Validation of a 0/1 h Algorithm for Rapid Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I Assay.


Journal

Clinical chemistry
ISSN: 1530-8561
Titre abrégé: Clin Chem
Pays: England
ID NLM: 9421549

Informations de publication

Date de publication:
28 04 2023
Historique:
received: 17 07 2022
accepted: 30 01 2023
medline: 1 5 2023
pubmed: 20 3 2023
entrez: 19 3 2023
Statut: ppublish

Résumé

Current guidelines recommend 0/1 h algorithms using high-sensitivity cardiac troponin (hs-cTn) for fast diagnosis of myocardial infarction (MI). Yet, for some assays, existing data is limited. We aimed to evaluate the diagnostic performance and the prognostic value of a rapid 0/1 h algorithm for the Access hs-cTnI assay. In consecutive patients presenting with suspected MI, we measured concentrations of Access hs-cTnI at presentation and after 1 hour. Final diagnosis was adjudicated independently by 2 cardiologists. Parameters for diagnostic performance were calculated, applying the recently derived European Society of Cardiology (ESC) 0/1 h algorithm for Access hs-cTnI. Additionally, we assessed the prognostic utility of Access hs-cTnI for the composite end point of all-cause mortality and incident MI at 3 years. In 1879 patients, 257 non-ST-elevation MIs occurred. Application of the 0/1 h algorithm classified 44.5% as rule-out, 20.3% as rule-in, and triaged 35.1% to the observe group. High rule-out safety was confirmed with a sensitivity of 97.7% (95% CI, 95.0%-99.1%) and a negative predictive value of 99.3% (95% CI, 98.4%-99.7%). Rule-in capacity was moderate with a specificity of 88.0% (95% CI, 86.3%-89.6%) and a positive predictive value of 50.8% (95% CI, 45.7%-55.9%). After exclusion of patients with ST-elevation MI the results showed strong prognostic value, even after adjustment for cardiovascular risk factors and comorbidities, with adjusted hazard ratios of 2.51 (95% CI, 1.56-4.04) in the observe and 3.55 (95% CI, 2.18-5.79) in the rule-in group for the composite end point of all-cause mortality and incident MI at 3 years, compared to ruled-out patients. The ESC 0/1 h algorithm for Access hs-cTnI allows safe and efficient triage of patients with suspected MI and has strong prognostic utility up to 3 years after the initial evaluation.

Sections du résumé

BACKGROUND
Current guidelines recommend 0/1 h algorithms using high-sensitivity cardiac troponin (hs-cTn) for fast diagnosis of myocardial infarction (MI). Yet, for some assays, existing data is limited. We aimed to evaluate the diagnostic performance and the prognostic value of a rapid 0/1 h algorithm for the Access hs-cTnI assay.
METHODS
In consecutive patients presenting with suspected MI, we measured concentrations of Access hs-cTnI at presentation and after 1 hour. Final diagnosis was adjudicated independently by 2 cardiologists. Parameters for diagnostic performance were calculated, applying the recently derived European Society of Cardiology (ESC) 0/1 h algorithm for Access hs-cTnI. Additionally, we assessed the prognostic utility of Access hs-cTnI for the composite end point of all-cause mortality and incident MI at 3 years.
RESULTS
In 1879 patients, 257 non-ST-elevation MIs occurred. Application of the 0/1 h algorithm classified 44.5% as rule-out, 20.3% as rule-in, and triaged 35.1% to the observe group. High rule-out safety was confirmed with a sensitivity of 97.7% (95% CI, 95.0%-99.1%) and a negative predictive value of 99.3% (95% CI, 98.4%-99.7%). Rule-in capacity was moderate with a specificity of 88.0% (95% CI, 86.3%-89.6%) and a positive predictive value of 50.8% (95% CI, 45.7%-55.9%). After exclusion of patients with ST-elevation MI the results showed strong prognostic value, even after adjustment for cardiovascular risk factors and comorbidities, with adjusted hazard ratios of 2.51 (95% CI, 1.56-4.04) in the observe and 3.55 (95% CI, 2.18-5.79) in the rule-in group for the composite end point of all-cause mortality and incident MI at 3 years, compared to ruled-out patients.
CONCLUSION
The ESC 0/1 h algorithm for Access hs-cTnI allows safe and efficient triage of patients with suspected MI and has strong prognostic utility up to 3 years after the initial evaluation.

Identifiants

pubmed: 36935359
pii: 7080707
doi: 10.1093/clinchem/hvad019
doi:

Substances chimiques

Troponin I 0
Biomarkers 0
Troponin T 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

482-491

Commentaires et corrections

Type : CommentIn

Informations de copyright

© American Association for Clinical Chemistry 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Auteurs

Jonas Lehmacher (J)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.

Betül Toprak (B)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.

Nils Arne Sörensen (NA)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Ramona Bei der Kellen (R)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Alina Goßling (A)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Tau Sarra Hartikainen (TS)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.
Department of Cardiology, University Heart Center Freiburg, Bad Krozingen, Germany.

Paul Michael Haller (PM)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.

Alina Schock (A)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Raphael Twerenbold (R)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.
Population Health Research Department, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Tanja Zeller (T)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.

Stefan Blankenberg (S)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Population Health Research Department, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Dirk Westermann (D)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.
Department of Cardiology, University Heart Center Freiburg, Bad Krozingen, Germany.

Johannes Tobias Neumann (JT)

Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
University Center of Cardiovascular Science, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Hamburg Kiel/Lübeck, Hamburg, Germany.
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

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Classifications MeSH