RESUMEN
OBJECTIVE: To present the design of a multicenter, randomized trial testing the effects of stress reduction treatment (SRT) on the prevalence of shock-treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials. METHODS: New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the last 6 months (n = 304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour Holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6, 12, and 24 months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), antitachycardia pacing events, medication changes, hospitalizations, deaths, and quality of life. RESULTS: Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock-treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on laboratory stress-induced and 24-hour arrhythmogenic electrophysiological indices from pre to post treatment, and both quality of life and measures of anger across the 2 years of the study. CONCLUSIONS: The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial is the first large-scale, randomized, clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia-provoked shock and improve quality of life.
Asunto(s)
Arritmias Cardíacas/terapia , Desfibriladores Implantables/psicología , Estrés Psicológico/terapia , Disfunción Ventricular/terapia , Adulto , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/prevención & control , Terapia Cognitivo-Conductual/métodos , Electrocardiografía Ambulatoria/métodos , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Educación del Paciente como Asunto , Psicoterapia de Grupo , Calidad de Vida , Proyectos de Investigación , Estrés Psicológico/prevención & control , Resultado del Tratamiento , Disfunción Ventricular/psicologíaRESUMEN
BACKGROUND AND AIM OF THE STUDY: The objective of this randomized trial was to compare the efficacy of two strategies of hemodynamic management during cardiopulmonary bypass (CPB) on morbidity, mortality, cognitive complications and deterioration in functional status. METHODS: Patients scheduled to undergo primary elective CABG were eligible. In one group, mean arterial pressure target during CPB was 80 mmHg ("high" MAP group); in the other group, MAP target was determined by patients' pre-bypass MAP ("custom" MAP group). The principal outcomes were mortality, major neurologic or cardiac complications, cognitive complications or deterioration in functional status. RESULTS: Of 412 enrolled patients, 36% were women, with overall mean age of 64.7 +/- 12.3 years. Duration of bypass was identical for the two randomization groups. Overall complication rates were similar: 16.5% of the high group and 14.6% of the custom group experienced one or more neurologic, cardiac or cognitive complications. When only cardiac and neurologic morbidity and mortality were considered, the rates were 11.7% and 12.6%, in the high and custom groups, respectively. The aggregate outcome rate, including functional deterioration, was 31.6% in the high group and 29.6% in the custom group. CONCLUSIONS: There were no statistically significant differences between the high MAP group and the custom MAP group for the combined outcome of mortality cardiac, neurologic or cognitive complications, and deterioration in the quality of life.