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1.
BMJ Open ; 12(6): e059311, 2022 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-35654463

RESUMO

OBJECTIVES: To investigate effects of appropriately and inappropriately dosed apixaban/rivaroxaban versus warfarin on effectiveness and safety outcomes in patients with non-valvular atrial fibrillation (NVAF). DESIGN: Cohort study with nested case-control analyses using primary care electronic health records (IQVIA Medical Research Data UK database). SETTING: UK primary care. PARTICIPANTS: Patients aged ≥18 years with NVAF newly prescribed apixaban (N=14 701), rivaroxaban (N=14 288) or warfarin (N=16 175) between 1 January 2012 and 30 June 2018, and followed up to 31 December 2018. PRIMARY AND SECONDARY OUTCOME MEASURES: Incident cases of ischaemic stroke/systemic embolism (IS/SE) and intracranial bleeding (ICB). Cases were matched to controls on age, sex and OAC naïve status. Using logistic regression, adjusted ORs with 95% CIs were calculated for the outcomes comparing apixaban/rivaroxaban use (appropriate or inappropriate dosing based on the product label criteria) and warfarin. RESULTS: For IS/SE, ORs (95% CIs) for apixaban versus warfarin were 1.19 (0.92-1.52) for appropriate dose and 1.01 (0.67-1.51) for inappropriate dose; for rivaroxaban versus warfarin, estimates were 1.07 (0.83-1.37) for appropriate dose and 1.21 (0.78-1.88) for inappropriate dose. For ICB, ORs (95% CIs) for apixaban versus warfarin were 0.67 (0.44-1.00) for appropriate dose and 0.45 (0.21-0.95) for inappropriate dose; for rivaroxaban versus warfarin, estimates were 0.81 (0.55-1.20) for appropriate dose and 1.14 (0.56-2.31) for inappropriate dose. CONCLUSIONS: Dosing appropriateness in NVAF was not associated with a significant difference in IS/SE risk or increase in ICB risk versus warfarin. These findings may reflect residual confounding and biases that were difficult to control, as also seen in other observational studies. They should, therefore, be interpreted with caution, and prescribers should adhere to the dosing instructions in the respective Summary of Product Characteristics. Further studies on this topic from real-world populations are needed.


Assuntos
Anticoagulantes , Fibrilação Atrial , Adolescente , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Estudos de Casos e Controles , Estudos de Coortes , Embolia/epidemiologia , Humanos , Hemorragias Intracranianas/epidemiologia , AVC Isquêmico/epidemiologia , Atenção Primária à Saúde , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Rivaroxabana/efeitos adversos , Reino Unido/epidemiologia , Varfarina/efeitos adversos
2.
J Stroke Cerebrovasc Dis ; 31(7): 106507, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35490471

RESUMO

OBJECTIVES: The purpose of this study is to investigate the relationship between the timing of starting direct oral anticoagulants (DOACs) and subsequent clinical outcomes in patients with hemorrhagic transformation (HT) after endovascular treatment (EVT). MATERIALS AND METHODS: The subjects were patients with acute cardioembolic stroke who underwent EVT and received DOACs in our department from February 2017 to August 2021. Based on CT at 24 h after EVT, the patients were classified using European Collaborative Acute Stroke Study criteria into three groups: no HT, hemorrhagic infarction (HI), and parenchymal hematoma (PH). Outcomes were assessed for incidence of recurrent ischemic stroke (RIS), new intracranial hemorrhage (ICH), and worsened HT associated with DOACs. RESULTS: Of 111 patients, 29 (26.1%) had HT, including 16 (14.4%) with HI and 13 (11.7%) with PH. The start of DOACs was significantly delayed in the PH group (no HT: 1.0 (1.0-3.0) days vs. HI: 3.0 (2.0-5.0) days vs. PH: 7.0 (7.0-10.0) days, P < 0.01). The incidence of RIS did not differ significantly among the three groups, but tended to be higher in the PH group (no HT: 3.7% vs. HI: 6.3% vs. PH: 15.4%, p = 0.12). There were no cases of new symptomatic ICH. New asymptomatic ICH occurred in 2 cases in the no HT group. Worsened HT after initiation of DOACs did not occur in the HI or PH group. CONCLUSIONS: The timing of starting DOACs in patients with HT after EVT may be divided by subtypes of HI and PH. In patients with HI, early initiation of DOACs can prevent RIS and is unlikely to cause new ICH or worsened HI. In PH, initiation of DOACs within 14 days appears to be safe and does not exacerbate PH. The later the start of DOACs, the higher the frequency of RIS, so early initiation of DOACs is desirable.


Assuntos
Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Anticoagulantes/efeitos adversos , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/terapia , Hematoma/complicações , Hemorragia/complicações , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/diagnóstico por imagem , Hemorragias Intracranianas/epidemiologia , AVC Isquêmico/diagnóstico por imagem , AVC Isquêmico/terapia , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/terapia
3.
Crit Care ; 26(1): 83, 2022 03 28.
Artigo em Inglês | MEDLINE | ID: mdl-35346314

RESUMO

BACKGROUND: In severe cases, SARS-CoV-2 infection leads to acute respiratory distress syndrome (ARDS), often treated by extracorporeal membrane oxygenation (ECMO). During ECMO therapy, anticoagulation is crucial to prevent device-associated thrombosis and device failure, however, it is associated with bleeding complications. In COVID-19, additional pathologies, such as endotheliitis, may further increase the risk of bleeding complications. To assess the frequency of bleeding events, we analyzed data from the German COVID-19 autopsy registry (DeRegCOVID). METHODS: The electronic registry uses a web-based electronic case report form. In November 2021, the registry included N = 1129 confirmed COVID-19 autopsy cases, with data on 63 ECMO autopsy cases and 1066 non-ECMO autopsy cases, contributed from 29 German sites. FINDINGS: The registry data showed that ECMO was used in younger male patients and bleeding events occurred much more frequently in ECMO cases compared to non-ECMO cases (56% and 9%, respectively). Similarly, intracranial bleeding (ICB) was documented in 21% of ECMO cases and 3% of non-ECMO cases and was classified as the immediate or underlying cause of death in 78% of ECMO cases and 37% of non-ECMO cases. In ECMO cases, the three most common immediate causes of death were multi-organ failure, ARDS and ICB, and in non-ECMO cases ARDS, multi-organ failure and pulmonary bacterial ± fungal superinfection, ordered by descending frequency. INTERPRETATION: Our study suggests the potential value of autopsies and a joint interdisciplinary multicenter (national) approach in addressing fatal complications in COVID-19.


Assuntos
COVID-19 , Oxigenação por Membrana Extracorpórea , Síndrome do Desconforto Respiratório , Insuficiência Respiratória , COVID-19/complicações , COVID-19/terapia , Oxigenação por Membrana Extracorpórea/efeitos adversos , Humanos , Hemorragias Intracranianas/complicações , Hemorragias Intracranianas/epidemiologia , Masculino , Síndrome do Desconforto Respiratório/terapia , Insuficiência Respiratória/etiologia , Insuficiência Respiratória/terapia , SARS-CoV-2
4.
ESC Heart Fail ; 9(3): 1931-1941, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35338605

RESUMO

AIMS: Left ventricular assist devices (LVADs) have reduced the mortality of patients with advanced heart failure both as bridge-to-transplant and as destination therapy. However, LVADs are associated with various complications, including bleedings, which affect the prognosis. The aim of the study was to explore the prevalence, management, and outcomes of haemorrhagic adverse events in LVAD recipients. METHODS AND RESULTS: We conducted a retrospective, single-centre, cohort study including all patients who received an LVAD from January 2008 to December 2019 in our tertiary centre (Rangueil University Hospital, Toulouse, France). Bleeding events, death, and heart transplantation were collected from electronic medical files. Eighty-eight patients were included, and 43 (49%) presented at least one bleeding event. Gastrointestinal (GI) bleeding was the most frequent (n = 21, 24%), followed by epistaxis (n = 12, 14%) and intracranial haemorrhage (n = 9, 10%). Bleeding events were associated with increased mortality [hazard ratio (HR) 3.8, 95% confidence interval (CI) 1.5-9.3, P < 0.01], particularly in case of intracranial haemorrhage (HR 14.6, 95% CI 4.2-51.1, P < 0.0001). GI bleedings were associated with a trend towards increased mortality (HR 3.0, 95% CI 0.9-9.3, P = 0.05). Each bleeding episode multiplied the risk of death by 1.8 (95% CI 1.2-2.7, P < 0.01). Finally, only early bleedings (<9 months post-implantation) had an impact on mortality (HR 4.2, 95% CI 1.6-11.1, P < 0.01). Therapeutic management was mainly based on temporary interruption of anticoagulation and permanent interruption of antiplatelet therapy. Invasive management was rarely performed. CONCLUSIONS: Haemorrhagic events in LVAD recipients are frequent and associated with increased mortality. GI bleedings are the most frequent, and intracranial haemorrhages the most associated with mortality. Management remains empirical requiring more research.


Assuntos
Coração Auxiliar , Estudos de Coortes , Coração Auxiliar/efeitos adversos , Hemorragia/epidemiologia , Hemorragia/etiologia , Humanos , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/etiologia , Prevalência , Estudos Retrospectivos
5.
J Am Heart Assoc ; 11(6): e022849, 2022 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-35243876

RESUMO

Background To investigate the effectiveness and safety of withholding or restarting antithrombotic agents, and different antithrombotic therapies among patients with atrial fibrillation post-intracranial hemorrhage. Methods and Results This is a nationwide retrospective cohort study involving patients with atrial fibrillation receiving antithrombotic therapies who subsequently developed intracranial hemorrhage between January 1, 2011 and December 31, 2017. The risk of ischemic stroke (IS), recurrent intracerebral hemorrhage (ICH), and all-cause mortality were investigated between patients receiving no treatment versus patients reinitiating oral anticoagulants (OACs) or antiplatelet agents, and warfarin versus non-vitamin K antagonist OACs. We applied inverse probability of treatment weighting to balance the baseline characteristics and Cox proportional hazards model to estimate the hazard ratios (HRs) of different outcomes of interest. Compared with no treatment, OACs reduced the risk of IS (HR, 0.61; 0.42-0.89), without increase in the risk of ICH (1.15, 0.66-2.02); antiplatelet agent users showed a similar risk of IS (1.13, 0.81-1.56) and increased risk of ICH (1.81, 1.07-3.04). Use of OACs or antiplatelet agents did not reduce the risk of all-cause mortality (0.85, 0.72-1.01; and 0.88, 0.75-1.03, respectively). Compared with warfarin, non-vitamin K antagonist OAC users showed a similar risk of IS (0.92, 0.50-1.70), non-significantly reduced risk of ICH (0.53, 0.22-1.30), and significantly reduced all-cause mortality (0.60, 0.43-0.84). Conclusions OACs are recommended in patients with atrial fibrillation and intracranial hemorrhage because they reduced the risk of IS with no increase in the risk of subsequent ICH. Non-vitamin K antagonist OACs are recommended over warfarin owing to their survival benefits.


Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Hemorragia Cerebral/induzido quimicamente , Hemorragia Cerebral/epidemiologia , Fibrinolíticos/efeitos adversos , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/complicações , Hemorragias Intracranianas/epidemiologia , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversos
6.
Drug Saf ; 45(4): 379-388, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35305263

RESUMO

INTRODUCTION: In Denmark, physicians are legally obliged to report serious adverse drug reactions (ADRs), such as intracranial hemorrhage (ICH) following anticoagulant (AC) treatment, to the Danish Medicines Agency. We were therefore puzzled to discover a high number of reports concerning ICHs following treatment with the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban, and apixaban compared with warfarin. This was surprising, as all DOACs have been found to be associated with a lower risk of ICH compared with warfarin in phase III randomized controlled trials. OBJECTIVES: The primary aim of the study was to estimate the level of underreporting of ICH as an ADR following treatment with warfarin, dabigatran, rivaroxaban, and apixaban. METHODS: This observational study covered a 5-year period (2014-2018). Using nationwide registries held by the Danish Health Data Authority, the number of users, exposure time in person-years, and related ICH events for each of the study drugs were estimated. Data on ADR-ICH reports were extracted from the interactive ADR overviews held by the Danish Medicines Agency. RESULTS: From 2014 to 2018, 97.0% of the identified warfarin-related ICH events were not reported as ADRs. For the DOACs, the level of underreporting ranged from 88.8 to 90.8%. CONCLUSION: We found a heavy and differentiated level of underreporting of ICH as an ADR following treatment with the four study drugs.


Assuntos
Fibrilação Atrial , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Anticoagulantes , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/efeitos adversos , Dinamarca/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/complicações , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Piridonas , Rivaroxabana/efeitos adversos , Varfarina
8.
Eur Heart J Acute Cardiovasc Care ; 11(4): 303-311, 2022 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-35213724

RESUMO

AIMS: Intracranial haemorrhage (ICH) is one of the most serious complications of adult patients treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO) and is associated with increased morbidity and mortality. However, the prevalence and risk factors of ICH in this cohort are still insufficiently understood. We hypothesized that a considerable proportion of patients undergoing VA-ECMO support suffer from ICH and that specific risk factors are associated with the occurrence of ICH. Therefore, the purpose of this study was to further investigate the prevalence and associated mortality as well as to identify risk factors for ICH in VA-ECMO patients. METHODS AND RESULTS: We conducted a retrospective multicentre study including adult patients (≥18 years) treated with VA-ECMO in cardiac intensive care units (ICUs) at five German clinical sites between January 2016 and March 2020, excluding patients with ICH upon admission. Differences in baseline characteristics and clinical outcome between VA-ECMO patients with and without ICH were analysed and risk factors for ICH were identified. Among the 598 patients included, 70/598 (12%) developed ICH during VA-ECMO treatment. In-hospital mortality in patients with ICH was 57/70 (81%) and 1-month mortality 60/70 (86%), compared to 332/528 (63%) (P = 0.002) and 340/528 (64%) (P < 0.001), respectively, in patients without ICH. Intracranial haemorrhage was positively associated with diabetes mellitus [odds ratio (OR) 2, 95% confidence interval (CI) 1.11-3.56; P = 0.020] and lactate (per mmol/L) (OR 1.06, 95% CI 1.01-1.11; P = 0.020), and negatively associated with platelet count (per 100 G/L) (OR 0.32, 95% CI 0.15-0.59; P = 0.001) and fibrinogen (per 100 mg/dL) (OR 0.64, 95% CI 0.49-0.83; P < 0.001). CONCLUSION: Intracranial haemorrhage was associated with a significantly higher mortality rate. Diabetes mellitus and lactate were positively, platelet count, and fibrinogen level negatively associated with the occurrence of ICH. Thus, platelet count and fibrinogen level were revealed as potentially modifiable, independent risk factors for ICH. The findings address an area with limited data, provide information about risk factors and the epidemiology of ICH, and may be a starting point for further investigations to develop effective strategies to prevent and treat ICH.


Assuntos
Oxigenação por Membrana Extracorpórea , Adulto , Oxigenação por Membrana Extracorpórea/métodos , Fibrinogênio , Humanos , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/etiologia , Lactatos , Estudos Retrospectivos , Choque Cardiogênico/etiologia
9.
CMAJ ; 194(1): E1-E12, 2022 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-35012946

RESUMO

BACKGROUND: Operative vaginal delivery (OVD) is considered safe if carried out by trained personnel. However, opportunities for training in OVD have declined and, given these shifts in practice, the safety of OVD is unknown. We estimated incidence rates of trauma following OVD in Canada, and quantified variation in trauma rates by instrument, region, level of obstetric care and institutional OVD volume. METHODS: We conducted a cohort study of all singleton, term deliveries in Canada between April 2013 and March 2019, excluding Quebec. Our main outcome measures were maternal trauma (e.g., obstetric anal sphincter injury, high vaginal lacerations) and neonatal trauma (e.g., subgaleal hemorrhage, brachial plexus injury). We calculated adjusted and stabilized rates of trauma using mixed-effects logistic regression. RESULTS: Of 1 326 191 deliveries, 38 500 (2.9%) were attempted forceps deliveries and 110 987 (8.4%) were attempted vacuum deliveries. The maternal trauma rate following forceps delivery was 25.3% (95% confidence interval [CI] 24.8%-25.7%) and the neonatal trauma rate was 9.6 (95% CI 8.6-10.6) per 1000 live births. Maternal and neonatal trauma rates following vacuum delivery were 13.2% (95% CI 13.0%-13.4%) and 9.6 (95% CI 9.0-10.2) per 1000 live births, respectively. Maternal trauma rates remained higher with forceps than with vacuum after adjustment for confounders (adjusted rate ratio 1.70, 95% CI 1.65-1.75) and varied by region, but not by level of obstetric care. INTERPRETATION: In Canada, rates of trauma following OVD are higher than previously reported, irrespective of region, level of obstetric care and volume of OVD among hospitals. These results support a reassessment of OVD safety in Canada.


Assuntos
Traumatismos do Nascimento/epidemiologia , Complicações do Trabalho de Parto/epidemiologia , Forceps Obstétrico/efeitos adversos , Vácuo-Extração/efeitos adversos , Canal Anal/lesões , Traumatismos do Nascimento/etiologia , Canadá/epidemiologia , Feminino , Humanos , Incidência , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/etiologia , Lacerações/epidemiologia , Lacerações/etiologia , Paralisia do Plexo Braquial Neonatal/epidemiologia , Paralisia do Plexo Braquial Neonatal/etiologia , Complicações do Trabalho de Parto/etiologia , Pelve/lesões , Gravidez , Fraturas Cranianas/epidemiologia , Fraturas Cranianas/etiologia , Traumatismos do Sistema Nervoso/epidemiologia , Traumatismos do Sistema Nervoso/etiologia , Uretra/lesões , Bexiga Urinária/lesões , Vagina/lesões
10.
JAMA ; 327(3): 248-263, 2022 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-35040888

RESUMO

IMPORTANCE: Despite improvement during recent decades, extremely preterm infants continue to contribute disproportionately to neonatal mortality and childhood morbidity. OBJECTIVE: To review survival, in-hospital morbidities, care practices, and neurodevelopmental and functional outcomes at 22-26 months' corrected age for extremely preterm infants. DESIGN, SETTING, AND PARTICIPANTS: Prospective registry for extremely preterm infants born at 19 US academic centers that are part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. The study included 10 877 infants born at 22-28 weeks' gestational age between January 1, 2013, and December 31, 2018, including 2566 infants born before 27 weeks between January 1, 2013, and December 31, 2016, who completed follow-up assessments at 22-26 months' corrected age. The last assessment was completed on August 13, 2019. Outcomes were compared with a similar cohort of infants born in 2008-2012 adjusting for gestational age. EXPOSURES: Extremely preterm birth. MAIN OUTCOMES AND MEASURES: Survival and 12 in-hospital morbidities were assessed, including necrotizing enterocolitis, infection, intracranial hemorrhage, retinopathy of prematurity, and bronchopulmonary dysplasia. Infants were assessed at 22-26 months' corrected age for 12 health and functional outcomes, including neurodevelopment, cerebral palsy, vision, hearing, rehospitalizations, and need for assistive devices. RESULTS: The 10 877 infants were 49.0% female and 51.0% male; 78.3% (8495/10848) survived to discharge, an increase from 76.0% in 2008-2012 (adjusted difference, 2.0%; 95% CI, 1.0%-2.9%). Survival to discharge was 10.9% (60/549) for live-born infants at 22 weeks and 94.0% (2267/2412) at 28 weeks. Survival among actively treated infants was 30.0% (60/200) at 22 weeks and 55.8% (535/958) at 23 weeks. All in-hospital morbidities were more likely among infants born at earlier gestational ages. Overall, 8.9% (890/9956) of infants had necrotizing enterocolitis, 2.4% (238/9957) had early-onset infection, 19.9% (1911/9610) had late-onset infection, 14.3% (1386/9705) had severe intracranial hemorrhage, 12.8% (1099/8585) had severe retinopathy of prematurity, and 8.0% (666/8305) had severe bronchopulmonary dysplasia. Among 2930 surviving infants with gestational ages of 22-26 weeks eligible for follow-up, 2566 (87.6%) were examined. By 2-year follow-up, 8.4% (214/2555) of children had moderate to severe cerebral palsy, 1.5% (38/2555) had bilateral blindness, 2.5% (64/2527) required hearing aids or cochlear implants, 49.9% (1277/2561) had been rehospitalized, and 15.4% (393/2560) required mobility aids or other supportive devices. Among 2458 fully evaluated infants, 48.7% (1198/2458) had no or mild neurodevelopmental impairment at follow-up, 29.3% (709/2419) had moderate neurodevelopmental impairment, and 21.2% (512/2419) had severe neurodevelopmental impairment. CONCLUSIONS AND RELEVANCE: Among extremely preterm infants born in 2013-2018 and treated at 19 US academic medical centers, 78.3% survived to discharge, a significantly higher rate than for infants born in 2008-2012. Among infants born at less than 27 weeks' gestational age, rehospitalization and neurodevelopmental impairment were common at 2 years of age.


Assuntos
Lactente Extremamente Prematuro , Doenças do Prematuro , Nascimento Prematuro , Displasia Broncopulmonar/epidemiologia , Paralisia Cerebral/epidemiologia , Pré-Escolar , Enterocolite Necrosante/epidemiologia , Feminino , Idade Gestacional , Mortalidade Hospitalar , Humanos , Lactente , Mortalidade Infantil , Recém-Nascido , Doenças do Prematuro/epidemiologia , Doenças do Prematuro/terapia , Hemorragias Intracranianas/epidemiologia , Masculino , Morbidade , Nascimento Prematuro/epidemiologia , Retinopatia da Prematuridade/epidemiologia , Estados Unidos/epidemiologia
11.
Crit Care Med ; 50(6): e526-e538, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35020672

RESUMO

OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) is a potentially lifesaving procedure in acute respiratory distress syndrome (ARDS) due to COVID-19. Previous studies have shown a high prevalence of clinically silent cerebral microbleeds in patients with COVID-19. Based on this fact, together with the hemotrauma and the requirement of therapeutic anticoagulation on ECMO support, we hypothesized an increased risk of intracranial hemorrhages (ICHs). We analyzed ICH occurrence rate, circumstances and clinical outcome in patients that received ECMO support due to COVID-19-induced ARDS in comparison to viral non-COVID-19-induced ARDS intracerebral hemorrhage. DESIGN: Multicenter, retrospective analysis between January 2010 and May 2021. SETTING: Three tertiary care ECMO centers in Germany and Switzerland. PATIENTS: Two-hundred ten ARDS patients on ECMO support (COVID-19, n = 142 vs viral non-COVID, n = 68). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Evaluation of ICH occurrence rate, parameters of coagulation and anticoagulation strategies, inflammation, and ICU survival. COVID-19 and non-COVID-19 ARDS patients showed comparable disease severity regarding Sequential Organ Failure Assessment score, while the oxygenation index before ECMO cannulation was higher in the COVID group (82 vs 65 mm Hg). Overall, ICH of any severity occurred in 29 of 142 COVID-19 patients (20%) versus four of 68 patients in the control ECMO group (6%). Fifteen of those 29 ICH events in the COVID-19 group were classified as major (52%) including nine fatal cases (9/29, 31%). In the control group, there was only one major ICH event (1/4, 25%). The adjusted subhazard ratio for the occurrence of an ICH in the COVID-19 group was 5.82 (97.5% CI, 1.9-17.8; p = 0.002). The overall ICU mortality in the presence of ICH of any severity was 88%. CONCLUSIONS: This retrospective multicenter analysis showed a six-fold increased adjusted risk for ICH and a 3.5-fold increased incidence of ICH in COVID-19 patients on ECMO. Prospective studies are needed to confirm this observation and to determine whether the bleeding risk can be reduced by adjusting anticoagulation strategies.


Assuntos
COVID-19 , Oxigenação por Membrana Extracorpórea , Síndrome do Desconforto Respiratório , Anticoagulantes/uso terapêutico , COVID-19/complicações , COVID-19/terapia , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Humanos , Hemorragias Intracranianas/tratamento farmacológico , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/etiologia , Síndrome do Desconforto Respiratório/epidemiologia , Síndrome do Desconforto Respiratório/terapia , Estudos Retrospectivos
12.
BMC Neurol ; 22(1): 6, 2022 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-34980004

RESUMO

BACKGROUND AND PURPOSE: This study assessed the predictive factors for symptomatic intracranial hemorrhage (sICH) in patients with acute ischemic stroke (AIS) after receiving intravenous thrombolysis (IVT) within 6 h in northern China. METHODS: We retrospectively analyzed ischemic stroke patients who were treated with IVT between November 2016 and December 2018 in 19 hospitals in Shandong Province, China. Potential predictors of sICH were investigated using univariate and multivariate analyses. RESULTS: Of the 1293 enrolled patients (845 men, aged 62 ± 11 years), 33 (2.6%) developed sICH. The patients with sICH had increased coronary heart disease (36.4% vs. 13.7%, P = 0.001), more severe stroke (mean National Institutes of Health Stroke Scale [NIHSS] score on admission of 14 vs.7, P < 0.001), longer door-to-needle time [DNT] (66 min vs. 50 min, P < 0.001), higher blood glucose on admission, higher white blood cell counts (9000/mm3 vs. 7950/mm3, P = 0.004) and higher neutrophils ratios (73.4% vs. 67.2%, P = 0.006) et al. According to the results of multivariate analysis, the frequency of sICH was independently associated with the NIHSS score (OR = 3.38; 95%CI [1.50-7.63]; P = 0.003), DNT (OR = 4.52; 95%CI [1.69-12.12]; P = 0.003), and white blood cell count (OR = 3.59; 95%CI [1.50-8.61]; P = 0.004). When these three predictive factors were aggregated, compared with participants without any factors, the multi-adjusted odds ratios (95% confidence intervals) of sICH for persons concurrently having one, two or three of these factors were 2.28 (0.25-20.74), 15.37 (1.96-120.90) and 29.05 (3.13-270.11), respectively (P for linear trend < 0.001), compared with participants without any factors. CONCLUSION: NIHSS scores higher than 10 on admission, a DNT > 50 min, and a white blood cell count ≥9000/mm3 were independent risk factors for sICH in Chinese patients within 6 h after IVT for AIS.


Assuntos
Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Isquemia Encefálica/complicações , Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/epidemiologia , China/epidemiologia , Fibrinolíticos/uso terapêutico , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Masculino , Estudos Retrospectivos , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/epidemiologia , Terapia Trombolítica/efeitos adversos , Ativador de Plasminogênio Tecidual/uso terapêutico , Resultado do Tratamento
13.
J Am Heart Assoc ; 11(3): e023032, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35048714

RESUMO

Background Insufficient evidence is available for patients with acute ischemic stroke with atrial fibrillation (AF) to determine the efficacy and safety of different dosages of intravenous thrombolysis treatment. This study examined clinical outcomes in Chinese patients with stroke with and without AF after intravenous thrombolysis treatment with different intravenous thrombolysis doses. Methods and Results This multicenter, prospective cohort study recruited 2351 patients with acute ischemic stroke (1371 with AF and 980 without AF) treated with intravenous thrombolysis using alteplase. The Totaled Health Risks in Vascular Events score is a validated risk-scoring tool used for assessing patients with acute ischemic stroke with and without AF. We evaluated favorable functional outcome at day 90 and symptomatic intracranial hemorrhage within 24 to 36 hours and outcomes of the patients receiving different doses of alteplase. Compared with the non-AF group, the AF group exhibited a 2- to 3-fold increased risk of symptomatic intracranial hemorrhage according to the National Institute of Neurological Disorders and Stroke standard (relative risk [RR], 2.10 [95% CI, 1.35-3.26]). Favorable functional outcome at 90 days and symptomatic intracranial hemorrhage rates according to the European Cooperative Acute Stroke Study II and the Safe Implementation of Thrombolysis in Stroke-Monitoring Study standards did not significantly differ between the AF and non-AF groups. In addition, the low-dose alteplase subgroup exhibited an increased risk of symptomatic intracranial hemorrhage according to the National Institute of Neurological Disorders and Stroke standard (RR, 2.84 [95% CI, 1.63-4.96]). A validation study confirmed these findings after adjustment for scores determined using different stroke risk-scoring tools. Conclusions Different alteplase dosages did not affect functional status at 90 days in the AF and non-AF groups. Thus, the adoption of low-dose alteplase simply because of AF is not recommended.


Assuntos
Fibrilação Atrial , Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Isquemia Encefálica/etiologia , Fibrinolíticos , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , AVC Isquêmico/diagnóstico , AVC Isquêmico/tratamento farmacológico , AVC Isquêmico/epidemiologia , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/etiologia , Taiwan/epidemiologia , Terapia Trombolítica/efeitos adversos , Ativador de Plasminogênio Tecidual , Resultado do Tratamento
14.
Am J Emerg Med ; 53: 185-189, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35063890

RESUMO

BACKGROUND: Repeat head CT in patients on direct oral anticoagulant therapy (DOACs) with minor traumatic brain injury (MTBI) after an initial CT scan without injury on arrival in the Emergency Department (ED) is a common clinical practice but is not based on clear evidence. AIM: To assess the incidence of delayed intracranial haemorrhage (ICH) in patients taking DOACs after an initial negative CT and the association of clinical and risk factors presented on patient arrival in the ED. METHODS: This retrospective multicentre observational study considered patients taking DOACs undergoing repeat CT after a first CT free of injury for the exclusion of delayed ICH after MTBI. Timing between trauma and first CT in the ED and pre- or post-trauma risk factors were analysed to assess a possible association with the risk of delayed ICH. RESULTS: A total of 1426 patients taking DOACs were evaluated in the ED for an MTBI. Of these, 68.3% (916/1426) underwent a repeat CT after an initial negative CT and 24 h of observation, with a rate of delayed ICH of 1.5% (14/916). Risk factors associated with the presence of a delayed ICH were post-traumatic loss of consciousness, post-traumatic amnesia and the presence of a risk factor when the patient presented to the ED within 8 h of the trauma. None of the patients with delayed ICH at 24-h repeat CT required neurosurgery or died within 30 days. CONCLUSIONS: Delayed ICH is an uncommon event at the 24-h control CT and does not affect patient outcome. Studying the timing and characteristics of the trauma may indicate patients who may benefit from more in-depth management.


Assuntos
Concussão Encefálica , Lesões Encefálicas Traumáticas , Anticoagulantes/efeitos adversos , Concussão Encefálica/complicações , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/diagnóstico por imagem , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/diagnóstico por imagem , Hemorragias Intracranianas/epidemiologia , Estudos Retrospectivos , Tomografia Computadorizada por Raios X/efeitos adversos
15.
Blood Adv ; 6(5): 1559-1565, 2022 03 08.
Artigo em Inglês | MEDLINE | ID: mdl-35086145

RESUMO

Although intracranial hemorrhage (ICH) is frequent in the setting of brain metastases, there are limited data on the influence of antiplatelet agents on the development of brain tumor-associated ICH. To evaluate whether the administration of antiplatelet agents increases the risk of ICH, we performed a matched cohort analysis of patients with metastatic brain tumors with blinded radiology review. The study population included 392 patients with metastatic brain tumors (134 received antiplatelet agents and 258 acted as controls). Non-small cell lung cancer was the most common malignancy in the cohort (74.0%), followed by small cell lung cancer (9.9%), melanoma (4.6%), and renal cell cancer (4.3%). Among those who received an antiplatelet agent, 86.6% received aspirin alone and 23.1% received therapeutic anticoagulation during the study period. The cumulative incidence of any ICH at 1 year was 19.3% (95% CI, 14.1-24.4) in patients not receiving antiplatelet agents compared with 22.5% (95% CI, 15.2-29.8; P = .22, Gray test) in those receiving antiplatelet agents. The cumulative incidence of major ICH was 5.4% (95% CI, 2.6-8.3) among controls compared with 5.5% (95% CI, 1.5-9.5; P = .80) in those exposed to antiplatelet agents. The combination of anticoagulation plus antiplatelet agents did not increase the risk of major ICH. The use of antiplatelet agents was not associated with an increase in the incidence, size, or severity of ICH in the setting of brain metastases.


Assuntos
Neoplasias Encefálicas , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Anticoagulantes/uso terapêutico , Neoplasias Encefálicas/complicações , Neoplasias Encefálicas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/induzido quimicamente , Carcinoma Pulmonar de Células não Pequenas/complicações , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Neoplasias Pulmonares/complicações , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Retrospectivos
16.
Stroke ; 53(5): 1674-1681, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-34872341

RESUMO

BACKGROUND: Prior studies have investigated the clinical and imaging factors for hemorrhagic transformation (HT), especially symptomatic intracranial hemorrhage (sICH); however, whether alteplase increases the risk of HT after endovascular thrombectomy (EVT) is unknown. This study aimed to assess clinical and imaging features associated with HT, sICH, and parenchymal hematoma (PH) in patients with acute ischemic stroke after EVT, with and without intravenous alteplase in DIRECT-MT (Direct Intraarterial Thrombectomy to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals: a Multicenter Randomized Clinical Trial). METHODS: The DIRECT-MT trial is a randomized trial of EVT alone versus intravenous thrombolysis combined with EVT. HT, sICH, and PH was evaluated on follow-up computed tomography. Multivariable ordinal logistic regression analysis was used to test the association of stepwise selected determinants with HT, sICH, and PH. RESULTS: In total, 633 patients were analyzed; 261 (41.2%) had HT; 34 (5.4%) had sICH; and 85 (13.4%) had PH. The median age was 69, and 56.7% were men. The median National Institutes of Health Stroke Scale score was 18, and 320 patients were in combination-therapy group. Symptomatic intracranial hemorrhage was associated with higher baseline National Institutes of Health Stroke Scale score (adjusted odds ratio [OR], 1.06 [95% CI, 1.10-1.12]) and higher glucose level at hospital arrival (adjusted OR, 1.14 [95% CI, 1.00-1.29]). No association was found between alteplase treatment and HT, sICH, or PH. The independent predictor of sICH was higher baseline National Institutes of Health Stroke Scale score (adjusted OR, 1.09 [95% CI, 1.01-1.18]) in EVT alone group, and history of anticoagulant drugs (adjusted OR, 3.75 [95% CI, 1.07-13.06]), higher glucose level at hospital arrival (adjusted OR, 1.19 [95% CI, 1.03-1.38]), >3 passes of device (adjusted OR, 4.42 [95% CI, 1.36-14.32]) in combination-therapy group. CONCLUSIONS: In DIRECT-MT, independent predictors of sICH were baseline National Institutes of Health Stroke Scale score and glucose level at hospital arrival. Alteplase treatment did not increase the risk of HT, sICH, or PH after EVT. The independent predictor of sICH was different in EVT alone group and combination-therapy group. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03469206.


Assuntos
AVC Isquêmico , Acidente Vascular Cerebral , Feminino , Glucose/uso terapêutico , Humanos , Hemorragias Intracranianas/diagnóstico por imagem , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/etiologia , Masculino , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/cirurgia , Trombectomia/efeitos adversos , Ativador de Plasminogênio Tecidual , Estados Unidos
17.
J Stroke Cerebrovasc Dis ; 31(1): 106211, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34823092

RESUMO

OBJECTIVES: Cerebral microbleeds (CMBs), which can be detected by gradient-echo T2*-weighted magnetic resonance imaging (MRI), represent small chronic brain hemorrhages caused by structural abnormalities in cerebral small vessels. CMBs are known to be a potential predictor of future stroke, and are associated with age, various cardiovascular risk factors, cognitive impairment, and the use of antithrombotic drugs. Patients with coronary artery disease (CAD) are at potentially high risk of CMBs due to the presence of coexistent conditions. However, little is known about CMBs in patients with CAD. We aimed to identify the factors associated with the presence of CMBs among patients with CAD. METHODS: We evaluated 356 consecutive patients [mean age, 72 ± 10 years; men = 276 (78%)] with angiographically proven CAD who underwent T2*-weighted brain MRI. The brain MRI was assessed by researchers blinded to the patients' clinical details. RESULTS: CMBs were found in 128 (36%) patients. Among 356 patients, 119 (33%) had previously undergone percutaneous coronary intervention (PCI), and 26 (7%) coronary artery bypass grafting (CABG). There was no significant relationship between CMBs and sex, hypertension, dyslipidemia, diabetes mellitus, anticoagulation therapy, antiplatelet therapy, or prior PCI. CMBs were significantly associated with advanced age, previous CABG, eGFR, non-HDL cholesterol, carotid artery disease, long-term antiplatelet therapy, and long-term dual antiplatelet therapy (DAPT) using univariate logistic regression analysis. The multivariate logistic regression analysis showed that long-term antiplatelet therapy (odds ratio, 1.73; 95% CI, 1.06 - 2.84; P = 0.03) or long-term DAPT (odds ratio, 2.92; 95% CI, 1.39 - 6.17; P = 0.004) was significantly associated with CMBs after adjustment for confounding variables. CONCLUSIONS: CMBs were frequently observed in patients with CAD and were significantly associated with long-term antiplatelet therapy, especially long-term DAPT.


Assuntos
Hemorragia Cerebral/epidemiologia , Doença da Artéria Coronariana/complicações , Hemorragias Intracranianas/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Hemorragia Cerebral/diagnóstico por imagem , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Feminino , Humanos , Hemorragias Intracranianas/diagnóstico por imagem , Japão/epidemiologia , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/efeitos adversos , Prevalência , Fatores de Risco
18.
Am J Cardiol ; 162: 92-99, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34756593

RESUMO

Patients with atrial fibrillation (AF) who take direct oral anticoagulants (DOACs) face the risk of intracranial hemorrhage (ICH), which can be serious and even life threatening, but the risk of ICH of anticoagulants is still controversial. In this meta-analysis, we compared the risk of ICH between vitamin K antagonists (VKAs) and DOACs. Furthermore, we also compared the risk of ICH in different DOACs. PubMed, Embase, Web of Science, and the Cochrane Library were searched for relevant randomized controlled trials. The outcome was ICH, shown as the odds ratio (OR) with a 95% confidence interval (CI). DOACs were ranked by calculating the surface under the cumulative ranking curve (SUCRA). We included a total of 82,404 patients with AF. DOACs reduced the ICH risk by nearly half compared with VKAs (OR 0.47, 95% CI 0.40 to 0.54, p <0.001). VKAs were the least safe among all oral anticoagulants (SUCRA 1.7). Dabigatran 110 mg was the safest DOAC (SUCRA 87.3) for ICH risk, whereas rivaroxaban 20 mg was a relatively unsafe DOAC (SUCRA 27.5). Compared with rivaroxaban 20 mg, dabigatran 110 mg presented 53% (OR 0.47, 95% CI 0.27 to 0.82) lower relative risk for ICH. In conclusion, DOACs present less ICH risk than VKAs in patients with AF. For patients with AF who are at high risk of ICH, dabigatran 110 mg may be the safest choice among the DOACs.


Assuntos
Fibrilação Atrial/complicações , Inibidores do Fator Xa/uso terapêutico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Humanos , Metanálise em Rede , Acidente Vascular Cerebral/etiologia , Vitamina K/antagonistas & inibidores
19.
Acta Neurochir (Wien) ; 164(1): 97-105, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34850288

RESUMO

BACKGROUND: Mild traumatic brain injury (TBI) in anticoagulated patients is a common challenge for emergency departments because of lack of appropriate epidemiological data and huge management variability for those under oral anticoagulation therapy. Given the discrepancies between guidelines, the aim of the present study was to quantify the association between oral anticoagulant therapy (either vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC)) and the post-traumatic intracranial hemorrhage worsening compared to admission CT scan. METHODS: We included all consecutive records of patients admitted to our emergency department for mild TBI as chief complaint and with a positive admission CT scan. After statistical univariate comparison, cause-specific hazard ratio (HR) and 95% confidence interval (CI) were determined with the use of Cox proportional hazard model. RESULTS: In the study period, 4667 patients had a CT scan for mild TBI; 439 (9.4%) were found to have intracranial hemorrhage. Among these patients, 299 (68.1%) were prescribed observation and control CT: 46 (15.38%) were on anticoagulant therapy, 23 (50%) on VKA, and 23 (50%) on DOAC. In multivariate analysis, only oral anticoagulation therapy was significantly associated to an increased risk of intracranial hemorrhage progression (HR 2.58; 95% CI 1.411-4.703; p = .002 and HR 1.9; 95% CI 1.004-3.735; p = .0048 for VKA and DOAC, respectively). Surgery was due to isolated subdural hematoma in 87.5% of cases, to subdural hematoma associated with intraparenchymal hemorrhage in 9.38% and to intraparenchymal hemorrhage only in 3.12%; 13 cases (4.35%) deceased in intensive care unit. CONCLUSIONS: In our series, anticoagulation was associated to a significant increase in intracranial progression, leaving the question open as to what this implies in current clinical practice; subdural hematoma was the major finding associated to evolution and surgery. Against this background, further studies are needed to clarify patients' management and DOAC safety profile compared to VKA in mild TBI.


Assuntos
Concussão Encefálica , Administração Oral , Anticoagulantes/efeitos adversos , Concussão Encefálica/epidemiologia , Humanos , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/epidemiologia , Fatores de Risco , Vitamina K
20.
Am J Surg ; 223(1): 146-150, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34340862

RESUMO

BACKGROUND: Enoxaparin is the recommended agent for deep vein thrombosis (DVT) chemoprophylaxis in trauma patients. Current literature suggests weight-based dosing is superior to standard dosing for adequate chemoprophylaxis. Literature regarding the use of weight-based enoxaparin in the setting of traumatic brain injury (TBI) however is limited. METHODS: A retrospective analysis of adult trauma patients admitted between January 1, 2018 to February 28, 2019 was performed. Sixty-six patients with TBI receiving weight-based enoxaparin met inclusion criteria. Incidence of intracranial hemorrhage (ICH) expansion was the primary endpoint. Newly diagnosed venous thromboembolism (VTE) and death were secondary endpoints. RESULTS: Two patients, out of sixty-six, had progression of their TBI requiring surgical intervention. Newly diagnosed VTE occurred in one patient. No deaths were due to ICH expansion or VTE. CONCLUSIONS: Use of weight-based enoxaparin dosing in the setting of TBI shows promise without an increased incidence of ICH expansion when compared to other studies. Level of Evidence and Study Type: Level IV, Therapeutic.


Assuntos
Anticoagulantes/administração & dosagem , Lesões Encefálicas Traumáticas/complicações , Enoxaparina/administração & dosagem , Hemorragias Intracranianas/epidemiologia , Trombose Venosa/prevenção & controle , Adulto , Idoso , Anticoagulantes/efeitos adversos , Peso Corporal , Lesões Encefálicas Traumáticas/sangue , Lesões Encefálicas Traumáticas/tratamento farmacológico , Cálculos da Dosagem de Medicamento , Enoxaparina/efeitos adversos , Feminino , Humanos , Incidência , Hemorragias Intracranianas/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Trombose Venosa/epidemiologia , Trombose Venosa/etiologia
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