Quality of life and psychological distress in patients with implantable cardioverter-defibrillators: the PSY-ICD study

Abstract Background The implantable cardioverter-defibrillator (ICD) is a well-established therapy for preventing sudden cardiac death. However, living with an ICD may be associated with psychological distress, depression, anxiety, and reduced quality of life (QoL). The PSY-ICD study assessed the prevalence of these conditions and their determinants in a contemporary ICD cohort. Purpose To evaluate psychological adjustment, distress, and device acceptance in ICD patients, and identify predictors of poorer outcomes. Methods A prospective observational study was conducted at our University Division of Cardiology. Between February and October 2025, patients eligible for or already carrying an ICD (single- or dual-chamber transvenous, cardiac resynchronization, subcutaneous, or extravascular systems) were enrolled. Exclusion criteria were severe cognitive impairment (Mini Mental State Examination) and major psychiatric disorders. Participants completed eight validated instruments: PsychoSocial Index (PSI), DASS-21, Euthymia Scale, Florida Patient Acceptance Scale (FPAS), WHO-5, Demoralization Scale-6 (DS-6), Mental Pain Questionnaire (MPQ), and Implanted Device Adjustment Scale (IDAS). Results A total of 227 patients were included (median age 62 years IQR 53–70; 73% male; mean time from implantation 6.6 ± 6.5 years; 77% primary prevention). Psychological distress affected about one quarter of participants, with clinical-level presentations in roughly one in ten. Women and patients who experienced ICD shocks in the past year showed significantly higher stress scores (p 0.05) (Figure). MPQ findings were consistent, revealing greater mental pain in these subgroups. Clinically relevant anxiety and depression (DASS-21) were observed in 12.8% and 14.9% of patients, respectively, while subclinical symptoms were frequent. FPAS indicated good device acceptance in most participants, although about half reported meaningful device-related distress. Conclusions Although most ICD patients demonstrate adequate psychological adaptation and device acceptance, a substantial subgroup—particularly women and those with recent shocks—experience significant distress or subclinical anxiety/depression. These findings highlight the need for integrated psychological assessment and multidisciplinary support to identify at-risk patients early and improve emotional well-being, QoL, and device acceptance.