In a prospective multicenter study of coping, subjective well-being and objective course of the disease we recruited patients with life-threatening cardiac arrhythmias awaiting the implantation of a cardioverter defibrillator. All patients received a semistructured interview and a number of well validated self-assessment questionnaires. In addition, detailed cardiological findings were documented. The present paper describes the study rationale and design as well as the main study hypotheses. In addition, we present representativity data for the inclusion sample and cross-sectional psychometric findings obtained before implantation of the device. The study sample consists of 286 patients with severe ventricular arrhythmias and is almost representative for all ICD recipients in the participating centers and ICD recipients in general. Despite their severe physical impairment, patients only showed moderate levels of psychological abnormalities. Only patients with severe heart failure or a history of repeated resuscitations showed elevated rates of anxiety or depression. However, there were relevant associations among the self-rating scales: Patients with abnormal anxiety or depression scores reported significantly elevated levels of physical complaints and depressive coping. They also showed low social support and an impaired quality of life. These cross-sectional findings add to the international literature on coping and well-being of patients with malignant cardiac arrhythmias. On the background of earlier research findings and clinical experience our results show high plausibility. Prospective changes over time in the different dimensions of psychosocial adjustment and their prognostic power for future quality of life and arrhythmic events will be reported separately.
