Comparative cost-effectiveness of surgery, angioplasty, or medical therapy in patients with multivessel coronary artery disease: MASS II trial.

BACKGROUND: The costs for treating coronary artery disease (CAD) are high worldwide. We performed a prespecified analyses of cost-effectiveness of three therapeutic strategies for multivessel CAD. METHODS: From May 1995 to May 2000, a total of 611 patients were randomly assigned to coronary artery bypass graft (CABG), n = 203; percutaneous coronary intervention (PCI), n = 205; or medical treatment (MT), n = 203. This cost analysis study was based on the perspective of the Public Health Care System. Initial procedural and follow-up costs for medications, cardiology examinations, and hospitalizations for complications were calculated after randomization. Life-years and quality-adjusted life years (QALYs) were used as effectiveness measures. Incremental cost-effectiveness ratios (ICER) were obtained by using nonparametric bootstrapping methods with 5000 resamples. RESULTS: Initial procedural costs were lower for MT. However, the subsequent 5-year cumulative costs were lower for CABG. Compared with baseline, the three treatment options produced significant improvements in QALYs. After 5 years, PCI and CABG had better QALYs results compared with MT. The ICER results favored CABG and PCI, and favored PCI over CABG in 61% of the drawings. On the other hand, sensitivity analysis showed MT as the preferred therapy compared with CABG and PCI, in the analysis considering higher costs. CONCLUSIONS: At 5-year follow-up, the three treatment options yielded improvements in quality of life, with comparable and acceptable costs. However, despite higher initial costs, the comparison of cost-effectiveness after 5 years of follow-up among the three treatments showed both interventions (CABG and PCI) to be cost-effective strategies compared with MT.Trial registration ISRCTN, ISRCTN66068876, Registered 06/10/1994, http://www.controlled-trials.com/ISRCTN66068876.

Cost-effectiveness of on-pump and off-pump coronary artery bypass grafting for patients with coronary artery disease: Results from the MASS III trial.

BACKGROUND: Recent trials have reported similar clinical outcomes between on-pump and off-pump coronary artery bypass graft (CABG). However, long-term cost-effectiveness of these strategies is unknown. METHODS: A prespecified economic study was performed based on the MASS III trial. Costs were estimated for all patients based on observed healthcare resource usage over a 5-year follow-up. Health state utilities were evaluated with the SF-6D questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a Markov model. Probabilistic sensitivity analysis with the Monte-Carlo simulation and cost-effectiveness acceptability curve were used to address uncertainty. RESULTS: Quality of life improved significantly in both groups during follow-up compared with baseline. At 5 years, when comparing on-pump and off-pump CABG groups, no differences were found in cumulative life-years (4.851 and 4.766 years, P = .319) and QALY gained (4.150 and 4.105 QALYs, P = .332). Mean cost in US dollars per patient during the trial did not differ significantly between the on-pump and off-pump groups ($5890.29 and $5674.75, respectively, P = .409). Over a lifetime horizon, the incremental cost-effectiveness ratio of on-pump versus off-pump CABG was $12,576 per QALY gained, which is above the suggested cost-effectiveness threshold range (from $3210 to 10,122). In the sensitivity analysis, the probability that on-pump CABG is cost-effective compared to off-pump surgery for a willingness-to-pay threshold of $3212 per QALY gained was <1%. For the $10,122 per QALY threshold, the same probability was 35%. CONCLUSION: This decision-analytic model suggests that on-pump CABG is not cost-effective when compared to off-pump CABG from a public health system perspective.

Utility and quality-adjusted life-years in coronary artery disease: Five-year follow-up of the MASS II trial.

OBJECTIVES: This study evaluated the utility and quality-of-life year measurements for patients with coronary artery disease who underwent any of 3 therapeutic strategies with a 5-year follow-up. METHODS: Quality-of-life data were obtained from the Medicine, Angioplasty, or Surgery Study II trial. To obtain utilities, the 36-Item Short-Form questionnaire was converted to a 6-Dimensional Health State Classification System. RESULTS: Of the 611 initial patients, 579 completed the questionnaire. In all, 188 patients received the surgical treatment-194 the percutaneous, and the remaining 197 the medical. The median utility scores for the 5 years analyzed were 0.809 (95% confidence interval [CI] 0.794-0.842) for patients assigned to percutaneous coronary intervention, 0.755 (95% CI 0.723-0.774) for medical treatment, and 0.780 (95% CI 0.761-0.809) for coronary artery bypass graft surgery. The difference between percutaneous coronary intervention and medical treatment was statistically significant (P < .05, Dunn test). The median cumulative quality-of-life years across the 5 years were 3.802 (95% CI 3.668-3.936) for percutaneous, 3.540 (95% CI 3.399-3.681) for medical, and 3.764 (95% CI 3.638-3.890) for surgery. Additionally, the median quality-of-life years between percutaneous and medical treatment was 0.262 (95% CI 0.068-0.456), between surgery and medical treatment it was 0.224 (95% CI 0.036-0.413), and between surgery and percutaneous coronary intervention it was -0.038 (95% CI -0.221 to -0.146). CONCLUSION: Coronary artery bypass surgery and percutaneous coronary intervention were similar regarding cumulative quality-of-life years; however, they were both superior to that of medical treatment. The results presented are valuable data for further cost-utility studies.

Accuracy of Myocardial Biomarkers in the Diagnosis of Myocardial Infarction After Revascularization as Assessed by Cardiac Resonance: The Medicine, Angioplasty, Surgery Study V (MASS-V) Trial.

BACKGROUND: The lack of a correlation between myocardial necrosis biomarkers and electrocardiographic abnormalities after revascularization procedures has resulted in a change in the myocardial infarction (MI) definition. METHODS: Patients with stable multivessel disease who underwent percutaneous or surgical revascularization were included. Electrocardiograms and concentrations of high-sensitive cardiac troponin I (cTnI) and creatine kinase (CK)-MB were assessed before and after procedures. Cardiac magnetic resonance and late gadolinium enhancement were performed before and after procedures. MI was defined as more than five times the 99th percentile upper reference limit for cTnI and 10 times for CK-MB in percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), respectively, and new late gadolinium enhancement for cardiac magnetic resonance. RESULTS: Of the 202 patients studied, 69 (34.1%) underwent on-pump CABG, 67 (33.2%) off-pump CABG, and 66 (32.7%) PCI. The receiver operating characteristic curve showed the accuracy of cTnI for on-pump CABG, off-pump CABG, and PCI patients was 21.7%, 28.3%, and 52.4% and for CK-MB was 72.5%, 81.2%, and 90.5%, respectively. The specificity of cTnI was 3.6%, 9.4%, and 42.1% and of CK-MB was 73.2%, 86.8%, and 96.4%, respectively. Sensitivity of cTnI was 100%, 100%, and 100% and of CK-MB was 69.2%, 64.3%, and 44.4%, respectively. The best cutoff of cTnI for on-pump CABG, off-pump CABG, and PCI was 6.5 ng/mL, 4.5 ng/mL, and 4.5 ng/mL (162.5, 112.5, and 112.5 times the 99th percentile upper reference limit) and of CK-MB was 37.5 ng/mL, 22.5 ng/mL, and 11.5 ng/mL (8.5, 5.1, and 2.6 times the 99th percentile upper reference limit), respectively. CONCLUSIONS: Compared with cardiac magnetic resonance, CK-MB was more accurate than cTnI for diagnosing MI. These data suggest a higher troponin cutoff for the diagnosis of procedure-related MI.

Type 2 diabetes mellitus and myocardial ischemic preconditioning in symptomatic coronary artery disease patients.

BACKGROUND: The influence of diabetes mellitus on myocardial ischemic preconditioning is not clearly defined. Experimental studies are conflicting and human studies are scarce and inconclusive. OBJECTIVES: Identify whether diabetes mellitus intervenes on ischemic preconditioning in symptomatic coronary artery disease patients. METHODS: Symptomatic multivessel coronary artery disease patients with preserved systolic ventricular function and a positive exercise test underwent two sequential exercise tests to demonstrate ischemic preconditioning. Ischemic parameters were compared among patients with and without type 2 diabetes mellitus. Ischemic preconditioning was considered present when the time to 1.0 mm ST deviation and rate pressure-product were greater in the second of 2 exercise tests. Sequential exercise tests were analyzed by 2 independent cardiologists. RESULTS: Of the 2,140 consecutive coronary artery disease patients screened, 361 met inclusion criteria, and 174 patients (64.2 ± 7.6 years) completed the study protocol. Of these, 86 had the diagnosis of type 2 diabetes. Among diabetic patients, 62 (72 %) manifested an improvement in ischemic parameters consistent with ischemic preconditioning, whereas among nondiabetic patients, 60 (68 %) manifested ischemic preconditioning (p = 0.62). The analysis of patients who demonstrated ischemic preconditioning showed similar improvement in the time to 1.0 mm ST deviation between diabetic and nondiabetic groups (79.4 ± 47.6 vs 65.5 ± 36.4 s, respectively, p = 0.12). Regarding rate pressure-product, the improvement was greater in diabetic compared to nondiabetic patients (3011 ± 2430 vs 2081 ± 2139 bpm x mmHg, respectively, p = 0.01). CONCLUSIONS: In this study, diabetes mellitus was not associated with impairment in ischemic preconditioning in symptomatic coronary artery disease patients. Furthermore, diabetic patients experienced an improvement in this significant mechanism of myocardial protection.

Hypotheses, rationale, design, and methods for evaluation of ischemic preconditioning assessed by sequential exercise tests in diabetic and non-diabetic patients with stable coronary artery disease--a prospective study.

BACKGROUND: Ischemic preconditioning is a powerful mechanism of myocardial protection and in humans it can be evaluated by sequential exercise tests. Coronary Artery Disease in the presence of diabetes mellitus may be associated with worse outcomes. In addition, some studies have shown that diabetes interferes negatively with the development of ischemic preconditioning. However, it is still unknown whether diabetes may influence the expression of ischemic preconditioning in patients with stable multivessel coronary artery disease. METHODS/DESIGN: This study will include 140 diabetic and non-diabetic patients with chronic, stable coronary artery disease and preserved left ventricular systolic function. The patients will be submitted to two sequential exercise tests with 30-minutes interval between them. Ischemic parameters will be compared between diabetic and non-diabetic patients. Ischemic preconditioning will be considered present when time to 1.0 mm ST-segment deviation is greater in the second of two sequential exercise tests. Exercise tests will be analyzed by two independent cardiologists. DISCUSSION: Ischemic preconditioning was first demonstrated by Murry et al. in dog's hearts. Its work was reproduced by other authors, clearly demonstrating that brief periods of myocardial ischemia followed by reperfusion triggers cardioprotective mechanisms against subsequent and severe ischemia. On the other hand, the demonstration of ischemic preconditioning in humans requires the presence of clinical symptoms or physiological changes difficult to be measured. One methodology largely accepted are the sequential exercise tests, in which, the improvement in the time to 1.0 mm ST depression in the second of two sequential tests is considered manifestation of ischemic preconditioning.Diabetes is an important and independent determinant of clinical prognosis. It's a major risk factor for coronary artery disease. Furthermore, the association of diabetes with stable coronary artery disease imposes worse prognosis, irrespective of treatment strategy. It's still not clearly known the mechanisms responsible by these worse outcomes. Impairment in the mechanisms of ischemic preconditioning may be one major cause of this worse prognosis, but, in the clinical setting, this is not known. The present study aims to evaluate how diabetes mellitus interferes with ischemic preconditioning in patients with stable, multivessel coronary artery disease and preserved systolic ventricular function.

Presença de microalbuminúria como fator de risco em pacientes diabéticos portadores de doença arterial coronária estável / Microalbuminuria as a risk factor in diabetic patients with stable coronary artery disease

A microalbuminúria é admitida como o principal marcadorpara o desenvolvimento de nefropatia diabética. Sua presençatambém é preditora independente de morbidade e mortalidadecardiovasculares. A relação da microalbuminúria com fatoresde risco clássicos para a doença multiarterial coronária (DAC)também tem sido mostrada em estudos epidemiológicos. Opresente estudo tem o objetivo de determinar a prevalênciade microalbuminúria em um grupo de pacientes diabéticosportadores de DAC e relacionar a sua presença com os fatoresclássicos de risco cardiovascular. Trata-se de um estudotransversal realizado com pacientes diabéticos portadoresde DAC, que realizam tratamento no Instituto do Coração(InCor-HCFMUSP). Foram avaliados os seguintes parâmetros:idade, presença ou ausência de HAS, tempo de diabetes,tabagismo, perfil lipídico, hemoglobina glicada e presença demicroalbuminúria/proteinúria, a partir da coleta urinária em24 horas. Os pacientes foram estratificados em três grupos,conforme o valor de albuminúria. Foram feitas análisesestatísticas comparando as diferentes variáveis entre os trêsgrupos. Nesta amostra de pacientes portadores de DM e DACmultiarterial estável, observou-se uma relação crescente entreos valores de albuminúria e o tempo de diabetes mellitus, níveisséricos de LDL-colesterol e triglicérides.

Microalbuminuria is accepted as a surrogate marker for thedevelopment of diabetic nephropathy. Its presence is alsoan independent predictor of cardiovascular morbidity andmortality. The relationship of microalbuminuria with classicrisk factors for coronary multivessel disease (CAD) has alsobeen shown in epidemiological studies. The present studyaims to determine the prevalence of microalbuminuria ina group of diabetic patients with CAD and correlate theirpresence with the classic cardiovascular risk factors. This isa cross-sectional study with diabetic patients with CAD whoperform treatment at the Heart Institute (Incor-HCFMUSP).We evaluated the following parameters: age, presence orabsence of hypertension, duration of diabetes, smoking, lipidprofile, glycated hemoglobin and microalbuminuria/proteinuriafrom urine collection in 24 hours. Patients were stratified into3 groups according to the value of albuminuria. Statisticalanalyzes were performed comparing the different variablesamong the three groups. In this sample of patients with diabetesand stable multivessel CAD there was a growing relationshipbetween the values of albuminuria and duration of diabetesmellitus, serum LDL-cholesterol and triglycerides.

Impact of diabetes on 10-year outcomes of patients with multivessel coronary artery disease in the Medicine, Angioplasty, or Surgery Study II (MASS II) trial.

INTRODUCTION: Diabetes mellitus is a major cause of coronary artery disease (CAD). Despite improvement in the management of patients with stable CAD, diabetes remains a major cause of increased morbidity and mortality. There is no conclusive evidence that either modality is better than medical therapy alone for the treatment of stable multivessel CAD in patients with diabetes in a very long-term follow-up. Our aim was to compare 3 therapeutic strategies for stable multivessel CAD in a diabetic population and non-diabetic population. METHODS: It was compared medical therapy (MT), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) in 232 diabetic patients and 379 nondiabetic patients with multivessel CAD. Endpoints evaluated were overall and cardiac mortality. RESULTS: Patients (n = 611) were randomized to CABG (n = 203), PCI (n = 205), or MT (n = 203). In a 10-year follow-up, more deaths occurred among patients with diabetes than among patients without diabetes (P = .001) for overall mortality. In this follow-up, 10-year mortality rates were 32.3% and 23.2% for diabetics and non-diabetics respectively (P = .024). Regarding cardiac mortality, 10-year cardiac mortality rates were 19.4% and 12.7% respectively (P = .031).Considering only diabetic patients and stratifying this population by treatment option, we found mortality rates of 31.3% for PCI, 27.5% for CABG and 37.5% for MT (P = .015 for CABG vs MT) and cardiac mortality rates of 18.8%, 12.5% and 26.1% respectively (P = .005 for CABG vs MT). CONCLUSIONS/INTERPRETATION: Among patients with stable multivessel CAD and preserved left ventricular ejection fraction, the 3 therapeutic regimens had high rates of overall and cardiac-related deaths among diabetic compared with non-diabetic patients. Moreover, better outcomes were observed in diabetic patients undergoing CABG compared to MT in relation to overall and cardiac mortality in a 10-year follow-up.

Aplicação de questionários de qualidade de vida na doença arterial coronariana / The application of surveys of quality of life in coronary artery disease

O avanço dos métodos diagnósticos, o melhor entendimento da fisiopatologia dos eventos coronarianos, a eficiência das medidas de prevenção cardiovasculares e a utilização de fármacos têm permitido modificar a evolução e o prognóstico da DAC. Essas ferramentas contribuíram, de um lado, para um aumento da sobrevivência e, de outro, para o prolongamento das possíveis comorbidades desencadeadas pelas doenças crônicas. Assim, tais condições poderão interferir no estado emocional, físico, social e, principalmente, na qualidade de vida. Qualidade de vida é uma expressão com diferentes representações, sendo hoje uma importante medida de desfecho, muito mencionada nos últimos tempos, seja na linguagem cotidiana ou no contexto científico. O conceito não é novo, porém sua importância e uso tem sido necessário na prática dos cuidados e nas pesquisas em saúde, que desperta o interesse em investigar este aspecto em decorrência das mudanças demográficas caracterizadas, principalmente, pela longevidade e pelo crescimento econômico que impõem a adoção de novos paradigmas nas políticas públicas e nas práticas de saúde...

Custos comparativos entre a cirurgia de revascularização miocárdica com e sem circulação extracorpórea / Comparative costs between myocardial revascularization with and without cardiopulmonary bypass

O surgimento do circuito de circulação extracorpórea, após os anos 50, habilitou os cirurgiões a realizarem grande variedade de procedimentos no coração, os quais eram tecnicamente impossíveis. Todavia, pela sua natureza não fisiológica desse circuito, observou-se o surgimento de uma série de efeitos adversos. Nessa condição estão incluídos o trauma cirúrgico, o contato do sangue com a superfície do circuito da circulação extracorpórea e problemas com a reperfusão pulmonar. Além disso, ocorre a ativação de respostas inflamatórias sistêmicas alterando os níveis de marcadores inflamatórios, os quais elevam o nível da ativação do complemento, discrasias sanguíneas com potenciais riscos de embolização com alteração da cascata de coagulação, da ativação de neutrófilos e da síntese de várias citoquinas. Estimula o aumento da liberação das células mononucleares, incluindo fator de necrose tumoral, interleucina-8 e marcadores neurobioquímicos, com repercussões sistêmicas, elevando a morbidade pós-operatória, e disfunções múltiplas em órgãos, tais como coração, cérebro e rins. Com o objetivo de diminuir esses efeitos deletérios da circulação extracorpórea houve um ressurgimento no interesse de técnicas menos invasivas nas cirurgias de revascularização miocárdica, suprimindo a necessidade do uso desse circuito e, com o auxílio dos estabilizadores do coração, temos observado um crescimento acentuado dessa alternativa, particularmente em pacientes de alto risco com disfunção renal, problemas respiratórios e outras doenças sistêmicas. Teoricamente, com a eliminação desses circuitos, muitos desses efeitos adversos podem ser suprimidos. Evidências sugerem que a revascularização cirúrgica do miocárdio sem circulação extracorpórea é tão segura e efetiva quanto à revascularização miocárdica com CEC e o custo inicial, em curto prazo, é menor que a revascularização miocárdica com CEC...

Avaliação de pacientes diabéticos portadores de doença arterial coronariana participantes de um programa de controle de peso / Evaluation of diabetic patients suffering from coronary artery disease participants in a weight control program

Este estudo avaliou a evolução do estado nutricional, perfil lipídico, glicêmico e consumo alimentar de diabéticos coronarianos participantes de um programa de controle de peso. O estudo foi retrospectivo, com coleta de dados de prontuários de 17 diabéticos participantes do programa, acompanhado durante um ano. Avaliou-se Índice de Massa Corporal (IMC), circunferência abdominal (Ca), perfil lipídico e glicêmico. Foi calculado valor energético total (VET) e consumo de nutrientes baseados em diários alimentares mensais. Os diabéticos tinham em média 65 ± 9 anos, sendo 41,2% mulheres. As principais alterações dietéticas foram a substituição dos laticínios integrais pelos desnatados, do açúcar pelo adoçante dietético e das carnes gordas pelas magras. Não se observou redução significante de peso (p=0,529), IMC (p=0,469) e da Ca (p=0,120), apesar de uma aparente redução calórica (p=0,026). O perfil lipídico não apresentou alterações significantes, enquanto a hemoglobina glicada mostrou aumento da glicemia (p=0,015). O consumo de nutrientes se manteve adequado em carboidratos (58% do VET), gordura total (21% do VET) e colesterol (138mg), alto consumo proteico (27% do VET) e de gordura saturada (8% do VET) e insuficiente em gorduras monoinsaturadas (9% do VET), poli-insaturadas (4% do VET) e fibras (13g). Os diabéticos que participaram do programa de redução de peso não apresentaram alteração ponderal e do perfil lipídico, mas a hemoglobina glicada aumentou ao longo de um ano de acompanhamento, apesar de modificações qualitativas positivas no seu padrão alimentar...

Effect of hypoglycemic agents on ischemic preconditioning in patients with type 2 diabetes and symptomatic coronary artery disease.

OBJECTIVE: To assess the effect of two hypoglycemic drugs on ischemic preconditioning (IPC) patients with type 2 diabetes and coronary artery disease (CAD). RESEARCH DESIGN AND METHODS: We performed a prospective study of 96 consecutive patients allocated into two groups: 42 to group repaglinide (R) and 54 to group vildagliptin (V). All patients underwent two consecutive exercise tests (ET1 and ET2) in phase 1 without drugs. In phase 2, 1 day after ET1 and -2, 2 mg repaglinide three times daily or 50 mg vildagliptin twice daily was given orally to patients in the respective group for 6 days. On the seventh day, 60 min after 6 mg repaglinide or 100 mg vildagliptin, all patients underwent two consecutive exercise tests (ET3 and ET4). RESULTS: In phase 1, IPC was demonstrated by improvement in the time to 1.0 mm ST-segment depression and rate pressure product (RPP). All patients developed ischemia in ET3; however, 83.3% of patients in group R experienced ischemia earlier in ET4, without significant improvement in RPP, indicating the cessation of IPC (P < 0.0001). In group V, only 28% of patients demonstrated IPC cessation, with 72% still having the protective effect (P < 0.0069). CONCLUSIONS: Repaglinide eliminated myocardial IPC, probably by its effect on the KATP channel. Vildagliptin did not damage this protective mechanism in a relevant way in patients with type 2 diabetes and CAD, suggesting a good alternative treatment in this population.

Custos comparativos entre a revascularização miocárdica com e sem circulação extracorpórea / Comparative costs between myocardial revascularization with or without extracorporeal circulation

FUNDAMENTO: Técnicas cirúrgicas de revascularização miocárdica sem o uso de circulação extracorpórea (CEC) projetaram esperanças de resultados operatórios com menor dano sistêmico, menor ocorrência de complicações clínicas e menor tempo de internação hospitalar, gerando expectativas de menor custo hospitalar. OBJETIVO: Avaliar o custo hospitalar em pacientes submetidos à cirurgia de revascularização miocárdica com e sem o uso de CEC, e em portadores de doença multiarterial coronariana estável com função ventricular preservada. MÉTODOS: Os custos hospitalares foram baseados na remuneração governamental vigente. Acrescentaram-se aos custos uso de órteses e próteses, complicações e intercorrências clínicas. Consideraram-se o tempo e os custos de permanência na UTI e de internação hospitalar. RESULTADOS: Entre janeiro de 2002 e agosto de 2006, foram randomizados 131 pacientes para cirurgia com CEC (CCEC) e 128 pacientes sem CEC (SCEC). As características basais foram semelhantes para os dois grupos. Os custos das intercorrências cirúrgicas foram significativamente menores (p < 0,001) para pacientes do grupo SCEC comparados ao grupo CCEC (606,00 ± 525,00 vs. 945,90 ± 440,00), bem como os custos na UTI: 432,20 ± 391,70 vs. 717,70 ± 257,70, respectivamente. Os tempos de permanência na sala cirúrgica foram (4,9 ± 1,1 h vs. 3,9 ± 1,0 h), (p < 0,001) na UTI (48,2 ± 17,2 h vs. 29,2 ± 26,1h) (p < 0,001), com tempo de entubação (9,2 ± 4,5 h vs. 6,4 ± 5,1h) (p < 0,001) para pacientes do grupo com e sem CEC, respectivamente. CONCLUSÃO: Os resultados permitem concluir que a cirurgia de revascularização miocárdica, sem circulação extracorpórea, proporciona diminuição de custos operacionais e de tempo de permanência em cada setor relacionado ao tratamento cirúrgico.

BACKGROUND: Surgical techniques of myocardial revascularization without the use of extracorporeal circulation (ECC) have raised hopes of attaining operative results with less systemic damage, lower occurrence of clinical complications and shorter hospital stay duration, generating expectations of lower hospital costs. OBJECTIVE: To evaluate the hospital costs in patients submitted to myocardial revascularization with and without ECC and in those with stable multiarterial coronary disease with preserved ventricular function. METHODS: The hospital costs were based on the existing governmental reimbursement. The costs included that of ortheses and prostheses and clinical complications. The time and costs of ICU stay and hospital stay duration were considered. RESULTS: Between January 2002 and August 2006, 131 patients were randomized to surgery with ECC (SECC), whereas 128 were randomized to surgery without ECC (WECC). The basal characteristics were similar for both groups. The costs of surgical complications were significantly lower (p < 0.001) in patients from the WECC when compared to the SECC group (606.00 ± 525.00 vs. 945.90 ± 440.00), as well as ICU costs: 432.20 ± 391.70 vs. 717.70 ± 257.70, respectively. The duration of the operating room stay were 4.9 ± 1.1 h vs. 3.9 ± 1.0 h, p < 0.001; at the ICU it was 48.2 ± 17.2 h vs. 29.2 ± 26.1h) (p < 0.001), with intubation time of 9.2 ± 4.5 h vs. 6.4 ± 5.1h, p < 0.001 for patients from the group with and without ECC, respectively. CONCLUSION: The present study allowed us to conclude that the myocardial revascularization surgery without extracorporeal circulation results in the decrease of operational costs and duration of the stay in each section related to the surgical treatment.

Quality of life after on-pump and off-pump coronary artery bypass grafting surgery.

BACKGROUND: Coronary artery bypass grafting techniques without using cardiopulmonary bypass (off-pump CABG) result in less systemic damage, less clinical complications, less time spent in the intensive care unit, and shorter hospital stays, thereby raising the perspective of improved quality of life (QOL) for patients. OBJECTIVE: To assess quality of life in patients who underwent on-pump and off-pump CABG. METHODS: The Short-Form Health Survey (SF-36) Questionnaire was administered to patients with stable multivessel coronary artery disease (CAD) and preserved ventricular function before and at six and 12 months after surgery. RESULTS: Between January 2002 and December 2006, a total of 202 patients were randomized to either on-pump or off-pump CABG. Demographic, clinical, laboratory, and angiographic characteristics were similar in both groups. One hundred and five patients underwent off-pump CABG and 97 underwent on-pump CABG. In the postoperative course, 22 patients had myocardial infarction, 29 reported angina, one was reoperated, and three experienced stroke. No patient died. Quality of life, as measured by the SF-36 questionnaire, was shown to be similar in both groups regarding physical and mental components. However, male patients showed a significant improvement in physical functioning and role limitations due to physical problems. Also, a large number of patients in both groups returned to work. CONCLUSION: Progressive enhancement in quality of life and early return to work were observed for all patients, regardless of the surgical technique used. Save for a greater improvement in physical functioning and role limitations due to physical problems experienced by male patients, no statistically significant differences were found in the other domains between groups.

Qualidade de vida após revascularização cirúrgica do miocárdio com e sem circulação extracorpórea / Quality of life after on-pump and off-pump coronary artery bypass grafting surgery

FUNDAMENTO: Técnicas de cirurgia de revascularização miocárdica (RM) sem o uso de circulação extracorpórea (CEC) possibilitou resultados operatórios com menor dano sistêmico, menor ocorrência de complicações clínicas, menor permanência na sala de terapia intensiva e também no tempo de internação, gerando expectativas de melhor qualidade de vida (QV) dos pacientes. OBJETIVO: Avaliar a QV em pacientes submetidos à cirurgia de revascularização com e sem CEC. MÉTODOS: Em pacientes com doença multiarterial coronariana (DAC) estável e função ventricular preservada, aplicou-se o Short-Form Health Survey (SF-36) Questionnaire antes da cirurgia e depois de 6 e 12 meses. RESULTADOS: Entre janeiro de 2002 e dezembro de 2006, foram randomizados 202 pacientes para cirurgia de RM. As características demográficas clínicas laboratoriais e angiográficas foram semelhantes nos dois grupos. Desses pacientes, 105 foram operados sem CEC e 97 com CEC. Na evolução, 22 pacientes sofreram infarto, 29 relataram angina, um reoperou, 3 tiveram AVC e nenhum morreu. A avaliação da QV mostrou similaridade nos dois grupos em relação ao componente físico e mental. Todavia, encontrou-se significativa melhora da capacidade funcional e percepção do aspecto físico nos pacientes do sexo masculino. Além disso, um expressivo número de pacientes dos dois grupos retornou ao trabalho. CONCLUSÃO: Em todos os pacientes estudados, observaram-se melhora progressiva da qualidade de vida e retorno precoce ao trabalho, independentemente da técnica cirúrgica empregada. Exceto pela melhor percepção da capacidade funcional e do aspecto físico experimentado pelos homens, não houve diferença estatística nos resultados dos demais domínios alcançados pelos dois grupos estudados.

BACKGROUND: Coronary artery bypass grafting techniques without using cardiopulmonary bypass (off-pump CABG) result in less systemic damage, less clinical complications, less time spent in the intensive care unit, and shorter hospital stays, thereby raising the perspective of improved quality of life (QOL) for patients. OBJECTIVE: To assess quality of life in patients who underwent on-pump and off-pump CABG. METHODS: The Short-Form Health Survey (SF-36) Questionnaire was administered to patients with stable multivessel coronary artery disease (CAD) and preserved ventricular function before and at six and 12 months after surgery. RESULTS: Between January 2002 and December 2006, a total of 202 patients were randomized to either on-pump or off-pump CABG. Demographic, clinical, laboratory, and angiographic characteristics were similar in both groups. One hundred and five patients underwent off-pump CABG and 97 underwent on-pump CABG. In the postoperative course, 22 patients had myocardial infarction, 29 reported angina, one was reoperated, and three experienced stroke. No patient died. Quality of life, as measured by the SF-36 questionnaire, was shown to be similar in both groups regarding physical and mental components. However, male patients showed a significant improvement in physical functioning and role limitations due to physical problems. Also, a large number of patients in both groups returned to work. CONCLUSION: Progressive enhancement in quality of life and early return to work were observed for all patients, regardless of the surgical technique used. Save for a greater improvement in physical functioning and role limitations due to physical problems experienced by male patients, no statistically significant differences were found in the other domains between groups.

Comparative costs between myocardial revascularization with or without extracorporeal circulation.

BACKGROUND: Surgical techniques of myocardial revascularization without the use of extracorporeal circulation (ECC) have raised hopes of attaining operative results with less systemic damage, lower occurrence of clinical complications and shorter hospital stay duration, generating expectations of lower hospital costs. OBJECTIVE: To evaluate the hospital costs in patients submitted to myocardial revascularization with and without ECC and in those with stable multiarterial coronary disease with preserved ventricular function. METHODS: The hospital costs were based on the existing governmental reimbursement. The costs included that of ortheses and prostheses and clinical complications. The time and costs of ICU stay and hospital stay duration were considered. RESULTS: Between January 2002 and August 2006, 131 patients were randomized to surgery with ECC (SECC), whereas 128 were randomized to surgery without ECC (WECC). The basal characteristics were similar for both groups. The costs of surgical complications were significantly lower (p < 0.001) in patients from the WECC when compared to the SECC group (606.00 +/- 525.00 vs. 945.90 +/- 440.00), as well as ICU costs: 432.20 +/- 391.70 vs. 717.70 +/- 257.70, respectively. The duration of the operating room stay were 4.9 +/- 1.1 h vs. 3.9 +/- 1.0 h, p < 0.001; at the ICU it was 48.2 +/- 17.2 h vs. 29.2 +/- 26.1h) (p < 0.001), with intubation time of 9.2 +/- 4.5 h vs. 6.4 +/- 5.1h, p < 0.001 for patients from the group with and without ECC, respectively. CONCLUSION: The present study allowed us to conclude that the myocardial revascularization surgery without extracorporeal circulation results in the decrease of operational costs and duration of the stay in each section related to the surgical treatment.

Quality of life after surgical myocardial revascularization, angioplasty or medical treatment.

BACKGROUND: Although the clinical benefits of coronary interventions seem to be confirmed, their effects on quality of life (QoL) are still scarcely studied. OBJECTIVE: To assess the QoL in multivessel coronary disease in patients randomly undergoing surgery, angioplasty or medical treatment. METHODS: The Short-Form Health Survey (SF-36) questionnaire was answered by 483 patients. Of these, 161 underwent surgical revascularization, 166 underwent angioplasty, and 153 were medically treated. RESULTS: At baseline, 86% of the patients referred angina, 34% referred infarction, and 32% were smokers. Medical Treatment: 12 patients (7.7%) had AMI, 24 (15.3%) underwent surgery, and 19 (12.1%) died. In addition, 5 (3.2%) had stroke, and 40 (25.6%) had angina. As regards the mental component, 64.1% and 30.8% had their condition improved and worsened, respectively. As regards the physical component, 70.5% and 27.6% had their condition improved and worsened, respectively. SURGERY: 13 patients (8.1%) had AMI, 2 (1.2%) underwent surgery, and 12(7.4%) died. Also, 9 (5.6%) had stroke and 30 (18.6%) had angina. As regards the mental component, 72.7 % and 25.5% had their condition improved and worsened, respectively. As regards the physical component, 82.6% and 16.1% had their condition improved and worsened, respectively. Angioplasty: 18 patients (10.9%) had AMI, 51 (30.7%) underwent interventions, and 18 (19.9%) died. Additionally, six (3.6%) presented stroke and 35 (21%) reported angina. As regards the mental component, 66.9% and 26.5% had their condition improved and worsened, respectively. As regards the physical component, 77.1% and 20.5% had their condition improved and worsened, respectively. CONCLUSION: Improvement was observed in all domains and in the three therapeutic modalities. Comparatively, surgery had provided a better quality of life after a four-year follow-up.

Qualidade de vida após revascularização cirúrgica do miocárdio, angioplastia ou tratamento clínico / Quality of life after surgical myocardial revascularization, angioplasty or medical treatment

FUNDAMENTO: Ainda que os benefícios clínicos das intervenções coronarianas parecem confirmados, seus efeitos na qualidade de vida (QV) permanecem pouco estudados. OBJETIVO: Avaliar a qualidade de vida (QV) na doença multiarterial coronariana em pacientes submetidos randomicamente a cirurgia, angioplastia ou tratamento clínico. MÉTODOS: Foi utilizando Short-Form Health Survey (SF36) questionnaire em 483 pacientes. Desses, 161 foram revascularizados; 166 receberam angioplastia e 153 tiveram tratamento clínico. RESULTADOS: Na internação, 86 por cento referiam angina; 34 por cento, infarto; e 32 por cento fumavam. Tratamento clínico: 12 pacientes (7,7 por cento) tiveram infarto agudo do miocárdio (IAM); 24 (15,3 por cento) receberam cirurgia; e 19 (12,1 por cento) morreram. Além disso, cinco (3,2 por cento) sofreram AVC e 40 (25,6 por cento) tinham angina. No componente mental, 64,1 por cento melhoram e 30,8 por cento pioram a condição. No componente físico, 70,5 por cento melhoram e 27,6 por cento pioram a condição. Cirurgia: 13 pacientes (8,1 por cento) tiveram IAM, dois (1,2 por cento) receberam cirurgia; 12 (7,4 por cento) morreram. Em adição, nove (5,6 por cento) sofreram AVC e 30 (18,6 por cento) sofriam angina. No componente mental, 72,7 por cento melhoram e 25,5 por cento pioram a condição. No componente físico, 82,6 por cento melhoram e 16,1 por cento pioram a condição. Angioplastia: 18 pacientes (10,9 por cento) tiveram IAM, 51 (30,7 por cento) receberam intervenções e 18 (19,9 por cento) morreram. Além disso, seis (3,6 por cento) sofreram AVC e 35 (21 por cento) relatavam angina. No componente mental, 66,9 por cento melhoram e 26,5 por cento pioram a condição No componente físico, 77,1 por cento melhoram e 20,5 por cento pioram a condição. CONCLUSÃO: Observou-se melhora em todos os domínios e nas três opções terapêuticas. Comparativamente, a cirurgia ofereceu melhor qualidade de vida após quatro anos de seguimento.

BACKGROUND: Although the clinical benefits of coronary interventions seem to be confirmed, their effects on quality of life (QoL) are still scarcely studied. OBJECTIVE: To assess the QoL in multivessel coronary disease in patients randomly undergoing surgery, angioplasty or medical treatment. METHODS: The Short-Form Health Survey (SF-36) questionnaire was answered by 483 patients. Of these, 161 underwent surgical revascularization, 166 underwent angioplasty, and 153 were medically treated. RESULTS: At baseline, 86 percent of the patients referred angina, 34 percent referred infarction, and 32 percent were smokers. Medical Treatment: 12 patients (7.7 percent) had AMI, 24 (15.3 percent) underwent surgery, and 19 (12.1 percent) died. In addition, 5 (3.2 percent) had stroke, and 40 (25.6 percent) had angina. As regards the mental component, 64.1 percent and 30.8 percent had their condition improved and worsened, respectively. As regards the physical component, 70.5 percent and 27.6 percent had their condition improved and worsened, respectively. Surgery: 13 patients (8.1 percent) had AMI, 2 (1.2 percent) underwent surgery, and 12(7.4 percent) died. Also, 9 (5.6 percent) had stroke and 30 (18.6 percent) had angina. As regards the mental component, 72.7 percent and 25.5 percent had their condition improved and worsened, respectively. As regards the physical component, 82.6 percent and 16.1 percent had their condition improved and worsened, respectively. Angioplasty: 18 patients (10.9 percent) had AMI, 51 (30.7 percent) underwent interventions, and 18 (19.9 percent) died. Additionally, six (3.6 percent) presented stroke and 35 (21 percent) reported angina. As regards the mental component, 66.9 percent and 26.5 percent had their condition improved and worsened, respectively. As regards the physical component, 77.1 percent and 20.5 percent had their condition improved and worsened, respectively. CONCLUSION: Improvement was observed in all domains...

Quality of life in patients with symptomatic multivessel coronary artery disease: a comparative post hoc analyses of medical, angioplasty or surgical strategies-MASS II trial.

OBJECTIVE: We evaluated the impact of Coronary Artery Bypass Graft Surgery (CABG), Percutaneous Coronary Intervention (PCI) or Medical Therapy (MT) on self-perceived quality of life among patients with stable Coronary Artery Disease (CAD). BACKGROUND: The Medicine, Angioplasty and Surgery Study (MASS-II) implemented initial policies of CABG, PCI or continued medical treatment in patients who allow assessment of mid-term health consequences. METHODS: A total of 542 patients were randomly assigned to CABG (175), to PCI (180) and to MT (187). The short form 36 (SF-36) self-administered quality of life (QoL) questionnaires were applied at baseline, 6 months and 12 months later. RESULTS: All the three therapeutic strategies presented significant improvement in all dimensions of the SF-36 during the follow-up (p<0.0001). However, the CABG group was the one that had significantly greater improvement in physical and social functioning, vitality and general health when compared to MT and PCI. Also, men had the best QoL at the beginning of the treatment when compared to women, with a progressive improvement after 6 and 12 months. CONCLUSIONS: The quality of life was better in both CABG and PCI groups compared to MT after 1 year of follow-up. However, the patients submitted to CABG were the ones that presented the greater and progressive improvement of QoL. Also, men presented better QoL at the beginning and after treatment when compared to women.