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

Wildi, Karin; Twerenbold, Raphael; Jaeger, Cédric; Giménez, María Rubini; Reichlin, Tobias; Stoll, Melanie; Hillinger, Petra; Puelacher, Christian; Boeddinghaus, Jasper; Nestelberger, Thomas; Grimm, Karin; Grob, Maja; Rentsch, Katharina; Arnold, Christiane

doi:10.1177/2048872616642952

Cited by 22 publications

(15 citation statements)

References 38 publications

(72 reference statements)

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“…Fifth , some lots of the hs-cTnT assay used clinically in the management of patients in Phase B were affected by the low-end shift. 33–36 According to several recent studies, the low-end shift nearly exclusively affected concentrations below 14 ng/L (the 99th percentile) and thereby seemed to have had no relevant impact on the clinical diagnosis of AMI. 33–36 Sixth , the findings from our cost analyses must be interpreted carefully.…”

Section: Discussionmentioning

confidence: 99%

“…33–36 According to several recent studies, the low-end shift nearly exclusively affected concentrations below 14 ng/L (the 99th percentile) and thereby seemed to have had no relevant impact on the clinical diagnosis of AMI. 33–36 Sixth , the findings from our cost analyses must be interpreted carefully. While we adjusted for multiple differences observed between the two phases such as age, history of coronary disease, and presence of arterial hypertension, there may have been differences that cannot be accounted for.…”

Section: Discussionmentioning

confidence: 99%

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Impact of high-sensitivity cardiac troponin on use of coronary angiography, cardiac stress testing, and time to discharge in suspected acute myocardial infarction

et al. 2016

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AimsHigh-sensitivity cardiac troponin (hs-cTn) assays provide higher diagnostic accuracy for acute myocardial infarction (AMI) when compared with conventional assays, but may result in increased use of unnecessary coronary angiographies due to their increased detection of cardiomyocyte injury in conditions other than AMI.Methods and resultsWe evaluated the impact of the clinical introduction of high-sensitivity cardiac troponin T (hs-cTnT) on the use of coronary angiography, stress testing, and time to discharge in 2544 patients presenting with symptoms suggestive of AMI to the emergency department (ED) within a multicentre study either before (1455 patients) or after (1089 patients) hs-cTnT introduction. Acute myocardial infarction was more often the clinical discharge diagnosis after hs-cTnT introduction (10 vs. 14%, P < 0.001), while unstable angina less often the clinical discharge diagnosis (14 vs. 9%, P = 0.007). The rate of coronary angiography was similar before and after the introduction of hs-cTnT (23 vs. 23%, P = 0.092), as was the percentage of coronary angiographies showing no stenosis (11 vs. 7%, P = 0.361). In contrast, the use of stress testing was substantially reduced from 29 to 19% (P < 0.001). In outpatients, median time to discharge from the ED decreased by 79 min (P < 0.001). Mean total costs decreased by 20% in outpatients after the introduction of hs-cTnT (P = 0.002).ConclusionThe clinical introduction of hs-cTn does not lead to an increased or inappropriate use of coronary angiography. Introduction of hs-cTn is associated with an improved rule-out process and thereby reduces the need for stress testing and time to discharge.Clinical Trial Registration Information . Identifier, NCT00470587.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Impact of high-sensitivity cardiac troponin on use of coronary angiography, cardiac stress testing, and time to discharge in suspected acute myocardial infarction

et al. 2016

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“…The proportion of patients with undetectable hs-cTnT levels changed substantially from 62% in 2011 to 42% in 2014 owing to the lower sensitivity of the early batches of reagents that were used for the hs-cTnT assay until April 2012 [10]. The change in the proportion of patients with hs-cTnT levels N 14 ng/l was smaller and the proportion of chest pain patients and MI remained unchanged [13].…”

Section: Patient Characteristicsmentioning

confidence: 96%

Trends in admissions for chest pain after the introduction of high-sensitivity cardiac troponin T

Bandstein

Ljung

Lundbäck

et al. 2017

International Journal of Cardiology

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“…Until now, only 2 manufacturers have overcome the difficulties of developing and introducing hs-cTn assays into clinical practice, 6 of which 1 had major quality issues initially. [33][34][35] These uncertainties and concerns have led to delays in the approval of these assays for clinical care in the United States. 36 The US Food and Drug Administration has only recently ratified the use of the fifth-generation hs-cTnT assay.…”

Section: Discussionmentioning

confidence: 99%

Direct Comparison of Cardiac Myosin-Binding Protein C to Cardiac Troponins for the Early Diagnosis of Acute Myocardial Infarction

Kaier

Twerenbold

Puelacher

et al. 2017

Journal of the American College of Cardiology

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ORIGINAL RESEARCH ARTICLE ORIGINAL RESEARCH ARTICLE BACKGROUND: Cardiac myosin-binding protein C (cMyC) is a cardiacrestricted protein that is more abundant than cardiac troponins (cTn) and is released more rapidly after acute myocardial infarction (AMI). We evaluated cMyC as an adjunct or alternative to cTn in the early diagnosis of AMI. METHODS:Unselected patients (N=1954) presenting to the emergency department with symptoms suggestive of AMI, concentrations of cMyC, and high-sensitivity (hs) and standard-sensitivity cTn were measured at presentation. The final diagnosis of AMI was independently adjudicated using all available clinical and biochemical information without knowledge of cMyC. The prognostic end point was long-term mortality. RESULTS:Final diagnosis was AMI in 340 patients (17%). Concentrations of cMyC at presentation were significantly higher in those with versus without AMI (median, 237 ng/L versus 13 ng/L, P<0.001). Discriminatory power for AMI, as quantified by the area under the receiver-operating characteristic curve (AUC), was comparable for cMyC (AUC, 0.924), hs-cTnT (AUC, 0.927), and hs-cTnI (AUC, 0.922) and superior to cTnI measured by a contemporary sensitivity assay (AUC, 0.909). The combination of cMyC with hs-cTnT or standard-sensitivity cTnI (but not hscTnI) led to an increase in AUC to 0.931 (P<0.0001) and 0.926 (P=0.003), respectively. Use of cMyC more accurately classified patients with a single blood test into rule-out or rule-in categories: Net Reclassification Improvement +0.149 versus hs-cTnT, +0.235 versus hs-cTnI (P<0.001). In early presenters (chest pain <3 h), the improvement in rule-in/ruleout classification with cMyC was larger compared with hs-cTnT (Net Reclassification Improvement +0.256) and hs-cTnI (Net Reclassification Improvement +0.308; both P<0.001). Comparing the C statistics, cMyC was superior to hs-cTnI and standard sensitivity cTnI (P<0.05 for both) and similar to hs-cTnT at predicting death at 3 years.CONCLUSIONS: cMyC at presentation provides discriminatory power comparable to hs-cTnT and hs-cTnI in the diagnosis of AMI and may perform favorably in patients presenting early after symptom onset.

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

Abstract: NCT0047058, NCT00470587.

Cited by 22 publications

References 38 publications

Impact of high-sensitivity cardiac troponin on use of coronary angiography, cardiac stress testing, and time to discharge in suspected acute myocardial infarction

Impact of high-sensitivity cardiac troponin on use of coronary angiography, cardiac stress testing, and time to discharge in suspected acute myocardial infarction

Trends in admissions for chest pain after the introduction of high-sensitivity cardiac troponin T

Direct Comparison of Cardiac Myosin-Binding Protein C to Cardiac Troponins for the Early Diagnosis of Acute Myocardial Infarction

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