Implementação do Programa Boas Práticas em Cardiologia adaptado do Get With The Guidelines ® em Hospitais Brasileiros: Desenho do Estudo e Fundamento / Implementation of a Best Practice in Cardiology (BPC) Program Adapted from Get With The Guidelines®in Brazilian Public Hospitals: Study Design and Rationale

Resumo Fundamento Existem grandes oportunidades de melhoria da qualidade do cuidado cardiovascular em países em desenvolvimento por meio da implementação de um programa de qualidade. Objetivo Avaliar o efeito de um programa de Boas Práticas em Cardiologia (BPC) nos indicadores de desempenho e desfechos clínicos dos pacientes relacionados à insuficiência cardíaca, fibrilação atrial e síndromes coronarianas agudas em um subconjunto de hospitais públicos brasileiros. Métodos O programa Boas Práticas em Cardiologia (BPC) foi adaptado do programa Get With The Guidelines (GWTG) da American Heart Association (AHA) para ser utilizado no Brasil. O programa está sendo iniciado em três domínios de cuidado simultaneamente (síndrome coronariana aguda, fibrilação atrial e insuficiência cardíaca), o que consiste em uma abordagem nunca testada no GWTG. Existem seis eixos de intervenções utilizadas pela literatura sobre tradução do conhecimento que abordará barreiras locais identificadas por meio de entrevistas estruturadas e reuniões regulares para auditoria e feedback. Planeja-se incluir no mínimo 10 hospitais e 1500 pacientes por doença cardíaca. O desfecho primário inclui as taxas de adesão às medidas de cuidado recomendadas pelas diretrizes. Desfechos secundários incluem o efeito do programa sobre o tempo de internação, mortalidade global e específica, taxas de readmissão, qualidade de vida, percepção do paciente sobre saúde e adesão dos pacientes às intervenções prescritas. Resultados Espera-se, nos hospitais participantes, uma melhoria e a manutenção das taxas de adesão as recomendações baseadas em evidência e dos desfechos dos pacientes. Este é o primeiro programa em melhoria da qualidade a ser realizado na América do Sul, que fornecerá informações importantes de como programas de sucesso originados em países desenvolvidos como os Estados Unidos podem ser adaptados às necessidades de países com economias em desenvolvimento como o Brasil. Um programa bem sucedido dará informações valiosas para o desenvolvimento de programas de melhoria da qualidade em outros países em desenvolvimento. Conclusões Este estudo de mundo real proverá informações para a avaliação e aumento da adesão às diretrizes de cardiologia no Brasil, bem como a melhora dos processos assistenciais. (Arq Bras Cardiol. 2020; 115(1):92-99)

Abstract Background There are substantial opportunities to improve the quality of cardiovascular care in developing countries through the implementation of a quality program. Objective To evaluate the effect of a Best Practice in Cardiology (BPC) program on performance measures and patient outcomes related to heart failure, atrial fibrillation and acute coronary syndromes in a subset of Brazilian public hospitals. Methods The Boas Práticas em Cardiologia (BPC) program was adapted from the American Heart Association's (AHA) Get With The Guidelines (GWTG) Program for use in Brazil. The program is being started simultaneously in three care domains (acute coronary syndrome, atrial fibrillation and heart failure), which is an approach that has never been tested within the GWTG. There are six axes of interventions borrowed from knowledge translation literature that will address local barriers identified through structured interviews and regular audit and feedback meetings. The intervention is planned to include at least 10 hospitals and 1,500 patients per heart condition. The primary endpoint includes the rates of overall adherence to care measures recommended by the guidelines. Secondary endpoints include the effect of the program on length of stay, overall and specific mortality, readmission rates, quality of life, patients' health perception and patients' adherence to prescribed interventions. Results It is expected that participating hospitals will improve and sustain their overall adherence rates to evidence-based recommendations and patient outcomes. This is the first such cardiovascular quality improvement (QI) program in South America and will provide important information on how successful programs from developed countries like the United States can be adapted to meet the needs of countries with developing economies like Brazil. Also, a successful program will give valuable information for the development of QI programs in other developing countries. Conclusions This real-world study provides information for assessing and increasing adherence to cardiology guidelines in Brazil, as well as improvements in care processes. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Rapid immunochromatographic tests for the diagnosis of dengue: a systematic review and meta-analysis.

Dengue is an important arthropod-borne viral disease in terms of morbidity, mortality, economic impact and challenges in vector control. Benchmarks are expensive, time consuming and require trained personnel. Preventing dengue complications with rapid diagnosis has been based on the testing of easy-to-perform optimized immunochromatographic methods (ICT). This is a systematic meta-analysis review of the diagnostic accuracy of IgA, NS1, IgM and/or IgG ICT studies in suspected cases of acute or convalescent dengue, using a combination of RT-PCR, ELISA NS1, IgM IgG or viral isolation as a reference standard. This protocol was registered in PROSPERO (CRD42014009885). Two pairs of reviewers searched the PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS and EMBASE databases, selected, extracted, and quality-assessed by QUADAS 2. Of 3,783 studies, we selected 57, of which 40 in meta-analyses according to the analyte tested, with high heterogeneity (I2 > 90%), as expected for diagnostic tests. We detected higher pooled sensitivity in acute phase IgA (92.8%) with excellent (90%) specificity. ICT meta-analysis with NS1/IgM/IgG showed 91% sensitivity and 96% specificity. Poorer screening performance was for IgM/IgG ICT (sensitivity = 56%). Thus, the studies with NS1/IgM/IgG ICT showed the best combined performance in the acute phase of the disease.

Implementation of a Best Practice in Cardiology (BPC) Program Adapted from Get With The Guidelines®in Brazilian Public Hospitals: Study Design and Rationale. / Implementação do Programa Boas Práticas em Cardiologia adaptado do Get With The Guidelines ® em Hospitais Brasileiros: Desenho do Estudo e Fundamento.

Background There are substantial opportunities to improve the quality of cardiovascular care in developing countries through the implementation of a quality program. Objective To evaluate the effect of a Best Practice in Cardiology (BPC) program on performance measures and patient outcomes related to heart failure, atrial fibrillation and acute coronary syndromes in a subset of Brazilian public hospitals. Methods The Boas Práticas em Cardiologia (BPC) program was adapted from the American Heart Association's (AHA) Get With The Guidelines (GWTG) Program for use in Brazil. The program is being started simultaneously in three care domains (acute coronary syndrome, atrial fibrillation and heart failure), which is an approach that has never been tested within the GWTG. There are six axes of interventions borrowed from knowledge translation literature that will address local barriers identified through structured interviews and regular audit and feedback meetings. The intervention is planned to include at least 10 hospitals and 1,500 patients per heart condition. The primary endpoint includes the rates of overall adherence to care measures recommended by the guidelines. Secondary endpoints include the effect of the program on length of stay, overall and specific mortality, readmission rates, quality of life, patients' health perception and patients' adherence to prescribed interventions. Results It is expected that participating hospitals will improve and sustain their overall adherence rates to evidence-based recommendations and patient outcomes. This is the first such cardiovascular quality improvement (QI) program in South America and will provide important information on how successful programs from developed countries like the United States can be adapted to meet the needs of countries with developing economies like Brazil. Also, a successful program will give valuable information for the development of QI programs in other developing countries. Conclusions This real-world study provides information for assessing and increasing adherence to cardiology guidelines in Brazil, as well as improvements in care processes. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0).

Rapid immunochromatographic tests for the diagnosis of dengue: a systematic review and meta-analysis / Testes imunocromatográficos rápidos para o diagnóstico da dengue: uma revisão sistemática e metanálise / Pruebas inmunocromatográficas rápidas para la diagnosis del dengue: una revisión sistemática y metaanálisis

Abstract: Dengue is an important arthropod-borne viral disease in terms of morbidity, mortality, economic impact and challenges in vector control. Benchmarks are expensive, time consuming and require trained personnel. Preventing dengue complications with rapid diagnosis has been based on the testing of easy-to-perform optimized immunochromatographic methods (ICT). This is a systematic meta-analysis review of the diagnostic accuracy of IgA, NS1, IgM and/or IgG ICT studies in suspected cases of acute or convalescent dengue, using a combination of RT-PCR, ELISA NS1, IgM IgG or viral isolation as a reference standard. This protocol was registered in PROSPERO (CRD42014009885). Two pairs of reviewers searched the PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS and EMBASE databases, selected, extracted, and quality-assessed by QUADAS 2. Of 3,783 studies, we selected 57, of which 40 in meta-analyses according to the analyte tested, with high heterogeneity (I2 > 90%), as expected for diagnostic tests. We detected higher pooled sensitivity in acute phase IgA (92.8%) with excellent (90%) specificity. ICT meta-analysis with NS1/IgM/IgG showed 91% sensitivity and 96% specificity. Poorer screening performance was for IgM/IgG ICT (sensitivity = 56%). Thus, the studies with NS1/IgM/IgG ICT showed the best combined performance in the acute phase of the disease.

Resumo: A dengue é uma importante arbovirose em termos de morbidade, mortalidade, impacto econômico e controle do vetor. Os testes de referência são dispendiosos e demorados e exigem pessoal capacitado. A prevenção das complicações da dengue com o diagnóstico rápido tem tomado como base a testagem com métodos imunocromatográficos (ICT). O estudo é uma revisão sistemática e meta-análise da acurácia diagnóstica de estudos de ICT de IgA, NS1, IgM e/ou IgG em casos suspeitos de dengue aguda ou convalescente, usando uma combinação de RT-PCR, ELISA NS1, IgM IgG ou isolamento viral como padrão de referência. O projeto foi registrado na base PROSPERO (CRD42014009885). Dois pares de revisores realizaram as buscas nas bases de dados PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS e EMBASE, além da seleção, extração e avaliação de qualidade com a ferramenta QUADAS 2. A partir de 3.783 estudos, selecionamos 57, dos quais 40 foram incluídos nas meta-análises de acordo com o analito testado, com alta heterogeneidade (I2 > 90%), conforme esperado para testes diagnósticos. Foi detectada a maior sensibilidade conjunta no IgA de fase aguda (92,8%), com excelente especificidade (90%). A meta-análise de ICT com NS1/IgM/IgG mostrou sensibilidade de 91% e especificidade de 96%. O pior desempenho para triagem foi com o ICT de IgM/IgG (sensibilidade = 56%). Portanto, os estudos de ICT com NS1/IgM/IgG mostraram o melhor desempenho combinado na fase aguda da doença.

Resumen: El dengue es una importante enfermedad arboviral, en términos de morbilidad, mortalidad, impacto económico y desafíos en el control del vector. Las mejores prácticas son caras, consumen mucho tiempo y requieren personal formado. Prevenir las complicaciones del dengue con un rápido diagnóstico se ha basado en pruebas con métodos inmunocromatográficos optimizados fáciles de realizar (ICT por sus siglas en inglés). Se trata de una revisión sistemática de metaanálisis sobre la precisión diagnóstica de estudios de IgA, NS1, IgM y/o IgG ICT en casos sospechosos de fases agudas o convalecientes de dengue, usando la combinación de RT-PCR, ELISA NS1, IgM IgG o el aislamiento viral como referencia estándar. Este proyecto se registró en PROSPERO (CRD42014009885). Dos parejas de revisores investigaron en las bases de datos de: PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS y EMBASE, seleccionaron, extrajeron, y realizaron la evaluación de calidad mediante QUADAS 2. De 3.783 estudios, se seleccionaron 57, de los cuales 40 fueron metaanálisis, según el analito probado, con una alta heterogeneidad (I2 > 90%), como se esperaba en las pruebas de diagnóstico. Detectamos una sensibilidad más alta combinada en la fase aguda IgA (92.8%) con una excelente (90%) especificidad. Los metaanálisis ICT con NS1/IgM/ IgG mostraron un 91% de sensibilidad y un 96% de especificidad. Se produjo un rendimiento más pobre en el diagnóstico IgM/IgG ICT (sensibilidad = 56%). De este modo, los estudios con NS1/IgM/IgG ICT mostraron un rendimiento mejor combinado en la fase aguda de la enfermedad.

'All the King's horses . . .': the problematical fate of born-again evidence-based medicine: commentary on Greenhalgh, T., Snow, R., Ryan, S., Rees, S., and Salisbury, H. (2015) six 'biases' against patients and carers in evidence-based medicine. BioMed Central Medicine, 13:200.

The phrase 'evidence-based medicine (EBM)' is being used by both EBM advocates and adversaries to broadly denote the production and use of clinical research throughout the healthcare system. Recently, this trend was joined by a call for a general expansion and rebirth of EBM to encompass a diverse range of healthcare activities otherwise corresponding to person-centred care. The call asserts that EBM is to blame for anti-patient biases within clinical practice and in policy and public health domains. Effective critique of either EBM or of the healthcare system requires that EBM itself be properly identified as a research literacy movement that grew out of clinical epidemiology of the 1970's and 1980's. We demonstrate the ineffectiveness of inappropriately targeted critiques of healthcare under the banner of born-again EBM.We identify the strengths and weaknesses of EBM as an educational movement drawing on the concept of literacy associated with the Brazilian educator Paolo Freire. We consider the relationship of EBM to clinical epidemiology and conclude that it cannot fruitfully divorce itself from the latter.We briefly consider existing precedents for philosophically sound conceptual platforms for advocacy of person-centred healthcare and broad based critique of the healthcare system including relationship-centred care. We conclude that traditional EBM, as a framework for research literacy training of both clinicians and policy makers, must continue to play a subsidiary role within an expanding patient-centred healthcare system and that advocacy efforts on behalf of patient voice and engagement are best pursued unencumbered by subsidiary agendas.

'One mission accomplished, more important ones remain': commentary on Every-Palmer, S., Howick, J. (2014) How evidence-based medicine is failing due to biased trials and selective publication. Journal of†Evaluation in†Clinical†Practice, 20 (6), 908-914.

Every-Palmer and Howick suggest that evidence-based medicine (EBM) is failing in its mission because of contamination of research by manufacturer and researcher-motivated bias and self-interest. They fail to define that mission and to distinguish between the EBM movement and the research enterprise it was developed to critique. An educational movement, EBM accomplished its mission to simplify and package clinical epidemiological concepts in a form accessible to clinical learners. Its wide adoption within educational circles fostered critical literacy among several generations of practitioners. Illumination of bias, subterfuge and incomplete reporting of research has been a strength of EBM. Increased uptake and use of clinical research within the health care system properly defines the failing mission that eludes Every-Palmer and Howick. Responsibility for failure to make progress towards its achievement is shared by virtually all relevant streams within the system, including policy, clinical guideline development, educational movements and the development of approaches to evidence synthesis. Discordance between the epistemological premises pervading today's research and health care community and the complex social processes that ultimately determine research use constitutes an important factor that must be addressed as part of a remedy. Enhanced emphasis on and demonstration of alternative approaches to research such as realism and realist synthesis and the momentum towards development of a learning health care system hold promise as guideposts for the rapidly evolving health care environment.

Qualidade de vida dos cuidadores de pacientes com insuficiência cardíaca: revisão integrativa / Quality of life of caregivers to patients with heart failure: integrative review

Objetivo: analisar as produções científicas sobre qualidade de vida do cuidador de paciente com insuficiência cardíaca. Metodologia: revisão integrativa, com recorte temporal de 5 anos (2009-2013) e busca na base de dados Medline. Foram selecionados 17 artigos, analisado e apresentados em duas categorias: O cuidador do paciente com IC como foco do artigo e O cuidador do paciente com IC como facilitador do tratamento. Resultados: dentre os 17 artigos analisados, 58,8% foram conduzidos nos Estados Unidos, 11,7% no Reino Unido, 11,7% na Holanda e 17,6% na Suécia. Destes, 82% apresentaram abordagem quantitativa; de forma geral, as mulheres desempenham o papel de cuidador, assim como os homens são os mais prevalentes entre os pacientes com insuficiência cardíaca. Conclusão: não existe um tratamento efetivo se o cuidador for esquecido, pois independente do foco do estudo, o grande objetivo das pesquisas é que ocorra uma otimização do tratamento e diminuição dos sinais e sintomas.(AU)

Objective: to analyze the scientific production on quality of life of caregivers to patients with heart failure. Methodology: an integrative review, with a time frame of 5 years (2009-2013) and research in the Medline database. 17 articles were selected, analyzed and presented in two categories: The HF patient's caregiver as the focus of the article and the HF patient's caregiver as a facilitator of treatment. Results: Among the 17 articles analyzed, 58.8% were conducted in the United States, 11.7% in the UK, 11.7% in the Netherlands and 17.6% in Sweden. Of these, 82% had a quantitative approach; in general, women play the role of the caregiver, as well as men are the most prevalent among patients with heart failure. Conclusion: there is no effective treatment if the caregiver is forgotten, because independent of the study focus, the main objective of the research is for an optimization of treatment and reduction of signs and symptoms to occur.(AU)

Objetivo: analizar la producción científica sobre la calidad de vida del cuidador de los pacientes con insuficiencia cardíaca. Metodología: revisión integradora, con el marco de tiempo de 5 años (2009-2013) y la búsqueda en la base de datos Medline. Un total de 17 artículos, analizados y presentados en dos categorías: enfoque el cuidador del paciente com IC del artículo y el cuidador del paciente con IC como facilitador del tratamiento. Resultados: de los 17 artículos analizados, el 58,8% se realizaron en los Estados Unidos, el 11,7% en el Reino Unido, el 11,7% en los Países Bajos y el 17,6% en Suecia. De éstos, el 82% tenían un enfoque cuantitativo; en general, las mujeres desempeñan el papel de cuidador, así como los hombres son los más prevalentes entre los pacientes con insuficiencia cardíaca. Conclusión: no existe un tratamiento eficaz si el cuidador se olvida, porque independiente del enfoque de estudio, el objetivo principal de la investigación es que se produzca una optimización del tratamiento y la reducción de los signos y síntomas.(AU)

Adaptação transcultural brasileira do “Family caregiver-specific quality of life scale”: estudo metodológico / Adaptación transcultural brasileña del “Family caregiver-specific quality of life scale”: estudio metodológico / Brazilian transcultural adaptation of the “Family caregiver-specific quality of life scale”: a methodological study

To perform a transcultural adaptation of the Family Caregiver-Specific Quality of Life Scale to be used in Brazil. Method: A simple, easily applicable questionnaire was applied, composed of 16 questions, subdivided into the physical, psychological, social and spiritual domains, which was originally tested on a population composed of caregivers for heart failure patients. In this methodological study, the process of adaptation involved the translation, synthesis of translations, back translation and a committee of evaluators. Results: After the translation process, the committee of evaluators suggested some changes to the questionnaire that were authorized by its original author. Discussion: The questionnaire was considered pertinent to Brazilian culture, and to adequately represent the target-population, as well as presenting a good semantic equivalence between the final version in Portuguese and the original version. Conclusion: The instrument has proven to be sufficiently adequate to be used in the general population, and it has also been psychometrically validated...

Realizar adaptação transcultural do Family Caregiver-Specific Quality of Life Scale para uso no Brasil. Método: O questionário é simples, de fácil aplicação, composto por 16 questões subdivididas nos domínios físico, psicológico, social e espiritual, tendo sido validado originalmente em uma população de cuidadores de pacientes com insuficiência cardíaca. Neste estudo metodológico, o processo de adaptação envolveu a tradução, síntese das traduções, retrotradução e comitê de juízes. Resultados: Após as etapas de tradução, o comitê de juízes sugeriu modificações no questionário que foram autorizadas pela autora do questionário original Discussão: O questionário foi considerado pertinente à cultura brasileira e seus itens adequados quanto à sua capacidade de representar à população-alvo, além de apresentar boa equivalência semântica entre a versão final em português e a original. Conclusão: O instrumento mostrou-se adequado para ser utilizado na população e está sendo validado psicometricamente...

Realizar la adaptación transcultural del Family Caregiver-Specific Quality of Life Scale para usarlo en Brasil. Método: El cuestionario es simple, de fácil aplicación, compuesto por 16 cuestiones subdivididas en los temas físicos, psicológicos, social y espiritual habiendo sido validado originalmente en una población de cuidadores de pacientes con insuficiencia cardíaca. En este estudio metodológico, el proceso de adaptación involucró la traducción, síntesis de traducciones, retro traducción y un comité de jueces. Resultados: Después de las etapas de traducción, el comité de jueces sugirió modificaciones en el cuestionario que fueron autorizadas por la autora del cuestionario original. Discusión: El cuestionario se consideró pertinente a la cultura brasileña y sus elementos adecuados en relación a su capacidad de representar la población a la cual está destinado, además de presentar buena equivalencia semántica entre la versión final en portugués y la original. Conclusión: El instrumento resultó adecuado para ser utilizado en la población y se está validando psicométricamente...

Intracoronary stem-cell injection after myocardial infarction: microcirculation sub-study.

BACKGROUND: The injection of stem cells in the context of acute myocardial infarction (AMI) has been tested almost exclusively by anterograde intra-arterial coronary (IAC) delivery. The retrograde intravenous coronary (IVC) delivery may be an additional route. OBJECTIVE: To compare the cell distribution and retention pattern in the anterograde and retrograde routes. To investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells (BMMC) in AMI. METHODS: This was a prospective, open label, randomized study. Patients with AMI who presented: (1) successful chemical or mechanical reperfusion within 24 hours of symptom onset and (2) infarction involving more than 10% of the left ventricle (LV) at the myocardial scintigraphy were included in the study. One hundred million BMMC were injected into the infarction-related artery through IAC route, or vein through the IVC route. One percent of the injected cells were labeled with 99mTc-hexamethyl-propylene-amine-oxime (99mTc-HMPAO). Cell distribution was evaluated at 4 and 24 hours after the myocardial scintigraphy injection. Cardiac magnetic resonance imaging was performed before cell injection. RESULTS: Thirty patients were randomized into three groups. There were no serious adverse events related to the procedure. The early and late retention of labeled cells was higher in the IAC group than in IVC group, regardless of the presence of microcirculation obstruction. CONCLUSION: The injection using the retrograde approach was feasible and safe. Cell retention by cardiac tissue was higher using the anterograde approach. More studies are needed to confirm these findings.

Injeção intracoronariana de células tronco após infarto do miocárdio: subestudo da microcirculação / Intracoronary stem-cell injection after myocardial infarction: microcirculation sub-study

FUNDAMENTO: A injeção de células-tronco no contexto do infarto agudo do miocárdio (IAM) tem sido testada quase exclusivamente pela via anterógrada intra-arterial coronariana (IAC). A via retrógrada intravenosa coronariana (IVC) pode ser uma via adicional. OBJETIVO: Comparar o padrão de distribuição e retenção celular nas vias anterógrada e retrógrada. Investigar o papel da obstrução microvascular pela ressonância magnética na retenção de células pelo tecido cardíaco após a injeção de células mononucleares da medula óssea (CMMO) no IAM. MÉTODOS: Estudo prospectivo, aberto, randomizado. Foram incluídos pacientes com IAM que apresentassem: (1) reperfusão mecânica ou química com sucesso em até 24 horas do início dos sintomas e (2) infarto acometendo mais de 10 por cento da área do ventrículo esquerdo (VE) pela cintilografia miocárdica. Cem milhões de CMMO foram injetadas na artéria relacionada ao infarto pela via IAC ou veia, pela via IVC. Um por cento das células injetadas foi marcado com Tc99m-hexametil-propileno-amina-oxima(99mTc-HMPAO). A distribuição das células foi avaliada 4 e 24 horas após a injeção da cintilografia miocárdica. Ressonância magnética cardíaca foi realizada antes da injeção de células. RESULTADOS: Trinta pacientes foram distribuídos aleatoriamente em três grupos. Não houve eventos adversos graves relacionados ao procedimento. A retenção precoce e tardia das células marcadas foi maior no grupo IAC do que no grupo IVC, independentemente da presença de obstrução da microcirculação. CONCLUSÃO: A injeção pela abordagem retrógrada mostrou-se viável e segura. A retenção de células pelo tecido cardíaco foi maior pela via anterógrada. Mais estudos são necessários para confirmar esses achados.

BACKGROUND: The injection of stem cells in the context of acute myocardial infarction (AMI) has been tested almost exclusively by anterograde intra-arterial coronary (IAC) delivery. The retrograde intravenous coronary (IVC) delivery may be an additional route. OBJECTIVE: To compare the cell distribution and retention pattern in the anterograde and retrograde routes. To investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells (BMMC) in AMI. METHODS: This was a prospective, open label, randomized study. Patients with AMI who presented: (1) successful chemical or mechanical reperfusion within 24 hours of symptom onset and (2) infarction involving more than 10 percent of the left ventricle (LV) at the myocardial scintigraphy were included in the study. One hundred million BMMC were injected into the infarction-related artery through IAC route, or vein through the IVC route. One percent of the injected cells were labeled with 99mTc-hexamethyl-propylene-amine-oxime (99mTc-HMPAO). Cell distribution was evaluated at 4 and 24 hours after the myocardial scintigraphy injection. Cardiac magnetic resonance imaging was performed before cell injection. RESULTS: Thirty patients were randomized into three groups. There were no serious adverse events related to the procedure. The early and late retention of labeled cells was higher in the IAC group than in IVC group, regardless of the presence of microcirculation obstruction. CONCLUSION: The injection using the retrograde approach was feasible and safe. Cell retention by cardiac tissue was higher using the anterograde approach. More studies are needed to confirm these findings.

Incidência e preditores de eventos cardiovasculares adversos maiores no tratamento percutâneo contemporâneo de enxertos de veia safena / Incidence and predictors of major adverse cardiac events in contemporary percutaneous treatment of saphenous vein grafts

Introdução: Pacientes submetidos a intervenção coronária percutânea (ICP) em enxertos de veia safena caracteristicamente exibem maior risco de eventos cardiovasculares adversos maiores (ECAM). Foram avaliados a incidência e os preditores de ECAM no cenário atual, em que dispositivos de proteção distal e de aspiração de trombos e o uso de stents farmacológicos fazem parte da prática diária. Métodos: Neste estudo foram avaliados 69 casos consecutivos de pacientes com enxertos de veia safena, tratados com stents, entre janeiro de 2005 e dezembro de 2008. Foram avaliadas as características clínicas, angiográficas e relacionadas ao procedimento, bem como a incidência e preditores de ECAM na evolução tardia. Resultados: A média de idade dos pacientes foi de 72 + 10,2 anos, 79,7% eram do sexo masculino, 31,9% eram diabéticos, e 56,5% foram tratados na vigência de síndrome coronária aguda. Foram abordados 71 enxertos de veia safena, com lesões predominantemente localizadas no corpo (35,3%), tratadas mais frequentemente com stents farmacológicos (82,8%). Dispositivos de proteção distal foram utilizados em 31,9% e de aspiração de trombo em 1,4% dos pacientes, e em 30,4% foram utilizados inibidores da glicoproteína IIb/IIIa. No-reflow ocorreu em 8,7% e o sucesso do procedimento foi constatado em 89,9% dos casos. Na evolução tardia, ECAM, óbito, infarto agudo do miocárdio e revascularização do vaso-alvo ocorreram em 15,9%, 7,2%, 4,3% e 14,5%, respectivamente, e trombose de stent foi observada em 2,9% dos pacientes. Na regressão de Cox apenas o uso de stents não-farmacológicos foi associado a ECAM [hazard ratio (HR) 4,1, intervalo de confiança de 95% (IC 95%) 1,2-13,3; P = 0,02]. Conclusões: Pacientes com lesões em enxertos de veia safena, tratados percutaneamente, exibiram elevada taxa de eventos adversos a médio prazo e o uso de stents não-farmacológicos esteve associado a pior evolução.

Background: Patients undergoing percutaneous coronary interventions(PCI) in saphenous vein grafts tipically have a higher risk of major adverse cardiac events (MACE). MACE incidence and predictors were evaluated in the current scenario, where distal protection and thrombus aspirationdevices and the use of drug-eluting stents are part of the daily practice. Methods: Sixty-nine consecutive patients undergoing coronary stenting in saphenous vein grafts from January 2005 to December 2008 were evaluated. Clinical, angiographic and procedure-related variables were evaluated as well as the incidence and predictors of MACE in the late follow-up. Results: Mean age was 72 + 10.2 years, 79.7% were male, 31.9% were diabetic, and 56.5% presented withacute coronary syndromes. Seventy-one saphenous vein grafts were treated, with lesions located mainly in the body of the graft (35.3%) and more frequently treated with drug-elutingstents (82.8%). Distal protection devices were used in 31.9% and thrombus aspiration in 1.4% of the patients, and 30.4% received glycoprotein IIb/IIIa inhibitors. No-reflow was observed in 8.7% and procedure success was observed in 89.9% of the cases. In the late follow-up, MACE, death, acutemyocardial infarction and target vessel revascularization were observed in 15.9%, 7.2%, 4.3%, and 14.5%, respectively and stent thrombosis was observed in 2.9% of the patients.In the Cox regression analysis only the use of bare metal stents was associated with MACE [hazard ratio (HR) 4.1, 95% confidence interval (95% CI) 1.2-13.3; P = 0.02]. Conclusions: Patients with lesions in saphenous vein grafts treated by percutaneous interventions had a high rate of mid-term adverse events and the use of bare metal stents was associated to a worse clinical outcome.

The marriage of evidence and narrative: scientific nurturance within clinical practice.

RATIONALE, AIMS AND OBJECTIVES: Published elaborations of evidence-based medicine (EBM) have failed to materially integrate the domains of interpersonal sensibility and relationship with tools intended to facilitate attention to biomedical research and knowledge within clinical practice. Furthermore, the elaboration of EBM skills has been confined to a narrow range of clinical research. As a result, crucial tools required to connect much clinically relevant research and practice remain hidden, and explorations of the deeper challenges faced by practitioners in their struggle to integrate sound science and shared clinical action remain elusive. METHODS: We developed a model for scientifically informed, individualized, medical practice and learning that embraces the goals, resources and skills of EBM within a larger framework of practice defined by narrative process: 'attention', 'representation' and 'affiliation'. We drew from published elaborations of EBM, narrative medicine (NM) and the results of a project to develop tools for assessment of the cognitive skills embedded within a practice based EBM domain. RESULTS: Within the resulting model, a tool of representation, whose components are Problem delineation, Actions, Choices and Targets, enables the clinical problem to be delineated and the patient and practitioner perspectives to be concretely defined with reference to four classes of clinical interaction: 'therapy', 'diagnosis', 'prognosis' and 'harm'. As a result, the 'information literacy' skills required to access, evaluate and apply clinical research using electronic resources are well defined but subordinated to shared appreciation of patient need. The model acknowledges the relevance of the full range and scope of scientifically derived medical knowledge. CONCLUSION: A model based on integration of NM and EBM can lead to instructional tools that integrate clinical epidemiological knowledge with enforced consideration of differing patient and practitioner perspectives. It also may inform avenues for qualitative research into the processes through which such differing perspectives can be productively identified and shared.

Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis.

CONTEXT: Theory and simulation suggest that randomized controlled trials (RCTs) stopped early for benefit (truncated RCTs) systematically overestimate treatment effects for the outcome that precipitated early stopping. OBJECTIVE: To compare the treatment effect from truncated RCTs with that from meta-analyses of RCTs addressing the same question but not stopped early (nontruncated RCTs) and to explore factors associated with overestimates of effect. DATA SOURCES: Search of MEDLINE, EMBASE, Current Contents, and full-text journal content databases to identify truncated RCTs up to January 2007; search of MEDLINE, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effects to identify systematic reviews from which individual RCTs were extracted up to January 2008. STUDY SELECTION: Selected studies were RCTs reported as having stopped early for benefit and matching nontruncated RCTs from systematic reviews. Independent reviewers with medical content expertise, working blinded to trial results, judged the eligibility of the nontruncated RCTs based on their similarity to the truncated RCTs. DATA EXTRACTION: Reviewers with methodological expertise conducted data extraction independently. RESULTS: The analysis included 91 truncated RCTs asking 63 different questions and 424 matching nontruncated RCTs. The pooled ratio of relative risks in truncated RCTs vs matching nontruncated RCTs was 0.71 (95% confidence interval, 0.65-0.77). This difference was independent of the presence of a statistical stopping rule and the methodological quality of the studies as assessed by allocation concealment and blinding. Large differences in treatment effect size between truncated and nontruncated RCTs (ratio of relative risks <0.75) occurred with truncated RCTs having fewer than 500 events. In 39 of the 63 questions (62%), the pooled effects of the nontruncated RCTs failed to demonstrate significant benefit. CONCLUSIONS: Truncated RCTs were associated with greater effect sizes than RCTs not stopped early. This difference was independent of the presence of statistical stopping rules and was greatest in smaller studies.

Systolic function of patients with myocardial infarction undergoing autologous bone marrow transplantation.

BACKGROUND: Several studies have been published on the effect of bone-marrow stem cells on the left ventricle when acting on post- acute myocardial infarction remodeling. However, the results have been controversial. OBJECTIVE: To carry out an echocardiographic analysis of the systolic function of patients with acute myocardial infarction after autologous mononuclear bone marrow cell transplantation (AMBMCT) as performed via the intracoronary and intravenous routes. METHODS: This is an open-label, prospective, randomized study. INCLUSION CRITERIA: patients admitted for ST-elevation acute myocardial infarction (MI) who had undergone mechanical or chemical reperfusion within 24 hours of the onset of symptoms and whose echocardiogram showed decreased segmental wall motion and fixed perfusion defect related to the culprit artery. Autologous bone marrow was aspirated from the posterior iliac crest under sedation and analgesia of the patients randomly assigned for the treatment group. After laboratory manipulation, intracoronary or intravenous injection of 100 x 106 mononuclear cells was performed. Echocardiography (Vivid 7) was used to assess ventricular function before and three and six months after cell infusion. RESULTS: A total of 30 patients were included, 14 in the arterial group (AG), 10 in the venous group (VG), and six in the control group (CG). No statistical difference was found between the groups for the echocardiographic parameters studied. CONCLUSION: Autologous mononuclear bone marrow cell transplantation did not improve the echocardiographic parameters of systolic function.