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Brief Summary

GUIDELINE TITLE

National Academy of Clinical Biochemistry laboratory medicine practice guidelines: Use of cardiac troponin and B-type natriuretic peptide or N-terminal proB-type Natriuretic Peptide for Etiologies other than acute coronary syndromes and 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 Cardiac Biomarkers in the Evaluation of Patients with Chronic Renal Failure

Utilization of Cardiac Biochemical Marker in the Setting of Chronic Renal Failure

Recommendations for use of biochemical markers in the setting of chronic renal failure

Class I

  1. In renal failure patients with symptoms (e.g., acute chest pain), electrocardiographic (ECG) or other clinical evidence suggesting myocardial ischemia, measurement of cardiac troponin (cTn) is warranted for evaluation of myocardial infarction (MI). (Level of Evidence A)
  2. For end-stage renal disease (ESRD) patients, as for all patients who may have baseline elevations of cTn, who present with possible acute coronary syndrome (ACS), relying on dynamic changes in the cTn values of 20% or more should be used to define those with acute myocardial infarction. (Level of Evidence B)

Class IIb

  1. cTnT and cTnI can be used as aids for defining the risk for mortality in ESRD patients and to provide baseline values for comparison when measured in the setting of an acute clinical change. (Level of Evidence B)
  2. In renal failure patients, B-type natriuretic peptide (BNP) or N-terminal B-type natriuretic peptide (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. However different decision point (cutoff) values must be used compared to patients with estimated glomerular filtration rate >60 mL/min/1.73m2. (Level of Evidence B)

Class III

  1. Routine BNP/NT-proBNP measurement is not warranted in asymptomatic end-stage renal disease patients. (Level of Evidence B)

Use of Biomarkers in the Evaluation of Other Non-Ischemic Etiologies

Use of Cardiac Biomarkers in the Setting Non-ischemic Etiologies

Recommendations for use of biochemical markers in other non-ischemic etiologies

Class IIb

  1. Increased cardiac telemetry may be warranted for patients who have increased cTn values following blunt chest trauma. (Level of Evidence B)
  2. The measurement of cTn can be used to define risk among patients who are critically ill. (Level of Evidence A)
  3. Increased cTn values identify individuals at increased risk for the development of congestive heart failure when treated with adriamycin therapy for cancer. (Level of Evidence B)
  4. Increased cTn values identify individuals at increased risk with acute pulmonary embolism. (Level of Evidence B)
  5. Routine BNP/NT-proBNP measurements may be warranted among patients with non-ischemic etiologies such as sepsis, myocarditis, or pulmonary embolism. (Level of Evidence C)

Class III

  1. Release of cTn from patients with cancer undergoing cardiotoxic chemotherapies represents myocardial damage, which may be associated with a worse prognosis (Level of Evidence B). However routine cTnT or cTnI measurements are not warranted among cancer patients undergoing chemotherapies that are toxic to the heart (except those receiving adriamycin). (Level of Evidence C)

Use of Biomarkers after Non-cardiac Surgery

Use of Cardiac Biochemical Markers After Non-cardiac Surgery

Recommendations for use of cardiac markers after non-cardiac surgery

Class IIb

  1. cTnT and cTnI are recommended for patients undergoing non-cardiac surgery if there is a question of cardiac ischemia. Cutoff concentrations that are used for diagnosis of MI are appropriate. (Level of Evidence C)
  2. cTnT and cTnI are recommended for post-surgical assessment of patients undergoing vascular surgery given the high frequency of underlying coronary artery disease and associated perioperative events. Such increases appear to be due to ischemia and are highly prognostic for both short- and long-term mortality. Cutoff concentrations that are used for diagnosis of MI are appropriate. (Level of Evidence B)
  3. Increases of cTn post operatively are associated with adverse prognosis and should prompt clinical follow up. (Level of Evidence B)

Class III

  1. Routine BNP/NT-proBNP measurements are not warranted among patients undergoing non-cardiac surgery. (Level of Evidence C)

Biomarker Use after Percutaneous Coronary Intervention (PCI)

Use of Cardiac Biochemical Markers after PCI

Recommendations for use of biomarkers after PCI

Class IIb

  1. It is appropriate to measure cTnT or cTnI before and after percutaneous coronary intervention to determine the presence of ischemic cardiac damage if the baseline pre-procedural value is less than 99th percentile for the reference control population. Any increase is indicative of cardiac damage. However, there is currently insufficient evidence to recommend the specific cTn cutoff concentration. (Level of Evidence C)

Class III

  1. Routine BNP/NT-proBNP measurements are not warranted among patients undergoing PCI. (Level of Evidence C)
  2. If the pre-procedural baseline cTn is increased above the 99th percentile of a reference control population, then biochemical markers should not be used to estimate whether increases are related to the procedure or to progression of the underlying disease state that caused the need for the procedure. If serial preprocedural cTn values are available, a falling trend followed by a post-procedural increase of 20% or more may be indicative of new myocardial injury, even if any or all of the pre-procedural results are above the 99th percentile. (Level of Evidence C)

Use of Biomarkers after Cardiac Surgery

Use of Cardiac Biochemical Markers after Cardiac Surgery

Recommendations for use of biomarkers after cardiac surgery

Class IIa

  1. The higher the cTn values post operatively, the greater the risk of adverse cardiac events. (Level of Evidence B)
  2. In addition to greater than 5-fold increase in cTn after the procedure, clinical and other (non-lab medicine) diagnostic testing criteria should be used to distinguish components related to the operative procedure and cardioprotection from vascular events. (Level of Evidence C)
  3. Preprocedural baseline cTn increases help to define risk among patients undergoing cardiac surgery. (Level of Evidence C)

Class III

  1. At this time, there is insufficient evidence to recommend routine measurement of BNP/NT-proBNP before or after cardiac surgery. (Level of Evidence C)

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 Dec)

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: Alan B. Storrow, MD, Section Leader; Fred S. Apple, PhD; Alan H.B. Wu, PhD; Robert L. Jesse, MD, PhD; Gary S. Francis, 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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