Psychological Adjustment in ICD Patients Living With Advisory Fidelis Leads

UNLABELLED: Psychological Adjustment and Fidelis ICD Leads. INTRODUCTION: Implantable cardioverter defibrillators (ICD) advisory notices present treatment dilemmas for physicians and patients. On one side, the risk of device malfunction and the likely severity of clinical sequelae have to be estimated. This estimate has to be weighed against the risks of surgery to replace the advisory component. It is unclear whether there is important psychological morbidity associated with living with an ICD under advisory and whether this should be factored into decision making. The study had 2 objectives: (1) to examine whether there is adverse psychological adjustment when an ICD is under advisory, and (2) to assess the psychological sequel of advisory ICD component malfunction. METHODS: This study focused on the Sprint Fidelis advisory. All patients in our practice who still had an in service Medtronic Fidelis lead were included in the study. Three groups were compared: advisory group but no fracture (n = 249), advisory group with lead fracture (n = 24), and a control group (n = 143). For both objectives, we used a general anxiety and depression instrument and also device-specific measures of psychological well being. RESULTS AND CONCLUSIONS: First, there was no evidence of differences in the psychological functioning of patients at risk of ICD lead malfunction compared to a control group. Second, patients who had experienced an ICD lead fracture had adverse psychological morbidity compared to control patients, and this appeared, primarily, to be related to receiving inappropriate shock(s) at the time of the fracture.