Measurement of Galectin-3 with the ARCHITECT assay: Clinical validity and cost-effectiveness in patients with heart failure.

ABSTRACT

OBJECTIVES: Galectin-3 (Gal-3) testing is emerging as a valuable tool for the prognosis of heart failure (HF). Our objectives were to determine the clinical validity and cost-effectiveness of the recently developed ARCHITECT Gal-3 automated immunoassay. DESIGN AND METHODS: Gal-3 levels were measured in HF patients with reduced left ventricular ejection fraction with the ARCHITECT i2000SR Gal-3 assay as well as with the reference Gal-3 ELISA assay. The relationship between Gal-3 levels determined with the automated assay and HF severity as well as its predictive value for long-term cardiovascular death were evaluated. The impact of Gal-3 testing on the diagnostic related group (DRG) based reimbursement was also estimated. RESULTS: Gal-3 levels measured with the ARCHITECT assay were related to the severity of HF based on New York Heart Association functional classes (p<0.001) and were also significantly and positively correlated to BNP concentrations (r=0.35, p<0.001). Gal-3 values higher than 19.2 ng/mL were predictive of long-term cardiovascular death in patients with systolic HF and also provided incremental prognostic information to BNP testing. In addition, Gal-3 testing was estimated to save DRG in comparison to standard of care. CONCLUSIONS: Our results demonstrated the clinical validity of the ARCHITECT Gal-3 automated immunoassay for the risk stratification of HF patients. The automation of Gal-3 testing was also cost-effective and might help to preserve hospital budget.