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

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.