High-sensitivity Troponin Assays Research Articles

Implementation of a High-Sensitivity Troponin-I Assay in an Academic Medical Center: A Qualitative and Quantitative Assessment.

To describe the clinical impact and lessons learned through implementation of a high sensitivity troponin (hsTn) assay. hsTn assays have received regulatory approval for use in the United States, and healthcare facilities are beginning to adopt these new assays. Questions remain about how to implement them and what effect they may have on demand for cardiovascular services. We conducted a mixed-methods implementation science-based investigation of hsTn adoption at a single academic medical center. We designed the investigation based on the Consolidated Framework for Implementation Research, exploring clinicians' perspectives on intervention characteristics, inner setting, individual characteristics, and process of implementation domains. Focus groups were conducted with clinicians from multiple service lines. Participants reported that the new hsTn assay did not fundamentally change processes of care such as cardiology consultations or inpatient admissions. Implementation was facilitated by leveraging the electronic medical record to provide useful suggestions for hsTn management at the point-of-care. The use of case-based teaching was considered most effective. Areas of ongoing concern included management of high-risk patients, outpatient follow-up, and feasibility of accelerated diagnostic protocols for early discharge from the emergency department. A decrease in the number of hsTn assays ordered was observed; no change was noted for admissions, cardiology consultations, or noninvasive cardiac imaging. A comprehensive educational campaign, based on multidisciplinary collaboration can effectively prepare clinicians for implementation of hsTn. New hsTn assays may not have any substantial effect on acute management of patients with cardiac complaints.

The problem(s) with troponin

Cardiac troponin has long been the preferred biomarker for the evaluation of acute coronary syndrome. Successive improvements in analytical performance have significantly enhanced the clinical utility of troponin assays, and the high sensitivity versions now in use are capable of measuring extremely low concentrations of troponin with high precision. Such assays have allowed contraction of the time frame required to confidently rule in and rule out acute myocardial infarction, permitting earlier intervention and earlier discharge, respectively. Robust analytical performance is essential to support clinical decision making, yet high sensitivity troponin assays are afflicted by a range of analytical issues that can undermine their value. These include a high rate of non-reproducible errors, or ‘fliers’, affecting certain assays; a high prevalence of macro-troponin interference affecting multiple assays; and possible loss of cardiac specificity of the troponin T assay in the setting of skeletal muscle disease. This talk will characterise the pitfalls and problems affecting troponin assays, and the risks they confer to patients, laboratories and health care services. Tension between the clinical importance of high sensitivity troponin assays and their analytical shortcomings highlights the need for continued innovation and solutions from our manufacturers.

How Well Do Laboratories Adhere to Recommended Guidelines for Cardiac Biomarkers Management in Europe? The CArdiac MARker Guideline Uptake in Europe (CAMARGUE) Study of the European Federation of Laboratory Medicine Task Group on Cardiac Markers.

The CARdiac MARker Guideline Uptake in Europe (CAMARGUE) program is a multi-country audit of the use of cardiac biomarkers in routine clinical practice. An email link to a web-based questionnaire of 30 multiple-choice questions was distributed via the professional societies in Europe. 374 questionnaires were returned from 39 countries, the majority of which were in northern Europe with a response rate of 8.2%-42.0%. The majority of the respondents were from hospitals with proportionately more responses from central hospitals than district hospitals. Cardiac troponin was the preferred cardiac biomarker, evenly split between cardiac troponin T (cTnT) and cardiac troponin I (cTnI). Aspartate transaminase and lactate dehydrogenase are no longer offered as cardiac biomarkers. Creatine kinase, creatine kinase MB isoenzyme, and myoglobin continue to be offered as part of the cardiac biomarker profile in approximately on 50% of respondents. There is widespread utilization of high sensitivity (hs) troponin assays. The majority of cTnT users measure hs-cTnT. 29.5% of laboratories measure cTnI by a non-hs method but there has been substantial conversion to hs-cTnI. The majority of respondents used ng/L and use the 99th percentile as the upper reference limit (71.9% of respondents). A range of diagnostic protocols are in use. There is widespread utilization of hs troponin methods. A significant minority do not use the 99th percentile as recommended and there is, as yet, little uptake of very rapid diagnostic strategies. Education of laboratory professionals and clinicians remains a priority.

Late Outcomes of the RAPID-TnT Randomized Controlled Trial: 0/1-Hour High-Sensitivity Troponin T Protocol in Suspected ACS.

High-sensitivity troponin assays are increasingly being adopted to expedite evaluation of patients with suspected acute coronary syndromes. Few direct comparisons have examined whether the enhanced performance of these assays at low concentrations leads to changes in care that improves longer-term outcomes. This study evaluated late outcomes of participants managed under an unmasked 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol compared with a 0/3-hour masked hs-cTnT protocol. We conducted a multicenter prospective patient-level randomized comparison of care informed by unmasked 0/1-hour hs-cTnT protocol (reported to <5 ng/L) versus standard practice masked hs-cTnT testing (reported to ≤29 ng/L) assessed at 0/3 hours and followed participants for 12 months. Participants included were those presenting to metropolitan emergency departments with suspected acute coronary syndromes, without ECG evidence of coronary ischemia. The primary end point was time to all-cause death or myocardial infarction using Cox proportional hazards models adjusted for clustering within hospitals. Between August 2015 and April 2019, we randomized 3378 participants, of whom 108 withdrew, resulting in 12-month follow-up for 3270 participants (masked: 1632; unmasked: 1638). Among these, 2993 (91.5%) had an initial troponin concentration of ≤29 ng/L. Deployment of the 0/1-hour hs-cTnT protocol was associated with reductions in functional testing. Over 12-month follow-up, there was no difference in invasive coronary angiography (0/1-hour unmasked: 232/1638 [14.2%]; 0/3-hour masked: 202/1632 [12.4%]; P=0.13), although an increase was seen among patients with hs-cTnT levels within the masked range (0/1-hour unmasked arm: 168/1507 [11.2%]; 0/3-hour masked arm: 124/1486 [8.3%]; P=0.010). By 12 months, all-cause death and myocardial infarction did not differ between study arms overall (0/1-hour: 82/1638 [5.0%] versus 0/3-hour: 62/1632 [3.8%]; hazard ratio, 1.32 [95% CI, 0.95-1.83]; P=0.10). Among participants with initial troponin T concentrations ≤29 ng/L, unmasked hs-cTnT reporting was associated with an increase in death or myocardial infarction (0/1-hour: 55/1507 [3.7%] versus 0/3-hour: 34/1486 [2.3%]; hazard ratio, 1.60 [95% CI, 1.05-2.46]; P=0.030). Unmasked hs-cTnT reporting deployed within a 0/1-hour protocol did not reduce ischemic events over 12-month follow-up. Changes in practice associated with the implementation of this protocol may be associated with an increase in death and myocardial infarction among those with newly identified troponin elevations. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615001379505.

Downstream Cascades of Care Following High-Sensitivity Troponin Test Implementation

BackgroundPatients with chest pain are often evaluated for acute myocardial infarction through troponin testing, which may prompt downstream services (cascades) of uncertain value. ObjectivesThis study sought to determine the association of high-sensitivity cardiac troponin (hs-cTn) assay implementation with cascade events. MethodsUsing electronic health record and billing data, this study examined patient-visits to 5 emergency departments from April 1, 2017, to April 1, 2019. Difference-in-differences analysis compared patient-visits for chest pain (n = 7,564) to patient-visits for other symptoms (n = 100,415) (irrespective of troponin testing) before and after hs-cTn assay implementation. Outcomes included presence of any cascade event potentially associated with an initial hs-cTn test (primary), individual cascade events, length of stay, and spending on cardiac services. ResultsFollowing hs-cTn implementation, patients with chest pain had a 2.8% (95% confidence interval [CI]: 0.72% to 4.9%) net increase in experiencing any cascade event. They were more likely to have multiple troponin tests (10.5%; 95% CI: 9.0% to 12.0%) and electrocardiograms (7.1 per 100 patient-visits; 95% CI: 1.8 to 12.4). However, they received net fewer computed tomography scans (−1.5 per 100 patient-visits; 95% CI: −1.8 to −1.1), stress tests (−5.9 per 100 patient-visits; 95% CI: −6.5 to −5.3), and percutaneous coronary intervention (PCI) (−0.65 per 100 patient-visits; 95% CI: −1.01 to −0.30) and were less likely to receive cardiac medications, undergo cardiology evaluation (−3.5%; 95% CI: −4.5% to 2.6%), or be hospitalized (−5.8%; 95% CI: −7.7% to −3.8%). Patients with chest pain had lower net mean length of stay (−0.24 days; 95% CI: −0.32 to −0.16) but no net change in spending. ConclusionsHs-cTn assay implementation was associated with more net upfront tests yet fewer net stress tests, PCI, cardiology evaluations, and hospital admissions in patients with chest pain relative to patients with other symptoms.

RACE-IT – Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial

BackgroundProtocols utilizing high-sensitivity cardiac troponin (hs-cTn) assays for the evaluation of suspected acute coronary syndrome (ACS) in the emergency department (ED) have been gaining popularity across the US and the world. These protocols more rapidly rule-out ACS and more accurately identify the presence of acute myocardial injury. At this time, few randomized trials have evaluated the safety and operational impact of these assays, resulting in limited evidence to guide the use and implementation of hs-cTn in the ED. ObjectiveThe main study objective is to test the effectiveness of a rapid ACS rule-out pathway using hs-cTnI in safely discharging patients from the ED for whom clinical suspicion for ACS exists. DesignThis prospective, implementation trial (n = 11,070) will utilize a stepped wedge cluster randomized trial design. The design will allow for all participating sites to capture benefit from the implementation of the hs-cTnI pathway while providing data evaluating the effectiveness in providing safe and rapid evaluation of patients with clinical suspicion for ACS. SummaryDemonstrating that clinical pathways using hs-cTnI can be effectively implemented to rapidly rule-out ACS while conserving costly hospital resources has significant implications for the care of patients with possible acute cardiac conditions in EDs across the US. Clinicaltrials.gov identifierNCT04488913.

Independent and combined effects of biotin and hemolysis on high-sensitivity cardiac troponin assays.

This study compared the independent and combined effects of hemolysis and biotin on cardiac troponin measurements across nine high-sensitivity cardiac troponin (hs-cTn) assays. Parallel cTn measurements were made in pooled lithium heparin plasma spiked with hemolysate and/or biotin using nine hs-cTn assays: Abbott Alinity, Abbott ARCHITECT i2000, Beckman Access 2, Ortho VITROS XT 7600, Siemens Atellica, Siemens Centaur, Siemens Dimension EXL cTnI, and two Roche Cobas e 411 Elecsys Troponin T-hs cTnT assays (outside US versions, with and without increased biotin tolerance). Absolute and percent cTn recovery relative to two baseline concentrations were determined in spiked samples and compared to manufacturer's claims. All assays except the Ortho VITROS XT 7600 showed hemolysis and biotin interference thresholds equivalent to or greater than manufacturer's claims. While imprecision confounded analysis of Ortho VITROS XT 7600 data, evidence of biotin interference was lacking. Increasing biotin concentration led to decreasing cTn recovery in three assays, specifically both Roche Cobas e 411 Elecsys Troponin T-hs assays and the Siemens Dimension EXL. While one of the Roche assays was the most susceptible to biotin among the nine studied, a new version showed reduced biotin interference by approximately 100-fold compared to its predecessor. Increasing hemolysis also generally led to decreasing cTn recovery for susceptible assays, specifically the Beckman Access 2, Ortho VITROS XT 7600, and both Roche Cobas e 411 Elecsys assays. Equivalent biotin and hemolysis interference thresholds were observed at the two cTn concentrations considered for all but two assays (Beckman Access 2 and Ortho VITROS XT 7600). When biotin and hemolysis were present in combination, biotin interference thresholds decreased with increasing hemolysis for two susceptible assays (Roche Cobas e 411 Elecsys and Siemens Dimension EXL). Both Roche Cobas e 411 Elecsys as well as Ortho VITROS XT assays were susceptible to interference from in vitro hemolysis at levels routinely encountered in clinical laboratory samples (0-3g/L free hemoglobin), leading to falsely low cTn recovery up to 3ng/L or 13%. While most assays are not susceptible to biotin at levels expected with over-the-counter supplementation, severely reduced cTn recovery is possible at biotin levels of 10-2000ng/mL (41-8,180nmol/L) for some assays. Due to potential additive effects, analytical interferences should not be considered in isolation.

Comparing conventional and high sensitivity troponin T measurements in identifying adverse cardiac events in patients admitted to an Asian emergency department chest pain observation unit.

BackgroundHigh sensitive cardiac troponin assays can be used for prediction of major adverse cardiac events (MACE) in patients with chest pain.MethodsWe included patients with symptoms suggestive of acute coronary syndrome in the emergency department observation unit. We compared the accuracy of conventional troponin T (cTnT) with high sensitive troponin T (hsTnT) at various ranges, as well as the utility of hsTnT and cTnT in prediction of 30-day and 1-year MACE.Results1023 patients were included (68.1% male, median age 56 years). There were 2712 hsTnT and cTnT values compared. hsTnT had a higher AUC than cTnT for 30-day and 1-year MACE. The optimal cut-off of 0-hour hsTnT for 30-day (PPV 34%, NPV 96.6%) and 1-year MACE (PPV 40.2%, NPV 94.2%) was 16 ng/L.For 844 patients who had values for both 0 and 2 h hsTnT, we proposed a rule-out cut-off of 0 and 2 h hsTnT < 16 ng/L (NPV 97.0%, 95%CI 95.5–98.1%) and a rule-in cut-off of 0 and 2 h hsTnT ≥ 26 ng/L (PPV 58.8%, 95%CI 40.7%-75.4%) for 30-day MACE. Negative 0–2 h delta-hsTnT had poor predictive discriminant capabilities on 30-day (PPV 8.2%) and 1-year MACE (PPV 12.3%).ConclusionThe cut off values of hsTnT used in the 0 and 2-hour algorithm to rule-out (16 ng/L) and rule-in MACE (26 ng/L) are in the range that previous cTnT assays are unable to measure accurately. Risk scores can be used to further improve NPV of the rule-out group. A fall in hsTnT level acutely is not predictive of MACE.

Disagreement between Cardiac Troponin Tests Yielding a Higher Incidence of Myocardial Injury in the Emergency Setting.

Differences in patient classification of myocardial injury between high-sensitivity cardiac troponin (hs-cTn) assays have largely been attributed to assay design and analytical sensitivity aspects. Our objective was to compare Ortho Clinical Diagnostics’ (OCD) hs-cTnI assay to OCD’s contemporary/conventional assay (cTnI ES) and another hs-cTnI assay (Abbott hs-cTnI) in samples obtained from different emergency departments (EDs). Two different sample types were evaluated (lithium heparin and ethylenediaminetetraacetic acid (EDTA) plasma) in a non-selected ED population (study 1, n = 469 samples) and in patients for which ED physicians ordered cardiac troponin testing (study 2, n = 1147 samples), from five different EDs. The incidence of injury in study 1 was higher with the OCD hs-cTnI assay (30.9%; 95% CI: 26.9 to 35.2) compared to that of the Abbott hs-cTnI (17.3%; 95% CI: 14.1 to 21.0) and the OCD cTnI ES (15.4%; 95% CI: 12.4 to 18.9) assays, with repeat testing identifying 4.8% (95% CI: 3.0 to 7.5) of the OCD hs-cTnI results with poor reproducibility. In study 2, 4.6% (95% CI: 3.5 to 6.0) of the results were not reported for the OCD hs-cTnI assay (i.e., poor reproducibility) with 12.7% (95%CI: 8.7 to 17.8) of the OCD hs-cTnI results positive for injury being negative for injury with the Abbott hs-cTnI assay. In summary, the OCD hs-cTnI assay yields higher rates of biochemical injury with a higher rate of poor reproducible results in different ED populations.

High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial.

High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome. We performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes. We enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73-0.83]; P<0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45-1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%]; P=0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74-1.40]; P=0.894), and there were no differences in hospital reattendance or all-cause mortality. Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.

Discordance of High-Sensitivity Troponin Assays in Patients With Suspected Acute Coronary Syndromes

BackgroundHigh-sensitivity cardiac troponin (hs-cTn) assays have different analytic characteristics. ObjectivesThe goal of this study was to quantify differences between assays for common analytical benchmarks and to determine whether they may result in differences in the management of patients with suspected acute coronary syndrome (ACS). MethodsThe authors included patients with suspected ACS enrolled in the ROMICAT (Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography) I and II trials, with blood samples taken at emergency department presentation (ROMICAT-I and -II) or at 2 and 4 h thereafter (ROMICAT-II). hs-cTn concentrations were measured using 3 assays (Roche Diagnostics, Elecsys 2010 platform; Abbott Diagnostics, ARCHITECT i2000SR; Siemens Diagnostics, HsVista). Per blood sample, we determined concordance across analytic benchmarks (<limit of detection [<LOD]/LOD-99th percentile/>99th percentile). Per-patient, the authors determined concordance of management recommendations (rule-out/observe/rule-in) per the 0/2-h algorithm, and their association with diagnostic test findings (coronary artery stenosis >50% on coronary computed tomography angiography or inducible ischemia on perfusion imaging) and ACS. ResultsAmong 1,027 samples from 624 patients (52.8 ± 10.0 years; 39.4% women), samples were classified as <LOD (56.3% vs. 10.4% vs. 41.2%; p < 0.001), LOD-99th percentile (36.5% vs. 83.5% vs. 52.6; p < 0.001), >99th percentile (7.2% vs. 6.0% vs. 6.2%) by Roche, Abbott, and Siemens, respectively. A total of 37.4% (n = 384 of 1,027) of blood samples were classified into the same analytical benchmark category, with low concordance across benchmarks (<LOD 11.1%; LOD-99th percentile 29.3%; >99th percentile 43.6%). Serial samples were available in 242 patients (40.1% women; mean age: 52.8 ± 8.0 years). The concordance of management recommendations across assays was 74.8% (n = 181 of 242) considering serial hs-cTn measurements. Of patients who were recommended to discharge, 19.6% to 21.1% had positive diagnostic test findings and 2.8% to 4.3% had ACS at presentation. ConclusionsCaregivers should be aware that there are significant differences between hs-cTn assays in stratifying individual samples and patients with intermediate likelihood of ACS according to analytical benchmarks that may result in different management recommendations. (Rule Out Myocardial Infarction by Computer Assisted Tomography [ROMICAT]; NCT00990262) (Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography [ROMICAT-II]; NCT01084239)

Effect of racing on cardiac troponin I concentration and associations with cardiac rhythm disturbances in Standardbred racehorses

Introduction/ObjectivesAccumulating evidence indicates intense exercise can be associated with myocardial damage. Investigating the impact of maximal effort on myocardium and exploring possible association of injury with rhythm disturbance requires a high-sensitivity cardiac troponin assay. The objectives of this study were: (1) to determine the effect of racing on serum cardiac troponin I (cTnI) in Standardbred horses using a high-sensitivity assay; (2) to determine the 99th percentile of cTnI in healthy horses and investigate the effect of demographic variables on cTnI prevailing pre-race in Standardbred horses using a validated high-sensitivity assay and a contemporary assay, and; (3) to explore associations between exercise-associated arrhythmia and cTnI concentration. AnimalsRacehorses (n = 145). Materials and methods≤ 2 h pre-race, cTnI concentrations were measured in 158 race starts. Electrocardiogram (ECG) monitoring was applied during racing and race recovery and screened for complex ventricular arrhythmia. Associations between cTnI prevailing before racing concentration, age, sex, and gait were investigated. Demographic and performance variables were evaluated for associations with cTnI concentration post-race and rhythm disturbance. ResultsIncidence of arrhythmia was 11.6% (16 horses). A significant increase in median (interquartile range) cTnI concentration of 1.36 (0.49–2.81) ng/L was found post-race (p < 0.0001). Serum cardiac troponin I (cTnI) concentration prevailing pre-race was positively associated with increasing age, and gait. Serum cardiac troponin I prevailing post-race was positively associated with concentration prevailing pre-race. Interaction between arrhythmia and finishing distanced revealed horses finishing distanced and experiencing arrhythmia displayed higher cTnI release than with the presence of either alone. ConclusionsRacing increased cTnI concentration. Horses finishing distanced and also exhibiting arrhythmia may be experiencing myocardial compromise.

Patients’ and health professionals’ perceptions of the LoDED (limit of detection and ECG discharge) strategy for low-risk chest pain management: a qualitative study

BackgroundRapid discharge strategies for patients with low-risk chest pain using high-sensitivity troponin assays have been extensively evaluated. The adherence to, and acceptability of such strategies, has largely been explored using...

Trends Over Time in the Incidences of ST-Segment Elevation Myocardial Infarction and Non-ST-Segment Elevation Myocardial Infarction During the Past Decade in a Rural Japanese High-Aged Population.

In developed countries, the incidence of non-ST-segment elevation myocardial infarction (NSTEMI) has outpaced that of ST-segment elevation myocardial infarction (STEMI). However, whether this trend is observed in Japan, in which the aging of society is rapidly progressing, remains to be elucidated. This study retrospectively investigated the trends over time in the incidence of acute coronary syndrome (ACS) between August 2009 and July 2019 at 2 institutions in Izumo City (in rural Japan), which has an elderly population. Crude and age-sex-adjusted incidences of total ACS, STEMI, and non-ST-segment elevation-ACS (NSTE-ACS; including NSTEMI and unstable angina pectoris) were calculated for each year. In the total population, factors associated with the development of NSTEMI were evaluated by multivariate analysis. In total, 1,087 patients were enrolled. The age-adjusted incidence of NSTE-ACS in male patients aged ≥75 years showed a significantly increasing trend. The proportion of NSTEMI per total ACS cases showed a significantly increasing trend over the entire study period. In the multivariate analysis, pre-development use of ≥3 medications for comorbidities was associated with the development of NSTEMI, independent of high-sensitivity cardiac troponin assay use. This study demonstrated an increasing trend in the incidence of NSTEMI in a rural high-aged Japanese population. In addition to the widespread use of high-sensitivity cardiac troponin assays, early medication use for comorbidities might have contributed to this trend.

Assessment of agreement of two high sensitivity troponin assays during an institutional transition

Vessel Plus is an open acccess journal, which publishes articles related to vascular diseases, including acute respiratory distress syndrome, aneurysm, atherosclerosis, hypertension, stroke, peripheral vascular or pulmonary vascular diseases, etc.

An Updated Meta-Analysis on the European Society of Cardiology 0/1-Hour Algorithm's Efficacy and Safety Outcomes

Background: In 2011, the European Society of Cardiology (ESC) has recommended the 0/1-hour algorithm with high-sensitivity cardiac troponin assays to diagnose acute myocardial infarction. However, there is no defined difference between high-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI). Methods: We conducted the first meta-analysis of randomized controlled trials and observation studies from inception to 13 August 2021 that evaluated the 0/1-hour algorithm with hs-cTnT or hs-cTnI. The statistical analysis was performed using R version 3.6.3 with packages “metaprop” and “metafor”. We constructed two-by-two tables, pooled studies by a random-effects model using proportion, and calculated sensitivity, NPV, specificity, and PPV with 95% confidence intervals (CI). Results: Two RCTs and 15 observational studies were included with total of 17,883 patients and a median weighted follow-up period of 267 days. For hs-cTnT-Roche, the rates of pooled sensitivity was 98% (95% CI 94-99, I2 =87%), NPV was 99% (95% CI 98-100%, I2 =88%), specificity was 93% (95% CI 90-96%, I2 =98%), and PPV was 61% (95% CI 44-75%, I2 =98%). On the other hand, hs-cTnI-Pooled had a sensitivity of 99% (95% CI 97-99%, I2 =48%), NPV of 100% (95% CI 100-100%, I2 =41%), specificity of 95% (95% CI 94-97%, I2 =95%), PPV of 68% (95% CI 63-73%, I2 =71%) Conclusion: Assays of hs-cTnI-Pooled have higher values of sensitivity, NPV, specificity, and PPV when compared to hs-cTnT-Roche.

Using Cardiac Magnetic Resonance Imaging to Evaluate Patients with Chest Pain in the Emergency Department.

Chest pain is one of the most common presenting symptoms in the emergency department (ED). Among patients with abnormal troponins, it is imperative to quickly and accurately distinguish type 1 acute myocardial infarction (AMI) from other etiologies of myocardial injury. Although high-sensitivity troponin assays introduced a high negative predictive value for AMI, they have exposed the need for diagnostic modalities that can determine the etiology of acute myocardial injury. Cardiac magnetic resonance imaging (CMR) is an effective tool to risk stratifying chest pain among patients in the ED. CMR is non-invasive and has a lower cost of care and shorter length of stay compared to those of invasive coronary angiography. It also provides detailed information on cardiac morphology, function, tissue edema, and location and pattern of tissue damage that can help to differentiate many etiologies of cardiac injury. CMR is particularly useful to distinguish chest pain due to type 1 AMI versus supply-demand mismatch due to acute cardiac noncoronary artery disease. A detailed review of the literature has shown that CMR with stress testing is safe to use in patients presenting to the ED with chest pain, with or without abnormal troponins. CMR is a useful, safe, economical, and effective alternative to the traditional diagnostic tools that are typically used in this patient population. It is a practical tool to risk-stratify patients with possible cardiac pathology and to clarify diagnosis without invasive testing.

The role of cardiac testing with the 0/1-hour high-sensitivity cardiac troponin algorithm evaluating for acute myocardial infarction

The role of cardiac testing in the 3 zones (rule-out, observation, and rule-in) of the 0/1-hour algorithm to evaluate for acute myocardial infarction (AMI) has not been well studied. This study evaluated the 0/1-hour algorithm with a high-sensitivity cardiac troponin (hs-cTnI) assay and investigated cardiac testing in the 3 zones. Patients (n = 552) at a single urban center were enrolled if they were evaluated for AMI. Blood samples were obtained at presentation, 1 hour, and 3 hours for hs-cTnI. Follow-up at 30 to 45 days for death/AMI was done. The results of echocardiograms, stress testing, and coronary angiography were recorded. In total, 45 (8.2%) had AMI (27 Type 1 and 18 Type 2) during the index hospitalization while at follow-up death/AMI occurred in 11 (2.0%) of patients. The rule-out algorithm had a negative predictive value for AMI of 99.6% while the rule-in zone had a positive predictive value of 56.6%. The MACE rate at follow-up was 0.4% for those in the rule-out group. There were 6/95 (6.3%) abnormal stress tests in the rule-out zone and 4 of these were false positives. The 0/1-hour algorithm had high diagnostic sensitivity and negative predictive value for AMI, and adverse events were very low in patients in the rule-out zone. Noninvasive testing in rule-out zone patients had low diagnostic yield.

Implementation of High-Sensitivity and Point-of-Care Cardiac Troponin Assays into Practice: Some Different Thoughts.

BackgroundThe primary role of the International Federation of Clinical Chemistry (IFCC) Committee on Clinical Application of Cardiac Bio-Markers (C-CB) is to provide educational materials about cardiac biomarker use, emphasizing high-sensitivity cardiac troponin assays.ContentThis mini-review, regarding high-sensitivity cardiac and point-of-care troponin assays, addresses 1) new IFCC C-CB/AACC Academy laboratory practice recommendations; 2) new and updated concepts from the Fourth Universal Definition of Myocardial Infarction; 3) the role of point-of-care assays in practice and research; 4) regulatory challenges concerning point-of-care assays; e) testing in the COVID-19 world.SummaryImplementation of high-sensitivity cardiac troponin assays makes a difference now and into the future in clinical practice and research. Providing point-of-care high-sensitivity cardiac troponin assays and optimizing studies to allow clearance of these assays by regulatory agencies, in a timely fashion, may provide improved patient management and outcomes.

Early Rule-Out Strategies in the Emergency Department Utilizing High-Sensitivity Cardiac Troponin Assays.

Over the past decade, intense collaboration between academic investigators and the diagnostic industry have allowed the integration of high-sensitivity cardiac troponin (hs-cTn) assays into clinical practice worldwide. The hs-cTn assays, with their increased diagnostic accuracy for acute myocardial infarction (AMI), have facilitated the maturation of early rule-out strategies. The first iteration was complex and required the combination of a biomarker panel, the electrocardiogram, and a clinical risk score and allowed the safe rule-out of AMI in only 10% of patients with acute chest pain. In contrast, the latest iterations, including the European Society of Cardiology (ESC) 0/1-h algorithm, are simple. They are based on hs-cTn concentrations only and allow the safe rule-out or rule-in of AMI in up to 75% of patients. The purposes of this minireview are (a) to describe the best validated hs-cTn-based strategies for early rule-out of AMI, (b) to discuss the advantages and limitations of the different strategies, (c) to identify patient subgroups requiring particular attention, (d) to recognize challenges for widespread clinical implementation, and (e) to provide guidance on strategies for their safe and effective clinical implementation. Physicians and institutions may choose among several well-validated rule-out algorithms. The ESC 0/1-h algorithm for hs-cTnT or hs-cTnI seems to be the most attractive option today. It best balances safety and efficacy, and it has been derived and validated for all currently available hs-cTnT/I assays, facilitating widespread clinical implementation.