Ten years of high-sensitivity cardiac troponin testing in the Netherlands: impact on the diagnosis of myocardial infarction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.M Kimenai ◽  
Y Appelman ◽  
H.M Den Ruijter ◽  
N.L Mills ◽  
S.J.R Meex

Abstract Introduction High-sensitivity cardiac troponin (hs-cTn) assays have enhanced sensitivity for myocardial injury and may lead to an increase in the diagnosis of myocardial infarction. Few real-world studies have investigated the transition from conventional cardiac troponin (cTn) to hs-cTn. We evaluated the impact of implementing hs-cTn assays and sex-specific thresholds in the Netherlands on the diagnosis of myocardial infarction in women and men. Methods Twelve Dutch hospitals were included (hs-cTnI assay [sex-specific thresholds], n=4; hs-cTnT assay [uniform threshold], n=8). Data from the health insurance claims of consecutive patients with anginal symptoms were collected before (cTn period) and after (hs-cTn period) implementation from January 2008 to December 2017. The proportion of patients with a diagnosis of myocardial infarction overall, and in men and women separately, and one-year mortality was compared before and after implementation of the hs-cTn assay. Results Across twelve hospitals, a total number of 77,464 patients presenting with anginal symptoms were included (cTn period: 35,409 [36.6% women]; hs-cTn period: 42,055 [34.6% women]). Following implementation of hs-cTn testing the proportion of patients with anginal symptoms diagnosed with myocardial infarction doubled from 24% (3,111/12,970) to 48% (7,014/14,560) in women, and from 25% (5,712/22,439) to 51% (13,912/27,495) in men, with similar increases in sites implementing hs-cTnI and hs-cTnT. The proportion of patients diagnosed with myocardial infarction who were women increased in sites implementing sex-specific thresholds (from 36.4% [1,435/3,941] to 37.5% [1,700/4,532], absolute change 1.1%), but did not increase in sites using a uniform threshold (from 34.3% [1,676/4,882] to 32.4% [5,314/16,394], absolute change −1.9%). In patients with a diagnosis of myocardial infarction, one-year mortality was 15.6% (485/3,111) and 11.6% (814/7,014) in women, and was 11.8% (673/5,712) and 9.4% (1,303/13,912) in men, before and after implementation of hs-cTn. Conclusions In patients presenting with anginal symptoms, the diagnosis of acute myocardial infarction doubled after implementation of hs-cTn testing in both women and men. Use of sex-specific thresholds increased the proportion of patients with myocardial infarction who were women compared to use of a uniform threshold. Implementation was associated with a reduction in one-year mortality, but further research is needed to understand whether this is due to differences in the risk profile of patients with myocardial infarction or improvements in treatment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was supported by a grant from Abbott Laboratories to S.J.R.M.

2016 ◽  
Vol 62 (6) ◽  
pp. 831-838 ◽  
Author(s):  
Christina Trambas ◽  
John W Pickering ◽  
Martin Than ◽  
Chris Bain ◽  
Lucy Nie ◽  
...  

Abstract BACKGROUND High-sensitivity cardiac troponin I (hs-cTnI) assays show sex-dependent differences in the 99th percentile of healthy populations, with concentrations in women approximately 50% lower. The adoption of sex-specific cutoffs seems appropriate, although it is not yet clear what effect these will have on acute myocardial infarction (AMI) diagnosis and management. METHODS We conducted a retrospective pre- and postchangeover analysis of troponin I testing in the 6 months before and after moving from the contemporary Abbott Architect TnI assay (cTnI) to hs-cTnI at 2 tertiary centers in Australia and New Zealand. The cTnI cutoff was 30 ng/L for both sexes, whereas a female-specific cutoff of 16 ng/L was adopted upon changeover to hsTnI. RESULTS Changeover from the cTnI assay to the hs-cTnI assay increased the number of female patients with increased troponin I concentrations at both sites (from 29.7% to 34.9% and from 22.4% to 30.8%; P < 0.001). There was no statistically significant change in the number of men with increased concentrations in the same time period (P = 0.09). The increased percentage of women with increased troponin I was not associated with an increase in the number of women with AMI diagnoses at either center. Angiographic data available from 1 center showed no change in the percentage of angiograms performed in women. CONCLUSIONS Although increasing the proportion of women with increased troponin I, adopting sex-specific cutoffs with the hs-cTnI assay did not lead to an increase in AMI diagnoses in females, or in the number of women undergoing angiography.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Lopez Ayala ◽  
T Nestelberger ◽  
I Strebel ◽  
P.D Ratmann ◽  
J Boeddinghaus ◽  
...  

Abstract Background The European Society of Cardiology (ESC) high sensitivity cardiac troponin T 0/1h-algorithm has substantially improved the management of patients with suspected acute myocardial infarction (AMI) by triaging about 75% of patients to rapid rule-out and/or rapid rule-in. However, about 25% of patients remain in the “observe-zone”, and the optimal management of these patients is unknown. Recently, a pilot single center study with a low prevalence of AMI suggested that an absolute change of less than 7ng/L between the 0h and 3h hs-cTnT concentration would allow to help in the evaluation of patients in the observe-zone and allow triage towards rule-out with very high negative predictive value [NPV]. Purpose To externally validate this suggested modification of the ESC 0/1h-algorithm for early rule out of AMI. Methods In an ongoing multicentre international study, we prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of MI. Final diagnoses were centrally adjudicated by two independent cardiologists using all available medical records obtained during clinical care including 90 day follow-up information and cardiac imaging. High sensitivity-cTnT (Elecsys) concentrations were measured at presentation and after 1 and 3 hours. The primary outcome was safety, quantified by the sensitivity and NPV for early rule out of NSTEMI. Results Among 1633 enrolled patients with available 0, 1 and 3h hs-cTnT concentrations, NSTEMI was the adjudicated final diagnosis in 337 (20.6%) patients. The ESC 0/1h-algorithm ruled out 918 (56.2%) patients, with a sensitivity of 98.8% (95% confidence interval [CI], 97.0–99.5) and a NPV of 99.6% (95% CI, 98.9–99.8). A total of 428 patients (26.2%) remained in the observe zone. After applying the suggested 0–3 hour absolute change cut-off criteria of 7ng/L, 393 (92.0%) additional patients from the observe zone were triaged towards ruled out. However, the safety of this triage step was poor with 62 patients with NSTEMI missed, resulting in a sensitivity of 33.3% and a NPV of 84.2% for rule-out. Conclusions The suggested 0/3h absolute change cut-off of 7ng/L for patients remaining in the observe zone of the ESC 0/1h-algorithm does NOT allow safe rule-out of AMI and should therefore NOT be implemented into routine clinical care. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Swiss National Science Foundation, the Swiss Heart Foundation, the Stiftung für kardiovaskuläre Forschung Basel, the University of Basel and the University Hospital Basel


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Wereski ◽  
K.K Lee ◽  
S Smith ◽  
A.R Chapman ◽  
D Lowe ◽  
...  

Abstract Background The widespread adoption of high-sensitivity cardiac troponin testing has encouraged the use of pathways to accelerate the rule-out and rule-in myocardial infarction in the Emergency Department. These pathways are not recommended for patients with ST-segment elevation, but there is a risk they may be applied incorrectly given that interpretation of the electrocardiogram is subjective, dependent on experience, and signs may be masked in those with posterior myocardial infarction. Methods Consecutive patients with suspected acute coronary syndrome were enrolled in a stepped-wedge cluster randomized controlled trial across ten hospitals in Scotland. The index diagnosis was adjudicated two clinicians independently in all patients with high-sensitivity cardiac troponin I concentrations above the sex-specific 99th centile on serial testing and abnormalities on the electrocardiogram recorded. The proportion of patients with ST-segment elevation myocardial infarction and concentrations below the rule-out threshold (<5 ng/L), 99th centile (<16 ng/L and <34 ng/L for women and men) and rule-in threshold (<52 ng/L) at presentation were determined. Results In total 48,282 patients were recruited between June 2013, and March 2016 of which 22% (10,360/48,282) had peak cardiac troponin concentrations above the 99th centile. The adjudicated diagnosis was type 1 myocardial infarction in 55% (4,981/9,115) of patients and 10% (925/9,115) had ST-segment elevation myocardial infarction (age 65 [14] years, 68% men). The majority presented within 6 hours of symptom onset (67%, 619/925), and 84% (772/925) had cardiac troponin concentrations above the 99th centile at presentation. However, troponin concentrations were below the rule-out threshold in 2% (20/925) and the rule-in threshold in 26% (240/925) of patients with ST-segment elevation myocardial infarction. Discussion In patients with suspected acute coronary syndrome who have a final diagnosis of ST-segment elevation myocardial infarction, high-sensitivity cardiac troponin concentrations are below the rule-out and rule-in threshold at presentation in 1 in 50 and 1 in 4 patients, respectively. Clinicians should not rely on cardiac troponin concentrations to guide initial treatment decisions in patients with possible ST-segment elevation myocardial infarction. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): British Heart Foundation


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Gualandro ◽  
C Puelacher ◽  
M Liffert ◽  
K Arslani ◽  
R Meister ◽  
...  

Abstract Background Death, acute heart failure (AHF) and perioperative myocardial infarction/injury (PMI) are the most relevant cardiovascular complications following non-cardiac surgery. Unfortunately, the incidence of these complications are higher than expected. Currently available tools to predict these complications have only modest accuracy. Purpose To determine the accuracy of preoperative high-sensitivity cardiac troponin T (hs-cTnT) concentrations for prediction of mortality, AHF and PMI after non-cardiac surgery. Methods We prospectively included 4,709 patients at high cardiovascular risk undergoing non-cardiac surgery. Hs-cTnT concentrations were measured before surgery and, daily after surgery, for two days. PMI was defined as an absolute increase of 14ng/L (the 99th percentile of the assay used) from hs-cTnT baseline values. The primary endpoint was the diagnostic accuracy of preoperative hs-cTnT concentration to predict death, AHF and PMI within 30 days, as quantified by the area under the receiving-operating curve (AUC). Multivariate logistic regression analysis was performed to test the association between preoperative hs-cTnT and each endpoint. Results All-cause mortality occurred in 133 (3%), AHF in 84 (2%) and PMI in 742 (16%) patients. Preoperative hs-cTnT concentrations had good accuracy for prediction of death, AHF and PMI (AUC = 0.75 [95% CI, 0.71–0.79], 0.72 [95% CI, 0.67–0.77] and 0.73 [95% CI, 0.71–0.75], respectively). After adjusting for confounders, hs-cTnT remained an independent predictor for death with an adjusted odds ratio (aOR) of 2.1 (95% CI, 1.7–2.7, P<0.001) and for PMI (aOR 2.2, 95% CI, 1.9–2.4, P<0.001), but not for AHF (aOR 1.0, 95% CI, 0.7–1.4, P=0.99). An hs-cTnT concentration below 5ng/L was found in 526 (11%) patients, and this cut-off yielded a negative predictive value of 99.6% for the occurrence of death, 99.2% for AHF and 95.6% for PMI. Conclusion The preoperative hs-cTnT concentration has a good accuracy to predict mortality, AHF and PMI after non-cardiac surgery, but is an independent predictor only for mortality and PMI. A cut-off value of 5ng/L identifies a subgroup of patients at low risk for these complications. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Swiss National Foundation, Swiss Herat Foundation


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Lopez Ayala ◽  
T Nestelberger ◽  
J Boeddinghaus ◽  
L Koechlin ◽  
I Strebel ◽  
...  

Abstract Background The latest non-ST elevation myocardial infarction (NSTEMI) guidelines from the European Society of Cardiology (ESC) recommend a 3h cardiac troponin determination in patients triaged to the observe-zone of the ESC 0/1h-algorithm; however, no specific cut-off for further triage is endorsed. Purpose To derive and internally, as well as externally, validate a novel 3-hour pathway for the observe-zone of the ESC 0/1h-algorithm. Methods In an ongoing multicentre international diagnostic study, we prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of myocardial infarction (MI). Final diagnoses were centrally adjudicated by two independent cardiologists applying the 4th universal definition of MI, based on complete cardiac work-up including cardiac imaging, serial high sensitivity cardiac troponin T (hs-cTnT) sampling and 90-day follow-up information. High sensitivity-cTnT concentrations were measured at presentation and after 1 and 3 hours. The primary outcome was safety, quantified by the sensitivity and NPV for early rule out of NSTEMI. External validation was performed in an independent multicentre international study. Results Among 2076 eligible patients, application of the ESC 0/1h-algorithm triaged 1512 patients (72.8%) to either rule-out or rule-in of NSTEMI, remaining 564 patients (27.2%) in the observe-zone (adjudicated NSTEMI prevalence 120/564 patients, 21.3%). The novel derived 3h-pathway for the observe-zone patients ruled-out NSTEMI with a 3h hs-cTnT concentration <15 ng/L and a 0/3h-hs-cTnT absolute change <4 ng/L, triaging 138 patients (25%) towards rule-out, resulting in a sensitivity of 99.2% (95% CI 96.0–99.9) and a NPV of 99.3% (95% CI 95.4–99.9). A 0/3h-hs-cTnT absolute change ≥6 ng/L ruled-in 63 patients (11.2%), resulting in a specificity of 98% (95% CI 96.2–98.9) and a PPV of 85.7% (95% CI75.0–92.3). The novel 3h-pathway reduced the number of patients in the observe zone by 36%, and the number of T1MI by 50% (Figure 1). Findings were confirmed in both internal and external validation. Conclusions A novel derived pathway combining a 3h hs-cTnT concentration <15 ng/L and a 0/3h absolute change <4 ng/L allowed to very safely rule-out NSTEMI in patients remaining in the observe-zone of the ESC 0/1h-algorithm. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Swiss Heart FoundationThe Swiss National Science Foundation Figure 1


Sign in / Sign up

Export Citation Format

Share Document