Qualidade de Vida Relacionada à Saúde e Desfechos em Longo Prazo após COVID-19 Sintomática Leve: Protocolo do Estudo Pós-COVID Brasil 2 / Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol

Resumo Fundamento Os efeitos em longo prazo da COVID-19 leve sobre a saúde física, mental e cognitiva ainda não são bem conhecidos. Objetivo Este artigo visa descrever o protocolo para o estudo em andamento Pós-COVID Brasil 2, o qual tem como objetivo avaliar os fatores associados à qualidade de vida associada à saúde e desfechos cardiovasculares e não cardiovasculares de longo prazo um ano após um episódio de COVID-19 sintomática leve. Métodos O estudo "Pós-COVID Brasil 2" é um estudo multicêntrico prospectivo que pretende incluir 1047 pacientes (NCT05197647). Entrevistas estruturas, centralizadas são conduzidas em um mês, e aos três, seis, nove e 12 meses após o diagnóstico de COVID-19. O desfecho primário é o escore de utilidade da qualidade de vida relacionada à saúde, avaliado usando o questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários incluem o EQ-5D-3L aos três, seis e nove meses, mortalidade por todas as causas, eventos cardiovasculares maiores, hospitalização, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático as três, seis, nove e doze meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. Resultados O desfecho primário será apresentado como frequência dos domínios do EQ-5D-3L doze meses após a infecção por SARS-CoV-2. A análise principal explorará a associação das variáveis independentes com os desfechos do estudo. Conclusão O estudo "Pós-COVID Brasil 2" tem como objetivo elucidar o impacto da COVID longa sobre a qualidade de vida e desfechos cardiovasculares e não cardiovasculares de brasileiros pacientes que apresentaram COVID-19 leve.

Abstract Background The long-term effects of mild COVID-19 on physical, cognitive, and mental health are not yet well understood. Objective The purpose of this paper is to describe the protocol for the ongoing "Post-COVID Brazil" study 2, which aims to evaluate the factors associated with health-related quality of life and long-term cardiovascular and non-cardiovascular outcomes one year after a mild episode of symptomatic COVID-19. Methods The "Post-COVID Brazil" study 2 is a prospective multicenter study that plans to enroll 1047 patients (NCT05197647). Centralized, structured telephone interviews are conducted at 1, 3, 6, 9, and 12 months after COVID-19 diagnosis. The primary outcome is the health-related quality-of-life utility score, assessed using the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints include the EQ-5D-3L at 3, 6, and 9 months, as well as all-cause mortality, major cardiovascular events, hospitalization, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value < 0.05 will be considered statistically significant for all analyses. Results The primary endpoint will be presented as the overall frequency of the EQ-5D-3L domains 12 months after SARS-CoV-2 infection. Main analysis will explore the association of independent variables with the study outcomes. Conclusion The "Post-COVID Brazil" study 2 aims to clarify the impact of long COVID on the quality of life and cardiovascular and non-cardiovascular outcomes of Brazilian patients who have had mild COVID-19.

Qualidade de Vida em Longo Prazo e Desfechos após Internação por COVID-19 no Brasil: Protocolo do Estudo Pós-COVID Brasil 1 / Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol

Resumo Fundamento O impacto em longo prazo da hospitalização por COVID-19 sobre a saúde física, mental e cognitiva dos pacientes requer mais investigação. Objetivos Este artigo visa avaliar os fatores associados com a qualidade de vida e desfechos cardiovasculares e não cardiovasculares 12 meses após a internação hospitalar por COVID-19. Métodos Este estudo multicêntrico prospectivo pretende incluir 611 pacientes internados por COVID-19 (NCT05165979). Entrevistas telefônicas centralizadas estão programadas para ocorrer em três, seis, nove e 12 meses após a alta hospitalar. O desfecho primário é definido como o escore de utilidade de qualidade de vida relacionada à saúde avaliada pelo questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários são definidos como o EQ-5D-3L aos três, seis e nove meses, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático, eventos cardiovasculares maiores, reinternação, e mortalidade por todas as causas aos três, seis, nove e 12 meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. Resultados O desfecho primário será apresentado como frequência do escore EQ-5D-3L 12 meses após a internação por COVID-19. Uma subanálise para identificar possíveis associações das variáveis independentes com desfechos do estudo será apresentada. Conclusão Este estudo determinará o impacto da COVID-19 sobre a qualidade de vida e de desfechos cardiovasculares e não cardiovasculares de pacientes internados 12 meses após a alta, e fornecerá novas informações ao sistema público de saúde no Brasil.

Abstract Background The long-term impact of hospitalization for COVID-19 on patients' physical, mental, and cognitive health still needs further assessment. Objectives This study aims to evaluate factors associated with quality of life and cardiovascular and non-cardiovascular outcomes 12 months after hospitalization for COVID-19. Methods This prospective multicenter study intends to enroll 611 patients hospitalized due to COVID-19 (NCT05165979). Centralized telephone interviews are scheduled to occur at three, six, nine, and 12 months after hospital discharge. The primary endpoint is defined as the health-related quality-of-life utility score assessed by the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints are defined as the EQ-5D-3L at three, six and nine months, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms, major cardiovascular events, rehospitalization, as well as all-cause mortality at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value <0.05 will be assumed as statistically significant for all analyses. Results The primary endpoint will be presented as the frequency of the EQ-5D-3L score 12 months after COVID-19 hospitalization. A sub-analysis to identify possible associations of independent variables with study outcomes will be presented. Conclusions This study will determine the impact of COVID-19 on the quality of life and cardiovascular and non-cardiovascular outcomes of hospitalized patients 12 months after discharge providing insights to the public health system in Brazil.

Heart Failure: An Overview of Morbidity and Mortality in Rio Grande do Sul

Abstract Background: Heart failure (HF) is the final pathway of most cardiac diseases. Although the prevalence of HF has increased, due to the ageing of the population, more comprehensive data have shown a reduction in the percentage of HF hospital admissions over the last years. Objective: Assess the morbidity and mortality of HF patients in Brazil, Rio Grande do Sul and Porto Alegre. Method: The study is a retrospective analysis of data from the Brazilian Unified Health System's (Sistema Único de Saúde [SUS]) Department of Informatics (DataSUS). We evaluated the incidence of HF hospital admissions, the average length of stay, hospital costs and sex ratio, during a ten-year period (2007 to 2016). Due to availability of the system, mortality rate and age range, the total duration of the study was nine years. Results: Within this period, the percentage of hospitalizations for HF decreased. On the other hand, the length of stay increased in all regions studied. Mortality rates were in decline in all regions. Hospital costs showed an increase of 110.8%. HF was more prevalent in patients between the seventh and eighth decades of life, with men being more affected than women, except in Rio Grande do Sul. Conclusion: We conclude that, in spite of the high costs of HF to healthcare providers, hospitalizations and mortality rates have shown a significant decline over the last years, which results from the advances in the treatment of this disease, through initiatives to improve patient education, engagement and planning in health care and self-care.

The five-point Likert scale for dyspnea can properly assess the degree of pulmonary congestion and predict adverse events in heart failure outpatients

OBJECTIVES: Proper assessment of dyspnea is important in patients with heart failure. Our aim was to evaluate the use of the 5-point Likert scale for dyspnea to assess the degree of pulmonary congestion and to determine the prognostic value of this scale for predicting adverse events in heart failure outpatients. METHODS: We undertook a prospective study of outpatients with moderate to severe heart failure. The 5-point Likert scale was applied during regular outpatient visits, along with clinical assessments. Lung ultrasound with ≥15 B-lines and an amino-terminal portion of pro-B-type natriuretic peptide (NT-proBNP) level >1000 pg/mL were used as a reference for pulmonary congestion. The patients were then assessed every 30 days during follow-up to identify adverse clinical outcomes. RESULTS: We included 58 patients (65.5% male, age 43.5±11 years) with a mean left ventricular ejection fraction of 27±6%. In total, 29.3% of these patients had heart failure with ischemic etiology. Additionally, pulmonary congestion, as diagnosed by lung ultrasound, was present in 58% of patients. A higher degree of dyspnea (3 or 4 points on the 5-point Likert scale) was significantly correlated with a higher number of B-lines (p = 0.016). Patients stratified into Likert = 3-4 were at increased risk of admission compared with those in class 1-2 after adjusting for age, left ventricular ejection fraction, New York Heart Association functional class and levels of NT-proBNP >1000 pg/mL (HR = 4.9, 95% CI 1.33-18.64, p = 0.017). CONCLUSION: In our series, higher baseline scores on the 5-point Likert scale were related to pulmonary congestion and were independently associated with adverse events during follow-up. This simple clinical tool can help to identify patients who are more likely to decompensate and whose treatment should be intensified. .

Intervenção coronária pelas vias radial ou femoral no infarto agudo do miocárdio com supradesnivelamento do segmento ST: um, a visão da prática clínica contemporânea / Coronary intevention by radial or femoral access in acute St-Segment elevation myocardial infarction: the real-world clinical practice

Introdução: A via radial é um acesso seguro para procedimentos percutâneos e reduz as complicações vasculares locais. Neste estudo comparou-se a evolução hospitalar de pacientes com infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCSST) submetidos a intervenção coronária percutânea primária (ICPp) por via radial vs. via femoral. Métodos: Estudo de coorte prospectivo com pacientes consecutivamente atendidos entre dezembro de 2009 e maio de 2011. Resultados: Foram incluídos 794 pacientes, 82 (10,3%) tratados por via radial e 712 (89,7%), por via femoral. Pacientes do grupo radial eram mais jovens (56,2 ± 10,7 anos vs. 61,2 ± 11,9 anos; P < 0,01), mais frequentemente do sexo masculino (78% vs. 68%; P = 0,06), com menor prevalência de diabetes (9,8% vs. 20%; P = 0,02) e maior fração de ejeção do ventrículo esquerdo (61,2 ± 11,8% vs. 55,5 ± 12,1%; P = 0,05). Não houve diferença em relação à maior parte das características angiográficas. Tromboaspiração (44% vs. 31%; P = 0,01) e administração de glicoproteína IIb/IIIa (41% vs. 26%; P = 0,004) foram mais utilizadas no grupo radial. O fluxo TIMI 3 final (93% vs. 88%; P = 0,47) e o blush miocárdico 3 (70% vs. 66%; P = 0,87) foram semelhantes entre os grupos. Não foram observadas diferenças em relação a óbito (7,5% vs. 8,4%; P = 0,78), reinfarto (4,9% vs. 4,4%; P = 0,77), revascularização de urgência (3,7% vs. 4,1%; P > 0,99), trombose do stent (2,4% vs. 3%; P > 0,99), sangramento maior (0 vs. 1,6%; P = 0,61) ou sangramento menor (5,3% vs. 7,3%; P = 0,81). Conclusões: A abordagem transradial mostrou-se segura e efetiva, com resultados semelhantes aos da abordagem transfemoral em pacientes com IAMCSST.

BACKGROUND: Radial access is a safe approach for percutaneous procedures and reduces local vascular complications. This study compared the hospital outcomes of patients with ST-elevation acute myocardial infarction (STEMI) submitted to primary percutaneous coronary intervention (pPCI) using the radial vs. femoral approaches. METHODS: Prospective cohort study with consecutive patients treated between December 2009 and May 2011. RESULTS: Seven hundred and ninety-four patients were included, 82 (10.3%) treated by radial access and 712 (89.7%) treated by femoral access. Radial access patients were younger (56.2 ± 10,7 years vs. 61,2 ± 11,9 years; P < 0.01), more often male (78% vs. 68%; P = 0.06), had a lower prevalence of diabetes (9.8% vs. 20%; P = 0.02) and higher left ventricle ejection fraction (61.2 ± 11.8% vs. 55.5 ± 12.1%; P = 0.05). There was no difference for most angiographic characteristics. Thromboaspiration (44% vs. 31%; P = 0.01) and glycoprotein IIb/IIIa administration (41% vs. 26%; P = 0.004) were used more often in the radial group. The final TIMI 3 flow (93% vs. 88%; P = 0.47) and myocardial blush grade 3 (70% vs. 66%; P = 0.87) were similar between groups. There were no differences for death (7.5% vs. 8.4%; P = 0.78), reinfarction (4.9% vs. 4.4%; P = 0.77), emergency revascularization (3.7% vs. 4.1%; P > 0.99), stent thrombosis (2.4% vs. 3%; P > 0.99), major bleeding (0 vs. 1.6%; P = 0.61) or minor bleeding (5.3% vs. 7.3%; P = 0.81) rates. CONCLUSIONS: The transradial approach has proven to be safe and effective with similar results to transfemoral approach in patients with STEMI.

Angioplastia primária no infarto agudo do miocárdio: existe diferença de resultados entre as angioplastias realizadas dentro e fora do horário de rotina? / Primary percutaneous coronary intervention in acute myocardial infarction: is there a difference in the outcomes of normal and off-hours procedures?

INTRODUÇÃO: Estudos demonstram que as angioplastias primárias realizadas fora do horário de rotina estão relacionadas a pior prognóstico. É objetivo deste estudo avaliar os desfechos das angioplastias primárias realizadas dentro e fora do horário de rotina de serviço de hemodinâmiva. Método: Estudo de coorte prospectivo, incluindo 112 pacientes consecutivamente atendidos por infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAM) entre dezembro de 2009 e janeiro de 2010. Características clínicas e angiográficas e evolução hospitalar foram registradas em banco de dados específicos. Houve dois grupos para comparação: grupo A, IAM tratado entre as 20 horas e as 8 horas e B, IAM tratado entre as 8 horas e as 20 horas. Resultados: A amostra inclui 44 pacientes no grupo A e 68 no grupo B. As características basais foram semelhantes em ambos os grupos. O tempo porta-balão foi significativamente maior no grupo A (133 minutos vs. 90 minutos; P < 0,001). No entanto, não houve diferença significante entre os grupos A e B...

BACKGROUND: Previous studies have reported that off-hours primary percutaneous coronary intervention is related to worse prognosis. The objective of this study is to evaluate the outcomes of normal and off-hours primary percutaneous coronary interventions. METHODS: A prospective observational study including 112 consecutive patients with ST elevation myocardial infarction (MI) was conducted from December 2009 to January 2010. Clinical and angiographic characteristics and in-hospital follow up were registered in a specific database. There were two groups for comparison: group A, MI treated between 8 pm and 8 am and group B, MI treated between 8 am and 8 pm. RESULTS: The sample included 44 patients in group A and 68 in group B. Baseline characteristics were similar in both groups. Door-to-balloon time was significantly longer in group A (133 minutes vs. 90 minutes; P < 0.001). However, there was no significant difference between groups A and B regarding mortality (13.7% vs. 5.9%; P = 0.28), reinfarction (6.8% vs. 4.4%; P = 0.90), progression to cardiogenic shock (11.4% vs. 4.4%; P = 0.30), stent thrombosis (6.8% vs. 1.5%; P = 0.33), or major bleeding (2.3% vs. 1.5%; P > 0.99). The only predictor of combined in-hospital outcome was heart rate at admission (odds ratio 1.02; P < 0.001). CONCLUSIONS: Patients with MI have similar in-hospital clinical outcomes during normal and off-hours primary percutaneous coronary intervention. However, door-to-balloon time is significantly longer during off-hours procedures.