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Am Heart J. 2017 Aug;190:135-139. doi: 10.1016/j.ahj.2017.04.016. Epub 2017 Jun 16.

Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis.

Author information

1
Terrence Donnelly Heart Centre, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address: bagaia@smh.ca.
2
Duke Clinical Research Institute, Durham, NC.
3
New York University School of Medicine, New York, NY.
4
National Heart and Lung Institute, Imperial College, London, UK; Northwick Park Hospital, Harrow, UK; Royal Brompton Hospital, London, UK.
5
Government Medical College Calicut, Kozhikode, Kerala, India.
6
Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw, Poland.
7
Atlanta VA Medical Center, Emory University School of Medicine, Decatur, GA.
8
Cardiology department, Hospital Universitario La Paz, Idipaz, Madrid, Spain.
9
Institut de Cardiologie de Montréal, Montreal, Québec, Canada.
10
University of Montreal, Campus Mauricie, Trois-Rivières, Québec, Canada.
11
Cardiology and ICCU-Ospedali Riuniti, Ancona, Italy.
12
Department Cardiology, Medical University, Lodz, Poland.
13
University Hospital, London, Ontario, Canada.
14
Vilnius University and Vilnius University Hospital "Santariskiu Clinic,", Vilnius, Lithuania.
15
Terrence Donnelly Heart Centre, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
16
Hôpital Pierre-Le Gardeur, Terrebonne, Québec, Canada.
17
Veterans Affairs North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, TX.
18
Mayo Clinic, Rochester, MN.
19
University Clinic of Cardiology, Vodnjanska 17, 1000 Skopje, Macedonia.
20
Department of Cardiology and Intensive Care, LHK Graz-Sued/West, Standort West, Graz, Austria.
21
Columbia University Medical Center and The Cardiovascular Research Foundation, New York, NY.
22
Terrence Donnelly Heart Centre, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Canadian Heart Research Centre, Toronto, Ontario, Canada.
23
Stanford Center for Clinical Research, Department of Medicine, Stanford University, Stanford, CA.
24
National Heart, Lung, and Blood Institute, Bethesda, MD.
25
St Louis University School of Medicine, St Louis, MO.

Abstract

BACKGROUND:

The Universal Definition of Myocardial Infarction recommends the 99th percentile concentration of cardiac troponin in a normal reference population as part of the decision threshold to diagnose type 1 spontaneous myocardial infarction. Adoption of this recommendation in contemporary worldwide practice is not well known.

METHODS:

We performed a cohort study of 276 hospital laboratories in 31 countries participating in the National Heart, Lung, and Blood Institute-sponsored International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial. Each hospital laboratory's troponin assay manufacturer and model, the recommended assay's 99th percentile upper reference limit (URL) from the manufacturer's package insert, and the troponin concentration used locally as the decision level to diagnose myocardial infarction were ascertained.

RESULTS:

Twenty-one unique troponin assays from 9 manufacturers were used by the surveyed hospital laboratories. The ratio of the troponin concentration used locally to diagnose myocardial infarction to the assay manufacturer-determined 99th percentile URL was <1 at 19 (6.6%) laboratories, equal to 1 at 91 (31.6%) laboratories, >1 to ≤5 at 101 (35.1%) laboratories, >5 to ≤10 at 34 (11.8%) laboratories, and >10 at 43 (14.9%) laboratories. The variability in troponin decision level for myocardial infarction relative to the assay 99th percentile URL was present for laboratories in and outside of the United States, as well as for high- and standard-sensitivity assays.

CONCLUSIONS:

There is substantial hospital-level variation in the troponin threshold used to diagnose myocardial infarction; only one-third of hospital laboratories currently follow the Universal Definition of Myocardial Infarction consensus recommendation for use of troponin concentration at the 99th percentile of a normal reference population as the decision level to diagnose myocardial infarction. This variability across laboratories has important implications for both the diagnosis of myocardial infarction in clinical practice as well as adjudication of myocardial infarction in clinical trials.

PMID:
28760208
PMCID:
PMC5543710
DOI:
10.1016/j.ahj.2017.04.016
[Indexed for MEDLINE]
Free PMC Article

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