Authors
- Li, Fen RN, BNg, ICUCert, Dip Crit Care, MN
- Clark, Robyn RN, RM, ICUCert, Dip AppliSci, BN, Med, PhD, ACCCN (Life Member), FCNA, FAHA, PhD
- Versace, Vincent BSc, PhD
- Newman, Peter BBs, Dip IT
Abstract
Review question/objective: The objective of this review is to investigate the association between Point-of-Care testing of Troponin (PoCT-cTn) and the management of chest pain patients suspected of Acute Coronary Syndrome (ACS), including timely diagnosis and triage, time to percutaneous coronary intervention (PCI) or fibrinolysis, and length of stay in the Emergency Department (ED).
Background: Cardiovascular diseases are defined by the World Health Organisation (WHO) as 'a group of disorders of the heart and blood vessels', which include coronary heart disease (acute coronary syndrome),cerebrovascular disease (stroke), peripheral arterial disease, rheumatic heart disease, congenital heart disease, deep vein thrombosis and pulmonary embolism.1
Acute coronary syndrome (ACS) is caused by athero-thrombotic lesions of heart that are associated with a thrombus formation on a ruptured atherosclerotic plaque, leading to a reduction in the supply of oxygen and nutrients to the heart muscle and impairing cardiac functions, presenting acute myocardial infarction (AMI).2
ACS reflects the spectrum of coronary artery disease (CAD) resulting in acute myocardial ischemia and includes unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI).3 They can be distinguished as per their definitions defined by the Global Registry of Acute Coronary Events (GRACE) (Table 1).4
Clinically these diagnoses encompass a wide variation in risk, requiring complex and timely risk stratification and representing a large social and economic burden. According to the World Health Organization, ACS claims 17 million lives every year.5 It has been and will continue to be the single leading cause of death.
Typical symptoms of acute ACS/MI include, but are not limited to, sudden retrosternal chest pain (usually radiating to the left arm, left side of the neck, or abdomen) with shortness of breath,nausea, vomiting,palpitations, sweating, anxiety and sudden death, with no precursor signs.6 However, a sizeable proportion of myocardial infarctions (22-64%) are 'silent', that is without chest pain or other symptoms.7 This has brought challenges to the diagnostic issues of AMI. Typically, the electrocardiogram (ECG) provides unique and important diagnostic information to distinguish STEMI and NSTEMI acute coronary syndromes. In the spectrum of ACS, UA/NSTEMI usually presents by chest pain, ECG with no ST-segment elevation but ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin).8
However, hyperacute T wave change on ECG may mislead diagnosis due to non-cardiac causes (e.g. hyperkalaemia, renal failure).9 If the patient has chest pain without ST-segment elevation on the ECG, the measurement of cardiac Troponin (cTn) becomes the cornerstone of ACS diagnosis.10
Introduction of point-of-care testing of Troponin
Only two thirds of chest pain patients (66%) presented to hospitals, responsible for emergency hospital admissions, and the main reason for hospital attendance could be the possibility of acute myocardial infarction (AMI).12 Among the chest pain patients, half of presentations (46%) had chest pain with unlikely ischemic chest pain or ACS, but one third of them (33%) experienced MI, and one fifth (21%) of them had unstable angina or likely ischemic chest pain.12 To distinguish different spectrums of ACSs and non-cardiac cases and to do appropriate risk stratification and triage, current guidelines of ACS require a troponin sample taken on arrival or at least 6 hours after the onset of chest pain.13
Troponin is a complex of three regulatory proteins (Troponin C, Troponin I and Troponin T) that is integral tomuscle contraction inskeletal andcardiac muscles, but not in smooth muscles.14 Troponin C has identical form in skeletal muscles, therefore, it has not been used as a cardiac marker of myocardial ischaemia.9 Troponin I (cTn I) and Troponin T (cTn T) have been the focus of studies to determine diagnostic values in detecting cardiac injury or infarction since the late 1980s.15,16 They are very sensitive and specific indicators of damage to the myocardium. When heart damage has occurred, the proteins are released into the blood stream and can be measured in a blood sample, especially when having 'heart attack'.17
Previously, Creatinine Kinase (CK) was preferred for diagnosis of ACS.18 In the past decade, cardiac Troponin (cTn) has emerged as a preferred choice over CK for the diagnostic need of ACS/AMI in chest pain patients. Cardio-specific enzyme Troponin I and Troponin T are not detectable in healthy people. Any elevation in cTn levels indicates some degree of myocardial necrosis. Therefore, cTn has become a gold standard cardiac marker (CM) of MI due to its high diagnostic specificity and prognostic value in the clinical setting.18,19
However, cTn is time dependent and needs to be detected within a few hours of chest pain onset. Point-of-Care testing of Troponin (PoCT-cTn) is a rapid test and practical in clinical settings. Point-of-Care Testing (PoCT) is defined as testing conducted at or near the site of patient care, allowing blood samples to be processed immediately.20 Point-of-Care testing of Troponin refers to PoCT for a rapid assay for cTn values, via doing finger pricks and testing on portable platforms. It can provide rapid results of cTn with turnaround times as short as 15-30 minutes in comparison with laboratory testing needing 60-90 minutes.21 PoCT-cTn can significantly reduce the turnaround time from testing to results, allowing more immediate patient triage and effective management.21
Evidence based management of ACS
The American College of Cardiology (ACC) states that the cTn result should be available within 60 minutes of presentation and preferably within 30 minutes.22 PoCT-cTn has been highly recommended and subsequently included in ACS guidelines, specifically where the timely management of the condition is the focus. It is important for NSTEMI patients presenting with chest pain, who should be diagnosed and assigned to a risk group as rapidly as possible.23 Relevant guidelines include the guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA),24 the European Society of Cardiology's guidelines,23,25 the Guidelines for the management of ACS generated in 2006 by the National Heart Foundation of Australia (NHFA) and the Cardiac Society of Australia and New Zealand (CCANZ),18 and its Addendum enacted in 2011.13
According to the above evidence, chest pain patients who are suspected of ACS should have a comprehensive initial assessment to screen the risk of ACS, including collecting a medical history, performing a physical examination and recording risk factors. Initial management includes a 12 lead ECG and Troponin testing. If ECG presents ST segment elevation >=1mm (STEMI) with or without Troponin changes, the patient is managed by the high risk pathway. However, if the patient's ECG is negative (NSTEMI), then Troponin values are significant to classify patients. If cTn is positive (above the 99th percentile or > 20% rise/fall of baseline by high sensitivity testing), MI is likely to be diagnosed and the patient will be managed with the moderate risk/high risk pathway, seeking cardiac consultation and further investigation. If a negative result is present, ACS is unlikely and treatment may proceed to early 'rule-out' CAD testing (e.g. stress ECG).13 Otherwise, the patient will be classified as low risk, and if there is no ongoing chest pain and hospitalization is not required, the patient can be discharged home.8, 26, 27
The national guidelines of ACS of Australia require that every chest pain patient suspected of ACS should perform cTn testing (high sensitivity) on arrival to the ED to 'rule in' ACS within the differential diagnosis in cTn level.13 In order to promptly rule in or rule out the risk of ACS, PoCT-cTn should be implemented if the high sensitivity cTn result is not available within 60 minutes. Although PoCT-cTn is not based on the new high sensitivity testing, it should be used to ensure timely risk assessment when likely substantial delay in cTn assays will occur.13
The thresholds of positive cTn values were reduced with technical development on the cTn assays. They were 1.5ng/ml defined in 1995, changed to1.0ng/ml in 2004 and further decreased to 0.04ng/ml since 2007.28 The positive value of acceptable accuracy for the diagnosis of AMI was defined as >99th percentile (equal to 0.04 mg/L), either doing serial specimens at least three hours apart or one specimen at least six hours from the onset of symptoms,29 which is sufficient to provide high accuracy for ruling out MI.13 If no high sensitivity testing is available, the diagnosis of MI requires both an elevation of troponin levels above the 99th percentile and a >20% change (rise and/or fall) when using older troponin assays, informed by recent consensus guidelines.30-32
The effects of PoCT-cTn
Point-of-care testing of Troponin is usually performed at the bedside by ED staff. The best use of the result of Point-of-Care testing depends on clinicians who are prepared to act on the test results immediately.33 Optimal outcomes in chest pain patients rely on rapid diagnosis, accurate risk stratification and the effective implementation of evidence-based therapies, as advocated by clinical guidelines. This goal is reachable but the challenge is in effectively applying evidence in clinical practice and in understanding the evidence-practice gap that is objective and needs standardized quantification of clinical practice.
It has been verified that PoCT-cTn rapidly provides a blood test of the Cardiac Enzyme of Troponin (cTn), being the gold standard of diagnosing ACS.18,19 It can be used to rule out and rule in ACS, thereby facilitating effective treatment of ACS patients.13 In a report from South Australia, PoCT-cTn benefited rural and remote areas where they did not have an on-site laboratory, and had to wait up to 36 hours to receive pathology results.34 PoCT-cTn was identified as a critical enabler for improving patient management in rural and remote areas.34
Conversely, the negative reports were found on the utilization of PoCT-cTn. Five studies opposed the utilization of PoCT-cTn in the ED and cardiac short-stay units.35-39 Two studies opposed the application of PoCT-cTn in the pre-hospital setting,40,41 and one opposed the utilization of PoCT-cTn in the outpatient clinic setting.42
In a large study performed by Takakuwa et al., on Point-of-care testing in ED patients suspected of ACS showed that of 568 hospitals and of 67,058 patients, differences existed in how hospitals utilized PoCT-cTn and the resultant intervention provided. High PoCT-cTn usage hospitals were less likely to give aspirin, [beta]-blockers and heparin within the first 24 hours of admission. Patients with positive PoCT-cTn had fewer electrocardiograms within 10 minutes, but were more likely to be administered aspirin, [beta]-blockers, glycoprotein IIb/IIIa inhibitors and heparin within 24 hours of arrival. They received fewer in-hospital and interventional procedures and had more adverse clinical events. This study showed negative outcomes of PoCT-cTn technology in triage and risk stratification of chest pain patients.43
In general, PoCT-cTn has been advocated by the guidelines for ACS and some studies have informed positive outcomes in clinical practice from its utilization. Within the literature, negative findings were also reported, yet there is no systematic review looking into whether PoCT-cTn improves the evidence-based practice (EBP) of chest pain patients suspected of ACS either in tertiary hospitals or country hospitals. Therefore, this review will be performed to pool evidence regarding the effect of PoCT-cTn on chest pain patients, determining the association of PoCT-cTn and the management of chest pain suspected ACS patients, focusing on timely diagnosis and triage, time to percutaneous coronary intervention (PCI) or fibrinolysis and length of stay in the ED.
Article Content
Inclusion criteria
Types of participants
Chest pain patients (no age limits) presenting to the ED or outpatient clinics, regardless of geographical locations (metropolitan or rural and remote).
Types of intervention:
This review will consider studies that investigate the use of the PoCT-cTn alone or in combination with other testing evaluating timely diagnosis of ACS, triage and risk stratification, intervention decision making and length of stay in the ED, either in routine clinical practice or in intervention trials
Comparator:
Clients who were not provided with rapid PoCT-cTn.
Types of outcomes
Primary outcomes:
* Compliance with the management of guidelines of ACS
* Time to triage/risk stratification of chest pain /ACS and time in the ED
Secondary outcomes:
* Diagnostic accuracy of a point-of-care troponin
* The proportion of patients successfully discharged home
* Mortality of ACS
Types of studies
This review will consider published quantitative studies having experimental and epidemiological study designs, including randomized controlled trials (RCTs), non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies, which evaluate the effect of PoCT-cTn.
Search strategy
The search strategy aims to find peer-reviewed published studies. A three-step search strategy for databases will be used and has been adapted from the Joanna Briggs Institute Reviewers' Manual (2011 edition) guidelines: (1) a limited search of MEDLINE and CINAHL will be undertaken followed by analysis of text words in the title and abstract, and of the index terms used to describe the article; (2) searching across all databases using all identified key words and index terms; (3) searching the reference lists of all identified reports and articles for additional studies.44 Studies published in English and up to August 2014 will be considered for inclusion in this review.
The databases to be searched include CINAHL, MEDLINE, EMBASE, the Web of Knowledge, PubMed, Cochrane Library, ProQuest, JBI, Web of Science, Google Scholar, AgeINFO (for literature related to older people), and the reference lists of included articles to find any other relevant studies. If there is any unclear information from the articles, an attempt will be made to contact authors for further information.
To ensure a broad range of research is reviewed, the search will also include the following websites:
http://www.ncbi.nlm.nih.gov/
http://www.nhmrc.gov.au/nics/asp/index.asp;
http:trove.nla.gov.au
http://www.sciencedirect.com
All studies retrieved will be screened and the full text of studies that potentially meet the inclusion criteria will be obtained.45 Final decisions will be made after reading the full-text of articles.
Exclusion criteria
This review will exclude all unpublished studies (there should be caution when including them in summaries of the evidence), due to unpublished studies commonly showing discrepancies between abstract results and subsequent full-length publication results.46 Also, this review will exclude publications that were published in languages other than English as no facilities are available for translation needs. Furthermore, this review will exclude all qualitative studies on this topic as the aim of this study is to evaluate the effectiveness of PoCT-cTn.
The search terms to be used will include:
The initial terms are to be used and include chest pain, acute coronary syndrome and Point-of-Care testing of Troponin. Following the initial search, more terms are to be applied including: chest pain, acute coronary syndrome; coronary syndrome, acute, syndromes, acute coronary, myocardial infarct, acute myocardial infarction, myocardial ischemia, coronary artery disease, cardiovascular disease, bedside testing, point-of-care systems, Troponin, Troponin I, Troponin T, Point-of-Care testing of Troponin, clinical laboratory techniques, biological markers, diagnosis, evidence based practice, triage, risk stratification, and length of stay.
Assessment of methodological quality
All quantitative papers on PoCT-cTn in chest pain/ACS patients selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with the third reviewer.
Data collection
Data will be extracted from individual studies. Information on the characteristics of participants, interventions and outcomes will be recorded on a standardized data extraction tool from JBI-MAStARI (Appendix II). In addition, aspects of trial methods will be categorized as RCTs (methods of RCTs and their allocation concealment, use of blinded outcome assessment, intention-to-diagnosis and intention-to-triage, reporting of ACS patient management outcomes), non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case-control studies and analytical cross sectional studies. The data extracted will include specific interventions, populations, study methods and outcomes of significance to the review question and specific objectives. If this is insufficient for analyzing variations of data, subgroup data of settings (ED, outpatient clinics) and populations (aged <65 and aged >= 65) will be considered.
Data synthesis
Quantitative papers will, where possible, be pooled in statistical meta-analysis using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument. Odds ratios (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed using the standard Chi-square. Where statistical pooling is not possible, the findings will be presented in narrative form.
Conflicts of interest:
No conflict of interest is known.
Acknowledgements
No external funding is involved in this review.
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Appendix I: Appraisal instruments
MAStARI appraisal instrument[Context Link]
Appendix II: Data extraction instruments
MAStARI data extraction instrument[Context Link]
Keywords: Chest pain; Acute coronary syndrome (ACS); Point-of-Care testing; Troponin; Diagnosis; Evidence based practice; Triage; Risk stratification; Length of stay; Cardiac pain; Heart Pain; Myocardial Infarction and Heart attack.