Abstract
Sudden death prophylaxis using a standard implantable defibrillator (ICD) improves survival in patients who develop lethal ventricular arrhythmias. Patients identified to be at risk for sustained ventricular arrhythmias can be offered an ICD as prophylaxis. We previously reported that poor pre-implantation mental health was associated with lower ICD acceptance in the first 3 months after implantation. Over the longer-term, the role of these variables, as well as device complications on patient device acceptance is less clear. We are reporting on our 12-month follow-up of findings from a prospective study of 70 primary prevention ICD recipients in Ontario. Patients receiving standard single or dual chamber ICDs for primary prevention were enrolled pre-implantation. Exclusions included those receiving devices with cardiovascular resynchronization or secondary prevention. The primary outcome was device acceptance using the Florida Patient Acceptance Scale (FPAS). Higher FPAS scores are associated with positive adjustment to the ICD. Multivariate regression was used to determine the relationship between one-year device acceptance (FPAS) and baseline generic HRQL (including mental and physical components), early device and health complications, and NYHA class. At 12-months, 62 participants completed follow-up (89% male; mean age 64.9 ± 9.1). Poor mental-HRQL scores and ICD complications within the first 3 months after implant contributed most to lower FPAS scores. The model revealed that these variables accounted for 27% of the variance in FPAS scores (R2 = .27; F6, 55; p < .005). By 12-months, 4 patients had died; one patient received multiple appropriate shocks from the device. Additional secondary analysis revealed that of the 33% of patients taking antidepressants who reported elevated depressive symptoms (based on Centre for Epidemiological Studies (CES-D) established cutoff scores ≥ 16), over half were undertreated pharmacologically. ICD complications within the first 3 months of device implant and poor pre-implant mental health contributed to lower patient-reported device acceptance at one year. Pre-implantation counseling regarding the potential for device complications is warranted. Ensuring adequate treatment for depressive symptoms should be considered to improve device adjustment.
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