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English to Spanish: Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device Detailed field: Medical: Cardiology
Source text - English Abstract
Patients with advanced heart failure have improved survival rates and quality of life
when treated with implanted pulsatile-flow left ventricular assist devices as compared
with medical therapy. New continuous-flow devices are smaller and may be
more durable than the pulsatile-flow devices.
In this randomized trial, we enrolled patients with advanced heart failure who were
ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuousflow
device (134 patients) or the currently approved pulsatile-flow device (66 patients).
The primary composite end point was, at 2 years, survival free from disabling stroke
and reoperation to repair or replace the device. Secondary end points included survival,
frequency of adverse events, the quality of life, and functional capacity.
Preoperative characteristics were similar in the two treatment groups, with a median
age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of
17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary
composite end point was achieved in more patients with continuous-flow devices
than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P
Translation - Spanish RESUMEN
Al ser tratados con un dispositivo implantable de asistencia ventricular izquierda de flujo pulsátil, los pacientes con insuficiencia cardiaca refractaria han revelado mejoras en la sobrevida y calidad de vida en comparación con la terapia médica. Los nuevos dispositivos de flujo continuo son más pequeños y duran más que los dispositivos de flujo pulsátil.
En este ensayo aleatorizado se enrolaron pacientes con insuficiencia cardiaca refractaria, no aptos para un transplante, con el fin de implantarles un dispositivo de flujo continuo (134 pacientes) o el recientemente aprobado dispositivo de flujo pulsátil (66 pacientes), en una relación 2:1. El objetivo principal compuesto a 2 años fue la sobrevida libre de accidente cardiovascular invalidante y la reoperación para reparar o reemplazar el dispositivo. Los objetivos secundarios incluyeron la sobrevida, la frecuencia de acontecimientos adversos, la calidad de vida y la capacidad funcional.
Las características preoperatorias fueron similares en los dos grupos: un promedio de edad de 64 años (rango, 26 a 81), una media de fracción de eyección ventricular izquierda de 17% y suministro de agentes inotrópicos por vía intravenosa en, aproximadamente, el 80% de los pacientes. El objetivo principal compuesto se consiguió en mayor medida, en los pacientes con dispositivos de flujo continuo (62 de 134 [46%] vs. 7 de 66 [11%] en pacientes con dispositivo de flujo pulsátil; P
Spanish to English: ¿Deben todos los pacientes con fracción de eyección menor del 30% recibir un desfibrilador implantable? General field: Medical Detailed field: Medical: Cardiology
Should every patient with an ejection fraction less than
30% receive an implantable cardioverter-defibrillator?
Sudden death is a serious complication in patients with heart failure. It is mostly lethal and poorly predictable by conventional diagnosis methods. The use of implantable cardioverter-defibrillators significantly prevents this complication in patients with demonstrated malignant arrhythmias. Some clinical trials have shown that the implant of a defibrillator diminishes mortality in patients with severe systolic left ventricular dysfunction, but without evidence of serious arrhythmias. This has generated a debate in relation to if all patients with severe systolic ventricular dysfunction should be subjected to the implant of these devices. The foregoing is a revision and discussion of the main works published recently in this respect, and also a critical point of view of the different fields that have been evaluated in controlled observational clinical trials.
In the last decade, cardiovascular mortality has decreased in countries where non-transmissible chronic diseases are the major cause of death. However, the number of patients dying suddenly has not changed, and in some countries it has even been increased1. In the decade of the 1960s, the first observational studies with continuous ECG recording showed that the great majority of SDs were caused by ventricular tachycardia (VT) and ventricular fibrillation (VF).
The development of ambulatory electrocardiography devices (Holter monitor) has made it possible to document that, in presence of ventricular systolic dysfunction (ejection fraction -- EF< 30 or 35%), ventricular arrhythmias (mainly VT) post acute myocardial infarction (AMI) were independent predictors of SD after an AMI (Fig. 1).
The aim of this review is to lay stress on the main studies supporting the use of implantable cardioverter-defibrillators (ICD) as primary prevention of SD in patients with left ventricular dysfunction, and to
* Cardiologist . Heart failure Unit
Hospital: Hospital DIPRECA. Santiago de Chile. Chile.
Correspondence: Dr. Roberto Concepción.
Servicio de Cardiología. Hospital DIPRECA.
Av. Vital Apoquindo 1200.
Las Condes. Santiago de Chile. Chile.
Available at http://www.insuficienciacardiaca.org Rev Insuf Cardíaca 2008; (Vol 3) 2:80-84
provide our point of view regarding the rationality and adequacy of this intervention in the setting of severe systolic left ventricular dysfunction.
As mentioned in the introduction, observational studies have shown an unequivocal relationship between ventricular arrhythmia (VT/VF), left ventricular systolic dysfunction and SD2, 3.
These findings soon led to an attempt to modify the prognosis of patients by suppressing ventricular arrhythmia with antiarrhythmic drugs.
Cardiac Mortality (%)
Ejection Fraction (%)
Figure 1. Mortality related to ejection fraction in patients with acute myochardial infarction. American and Canadian Records.
Studies developed to analyze such a hypothesis failed to prove it, and instead, they proved to be hazardous strategies in the setting of AMI. The Cardiac Arrhythmia Suppression Trial (CAST) was prematurely suspended owing to high mortality rates in relation to antiarrhythmic drugs (flecainide, encainide) as compared to placebo 4.
Evidence on the efficacy of IMD in preventing arrhythmic sudden death
Michael Mirowski developed the implantable cardioverter-defibrillator, and published his first experience in 19805. Ten years later, it was possible to assess the efficacy of the device with a randomized and controlled method. The first ICDs were implanted in the abdomen and with epicardial electrodes, but their voluminous “anatomy” was soon modified and ICDs were turned into devices similar to the commonly used pacemakers.
The first controlled studies on secondary prevention of SD, comparing ICD vs. amiodarone treatment and other pharmacological agents in survivors of a cardiac attack, proved ICDs6-10 to be superior.
The next step was to prove that the ICD could reduce mortality in patients with chronic coronary disease and left ventricular dysfunction with no evidence of spontaneous VT/VF, though inducible in an electrophysiological study (EPS).
The Multicenter Unsustained Tachycardia Trial (MUSTT) and the Multicenter Automatic Defibrillators Implantation Trial (MADIT) included patients with an ejection fraction (EF) less than 40% and 35% respectively, thereby taking into consideration the relationship between patients with LVEF < 40% and arrhythmic mortality established by pre and post thrombolytic studies11. In absolute terms, the strategy involving implantation of ICD in patients with ventricular dysfunction proved superior to the conventional treatment in this group of patients. However, subsequent substudies revealed that in MADIT, for instance, the subgroup of patients with FE between 26% and 35% did not show significant improvements regarding mortality, the use of the ICD being compared with conventional treatment post AMI. Only patients with EF below 26% were significantly benefited.
DAI as primary prevention of SD in severe systolic left ventricular dysfunction
The MADIT II study was designed in order to prove ICD superiority vs. the optimal treatment for heart failure (HF) in coronary patients with severe systolic dysfunction. This clinical trial had two inclusion criteria, different from previous studies: EF < 30%, and no need of EPS previous to randomization13.
Figure2. Prescription of implantable cardioverter-defibrillator (ICD) in patients with severe systolic dysfunction in EEUU.
It is important to note that symptomatic HF was not a requisite for enrollment in any of these trials; however, 2/3 of the patients enrolled in MADIT II revealed functional class II-III according to the New York Heart Association (NYHA). Thus, these were “high risk” patients not only because of the “number” (EF of 30%) but also because of the presence of symptomatic HF.
Recently, the role of ICDs in patients with HF whose etiology is non-ischemic (basically, primary dilated myocardiopathies) has been studied in, at least, 3 extended clinical trials. The German Cardiomiophathy Trial (CAT) enrolling 104 patients with non-coronary myocardiopathy, functional class V according to NYHA and average EF of 24% has not proved ICD superiority vs. conventional treatment14. It is important to note that in the CAT study, there was a small number of patients and a low mortality rate in the control group, which undermines statistical value to such report.
The Defibrilators In Non Ischemic Cardiomiophathy Treatment Evaluation (DEFINITE) included 458 patients with EF < 35%, and a history of symptomatic HF (FC II-III according to NYHA), and spontaneous non-sustained VT. Patients were randomly assigned to ICD or optimal treatment of HF (mostly angiotensin converting enzyme (ACE) inhibitors, beta-blockers and diuretics).
At 2 years of follow up, the mortality of the control group was of 14.1% vs. 7.9% for the ICD group (not significant).15
The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) enrolled 2521 patients with HF of coronary and non-coronary etiology in FC II-III of the NYHA and average EF of 25%, all of them treated with optimal therapy for HF. Patients were included into one of the following strategies: placebo, amiodarone o ICD. Mortality of the control group at 2 years was 14%, and mortality of patients assigned to ICD was 23%, lower than the patients assigned to placebo with a follow-up of 4 years (p=0,007). ICD proved also beneficial for patients with non-coronary etiology.
Treatment with amidorane proved not beneficial in relation to the mortality of the patients treated16 (Figure 2 y Table 1).
Over the last decade, the ICDs have improved survival of patients with left ventricle dysfunction, independently of the benefits from inhibition of the renin-angiotensin system by using angiotensin converting enzyme (ACE) inhibitors, beta-blockers and antialdosteronics, mainly those of ischemic etiology and mostly in patients with other indicators of SD (VT/VF, inducible or not). Yet, it is worth asking ourselves: should we adopt the reduction in mortality observed in the studied populations (with enrollment defined criteria), as a guideline in our everyday clinical practice? The answer to this question is yet controversial.
Main mechanisms of Sudden Death
Mechanisms causing SD are complex and multiple, even in the same patient. For instance, in patients with coronary disease, but with no evidence of previous AMI, the most common mechanism responsible for SD is ventricular fibrillation arose from an ischemic event. Many of these patients have an EF > 40%.
In the Dutch prospective record, more than the 50% of SDs in “coronary” patients occurred with EF >30% and a 25% even with EF of 50%.17
Patients with AMI suffer multiple mechanisms leading to VT/VF: intramyocardial re-entry due to a “non-uniform anisotropy”, as well as other electrophysiological abnormalities created by the fibrous tissue formed during the cicatrizant process. These reentry circuits do not require ischemia to develop VT/VF. Also, myocardial hypertrophy of the non-infarcted tissue could predispose VF18. To this, we should add the neurohormonal changes involving ventricular remodeling produced after extended infarctions and which in many cases lead to HF Syndrome19.
All in all, we should conclude that the mechanisms which could possibly cause VT/VF are multiple, and therefore, there is no single test or independent variable defining in itself the real risk of SD, especially in coronary patients.
Limitation of the EF as an independent variable to predict SD
A report from the prospective Maastricht Circulatory Arrest Registry showed that only 19% of the patients with demonstrated coronary disease and who experienced SD, had an EF< 30% before the event 17.
A substudy of this registry proved that the EF was higher than 30% in 56% of the patients with documented AMI and SD20. The limitation of the EF as an independent indicator of risk of SD was also evaluated by the European Autonomic Tone and Reflexes After Myocardial Infarction study (ATRAMI) 21. This study included 1248 patients within the first month post AMI, and evaluated multiple SD risk stratification strategies (the average EF was of 49%). After 21 months of follow up, 49 patients died, less than half of them having EF
Spanish to English: “El uso de los indicadores en la Evaluación de Políticas Sociales: el Programa “Servicio Alimentario Escolar” (S.A.E.) en el Partido de General Pueyrredón.” General field: Bus/Financial Detailed field: Finance (general)
Source text - Spanish RESUMEN
Los propósitos de la Evaluación de políticas son determinar el impacto de una intervención y sistematizar la experiencia mediante las lecciones aprendidas.
El proceso de “evaluación” debe proporcionar información útil y creíble, que permita integrar las enseñanzas obtenidas en los mecanismos de toma de decisiones para retroalimentar los procesos de gestión. La operacionalización de la misma se materializa a través del uso de indicadores, definidos como apropiados en cada caso por la importancia de la información que brindan, para apreciar o medir la variable respectiva.
La mejor manera de arribar a los objetivos deseados de un programa, proyecto o política es planeando, y para planear es necesario evaluar, utilizando la mejor herramienta, que son los indicadores.
Los indicadores son una medida o apreciación, directa o indirecta de un evento, una condición, una situación o un concepto. Son a su vez variables, aunque de menores niveles de abstracción, observables o medibles, que permiten inferir conclusiones apreciativas acerca de las variables correspondientes; por eso se dice que especifican las variables a las que hacen referencia.
La selección de indicadores permite definir las técnicas apropiadas y el posterior diseño de instrumentos de recolección de información.
Para el análisis del programa Servicio Alimentario Escolar se buscó evaluar las dos dimisiones posibles. Es decir, considerar los datos del tipo cuantitativos así como los cualitativos. Si bien la información que aporta la medición objetiva de valores (datos cuantitativos) es imprescindible a la hora de evaluar, ya sea por la objetividad, claridad y robustez de la misma, no debemos dejar de considerar aquella otra faz de la información. De esta forma se torna ineludible la apreciación de los datos cualitativos para completar el proceso de evaluación.
Al hablar de programas sociales se hace necesaria esta consideración, justamente por el impacto o efecto que genera en la sociedad. Estas consecuencias de la ejecución los programas debe incluir este tipo de datos en su medición dado que la existencia de intersubjetividades que no se hacen manifiestas por ningún tipo de medición numérica calculable. Ningún análisis social estaría completo si no se considera la dimensión cualitativa.
Al buscar evaluar, medir, cuantificar o calificar determinados efectos que resultaron de la ejecución del programa es necesario desarrollar “creativamente” una serie de indicadores específicos que resulten aplicables al programa abordado. En la mayoría de los casos nos encontramos con indicadores que quizá resulten únicos para evaluar el programa o la política en la que el evaluador se encuentra inmerso.
Evaluación - Indicadores – Programas Sociales – Políticas Sociales - S.A.E. – Partido de General Pueyrredón
Translation - English Abstract
The aims of policy assessment are to determine the impact of an intervention and to systematize experience by drawing upon lessons learned.
The assessment process must provide useful and plausible information which could allow for the integration of the information obtained from the decision making mechanisms in order to feed back the management process. The assessment process is developed through the use of indicators, each of them selected according to the information relevance they provide to appreciate the corresponding variable.
The most effective way to reach the objectives of any program, project or policy is to plan, and in order to do so, we need to assess by using indicators.
Indicators are either a direct or indirect form of measuring an event, condition, situation or concept. They are also observable or measurable variables (only of a lower level of abstraction) allowing for the inference of observable conclusions on the corresponding variables; that is why they are said to specify the variables they make reference to.
The selection of indicators defines the appropriate techniques and the subsequent design of data collection instruments.
Both qualitative and quantitative data were assessed for the analysis of the School Feeding Program (Servicio Alimentario Escolar). Although the information provided by the objective assessment of values (quantitative data) is vital on the grounds of its clarity and objectivity, we should not neglect qualitative data, which are ineludible for completing the assessment process.
When considering social programs, the concept of qualitative data becomes vital precisely because of the impact it causes on society. The existence of intersubjectivities not accounted for by any kind of calculable numerical measure calls for the inclusion of qualitative data. No analysis would be complete without considering the qualitative dimension.
In seeking to assess, measure, quantify, or qualify certain effects resulting from the implementation of the program, a series of specific indicators have to be creatively developed. In most cases, we find indicators which may be exclusive for assessing the program or policy in which the evaluator is immersed.
Assessment - Indicators – Social Program – Social Policy - School Feeding Program (S.A.E) –General Pueyrredón District
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