Clinical impact of the 2010-2012 low-end shift of high-sensitivity cardiac troponin T

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 -