Abstract
BACKGROUND: The fibrosis-4 (FIB-4) index has attracted attention as a predictive factor for cardiovascular events and mortality in patients with heart disease. However, its clinical value in patients with implanted pacemakers remains unclear. METHODS: This study included patients who underwent pacemaker implantation. The FIB-4 index was calculated based on blood tests performed during the procedure. The primary outcome was all-cause mortality, and the secondary outcomes included cardiovascular death, non-cardiovascular death, and major adverse cardiovascular events (MACE; composite of cardiovascular death, heart failure hospitalization, non-fatal myocardial infarction, and non-fatal stroke). The FIB-4 index was stratified into tertiles. Between-group comparisons were performed using log-rank tests and multivariate analysis using Cox proportional hazards. The predictive accuracy and cut-off value of the FIB-4 index were calculated from the receiver operating characteristic curve for all-cause mortality. Finally, based on the calculated cut-off values, the patients were divided into two groups for outcome validation and subgroup analysis. RESULTS: This study included 201 participants, of whom 38 experienced death during the observation period (median: 1097 days). All-cause mortality, non-cardiovascular death, and MACE differed significantly between groups stratified by the FIB-4 index tertiles (log-rank test: P<0.001, P<0.001, and P = 0.045, respectively). Using Cox proportional hazards analysis, the unadjusted hazard ratio was 4.75 (95% confidence interval [CI]: 2.05-11.0, P<0.001) for Tertile 3 compared to Tertile 1. After adjustment for confounding factors, including sex, the presence or absence of left bundle branch block at baseline, QRS duration during pacing, and pacing rate at the last check, the hazard ratio was 4.79 (95% CI: 2.04-11.2, P<0.001). The cut-off value of the FIB-4 index was 3.75 (area under the curve: 0.72, 95% CI: 0.62-0.82). CONCLUSIONS: In patients with pacemakers, the FIB-4 index may be a predictor of early all-cause mortality, with a cut-off value of 3.75.