Predictors of bleeding and thrombotic events among patients admitted to the hospital with COVID-19 and elevated D-dimer: insights from the ACTION randomized clinical trial.

Therapeutic anticoagulation showed inconsistent results in hospitalized patients with COVID-19 and selection of the best patients to use this strategy still a challenge balancing the risk of thrombotic and hemorrhagic outcomes. The present post-hoc analysis of the ACTION trial evaluated the variables independently associated with both bleeding events (major bleeding or clinically relevant non-major bleeding) and the composite outcomes thrombotic events (venous thromboembolism, myocardial infarction, stroke, systemic embolism, or major adverse limb events). Variables were assessed one by one with independent logistic regressions and final models were chosen based on Akaike information criteria. The model for bleeding events showed an area under the curve of 0.63 (95% confidence interval [CI] 0.53 to 0.73), while the model for thrombotic events had an area under the curve of 0.72 (95% CI 0.65 to 0.79). Non-invasive respiratory support was associated with thrombotic but not bleeding events, while invasive ventilation was associated with both outcomes (Odds Ratio of 7.03 [95 CI% 1.95 to 25.18] for thrombotic and 3.14 [95% CI 1.11 to 8.84] for bleeding events). Beyond respiratory support, creatinine level (Odds Ratio [OR] 1.01 95% CI 1.00 to 1.02 for every 1.0 mg/dL) and history of coronary disease (OR 3.67; 95% CI 1.32 to 10.29) were also independently associated to the risk of thrombotic events. Non-invasive respiratory support, history of coronary disease, and creatinine level may help to identify hospitalized COVID-19 patients at higher risk of thrombotic complications.ClinicalTrials.gov: NCT04394377.

Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial.

Importance: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. Objective: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. Design, Setting, and Participants: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. Intervention: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. Main Outcomes and Measures: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. Results: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). Conclusions and Relevance: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT04062461.

In-Hospital Management and Long-term Clinical Outcomes and Adherence in Patients With Acute Decompensated Heart Failure: Primary Results of the First Brazilian Registry of Heart Failure (BREATHE).

BACKGROUND: Heart failure (HF), a common cause of hospitalization, is associated with poor short-term clinical outcomes. Little is known about the long-term prognoses of patients with HF in Latin America. METHODS: BREATHE was the first nationwide prospective observational study in Brazil that included patients hospitalized due to acute heart failure (HF). Patients were included during 2 time periods: February 2011-December 2012 and June 2016-July 2018 SUGGESTION FOR REPHRASING: In-hospital management, 12-month clinical outcomes and adherence to evidence-based therapies were evaluated. RESULTS: A total of 3013 patients were enrolled at 71 centers in Brazil. At hospital admission, 83.8% had clear signs of pulmonary congestion. The main cause of decompensation was poor adherence to HF medications (27.8%). Among patients with reduced ejection fraction, concomitant use of beta-blockers, renin-angiotensin-aldosterone inhibitors and spironolactone decreased from 44.5% at hospital discharge to 35.2% at 3 months. The cumulative incidence of mortality at 12 months was 27.7%, with 24.3% readmission at 90 days and 44.4% at 12 months. CONCLUSIONS: In this large national prospective registry of patients hospitalized with acute HF, rates of mortality and readmission were higher than those reported globally. Poor adherence to evidence-based therapies was common at hospital discharge and at 12 months of follow-up.

First Evaluation of the Brazilian Advanced Life Support Training (TECA A)

Abstract Background Cardiac arrest (CA) is a common condition associated with high mortality. The Brazilian advanced life support training TECA A (Treinamento em Emergências Cardiovasculares Avançado — Advanced Cardiovascular Emergency Training) was created to train healthcare professionals in the management of CA. However, there are no studies evaluating the effectiveness of TECA A. Objective To assess the impact of TECA A on the management of CA using a simulated CA situation. Methods Fifty-six students underwent a simulated case of CA in a manikin. The students' performance in the management of CA was assessed for the time to first chest compression and defibrillation and for a global assessment score using a structured tool. These items were assessed and compared before and after the TECA A. Exclusion criteria were previous participation in CA trainings and absence from class. Categorical variables were compared using the McNemar test and quantitative variables using the Wilcoxon test. All tests were two-tailed, and statistical significance was set at p < 0.05. Results Compared with before TECA A, median global assessment scores were higher after TECA A (pre-training: 4.0 points [2.0-5.0] vs. 10 points [9.0-10.0]; p<0.001), the time to start chest compressions was shorter (pre-training: 25 seconds [15-34] vs. 19 seconds [16.2-23.0]; p=0.002) and so was the time to defibrillation (pre-training: 82.5 seconds [65.0-108.0] vs. 48 seconds [39.0-53.0]; p<0.001). Conclusions The TECA A promoted a higher adherence to cardiopulmonary resuscitation (CPR) guidelines and a reduction in the time elapsed from CA to first chest compression and defibrillation.

Learning: New Strategy for Humanized Digital Medical Education and Training in Cardiology. / Virtual Case-Based Learning: Nova Estratégia de Ensino e de Treinamento Médico Digital Humanizado em Cardiologia.

BACKGROUND: The consolidation of new educational paradigms requires the implementation of innovative strategies to transform students into competent professionals. OBJECTIVES: To assess knowledge and satisfaction of medical students before and after the use of a new humanized digital model of active learning, called virtual case-based learning (VCBL). METHODS: This was a descriptive, documentary analysis of the teaching-learning process of medical students. Data obtained from theoretical knowledge assessment and satisfaction evaluation questionnaires applied in 2018 and 2019 were analyzed, and the new VCBL was compared with the traditional active methodology PBL (problem-based learning). Descriptive and association analyses were made using the Statistical Package for the Social Sciences. RESULTS: A total of 167 evaluation forms administered to medical students were analyzed. In the evaluation of theoretical knowledge, the 2018 and the 2019 student groups had a mean of 41.7% and 73.3%, respectively (p<0.001). Among the students who responded to the satisfaction evaluation form, 76.0% gave the highest rating to question one, and 83.0% to question two. Nearly 70.0% of students positively evaluated knowledge acquisition with the Paciente 360 platform; 78.0% reported to feel prepared for working in outpatient care; and 94.0% positively evaluated the new method. CONCLUSION: In this initial study, the results indicate that the new active method for humanized digital medical education, the VCBL, can help in the betterment of the teaching-learning process, promoting knowledge and satisfaction by the students.

FUNDAMENTO: A consolidação de novos paradigmas educacionais exige a implantação de estratégias inovadoras com potencial de transformar estudantes em profissionais competentes. OBJETIVOS: Analisar o conhecimento e a satisfação de estudantes antes e após a utilização de uma nova metodologia ativa de ensino médico de modelo digital humanizado chamada Virtual Case-Based Learning (VCBL). MÉTODOS: Estudo descritivo com análise documental sobre o processo de ensino-aprendizagem de estudantes de medicina. Dados obtidos da avaliação de conhecimento teórico e do instrumento de satisfação dos alunos nos anos de 2018 e 2019 foram analisados, e a nova metodologia proposta VCBL foi comparada com a metodologia ativa de ensino tradicional, o Problem-Based Learning (PBL). As análises descritivas e de associação foram realizadas utilizando o programa Statistical Package for the Social Sciences. RESULTADOS: Foram analisados 167 documentos aplicados a estudantes de medicina. Em relação à avaliação do conhecimento teórico, os alunos avaliados em 2018 obtiveram média 41,7%, comparados aos alunos de 2019 que alcançaram 73,3% (p<0,001). Entre os estudantes submetidos à avaliação da satisfação com a metodologia de aprendizagem proposta, 76,0% pontuaram o valor máximo para a questão um, e 83,0% para a questão número dois. Cerca de 70,0% dos estudantes classificaram positivamente o aprendizado adquirido após utilização da plataforma Paciente 360; 78,0% responderam que se sentem preparados para o atendimento ambulatorial; e 94,0% pontuaram de forma positiva a metodologia empregada. CONCLUSÃO: Neste estudo inicial, os resultados indicaram que a nova ferramenta em metodologia ativa de ensino médico digital humanizado, o VCBL, pode auxiliar no aprimoramento do processo de ensino-aprendizagem, proporcionando conhecimento e satisfação dos estudantes.

Virtual Case-Based Learning: Nova Estratégia de Ensino e de Treinamento Médico Digital Humanizado em Cardiologia / Learning: New Strategy for Humanized Digital Medical Education and Training in Cardiology

Resumo Fundamento A consolidação de novos paradigmas educacionais exige a implantação de estratégias inovadoras com potencial de transformar estudantes em profissionais competentes. Objetivos Analisar o conhecimento e a satisfação de estudantes antes e após a utilização de uma nova metodologia ativa de ensino médico de modelo digital humanizado chamada Virtual Case-Based Learning (VCBL). Métodos Estudo descritivo com análise documental sobre o processo de ensino-aprendizagem de estudantes de medicina. Dados obtidos da avaliação de conhecimento teórico e do instrumento de satisfação dos alunos nos anos de 2018 e 2019 foram analisados, e a nova metodologia proposta VCBL foi comparada com a metodologia ativa de ensino tradicional, o Problem-Based Learning (PBL). As análises descritivas e de associação foram realizadas utilizando o programa Statistical Package for the Social Sciences. Resultados Foram analisados 167 documentos aplicados a estudantes de medicina. Em relação à avaliação do conhecimento teórico, os alunos avaliados em 2018 obtiveram média 41,7%, comparados aos alunos de 2019 que alcançaram 73,3% (p<0,001). Entre os estudantes submetidos à avaliação da satisfação com a metodologia de aprendizagem proposta, 76,0% pontuaram o valor máximo para a questão um, e 83,0% para a questão número dois. Cerca de 70,0% dos estudantes classificaram positivamente o aprendizado adquirido após utilização da plataforma Paciente 360; 78,0% responderam que se sentem preparados para o atendimento ambulatorial; e 94,0% pontuaram de forma positiva a metodologia empregada. Conclusão Neste estudo inicial, os resultados indicaram que a nova ferramenta em metodologia ativa de ensino médico digital humanizado, o VCBL, pode auxiliar no aprimoramento do processo de ensino-aprendizagem, proporcionando conhecimento e satisfação dos estudantes.

Abstract Background The consolidation of new educational paradigms requires the implementation of innovative strategies to transform students into competent professionals. Objectives To assess knowledge and satisfaction of medical students before and after the use of a new humanized digital model of active learning, called virtual case-based learning (VCBL). Methods This was a descriptive, documentary analysis of the teaching-learning process of medical students. Data obtained from theoretical knowledge assessment and satisfaction evaluation questionnaires applied in 2018 and 2019 were analyzed, and the new VCBL was compared with the traditional active methodology PBL (problem-based learning). Descriptive and association analyses were made using the Statistical Package for the Social Sciences. Results A total of 167 evaluation forms administered to medical students were analyzed. In the evaluation of theoretical knowledge, the 2018 and the 2019 student groups had a mean of 41.7% and 73.3%, respectively (p<0.001). Among the students who responded to the satisfaction evaluation form, 76.0% gave the highest rating to question one, and 83.0% to question two. Nearly 70.0% of students positively evaluated knowledge acquisition with the Paciente 360 platform; 78.0% reported to feel prepared for working in outpatient care; and 94.0% positively evaluated the new method. Conclusion In this initial study, the results indicate that the new active method for humanized digital medical education, the VCBL, can help in the betterment of the teaching-learning process, promoting knowledge and satisfaction by the students.

Design of a multifaceted strategy based on automated text messaging in patients with recent heart failure admission.

AIMS: To evaluate a telemonitoring strategy based on automated text messaging and telephone support after heart failure (HF) hospitalization. METHODS AND RESULTS: The MESSAGE-HF study is a prospective multicentre, randomized, nationwide trial enrolling patients from 30 clinics in all regions of Brazil. HF patients with reduced left ventricular ejection fraction (<40%) and access to mobile phones are eligible after an acute decompensated HF hospitalization. Patients meeting eligibility criteria undergo an initial feasibility text messaging assessment and are randomized to usual care or telemonitoring intervention. All patients receive a HF booklet with basic information and recommendations about self-care. Patients in the intervention group receive four daily short text messages (educational and feedback) during the first 30 days of the protocol to optimize self-care; the feedback text messages from patients could trigger diuretic adjustments or a telephone call from the healthcare team. After 30 days, the frequency of text messages can be adjusted. Patients are followed up after 30, 90, and 180 days, with final status ascertained at 365 days by telephone. Our primary endpoint is the change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels after 180 days. Secondary endpoints include changes in NT-proBNP after 30 days; health-related quality of life, HF self-care, and knowledge scales after 30 and 180 days; and a composite outcome of HF hospitalization and cardiovascular death, adjudicated by a blinded and independent committee. CONCLUSIONS: The MESSAGE-HF trial is evaluating an educational and self-care promotion strategy involving a simple, intensive, and tailored telemonitoring system. If proven effective, it could be applied to a broader population worldwide.

Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial.

BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3-0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59-1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61-8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. FUNDING: Coalition COVID-19 Brazil, Bayer SA.

Avaliação dos 12 anos da campanha de acesso público a desfibrilação / Evaluation of ten years of the Campaign for public access defibrillation

JUSTIFICATIVA: Campanhas públicas e leis que visam desenvolver métodos de esclarecimento e incentivo na busca de informações sobre o tratamento da parada cardiorrespiratória devem ser objetivo de todos e implicam em excelentes resultados em todas as esferas de leigos, gestores e profissionais de saúde. OBJETIVO: Avaliar o impacto de uma Campanha de Acesso Público a Desfibrilação na população leiga, profissionais de saúde e gestores. MÉTODO: A pesquisa quantitativa foi desenvolvida após a avaliação de 12 anos das atividades efetuadas por uma Comissão de Ressuscitação Cardiopulmonar sobre a Campanha de Acesso Público a Desfibrilação voltada para as manobras de ressuscitação cardiopulmonar. RESULTADOS: Como principais resultados diretos e indiretos nos 12 anos de análise, promoveu-se a realização de cursos de suporte básico de vida para profissionais de saúde e leigos, cursos de suporte avançado de vida em cardiologia para profissionais de saúde, treinamento em massa para a população geral, implantação da temática no currículo da Faculdade de Medicina e a primeira lei de Acesso Público a Desfibrilação da América Latina, assim como o modelo para a lei federal que se encontra em tramitação. CONCLUSÕES: É evidente que mesmo com os resultados positivos ainda há necessidade real de maior número de profissionais e leigos treinados, assim como o amplo estabelecimento dos cinco elos atuais da corrente de sobrevivência em nosso território nacional, podendo outras campanhas, espelhadas nesta, serem implantadas.

BACKGROUND: Public campaigns and laws developing methods of enlightenment and encouragement in finding information on the treatment of cardiac arrest should be the objective of all and imply excellent results in all spheres of lay people, government managers and health professionals. OBJECTIVE: To evaluate the impact of a Public Access Defibrillation Campaign implementation in the lay population, health professionals and government managers. METHODS: The quantitative study was conducted after the 12 year review of the activities undertaken by a Hospital Committee of Cardiopulmonary Resuscitation and a Campaign for Public Access Defibrillation geared toward cardiopulmonary resuscitation. RESULTS: The main direct and indirect results in the 12 years of analysis promoted courses in basic life support for health professionals and lay public, courses of advanced cardiac life support for health professionals, mass training for general population, implementation of the thematic curriculum in the School of Medicine and the first law of Public Access Defibrillation in Latin America as well as the model for the federal law that steel in progress. CONCLUSIONS: It is clear that with the direct and indirect experiences of these 12 years of Public Access Defibrillation Campaign we shown positive results. There is real need for more professionals and trained lay people as well as the extensive establishment of five current links in the chain of survival in our Nationwide.