Device-related events do not alter long-term psychological distress after implantable cardioverter-defibrillator implantation: A 24-month prospective cohort study.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) have long been established as effective in reducing all-cause mortality in patients at risk of sudden cardiac death. However, in recent years, the balance between benefit and harm has come under scrutiny. A substantial proportion of patients with an ICD experience psychological distress. OBJECTIVE: This study aimed to evaluate whether device-related events influence psychological outcomes after ICD implantation. METHODS: The prospective PSYCHE-ICD study enrolled 178 patients (mean age 64 ± 12 years; 79% male) undergoing ICD or cardiac resynchronization therapy defibrillator implantation with a follow-up time of 24 months. Device-related events, including complications and ICD therapy events, were assessed. Psychological outcomes were measured using the Florida Shock Anxiety Scale, Inventory of Depressive Symptomatology, and Beck Anxiety Inventory at baseline and 2, 12, and 24 months after ICD implantation. RESULTS: Device-related events occurred in 33% of patients. Over 24 months, Florida Shock Anxiety Scale, Inventory of Depressive Symptomatology, and Beck Anxiety Inventory scores all decreased significantly (all P < .005), indicating an overall reduction in psychological distress, independent of device-related events. Psychological distress at 24 months was primarily predicted by baseline depressive and anxiety symptoms, but not by the occurrence of device-related events. CONCLUSION: Psychological distress generally decreases during the first 24 months after ICD implantation. Long-term outcomes are determined more by pre-existing psychological vulnerability than by the occurrence of device-related events.