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Diagnostic Reclassification by a High-Sensitivity Cardiac Troponin Assay - 21/10/20

Doi : 10.1016/j.annemergmed.2020.06.047 
Bryn E. Mumma, MD, MAS a, , Scott D. Casey, MD, MS a, Robert K. Dang, BS a, Michelle K. Polen, BS a, Jasmanpreet C. Kaur, BS a, John Rodrigo, MD b, Daniel J. Tancredi, PhD c, Robert A. Narverud, MD a, Ezra A. Amsterdam, MD d, Nam Tran, PhD b
a Department of Emergency Medicine, University of California, Davis, Sacramento, CA 
b Department of Pathology and Laboratory Medicine, University of California, Davis, Sacramento, CA 
c Department of Pediatrics, University of California, Davis, Sacramento CA 
d Division of Cardiovascular Medicine, Department of Internal Medicine, University of California, Davis, Sacramento CA 

Corresponding Author.

Abstract

Study objective

Our objective is to describe the rates of diagnostic reclassification between conventional cardiac troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) and between combined and sex-specific hs-cTnT thresholds in adult emergency department (ED) patients in the United States.

Methods

We conducted a prospective, single-center, before-and-after, observational study of ED patients aged 18 years or older undergoing single or serial cardiac troponin testing in the ED for any reason before and after hs-cTnT implementation. Conventional cTnI and hs-cTnT results were obtained from a laboratory quality assurance database. Combined and sex-specific thresholds were the published 99th percentile upper reference limits for each assay. Cases underwent physician adjudication using the Fourth Universal Definition of Myocardial Infarction. Diagnostic reclassification occurred when a patient received a diagnosis of myocardial infarction or myocardial injury with one assay but not the other assay. Our primary outcome was diagnostic reclassification between the conventional cTnI and hs-cTnT assays. Diagnostic reclassification probabilities were assessed with sample proportions and 95% confidence intervals for binomial data.

Results

We studied 1,016 patients (506 men [50%]; median age 60 years [25th, 75th percentiles 49, 71]). Between the conventional cTnI and hs-cTnT assays, 6 patients (0.6%; 95% confidence interval 0.2% to 1.3%) underwent diagnostic reclassification regarding myocardial infarction (5/6 reclassified as no myocardial infarction) and 166 patients (16%; 95% confidence interval 14% to 19%) underwent diagnostic reclassification regarding myocardial injury (154/166 reclassified as having myocardial injury) by hs-cTnT.

Conclusion

Compared with conventional cTnI, the hs-cTnT assay resulted in no clinically relevant change in myocardial infarction diagnoses but substantially more myocardial injury diagnoses.

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Plan


 Please see page 567 for the Editor’s Capsule Summary of this article.
 Supervising editor: Keith A. Marill, MD, MS. Specific detailed information about possible conflict of interest for individual editors is available at editors.
 Author contributions: BEM and NT conceived and designed the study and supervised the data collection. BEM obtained research funding. RAN and EAA assisted with study design and adjudication. DJT provided statistical advice on study design and data analysis. SDC, RKD, MKP, and JCK assisted with data acquisition. JR performed relevant laboratory testing. BEM, SDC, and RKD drafted the article, and all authors critically reviewed the content and approved the final version. BEM takes responsibility for the paper as a whole.
 All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
 Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. This research was supported by the Alpha Phi Foundation Heart to Heart Grant; the UC Davis Collaborative for Diagnostic Innovation Improving Diagnosis in Healthcare Award; an investigator-initiated grant from Roche Diagnostics; and the National Heart, Lung, and Blood Institute through grant 5K08HL130546.
 The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the article.
 Readers: click on the link to go directly to a survey in which you can provide ND9XYCP to Annals on this particular article.
 A podcast for this article is available at www.annemergmed.com.


© 2020  American College of Emergency Physicians. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 76 - N° 5

P. 566-579 - novembre 2020 Retour au numéro
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