Abstract 1179: REFORM: Registry Evaluating Functional Outcomes of Resynchronization Management
Background: Implantable cardioverter defibrillators (ICDs) prolong survival. However, ICD shocks are associated with diminished psychosocial function (Psyf) and quality of life (QOL). Cardiac resynchronization therapy (CRT-D) provides significant symptomatic and QOL benefits in patients with drug refractory heart failure (HF). This pilot study compared Psyf, QOL and device acceptance in ICD and CRT-D patients at implant (BL) and 9 months (9m).
Methods: 100 patients were enrolled in the study at 3 centers. Psyf and QOL were assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-12 v1, Speilberger’s State-Trait Anxiety Inventory (STAI), Patient Health Questionnaire-9 (PHQ-9), Florida Shock Anxiety Scale (FSAS) and Florida Patient Acceptance Survey (FPAS). FSAS and FPAS provide quantitative scores of ICD specific patient function related to fear of receiving ICD shocks and psychological and behavioral adjustment to the ICD, respectively. Greater FSAS scores indicate greater shock anxiety, while higher FPAS scores indicate greater ICD acceptance.
Results: Data are presented for patients completing a 9m follow-up. There were no significant differences in Psyf or QOL between treatment groups at BL or 9m with the exception of BL SF-12 physical component scores (ICD: 35.8±8.4; CRT-D: 27.6±7.3, p=0.003). There was a greater, non-significant, increase in KCCQ score in the CRT-D group from BL to 9m (p=0.47). FPAS scores were similar between groups at BL and 9m. In ICD patients, FPAS scores increased over time suggesting greater device acceptance, while CRT-D FPAS scores decreased over time.
Conclusions: This is the first study to compare Psyf, QOL and device acceptance between ICD and CRT-D patient groups. The data suggest that HF patients, with ICD or CRT-D, have similar Psyf, QOL and device acceptance at BL and 9m follow-up. Enrollment of additional patients may elucidate Psyf, QOL and device acceptance differences in these patient groups.