In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial.

BACKGROUND: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain. METHODS: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization). RESULTS: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed. CONCLUSION: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization.

Cardiovascular Statistics ­ Brazil 2023 / Estatística Cardiovascular ­ Brasil 2023

The publication Cardiovascular Statistics ­ Brazil aims to provide an annual compilation of data and research on the epidemiology of CVDs in Brazil.  The report integrates official statistics from the Brazilian Ministry of Health and other governmental entities alongside data from the GBD project, coordinated by the IHME at the University of Washington. Additionally, it incorporates data derived from various sources and scientific studies, including cohorts and registries, that relate to CVDs and their associated risk factors. This publication is intended for a wide range of individuals, including researchers, clinicians, patients, healthcare policymakers, media professionals, the general public, and other interested parties seeking extensive national data about heart disease and stroke.  Volunteer researchers from various Brazilian universities and research institutions carry out the project. The group is led by a five-member steering committee (ALPR, CAP, DCM, GMMO, and LCCB). The Brazilian Society of Cardiology fully supports this initiative, and the project receives collaborative support from the GBD Brazil Network and an International Committee (GAR, PP, and TAG) from both the IHME/University of Washington (GAR) and the World Heart Federation (PP and TAG). 

A publicação Estatística Cardiovascular ­ Brasil tem por objetivo fornecer uma compilação anual dos dados e das pesquisas sobre a epidemiologia das DCV no Brasil.  Este documento integra as estatísticas oficiais do Ministério da Saúde do Brasil e outras entidades governamentais ao lado de dados do projeto GBD, coordenado pelo IHME da Universidade de Washington. Além disso, incorpora dados derivados de várias fontes e estudos científicos, inclusive coortes e registros, relacionados às DCV e fatores de risco associados. Esta publicação destina-se a um público variado, incluindo pesquisadores, clínicos, pacientes, formuladores de políticas de saúde, profissionais da mídia, o público em geral e todos aqueles que buscam dados nacionais abrangentes sobre DCV e acidente vascular cerebral. Pesquisadores voluntários de várias universidades e instituições de pesquisa brasileiros realizaram este projeto. O grupo é liderado por um comitê diretivo com cinco membros (ALPR, CAP, DCM, GMMO e LCCB). A Sociedade Brasileira de Cardiologia apoia integralmente esta iniciativa e o projeto recebe colaboração da Rede GBD Brasil1 e do GBD International Committee (GAR, PP e TAG) do IHME/Universidade de Washington (GAR) e da World Heart Federation (PP e TAG). 

Redesign of radiotherapy for prostate cancer: a proposal for universal healthcare systems.

Aim: This study was designed to recommend strategies to improve prostate patients' access to radiotherapy treatment in the Brazilian Unified Health System, along with a cost-tool to support radiotherapy care pathways' lead times and costs. Methods: Data was collected prospectively from patients with prostate cancer receiving radiotherapy in two Brazilian centers to provide data to apply design thinking and process reengineering techniques. The current status of the radiotherapy pathway was determined and the length of time taken for in-hospital activities was measured using data exported from ARIA®. Interviews with patients were used to estimate their waiting periods. This provided the data used to provide recommended strategies and the cost tool based on time-driven activity-based costing. The strategies were classified according to priority. Results: Data from 47 patients were analyzed. The mean interval from diagnosis to start of radiotherapy was 349 days (SD581), and the mean interval from seeking medical attention to starting treatment was 635 days (SD629). Twelve strategies affecting in-hospital processes and 11 impacting patients' care pathways and experiences are recommended, mostly focused on system improvement opportunities. A time-driven activity-based costing monitoring using data extracted from ARIA was coded and can be used by centers as a cost assessment guide. Conclusion: This study uses reengineering and design techniques to introduce priority strategies to allow more efficient and patient-centered radiotherapy.

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

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.

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.

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

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.

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.

Real-Life Data on Hydroxychloroquine or Chloroquine with or Without Azithromycin in COVID-19 Patients: A Retrospective Analysis in Brazil. / Dados de Vida Real sobre o Uso da Hidroxicloroquina ou da Cloroquina Combinadas ou Não à Azitromicina em Pacientes com Covid-19: Uma Análise Retrospectiva no Brasil.

BACKGROUND: Despite no evidence showing benefits of hydroxychloroquine and chloroquine with or without azithromycin for COVID-19 treatment, these medications have been largely prescribed in Brazil. OBJECTIVES: To assess outcomes, including in-hospital mortality, electrocardiographic abnormalities, hospital length-of-stay, admission to the intensive care unit, and need for dialysis and mechanical ventilation, in hospitalized COVID-19 patients who received chloroquine or hydroxychloroquine, and to compare outcomes between those patients and their matched controls. METHODS: A retrospective multicenter cohort study that included consecutive laboratory-confirmed COVID-19 patients from 37 Brazilian hospitals from March to September 2020. Propensity score was used to select matching controls by age, sex, cardiovascular comorbidities, and in-hospital use of corticosteroid. A p-value <0.05 was considered statistically significant. RESULTS: From 7,850 COVID-19 patients, 673 (8.6%) received hydroxychloroquine and 67 (0.9%) chloroquine. The median age in the study group was 60 years (46 - 71) and 59.1% were women. During hospitalization, 3.2% of patients presented side effects and 2.2% required therapy discontinuation. Electrocardiographic abnormalities were more prevalent in the chloroquine/hydroxychloroquine group (13.2% vs. 8.2%, p=0.01), and the long corrected QT interval was the main difference (3.6% vs. 0.4%, p<0.001). The median hospital length of stay was longer in the HCQ/CQ + AZT group than in controls (9.0 [5.0, 18.0] vs. 8.0 [4.0, 14.0] days). There was no statistical differences between groups in intensive care unit admission (35.1% vs. 32.0%; p=0.282), invasive mechanical ventilation support (27.0% vs. 22.3%; p=0.074) or mortality (18.9% vs. 18.0%; p=0.682). CONCLUSION: COVID-19 patients treated with chloroquine or hydroxychloroquine had a longer hospital length of stay, when compared to matched controls. Intensive care unit admission, invasive mechanical ventilation, dialysis and in-hospital mortality were similar.

FUNDAMENTO: Apesar da ausência de evidência mostrando benefícios da hidroxicloroquina e da cloroquina combinadas ou não à azitromicina no tratamento da covid-19, esses medicamentos têm sido amplamente prescritos no Brasil. OBJETIVOS: Avaliar desfechos, incluindo moralidade hospitalar, alterações eletrocardiográficas, tempo de internação, admissão na unidade de terapia intensiva, e necessidade de diálise e de ventilação mecânica em pacientes hospitalizados com covid-19 que receberam cloroquina ou hidroxicloroquina, e comparar os desfechos entre aqueles pacientes e seus controles pareados. MÉTODOS: Estudo multicêntrico retrospectivo do tipo coorte que incluiu pacientes com diagnóstico laboratorial de covid-19 de 37 hospitais no Brasil de março a setembro de 2020. Escore de propensão foi usado para selecionar controles pareados quanto a idade, sexo, comorbidades cardiovasculares, e uso de corticosteroides durante a internação. Um valor de p<0,05 foi considerado estatisticamente significativo. RESULTADOS: Dos 7850 pacientes com covid-19, 673 (8,6%) receberam hidroxicloroquina e 67 (0,9%) cloroquina. A idade mediana no grupo de estudo foi 60 (46-71) anos e 59,1% eram mulheres. Durante a internação, 3,2% dos pacientes apresentaram efeitos adversos e 2,2% necessitaram de interromper o tratamento. Alterações eletrocardiográficas foram mais prevalentes no grupo hidroxicloroquina/cloroquina (13,2% vs. 8,2%, p=0,01), e o prolongamento do intervalo QT corrigido foi a principal diferença (3,6% vs. 0,4%, p<0,001). O tempo mediano de internação hospitalar foi maior no grupo usando CQ/HCQ em relação aos controles (9,0 [5,0-18,0] vs. 8,0 [4,0-14,0] dias). Não houve diferenças estatisticamente significativas entre os grupos quanto a admissão na unidade de terapia intensiva (35,1% vs. 32,0%; p=0,282), ventilação mecânica invasiva (27,0% vs. 22,3%; p=0,074) ou mortalidade (18,9% vs. 18,0%; p=0,682). CONCLUSÃO: Pacientes com covid-19 tratados com cloroquina ou hidroxicloroquina apresentaram maior tempo de internação hospitalar, em comparação aos controles. Não houve diferença em relação a admissão em unidade de terapia intensiva, necessidade de ventilação mecânica e mortalidade hospitalar.

Variation in Ischemic Stroke Payments in the USA: A Medicare Beneficiary Study.

INTRODUCTION: The growing cost of stroke care has created the need for outcome-oriented and cost-saving payment models. Identifying imbalances in the current reimbursement model is an essential step toward designing impactful value-based reimbursement strategies. This study describes the variation in reimbursement fees for ischemic stroke management across the USA. METHODS: This Medicare Fee-For-Service claims study examines USA beneficiaries who suffered an ischemic stroke from 2021Q1 to 2022Q2 identified using the Medicare-Severity Diagnosis-Related Groups (MS-DRGs). Demographic national and regional US data were extracted from the Census Bureau. The MS-DRG codes were grouped into four categories according to treatment modality and clinical complexity. Our primary outcome of interest was payments made across individual USA and US geographic regions, assessed by computing the mean incremental payment in cases of comparable complexity. Differences between states for each MS-DRG were statistically evaluated using a linear regression model of the logarithmic transformed payments. RESULTS: 227,273 ischemic stroke cases were included in our analysis. Significant variations were observed among all DRGs defined by medical complexity, treatment modality, and states (p < 0.001). Differences in mean payment per case with the same MS-DRG vary by as high as 500% among individual states. Although higher payment rates were observed in MS-DRG codes with major comorbidities or complexity (MCC), the variation was more expressive for codes without MCC. It was not possible to identify a standard mean incremental fee at a state level. At a regional level, the Northeast registered the highest fees, followed by the West, Midwest, and South, which correlate with poverty rates and median household income in the regions. CONCLUSIONS: The payment variability observed across USA suggests that the current reimbursement system needs to be aligned with stroke treatment costs. Future studies may go one step further to evaluate accurate stroke management costs to guide policymakers in introducing health policies that promote better care for stroke patients.

Estimated costs for Duchenne muscular dystrophy care in Brazil.

BACKGROUND: The economic burden of rare diseases on health systems is still not widely measured, with the generation of accurate information about the costs with medical care for subjects with rare diseases being crucial when defining health policies. Duchenne Muscular Dystrophy (DMD) is the most common form of muscular dystrophy, with new technologies recently being studied for its management. Information about the costs related to the disease in Latin America is scarce, and the objective of this study is to evaluate the annual hospital, home care and transportation costs per patient with DMD treatment in Brazil. RESULTS: Data from 27 patients were included, the median annual cost per patient was R$ 17,121 (IQR R$ 6,786; 25,621). Home care expenditures accounted for 92% of the total costs, followed by hospital costs (6%) and transportation costs (2%). Medications and loss of family, and patient's productivity are among the most representative consumption items. When disease worsening due to loss of the ability to walk was incorporated to the analysis, it was shown that wheelchair users account for an incremental cost of 23% compared with non-wheelchair users. CONCLUSIONS: This is an original study in Latin America to measure DMD costs using the micro-costing technique. Generating accurate information about costs is crucial to provide health managers with information that could help establish more sustainable policies when deciding upon rare diseases in emerging countries.

Sex Differences in Outcomes of ST Elevation Myocardial Infarction Patients Submitted to Primary Percutaneous Coronary Intervention. / Diferenças entre os Sexos nos Desfechos de Pacientes com Infarto do Miocárdio com Supradesnivelamento do Segmento ST Submetidos à Intervenção Coronária Percutânea Primária.

BACKGROUND: Several studies have shown that women are usually undertreated and have worse outcomes after ST-segment elevation myocardial infarction (STEMI), hence the need to investigate questions related to sex in Brazil to better deal with the problem. OBJECTIVE: To determine whether female sex is still associated with adverse events in a contemporary cohort of patients with STEMI undergoing primary percutaneous coronary intervention (pPCI). METHODS: This was a prospective cohort study of STEMI patients submitted to pPCI in a tertiary university hospital between March 2011 and December 2021. Patients were categorized into groups based on their sex at birth. The primary clinical outcome was long-term MACCE. Patients were followed-up for up to five years. All hypothesis tests had a two-sided significance level of 0.05. RESULTS: Among 1457 patients admitted with STEMI in the study period, 1362 were included and 468 (34.4%) were women. Female patients had a higher prevalence of hypertension (73% vs. 60%, p <0.001), diabetes (32% vs. 25%, p=0.003) and Killip class 3-4 at hospital admission (17% vs. 12%, p=0.01); TIMI risk score was higher among women (4 [2, 6] vs. 3 [2, 5], p<0.001). In-hospital mortality was not different between groups (12.8% vs. 10.5%, p=0.20). In-hospital MACCE (16.0% vs. 12.6%, p=0.085) and long-term MACCE (28.7% vs. 24.4%, p=0.089) were numerically higher in women, with borderline significance. After multivariate analysis, female sex was not associated with MACCE (HR = 1.14; 95% CI 0.86 - 1.51; p = 0.36). CONCLUSION: In a prospective cohort of STEMI patients submitted to pPCI, female patients were older and had more comorbidities at baseline, but no significant differences were found in terms of long-term adverse outcomes.

FUNDAMENTO: Vários estudos têm mostrado que as mulheres não recebem tratamento adequado e apresentam piores desfechos após infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCSST). Por isso, é necessário investigar questões relacionadas ao gênero para melhor lidar com esse problema no Brasil. OBJETIVO: Determinar se existe associação entre o sexo feminino e eventos adversos em uma coorte contemporânea de pacientes com IAMCSST submetidos à intervenção coronária percutânea primária (ICPp). MÉTODOS: Este foi um estudo prospectivo do tipo coorte de pacientes com IAMCSST submetidos à ICPp em um hospital universitário terciário entre março de 2011 e dezembro de 2021. Os pacientes foram categorizados em grupos de acordo com o sexo ao nascimento. O primeiro desfecho clínico foi ECAM em longo prazo. Os pacientes foram acompanhados por um período máximo de cinco anos. Um nível de significância bilateral de 0,05 foi aplicado em todos os testes de hipóteses. RESULTADOS: Entre os 1457 pacientes internados por IAMCSST no período do estudo, 1362 foram incluídos e 468 (34,4%) eram do sexo feminino. As mulheres apresentaram maior prevalência de hipertensão (73% vs. 60%, p<0,001), diabetes (32% vs. 25%, p=0,003) e classe Killip 3-4 na internação (17% vs. 12%, p=0,01); o escore de risco TIMI foi maior nas mulheres [4 (2, 6) vs. 3 (2, 5), p<0.001]. A mortalidade hospitalar não foi diferente entre os grupos (12,8% vs. 10,5%; p=0,20). Os ECAMs foram numericamente maiores nas mulheres que nos homens tanto durante a internação (16,0% vs. 12,6%, p=0,085) como em longo prazo (28,7% vs. 24,4%, p=0,089), com significância limítrofe. Após a análise multivariada, o sexo feminino não foi associado a ECAMs (HR = 1,14; IC95% 0,86 ­ 1,51; p = 0,36). CONCLUSÃO: Em uma coorte prospectiva contemporânea de pacientes com IAMCSST submetidos à ICPp, pacientes do sexo feminino apresentaram idade mais avançada e mais comorbidades no basal que os pacientes do sexo masculino, mas não houve diferenças significativas entre os sexos quanto aos desfechos adversos no hospital ou em longo prazo.

Efetividade do Trastuzumabe adjuvante em mulheres com câncer de mama HER-2+ no SUS / Effectiveness of adjuvant trastuzumab in women with HER-2+ breast cancer in the SUS

Resumo O objetivo deste artigo é avaliar a efetividade em estudo de vida real do trastuzumabe adjuvante em mulheres com câncer de mama inicial HER-2 positivo na sobrevida global e livre de recidiva. Foi realizado um estudo de coorte retrospectiva em mulheres com câncer de mama inicial HER-2 positivo atendidas no SUS, desde a incorporação da medicação. Trata-se de uma coorte retrospectiva com mulheres com câncer de mama HER-2 positivo, que foram tratadas entre julho de 2012 e maio de 2017 com seguimento até julho de 2021. A taxa de incidência de óbito foi de 2,62 por 100 pessoa/ano e a de recidiva foi de 7,52 por 100 pessoa/ano. A probabilidade de sobrevida em 8,7 anos foi 85,9%, enquanto a probabilidade de sobrevida livre de doença no mesmo período foi 62,8%. O uso de trastuzumabe se mostrou efetivo no tratamento adjuvante do câncer de mama em um serviço público de saúde no Sul do Brasil. Fatores prognósticos associados com pior sobrevida ou recidiva não influenciaram na história natural da doença, exceto doença localmente avançada no início do tratamento. Os dados apresentados podem vir a ser úteis em auxiliar na tomada de decisão sobre a manutenção ou não do uso do trastuzumabe no tratamento do câncer de mama inicial ou localmente avançado no serviço público de saúde brasileiro.

Abstract The aim of this study was to evaluate the effectiveness in a real-world study of adjuvant trastuzumab in women with HER-2+ initial breast cancer in overall survival and recurrence-free survival. A retrospective cohort study was conducted with women who had HER-2+ breast cancer treated with trastuzumab from July 2012 to May 2017 and followed up until July 2021. The death rate was 2.62 per 100 persons/year, and the incidence rate of recurrence was 7.52 per 100 persons/year. The probability of survival at 8.7 years was 85.9%, while the probability of recurrence-free survival in the same period was 62.8%. The use of trastuzumab proved to be effective in the adjuvant treatment of breast cancer in a public health service in southern Brazil. Prognostic factors associated with worse overall survival or relapse did not influence the natural history of the disease, except locally advanced disease at the beginning of treatment. The data presented may prove to be useful in helping to make decisions about whether to use trastuzumab in the treatment of initial or locally advanced breast cancer in the Brazilian SUS.

Reply to the letter "Understanding lactate and its clearance during extracorporeal membrane oxygenation for supporting refractory cardiogenic shock patients".

This is a reply to the letter titled "Understanding lactate and its clearance during extracorporeal membrane oxygenation for supporting refractory cardiogenic shock patients" by Eva Rully Kurniawati et al. In response to the concerns raised about our paper published in BMC Cardiovascular Disorders, titled "Association between serum lactate levels and mortality in patients with cardiogenic shock receiving mechanical circulatory support: a multicenter retrospective cohort study," we have addressed the confounding bias on the population included and the use of VA-ECMO and Impella CP. Furthermore, we have provided new data on the correlation of oxygen supply and lactate levels at admission of cardiogenic shock.

Effectiveness of adjuvant trastuzumab in women with HER-2+ breast cancer in the SUS. / Efetividade do Trastuzumabe adjuvante em mulheres com câncer de mama HER-2+ no SUS.

The aim of this study was to evaluate the effectiveness in a real-world study of adjuvant trastuzumab in women with HER-2+ initial breast cancer in overall survival and recurrence-free survival. A retrospective cohort study was conducted with women who had HER-2+ breast cancer treated with trastuzumab from July 2012 to May 2017 and followed up until July 2021. The death rate was 2.62 per 100 persons/year, and the incidence rate of recurrence was 7.52 per 100 persons/year. The probability of survival at 8.7 years was 85.9%, while the probability of recurrence-free survival in the same period was 62.8%. The use of trastuzumab proved to be effective in the adjuvant treatment of breast cancer in a public health service in southern Brazil. Prognostic factors associated with worse overall survival or relapse did not influence the natural history of the disease, except locally advanced disease at the beginning of treatment. The data presented may prove to be useful in helping to make decisions about whether to use trastuzumab in the treatment of initial or locally advanced breast cancer in the Brazilian SUS.

O objetivo deste artigo é avaliar a efetividade em estudo de vida real do trastuzumabe adjuvante em mulheres com câncer de mama inicial HER-2 positivo na sobrevida global e livre de recidiva. Foi realizado um estudo de coorte retrospectiva em mulheres com câncer de mama inicial HER-2 positivo atendidas no SUS, desde a incorporação da medicação. Trata-se de uma coorte retrospectiva com mulheres com câncer de mama HER-2 positivo, que foram tratadas entre julho de 2012 e maio de 2017 com seguimento até julho de 2021. A taxa de incidência de óbito foi de 2,62 por 100 pessoa/ano e a de recidiva foi de 7,52 por 100 pessoa/ano. A probabilidade de sobrevida em 8,7 anos foi 85,9%, enquanto a probabilidade de sobrevida livre de doença no mesmo período foi 62,8%. O uso de trastuzumabe se mostrou efetivo no tratamento adjuvante do câncer de mama em um serviço público de saúde no Sul do Brasil. Fatores prognósticos associados com pior sobrevida ou recidiva não influenciaram na história natural da doença, exceto doença localmente avançada no início do tratamento. Os dados apresentados podem vir a ser úteis em auxiliar na tomada de decisão sobre a manutenção ou não do uso do trastuzumabe no tratamento do câncer de mama inicial ou localmente avançado no serviço público de saúde brasileiro.

Myocardial Injury and Prognosis in Hospitalized COVID-19 Patients in Brazil: Results From The Brazilian COVID-19 Registry. / Lesão Miocárdica e Prognóstico em Pacientes Hospitalizados com COVID-19 no Brasil: Resultados do Registro Nacional de COVID-19.

BACKGROUND: Cardiovascular complications of COVID-19 are important aspects of the disease's pathogenesis and prognosis. Evidence on the prognostic role of troponin and myocardial injury in Latin American hospitalized COVID-19 patients is still scarce. OBJECTIVES: To evaluate myocardial injury as independent predictor of in-hospital mortality and invasive mechanical ventilation support in hospitalized patients, from the Brazilian COVID-19 Registry. METHODS: This cohort study is a substudy of the Brazilian COVID-19 Registry, conducted in 31 Brazilian hospitals of 17 cities, March-September 2020. Primary outcomes included in-hospital mortality and invasive mechanical ventilation support. Models for the primary outcomes were estimated by Poisson regression with robust variance, with statistical significance of p<0.05. RESULTS: Of 2,925 patients (median age of 60 years [48-71], 57.1% men), 27.3% presented myocardial injury. The proportion of patients with comorbidities was higher among patients with cardiac injury (median 2 [1-2] vs. 1 [0-2]). Patients with myocardial injury had higher median levels of brain natriuretic peptide, lactate dehydrogenase, creatine phosphokinase, N-terminal pro-brain natriuretic peptide, and C-reactive protein than patients without myocardial injury. As independent predictors, C-reactive protein and platelet counts were related to the risk of death, and neutrophils and platelet counts were related to the risk of invasive mechanical ventilation support. Patients with high troponin levels presented a higher risk of death (RR 2.03, 95% CI 1.60-2.58) and invasive mechanical ventilation support (RR 1.87, 95% CI 1.57-2.23), when compared to those with normal troponin levels. CONCLUSION: Cardiac injury was an independent predictor of in-hospital mortality and the need for invasive mechanical ventilation support in hospitalized COVID-19 patients.

FUNDAMENTO: As complicações cardiovasculares da COVID-19 são aspectos importantes da patogênese e do prognóstico da doença. Evidências do papel prognóstico da troponina e da lesão miocárdica em pacientes hospitalizados com COVID-19 na América Latina são ainda escassos. OBJETIVOS: Avaliar a lesão miocárdica como preditor independente de mortalidade hospitalar e suporte ventilatório mecânico em pacientes hospitalizados, do registro brasileiro de COVID-19. MÉTODOS: Este estudo coorte é um subestudo do registro brasileiro de COVID-19, conduzido em 31 hospitais brasileiros de 17 cidades, de março a setembro de 2020. Os desfechos primários incluíram mortalidade hospitalar e suporte ventilatório mecânico invasivo. Os modelos para os desfechos primários foram estimados por regressão de Poisson com variância robusta, com significância estatística de p<0,05. RESULTADOS: Dos 2925 pacientes [idade mediana de 60 anos (48-71), 57,1%], 27,3% apresentaram lesão miocárdica. A proporção de pacientes com comorbidades foi maior nos pacientes com lesão miocárdica [mediana 2 (1-2) vs. 1 (0-20)]. Os pacientes com lesão miocárdica apresentaram maiores valores medianos de peptídeo natriurético cerebral, lactato desidrogenase, creatina fosfoquinase, N-terminal do pró-peptídeo natriurético tipo B e proteína C reativa em comparação a pacientes sem lesão miocárdica. Como fatores independentes, proteína C reativa e contagem de plaquetas foram relacionados com o risco de morte, e neutrófilos e contagem de plaquetas foram relacionados ao risco de suporte ventilatório mecânico invasivo. Os pacientes com níveis elevados de troponina apresentaram um maior risco de morte (RR 2,03, IC95% 1,60-2,58) e suporte ventilatório mecânico (RR 1,87;IC95% 1,57-2,23), em comparação àqueles com níveis de troponina normais. CONCLUSÃO: Lesão cardíaca foi um preditor independente de mortalidade hospitalar e necessidade de suporte ventilatório mecânico em pacientes hospitalizados com COVID-19.

Comparison of COVID-19 hospitalization costs across care pathways: a patient-level time-driven activity-based costing analysis in a Brazilian hospital.

BACKGROUND: The COVID-19 pandemic raised awareness of the need to better understand where and how patient-level costs are incurred in health care organizations, as health managers and other decision-makers need to plan and quickly adapt to the increasing demand for health care services to meet patients' care needs. Time-driven activity-based costing offers a better understanding of the drivers of cost throughout the care pathway, providing information that can guide decisions on process improvement and resource optimization. This study aims to estimate COVID-19 patient-level hospital costs and to evaluate cost variability considering the in-hospital care pathways of COVID-19 management and the patient clinical classification. METHODS: This is a prospective cohort study that applied time-driven activity-based costing (TDABC) in a Brazilian reference center for COVID-19. Patients hospitalized during the first wave of the disease were selected for their data to be analyzed to estimate in-hospital costs. The cost information was calculated at the patient level and stratified by hospital care pathway and Ordinal Scale for Clinical Improvement (OSCI) category. Multivariable analyses were applied to identify predictors of cost variability in the care pathways that were evaluated. RESULTS: A total of 208 patients were included in the study. Patients followed five different care pathways, of which Emergency + Ward was the most followed (n = 118, 57%). Pathways which included the intensive care unit presented a statistically significant influence on costs per patient (p <  0.001) when compared to Emergency + Ward. The median cost per patient was I$2879 (IQR 1215; 8140) and mean cost per patient was I$6818 (SD 9043). The most expensive care pathway was the ICU only, registering a median cost per patient of I$13,519 (IQR 5637; 23,373) and mean cost per patient of I$17,709 (SD 16,020). All care pathways that included the ICU unit registered a higher cost per patient. CONCLUSIONS: This is one of the first microcosting study for COVID-19 that applied the TDABC methodology and demonstrated how patient-level costs vary as a function of the care pathways followed by patients. These findings can be used to develop value reimbursement strategies that will inform sustainable health policies in middle-income countries such as Brazil.

Association between acute disease severity and one-year quality of life among post-hospitalisation COVID-19 patients: Coalition VII prospective cohort study.

PURPOSE: To assess the association between acute disease severity and 1-year quality of life in patients discharged after hospitalisation due to coronavirus disease 2019 (COVID-19). METHODS: We conducted a prospective cohort study nested in 5 randomised clinical trials between March 2020 and March 2022 at 84 sites in Brazil. Adult post-hospitalisation COVID-19 patients were followed for 1 year. The primary outcome was the utility score of EuroQol five-dimension three-level (EQ-5D-3L). Secondary outcomes included all-cause mortality, major cardiovascular events, and new disabilities in instrumental activities of daily living. Adjusted generalised estimating equations were used to assess the association between outcomes and acute disease severity according to the highest level on a modified ordinal scale during hospital stay (2: no oxygen therapy; 3: oxygen by mask or nasal prongs; 4: high-flow nasal cannula oxygen therapy or non-invasive ventilation; 5: mechanical ventilation). RESULTS: 1508 COVID-19 survivors were enrolled. Primary outcome data were available for 1156 participants. At 1 year, compared with severity score 2, severity score 5 was associated with lower EQ-5D-3L utility scores (0.7 vs 0.84; adjusted difference, - 0.1 [95% CI - 0.15 to - 0.06]); and worse results for all-cause mortality (7.9% vs 1.2%; adjusted difference, 7.1% [95% CI 2.5%-11.8%]), major cardiovascular events (5.6% vs 2.3%; adjusted difference, 2.6% [95% CI 0.6%-4.6%]), and new disabilities (40.4% vs 23.5%; adjusted difference, 15.5% [95% CI 8.5%-22.5]). Severity scores 3 and 4 did not differ consistently from score 2. CONCLUSIONS: COVID-19 patients who needed mechanical ventilation during hospitalisation have lower 1-year quality of life than COVID-19 patients who did not need mechanical ventilation during hospitalisation.

COVID-19 Telehealth Service Can Increase Access to the Health Care System and Become a Cost-Saving Strategy.

Introduction: Data addressing the economic aspects of telehealth initiatives are incipient. This study aimed to evaluate the labor costs for running a COVID-19 telehealth system and its potential incremental access to health care service. Methods: From July 2020 to July 2021, data from a Brazilian teleconsultation service were analyzed. Labor costs were estimated by time-driven activity-based costing. A Generalized Reduced Gradient solving method was coded to maximize the mean incremental access rate and two scenarios were considered to compare the teleconsultation with the in-person consultation: (1) only the length of time that patients spent with a clinician in an in-person consultation was accounted and (2) in addition to the medical consultation, nursing screening was accounted. The mean incremental access rate of the teleconsultation service was defined as a maximization objective in the model. Results: Mean labor costs per medical and nursing teleconsultations are Int$ 24 and Int$ 10, based on data analyses from 25,258 patients. Telemonitoring a patient with a daily call for 7 days costs, on average, Int$ 14. COVID-19 teleconsultation service represents, on average, an incremental access to medical consultation rate of 35% to 52% (min 23% max 63%) for the scenarios (1) and (2), respectively, and considering the current consumed budget for this service. Discussion: A COVID-19 telehealth service contributes to increasing access to the health care system without increasing costs. These services can be included in the bundle of care strategies offered in a national public health care system that looks for more sustainable strategies to provide care.