Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin
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Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin. / Wildi, Karin; Gimenez, Maria Rubini; Twerenbold, Raphael; Reichlin, Tobias; Jaeger, Cedric; Heinzelmann, Amely; Arnold, Christiane; Nelles, Berit; Druey, Sophie; Haaf, Philip; Hillinger, Petra; Schaerli, Nicolas; Kreutzinger, Philipp; Tanglay, Yunus; Herrmann, Thomas; Moreno Weidmann, Zoraida; Krivoshei, Lian; Freese, Michael; Stelzig, Claudia; Puelacher, Christian; Rentsch, Katharina; Osswald, Stefan; Mueller, Christian.
in: CIRCULATION, Jahrgang 131, Nr. 23, 2015, S. 2032-2040.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin
AU - Wildi, Karin
AU - Gimenez, Maria Rubini
AU - Twerenbold, Raphael
AU - Reichlin, Tobias
AU - Jaeger, Cedric
AU - Heinzelmann, Amely
AU - Arnold, Christiane
AU - Nelles, Berit
AU - Druey, Sophie
AU - Haaf, Philip
AU - Hillinger, Petra
AU - Schaerli, Nicolas
AU - Kreutzinger, Philipp
AU - Tanglay, Yunus
AU - Herrmann, Thomas
AU - Moreno Weidmann, Zoraida
AU - Krivoshei, Lian
AU - Freese, Michael
AU - Stelzig, Claudia
AU - Puelacher, Christian
AU - Rentsch, Katharina
AU - Osswald, Stefan
AU - Mueller, Christian
N1 - Publisher Copyright: © 2015 American Heart Association, Inc.
PY - 2015
Y1 - 2015
N2 - 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. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587.
AB - 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. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587.
KW - Acute cardiac care
KW - Biological markers
KW - Myocardial infarction
KW - Troponin
UR - http://www.scopus.com/inward/record.url?scp=84936105484&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.114.014129
DO - 10.1161/CIRCULATIONAHA.114.014129
M3 - SCORING: Journal article
C2 - 25948541
AN - SCOPUS:84936105484
VL - 131
SP - 2032
EP - 2040
JO - CIRCULATION
JF - CIRCULATION
SN - 0009-7322
IS - 23
ER -
