15 research outputs found

    Immunothrombosis and COVID-19 ‒ a nested post-hoc analysis from a 3186 patient cohort in a Latin American public reference hospital

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    Objective: COVID-19 is associated with an elevated risk of thromboembolism and excess mortality. Difficulties with best anticoagulation practices and their implementation motivated the current analysis of COVID-19 patients who developed Venous Thromboembolism (VTE). Method: This is a post-hoc analysis of a COVID-19 cohort, described in an economic study already published. The authors analyzed a subset of patients with confirmed VTE. We described the characteristics of the cohort, such as demographics, clinical status, and laboratory results. We tested differences amid two subgroups of patients, those with VTE or not, with the competitive risk Fine and Gray model. Results: Out of 3186 adult patients with COVID-19, 245 (7.7%) were diagnosed with VTE, 174 (5.4%) of them during admission to the hospital. Four (2.3% of these 174) did not receive prophylactic anticoagulation and 19 (11%) discontinued anticoagulation for at least 3 days, resulting in 170 analyzed. During the first week of hospitalization, the laboratory most altered results were C-reactive protein and D-dimer. Patients with VTE were more critical, had a higher mortality rate, worse SOFA score, and, on average, 50% longer hospital stay. Conclusion: Proven VTE incidence in this severe COVID-19 cohort was 7.7%, despite 87% of them complying completely with VTE prophylaxis. The clinician must be aware of the diagnosis of VTE in COVID-19, even in patients receiving proper prophylaxis

    Use and misuse of biomarkers and the role of D-dimer and C-reactive protein in the management of COVID-19: A post-hoc analysis of a prospective cohort study

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    OBJECTIVE: Coronavirus disease 2019 (COVID-19) is associated with high mortality among hospitalized patients and incurs high costs. Severe acute respiratory syndrome coronavirus 2 infection can trigger both inflammatory and thrombotic processes, and these complications can lead to a poorer prognosis. This study aimed to evaluate the association and temporal trends of D-dimer and C-reactive protein (CRP) levels with the incidence of venous thromboembolism (VTE), hospital mortality, and costs among inpatients with COVID-19. METHODS: Data were extracted from electronic patient records and laboratory databases. Crude and adjusted associations for age, sex, number of comorbidities, Sequential Organ Failure Assessment score at admission, and D-dimer or CRP logistic regression models were used to evaluate associations. RESULTS: Between March and June 2020, COVID-19 was documented in 3,254 inpatients. The D-dimer level ≥4,000 ng/mL fibrinogen equivalent unit (FEU) mortality odds ratio (OR) was 4.48 (adjusted OR: 1.97). The CRP level ≥220 mg/dL OR for death was 7.73 (adjusted OR: 3.93). The D-dimer level ≥4,000 ng/mL FEU VTE OR was 3.96 (adjusted OR: 3.26). The CRP level ≥220 mg/dL OR for VTE was 2.71 (adjusted OR: 1.92). All these analyses were statistically significant (p<0.001). Stratified hospital costs demonstrated a dose-response pattern. Adjusted D-dimer and CRP levels were associated with higher mortality and doubled hospital costs. In the first week, elevated D-dimer levels predicted VTE occurrence and systemic inflammatory harm, while CRP was a hospital mortality predictor. CONCLUSION: D-dimer and CRP levels were associated with higher hospital mortality and a higher incidence of VTE. D-dimer was more strongly associated with VTE, although its discriminative ability was poor, while CRP was a stronger predictor of hospital mortality. Their use outside the usual indications should not be modified and should be discouraged

    Adoption and asessment of innovative health technologies within the Brazilian health care system: a case study in cardiology

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    Introdução: Amplo debate tem associado a incorporação de novas tecnologias para a saúde com os custos crescentes dos sistemas de saúde. Face à dúvidas \"se as novas tecnologias são parte do problema, parte da solução ou as duas coisas\" relativamente à saúde da população e do sistema de saúde, este estudo de caso analisa a incorporação de três inovações no Instituto do Coração, InCor-HC/FMUSP, visando elaborar quais fatores influenciaram a decisão de adoção e exemplificar as metodologias de avaliação de novo medicamento, de procedimento diagnóstico e intervenção cirúrgica. A avaliação das tecnologias para a saúde, ATS, pode auxiliar a constituir algumas propostas de respostas. Metodologia: estudo qualitativo empírico em caso retrospectivo de incorporação de três inovações para assistência de alta complexidade em cardiologia. As metodologias utilizadas consistiram em entrevistas aos tomadores de decisão, revisões sistemáticas da literatura relevante, descritiva ou meta-analítica, e análise de impacto econômico hospitalar. Resultados: O padrão do InCor para a incorporação das inovações funciona como um sistema social criativo, sob uma estratégia prática pluralista, ou seja, utilizam as pesquisas, aprovadas pela Comissão de Ética e Pesquisa do InCor e do HC, que se sucederam e que sucedem em incrementos, verificando e ajustando as informações segundo os resultados obtidos para desenhar novas pesquisas. Os atores construíram conhecimentos e negociaram protocolos de pesquisa, promoveram a capacitação de super-especialistas técnicos, transferindo práticas internacionais e gerando conhecimentos adaptados à realidade do Brasil. A avaliação do medicamento tacrolimus demonstra que se poderia resgatar uma média de 75% das rejeições refratárias às terapias convencionais, proporcionando um custo hospitalar de RR R 102,99 por dia de sobrevida nos 8 adultos e R137,53nas13crianc\casobservadas,comparativamenteaˋR 137,53 nas 13 crianças observadas, comparativamente à R 229,00 e R260,00,comciclosporina,respectivamente.Assim,seevitaria37 260,00, com ciclosporina, respectivamente. Assim, se evitaria 37% da mortalidade associada à episódios de rejeição nos pacientes com transplante cardíaco e, mesmo no único óbito, o custo hospitalar por dia de sobrevida foi de metade que o custo dos períodos observados nos 32 pacientes sob ciclosporina que foram a óbito. O diagnóstico por angiotomocoronariografia em pacientes com angina atípica e risco moderado permitiria orientar o manejo de até dois terços destes casos evitandose coronariografias invasivas. Isto permitiria aumentar a resolutividade do Departamento de Hemodinâmica de 25% para mais 20% dos casos assim estudados, com economias para o InCor, aumento do acesso e resolutividade, podendo evitar até 2.000 mortes, e com o acréscimo estimado de 10% das fibrilações atriais refratárias a medicamentos em pacientes com indicação de cirurgia aberta para correção de problemas cardíacos estruturais, evitando morbidade e mortalidade em até 1.000 pacientes por ano, se houver suposição que esta seja utilizada apenas com as cirurgias valvares no âmbito do SUS. Conclusões e discussão: As novas tecnologias estudadas proporcionam benefícios à saúde, mas ainda possuem variados graus de incerteza sobre aspectos de segurança e sobre seu potencial de impacto econômico para os programas assistenciais para o InCor e para o SUS. O InCor e os demais hospitais universitários possuem alta capacidade técnica instalada, onde a estruturação de pesquisas facilita e permite a incorporação de inovações de alta complexidade, sem contudo haver planejamento econômico para os programas de assistência à saúde. O isolamento destes atores, em relação às instâncias gestoras do SUS, permite construções sob visões parciais e imediatistas, permite desenvolvimento de interesses externos e diversos, e, por outro lado, pressiona de maneira desordenada a organização e o sistema de saúde. A integração da capacidade profissional, instalada nos hospitais universitários, dentro do circuito de planejamento de médio e longo prazo para o SUS, avaliando as tecnologias inovadoras comparativamente às estabelecidas para a saúde, com base na epidemiologia local observada, pode permitir uma atualização planejada e contínua dos serviços de saúde, construída sobre bases sólidas de conhecimento científico adaptado à nossa realidade e com o responsável equilíbrio orçamentário.Introduction: There is an ongoing international debate associating the increasing health care costs with adoption of new health technologies. To aid to ascertain whether new health technologies are part of the problem, part of the solution or both in relation to the health of the population and of the health care system, this case study analyses retrospectively three recent decisions to adopt innovations at the Heart Institute, InCor-HC/FMUSP. In order to provide examples of the application of methods for health technologies assessment, the InCor Board of Directors indicated one innovative drug, a new diagnostic procedure and a recent surgery. Methods: Qualitative, retrospective field evaluation of the three decisions for the highest complexity of care in cardiology. Decision-makers survey, systematic reviews (descriptive or meta-analytic) and hospital economic impact analysis were the methodologies applied to this case. Results: A pattern of new technologies incorporation through incremental research, a strategic and pluralist practice emerged within a creative social system. Approved by the InCor and HC Research Ethics Boards and based on previous research results, successive investigations verified and adjusted the informations and generated additional research. Thus, the decision-makers do build knowledge, negotiate research protocols, promote very technical specialists formation and transfer international practice, inter- and up-grading it to the Brazilian reality. Evaluation of these three innovative technologies results are: - The drug tacrolimus may rescue and resolve an average of 75% of the episodes of rejection refractory to conventional medications. The average hospital cost observed (since conversion from CSA, censored at March the 30th, 2006) was of US45 or R102.99perdayofsurvivalin8adultsandofUS102.99 per day of survival in 8 adults and of US61 or R137.53forthe13children(<18yearsofage),comparedwithR137.53 for the 13 children (<18 years of age), compared with R 229.00 and R$ 260.00, respectively, in those who remained under cyclosporine treatment. Thus, it could prevent 37% rejection related mortality and bring some economy (even in the single child death observed, the hospital cost per day until death was the half of the cost observed for the 32 cyclosporine treated). - The tomoangiocoronariography diagnosis for patients presenting atypical angina and moderate to low risk of stenosis may orient and modify up to 66% clinical decisions preventing requirement of an invasive procedure. This would increase 20% to the Haemodynamic Department 25% resolutivity, may prevent up to 2000 deaths with an estimated additional 10% of the costs of 14% more angioplasties and 6% increase in surgical coronary bypasses for the health care system. - Surgical ablation has the potential to cure more than 10% of medications refractory atrial fibrillation in patients undergoing open heart surgery for structural corrections. Supposing it is restricted only to the group of patients undergoing valve surgery in the health care system, it could prevent morbidity and mortality for up to 1000 patients. Conclusions and discussion: The new technologies evaluated bring benefits to the health of the patients. Safety concerns and economic impact for the InCor and for the health care system assistance programs require further investigation. InCor and the other university hospitals have enhanced technical capacity installed. The structured research facilitates and allows incorporation of highly complex innovations without planning future programs for care. The isolation of these decision makers from the health care system decision planners allows partial views and immediacies. Such a distance facilitates development of external and diverse interests. These facts, consequently, pressures on the organization and the health care system. The integration of the university hospitals installed professional capacities, within an average and long term health care system plans, making evaluations of the innovative health technologies in comparison with the established ones based on local epidemiology, may permit a planned and continuous actualization of the health services on solid scientific basis adapted to the Brazilian reality and with a responsible financial balance

    Financial Impact of Deep Sternal Wound Infections After Coronary Surgery: A Microcosting Analysis

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    ABSTRACT Introduction: Deep sternal wound infections (DSWI) are so serious and costly that hospital services continue to strive to control and prevent these outcomes. Microcosting is the more accurate approach in economic healthcare evaluation, but there are no studies in this field applying this method to compare DSWI after isolated coronary artery bypass grafting (CABG). This study aims to evaluate the incremental risk-adjusted costs of DSWI on isolated CABG. Methods: This is a retrospective, single-center observational cohort study with a propensity score matching for infected and non-infected patients to compare incremental risk-adjusted costs between groups. Data to homogeneity sample was obtained from a multicentric database, REPLICCAR II, and additional sources of information about costs were achieved with the electronic hospital system (Si3). Inflation variation and dollar quotation in the study period were corrected using the General Market Price Index. Groups were compared using analysis of variance, and multiple linear regression was performed to evaluate the cost drivers related to the event. Results: As expected, infections were costly; deep infection increased the costs by 152% and mediastinitis by 188%. Groups differed among hospital stay, exams, medications, and multidisciplinary labor, and hospital stay costs were the most critical cost driver. Conclusion: In summary, our results demonstrate the incremental costs of a detailed microcosting evaluation of infections on CABG patients in São Paulo, Brazil. Hospital stay was an important cost driver identified, demonstrating the importance of evaluating patients’ characteristics and managing risks for a faster, safer, and more effective discharge

    Eltrombopag for Adults and Children with Immune-Refractory Thrombocytopenic Purpura: A Systematic Review

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    Eltrombopag is an agonist that binds to the membrane-bound domain of the thrombopoietin receptor used in immune thrombocytopenic purpura (ITP). We conducted a meta-analysis of randomized controlled trials to assess the efficacy and safety of eltrombopag in adults and children with refractory ITP. Adults who received eltrombopag had a significantly better platelet response (relative risk [RR], 3.65; 95% confidence interval [CI], 2.39–5.55), but there were no differences in the incidence of bleeding (RR, 0.8; 95% CI, 0.52–1.22) and adverse effects (RR, 0.99; 95% CI, 0.55–1.78) compared with the placebo. In children, there was no difference between eltrombopag and placebo for a platelet response >50,000/mm3 (RR, 3.93; 95% CI, 0.56–27.79) and the number of adverse events (RR, 0.99; 95% CI, 0.25–1.49); however, a lower incidence of bleeding was observed (RR, 0.47; 95% CI, 0.27–0.83). Treatment with eltrombopag protected adults and children from severe disease and death

    Heart surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SP-SCORE-SUS STUDY

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    Doenças cardiovasculares representam a maior carga de morbimortalidade para o sistema de saúde e a cirurgia cardíaca desempenha importante impacto na sua resolutividade. O agrupamento das informações demográficas e clínicas relevantes dos pacientes acometidos, no nível de estratos específicos e em correlação com os conjuntos de recursos requeridos, representa a possibilidade de adaptar, aprimorar e inovar nos programas assistenciais. Este projeto tem por objetivo remodelar o escore de risco "InsCor" para formulação do SP-SCORE (São Paulo System for Cardiac Operative Risk Evaluation), visando refletir melhor a complexidade da assistência cirúrgica cardíaca. Os hospitais participantes integram os Núcleos de Avaliação de Tecnologias da Secretaria de Estado da Saúde de São Paulo (NATSs/SES-SP). Para a elaboração do SP-SCORE, serão utilizadas as 10 variáveis do modelo InsCor e 8 outras com suposta influência no Brasil. Os desfechos primários consistem na morbidade e na mortalidade hospitalar. A técnica de bootstrap junto a procedimentos de seleção automatizada de variáveis "stepwise" será utilizada para desenvolver um modelo parcimonioso por meio da regressão logística múltipla. Este projeto visa subsidiar a sustentabilidade e o financiamento do SUS-SP para as Redes Regionalizadas de Atenção à Saúde (RRAS) de cirurgias de coronária e/ou valva, promovendo alocação equitativa, incremento do acesso e efetividade, bem como caracterizar a magnitude dos recursos disponíveis e seu impacto

    Cardiac Surgery Costs According to the Preoperative Risk in the Brazilian Public Health System

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    Abstract Background: Heart surgery has developed with increasing patient complexity. Objective: To assess the use of resources and real costs stratified by risk factors of patients submitted to surgical cardiac procedures and to compare them with the values reimbursed by the Brazilian Unified Health System (SUS). Method: All cardiac surgery procedures performed between January and July 2013 in a tertiary referral center were analyzed. Demographic and clinical data allowed the calculation of the value reimbursed by the Brazilian SUS. Patients were stratified as low, intermediate and high-risk categories according to the EuroSCORE. Clinical outcomes, use of resources and costs (real costs versus SUS) were compared between established risk groups. Results: Postoperative mortality rates of low, intermediate and high-risk EuroSCORE risk strata showed a significant linear positive correlation (EuroSCORE: 3.8%, 10%, and 25%; p < 0.0001), as well as occurrence of any postoperative complication EuroSCORE: 13.7%, 20.7%, and 30.8%, respectively; p = 0.006). Accordingly, length-of-stay increased from 20.9 days to 24.8 and 29.2 days (p < 0.001). The real cost was parallel to increased resource use according to EuroSCORE risk strata (R27.116,00±R 27.116,00 ± R 13.928,00 versus R34.854,00±R 34.854,00 ± R 27.814,00 versus R43.234,00±R 43.234,00 ± R 26.009,00, respectively; p < 0.001). SUS reimbursement also increased (R14.306,00±R 14.306,00 ± R 4.571,00 versus R16.217,00±R 16.217,00 ± R 7.298,00 versus R19.548,00±R 19.548,00 ± R935,00; p < 0.001). However, as the EuroSCORE increased, there was significant difference (p < 0.0001) between the real cost increasing slope and the SUS reimbursement elevation per EuroSCORE risk strata. Conclusion: Higher EuroSCORE was related to higher postoperative mortality, complications, length of stay, and costs. Although SUS reimbursement increased according to risk, it was not proportional to real costs
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