Turnaround Time: 4 - 6 days
CPT Code:

82777

Test Type: 0.8 mL Serum or plasma

Overview:

For use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients with chronic heart failure. Galectin-3 levels >17.8 ng/mL are present in a proportion of patients with NYHA class II-IV. Such elevated levels are associated with a more progressive form of heart failure resulting in an increased hazard for death or hospitalization.

Levels of galectin-3 in blood may be increased in patients with certain forms of advanced cancer and other conditions associated with organ fibrosis. Galectin-3 results should be interpreted with caution in such patients. Presence of human antimouse antibodies (HAMA) or rheumatoid factor (RF) may interfere with the galectin-3 assay, which could cause falsely elevated results. The galectin-3 assay should not be used in patients with known HAMA or RF. Galectin-3 results should be interpreted with caution in patients with a history of therapeutic use of murine monoclonal antibodies (IgG) or their fragments or in those who have known autoimmune disorders.

Specimens with high levels of γ-globulins (>2.5 g/dL) may cause false elevation in results. Galectin-3 results from patients with diseases associated with hyperglobulinemia, such as multiple myeloma, should be interpreted with caution.

Galectin-3 is member of the protein family known as galectins. Galectins bind to certain carbohydrates via specific carbohydrate recognition domains (CRDs). Galectin-3 is a 29 to 35 kDa chimera-type galectin − the only member of the galectin family with an extended N-terminal domain constituted of tandem repeats of short amino acid segments (a total of 110-130 amino acids) linked to a single C-terminal CRD of about 130 amino acids.

Galectin-3 interacts with carbohydrates, such as N-acetyllactosamine (LacNac), certain cell surface receptors (such as macrophage CD11b/CD18) and extracellular receptors (such as collagen). Galectins play an important and complex role in intracellular pathways and disease mechanisms. Under certain circumstances, galectin-3 is secreted in the extracellular matrix and galectin-3 can be measured in plasma or serum of healthy individuals. Galectin-3 has been implicated in a variety of biological processes important in heart failure including myofibroblast proliferation, fibrogenesis, tissue repair, cardiac remodeling and inflammation. Experimental data implicate galectin-3 in heart failure development and progression and administration of galectin-3 can induce cardiac fibrosis and reduced ejection fraction in animals. Blockade of galectin-3 prevents organ fibrosis following inflammation and organ damage.

The experimental data are corroborated by several independent clinical studies that indicated that elevated levels of galectin-3 (>17.8 ng/mL) are associated with an increased near-term or long-term risk for hospitalization or death (p<0.05 after adjusting for pertinent covariates). Galectin-3 levels reflect the presence of specific underlying disease processes and are not affected by the degree of decompensation. Hence galectin-3 levels, once elevated, remain generally constant and do not fluctuate with signs and symptoms of heart failure. Although certain medical and device treatments appear to be effective in patients with elevated galectin-3, galectin-3 plasma levels are generally not affected by these treatments.

Galectin-3 and natriuretic peptides are measures of separate and distinct biological processes. Each marker provides independent and complementary information on the status and prognosis of patients with chronic heart failure.

Christenson RH, Duh SH, Wu AH, et al. Multi-center determination of galectin-3 assay performance characteristics: Anatomy of a novel assay for use in heart failure.

Clin Biochem. 2010 May;43(7-8):683-690. PubMed 20153309

de Boer RA, Lok D, Jaarsma T, et al. Predictive value of plasma galectin-3 levels in heart failure with reduced and preserved ejection fraction. Ann Med. 2011 Feb;43(1):60-68. PubMed 21189092

de Boer RA, Yu L, van Veldhuisen DJ. Galectin-3 in cardiac remodeling and heart failure. Curr Heart Fail Rep. 2010 Mar;7(1):1-8. PubMed 20425490

Galectin-3 [package insert]. Waltham, Mass: BG Medicine Inc. Document LAB-IVD-001R04; January 5, 2010.

Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009 Apr 14;53(15):e391-e479. PubMed 19324966

Lok DJ, Van Der Meer P, de la Porte PW, et al. Prognostic value of galectin-3, a novel marker of fibrosis, in patients with chronic heart failure: data from the DEAL-HF study. Clin Res Cardiol. 2010 May;99(5):323-328. PubMed 20130888

Milting H, Ellinghaus P, Seewald M, et al. Plasma biomarkers of myocardial fibrosis and remodeling in terminal heart failure patients supported by mechanical circulatory support devices.J Heart Lung Transplant. 2008 Jun;27(6):589-596. PubMed 18503956

Sharma UC, Pokharel S, van Brakel TJ, et al. Galectin-3 marks activated macrophages in failure-prone hypertrophied hearts and contributes to cardiac dysfunction. Circulation. 2004 Nov 9;110(19):3121-3128. PubMed 15520318

Collection Details:

Collection Instructions:

Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube.

Transfer separated serum or plasma to a plastic transport tube.

Room temperature. Stable at room temperature or refrigerated for 22 days, or frozen for 12 months. Freeze/Thaw Cycle: Stable x9