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1.
Am Heart J ; 167(5): 646-52, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24766973

RESUMO

BACKGROUND: Anticoagulation before, during, and after cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. OBJECTIVE: The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective cardioversion. METHODS: This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 cardioversion strategies: the first approach is early cardioversion with the precardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before cardioversion. All patients will receive study treatment for 6 weeks postcardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. CLINICAL CONTEXT: This will be the first prospective study of a novel oral anticoagulant in the setting of cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after cardioversion in a broad patient population.


Assuntos
Fibrilação Atrial/terapia , Cardioversão Elétrica , Embolia/prevenção & controle , Morfolinas/administração & dosagem , Tiofenos/administração & dosagem , Vitamina K/antagonistas & inibidores , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Relação Dose-Resposta a Droga , Método Duplo-Cego , Ecocardiografia Transesofagiana , Embolia/etiologia , Inibidores do Fator Xa , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Rivaroxabana , Fatores de Tempo , Resultado do Tratamento
2.
Arq Bras Cardiol ; 98(6): 471-9, 2012 Jun.
Artigo em Inglês, Português | MEDLINE | ID: mdl-22892693

RESUMO

Disclosure of potential conflicts of interest (COI) is used by biomedical journals to guarantee credibility and transparency of the scientific process. COI disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for COI disclosure. This paper provides a comprehensive editorial perspective on classical COI-related issues. New insights into current COI policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardised questionnaire, are discussed.


Assuntos
Autoria/normas , Conflito de Interesses , Revelação/ética , Políticas Editoriais , Publicações Periódicas como Assunto/ética , Cardiologia/ética , Coleta de Dados , Revelação/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Europa (Continente) , Humanos , Publicações Periódicas como Assunto/normas , Apoio à Pesquisa como Assunto/ética , Sociedades Médicas
3.
Rev. urug. cardiol ; 27(3): 313-325, ago. 2012. ilus
Artigo em Espanhol | LILACS | ID: biblio-962306

RESUMO

Resumen Especialmente en las últimas décadas varios estudios han intentado confirmar la hipótesis que sostiene que la contracción miocárdica inapropiadamente rápida, irregular, o asincrónica provoca miocardiopatía. Las frecuencias ventriculares rápidas resultantes de arritmias supraventriculares y fibrilación auricular (FA), la irregularidad del ritmo cardíaco -elemento básico de la FA- y la asincronía, determinada por estimulación ventricular derecha, bloqueo de rama, o complejos ventriculares prematuros frecuentes, han sido establecidas como las causas primarias de miocardiopatía inducida por arritmias. Se han aclarado las principales vías fisiopatológicas involucradas; éstas incluyen la activación neurohumoral, el agotamiento de los depósitos energéticos, y anomalías que ocurren durante el estrés y la sobrecarga. Desgraciadamente, desde un punto de vista clínico, los pacientes habitualmente consultan recién cuando aparecen síntomas, a pesar de que la arritmia causal pueda haber aparecido ya meses o años antes, llevando así a una remodelación del miocardio y disfunción diastólica y sistólica. En algunos casos, tratar de establecer un diagnóstico definitivo puede convertirse en un ejercicio agotador para el médico tratante, ya que la arritmia puede no estar siempre presente, y además, implica que primero tiene que indicar un tratamiento, para confirmar el diagnóstico recién retrospectivamente. Otra dificultad que plantea el proceso diagnóstico es que los criterios diagnósticos estrictos siguen siendo tema de controversia. Las opciones terapéuticas incluyen pruebas empíricas con agentes farmacológicos, terapias por catéter, y en el contexto de la estimulación ventricular crónica, la resincronización. Es de esperar que en la mayoría de los pacientes se logre una recuperación parcial o completa, pero aun así los pacientes tendrán que ser seguidos cuidadosamente debido al riesgo de recurrencia. Se hace entonces indispensable realizar ensayos aleatorizados controlados de gran tamaño que permitan optimizar la estratificación de los pacientes y definir la elección de estrategias terapéuticas


The hypothesis testing of inappropriate fast, irregular, or asynchronous myocardial contraction provoking cardiomyopathy has been the primary focus of numerous research efforts, especially during the last few decades. Rapid ventricular rates resulting from supraventricular arrhythmias and atrial fibrillation (AF), irregularity of heart rhythm-basic element of AF-and asynchrony, as a consequence of right ventricular pacing, bundle branch block, or frequent premature ventricular complexes, have been established as primary causes of arrhythmia-induced cardiomyopathy. The main pathophysiological pathways involved have been clarified, including neurohumoral activation, energy stores depletion, and abnormalities in stress and strain. Unfortunately, from a clinical point of view, patients usually seek medical advice only when symptoms develop, while the causative arrhythmia may be present for months or years, resulting in myocardial remodelling, diastolic, and systolic dysfunction. In some cases, making a definite diagnosis may become a strenuous exercise for the treating physician, as the arrhythmia may not be present and, additionally, therapy must be applied for the diagnosis to be confirmed retrospectively. The diagnostic process is also hardened due to the fact that strict diagnosing criteria are still a matter of discrepancy. Therapy options include pharmaceutical agents trials, catheter-based therapies and, in the context of chronic ventricular pacing, resynchronization. For the majority of patients, partial or complete recovery is expected, although they have to be followed up thoroughly due to the risk of recurrence. Large, randomized controlled trials are more than necessary to optimize patients’ stratification and therapeutic strategy choices

4.
Arch Cardiol Mex ; 82(2): 170-80, 2012.
Artigo em Espanhol | MEDLINE | ID: mdl-22735658

RESUMO

Disclosure of potential conflicts of interest is used by biomedical journals to guarantee credibility and transparency of the scientific process. Conflict of interest disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for conflicts of interest disclosure. This paper provides a comprehensive editorial perspective on classical conflict of interest-related issues. New insights into current conflicts of interest policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardized questionnaire, are discussed.


Assuntos
Cardiologia , Conflito de Interesses , Revelação/normas , Publicações Periódicas como Assunto/normas , Sociedades Médicas
5.
Arch. cardiol. Méx ; 82(2): 170-180, abr.-jun. 2012. tab
Artigo em Espanhol | LILACS | ID: lil-657954

RESUMO

Las revistas biomédicas utilizan la declaración de posibles conflictos de intereses para garantizar la credibilidad y la transparencia del proceso científico. Sin embargo, las revistas no abordan la declaración de conflictos de intereses de manera sistemática ni uniforme. Recientes esfuerzos editoriales conjuntos han abierto el camino a la aplicación de herramientas uniformes para la declaración de conflictos de intereses. En este artículo se presenta una visión integral sobre cuestiones clásicas relacionadas con los conflictos de intereses desde un punto de vista editorial. Además, a partir de los datos de un estudio transversal basado en el empleo de un cuestionario estandarizado, se comentan nuevas apreciaciones sobre las políticas y los actuales procedimientos editoriales relativos a los conflictos de intereses en las diversas revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.


Disclosure of potential conflicts of interest is used by biomedical journals to guarantee credibility and transparency of the scientific process. Conflict of interest disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for conflicts of interest disclosure. This paper provides a comprehensive editorial perspective on classical conflict of interest-related issues. New insights into current conflicts of interest policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardized questionnaire, are discussed.


Assuntos
Autoria/normas , Conflito de Interesses , Revelação , Políticas Editoriais , Publicações Periódicas como Assunto , Cardiologia , Coleta de Dados , Revelação/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica , Europa (Continente) , Publicações Periódicas como Assunto/normas , Apoio à Pesquisa como Assunto , Sociedades Médicas
6.
Arq. bras. cardiol ; 98(6): 471-479, jun. 2012. tab
Artigo em Português | LILACS | ID: lil-645346

RESUMO

A divulgação de possíveis conflitos de interesses (COI) é um recurso utilizado por revistas científicas biomédicas para garantir a credibilidade e transparência do processo científico. No entanto, a divulgação de COI não constitui um foco sistemático ou consistente das revistas científicas. As recentes ações editoriais conjuntas prepararam o terreno para a implementação de veículos uniformes para a divulgação de COI. Este artigo fornece uma perspectiva editorial abrangente de questões clássicas associadas a COI. Discutem-se, ademais, perspectivas sobre as políticas e práticas atuais de COI de revistas científicas de cardiologia nacionais da Sociedade Europeia de Cardiologia, tendo como base uma pesquisa transversal utilizando um questionário padronizado.


Disclosure of potential conflicts of interest (COI) is used by biomedical journals to guarantee credibility and transparency of the scientific process. COI disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for COI disclosure. This paper provides a comprehensive editorial perspective on classical COI-related issues. New insights into current COI policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardised questionnaire, are discussed.


Assuntos
Humanos , Autoria/normas , Cardiologia , Conflito de Interesses , Revelação , Políticas Editoriais , Sociedades Médicas , Europa (Continente)
7.
Ann Noninvasive Electrocardiol ; 17(1): 36-56, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22276627

RESUMO

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.


Assuntos
Desfibriladores Implantáveis , Marca-Passo Artificial , Tecnologia de Sensoriamento Remoto/instrumentação , Tecnologia de Sensoriamento Remoto/métodos , Telemedicina , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Desenho de Equipamento , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Medição de Risco , Telemedicina/instrumentação
8.
Europace ; 14(2): 278-93, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22232544

RESUMO

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca/normas , Desfibriladores Implantáveis/normas , Guias de Prática Clínica como Assunto , Telemedicina/normas , Terapia Assistida por Computador/normas , Europa (Continente)
9.
Rev. urug. cardiol ; 27(2): 191-203, 2012. tab
Artigo em Espanhol | LILACS | ID: biblio-962303

RESUMO

Resumen Las revistas biomédicas utilizan la declaración de posibles conflictos de intereses para garantizar la credibilidad y la transparencia del proceso científico. Sin embargo, las revistas no abordan la declaración de conflictos de intereses de manera sistemática ni uniforme. Recientes esfuerzos editoriales conjuntos han abierto el camino a la aplicación de herramientas uniformes para la declaración de conflictos de intereses. En este artículo se presenta una visión integral sobre cuestiones clásicas relacionadas con los conflictos de intereses desde un punto de vista editorial. Además, a partir de los datos de un estudio transversal basado en el empleo de un cuestionario estandarizado, se comentan nuevas apreciaciones sobre las políticas y los actuales procedimientos editoriales relativos a los conflictos de intereses en las diversas revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología


Summary Disclosure of potential conflicts of interest is used by biomedical journals to guarantee credibility and transparency of the scientific process. Conflict of interest disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for conflicts of interest disclosure. This paper provides a comprehensive editorial perspective on classical conflict of interest-related issues. New insights into current conflicts of interest policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardised questionnaire, are discussed.

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