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

Akshay Bagai, Karen P. Alexander, Jeffrey S. Berger, Roxy Senior, Chakkanalil Sajeev, Radoslaw Pracon, Kreton Mavromatis, Jose Luis Lopez-Sendón, Gilbert Gosselin, Ariel Diaz, Gian Perna, Jarozlaw Drozdz, Dennis Humen, Birute Petrauskiene, Asim N. Cheema, Denis Phaneuf, Subhash Banerjee, Todd D. Miller, Sasko Kedev, Herwig Schuchlenz & 10 others Gregg W. Stone, Shaun G. Goodman, Kenneth W. Mahaffey, Allan S. Jaffe, Yves D. Rosenberg, Sripal Bangalore, L. Kristin Newby, David J. Maron, Judith S. Hochman, Bernard R. Chaitman

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
JournalAmerican Heart Journal
DOIs
StateAccepted/In press - 2017

Fingerprint

Troponin
Myocardial Infarction
Hospital Laboratories
Product Labeling
National Heart, Lung, and Blood Institute (U.S.)
Population
Cohort Studies
Clinical Trials

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Bagai, A., Alexander, K. P., Berger, J. S., Senior, R., Sajeev, C., Pracon, R., ... Chaitman, B. R. (Accepted/In press). Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis. American Heart Journal. https://doi.org/10.1016/j.ahj.2017.04.016

Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis. / Bagai, Akshay; Alexander, Karen P.; Berger, Jeffrey S.; Senior, Roxy; Sajeev, Chakkanalil; Pracon, Radoslaw; Mavromatis, Kreton; Lopez-Sendón, Jose Luis; Gosselin, Gilbert; Diaz, Ariel; Perna, Gian; Drozdz, Jarozlaw; Humen, Dennis; Petrauskiene, Birute; Cheema, Asim N.; Phaneuf, Denis; Banerjee, Subhash; Miller, Todd D.; Kedev, Sasko; Schuchlenz, Herwig; Stone, Gregg W.; Goodman, Shaun G.; Mahaffey, Kenneth W.; Jaffe, Allan S.; Rosenberg, Yves D.; Bangalore, Sripal; Newby, L. Kristin; Maron, David J.; Hochman, Judith S.; Chaitman, Bernard R.

In: American Heart Journal, 2017.

Research output: Contribution to journalArticle

Bagai, A, Alexander, KP, Berger, JS, Senior, R, Sajeev, C, Pracon, R, Mavromatis, K, Lopez-Sendón, JL, Gosselin, G, Diaz, A, Perna, G, Drozdz, J, Humen, D, Petrauskiene, B, Cheema, AN, Phaneuf, D, Banerjee, S, Miller, TD, Kedev, S, Schuchlenz, H, Stone, GW, Goodman, SG, Mahaffey, KW, Jaffe, AS, Rosenberg, YD, Bangalore, S, Newby, LK, Maron, DJ, Hochman, JS & Chaitman, BR 2017, 'Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis', American Heart Journal. https://doi.org/10.1016/j.ahj.2017.04.016
Bagai, Akshay ; Alexander, Karen P. ; Berger, Jeffrey S. ; Senior, Roxy ; Sajeev, Chakkanalil ; Pracon, Radoslaw ; Mavromatis, Kreton ; Lopez-Sendón, Jose Luis ; Gosselin, Gilbert ; Diaz, Ariel ; Perna, Gian ; Drozdz, Jarozlaw ; Humen, Dennis ; Petrauskiene, Birute ; Cheema, Asim N. ; Phaneuf, Denis ; Banerjee, Subhash ; Miller, Todd D. ; Kedev, Sasko ; Schuchlenz, Herwig ; Stone, Gregg W. ; Goodman, Shaun G. ; Mahaffey, Kenneth W. ; Jaffe, Allan S. ; Rosenberg, Yves D. ; Bangalore, Sripal ; Newby, L. Kristin ; Maron, David J. ; Hochman, Judith S. ; Chaitman, Bernard R. / Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis. In: American Heart Journal. 2017.
@article{6f2d43aa6acc4605a8f42131aac2337e,
title = "Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis",
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.",
author = "Akshay Bagai and Alexander, {Karen P.} and Berger, {Jeffrey S.} and Roxy Senior and Chakkanalil Sajeev and Radoslaw Pracon and Kreton Mavromatis and Lopez-Send{\'o}n, {Jose Luis} and Gilbert Gosselin and Ariel Diaz and Gian Perna and Jarozlaw Drozdz and Dennis Humen and Birute Petrauskiene and Cheema, {Asim N.} and Denis Phaneuf and Subhash Banerjee and Miller, {Todd D.} and Sasko Kedev and Herwig Schuchlenz and Stone, {Gregg W.} and Goodman, {Shaun G.} and Mahaffey, {Kenneth W.} and Jaffe, {Allan S.} and Rosenberg, {Yves D.} and Sripal Bangalore and Newby, {L. Kristin} and Maron, {David J.} and Hochman, {Judith S.} and Chaitman, {Bernard R.}",
year = "2017",
doi = "10.1016/j.ahj.2017.04.016",
language = "English (US)",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",

}

TY - JOUR

T1 - Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis

AU - Bagai, Akshay

AU - Alexander, Karen P.

AU - Berger, Jeffrey S.

AU - Senior, Roxy

AU - Sajeev, Chakkanalil

AU - Pracon, Radoslaw

AU - Mavromatis, Kreton

AU - Lopez-Sendón, Jose Luis

AU - Gosselin, Gilbert

AU - Diaz, Ariel

AU - Perna, Gian

AU - Drozdz, Jarozlaw

AU - Humen, Dennis

AU - Petrauskiene, Birute

AU - Cheema, Asim N.

AU - Phaneuf, Denis

AU - Banerjee, Subhash

AU - Miller, Todd D.

AU - Kedev, Sasko

AU - Schuchlenz, Herwig

AU - Stone, Gregg W.

AU - Goodman, Shaun G.

AU - Mahaffey, Kenneth W.

AU - Jaffe, Allan S.

AU - Rosenberg, Yves D.

AU - Bangalore, Sripal

AU - Newby, L. Kristin

AU - Maron, David J.

AU - Hochman, Judith S.

AU - Chaitman, Bernard R.

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85021251454&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021251454&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2017.04.016

DO - 10.1016/j.ahj.2017.04.016

M3 - Article

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -