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INTRODUCTION: Clinical assessment in emergency departments (EDs) for possible acute myocardial infarction (AMI) requires at least one cardiac troponin (cTn) blood test. The turn-around time from blood draw to posting results in the clinical portal for central laboratory analysers is ~1-2 hours. New generation, high-sensitivity, point-of-care cardiac troponin I (POC-cTnI) assays use whole blood on a bedside (or near bedside) analyser that provides a rapid (8 min) result. This may expedite clinical decision-making and reduce length of stay. Our purpose is to determine if utilisation of a POC-cTnI testing reduces ED length of stay. We also aim to establish an optimised implementation process for the amended clinical pathway. METHODS AND ANALYSIS: This quality improvement initiative has a pragmatic multihospital stepped-wedge cross-sectional cluster randomised design. Consecutive patients presenting to the ED with symptoms suggestive of possible AMI and having a cTn test will be included. Clusters (comprising one or two hospitals each) will change from their usual-care pathway to an amended pathway using POC-cTnI-the 'intervention'. The dates of change will be randomised. Changes occur at 1 month intervals, with a minimum 2 month 'run-in' period. The intervention pathway will use a POC-cTnI measurement as an alternate to the laboratory-based cTn measurement. Clinical decision-making steps and logic will otherwise remain unchanged. The POC-cTnI is the Siemens (Erlangen Germany) Atellica VTLi high-sensitivity cTnI assay. The primary outcome is ED length of stay. The safety outcome is cardiac death or AMI within 30 days for patients discharged directly from the ED. ETHICS AND DISSEMINATION: Ethics approval has been granted by the New Zealand Southern Health and Disability Ethics Committee, reference 21/STH/9. Results will be published in a peer-reviewed journal. Lay and academic presentations will be made. Maori-specific results will be disseminated to Maori stakeholders. TRIAL REGISTRATION NUMBER: ACTRN12619001189112.
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Síndrome Coronariana Aguda , Serviço Hospitalar de Emergência , Melhoria de Qualidade , Humanos , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Biomarcadores/sangue , Tomada de Decisão Clínica , Estudos Transversais , Tempo de Internação/estatística & dados numéricos , Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico , Sistemas Automatizados de Assistência Junto ao Leito , Testes Imediatos , Medição de Risco , Troponina I/sangueRESUMO
BACKGROUND AND AIMS: Strategies to assess patients with suspected acute myocardial infarction (AMI) using a point-of-care (POC) high-sensitivity cardiac troponin I (hs-cTnI) assay may expedite emergency care. A 2-h POC hs-cTnI strategy for emergency patients with suspected AMI was derived and validated. METHODS: In two international, multi-centre, prospective, observational studies of adult emergency patients (1486 derivation cohort and 1796 validation cohort) with suspected AMI, hs-cTnI (Siemens Atellica® VTLi) was measured at admission and 2â h later. Adjudicated final diagnoses utilized the hs-cTn assay in clinical use. A risk stratification algorithm was derived and validated. The primary diagnostic outcome was index AMI (Types 1 and 2). The primary safety outcome was 30-day major adverse cardiac events incorporating AMI and cardiac death. RESULTS: Overall, 81 (5.5%) and 88 (4.9%) patients in the derivation and validation cohorts, respectively, had AMI. The 2-h algorithm defined 66.1% as low risk with a sensitivity of 98.8% [95% confidence interval (CI) 89.3%-99.9%] and a negative predictive value of 99.9 (95% CI 99.2%-100%) for index AMI in the derivation cohort. In the validation cohort, 53.3% were low risk with a sensitivity of 98.9% (95% CI 92.4%-99.8%) and a negative predictive value of 99.9% (95% CI 99.3%-100%) for index AMI. The high-risk metrics identified 5.4% of patients with a specificity of 98.5% (95% CI 96.6%-99.4%) and a positive predictive value of 74.5% (95% CI 62.7%-83.6%) for index AMI. CONCLUSIONS: A 2-h algorithm using a POC hs-cTnI concentration enables safe and efficient risk assessment of patients with suspected AMI. The short turnaround time of POC testing may support significant efficiencies in the management of the large proportion of emergency patients with suspected AMI.
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Algoritmos , Infarto do Miocárdio , Troponina I , Humanos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/sangue , Masculino , Feminino , Estudos Prospectivos , Troponina I/sangue , Idoso , Pessoa de Meia-Idade , Sistemas Automatizados de Assistência Junto ao Leito , Biomarcadores/sangue , Medição de Risco/métodos , Sensibilidade e Especificidade , Testes ImediatosRESUMO
BACKGROUND: Single-sample (screening) rule-out of acute myocardial infarction (AMI) with troponin requires derivation of a single-test screening threshold. In data sets with small event numbers, the lowest one or two concentrations of myocardial infarction (MI) patients dictate the threshold. This is not optimal. We aimed to demonstrate a process incorporating both real and synthetic data for deriving such thresholds using a novel pre-production high-precision point-of-care assay. METHODS: cTnI concentrations were measured from thawed plasma using the Troponin I Next (TnI-Nx) assay (i-STAT; Abbott) in adults on arrival to the emergency department with symptoms suggestive of AMI. The primary outcome was an AMI or cardiac death within 30 days. We used internal-external validation with synthetic data production based on clinical and demographic data, plus the measured TnI-Nx concentration, to derive and validate decision thresholds for TnI-Nx. The target low-risk threshold was a sensitivity of 99% and a high-risk threshold specificity of >95%. RESULTS: In total, 1356 patients were included, of whom 191 (14.1%) had the primary outcome. A total of 500 synthetic data sets were constructed. The mean low-risk threshold was determined to be 5â ng/L. This categorized 38% (95% CI, 6%-68%) to low-risk with a sensitivity of 99.0% (95% CI, 98.6%-99.5%) and a negative predictive value of 99.4% (95% CI, 97.6%-99.8%). A similarly derived high-risk threshold of 25â ng/L had a specificity of 95.0% (95% CI, 94.8%-95.1%) and a positive predictive value of 74.8% (95% CI, 71.5%-78.0%). CONCLUSIONS: With the TnI-Nx assay, we successfully demonstrated an approach using synthetic data generation to derive low-risk thresholds for safe and effective screening.
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Serviço Hospitalar de Emergência , Infarto do Miocárdio , Troponina I , Humanos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/sangue , Serviço Hospitalar de Emergência/estatística & dados numéricos , Masculino , Feminino , Troponina I/sangue , Pessoa de Meia-Idade , Idoso , Testes Imediatos , Biomarcadores/sangue , Sistemas Automatizados de Assistência Junto ao Leito , Sensibilidade e Especificidade , Programas de Rastreamento/métodos , Programas de Rastreamento/normasRESUMO
INTRODUCTION: Opioids and imaging are considered low-value care for most people with low back pain. Yet around one in three people presenting to the emergency department (ED) will receive imaging, and two in three will receive an opioid. NUDG-ED aims to determine the effectiveness of two different behavioural 'nudge' interventions on low-value care for ED patients with low back pain. METHODS AND ANALYSIS: NUDG-ED is a 2×2 factorial, open-label, before-after, cluster randomised controlled trial. The trial includes 8 ED sites in Sydney, Australia. Participants will be ED clinicians who manage back pain, and patients who are 18 years or over presenting to ED with musculoskeletal back pain. EDs will be randomly assigned to receive (i) patient nudges, (ii) clinician nudges, (iii) both interventions or (iv) no nudge control. The primary outcome will be the proportion of encounters in ED for musculoskeletal back pain where a person received a non-indicated lumbar imaging test, an opioid at discharge or both. We will require 2416 encounters over a 9-month study period (3-month before period and 6-month after period) to detect an absolute difference of 10% in use of low-value care due to either nudge, with 80% power, alpha set at 0.05 and assuming an intra-class correlation coefficient of 0.10, and an intraperiod correlation of 0.09. Patient-reported outcome measures will be collected in a subsample of patients (n≥456) 1 week after their initial ED visit. To estimate effects, we will use a multilevel regression model, with a random effect for cluster and patient, a fixed effect indicating the group assignment of each cluster and a fixed effect of time. ETHICS AND DISSEMINATION: This study has ethical approval from Southwestern Sydney Local Health District Human Research Ethics Committee (2023/ETH00472). We will disseminate the results of this trial via media, presenting at conferences and scientific publications. TRIAL REGISTRATION NUMBER: ACTRN12623001000695.
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Dor Lombar , Dor Musculoesquelética , Humanos , Analgésicos Opioides/uso terapêutico , Austrália , Serviço Hospitalar de Emergência , Dor Lombar/terapia , Cuidados de Baixo Valor , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem , AdultoRESUMO
OBJECTIVE: We sought to validate the clinical performance of a rapid assessment pathway incorporating the Siemens Atellica IM high sensitivity cardiac troponin I (hs-cTnI) assay in patients presenting to the emergency department (ED) with suspected acute myocardial infarction (AMI). METHODS: This was a multicentre prospective observational study of adult ED patients presenting to five Australian hospitals between November 2020 and September 2021. Participants included those with symptoms of suspected AMI (without ST-segment elevation MI on presentation ECG). The Siemen's Atellica IM hs-cTnI laboratory-based assay was used to measure troponin concentrations at admission and after 2-3 hours and cardiologists adjudicated final diagnoses. The HighSTEACS diagnostic algorithm was evaluated, incorporating hs-cTnI concentrations at presentation and absolute changes within the first 2 to 3 hours. The primary outcome was index AMI, including type 1 or 2 non-ST segment elevation MI (NSTEMI) or ST-elevation MI (STEMI) following presentation. 30-day major adverse cardiac outcomes (including AMI, urgent revascularisation or cardiac death) were also reported. The trial was registered with the Australian and New Zealand Clinical Trials Registry. RESULTS: 1994 patients were included. The average age was 56.2 years (SD=15.6), and 44.9% were women. 118 (5.9%) patients had confirmed index AMI. The 2-hour algorithm defined 61.3% of patients as low risk. Sensitivity was 99.1% (94.0%-99.9%) and negative predictive value was 99.9% (99.3%-100%). 24.4% of patients were deemed intermediate risk. When applying the parameters for high risk, 252 (14.3%) were identified, with a specificity of 91.5% (88.7%-93.6%) and a PPV of 42.0% (35.6-48.7%). CONCLUSIONS: A 2-hour algorithm based on the HighSTEACS strategy using the Siemens Atellica IM hs-cTnI laboratory-based assay enables safe and efficient risk assessment of emergency patients with suspected AMI. TRIAL REGISTRATION NUMBER: ACTRN12621000053820.
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OBJECTIVES: Patients presenting with symptoms suggestive of acute coronary syndrome (ACS) contribute to a high workload and overcrowding in the Emergency Department (ED). Accelerated diagnostic protocols for non-ST-elevation myocardial infarction have proved challenging to implement. One obstacle is the turnaround time for analyzing high-sensitivity cardiac troponin (hs-cTn). In the WESTCOR-POC study (Clinical Trials number NCT05354804) we aim to evaluate safety and efficiency of a 0/1 h hs-cTn algorithm utilizing a hs-cTnI point of care (POC) instrument in comparison to central laboratory hs-cTnT measurements. DESIGN: This is a prospective single-center randomized clinical trial aiming to include 1500 patients admitted to the ED with symptoms suggestive of ACS. Patients will receive standard investigations following the European Society of Cardiology 0/1h protocols for centralized hs-cTnT measurements or the intervention using a 0/1h POC hs-cTnI algorithm. Primary end-points are 1) Safety; death, myocardial infarction or acute revascularization within 30 days 2) Efficiency; length of stay in the ED, 3) Cost- effectiveness; total episode cost, 4) Patient satisfaction, 5) Patient symptom burden and 6) Patients quality of life. Secondary outcomes are 12-months death, myocardial infarction or acute revascularization, percentage discharged after 3 and 6 h, total length of hospital stay and all costs related to hospital contact within 12 months. CONCLUSION: Results from this study may facilitate implementation of POC hs-cTn testing assays and accelerated diagnostic protocols in EDs, and may serve as a valuable resource for guiding future investigations for the use of POC high sensitivity troponin assays in outpatient clinics and prehospital settings.
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Síndrome Coronariana Aguda , Infarto do Miocárdio , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , Estudos Prospectivos , Qualidade de Vida , Infarto do Miocárdio/diagnóstico , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Troponina I , Dor no Peito/diagnóstico , Dor no Peito/etiologia , Testes Imediatos , Biomarcadores , Troponina TRESUMO
BACKGROUND: The impacts of high sensitivity cardiac troponin (hs-cTn) reporting on downstream interventions amongst suspected acute coronary syndrome (ACS) in the emergency department (ED), especially amongst those with newly identified hs-cTn elevations and in consideration of well-established sex-related disparities, has not been critically evaluated to date. This investigation explores the impact of hs-cTnT reporting on care and outcomes, particularly by participant sex. METHODS: Two similarly ED-based randomized controlled trials conducted between July 2011 to March 2013 (n = 1988) and August 2015 to April 2019 (n = 3378) were comparatively evaluated. Clinical outcomes were adjudicated to the Fourth Universal Definition of MI. Changes in practice were assessed at 30 days, and death or MI were explored to 12 months. RESULTS: The HS-Troponin study demonstrated no difference in death or MI with unmasking amongst those with hs-cTnT <30 ng/L, whereas the RAPID TnT study demonstrated a significantly higher rate. In RAPID TnT, there was significant increase in death or MI associated with unmasking for females with hs-cTnT <30 ng/L (masked: 11[1.5%], unmasked: 25[3.4%],HR: 2.27,95%C.I.:1.87-2.77,P < 0.001). Less cardiac stress testing with unmasking amongst those <30 ng/L was observed in males in both studies, which was significant in RAPID TnT (masked: 92[12.0%], unmasked: 55[7.0%], P = 0.008). In RAPID TnT, significantly higher rates of angiography in males were observed with unmasking, with no such changes amongst females <30 ng/L (masked: 28[3.7%], unmasked: 51[6.5%],P = 0.01). CONCLUSION: Compared with males, there were no evident impacts on downstream practices for females with unmasking in RAPID TnT, likely representing missed opportunities to reduce late death or MI.
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Síndrome Coronariana Aguda , Troponina T , Masculino , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Serviço Hospitalar de Emergência , Troponina I , BiomarcadoresRESUMO
OBJECTIVE: The primary objective was to determine rapid rule-out (RRO) criteria for the outcome of myocardial infarction (MI) using the Beckman Coulter Access high-sensitivity cardiac troponin I (hs-cTnI) assay. Secondary objectives were to explore cut-points for rapid rule-in (RRI) and amount of change at 3-h (3-h delta) indicative of MI. METHODS: A retrospective study included ED patients with suspected MI between June and September 2019. hs-cTnI levels were performed at baseline and after 3 h. The performance benchmark for RRO criteria was a negative predictive value (NPV) for MI with a lower 95% confidence limit >99%, and for RRI and 3-h delta cut-points was a positive predictive value (PPV) for MI >70%. Delta calculation required rising hs-cTnI levels, with at least one above the 99th percentile of the upper reference limit. Analyses utilised receiver operating characteristic (ROC) curves and contingency tables. RESULTS: Baseline hs-cTnI levels from 935 patients were available for RRO analyses. Of tested criteria, baseline hs-cTnI <6 ng/L (females) or <11 ng/L (males) plus symptom onset >2 h met the performance benchmark (NPV: 100% [95% confidence interval 99-100]). hs-cTnI levels were available for RRI and 3-h delta analyses from 935 and 52 patients, respectively. A 3-h delta cut-point >35 ng/L met the performance benchmark (PPV: 81% [95% confidence interval 58-95]) but no RRI cut-point did so. CONCLUSIONS: For the Beckman Coulter Access hs-cTnI assay, RRO criteria of baseline hs-cTnI <6 ng/L (females) or <11 ng/L (males) plus symptom onset >2 h met our performance benchmark. A 3-h delta cut-point >35 ng/L met the performance benchmark, but poor precision means further adequately powered research is required.
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Infarto do Miocárdio , Troponina I , Masculino , Feminino , Humanos , Estudos Retrospectivos , Biomarcadores , Infarto do Miocárdio/diagnóstico , Serviço Hospitalar de EmergênciaRESUMO
BACKGROUND: Peripheral intravenous catheters (PIVCs) are the most used invasive medical device in healthcare. Yet around half of insertion attempts are unsuccessful leading to delayed medical treatments and patient discomfort of harm. Ultrasound-guided PIVC (USGPIVC) insertion is an evidence-based intervention shown to improve insertion success especially in patients with Difficult IntraVenous Access (BMC Health Serv Res 22:220, 2022), however the implementation in some healthcare settings remains suboptimal. This study aims to co-design interventions that optimise ultrasound guided PIVC insertion in patients with DIVA, implement and evaluate these initiatives and develop scale up activities. METHODS: A stepped-wedge cluster randomized controlled trial will be conducted in three hospitals (two adult, one paediatric) in Queensland, Australia. The intervention will be rolled out across 12 distinct clusters (four per hospital). Intervention development will be guided by Michie's Behavior Change Wheel with the aim to increase local staff capability, opportunity, and motivation for appropriate, sustainable adoption of USGPIVC insertion. Eligible clusters include all wards or departments where > 10 PIVCs/week are typically inserted. All clusters will commence in the control (baseline) phase, then, one cluster per hospital will step up every two months, as feasible, to the implementation phase, where the intervention will be rolled out. Implementation strategies are tailored for each hospital by local investigators and advisory groups, through context assessments, staff surveys, and stakeholder interviews and informed by extensive consumer interviews and consultation. Outcome measures align with the RE-AIM framework including clinical-effectiveness outcomes (e.g., first-time PIVC insertion success for DIVA patients [primary outcome], number of insertion attempts); implementation outcomes (e.g., intervention fidelity, readiness assessment) and cost effectiveness outcomes. The Consolidated Framework for Implementation Research framework will be used to report the intervention as it was implemented; how people participated in and responded to the intervention; contextual influences and how the theory underpinning the intervention was realised and delivered at each site. A sustainability assessment will be undertaken at three- and six-months post intervention. DISCUSSION: Study findings will help define systematic solutions to implement DIVA identification and escalation tools aiming to address consumer dissatisfaction with current PIVC insertion practices. Such actionable knowledge is critical for implementation of scale-up activities. TRIAL REGISTRATION: Prospectively registered (Australian and New Zealand Clinical Trials Registry; ACTRN12621001497897).
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Hospitais , Tecnologia , Adulto , Humanos , Criança , Austrália , Queensland , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Although guidelines recommend fixed cardiac troponin thresholds for the diagnosis of myocardial infarction, troponin concentrations are influenced by age, sex, comorbidities and time from symptom onset. To improve diagnosis, we developed machine learning models that integrate cardiac troponin concentrations at presentation or on serial testing with clinical features and compute the Collaboration for the Diagnosis and Evaluation of Acute Coronary Syndrome (CoDE-ACS) score (0-100) that corresponds to an individual's probability of myocardial infarction. The models were trained on data from 10,038 patients (48% women), and their performance was externally validated using data from 10,286 patients (35% women) from seven cohorts. CoDE-ACS had excellent discrimination for myocardial infarction (area under curve, 0.953; 95% confidence interval, 0.947-0.958), performed well across subgroups and identified more patients at presentation as low probability of having myocardial infarction than fixed cardiac troponin thresholds (61 versus 27%) with a similar negative predictive value and fewer as high probability of having myocardial infarction (10 versus 16%) with a greater positive predictive value. Patients identified as having a low probability of myocardial infarction had a lower rate of cardiac death than those with intermediate or high probability 30 days (0.1 versus 0.5 and 1.8%) and 1 year (0.3 versus 2.8 and 4.2%; P < 0.001 for both) from patient presentation. CoDE-ACS used as a clinical decision support system has the potential to reduce hospital admissions and have major benefits for patients and health care providers.
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Síndrome Coronariana Aguda , Infarto do Miocárdio , Humanos , Feminino , Masculino , Biomarcadores , Troponina I , Infarto do Miocárdio/diagnóstico , Síndrome Coronariana Aguda/diagnóstico , Aprendizado de MáquinaRESUMO
BACKGROUND: In suspected myocardial infarction (MI), guidelines recommend using high-sensitivity cardiac troponin (hs-cTn)-based approaches. These require fixed assay-specific thresholds and timepoints, without directly integrating clinical information. Using machine-learning techniques including hs-cTn and clinical routine variables, we aimed to build a digital tool to directly estimate the individual probability of MI, allowing for numerous hs-cTn assays. METHODS: In 2,575 patients presenting to the emergency department with suspected MI, two ensembles of machine-learning models using single or serial concentrations of six different hs-cTn assays were derived to estimate the individual MI probability (ARTEMIS model). Discriminative performance of the models was assessed using area under the receiver operating characteristic curve (AUC) and logLoss. Model performance was validated in an external cohort with 1688 patients and tested for global generalizability in 13 international cohorts with 23,411 patients. RESULTS: Eleven routinely available variables including age, sex, cardiovascular risk factors, electrocardiography, and hs-cTn were included in the ARTEMIS models. In the validation and generalization cohorts, excellent discriminative performance was confirmed, superior to hs-cTn only. For the serial hs-cTn measurement model, AUC ranged from 0.92 to 0.98. Good calibration was observed. Using a single hs-cTn measurement, the ARTEMIS model allowed direct rule-out of MI with very high and similar safety but up to tripled efficiency compared to the guideline-recommended strategy. CONCLUSION: We developed and validated diagnostic models to accurately estimate the individual probability of MI, which allow for variable hs-cTn use and flexible timing of resampling. Their digital application may provide rapid, safe and efficient personalized patient care. TRIAL REGISTRATION NUMBERS: Data of following cohorts were used for this project: BACC ( www. CLINICALTRIALS: gov ; NCT02355457), stenoCardia ( www. CLINICALTRIALS: gov ; NCT03227159), ADAPT-BSN ( www.australianclinicaltrials.gov.au ; ACTRN12611001069943), IMPACT ( www.australianclinicaltrials.gov.au , ACTRN12611000206921), ADAPT-RCT ( www.anzctr.org.au ; ANZCTR12610000766011), EDACS-RCT ( www.anzctr.org.au ; ANZCTR12613000745741); DROP-ACS ( https://www.umin.ac.jp , UMIN000030668); High-STEACS ( www. CLINICALTRIALS: gov ; NCT01852123), LUND ( www. CLINICALTRIALS: gov ; NCT05484544), RAPID-CPU ( www. CLINICALTRIALS: gov ; NCT03111862), ROMI ( www. CLINICALTRIALS: gov ; NCT01994577), SAMIE ( https://anzctr.org.au ; ACTRN12621000053820), SEIGE and SAFETY ( www. CLINICALTRIALS: gov ; NCT04772157), STOP-CP ( www. CLINICALTRIALS: gov ; NCT02984436), UTROPIA ( www. CLINICALTRIALS: gov ; NCT02060760).
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Infarto do Miocárdio , Troponina I , Humanos , Angina Pectoris , Biomarcadores , Infarto do Miocárdio/diagnóstico , Curva ROC , Troponina T , Estudos Clínicos como AssuntoRESUMO
BACKGROUND: Our study addressed the diagnostic performance of the Atellica® IM High-Sensitivity Troponin I (hs-cTnI) assay for the rapid rule-out of myocardial infarction (MI) using a single hs-cTnI measurement at presentation in patients presenting to a US emergency department (ED). METHODS: This was a prospective, observational, cohort study of consecutive ED patients with suspected acute coronary syndrome, using 12-lead electrocardiogram and serial hs-cTnI measurements ordered on clinical indication (SAFETY, NCT04280926). ST-segment elevation MI patients were excluded. The optimal threshold required a sensitivity ≥99% and a negative predictive value (NPV) ≥99.5% for MI during index hospitalization as primary outcome. Type 1 MI (T1MI), myocardial injury, and 30-day adverse events were considered secondary outcomes. Event adjudications were established using the hs-cTnI assay used in clinical care. RESULTS: In 1171 patients, MI occurred in 97 patients (8.3%), 78.3% of which were type 2 MI. The optimal rule out hs-cTnI threshold was <10 ng/L, which identified 519 (44.3%) patients as low risk at presentation, with sensitivity of 99.0% (95% CI, 94.4-100) and NPV of 99.8% (95% CI, 98.9-100). For T1MI, sensitivity was 100% (95% CI, 83.9-100) and NPV 100% (95% CI, 99.3-100). Regarding myocardial injury, the sensitivity and NPV were 99.5% (95% CI, 97.9-100) and 99.8% (95% CI, 98.9-100), respectively. For 30-day adverse events, sensitivity was 96.8% (95% CI, 94.3-98.4) and NPV 97.9% (95% CI, 96.2-98.9). CONCLUSIONS: A single hs-cTnI measurement strategy enabled the rapid identification of patients at low risk of MI and 30-day adverse events, allowing potential discharge early after ED presentation. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT04280926.
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Infarto do Miocárdio , Troponina I , Humanos , Estudos de Coortes , Estudos Prospectivos , Infarto do Miocárdio/diagnóstico , Serviço Hospitalar de Emergência , Biomarcadores , Troponina TRESUMO
BACKGROUND: This study aimed to estimate the direct healthcare cost burden of acute chest pain attendances presenting to ambulance in Victoria, Australia, and to identify key cost drivers especially among low-risk patients. METHODS: State-wide population-based cohort study of consecutive adult patients attended by ambulance for acute chest pain with individual linkage to emergency and hospital admission data in Victoria, Australia (1 January 2015-30 June 2019). Direct healthcare costs, adjusted for inflation to 2020-2021 ($A), were estimated for each component of care using a casemix funding method. RESULTS: From 241 627 ambulance attendances for chest pain during the study period, mean chest pain episode cost was $6284, and total annual costs were estimated at $337.4 million ($68 per capita per annum). Total annual costs increased across the period ($310.5 million in 2015 vs $384.5 million in 2019), while mean episode costs remained stable. Cardiovascular conditions (25% of presentations) were the most expensive (mean $11 523, total annual $148.7 million), while a non-specific pain diagnosis (49% of presentations) was the least expensive (mean $3836, total annual $93.4 million). Patients classified as being at low risk of myocardial infarction, mortality or hospital admission (Early Chest pain Admission, Myocardial infarction, and Mortality (ECAMM) score) represented 31%-57% of the cohort, with total annual costs estimated at $60.6 million-$135.4 million, depending on the score cut-off used. CONCLUSIONS: Total annual costs for acute chest pain presentations are increasing, and a significant proportion of the cost burden relates to low-risk patients and non-specific pain. These data highlight the need to improve the cost-efficiency of chest pain care pathways.
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Serviço Hospitalar de Emergência , Infarto do Miocárdio , Adulto , Humanos , Estudos de Coortes , Dor no Peito/diagnóstico , Custos de Cuidados de Saúde , VitóriaRESUMO
BACKGROUND: Discrepancies in cardiovascular care for women are well described, but few data assess the entire patient journey for chest pain care. OBJECTIVES: This study aimed to assess sex differences in epidemiology and care pathways from emergency medical services (EMS) contact through to clinical outcomes following discharge. METHODS: This is a state-wide population-based cohort study including consecutive adult patients attended by EMS for acute undifferentiated chest pain in Victoria, Australia (January 1, 2015, to June 30, 2019). EMS clinical data were individually linked to emergency and hospital administrative datasets, and mortality data and differences in care quality and outcomes were assessed using multivariable analyses. RESULTS: In 256,901 EMS attendances for chest pain, 129,096 attendances (50.3%) were women, and mean age was 61.6 years. Age-standardized incidence rates were marginally higher for women compared with men (1,191 vs 1,135 per 100,000 person-years). In multivariable models, women were less likely to receive guideline-directed care across most care measures including transport to hospital, prehospital aspirin or analgesia administration, 12-lead electrocardiogram, intravenous cannula insertion, and off-load from EMS or review by emergency department clinicians within target times. Similarly, women with acute coronary syndrome were less likely to undergo angiography or be admitted to a cardiac or intensive care unit. Thirty-day and long-term mortality was higher for women diagnosed with ST-segment elevation myocardial infarction, but lower overall. CONCLUSIONS: Substantial differences in care are present across the spectrum of acute chest pain management from first contact through to hospital discharge. Women have higher mortality for STEMI, but better outcomes for other etiologies of chest pain compared with men.
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Serviços Médicos de Emergência , Infarto do Miocárdio com Supradesnível do Segmento ST , Adulto , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Estudos de Coortes , Caracteres Sexuais , Dor no Peito/diagnóstico , Dor no Peito/epidemiologia , Dor no Peito/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Vitória/epidemiologiaRESUMO
Importance: Prehospital point-of-care troponin testing and paramedic risk stratification might improve the efficiency of chest pain care pathways compared with existing processes with equivalent health outcomes, but the association with health care costs is unclear. Objective: To analyze whether prehospital point-of-care troponin testing and paramedic risk stratification could result in cost savings compared with existing chest pain care pathways. Design, Setting, and Participants: In this economic evaluation of adults with acute chest pain without ST-segment elevation, cost-minimization analysis was used to assess linked ambulance, emergency, and hospital attendance in the state of Victoria, Australia, between January 1, 2015, and June 30, 2019. Interventions: Paramedic risk stratification and point-of-care troponin testing. Main Outcomes and Measures: The outcome was estimated mean annualized statewide costs for acute chest pain. Between May 17 and June 25, 2022, decision tree models were developed to estimate costs under 3 pathways: (1) existing care, (2) paramedic risk stratification and point-of-care troponin testing without prehospital discharge, or (3) prehospital discharge and referral to a virtual emergency department (ED) for low-risk patients. Probabilities for the prehospital pathways were derived from a review of the literature. Multivariable probabilistic sensitivity analysis with 50â¯000 Monte Carlo iterations was used to estimate mean costs and cost differences among pathways. Results: A total of 188â¯551 patients attended by ambulance for chest pain (mean [SD] age, 61.9 [18.3] years; 50.5% female; 49.5% male; Indigenous Australian, 2.0%) were included in the model. Estimated annualized infrastructure and staffing costs for the point-of-care troponin pathways, assuming a 5-year device life span, was $2.27 million for the pathway without prehospital discharge and $4.60 million for the pathway with prehospital discharge (incorporating virtual ED costs). In the decision tree model, total annual cost using prehospital point-of-care troponin and paramedic risk stratification was lower compared with existing care both without prehospital discharge (cost savings, $6.45 million; 95% uncertainty interval [UI], $0.59-$16.52 million; lower in 94.1% of iterations) and with prehospital discharge (cost savings, $42.84 million; 95% UI, $19.35-$72.26 million; lower in 100% of iterations). Conclusions and Relevance: Prehospital point-of-care troponin and paramedic risk stratification for patients with acute chest pain could result in substantial cost savings. These findings should be considered by policy makers in decisions surrounding the potential utility of prehospital chest pain risk stratification and point-of-care troponin models provided that safety is confirmed in prospective studies.
Assuntos
Infarto do Miocárdio , Troponina , Adulto , Humanos , Pessoa de Meia-Idade , Sistemas Automatizados de Assistência Junto ao Leito , Paramédico , Estudos Prospectivos , Manejo da Dor , Austrália , Dor no Peito/diagnóstico , Serviço Hospitalar de Emergência/economia , Medição de Risco , Análise Custo-BenefícioRESUMO
OBJECTIVE: The Snapshot of Suspected ACS Assessment (SSAASY) study aims to describe the assessment processes for patients with suspected acute coronary syndrome (ACS) in Australian EDs, and to compare these processes with the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand (NHFA/CSANZ) guidelines. METHODS: Between March and May 2021, a cross-sectional survey of Australian EDs was undertaken to investigate the assessment strategies used within the ED. All public and private hospitals identified as having dedicated EDs were invited to participate. Respondents provided data on hospital, ED and cardiac service characteristics. They also provided data on the risk stratification process recommended within their department (risk scores, troponin testing, objective testing for coronary artery disease). Awareness of the NHFA/CSANZ guidelines was assessed. RESULTS: Responses were received from 109/162 departments (67%). Most sites (n = 100, 92%) reported using dedicated protocols developed by ED clinicians that included risk stratification scores. Highly sensitive troponin assays were used at 103 (94%) sites. Serial troponin testing was performed over 2 h for low-risk patients in 53 (49%) sites and 2-3 h for intermediate and high-risk patients in 74 (68%) sites. Further investigations included exercise stress tests (48%) and stress echocardiography (38%), with 45% of sites ordering outpatient investigations. CONCLUSIONS: The SSAASY study reported the strategies used to assess suspected ACS. In line with current NHFA/CSANZ guidelines, highly sensitive troponin assays are widely utilised. However, serial sampling intervals were longer than guideline recommendations, suggesting a translational gap between guidelines and clinical practice.
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Síndrome Coronariana Aguda , Humanos , Síndrome Coronariana Aguda/diagnóstico , Estudos Transversais , Medição de Risco , Austrália , Troponina , Serviço Hospitalar de Emergência , BiomarcadoresRESUMO
OBJECTIVES: To describe the demographics, presentation characteristics, clinical features and cardiac outcomes for Aboriginal and Torres Strait Islander patients who present to a regional cardiac referral centre ED with suspected acute coronary syndrome (ACS). METHODS: This was a single-centre observational study conducted at a regional referral hospital in Far North Queensland, Australia from November 2017 to September 2018 and January 2019 to December 2019. Study participants were 278 Aboriginal and Torres Strait Islander people presenting to an ED and investigated for suspected ACS. The main outcome measure was the proportion of patients with ACS at index presentation and differences in characteristics between those with and without ACS. RESULTS: ACS at presentation was diagnosed in 38.1% of patients (n = 106). The mean age of patients with ACS was 53.5 years (SD 9.5) compared with 48.7 years (SD 12.1) in those without ACS (P = 0.001). Patients with ACS were more likely to be male (63.2% vs 39.0%, P < 0.001), smokers (70.6% vs 52.3%, P = 0.002), have diabetes (56.6% vs 38.4%, P = 0.003) and have renal impairment (24.5% vs 10.5%, P = 0.002). CONCLUSIONS: Aboriginal and Torres Strait Islander patients with suspected ACS have a high burden of traditional cardiac risk factors, regardless of whether they are eventually diagnosed with ACS. These patients may benefit from assessment for coronary artery disease regardless of age at presentation.
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Síndrome Coronariana Aguda , Povos Aborígenes Australianos e Ilhéus do Estreito de Torres , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Síndrome Coronariana Aguda/diagnóstico , Austrália , Queensland/epidemiologia , Encaminhamento e ConsultaRESUMO
BACKGROUND: Elevations of high-sensitivity cardiac troponin (hs-cTn) concentrations not related to type 1 myocardial infarction are common in chest pain patients presenting to emergency departments. The discrimination of these patients from those with type 1 myocardial infarction (MI) is challenging and resource-consuming. We aimed to investigate whether the hs-cTn I/T ratio might provide diagnostic and prognostic increment in this context. METHODS: We calculated the hs-cTn I/T ratio in 888 chest pain patients having hs-cTnI (Abbott Laboratories) or hs-cTnT (Roche Diagnostics) concentrations above the respective 99th percentile at 2 hours from presentation. All patients were followed for one year regarding mortality. RESULTS: The median hs-cTn I/T ratio was 3.45 (25th, 75th percentiles 1.80-6.59) in type 1 MI patients (n = 408 â¯46.0%]), 1.18 (0.81-1.90) in type 2 MI patients (n = 56 â¯6.3%]) and 0.67 (0.39-1.12) in patients without MI. The hs-cTn I/T ratio provided good discrimination of type 1 MI from no type 1 MI (area under the receiver-operator characteristic curve 0.89 â¯95% confidence interval 0.86-0.91]), of type 1 MI from type 2 MI (area under the curve 0.81 â¯95% confidence interval 0.74-0.87]), and was associated with type 1 MI in adjusted analyses. The hs-cTn I/T ratio provided no consistent prognostic value. CONCLUSIONS: The hs-cTn I/T ratio appears to be useful for early diagnosis of type 1 MI and its discrimination from type 2 MI in chest pain patients presenting with elevated hs-cTn. Differences in hs-cTn I/T ratio values may reflect variations in hs-cTn release mechanisms in response to different types of myocardial injury.
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Infarto do Miocárdio , Troponina T , Humanos , Biomarcadores , Dor no Peito/complicações , Infarto do Miocárdio/complicações , Prognóstico , Troponina IRESUMO
BACKGROUND: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turnaround times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid point-of-care (POC) whole-blood hs-cTnI assay at presentation with potential early patient discharge. METHODS: Consecutive patients presenting to the emergency department from 2 prospective observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica VTLi) threshold using whole blood at presentation, which resulted in a negative predictive value of ≥99.5% and sensitivity of >99% for index MI, was derived (SEIGE [Safe Emergency Department Discharge Rate]) and validated with plasma (SAMIE [Suspected Acute Myocardial Infarction in Emergency]). Event adjudications were established with hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30 days. RESULTS: A total of 1086 patients (8.1% with MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole-blood POC hs-cTnI concentration of <4 ng/L provided a sensitivity of 98.9% (95% CI, 93.8%-100%) and negative predictive value of 99.5% (95% CI, 97.2%-100%) for ruling out MI. In the validation cohort, the sensitivity was 98.8% (95% CI, 93.3%-100%), and negative predictive value was 99.8% (95% CI, 99.1%-100%); 17.8% and 41.8%, respectively, were defined as low risk for discharge. The 30-day adverse cardiac events were 0.1% (n=1) for SEIGE and 0.8% (n=5) for SAMIE. CONCLUSIONS: A POC whole-blood hs-cTnI assay permits accessible, rapid, and safe exclusion of MI and may expedite discharge from the emergency department. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04772157. URL: https://www.australianclinicaltrials.gov.au/anzctr_feed/form; Unique identifier: 12621000053820.