Clinical Validation of a Novel Assay for Galectin-3 for Risk Assessment in Acutely Destabilized Heart Failure

Background: The role of biomarkers for the assessment of risk in acutely destabilized heart failure (ADHF) has recently increased. Galectin-3, a lectin involved in inflammation and fibrosis, was recently shown to be prognostically meaningful in ADHF. We describe the clinical validation of a novel assay for galectin-3. Methods: Patients from two ADHF trials, based at the University of Maryland and Massachusetts General Hospital, were included in the present analysis. Plasma galectin-3 concentrations were measured using a novel assay provided by BG Medicine (Waltham, MA). Vital statistics were available on all subjects out to 800 days of follow up; plasma galectin-3 values were examined as a function of mortality to this time point. Results: 310 subjects (61% male, mean age 68 years, 70% Caucasian, mean ejection fraction 44%) were included. The majority of subjects had severe ADHF, with class III-IV symptoms in nearly 80%. The baseline galectin-3 value had an area under the receiver operating characteristic (ROC) curve of 0.70 (P<0.001) for death at 800 days, comparable to NT-proBNP (0.70; P <0.001), however superior area under the ROC was seen when combining galectin-3 with NT-proBNP results (0.74; P <0.01 for difference). In a Cox proportional hazards model, log-transformed galectin-3 remained a significant predictor of death at 800 days (HR 2.19; P <0.001) after adjustment for NT-proBNP (HR 1.23; P =.01), CRP (HR 1.18; P =.009), age and race. Conclusion: We report the clinical validation of a new assay for galectin-3, a novel marker of inflammation and fibrosis. Galectin-3 is independently prognostic for long term mortality in patients with ADHF, and additive to other biomarkers of risk for this indication.