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Cost-effectiveness analysis has long been practiced; registries date back to the United States of America War Department in 1886. In addition, everyone does intuitive cost-effectiveness analyses in their daily lives. In routine medical care, health economic assessment becomes increasingly important due to progressively limited resources, rising demands, population increases, and continuous therapeutic innovations. The health economic assessment must analyze the outcomes and costs of actions and technologies as objectively as possible to guarantee efficient assessment of novel interventions for Public Health Policy. In other words, it is necessary to determine how much society or patients are willing to or able to pay for novel interventions compared with existing alternatives, given the available resources. In addition, increased cost may displace other health care services already provided in case of fixed budget health care systems. To conduct such analyses, researchers must use standard methodologies and interpretations in light of regional characteristics according to social and economic determinants as well as clinical practice. Such an approach may be essential for transforming the current healthcare system to a value-based model. In this narrative review, concepts of the importance of and some approaches to health economic evaluation in clinical practice will be discussed.

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OBJECTIVE: The use of ventricular assist devices (VAD) is increasing; however, diagnosis and management of device complications, such as the driveline exit site (DES) being the portal of entry for fungal infection, is not well known. METHOD: A systematic review involving searching PubMed (2005 to July 2020) was conducted. The case of a 43-year-old female patient who had a left VAD (LVAD) (HeartMate 3, Abbott, US) is also reported. RESULTS: The patient was successfully treated with ketoconazole cream and oral fluconazole for likely superficial DES fungal infections. We included 36 studies that met our inclusion criteria; however, only one was included in our review. In the literature, five cases of DES fungal infection were reported, with Candida being the only fungal pathogen. CONCLUSION: LVAD fungal infections are uncommon but can be responsible for high mortality rates, require a prolonged period of treatment, and can present a huge problem when surgical alternatives are not available. However, Candida species are most common. Fungal infections can only produce clear discharge, and so the classic definition of driveline infection based on purulent secretion can vary. Negative skin culture does not exclude the diagnosis of infection of the DES, and so empirical diagnosis may only be clinically based.

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BACKGROUND: Anthracycline (ANT) is often used for breast cancer treatment but its clinical use is limited by cardiotoxicity (CTX). CECCY trial demonstrated that the ß-blocker carvedilol (CVD) could attenuate myocardial injury secondary to ANT. Mieloperoxydase (MPO) is a biomarker of oxidative stress and galectin-3 (Gal-3) is a biomarker of fibrosis and cardiac remodeling. We evaluated the correlation between MPO and Gal-3 behavior with CTX. MATERIALS AND METHODS: A post hoc analysis was performed in the patients who were included in the CECCY trial. A total of 192 women had her blood samples stored during the study at -80°C until the time of assay in a single batch. Stored blood samples were obtained at baseline, 3 and 6 months after randomization. We excluded samples from 18 patients because of hemolysis. MPO and Gal-3 were measured using Luminex xMAP technology through MILLIPLEX MAP KIT (Merck Laboratories). RESULTS: 26 patients (14.9%) had a decrease of at least 10% in LVEF at 6 months after the initiation of chemotherapy. Among these, there was no significant difference in the MPO and Gal-3 when compared to the group without drop in LVEF (p = 0.85 for both MPO and Gal-3). Blood levels of MPO [baseline: 13.2 (7.9, 24.8), 3 months: 17.7 (11.1, 31.1), 6 months: 19.2 (11.1, 37.8) ng/mL] and Gal-3 [baseline: 6.3 (5.2, 9.6), 3 months: 12.3 (9.8, 16.0), 6 months: 10.3 (8.2, 13.1) ng/mL] increased after ANT chemotherapy, and the longitudinal changes were similar between the placebo and CVD groups (p for interaction: 0.28 and 0.32, respectively). In an exploratory analysis, as there is no normal cutoff value established for Gal-3 and MPO in the literature, the MPO and Gal-3 results were splited in two groups: above and below median. In the placebo group, women with high (above median) baseline MPO blood levels demonstrated a greater increase in TnI blood levels than those with low baseline MPO blood levels (p = 0.041). Compared with placebo, CVD significantly reduced TnI blood levels in women with high MPO blood levels (p < 0.001), but did not reduce the TnI levels in women with low baseline MPO blood levels (p = 0.97; p for interaction = 0.009). There was no significant interaction between CVD treatment and baseline Gal-3 blood levels (p for interaction = 0.99). CONCLUSIONS: In this subanalysis of the CECCY trial, MPO and Gal-3 biomarkers did not predict the development of CTX. However, MPO blood levels above median was associated with more severe myocardial injury and identified women who were most likely to benefit from carvedilol for primary prevention (NCT01724450).

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Objetivo: Apreender representações sociais de puérperas sobre as mamas no período do aleitamento. Método: Pesquisa qualitativa, fundamentada na teoria das representações sociais. Utilizou-se o teste de associação livre de palavras, aplicado a 95 puérperas num Centro de Parto Normal de Salvador-Ba, no período de novembro de 2017 a fevereiro de 2018. Realizou-se a análise da estrutura das representações sociais a partir da árvore de similitude das evocações livres. Resultados: As representações sociais das puérperas sobre as mamas são marcantemente a dor e o tamanho, influenciadas por elementos periféricos que envolvem o ato de amamentar e a saúde, estando associadas as suas crenças, conhecimentos e valores afetivos. As participantes reconhecem que as mamas são partes importantes do corpo que requerem cuidado cotidianamente. Conclusão: Os achados corroboram para novos olhares para subjetividades que envolvem o aleitamento, podendo nortear práticas de cuidado em saúde que colaborem para satisfação enquanto nutriz.(AU)

Objective: To apprehend social representations of postpartum women about their breasts during the breastfeeding period. Method: Qualitative research, based on the theory of social representations. The free word association test was used, applied to 95 postpartum women in a Normal Delivery Center in Salvador-Ba, from November 2017 to February 2018. The analysis of the structure of social representations was carried out from the tree of similarity of free evocations. Results: The postpartum women's social representations about the breasts are markedly pain and size, influenced by peripheral elements that involve the act of breastfeeding and health, being associated with their beliefs, knowledge and affective values. Participants recognize that the breasts are important parts of the body that require daily care. Conclusion: The findings corroborate new perspectives on subjectivities that involve breastfeeding, which may guide health care practices that contribute to satisfaction as a nursing mother.(AU)

Objetivo: Aprender las representaciones sociales de las mujeres posparto sobre sus senos durante el período de lactancia. Método: Investigación cualitativa, basada en la teoría de las representaciones sociales. Se utilizó la prueba de asociación libre de palabras, aplicada a 95 puérperas en un Centro de Parto Normal en Salvador-Ba, de noviembre de 2017 a febrero de 2018. El análisis de la estructura de las representaciones sociales se realizó a partir del árbol de similitud de evocaciones libres. Resultados: Las representaciones sociales de las mujeres posparto sobre las mamas son marcadamente dolorosas y de tamaño, influenciadas por elementos periféricos que involucran el acto de la lactancia materna y la salud, estando asociadas a sus creencias, conocimientos y valores afectivos. Los participantes reconocen que los senos son partes importantes del cuerpo que requieren cuidados diarios. Conclusión: Los hallazgos corroboran nuevas perspectivas sobre subjetividades que involucran la lactancia materna, las cuales pueden orientar prácticas de cuidado de la salud que contribuyan a la satisfacción como madre lactante.(AU)

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Fundamento: A cardiotoxicidade induzida por quimioterapia (CiC) é uma complicação importante entre os pacientes que recebem antraciclinas. Biomarcadores e parâmetros de imagem têm sido estudados por sua capacidade de identificar pacientes com risco de desenvolver essa complicação. O strain longitudinal global do ventrículo esquerdo (SLG-VE) tem sido descrito como um parâmetro sensível para detectar disfunção sistólica, mesmo na presença de fração de ejeção do ventrículo esquerdo (FEVE) preservada. Objetivo: avaliar o papel do SLG-VE como preditor de CiC. Métodos: O presente estudo consiste em uma análise post-hoc do estudo CECCY (Carvedilol for Prevention of ChemotherapyRelated Cardiotoxicity [Carvedilol para Prevenção da Cardiotoxicidade Relacionada à Quimioterapia]), que avaliou a prevenção primária de cardiotoxicidade com carvedilol durante quimioterapia com doxorrubicina em uma população com câncer de mama. Definiu-se cardiotoxicidade como uma redução >10% na FEVE. O SLG-VE foi obtido antes da quimioterapia em pacientes sem doença cardiovascular prévia ou anormalidades no ecocardiograma. Resultados: Trinta e um pacientes submetidos a estudo ecocardiográfico completo incluindo avaliação de SLG-VE antes da quimioterapia foram incluídos nesta análise. Um SLG-VE absoluto <16,9% antes da quimioterapia mostrou 100% de sensibilidade e 73% de especificidade para predizer cardiotoxicidade (AUC=0,85; IC 95% 0,680­0,959, p<0,001). Nesta população, os valores de FEVE antes da quimioterapia não foram preditores de CiC (IC 95% 0,478 a -0,842, p=0,17). A associação de baixos níveis séricos de SLG-VE (<17%) e BNP (>17 pg/mL) dois meses após a quimioterapia aumentou a precisão para detectar CiC de início precoce (100% de sensibilidade, 88% de especificidade, AUC=0,94; IC 95% 0,7810,995, p<0,0001). Conclusões: Nossos dados sugerem que o SLG-VE é um possível preditor de cardiotoxicidade induzida por quimioterapia. São necessários estudos maiores para confirmar a relevância clínica desse parâmetro ecocardiográfico nesse cenário clínico. (AU)

Background: Chemotherapy-induced cardiotoxicity (ChC) is an important complication among patients receiving anthracyclines. Biomarkers and imaging parameters have been studied for their ability to identify patients at risk of developing ChC. Left ventricular global longitudinal strain (LV-GLS) is a sensitive parameter for detecting systolic dysfunction despite the presence of preserved left ventricular ejection fraction (LVEF). Objective: To evaluate the role of the LV-GLS as a predictor of ChC. Methods: This was a post-hoc analysis of the Carvedilol for Prevention of Chemotherapy-Related Cardiotoxicity trial, which evaluated the primary prevention of cardiotoxicity with carvedilol during doxorubicin chemotherapy in a population of patients with breast cancer. Cardiotoxicity was defined as a reduction ≥10% in LVEF. LV-GLS was determined before chemotherapy in patients with no prior cardiovascular disease or echocardiogram abnormalities. Results: Thirty-one patients for whom a complete echocardiography study including measurement of LV-GLS was performed before chemotherapy were included in this analysis. An absolute LV-GLS<16.9% before chemotherapy showed 100% sensitivity and 73% specificity for predicting cardiotoxicity (area under the curve [AUC], 0.85; 95% confidence interval [CI], 0.680­0.959; p<0.001). In this population, LVEF values before chemotherapy did not predict ChC (95% CI, 0.478 to -0.842; p=0.17). The association of low LV-GLS (<17%) and brain-type natriuretic peptide serum levels (>17 pg/mL) at 2 months after chemotherapy increased the accuracy for detecting early-onset ChC (100% sensitivity, 88% specificity; AUC, 0.94; 95% CI, 0.781­0.995; p<0.0001). Conclusions: Our data suggest that LV-GLS is a potential predictor of ChC. Larger studies are needed to confirm its clinical relevance in this clinical setting. (AU)

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OBJECTIVES: to learn and analyze the structure of nurses' social representations about transvestite people. METHODS: a qualitative research based on the Theory of Social Representations, with 110 nurses enrolled in Graduate Nursing courses, who answered the Free-Association Test, with the stimulus 'transvestite'. Data were processed by the software Ensemble de Programmes Permettant I' Analysedes Évocations. RESULTS: in the central nucleus, the term "prejudice" was the most evoked, followed by "homosexual", "identity" and "female-make-up". Social representation is anchored in the social organization in which transvestite people are still seen and/or associated with homosexuals who make up and assume an identity, without being seen and/or understood as they really are. FINAL CONSIDERATIONS: although prejudice is noteworthy as a central element, terms present in the peripheral system reveal that the group recognizes transvestites as a person with rights, which can translate into health care practices.

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ABSTRACT Objectives: to learn and analyze the structure of nurses' social representations about transvestite people. Methods: a qualitative research based on the Theory of Social Representations, with 110 nurses enrolled in Graduate Nursing courses, who answered the Free-Association Test, with the stimulus 'transvestite'. Data were processed by the software Ensemble de Programmes Permettant I' Analysedes Évocations. Results: in the central nucleus, the term "prejudice" was the most evoked, followed by "homosexual", "identity" and "female-make-up". Social representation is anchored in the social organization in which transvestite people are still seen and/or associated with homosexuals who make up and assume an identity, without being seen and/or understood as they really are. Final Considerations: although prejudice is noteworthy as a central element, terms present in the peripheral system reveal that the group recognizes transvestites as a person with rights, which can translate into health care practices.

RESUMEN Objetivos: aprehender y analizar la estructura de las representaciones sociales de las enfermeras sobre la persona travesti. Métodos: investigación cualitativa, basada en la teoría de las representaciones sociales, con 110 enfermeras matriculadas en cursos de posgrado de enfermería, que respondieron a la prueba de asociación de la palabra libre, con el estímulo 'travesti'. Los datos se procesaron utilizando el software Ensemble de Programmes Permettant I' Analysedes Évocations. Resultados: en el núcleo central, el término "prejuicio" fue el más evocado, seguido de "homosexual", "identidad" y "maquillaje-femenino". La representación social está anclada en la organización social en la que las personas travestis todavía son vistas y/o asociadas con el homosexual que se maquilla y asume una identidad, sin embargo, sin ser visto y/o entendido como realmente es. Consideraciones finales: aunque el prejuicio se destaca como un elemento central, los términos presentes en el sistema periférico revelan que el grupo reconoce a los travestis como una persona con derechos, lo que puede traducirse en prácticas de atención médica.

RESUMO Objetivos: apreender e analisar a estrutura das representações sociais de enfermeiras(os) sobre a pessoa travesti. Métodos: pesquisa qualitativa, fundamentada na Teoria das Representações Sociais, com 110 enfermeiras(os) matriculadas(os) em cursos de Pós-Graduação em Enfermagem, que responderam ao Teste de Associação Livre de Palavras, com o estímulo 'travesti'. Os dados foram processados pelo softwareEnsemble de Programmes Permettant I' Analysedes Évocations. Resultados: no núcleo central, o termo "preconceito" foi o mais evocado, seguido por "homossexual", "identidade" e "maquiagem-feminino". A representação social está ancorada na organização social em que as pessoas travestis ainda são vistas e/ou associadas ao homossexual que se maquia e assume uma identidade, sem, no entanto, serem vistas e/ou compreendidas como realmente são/estão. Considerações Finais: embora o preconceito se notabilize como elemento central, termos presentes no sistema periférico revelam que o grupo reconhece a travesti enquanto pessoa de direitos, o que pode traduzir-se nas práticas de cuidado em saúde.

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BACKGROUND: Anthracycline (ANT) chemotherapy is associated with cardiotoxicity. Prevention with ß-blockers remains controversial. OBJECTIVES: This prospective, randomized, double-blind, placebo-controlled study sought to evaluate the role of carvedilol in preventing ANT cardiotoxicity. METHODS: The authors randomized 200 patients with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction (LVEF) referred for ANT (240 mg/m2) to receive carvedilol or placebo until chemotherapy completion. The primary endpoint was prevention of a ≥10% reduction in LVEF at 6 months. Secondary outcomes were effects of carvedilol on troponin I, B-type natriuretic peptide, and diastolic dysfunction. RESULTS: Primary endpoint occurred in 14 patients (14.5%) in the carvedilol group and 13 patients (13.5%) in the placebo group (p = 1.0). No differences in changes of LVEF or B-type natriuretic peptide were noted between groups. A significant difference existed between groups in troponin I levels over time, with lower levels in the carvedilol group (p = 0.003). Additionally, a lower incidence of diastolic dysfunction was noted in the carvedilol group (p = 0.039). A nonsignificant trend toward a less-pronounced increase in LV end-diastolic diameter during the follow-up was noted in the carvedilol group (44.1 ± 3.64 mm to 45.2 ± 3.2 mm vs. 44.9 ± 3.6 mm to 46.4 ± 4.0 mm; p = 0.057). CONCLUSIONS: In this largest clinical trial of ß-blockers for prevention of cardiotoxicity under contemporary ANT dosage, the authors noted a 13.5% to 14.5% incidence of cardiotoxicity. In this scenario, carvedilol had no impact on the incidence of early onset of LVEF reduction. However, the use of carvedilol resulted in a significant reduction in troponin levels and diastolic dysfunction. (Carvedilol Effect in Preventing Chemotherapy-Induced Cardiotoxicity [CECCY]; NCT01724450).

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Cardiotoxicity is associated with the chronic use of doxorubicin leading to cardiomyopathy and heart failure. Identification of cardiotoxicity-specific miRNA biomarkers could provide clinicians with a valuable prognostic tool. The aim of the study was to evaluate circulating levels of miRNAs in breast cancer patients receiving doxorubicin treatment and to correlate with cardiac function. This is an ancillary study from "Carvedilol Effect on Chemotherapy-induced Cardiotoxicity" (CECCY trial), which included 56 female patients (49.9±3.3 years of age) from the placebo arm. Enrolled patients were treated with doxorubicin followed by taxanes. cTnI, LVEF, and miRNAs were measured periodically. Circulating levels of miR-1, -133b, -146a, and -423-5p increased during the treatment whereas miR-208a and -208b were undetectable. cTnI increased from 6.6±0.3 to 46.7±5.5 pg/mL (p<0.001), while overall LVEF tended to decrease from 65.3±0.5 to 63.8±0.9 (p=0.053) over 12 months. Ten patients (17.9%) developed cardiotoxicity showing a decrease in LVEF from 67.2±1.0 to 58.8±2.7 (p=0.005). miR-1 was associated with changes in LVEF (r=-0.531, p<0.001). In a ROC curve analysis miR-1 showed an AUC greater than cTnI to discriminate between patients who did and did not develop cardiotoxicity (AUC = 0.851 and 0.544, p= 0.0016). Our data suggest that circulating miR-1 might be a potential new biomarker of doxorubicin-induced cardiotoxicity in breast cancer patients.

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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.

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Background:Polypharmacy is a significant economic burden.Objective:We tested whether using reverse auction (RA) as compared with commercial pharmacy (CP) to purchase medicine results in lower pharmaceutical costs for heart failure (HF) and heart transplantation (HT) outpatients.Methods:We compared the costs via RA versus CP in 808 HF and 147 HT patients followed from 2009 through 2011, and evaluated the influence of clinical and demographic variables on cost.Results:The monthly cost per patient for HF drugs acquired via RA was $10.15 (IQ 3.51-40.22) versus $161.76 (IQ 86.05‑340.15) via CP; for HT, those costs were $393.08 (IQ 124.74-774.76) and $1,207.70 (IQ 604.48-2,499.97), respectively.Conclusion:RA may reduce the cost of prescription drugs for HF and HT, potentially making HF treatment more accessible. Clinical characteristics can influence the cost and benefits of RA. RA may be a new health policy strategy to reduce costs of prescribed medications for HF and HT patients, reducing the economic burden of treatment.

Fundamento:A polifarmácia tem um significativo peso econômico.Objetivo:Testar se o uso de pregão em comparação ao de farmácias comerciais (FC) para a compra de medicamentos reduz o custo do tratamento de pacientes ambulatoriais de insuficiência cardíaca (IC) e transplante cardíaco (TC).Métodos:Comparação dos custos do tratamento através de pregão versus FC em pacientes de IC (808) e TC (147) acompanhados de 2009 a 2011, avaliando-se a influência de variáveis clínicas e demográficas no custo.Resultados:Os custos mensais por paciente para medicamentos de IC adquiridos através de pregão e através de FC foram $10,15 (IQ 3,51-40,22) e $161,76 (IQ 86,05-340,15), respectivamente. Para TC, aqueles custos foram $393,08 (IQ 124,74-774,76) e $1.207,70 (IQ 604,48-2.499,97), respectivamente.Conclusão:O pregão pode reduzir o custo dos medicamentos prescritos para IC e TC, podendo tornar o tratamento de IC mais acessível. As características clínicas podem influenciar o custo e os benefícios do pregão, que pode ser uma nova estratégia de política de saúde para baixar os custos dos medicamentos prescritos para IC e TC, diminuindo o peso econômico do tratamento. (Arq Bras Cardiol. 2015; [online].ahead print, PP.0-0).

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BACKGROUND: Polypharmacy is a significant economic burden. OBJECTIVE: We tested whether using reverse auction (RA) as compared with commercial pharmacy (CP) to purchase medicine results in lower pharmaceutical costs for heart failure (HF) and heart transplantation (HT) outpatients. METHODS: We compared the costs via RA versus CP in 808 HF and 147 HT patients followed from 2009 through 2011, and evaluated the influence of clinical and demographic variables on cost. RESULTS: The monthly cost per patient for HF drugs acquired via RA was $10.15 (IQ 3.51-40.22) versus $161.76 (IQ 86.05­340.15) via CP; for HT, those costs were $393.08 (IQ 124.74-774.76) and $1,207.70 (IQ 604.48-2,499.97), respectively. CONCLUSION: RA may reduce the cost of prescription drugs for HF and HT, potentially making HF treatment more accessible. Clinical characteristics can influence the cost and benefits of RA. RA may be a new health policy strategy to reduce costs of prescribed medications for HF and HT patients, reducing the economic burden of treatment.

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OBJECTIVE: The study aims to proceed a literature review of defining characteristics (DCs) of decreased cardiac output (DCO). METHODS: Medline database was used to perform this study. The descriptors used were "low cardiac output" and "nursing diagnosis." RESULTS: Seventy-nine DCs were identified. Among them, 28 have already been approved by NANDA-I. Some data from microcirculation assessment such as high levels of serum lactate and decreased oxygen venous saturation were identified as indicators of this nursing diagnosis. CONCLUSIONS: Some of the approved DCs were identified through literature review but others seem to be new as they have not been cited in the NANDA-I classification. PRACTICAL IMPLICATIONS: Further content and clinical validations are needed to confirm if data from microcirculation might be considered as DCs of DCO.

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AIMS AND OBJECTIVES: To compare the clinical profile of patients included in a clinical trial of autologous bone marrow cells as an adjunctive therapy to coronary artery bypass grafting with that of patients undergoing routine coronary artery bypass grafting. BACKGROUND: The therapeutic potential of autologous bone marrow cells has been explored in the treatment of severe coronary artery disease. There are few data regarding the clinical and socio-economic profile of patients included in clinical trials using bone marrow cell. DESIGN: Case-control study. METHOD: Sixty-seven patients (61 SD 9) years, 82% men) with multivessel coronary artery disease were divided into two groups: patients in the bone marrow cell group (n = 34) underwent incomplete coronary artery bypass grafting + intramyocardial injection of autologous bone marrow cells (lymphomonocytic fraction -2.0 (SD 0.2 x 10(8)) cells/patient) in the ischaemic, non-revascularised myocardium, whereas patients in the coronary artery bypass grafting group (n = 33) underwent routine bypass surgery. Demographics, socio-economic status, clinical and echocardiographic data were collected. Statistical analysis included the Fisher's exact test (categorical variables) and the Student's t-test (continuous variables). RESULTS: There were no significant differences between groups regarding age, gender, BMI, heart rate, blood pressure and echo data. There was a greater prevalence of obesity (65 vs. 33%; OR = 3.7 [1.3-10.1]), of previous myocardial infarction (68 vs. 39%; OR = 3.2 [1.2-8.8]) and prior revascularisation procedures (59 vs. 24%; OR = 4.5 [1.6-12.7]) in the autologous bone marrow cells group and of smokers in the coronary artery bypass grafting group (51 vs. 23%; OR = 3.5 [1.2-10.4]). CONCLUSIONS: Patients included in this clinical trial of autologous bone marrow cells for severe coronary artery disease presented a greater prevalence of myocardial revascularisation procedures, indicating a more severe clinical presentation of the disease. Fewer smokers in this group could be attributable to life style changes after previous cardiovascular events and/or interventions. RELEVANCE TO CLINICAL PRACTICE: The knowledge of the clinical profile of patients included in cell therapy trials may help researchers in the identification of patients that may be enroled in future clinical trials of this new therapeutic strategy.

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BACKGROUND: The effectiveness of heart failure disease management programs in patients under cardiologists' care over long-term follow-up is not established. METHODS AND RESULTS: We investigated the effects of a disease management program with repetitive education and telephone monitoring on primary (combined death or unplanned first hospitalization and quality-of-life changes) and secondary end points (hospitalization, death, and adherence). The REMADHE [Repetitive Education and Monitoring for ADherence for Heart Failure] trial is a long-term randomized, prospective, parallel trial designed to compare intervention with control. One hundred seventeen patients were randomized to usual care, and 233 to additional intervention. The mean follow-up was 2.47+/-1.75 years, with 54% adherence to the program. In the intervention group, the primary end point composite of death or unplanned hospitalization was reduced (hazard ratio, 0.64; confidence interval, 0.43 to 0.88; P=0.008), driven by reduction in hospitalization. The quality-of-life questionnaire score improved only in the intervention group (P<0.003). Mortality was similar in both groups. Number of hospitalizations (1.3+/-1.7 versus 0.8+/-1.3, P<0.0001), total hospital days during the follow-up (19.9+/-51 versus 11.1+/-24 days, P<0.0001), and the need for emergency visits (4.5+/-10.6 versus 1.6+/-2.4, P<0.0001) were lower in the intervention group. Beneficial effects were homogeneous for sex, race, diabetes and no diabetes, age, functional class, and etiology. CONCLUSIONS: For a longer follow-up period than in previous studies, this heart failure disease management program model of patients under the supervision of a cardiologist is associated with a reduction in unplanned hospitalization, a reduction of total hospital days, and a reduced need for emergency care, as well as improved quality of life, despite modest program adherence over time.

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