basis of carrying out the same activities, the same size in terms of the number of employees, amount of turnover and amount of assets, and operating in the same region of the Czech Republic. The national average of values under the Golden Rules of Fiscal Policy was determined from the statistical data published by the Ministry of Industry and Trade of the Czech Republic (MIT) on its website [4]. Methods of both vertical and horizontal analyses, which represent the basic methods of financial analysis, were used to determine the values of individual Golden Rules of Fiscal Policy for construction companies.
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Anterior circulation stroke (ACS) is associated with typical symptoms, while posterior circulation stroke (PCS) may cause a wide spectrum of less specific symptoms. We aim to assess the correlation between the initial presentation of acute ischemic stroke (AIS) symptoms and the treatment timeline. Using a retrospective, observational, single-center study, the set consists of 809 AIS patients treated with intravenous thrombolysis (IVT) and/or endovascular treatment (EVT). We investigate the impact of baseline clinical AIS symptoms and the affected vascular territory on recanalization times in patients treated with IVT only and EVT (±IVT). Regarding the IVT-only group, increasing the National Institutes of Health Stroke Scale (NIHSS) score on admission and speech difficulties are associated with shorter (by 1.59 ± 0.76 min per every one-point increase; p = 0.036, and by 24.56 ± 8.42 min; p = 0.004, respectively) and nausea/vomiting with longer (by 43.72 ± 13.13 min; p = 0.001) onset-to-needle times, and vertigo with longer (by 8.58 ± 3.84 min; p = 0.026) door-to-needle times (DNT). Regarding the EVT (±IVT) group, coma is associated with longer (by 22.68 ± 6.05 min; p = 0.0002) DNT, anterior circulation stroke with shorter (by 47.32 ± 16.89 min; p = 0.005) onset-to-groin time, and drooping of the mouth corner with shorter (by 20.79 ± 6.02 min; p = 0.0006) door-to-groin time. Our results demonstrate that treatment is initiated later in strokes with less specific symptoms than in strokes with typical symptoms.
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INTRODUCTION: Fusiform dilatation of the internal carotid artery (ICA) is reported as a possible complication of craniopharyngioma resection in childhood. Here, the authors describe such a complication in an adult patient who presented with acute symptomatic thrombosis 7 months after surgery. MATERIALS AND METHODS: A 45-year-old woman presented with left hemispheric stroke due to a thrombotic supraclinoid occlusion of the terminal ICA (so called "T" occlusion). Successful revascularisation was achieved with mechanical thrombectomy. Beside recanalization of the M1 middle cerebral artery segment and ICA, an irregular filling of the fusiform aneurysm of the communicating segment of the left ICA was observed. The patient recovered after mechanical thrombectomy with no clinical sequelae. Due to the persistent filling of the aneurysm sac, a flow diverter stent was deployed across the diseased vessel segment two weeks later. The patient underwent resection of the craniopharyngioma from ipsilateral pterional craniotomy 7 months ago. Five years later the patient works full time as a nurse with no regrowth of the craniopharyngioma and no aneurysm reperfusion. RESULTS: This case, together with four other previously reported cases, documents that fusiform aneurysm as a complication of the craniopharygioma resection is not restricted to the childhood population but may also rarely occur in adults. As the patient suffered from acute symptomatic thrombosis which required treatment under the protocol for acute large vessel occlusions, we decided to treat the aneurysm with the flow diverter stent.
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Aneurisma , Craniofaringioma , Procedimentos Endovasculares , Neoplasias Hipofisárias , Trombose , Adulto , Craniofaringioma/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasias Hipofisárias/diagnóstico por imagem , Neoplasias Hipofisárias/cirurgia , Stents , Trombectomia , Resultado do TratamentoRESUMO
BACKGROUND: The composition of intra-arterial clots might influence the efficacy of mechanical thrombectomy (MT) in ischemic stroke (IS) due to the acute occlusions within large cerebral arteries. The aims were to assess the factors associated with blood clot structure and the impact of thromboembolus structure on MT using stent-retrievers in patients with acute large artery IS in the anterior circulation.MethodsâandâResults:In an observational cohort study, we studied the components of intra-arterial clots retrieved from large cerebral arteries in 80 patients with acute IS treated with MT with or without i.v. thrombolysis (IVT). Histology of the clots was carried out without knowledge of the clinical findings, including the treatment methods. The components of the clots, their age, origin and semi-quantitative graded changes in the architecture of the fibrin components (e.g., "thinning") were compared via neuro-interventional, clinical and laboratory data. The most prominent changes in the architecture of the fibrin components in the thromboemboli were associated with IVT (applied in 44 patients; OR, 3.50; 95% CI: 1.21-10.10, P=0.02) and platelet count (OR, 2.94; 95% CI: 1.06-8.12, P=0.04). CONCLUSIONS: In patients with large artery IS treated with the MT using stent-retrievers, bridging therapy with IVT preceding MT and higher platelet count were associated with significant changes of the histological structure of blood clots.
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Fibrina/ultraestrutura , Acidente Vascular Cerebral/patologia , Trombose/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica , Estudos de Coortes , Feminino , Humanos , Masculino , Trombólise Mecânica , Pessoa de Meia-Idade , Contagem de Plaquetas , Stents , Acidente Vascular Cerebral/terapia , Adulto JovemRESUMO
PURPOSE: We aimed to assess the safety and effectiveness of mechanical recanalization in patients with ischemic stroke in the anterior circulation within 8 h since symptoms onset and with unknown onset time. We compared time intervals <6 h vs. 6-8 h/unknown onset time, as only limited data are available for a time window beyond 6 h. METHODS: Our cohort included 110 consecutive patients (44 males; mean age, 73.0±11.5 years) with ischemic stroke in the anterior circulation due to the acute occlusion of a large intracranial artery who underwent mechanical recanalization within an 8-hour time window or with unknown onset time. All patients underwent unenhanced computed tomography (CT) of the brain, CT angiography of the cervical and intracranial arteries and digital subtraction angiography. Perfusion CT was performed in patients beyond a 6-hour time window/with unknown onset time. We collected the following data: baseline characteristics, presence of risk factors, neurologic deficit at the time of treatment, time to therapy, recanalization rate, and 3-month clinical outcome. Successful recanalization was defined as Thrombolysis in Cerebral Infarction score of 2b/3 and good clinical outcome as modified Rankin scale value of 0-2 points. RESULTS: Successful recanalization was achieved in 82 patients (74.5%): in 61 patients treated within 6 h (73.5%), 7 patients treated within 6-8 h (63.6%), and 13 patients with unknown onset time (81.3%). Good 3-month clinical outcome was achieved in 61 patients (55.5%): in 46 patients treated within 6 h (55.4%), 5 patients treated within 6-8 h (45.5%), and 10 patients with unknown onset time (62.5%). Recanalization success or clinical outcome were not significantly different between patients treated at different time windows. CONCLUSION: Our data confirms the safety and effectiveness of mechanical recanalization performed in carefully selected patients with ischemic stroke in the anterior circulation within 8 h of stroke onset or with unknown onset time in everyday practice.
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Isquemia Encefálica/terapia , Trombólise Mecânica/métodos , Acidente Vascular Cerebral/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Angiografia Digital/métodos , Isquemia Encefálica/complicações , Isquemia Encefálica/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnóstico por imagem , Fatores de Tempo , Tomografia Computadorizada por Raios X/métodos , Resultado do TratamentoRESUMO
Mumps vaccines are live attenuated viruses. They are known to vary in effectiveness, degree of attenuation and adverse event profile. However, the underlying reasons are poorly understood. We studied two closely related mumps vaccines which originate from the same attenuated Jeryl Lynn-5 strain but have different efficacies. Jeryl Lynn-Canine Kidney (JL-CK), produced on primary canine kidney cells, is less effective than RIT4385, which is produced on chicken embryo fibroblasts. JL-CK and RIT4385 could be distinguished by a number of in vitro and in vivo properties. JL-CK produced heterogeneous, generally smaller plaques than RIT4385, but gave 100-fold higher titres when grown in cells and showed a higher degree of hydrocephalus formation in neonatal rat brains. Sanger sequencing of JL-CK identified 14 regions of heterogeneity throughout the genome. Plaque purification of JL-CK demonstrated the presence of five different Jeryl Lynn-5 variants encompassing the 14 mutations. One JL-CK mutation was associated with a small plaque phenotype, the effects of the others in vitro or in vivo were less clear. Only 4% of the JL-CK population corresponded to the parental Jeryl Lynn-5 strain. Next generation sequencing of JL-CK and virus before and after growth in cell lines or neonatal rat brains showed that propagation in vitro or in vivo altered the population dramatically. Our findings indicate that growth of JL-CK in primary canine kidney cells resulted in the selection of a mixture of mumps virus variants that have different biological properties compared to the parent Jeryl Lynn-5 virus. We also report three previously unknown heterogenic regions within the N gene of the RIT4385 vaccine.
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Vacina contra Caxumba/imunologia , Vírus da Caxumba/crescimento & desenvolvimento , Vírus da Caxumba/imunologia , Tecnologia Farmacêutica/métodos , Cultura de Vírus/métodos , Animais , Animais Recém-Nascidos , Células Cultivadas , Embrião de Galinha , Modelos Animais de Doenças , Células Epiteliais , Hidrocefalia/patologia , Hidrocefalia/virologia , Vacina contra Caxumba/administração & dosagem , Dinâmica Populacional , Ratos , Carga Viral , Ensaio de Placa Viral , VirulênciaRESUMO
Dissections of the carotid and vertebral arteries are the common cause of stroke in young and middle-aged people. The incidence and prevalence are difficult to define, because dissection may be asymptomatic and patients with mild symptoms may not undergo extensive investigation. Cervicocephalic artery dissections have a wide spectrum of precipitating factors, symptoms and signs. Authors report an unusual case of carotid artery dissection with favourable outcome.
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Dissecação da Artéria Carótida Interna/diagnóstico , Adulto , Humanos , MasculinoRESUMO
Endovascular surgery has dramatically changed the possibilities for treatment of occlusive arterial diseases. The first reports on balloon dilatation of internal carotid artery stenosis appeared 20 years ago. Between January 1997 and June 2002 37 patients were treated at our institution and 41 carotid angioplasties were performed. The first group includes the patients who were not indicated for conventional surgical treatment (vertebral artery 6 patients, intracranial stenosis of internal carotid artery 2 patients and one patient with stenosis of midle part of basilar artery). The second group were the patients with extracranial internal carotid stenosis combined with contralateral carotid occlusion (13 patients). The third group were the patients with restenosis following surgical carotid endarterectomy (11 patients). One patient had fibromuscular dysplastic stenosis. Seven patients were contraindicated for conventional surgical endarterectomy either for cardiopulmonary or other reasons. The result of the treatment by angioplasty was excellent because only three patients had restenosis (7,5%). Mortality rate in our set was 0. Nowadays it is too early to say if outcomes and safety of carotid angioplasty are comparable with surgical endarterectomy. For this reason it is necessary to have many randomized studies.