Clinical impact of the 2010-2012 low-end shift of high-sensitivity cardiac troponin T
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Clinical impact of the 2010-2012 low-end shift of high-sensitivity cardiac troponin T. / Wildi, Karin; Twerenbold, Raphael; Jaeger, Cedric; Rubini Giménez, Maria; Reichlin, Tobias; Stoll, Melanie; Hillinger, Petra; Puelacher, Christian; Boeddinghaus, Jasper; Nestelberger, Thomas; Grimm, Karin; Grob, Maja; Rentsch, Katharina; Arnold, Christiane; Mueller, Christian.
In: EUR HEART J-ACUTE CA, Vol. 5, No. 6, 10.2016, p. 399-408.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Clinical impact of the 2010-2012 low-end shift of high-sensitivity cardiac troponin T
AU - Wildi, Karin
AU - Twerenbold, Raphael
AU - Jaeger, Cedric
AU - Rubini Giménez, Maria
AU - Reichlin, Tobias
AU - Stoll, Melanie
AU - Hillinger, Petra
AU - Puelacher, Christian
AU - Boeddinghaus, Jasper
AU - Nestelberger, Thomas
AU - Grimm, Karin
AU - Grob, Maja
AU - Rentsch, Katharina
AU - Arnold, Christiane
AU - Mueller, Christian
N1 - © The European Society of Cardiology 2016.
PY - 2016/10
Y1 - 2016/10
N2 - BACKGROUND: The clinical implications of the 2010-2012 low-end shift of high-sensitivity cardiac troponin T (hs-cTnT) regarding possible misdiagnosis of acute myocardial infarction are largely unknown.METHODS: We aimed to quantify the impact of the 2010-2012 low-end shift and adjustment issue in 857 patients presenting to the emergency department with suspected acute myocardial infarction by comparing measurements performed with affected 2010-2012 lots with recalculated 2010-2012 values using a linear regression formula (provided by the manufacturer) and the corrected assay (re-measured in 2013). The final diagnosis was adjudicated by two independent cardiologists using all information including coronary angiography, echocardiography and serial hs-cTnT levels (with the corrected 2013 assay).RESULTS: Acute myocardial infarction was the adjudicated diagnosis in 195 patients (22.7%). Median hs-TnT values were 8.5 ng/l for affected lots, 11.1 ng/l with recalculated and 10 ng/l with the corrected assay (P<0.001 for all comparisons). Spearman correlation coefficient was 0.937 (<0.001) for correct and affected respective correct and recalculated values. The Cusum test indicated significant deviation from linearity (P<0.01) for both correlations. Deviations nearly exclusively affected hs-cTnT levels below the 99th percentile (14 ng/L). Among the 195 patients with an adjudicated diagnosis of acute myocardial infarction, no patient was misclassified using affected lots if using conventional serial sampling. In contrast, misdiagnosis of acute myocardial infarction was significantly increased by affected lots if applying the novel ESC 0 h/1 h algorithm for the early rule-out of acute myocardial infarction (negative predictive value with affected lots 97.7% versus 99.7% with corrected lots).CONCLUSION: The 2010-2012 hs-cTnT low-end shift affected nearly exclusively levels below the 99th percentile cut-off. While it did not affect the diagnosis of acute myocardial infarction when using conventional serial sampling as done in 2010-2012, it would impact on new early rule-out strategies using very low levels of hs-cTnT such as the ESC 0 h/1 h algorithm.CLINICAL TRIALS REGISTRATION: NCT0047058, NCT00470587.
AB - BACKGROUND: The clinical implications of the 2010-2012 low-end shift of high-sensitivity cardiac troponin T (hs-cTnT) regarding possible misdiagnosis of acute myocardial infarction are largely unknown.METHODS: We aimed to quantify the impact of the 2010-2012 low-end shift and adjustment issue in 857 patients presenting to the emergency department with suspected acute myocardial infarction by comparing measurements performed with affected 2010-2012 lots with recalculated 2010-2012 values using a linear regression formula (provided by the manufacturer) and the corrected assay (re-measured in 2013). The final diagnosis was adjudicated by two independent cardiologists using all information including coronary angiography, echocardiography and serial hs-cTnT levels (with the corrected 2013 assay).RESULTS: Acute myocardial infarction was the adjudicated diagnosis in 195 patients (22.7%). Median hs-TnT values were 8.5 ng/l for affected lots, 11.1 ng/l with recalculated and 10 ng/l with the corrected assay (P<0.001 for all comparisons). Spearman correlation coefficient was 0.937 (<0.001) for correct and affected respective correct and recalculated values. The Cusum test indicated significant deviation from linearity (P<0.01) for both correlations. Deviations nearly exclusively affected hs-cTnT levels below the 99th percentile (14 ng/L). Among the 195 patients with an adjudicated diagnosis of acute myocardial infarction, no patient was misclassified using affected lots if using conventional serial sampling. In contrast, misdiagnosis of acute myocardial infarction was significantly increased by affected lots if applying the novel ESC 0 h/1 h algorithm for the early rule-out of acute myocardial infarction (negative predictive value with affected lots 97.7% versus 99.7% with corrected lots).CONCLUSION: The 2010-2012 hs-cTnT low-end shift affected nearly exclusively levels below the 99th percentile cut-off. While it did not affect the diagnosis of acute myocardial infarction when using conventional serial sampling as done in 2010-2012, it would impact on new early rule-out strategies using very low levels of hs-cTnT such as the ESC 0 h/1 h algorithm.CLINICAL TRIALS REGISTRATION: NCT0047058, NCT00470587.
KW - Aged
KW - Algorithms
KW - Biomarkers/blood
KW - Diagnostic Errors
KW - Electrocardiography
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Myocardial Infarction/diagnosis
KW - Observer Variation
KW - Prospective Studies
KW - Sensitivity and Specificity
KW - Troponin T/blood
U2 - 10.1177/2048872616642952
DO - 10.1177/2048872616642952
M3 - SCORING: Journal article
C2 - 27055466
VL - 5
SP - 399
EP - 408
JO - EUR HEART J-ACUTE CA
JF - EUR HEART J-ACUTE CA
SN - 2048-8726
IS - 6
ER -