Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF).

BACKGROUND: Ischemic cardiomyopathy and severe left ventricular dysfunction are well established to represent the main determinants of poor survival and premature death compared with preserved ventricular function. However, the role of myocardial revascularization as a therapeutic alternative is not known to improve the long-term prognosis in this group of patients. This study will investigate whether myocardial revascularization contributes to a better prognosis for patients compared with those treated with drugs alone and followed over the long term. METHODS: The study will include 600 patients with coronary artery disease associated with ischemic cardiomyopathy. The surgical or drug therapy option will be randomized, and the events considered for analysis will be all-cause mortality, nonfatal infarction, unstable angina requiring additional revascularization, and stroke. The events will be analyzed according to the intent-to-treat principle. Patients with multivessel coronary disease and left ventricular ejection fraction measurements of less than 35% will be included. In addition, myocardial ischemia will be documented by myocardial scintigraphy. Markers of myocardial necrosis will be checked at admission and after the procedure. DISCUSSION: The role of myocardial revascularization (CABG) in the treatment of patients with coronary artery disease and heart failure is not clearly established. The surgical option of revascularizing the myocardium is a procedure designed to reduce the load of myocardial hibernation in patients with heart failure caused by coronary artery disease. On the other hand, the assessment of myocardial viability is frequently used to identify patients with left ventricular ischemic dysfunction in which CABG may add survival benefit. However, the effectiveness of this option is uncertain. The great difficulty in establishing the efficacy of surgical intervention is based on the understanding of viability without ischemia. Thus, this study will include only patients with viable and truly ischemic myocardium to correct this anomaly. TRIAL REGISTRATION: Evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment: MASS-VI (HF), ISRCTN77449548, Oct 10th, 2019 (retrospectively registered).

Cardiac Surgery Costs According to the Preoperative Risk in the Brazilian Public Health System / Custos das Cirurgias Cardíacas Segundo o Risco Pré-Operatório no Sistema Público de Saúde Brasileiro

AbstractBackground: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 (R$ 27.116,00 ± R$ 13.928,00 versus R$ 34.854,00 ± R$ 27.814,00 versus R$ 43.234,00 ± R$ 26.009,00, respectively; p < 0.001). SUS reimbursement also increased (R$ 14.306,00 ± R$ 4.571,00 versus R$ 16.217,00 ± R$ 7.298,00 versus R$ 19.548,00 ± R$935,00; 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.

ResumoFundamentos:A cirurgia cardíaca evoluiu progressivamente com o aumento da complexidade dos pacientes.Objetivo:Avaliar a utilização de recursos e o custo real segundo o grupo de risco dos pacientes submetidos à cirurgia cardíaca, e compará-los com o valor ressarcido pelo Sistema Único de Saúde (SUS).Método:Foram analisadas todas as cirurgias cardíacas realizadas entre janeiro e julho de 2013 em um centro terciário. Dados demográficos e clínicos permitiram o cálculo do valor ressarcido pelo SUS. Os pacientes foram estratificados em baixo, médio e alto risco pelo EuroSCORE. Os resultados clínicos, o uso de recursos e os custos (real versus SUS) foram comparados entre os grupos de risco estabelecidos.Resultados:Taxas de mortalidade pós-operatória de baixo, intermediário e alto risco apresentaram correlação linear positiva (EuroSCORE: 3,8%, 10% e 25%, respectivamente; p < 0,0001), assim como a ocorrência de alguma complicação pós-operatória (EuroSCORE: 13,7%, 20,7% e 30,8%, respectivamente; p = 0,006). O tempo de internação aumentou de 20,9 para 24,8 e 29,2 dias, respectivamente (p < 0,001). O custo real foi paralelo ao aumento da utilização de recursos, segundo o EuroSCORE (R$ 27.116,00 ± R$13.928,00 versus R$ 34.854,00 ± R$ 27.814,00 versus R$ 43.234,00 ± R$ 26.009,00, respectivamente; p < 0,001). O ressarcimento do SUS também aumentou (R$ 14.306,00 ± R$ 4.571,00 versus R$ 16.217,00 ± R$ 7.298,00 versus R$ 19.548,00 ± R$ 935,00; p < 0,001). Mesmo com aumento do EuroSCORE, houve diferença (p < 0,0001) progressiva entre o incremento do custo real e o ressarcimento do SUS.Conclusão:O aumento do EuroSCORE esteve relacionado a maiores morbimortalidade, tempo de internação e custos no pós-operatório. Embora o ressarcimento do SUS também aumente conforme o risco, ele não é proporcional ao custo real.

Cardiac surgery costs according to the preoperative risk in the Brazilian public health system.

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 (R$ 27.116,00 ± R$ 13.928,00 versus R$ 34.854,00 ± R$ 27.814,00 versus R$ 43.234,00 ± R$ 26.009,00, respectively; p < 0.001). SUS reimbursement also increased (R$ 14.306,00 ± R$ 4.571,00 versus R$ 16.217,00 ± R$ 7.298,00 versus R$ 19.548,00 ± R$935,00; 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.

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

Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has an important impact on their resolutivity. The association and correlation of patients' demographic and clinical relevant information with the resources required for each stratum represent the possibility to adapt, improve and innovate into the healthcare programs. This project aims to remodel the "InsCor" risk score for the formulation of the SP-SCORE (Sao Paulo System for Cardiac Operative Risk Evaluation) in order to better reflects the complexity of cardiac surgical care. The participating hospitals include the Health Technology Assessment Centers in of the Health Secretariat' HTA Network of São Paulo State (HTA-NATSs / SES-SP). The SP-SCORE will use 10 variables of the InsCor model and others 8 variables with presumed influence in Brazil. The primary endpoints are morbidity and mortality. Bootstrap technique besides automated selection of variables (stepwise) will be used to develop a parsimonious model by multiple logistic regression. This project will contribute for the SUS-SP regionalized health-care (RRAS) sustainability and financing of the CABG and/or heart valve surgery programs promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and its impact.

Estratificação de risco cirúrgico como instrumento de inovação em programas de cirurgia cardíaca no Sistema Único de Saúde do Estado de São Paulo: ESTUDO SP-SCORE-SUS / Heart surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SP-SCORE-SUS STUDY

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.

Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has an important impact on their resolutivity. The association and correlation of patients' demographic and clinical relevant information with the resources required for each stratum represent the possibility to adapt, improve and innovate into the healthcare programs. This project aims to remodel the "InsCor" risk score for the formulation of the SP-SCORE (Sao Paulo System for Cardiac Operative Risk Evaluation) in order to better reflects the complexity of cardiac surgical care. The participating hospitals include the Health Technology Assessment Centers in of the Health Secretariat' HTA Network of São Paulo State (HTA-NATSs / SES-SP). The SP-SCORE will use 10 variables of the InsCor model and others 8 variables with presumed influence in Brazil. The primary endpoints are morbidity and mortality. Bootstrap technique besides automated selection of variables (stepwise) will be used to develop a parsimonious model by multiple logistic regression. This project will contribute for the SUS-SP regionalized health-care (RRAS) sustainability and financing of the CABG and/or heart valve surgery programs promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and its impact.