Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin.

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  • dc.contributor.author Wildi, Karinca
  • dc.contributor.author Mueller, Christianca
  • dc.contributor.author Rubini Gimenez, Mariaca
  • dc.date.accessioned 2015-10-23T06:34:14Z
  • dc.date.available 2015-10-23T06:34:14Z
  • dc.date.issued 2015
  • dc.description.abstract BACKGROUND: Misdiagnosis of acute myocardial infarction (AMI) may significantly harm patients and may result from inappropriate clinical decision values (CDVs) for cardiac troponin (cTn) owing to limitations in the current regulatory process. METHODS AND RESULTS: In an international, prospective, multicenter study, we quantified the incidence of inconsistencies in the diagnosis of AMI using fully characterized and clinically available high-sensitivity (hs) cTn assays (hs-cTnI, Abbott; hs-cTnT, Roche) among 2300 consecutive patients with suspected AMI. We hypothesized that the approved CDVs for the 2 assays are not biologically equivalent and might therefore contribute to inconsistencies in the diagnosis of AMI. Findings were validated by use of sex-specific CDVs and parallel measurements of other hs-cTnI assays. AMI was the adjudicated diagnosis in 473 patients (21%). Among these, 86 patients (18.2%) had inconsistent diagnoses when the approved uniform CDV was used. When sex-specific CDVs were used, 14.1% of female and 22.7% of male AMI patients had inconsistent diagnoses. Using biologically equivalent CDV reduced inconsistencies to 10% (P<0.001). These findings were confirmed with parallel measurements of other hs-cTn assays. The incidence of inconsistencies was only 7.0% for assays with CDVs that were nearly biologically equivalent. Patients with inconsistent AMI had long-term mortality comparable to that of patients with consistent diagnoses (P=NS) and a trend toward higher long-term mortality than patients diagnosed with unstable angina (P=0.05). CONCLUSIONS: Currently approved CDVs are not biologically equivalent and contribute to major inconsistencies in the diagnosis of AMI. One of 5 AMI patients will receive a diagnosis other than AMI if managed with the alternative hs-cTn assay.ca
  • dc.description.sponsorship This study was supported by research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the European Union, the Cardiovascular Research Foundation Basel, the University Hospital Basel, Abbott, Roche, anosphere, Siemens, 8sense, Bühlmann, and BRAHMS.
  • dc.format.mimetype application/pdfca
  • dc.identifier.citation Wildi K, Gimenez MR, Twerenbold R, Reichlin T, Jaeger C, Heinzelmann A. et al. Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin. Circulation. 2015 Jun 9;131(23):2032-40. doi: 10.1161/CIRCULATIONAHA.114.014129.ca
  • dc.identifier.doi http://dx.doi.org/10.1161/CIRCULATIONAHA.114.014129
  • dc.identifier.issn 0009-7322
  • dc.identifier.uri http://hdl.handle.net/10230/24890
  • dc.language.iso engca
  • dc.publisher Lippincott, Williams & Wilkinsca
  • dc.relation.ispartof Circulation. 2015 Jun 9;131(23):2032-40
  • dc.rights ©2015 The Authors. Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under/nthe terms of thehttps://creativecommons.org/licenses/by-nc-nd/3.0/, which permits use, distribution, and reproduction in any medium,/nprovided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.ca
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/3.0/ca
  • dc.subject.other Sistema cardiovascular -- Malaltiesca
  • dc.subject.other Infart de miocardica
  • dc.subject.other Marcadors bioquímicsca
  • dc.title Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin.ca
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersionca

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