Heart failure

Diagnosis
Evaluation
Management
Risk Assessment

Cardiology
Emergency Medicine
Family Practice
Internal Medicine
Pathology

Advanced Practice Nurses
Allied Health Personnel
Clinical Laboratory Personnel
Emergency Medical Technicians/Paramedics
Health Care Providers
Hospitals
Nurses
Physician Assistants
Physicians

• To provide analytical and clinical guidance for the measurement and interpretation of cardiac biochemical markers of heart failure
• To address analytical aspects of B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) for clinical use in heart failure

Patients with suspected or known heart failure

Characterization of assays for analytical biomarkers (B-type natriuretic peptide [BNP] and N-Terminal proBNP [NT-proBNP]:

• Preanalytical issues (sample type, effect of storage time and temperature)
• Analytical (identification of recognition epitopes, description of calibration material, determination of cross reactivity characteristics, evaluation of dilution response, evaluation of interferences)
• Upper reference limits
• Patients specimen comparisons and regression analyses
• Establishment of receiver operator characteristic (ROC) curves
• Consideration of effects of ethnicity

Clinical effectiveness (sensitivity and specificity) and prognostic/therapeutic utility of clinical biomarker testing in heart failure

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
Searches of Unpublished Data

These National Academy of Clinical Biochemistry (NACB) guidelines were developed rigorously; however it was possible to include only papers published in the English language. The specified method for developing the evidence base for recommendations listed involved use of PubMed, EMBASE, and other databases that were not necessarily published. Systematic methods were used whenever available; searches were first set to be sensitive to avoid missing papers of possible interest, and then narrowed to sort through the literature in order to enhance specificity. The writing group contacted recognized experts to assure that important evidence had not been missed.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Weight of Evidence

A - Data derived from multiple randomized or appropriately designed clinical trials that involved large numbers of patients

B - Data derived from a limited number of randomized or appropriately designed trials that involved small numbers of patients or from careful analyses of observational registries

C - Expert Consensus was the primary basis for the recommendation

Systematic Review

Not stated

Expert Consensus

The National Academy of Clinical Biochemistry's (NACB) Laboratory Medicine Practice Guidelines (LMPG) for use of cardiac markers in coronary artery diseases were published in July of 1999. Since production of this initial document, numerous published studies and presented data have added significantly to the knowledge base for cardiac biomarkers. This increased knowledge has substantially expanded the scope of recommendations for cardiac biomarker utilization since the 1999 document, and in particular has required the inclusion of recommendations regarding biomarkers that extend beyond myocardial necrosis. Toward addressing these advances and their impact on biomarker utilization in clinical practice, the NACB appointed a chair and members of a LMPG committee that was charged with the overall objective of revising and extending the earlier recommendations by establishing modern guidelines for Utilization of Biomarkers in Acute Coronary Syndrome and Heart Failure. This LMPG is aimed at providing analytical and clinical guidance for the measurement and interpretation of cardiac biochemical markers of acute coronary syndromes (ACS), heart failure and point-of-care measurement and logistics of providing ACS biomarker data for patient care; guidance for interpretation of biomarkers in etiologies other than ACS and Heart Failure is included as well.

These guidelines and their recommendations are structured into six chapters that include Chapter 1: Clinical Utilization of Biomarkers in Acute Coronary Syndromes (ACS); Chapter 2: Analytical Issues of ACS Biomarkers; Chapter 3: Clinical Utilization of Biomarkers of Heart Failure; Chapter 4: Analytical Issues of Heart Failure Biomarkers; Chapter 5: Point of Care Testing and Logistics; and Chapter 6: Cardiac Biomarkers and Other Etiologies. Each chapter was spearheaded by a writing group, which was a subset of the overall committee. In addition, other ad hoc expertise contributed to the writing group of some subsections and chapters to optimize the content and quality of the guidelines. The "questions" for each chapter are in the form of issues addressed and specified in the organization of each individual chapter. The chapter design of the guidelines was used to facilitate finding guidance by users; this format was also used, in part, to provide an easy and focused procedure for updating the guidelines in the future. Also, the chapter design allowed publication of sections in appropriate laboratory medicine and clinical specialty journals.

Stakeholder involvement in development and refinement of these guidelines was substantial. The guideline team was comprised of laboratory medicine, ACS cardiology experts, and heart failure cardiology experts. As these guidelines target acutely ill patients, Emergency Medicine stakeholders were represented by a specialist; it is also noteworthy that all of the laboratory professionals and cardiology experts on the guideline committee have substantial interaction, knowledge, and publications in the area of laboratory and clinical medicine in the Emergency Medicine environment.

Modified American College of Cardiology/American Heart Association Classifications: Summary of Indications

Class I: Conditions for which there is evidence and/or general agreement that a given laboratory procedure or treatment is useful and effective.

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a laboratory procedure or treatment.

Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.

Class IIb: Usefulness/efficacy is less well established by evidence/opinion.

Class III: Conditions for which there is evidence and/or general agreement that the laboratory procedure/treatment is not useful/effective and in some cases may be harmful.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

This guideline may help establish uniform criteria so that the analytical qualities and clinical performance of assays natriuretic peptide and their related co-metabolites can be evaluated objectively.

Not stated

The materials in this publication represent the opinions of the authors and committee members, and do not necessarily represent the official position of the National Academy of Clinical Biochemistry (NACB) or the International Federation of Clinical Chemistry (IFCC). The National Academy of Clinical Biochemistry is the academy of the American Association for Clinical Chemistry.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness

Not applicable: The guideline was not adapted from another source.

1999 Jul (revised 2007 Jul)

National Academy of Clinical Biochemistry - Professional Association

National Academy of Clinical Biochemistry

The National Academy of Clinical Biochemistry

National Academy of Clinical Biochemistry (NACB) Writing Group Members: Fred S. Apple, Alan H.B. Wu, Allan S. Jaffe, Mauro Panteghini, Robert H. Christenson

NACB Committee Members: Robert H. Christenson, Chair, University of Maryland School of Medicine, Baltimore, Maryland, USA; Fred S. Apple, Hennepin County Medical Center and University of Minnesota, Minneapolis, Minnesota, USA; Christopher P. Cannon, Brigham and Women's Hospital, Boston, Massachusetts, USA; Gary S. Francis, Cleveland Clinic Foundation, Cleveland, Ohio, USA; Robert L. Jesse, Medical College of Virginia, Richmond, Virginia, USA; David A. Morrow, Brigham and Women's Hospital, Boston, Massachusetts, USA; L. Kristin Newby, Duke University Medical Center, Durham, North Carolina, USA; Jan Ravkilde, Aarhus University Hospital, Aarhus, Denmark; Alan B. Storrow, Vanderbilt University, Nashville, Tennessee, USA; W. H. Wilson Tang, Cleveland Clinic Foundation, Cleveland, Ohio, USA; Alan H. B. Wu, San Francisco General Hospital and University of California at San Francisco, San Francisco, California, USA

Ad Hoc members of the committee for selected sections: Allan S. Jaffe, Mayo Clinic, Rochester, Minnesota, USA; Alan S. Maisel, University of California at San Diego, San Diego, California, USA; Mauro Panteghini, University of Milan, Milan, Italy

IFCC Committee On Standardization Of Markers Of Cardiac Damage (C-SMCD) members: Fred S. Apple, Chair; Robert H. Christenson; Allan S. Jaffe, Rochester, MN; Franca Pagani, Brecia, Italy; Jillian Tate, Brisbane, Australia; Jordi Ordonez-Llanos, Barcelona, Spain; Johannes Mair, Innsbruck, Austria

None available

This NGC summary was completed by ECRI Institute on March 12, 2008. The information was verified by the guideline developer on April 2, 2008.

National Academy of Clinical Biochemistry's (NACB) terms for reproduction of guidelines are posted with each set of guidelines.