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Aims: The experiences of patients who received shocks from their implantable cardioverter defibrillator (ICD) and how these events affect their overall adjustment are poorly understood. Our goal was to evaluate quality of life and psychological well-being, and the prevalence of, and changes in, depression and anxiety of patients who did or did not experience defibrillatory shocks in the first 12 months after ICD implantation. In total 167 patients were monitored after discharge. Four self-administered questionnaires were used. The first assessment took place before ICD implantation, the remaining three at 1, 6 and 12 months after discharge., Results: We classified patients into three shock groups and one no shock group. A small group of ICD recipients (26%) received ICD shock delivery, usually during the last 6 months of the study. Borderline significant differences were found within the groups over time regarding physical role limitations (P < 0.051). Those who experienced shocks throughout the year (group 1) felt more limited in their daily activities due to physical or mental problems. All groups health (P < 0.001). Overall quality of life did not change significantly after 6 months. Anxiety and depression did not change significantly over time. In total 22-66% of patients reported clinically significant depressive symptoms throughout the first year, and 31-83% clinically significant symptoms of anxiety. ICD recipients who had experienced a shock were significantly more anxious one-year postdischarge than those who had not received a shock., Conclusions: Overall quality of life and psychological well-being did not change in ICD recipients, irrespective of whether they experienced defibrillatory shocks. The high prevalence of depression and anxiety can be interpreted as a response to the perceived physical and mental problems regarding daily activities. Our data indicate that patients who have experienced an ICD shock do not adapt well to living with an ICD, they are more anxious than ICD recipients who received no shocks. However, the anticipation of having another shock after experiencing one is less stressful than that of the first shock. We conclude that the lasting psychological distress will not dissipate spontaneously or naturally and that psychosocial interventions may be warranted.

Background: Evidence from earlier studies indicates that intake of very long-chain n-3 polyunsaturated fatty acids (n-3 PUFA, also named omega-3 fatty acids) as present in fish oil reduces the risk of sudden death. Sudden death forms a major part of mortality from cardiovascular disease and is in most cases a direct consequence of cardiac arrhythmia. n-3 PUFA may exert their protective effect through reducing the susceptibility for cardiac arrhythmia., Objective: To investigate the effect of n-3 PUFA on the incidence of recurrent ventricular arrhythmia. This paper presents the rationale, design and methods of the Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) and discusses problems encountered in conducting a multicentre clinical trial on food., Design: A randomised, parallel, placebo-controlled, double blind intervention study, which obeys the guidelines for Good Clinical Practice., Setting: Multiple cardiology centres in Europe., Subjects: A total of 500 patients with an implantable cardioverter defibrillator (ICD). An ICD detects, treats and stores cardiac arrhythmic events in its memory chip., Interventions: Patients receive either 2 g/day of fish oil, containing approximately 450 mg eicosapentaenoic acid and 350 mg docosahexaenoic acid, or placebo for 12 months., Primary Outcome: Spontaneous ventricular tachyarrhythmias as recorded by the ICD or all-cause mortality., Conclusion: SOFA is designed to answer the question whether intake of n-3 PUFA from fish-a regular food ingredient-can reduce the incidence of life-threatening cardiac arrhythmia. If this proves to be true, increasing the intake of n-3 PUFA could be an easy, effective and safe measure to prevent fatal arrhythmia in the general population.