Psychological effects of device recalls and advisories in patients with implantable cardioverter defibrillators

Abstract

Implantable cardioverter defibrillators (ICD) are subject to technical failures. The current chapter reviews the impact of the resulting public advisories on patient psychological welfare and quality of life. Despite the paucity of research on the impact of ICD advisories, available data suggest that ICD advisories, involving either possible generator or lead malfunction, result in limited long-term adverse psychosocial effects in most patients. This appears particularly true in patients followed in supportive device clinics where provision of prompt information, counselling, and reassurance is provided by healthcare professionals. Individuals dependent on the ICD for pacing or requiring more intensive interventions (such as device replacement) following the advisory may be more vulnerable to increased distress, as may patients who have experienced inappropriate shocks. Additional counselling or psychological support in these patients may be required. As research to date has relied mostly on small single-center observational ad hoc studies, more reliable information is required to confirm these impressions. Ideally, patient-reported outcomes would need to be routinely and repeatedly assessed and included within national registries. Moreover, research on the psychosocial impact of advisories is consistent with other research in ICD patients, showing significant impairments in QoL and psychological status in many patients that persist for years, independently of advisories. The psychosocial experiences of many patients are not adequately attended to, and this may contribute to a worse prognosis. Information gleaned from research on this issue could facilitate physician-patient decision-making and lead to improved psychological support for patients whose devices are under advisory as well as those considering ICD therapy for the first time.