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Brief Summary

GUIDELINE TITLE

National Academy of Clinical Biochemistry laboratory medicine practice guidelines: Clinical utilization of cardiac biomarker testing in heart failure.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s)/intervention(s) for which important revised regulatory and/or warning information has been released.

  • June 8, 2007, Troponin-I Immunoassay: Class I Recall of all lots of the Architect Stat Troponin-I Immunoassay. The assay may report falsely elevated or falsely decreased results at and near a low level, which may impact patient treatment.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions of the weight of evidence (A-C) and the summary of indications (Classes I, II, IIa, IIb, III) are presented at the end of the "Major Recommendations" field.

Note from the National Academy of Clinical Biochemistry (NACB) and the National Guideline Clearinghouse (NGC): The Laboratory Medicine Practice Guidelines (LMPG) for utilization of biochemical markers in acute coronary syndromes and heart failure have been divided into individual summaries. In addition to the current summary, the following are available:

Use of Biochemical Markers in the Initial Evaluation of Heart Failure

Diagnosis of Heart Failure

Recommendations for use of biochemical markers for diagnosis of Heart Failure

Class I

  1. B-type natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) testing can be used in the acute setting to rule out or to confirm the diagnosis of heart failure among patients presenting with ambiguous signs and symptoms. (Level of Evidence: A)

Class IIa

  1. BNP and NT-proBNP testing can be helpful to exclude the diagnosis of heart failure among patients with signs and symptoms suspicious of heart failure in the non-acute setting. (Level of Evidence: C)

Class III

  1. In diagnosing patients with heart failure, routine blood BNP or NT-proBNP testing for patients with an obvious clinical diagnosis of heart failure is not recommended. (Level of Evidence: C)
  2. In diagnosing patients with heart failure, blood BNP or NT-proBNP testing should not be used to replace conventional clinical evaluation or assessment of the degree of left ventricular structural or functional abnormalities (e.g., echocardiography, invasive hemodynamic assessment). (Level of Evidence: C)

Risk Stratification of Heart Failure

Recommendations for use of biochemical markers for risk stratification of Heart Failure

Class IIa

  1. Blood BNP or NT-proBNP testing can provide a useful addition to clinical assessment in selected situations when additional risk stratification is required. (Level of Evidence: A)
  2. Serial blood BNP or NT-proBNP concentrations may be used to track changes in risk profiles and clinical status among patients with heart failure in selected situations where additional risk stratification is required. (Level of Evidence: B)

Class IIb

  1. Cardiac troponin testing can identify patients with heart failure at increased risk beyond the setting of acute coronary syndromes. (Level of Evidence: B)

Class III

  1. Routine blood biomarker testing for the sole purpose of risk stratification in patients with heart failure is not warranted. (Level of Evidence: B)

Use of Biochemical Markers in Screening for Cardiac Dysfunction

Recommendations for use of BNP and NT-proBNP in screening of Heart Failure

Class IIb

  1. Blood BNP or NT-proBNP testing can be helpful to identify selected patients with left ventricular systolic dysfunction in the post-infarction setting or to identify patients at high risk of developing heart failure (e.g., history of myocardial infarction, diabetes mellitus). However, the diagnostic ranges and cost-effectiveness in different populations remain controversial. (Level of Evidence: B)

Class III

  1. Routine blood natriuretic peptide (BNP or NTproBNP) testing is not recommended for screening large asymptomatic patient populations for left ventricular dysfunction. (Level of Evidence: B)

Use of Biochemical Markers in Guiding Management of Heart Failure

Recommendations for use of biochemical markers in guiding management of Heart Failure patients

Class III

  1. Routine blood BNP or NT-proBNP testing is not warranted for making specific therapeutic decisions for patients with acute or chronic heart failure because of the still emerging but incomplete data as well as intra and inter-individual variations. (Level of Evidence: B)

Definitions:

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

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.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

1999 Jul (revised 2007 Jul)

GUIDELINE DEVELOPER(S)

National Academy of Clinical Biochemistry - Professional Association

SOURCE(S) OF FUNDING

National Academy of Clinical Biochemistry

GUIDELINE COMMITTEE

The National Academy of Clinical Biochemistry

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

National Academy of Clinical Biochemistry (NACB) Writing Group Members: W. H. Wilson Tang, MD; Gary S. Francis, MD; David A. Morrow, MD; L. Kristin Newby, MD; Christopher P. Cannon, MD, MHS; Robert L. Jesse, MD, PhD; Alan B. Storrow, MD; Robert H. Christenson, PhD

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

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

GUIDELINE STATUS

GUIDELINE AVAILABILITY

Electronic copies: Available from the National Academy of Clinical Biochemistry (NACB) Web site.

Print copies: National Academy of Clinical Biochemistry publications are available through American Association for Clinical Chemistry (AACC) Press. To make a purchase or request a catalog, contact AACC Customer Service at 202-857-0717 or custserv@aacc.org.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

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

COPYRIGHT STATEMENT

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

DISCLAIMER

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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