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1.
Emerg Med J ; 37(1): 2-7, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31719104

RESUMO

BACKGROUND: Emergency physicians frequently assess risk of acute cardiac events (ACEs) in patients with undifferentiated chest pain. Such estimates have been shown to have moderate to high sensitivity for ACE but are conservative. Little is known about the factors implicitly used by physicians to determine the pretest probability of risk. This study sought to identify the accuracy of physician risk estimates for ACE in patients presenting to the ED with chest pain and to identify the demographic and clinical information emergency physicians use in their determination of patient risk. METHODS: This study used data from two prospective studies of consenting adult patients presenting to the ED with symptoms of possible acute coronary syndrome. ED physicians estimated the pretest probability of ACE. Multiple linear regression analysis was used to identify predictors of physician risk estimates. Logistic regression was used to determine whether there was a correlation between physicians' estimated risk and ACE. RESULTS: Increasing age, male sex, abnormal ECG features, heavy/crushing chest pain and risk factors were correlated with physician risk estimates. Physician risk estimates were consistently found to be higher than the expected proportion of ACE from the sampled population. CONCLUSION: Physicians systematically overestimate ACE risk. A range of factors are associated with physician risk estimates. These include factors strongly predictive of ACE, such as age and ECG characteristics. They also include other factors that have been shown to be unreliable predictors of ACE in an ED setting, such as typicality of pain and risk factors.

2.
BMJ Open ; 9(11): e029360, 2019 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-31678937

RESUMO

OBJECTIVES: We aimed to estimate the annual pharmaceutical costs for patients with stable coronary artery disease, using Australian administrative data, comparing patients who had undergone interventional treatment with those had not. We also aimed to compare the duration of dual antiplatelet therapy (DAPT) prescription in the real-world, with recommended guidelines. DESIGN: An observational study using administrative data. PARTICIPANTS: We used data from the QSkin study, a population-based prospective study assessing skin cancer risk. Participants were invited from the Queensland population, not based on perceived skin cancer risk, and had consented to future use of their data for approved research projects. MAIN OUTCOME MEASURES: We calculated 12-month costs of pharmaceutical therapy for coronary artery disease for patients in each of three clinically relevant groups: medical therapy only, following coronary stent implantation and following coronary artery bypass graft surgery. We measured the duration of DAPT following stent implantation and total duration of DAPT, where it was prescribed, in the medical therapy only group. RESULTS: Estimated mean annual pharmaceutical costs were highest in the stent group at AUD$1920, compared with AUD$1481 in the medical therapy group, and AUD$881 in the coronary artery bypass group. There were similar rates of prescriptions of symptom relief drugs following stent insertion, compared with the medical therapy only group. The median duration of DAPT in the stent group was 16, and 31 months in the medical therapy group. CONCLUSIONS: Our results suggest that despite the common expectation that the burden of medical therapy is reduced following coronary stent insertion for stable coronary artery disease, this does not occur in practice. Many patients also appear to continue DAPT longer than guidelines recommend, which may put them at unnecessarily elevated risk of bleeding events.

3.
Clin Chem ; 65(11): 1437-1447, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31570634

RESUMO

BACKGROUND: We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay. METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion. RESULTS: AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration <4 ng/L in patients with an onset of chest pain >3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration <5 ng/L and an absolute change within 2 h <5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3-100) and sensitivity of 99.4% (95% CI, 96.5-99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1-79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3-100) and sensitivity of 97.7% (95% CI, 92.0-99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8-86) in the validation cohort. CONCLUSIONS: Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high. TRIAL REGISTRATION: APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.

5.
N Engl J Med ; 380(26): 2529-2540, 2019 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-31242362

RESUMO

BACKGROUND: Data regarding high-sensitivity troponin concentrations in patients presenting to the emergency department with symptoms suggestive of myocardial infarction may be useful in determining the probability of myocardial infarction and subsequent 30-day outcomes. METHODS: In 15 international cohorts of patients presenting to the emergency department with symptoms suggestive of myocardial infarction, we determined the concentrations of high-sensitivity troponin I or high-sensitivity troponin T at presentation and after early or late serial sampling. The diagnostic and prognostic performance of multiple high-sensitivity troponin cutoff combinations was assessed with the use of a derivation-validation design. A risk-assessment tool that was based on these data was developed to estimate the risk of index myocardial infarction and of subsequent myocardial infarction or death at 30 days. RESULTS: Among 22,651 patients (9604 in the derivation data set and 13,047 in the validation data set), the prevalence of myocardial infarction was 15.3%. Lower high-sensitivity troponin concentrations at presentation and smaller absolute changes during serial sampling were associated with a lower likelihood of myocardial infarction and a lower short-term risk of cardiovascular events. For example, high-sensitivity troponin I concentrations of less than 6 ng per liter and an absolute change of less than 4 ng per liter after 45 to 120 minutes (early serial sampling) resulted in a negative predictive value of 99.5% for myocardial infarction, with an associated 30-day risk of subsequent myocardial infarction or death of 0.2%; a total of 56.5% of the patients would be classified as being at low risk. These findings were confirmed in an external validation data set. CONCLUSIONS: A risk-assessment tool, which we developed to integrate the high-sensitivity troponin I or troponin T concentration at emergency department presentation, its dynamic change during serial sampling, and the time between the obtaining of samples, was used to estimate the probability of myocardial infarction on emergency department presentation and 30-day outcomes. (Funded by the German Center for Cardiovascular Research [DZHK]; ClinicalTrials.gov numbers, NCT00470587, NCT02355457, NCT01852123, NCT01994577, and NCT03227159; and Australian New Zealand Clinical Trials Registry numbers, ACTRN12611001069943, ACTRN12610000766011, ACTRN12613000745741, and ACTRN12611000206921.).


Assuntos
Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico , Medição de Risco/métodos , Troponina/sangue , Adulto , Idoso , Biomarcadores/sangue , Estudos de Coortes , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Sensibilidade e Especificidade , Troponina I/sangue
6.
Heart ; 105(20): 1559-1567, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31142594

RESUMO

OBJECTIVE: Patients with suspected acute myocardial infarction (AMI) in the setting of left bundle branch block (LBBB) present an important diagnostic and therapeutic challenge to the clinician. METHODS: We prospectively evaluated the incidence of AMI and diagnostic performance of specific ECG and high-sensitivity cardiac troponin (hs-cTn) criteria in patients presenting with chest discomfort to 26 emergency departments in three international, prospective, diagnostic studies. The final diagnosis of AMI was centrally adjudicated by two independent cardiologists according to the universal definition of myocardial infarction. RESULTS: Among 8830 patients, LBBB was present in 247 (2.8%). AMI was the final diagnosis in 30% of patients with LBBB, with similar incidence in those with known LBBB versus those with presumably new LBBB (29% vs 35%, p=0.42). ECG criteria had low sensitivity (1%-12%) but high specificity (95%-100%) for AMI. The diagnostic accuracy as quantified by the receiver operating characteristics (ROC) curve of hs-cTnT and hs-cTnI concentrations at presentation (area under the ROC curve (AUC) 0.91, 95% CI 0.85 to 0.96 and AUC 0.89, 95% CI 0.83 to 0.95), as well as that of their 0/1-hour and 0/2-hour changes, was very high. A diagnostic algorithm combining ECG criteria with hs-cTnT/I concentrations and their absolute changes at 1 hour or 2 hours derived in cohort 1 (45 of 45(100%) patients with AMI correctly identified) showed high efficacy and accuracy when externally validated in cohorts 2 and 3 (28 of 29 patients, 97%). CONCLUSION: Most patients presenting with suspected AMI and LBBB will be found to have diagnoses other than AMI. Combining ECG criteria with hs-cTnT/I testing at 0/1 hour or 0/2 hours allows early and accurate diagnosis of AMI in LBBB. TRIAL REGISTRATION NUMBER: APACE: NCT00470587; ADAPT: ACTRN12611001069943; TRAPID-AMI: RD001107;Results.

7.
Eur Heart J ; 40(47): 3848-3855, 2019 Dec 14.
Artigo em Inglês | MEDLINE | ID: mdl-30907409

RESUMO

AIMS: Reducing maternal mortality is a World Health Organization (WHO) global health goal. Although maternal deaths due to haemorrhage and infection are declining, those related to heart disease are increasing and are now the most important cause in western countries. The aim is to define contemporary diagnosis-specific outcomes in pregnant women with heart disease. METHODS AND RESULTS: From 2007 to 2018, pregnant women with heart disease were prospectively enrolled in the Registry Of Pregnancy And Cardiac disease (ROPAC). Primary outcome was maternal mortality or heart failure, secondary outcomes were other cardiac, obstetric, and foetal complications. We enrolled 5739 pregnancies; the mean age was 29.5. Prevalent diagnoses were congenital (57%) and valvular heart disease (29%). Mortality (overall 0.6%) was highest in the pulmonary arterial hypertension (PAH) group (9%). Heart failure occurred in 11%, arrhythmias in 2%. Delivery was by Caesarean section in 44%. Obstetric and foetal complications occurred in 17% and 21%, respectively. The number of high-risk pregnancies (mWHO Class IV) increased from 0.7% in 2007-2010 to 10.9% in 2015-2018. Determinants for maternal complications were pre-pregnancy heart failure or New York Heart Association >II, systemic ejection fraction <40%, mWHO Class 4, and anticoagulants use. After an increase from 2007 to 2009, complication rates fell from 13.2% in 2010 to 9.3% in 2017. CONCLUSION: Rates of maternal mortality or heart failure were high in women with heart disease. However, from 2010, these rates declined despite the inclusion of more high-risk pregnancies. Highest complication rates occurred in women with PAH.

8.
Int J Cardiol ; 282: 93-98, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30745254

RESUMO

Cardiac troponin is a sensitive and specific biomarker for acute myocardial injury and has been used in the diagnosis of acute coronary syndromes, and has emerged as a tool for identifying high risk individuals for primary preventive therapy. Recent evidence has emerged indicating that high-sensitivity cardiac troponin assays, which allow robust detection of very low troponin concentrations, could detect subclinical injury in asymptomatic patients. On 24 March 2018, a group of cardiologists from the Asia Pacific region convened to review the data and discuss the potential utility of high-sensitivity troponin I (hsTnI) in the risk assessment of cardiovascular disease in the general population. The group recognized the immense burden of cardiovascular disease in the Asia-Pacific region, and the limitations of current risk stratification strategies. Data demonstrates that cardiac biomarkers like hsTnI could improve risk stratification, and thresholds for hsTnI in cardiovascular disease risk classification have been developed in Caucasian populations but not validated in Asian populations. There is an urgent need to improve cardiovascular risk assessment in the Asia Pacific general population, validate the Asian threshold of high risk and prove the utility of targeting these high-risk individuals for primary preventive strategies.


Assuntos
Doenças Assintomáticas/epidemiologia , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/epidemiologia , Troponina I/sangue , Ásia/epidemiologia , Biomarcadores/sangue , Humanos , Oceano Pacífico/epidemiologia , Medição de Risco , Fatores de Risco
9.
BMJ Open ; 8(9): e022755, 2018 09 28.
Artigo em Inglês | MEDLINE | ID: mdl-30269070

RESUMO

OBJECTIVE: Cardiac disease in pregnancy is a leading cause of maternal death in high-income countries. Evidence-based guidelines to assist in planning and managing the healthcare of affected women is lacking. The objective of this research was to produce the first qualitative metasynthesis of the experiences of pregnant women with existing or acquired cardiac disease to inform improved healthcare services. METHOD: We conducted a systematic search of peer-reviewed publications in five databases to investigate the decision-making processes, supportive strategies and healthcare experiences of pregnant women with existing or acquired cardiac disease, or of affected women contemplating pregnancy. Identified publications were screened for duplication and eligibility against selection criteria, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We then undertook a thematic analysis of the data relating to women's experiences extracted from each publication to inform new healthcare practices and communication. RESULTS: Eleven studies from six countries were included in our meta-synthesis. Four themes were revealed. Women with congenital and acquired heart disease identified situations where they had either taken charge of decision-making, lacked control or experienced emotional uncertainty when making decisions. Some women were risk aware and determined to take care of themselves in pregnancy while others downplayed the risks. Women with heart disease acknowledged the importance of specific social support measures during pregnancy and after child birth, and reported a spectrum of healthcare experiences. CONCLUSIONS: There is a lack of integrated and tailored healthcare services and information for women with cardiac disease in pregnancy. The experiences of women synthesised in this research has the potential to inform new evidence-based guidelines to support the decision-making needs of women with cardiac disease in pregnancy. Shared decision-making must consider communication across the clinical team. However, coordinated care is challenging due to the different specialists involved and the limited clinical evidence concerning effective approaches to managing such complex care.


Assuntos
Cardiopatias/psicologia , Complicações Cardiovasculares na Gravidez/psicologia , Tomada de Decisões , Medo , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Necessidades e Demandas de Serviços de Saúde , Humanos , Participação do Paciente , Autonomia Pessoal , Gravidez , Autocuidado , Apoio Social , Incerteza
10.
CMAJ ; 190(33): E974-E984, 2018 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-30127037

RESUMO

BACKGROUND: Testing for high-sensitivity cardiac troponin (hs-cTn) may assist triage and clinical decision-making in patients presenting to the emergency department with symptoms of acute coronary syndrome; however, this could result in the misclassification of risk because of analytical variation or laboratory error. We sought to evaluate a new laboratory-based risk-stratification tool that incorporates tests for hs-cTn, glucose level and estimated glomerular filtration rate to identify patients at risk of myocardial infarction or death when presenting to the emergency department. METHODS: We constructed the clinical chemistry score (CCS) (range 0-5 points) and validated it as a predictor of 30-day myocardial infarction (MI) or death using data from 4 cohort studies involving patients who presented to the emergency department with symptoms suggestive of acute coronary syndrome. We calculated diagnostic parameters for the CCS score separately using high-sensitivity cardiac troponin I (hs-cTnI) and high-sensitivity cardiac troponin T (hs-cTnT). RESULTS: For the combined cohorts (n = 4245), 17.1% of participants had an MI or died within 30 days. A CCS score of 0 points best identified low-risk participants: the hs-cTnI CCS had a sensitivity of 100% (95% confidence interval [CI] 99.5%-100%), with 8.9% (95% CI 8.1%-9.8%) of the population classified as being at low risk of MI or death within 30 days; the hs-cTnT CCS had a sensitivity of 99.9% (95% CI 99.2%-100%), with 10.5% (95% CI 9.6%-11.4%) of the population classified as being at low risk. The CCS had better sensitivity than hs-cTn alone (hs-cTnI < 5 ng/L: 96.6%, 95% CI 95.0%-97.8%; hs-cTnT < 6 ng/L: 98.2%, 95% CI 97.0%-99.0%). A CCS score of 5 points best identified patients at high risk (hs-cTnI CCS: specificity 96.6%, 95% CI 96.0%-97.2%; 11.2% [95% CI 10.3%-12.2%] of the population classified as being at high risk; hs-cTnT CCS: specificity 94.0%, 95% CI 93.1%-94.7%; 13.1% [95% CI 12.1%-14.1%] of the population classified as being at high risk) compared with using the overall 99th percentiles for the hs-cTn assays (specificity of hs-cTnI 93.2%, 95% CI 92.3-94.0; specificity of hs-cTnT 73.8%, 95% CI 72.3-75.2). INTERPRETATION: The CCS score at the chosen cut-offs was more sensitive and specific than hs-cTn alone for risk stratification of patients presenting to the emergency department with suspected acute coronary syndrome. Study registration: ClinicalTrials.gov, nos. NCT01994577; NCT02355457.


Assuntos
Síndrome Coronariana Aguda/diagnóstico , Técnicas de Laboratório Clínico , Miocárdio/química , Troponina I/análise , Troponina T/análise , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/fisiopatologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Glicemia/análise , Morte , Serviço Hospitalar de Emergência , Feminino , Taxa de Filtração Glomerular , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Valor Preditivo dos Testes , Estudos Prospectivos , Fatores de Tempo
11.
PLoS One ; 13(7): e0198658, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29965967

RESUMO

BACKGROUND: Group A streptococcus (GAS) is a serious human pathogen that affects people of different ages and socio-economic levels. Although vaccination is potentially one of the most effective methods to control GAS infection and its sequelae, few prototype vaccines have been investigated in humans. In this study, we report the safety and immunogenicity of a novel acetylated peptide-protein conjugate vaccine candidate MJ8VAX (J8-DT), when delivered intramuscularly to healthy adults. METHODS: A randomized, double-blinded, controlled Phase I clinical trial was conducted in 10 healthy adult participants. Participants were randomized 4:1 to receive the vaccine candidate (N = 8) or placebo (N = 2). A single dose of the vaccine candidate (MJ8VAX), contained 50 µg of peptide conjugate (J8-DT) adsorbed onto aluminium hydroxide and re-suspended in PBS in a total volume of 0.5 mL. Safety of the vaccine candidate was assessed by monitoring local and systemic adverse reactions following intramuscular administration. The immunogenicity of the vaccine was assessed by measuring the levels of peptide (anti-J8) and toxoid carrier (anti-DT)-specific antibodies in serum samples. RESULTS: No serious adverse events were reported over 12 months of study. A total of 13 adverse events (AEs) were recorded, two of which were assessed to be associated with the vaccine. Both were mild in severity. No local reactogenicity was recorded in any of the participants. MJ8VAX was shown to be immunogenic, with increase in vaccine-specific antibodies in the participants who received the vaccine. The maximum level of vaccine-specific antibodies was detected at 28 days post immunization. The level of these antibodies decreased with time during follow-up. Participants who received the vaccine also had a corresponding increase in anti-DT serum antibodies. CONCLUSIONS: Intramuscular administration of MJ8VAX was demonstrated to be safe and immunogenic. The presence of DT in the vaccine formulation resulted in a boost in the level of anti-DT antibodies. TRIAL REGISTRATION: ACTRN12613000030774.


Assuntos
Infecções Estreptocócicas/tratamento farmacológico , Vacinas Estreptocócicas/administração & dosagem , Vacinação/efeitos adversos , Vacinas Conjugadas/administração & dosagem , Adolescente , Adulto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infecções Estreptocócicas/imunologia , Infecções Estreptocócicas/microbiologia , Vacinas Estreptocócicas/efeitos adversos , Streptococcus pyogenes/efeitos dos fármacos , Streptococcus pyogenes/patogenicidade , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia
12.
Clin Chem ; 64(7): 1044-1053, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29760219

RESUMO

BACKGROUND: Increased cardiac troponin I or T detected by high-sensitivity assays (hs-cTnI or hs-cTnT) confers an increased risk of adverse prognosis. We determined whether patients presenting with putatively normal, detectable cTn concentrations [> limit of detection and < upper reference limit (URL)] have increased risk of major adverse cardiovascular events (MACE) or all-cause mortality. METHODS: A prospective 5-year follow-up of patients recruited in the emergency department with possible acute coronary syndrome (ACS) and cTn concentrations measured with hs-cTnI (Abbott) and hs-cTnT (Roche) assays. Cox regression models were generated with adjustment for covariates in those without MACE on presentation. Hazard ratios (HRs) for hs-cTn were calculated relative to the HRs at the median concentration. RESULTS: Of 1113 patients, 836 were without presentation MACE. Of these, 138 incurred a MACE and 169 died during a median 5.8-year follow-up. HRs for MACE at the URLs were 2.3 (95% CI, 1.7-3.2) for hs-cTnI and 1.8 (95% CI, 1.3-2.4) for hs-cTnT. Corresponding HRs for mortality were 1.7 (95% CI, 1.2-2.2) for hs-cTnI and 2.3 (95 % CI, 1.7-3.1) for hs-cTnT. The HR for MACE increased with increasing hs-cTn concentration similarly for both assays, but the HR for mortality increased at approximately twice the rate for hs-cTnT than hs-cTnI. Patients with hs-cTnI ≥10 ng/L or hs-cTnT ≥16 ng/L had the same percentage of MACE at 5-year follow-up (33%) as patients with presentation MACE. CONCLUSIONS: Many patients with ACS ruled out and putatively normal but detectable hs-cTnI concentrations are at similar long-term risk as those with MACE. hs-cTnT concentrations are more strongly associated with 5-year mortality than hs-cTnI.


Assuntos
Troponina I/sangue , Troponina T/sangue , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/diagnóstico , Humanos , Limite de Detecção , Padrões de Referência , Fatores de Risco
13.
Circulation ; 138(10): 989-999, 2018 09 04.
Artigo em Inglês | MEDLINE | ID: mdl-29691270

RESUMO

BACKGROUND: Combining 2 signals of cardiomyocyte injury, cardiac troponin I (cTnI) and T (cTnT), might overcome some individual pathophysiological and analytical limitations and thereby increase diagnostic accuracy for acute myocardial infarction with a single blood draw. We aimed to evaluate the diagnostic performance of combinations of high-sensitivity (hs) cTnI and hs-cTnT for the early diagnosis of acute myocardial infarction. METHODS: The diagnostic performance of combining hs-cTnI (Architect, Abbott) and hs-cTnT (Elecsys, Roche) concentrations (sum, product, ratio, and a combination algorithm) obtained at the time of presentation was evaluated in a large multicenter diagnostic study of patients with suspected acute myocardial infarction. The optimal rule-out and rule-in thresholds were externally validated in a second large multicenter diagnostic study. The proportion of patients eligible for early rule-out was compared with the European Society of Cardiology 0/1 and 0/3 hour algorithms. RESULTS: Combining hs-cTnI and hs-cTnT concentrations did not consistently increase overall diagnostic accuracy as compared with the individual isoforms. However, the combination improved the proportion of patients meeting criteria for very early rule-out. With the European Society of Cardiology 2015 guideline recommended algorithms and cut-offs, the proportion meeting rule-out criteria after the baseline blood sampling was limited (6% to 24%) and assay dependent. Application of optimized cut-off values using the sum (9 ng/L) and product (18 ng2/L2) of hs-cTnI and hs-cTnT concentrations led to an increase in the proportion ruled-out after a single blood draw to 34% to 41% in the original (sum: negative predictive value [NPV] 100% [95% confidence interval (CI), 99.5% to 100%]; product: NPV 100% [95% CI, 99.5% to 100%]) and in the validation cohort (sum: NPV 99.6% [95% CI, 99.0-99.9%]; product: NPV 99.4% [95% CI, 98.8-99.8%]). The use of a combination algorithm (hs-cTnI <4 ng/L and hs-cTnT <9 ng/L) showed comparable results for rule-out (40% to 43% ruled out; NPV original cohort 99.9% [95% CI, 99.2-100%]; NPV validation cohort 99.5% [95% CI, 98.9-99.8%]) and rule-in (positive predictive value [PPV] original cohort 74.4% [95% Cl, 69.6-78.8%]; PPV validation cohort 84.0% [95% Cl, 79.7-87.6%]). CONCLUSIONS: New strategies combining hs-cTnI and hs-cTnT concentrations may significantly increase the number of patients eligible for very early and safe rule-out, but do not seem helpful for the rule-in of acute myocardial infarction. CLINICAL TRIAL REGISTRATION: URL (APACE): https://www.clinicaltrial.gov . Unique identifier: NCT00470587. URL (ADAPT): www.anzctr.org.au . Unique identifier: ACTRN12611001069943.


Assuntos
Infarto do Miocárdio/diagnóstico , Troponina I/sangue , Troponina T/sangue , Austrália , Biomarcadores/sangue , Diagnóstico Precoce , Europa (Continente) , Humanos , Infarto do Miocárdio/sangue , Nova Zelândia , Valor Preditivo dos Testes , Estudos Prospectivos , Reprodutibilidade dos Testes , Fatores de Tempo , Regulação para Cima
14.
Clin Chem ; 64(5): 820-829, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29419380

RESUMO

BACKGROUND: Low concentrations of cardiac troponin (cTn) have been recommended for rapid rule-out of acute myocardial infarction (AMI). We examined the Beckman Coulter Access high-sensitivity cardiac troponin I (hs-cTnI) assay to identify a single test threshold that can safely rule out AMI. METHODS: This analysis used stored samples collected in 2 prospective observational studies. In all, 1871 patients presenting to a tertiary emergency department with symptoms of acute coronary syndrome had blood taken for measurement of cTnI on presentation. The endpoint was type 1 myocardial infarction (T1MI). Sensitivity and negative predictive value (NPV) were calculated for hs-cTnI values below the 99th percentile. RESULTS: Ninety-eight patients had T1MI (5.2%), and 638 (34.1%) patients had an hs-cTnI <2 ng/L (limit of detection), with sensitivity of 99.0% (95% CI, 94.4%-100%) and NPV of 99.8% (95% CI, 99.1%-100%). No hs-cTnI value above a concentration of 2 ng/L achieved sensitivity of 99%. However, an NPV of 99.5% was achieved at values <6 ng/L. A cutoff <6 ng/L enabled 1475 (78.8%) patients to be ruled out on presentation with sensitivity of 93.9% (95% CI, 87.1%-97.7%). CONCLUSIONS: A single baseline cTn <2 ng/L measured with the Access hs-cTnI assay performed well for rule-out of AMI. This cutoff concentration identified 99% of patients with AMI and could reduce the number of patients requiring lengthy assessment. A cutoff of <6 ng/L yielded a high NPV but missed more cases of AMI than would be acceptable to clinicians.


Assuntos
Infarto do Miocárdio/diagnóstico , Troponina I/sangue , Adulto , Feminino , Humanos , Masculino , Infarto do Miocárdio/sangue , Sensibilidade e Especificidade , Adulto Jovem
15.
Clin Biochem ; 52: 161-163, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29054440

RESUMO

OBJECTIVE: To externally validate a clinical decision rule incorporating heart fatty acid binding protein (h-FABP), high-sensitivity troponin (hs-cTn) and electrocardiogram (ECG) for the detection of acute myocardial infarction (AMI) on presentation to the Emergency Department. We also investigated whether this clinical decision rule improved identification of AMI over algorithms incorporating hs-cTn and ECG only. DESIGN AND METHODS: This study included data from 789 patients from the Brisbane ADAPT cohort and 441 patients from the Christchurch TIMI RCT cohort. The primary outcome was index AMI. Sensitivity, specificity, positive predictive value and negative predictive value were used to assess the diagnostic accuracy of the algorithms. RESULTS: 1230 patients were recruited, including 112 (9.1%) with AMI. The algorithm including h-FABP and hs-cTnT had 100% sensitivity and 32.4% specificity. The algorithm utilising h-FABP and hs-cTnI had similar sensitivity (99.1%) and higher specificity (43.4%). The hs-cTnI and hs-cTnT algorithms without h-FABP both had a sensitivity of 98.2%; a result that was not significantly different from either algorithm incorporating h-FABP. Specificity was higher for the hs-cTnI algorithm (68.1%) compared to the hs-cTnT algorithm (33.0%). The specificity of the algorithm incorporating hs-cTnI alone was also significantly higher than both of the algorithms incorporating h-FABP (p<0.01). CONCLUSION: For patients presenting to the Emergency Department with chest pain, an algorithm incorporating h-FABP, hs-cTn and ECG has high accuracy and can rule out up to 40% of patients. An algorithm incorporating only hs-cTn and ECG has similar sensitivity and may rule out a higher proportion of patients. Each of the algorithms can be used to safely identify patients as low risk for AMI on presentation to the Emergency Department.


Assuntos
Proteína 3 Ligante de Ácido Graxo/análise , Infarto do Miocárdio/diagnóstico , Idoso , Algoritmos , Biomarcadores , Dor no Peito/diagnóstico , Eletrocardiografia/métodos , Serviço Hospitalar de Emergência , Proteína 3 Ligante de Ácido Graxo/sangue , Proteínas de Ligação a Ácido Graxo/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Infarto do Miocárdio/metabolismo , Valor Preditivo dos Testes , Estudos Prospectivos , Sensibilidade e Especificidade , Troponina/análise , Troponina/sangue , Troponina I/sangue , Troponina T/sangue
16.
Acad Emerg Med ; 25(4): 434-443, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29131477

RESUMO

OBJECTIVES: Early discharge of patients with presentations triggering assessment for possible acute coronary syndrome (ACS) is safe when clinical assessment indicates low risk, biomarkers are negative, and electrocardiograms (ECGs) are nonischemic. We hypothesized that the Emergency Department Assessment of Chest Pain Score (EDACS) combined with a single measurement of high-sensitivity cardiac troponin (hs-cTn) could allow early discharge of a clinically meaningful proportion of patients. METHODS: We pooled data from four patient cohorts from New Zealand and Australia presenting to an emergency department with symptoms suggestive of ACS. The primary outcome was major adverse cardiac events (MACE) within 30 days of presentation. In patients with a nonischemic ECG we evaluated the sensitivity for MACE and percentage low risk of every combination of high-sensitivity cardiac troponin T (hs-cTnT) concentration and high-sensitivity cardiac troponin I (hs-cTnI) concentration with EDACS. We used a standard smoothing technique on the probability density function for hs-cTn and EDACS and applied bootstrapping to determine the optimal threshold combinations, namely, the combination that maximized the percentage low risk with ≥98.5% sensitivity for MACE. RESULTS: From 2,536 patients, 2,258 presented without an ischemic ECG of whom 272 (12.1%) had a MACE within 30 days. The optimal threshold for hs-cTnI was 7 ng/L combined with an EDACS threshold of 16 (36.8% patients low risk). The optimal thresholds for hs-cTnT were 8 ng/L combined with an EDACS threshold of 15 (30.2% patients low risk). CONCLUSION: Single measurements of both hs-cTnI and hs-cTnT at presentation combined with EDACS to identify over 30% of patients as low risk and therefore eligible for safe early discharge after only one blood draw.


Assuntos
Dor no Peito/diagnóstico , Técnicas de Apoio para a Decisão , Serviço Hospitalar de Emergência/organização & administração , Infarto do Miocárdio/diagnóstico , Troponina I/sangue , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Biomarcadores , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia/epidemiologia , Alta do Paciente , Estudos Prospectivos , Medição de Risco , Troponina T/sangue , Adulto Jovem
17.
Circulation ; 137(4): 354-363, 2018 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-29138293

RESUMO

BACKGROUND: Efforts to safely reduce length of stay for emergency department patients with symptoms suggestive of acute coronary syndrome (ACS) have had mixed success. Few system-wide efforts affecting multiple hospital emergency departments have ever been evaluated. We evaluated the effectiveness of a nationwide implementation of clinical pathways for potential ACS in disparate hospitals. METHODS: This was a multicenter pragmatic stepped-wedge before-and-after trial in 7 New Zealand acute care hospitals with 31 332 patients investigated for suspected ACS with serial troponin measurements. The implementation was a clinical pathway for the assessment of patients with suspected ACS that included a clinical pathway document in paper or electronic format, structured risk stratification, specified time points for electrocardiographic and serial troponin testing within 3 hours of arrival, and directions for combining risk stratification and electrocardiographic and troponin testing in an accelerated diagnostic protocol. Implementation was monitored for >4 months and compared with usual care over the preceding 6 months. The main outcome measure was the odds of discharge within 6 hours of presentation RESULTS: There were 11 529 participants in the preimplementation phase (range, 284-3465) and 19 803 in the postimplementation phase (range, 395-5039). Overall, the mean 6-hour discharge rate increased from 8.3% (range, 2.7%-37.7%) to 18.4% (6.8%-43.8%). The odds of being discharged within 6 hours increased after clinical pathway implementation. The odds ratio was 2.4 (95% confidence interval, 2.3-2.6). In patients without ACS, the median length of hospital stays decreased by 2.9 hours (95% confidence interval, 2.4-3.4). For patients discharged within 6 hours, there was no change in 30-day major adverse cardiac event rates (0.52% versus 0.44%; P=0.96). In these patients, no adverse event occurred when clinical pathways were correctly followed. CONCLUSIONS: Implementation of clinical pathways for suspected ACS reduced the length of stay and increased the proportions of patients safely discharged within 6 hours. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au/ (Australian and New Zealand Clinical Trials Registry). Unique identifier: ACTRN12617000381381.


Assuntos
Síndrome Coronariana Aguda/diagnóstico , Serviço Hospitalar de Cardiologia/normas , Procedimentos Clínicos/normas , Serviço Hospitalar de Emergência/normas , Hospitalização , Melhoria de Qualidade/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/terapia , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Tomada de Decisão Clínica , Eletrocardiografia , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Nova Zelândia/epidemiologia , Valor Preditivo dos Testes , Prevalência , Prognóstico , Medição de Risco , Fatores de Risco , Fatores de Tempo , Troponina/sangue
18.
Emerg Med Australas ; 30(1): 47-54, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29232768

RESUMO

OBJECTIVE: To develop a modified Thrombolysis in Myocardial Infarction (TIMI) score to effectively risk stratify patients presenting to the ED with chest pain. METHODS: A prospective observational study was conducted at two metropolitan EDs. Data were obtained during patient interview. The primary outcome was major adverse cardiovascular events (MACE) within 30 days of presentation. Two separate modifications of the TIMI score were developed. These scores were compared to the original TIMI in terms of the area under the receiver operating characteristic curve and diagnostic accuracy statistics (sensitivity, specificity, positive and negative predictive values). RESULTS: Of 1760 patients, 364 (20.7%) experienced 30 day MACE. The first modified TIMI score was a simplified TIMI (s-TIMI) including four variables: age ≥65 years, three or more risk factors, high-sensitivity troponin (hs-cTnI) and electrocardiogram changes. The second score included the same four variables plus two Global Registry of Acute Coronary Events (GRACE) variables (systolic blood pressure and estimated glomerular filtration rate). This score was termed the GRACE TIMI (g-TIMI). s-TIMI had a lower sensitivity compared to the original TIMI score (93.41 and 96.98%), but higher specificity (45.49 and 24.50%). The g-TIMI had a sensitivity of 98.90% and specificity of 14.90%. CONCLUSIONS: Attempts to modify the TIMI score yielded two scores with added predictive utility in comparison to the original TIMI model. The addition of GRACE variables (g-TIMI) increased sensitivity for MACE, but decreased the specificity of the model. The s-TIMI score yielded good specificity but had sensitivity that would not be acceptable by emergency physicians. The s-TIMI may be useful as part of an accelerated chest pain protocol.


Assuntos
Infarto do Miocárdio/classificação , Infarto do Miocárdio/diagnóstico , Medição de Risco/normas , Índice de Gravidade de Doença , Idoso , Biomarcadores/análise , Biomarcadores/sangue , Dor no Peito/complicações , Dor no Peito/diagnóstico , Serviço Hospitalar de Emergência/organização & administração , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Estudos Prospectivos , Medição de Risco/métodos , Fatores de Risco , Triagem/métodos , Troponina I/análise , Troponina I/sangue
19.
Heart ; 104(8): 665-672, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-28864718

RESUMO

OBJECTIVE: We aimed to evaluate the limit of detection of high-sensitivity troponin (hs-cTn) and Thrombolysis In Myocardial Infarction (TIMI) score combination rule-out strategy suggested within the 2016 National Institute for Health and Care Excellence (NICE) Chest Pain of Recent Onset guidelines and establish the optimal TIMI score threshold for clinical use. METHODS: A pooled analysis of adult patients presenting to the emergency department with chest pain and a non-ischaemic ECG, recruited into six prospective studies, from Australia, New Zealand and the UK. We evaluated the sensitivity of TIMI score thresholds from 0 to 2 alongside hs-cTnT or hs-cTnI for the primary outcome of major adverse cardiac events within 30 days. RESULTS: Data were available for 3159 patients for hs-cTnT and 4532 for hs-cTnI, of these 376 (11.9%) and 445 (9.8%) had major adverse cardiac events, respectively. Using a TIMI score of 0, the sensitivity for the primary outcome was 99.5% (95% CI 98.1% to 99.9%) alongside hs-cTnT and 98.9% (97.4% to 99.6%)%) alongside hs-cTnI, identifying 17.9% and 21.0% of patients as low risk, respectively. For a TIMI score ≤1 sensitivity was 98.9% (97.3% to 99.7%)%) alongside hs-cTnT and 98.4% (96.8% to 99.4%)%) alongside hs-cTnI, identifying 28.1% and 35.7% as low risk, respectively. For TIMI≤2, meta-sensitivity was <98% with either assay. CONCLUSIONS: Our findings support the rule-out strategy suggested by NICE. The TIMI score threshold suggested for clinical use is 0. The proportion of patients identified as low risk (18%-21%) and suitable for early discharge using this threshold may be sufficient to encourage change of practice. TRIAL REGISTRATION NUMBERS: ADAPT observational study/IMPACT intervention trial ACTRN12611001069943.ADAPT-ADP randomised controlled trial ACTRN12610000766011. EDACS-ADP randomised controlled trial ACTRN12613000745741. TRUST observational study ISRCTN no. 21109279.


Assuntos
Angina Instável/etiologia , Infarto do Miocárdio/diagnóstico , Troponina/metabolismo , Bioensaio , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Estudos Observacionais como Assunto , Estudos Prospectivos , Queensland , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco/métodos , Sensibilidade e Especificidade
20.
Emerg Med J ; 35(3): 169-175, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28784608

RESUMO

OBJECTIVE: To identify differences in prevalence, demographics, clinical features and outcomes for type 1 myocardial infarction (T1MI) and type 2 myocardial infarction (T2MI) in a cohort of patients presenting to the Emergency Department (ED) with chest pain. METHODS: This was a post hoc analysis of data collected from two prospective studies. Data were collected between November 2008 and February 2011 for the first study, and between February 2011 and March 2014 for the second. Participants were patients presenting to the ED with symptoms suggestive of acute coronary syndrome (ACS). The outcome was 30-day diagnosis; classified into T1MI, T2MI or non-MI. Descriptive statistics were used to compare the demographics, clinical history and presenting symptoms across diagnoses (T1MI, T2MI and non-MI). Cumulative mortality over 1 year was compared for T1MI and T2MI. RESULTS: 147 patients (6.3%; 95% CI 5.3% to 7.3%) were classified as T1MI and 52 (2.2%; 95% CI 1.7% to 2.9%) were classified as T2MI. T2MIs were more likely to be female (OR 4.71, 95% CI 2.28 to 9.76), have an abnormal but non-ischaemic ECG (OR 2.95, 95% CI 1.45 to 6.00), report prior hypertension (OR 2.83, 95% CI 1.35 to 6.12), have tachycardia (OR 9.26, 95% CI 3.08 to 30.77) and pain at rest (OR 3.04, 95% CI 1.28 to 8.02) compared with T1MI. One-year mortality was similar between T1MI and T2MI (9% and 14.6%, respectively, p=0.37). CONCLUSIONS: T2MIs comprised one quarter of all MIs diagnosed in the ED. Among patients presenting to the ED with symptoms of ACS, symptoms do not allow clinicians to reliably differentiate patients with T1MI and T2MI. Prior hypertension, tachycardia and abnormal non-ischaemic ECGs are seen more often in T2MI compared with T1MI. One-year mortality was substantial in patients with T1MI and T2MI, but low power precludes conclusions about mortality differences between groups.


Assuntos
Infarto do Miocárdio/classificação , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/epidemiologia , Adulto , Idoso , Eletrocardiografia/métodos , Serviço Hospitalar de Emergência/organização & administração , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Estudos Prospectivos
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