Point-of-care high-sensitivity cardiac troponin in suspected acute myocardial infarction assessed at baseline and 2†h.

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 2 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.

Implementing neurodevelopmental follow-up care for children with congenital heart disease: A scoping review with evidence mapping.

AIM: To identify and map evidence describing components of neurodevelopmental follow-up care for children with congenital heart disease (CHD). METHOD: This was a scoping review of studies reporting components of neurodevelopmental follow-up programmes/pathways for children with CHD. Eligible publications were identified through database searches, citation tracking, and expert recommendations. Two independent reviewers screened studies and extracted data. An evidence matrix was developed to visualize common characteristics of care pathways. Qualitative content analysis identified implementation barriers and enablers. RESULTS: The review included 33 studies. Twenty-one described individual care pathways across the USA (n = 14), Canada (n = 4), Australia (n = 2), and France (n = 1). The remainder reported surveys of clinical practice across multiple geographical regions. While heterogeneity in care existed across studies, common attributes included enrolment of children at high-risk of neurodevelopmental delay; centralized clinics in children's hospitals; referral before discharge; periodic follow-up at fixed ages; standardized developmental assessment; and involvement of multidisciplinary teams. Implementation barriers included service cost/resourcing, patient burden, and lack of knowledge/awareness. Multi-level stakeholder engagement and integration with other services were key drivers of success. INTERPRETATION: Defining components of effective neurodevelopmental follow-up programmes and care pathways, along with enhancing and expanding guideline-based care across regions and into new contexts, should continue to be priorities. WHAT THIS PAPER ADDS: Twenty-two different neurodevelopmental follow-up care pathways/programmes were published, originating from four countries. Twelve additional publications described broad practices for neurodevelopmental follow-up across regions Common attributes across eligibility, service structure, assessment processes, and care providers were noted. Studies reported programme acceptability, uptake, cost, and effectiveness. Implementation barriers included service cost/resourcing, patient burden, and lack of knowledge/awareness.

Mapping Kansas City cardiomyopathy, Seattle Angina, and minnesota living with heart failure to the MacNew-7D in patients with heart disease.

INTRODUCTION: The Kansas City Cardiomyopathy Questionnaire (KCCQ), Seattle Angina Questionnaire (SAQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) are widely used non-preference-based instruments that measure health-related quality of life (QOL) in people with heart disease. However, currently it is not possible to estimate quality-adjusted life-years (QALYs) for economic evaluation using these instruments as the summary scores produced are not preference-based. The MacNew-7D is a heart disease-specific preference-based instrument. This study provides different mapping algorithms for allocating utility scores to KCCQ, MLHFQ, and SAQ from MacNew-7D to calculate QALYs for economic evaluations. METHODS: The study included 493 participants with heart failure or angina who completed the KCCQ, MLHFQ, SAQ, and MacNew-7D questionnaires. Regression techniques, namely, Gamma Generalized Linear Model (GLM), Bayesian GLM, Linear regression with stepwise selection and Random Forest were used to develop direct mapping algorithms. Cross-validation was employed due to the absence of an external validation dataset. The study followed the Mapping onto Preference-based measures reporting Standards checklist. RESULTS: The best models to predict MacNew-7D utility scores were determined using KCCQ, MLHFQ, and SAQ item and domain scores. Random Forest performed well for item scores for all questionnaires and domain score for KCCQ, while Bayesian GLM and Linear Regression were best for MLHFQ and SAQ domain scores. However, models tended to over-predict severe health states. CONCLUSION: The three cardiac-specific non-preference-based QOL instruments can be mapped onto MacNew-7D utilities with good predictive accuracy using both direct response mapping techniques. The reported mapping algorithms may facilitate estimation of health utility for economic evaluations that have used these QOL instruments.

External validation of a rapid algorithm using high-sensitivity troponin assay results for evaluating patients with suspected acute myocardial infarction.

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.

Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk.

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.

Global and regional burden of ischemic stroke associated with atrial fibrillation, 2009-2019.

The extent of the preventable burden of ischaemic stroke associated with atrial fibrillation (AF) remains uncertain to date. To address this knowledge gap, we utilised the comparative risk assessment methodology to estimate the burden of ischaemic stroke associated with AF at both global and regional levels. The population attributable fraction for ischaemic stroke and AF was obtained from published literature, while data on the prevalence, incidence, deaths, and disability-adjusted life years (DALY) associated with ischaemic stroke were sourced from the Global Burden of Disease study database. Our analysis revealed that in 2019, globally, there were an estimated 0.7 (95% uncertainty interval [UI] of 0.55 to 0.83) million incident cases, 6.9 (5.81 to 8.12) million prevalence cases, 0.3 0.25 to 0.34) million deaths and 5.7 (4.91 to 6.57) million DALY resulting from ischaemic stroke associated with AF. The age-standardised death and DALY rates declined between 2009 and 2019 in all regions to varying degrees. Conversely, the age-standardised incidence and prevalence rates reduced only in high-income countries, Central Europe, Eastern Europe and Central Asia and Latin America and Caribbean regions. It is likely that our findings under-estimated the true burden of ischaemic stroke associated with AF due to limitations such as the use of a fixed population attributable fraction and poor quality of data. Nevertheless, we believe that our estimates provide valuable insights and highlight the urgent need for optimised management of AF through the implementation of efficacious interventions. Such efforts can help reduce the occurrence of preventable ischaemic strokes.

Cost-effectiveness of left atrial appendage closure for stroke prevention in atrial fibrillation: a systematic review appraising the methodological quality.

BACKGROUND: The increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs. High-quality economic evaluations of stroke prevention strategies can play a crucial role in maximising efficient allocation of resources. In this systematic review, we assessed the methodological quality of such economic evaluations. METHODS: We searched electronic databases of PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Econ Lit to identify model-based economic evaluations comparing the left atrial appendage closure procedure (LAAC) and oral anticoagulants published in English since 2000. Data on study characteristics, model-based details, and analyses were collected. The methodological quality was evaluated using the modified Economic Evaluations Bias (ECOBIAS) checklist. For each of the 22 biases listed in this checklist, studies were categorised into one of four groups: low risk, partial risk, high risk due to inadequate reporting, or high risk. To gauge the overall quality of each study, we computed a composite score by assigning + 2, 0, - 1 and - 2 to each risk category, respectively. RESULTS: In our analysis of 12 studies, majority adopted a healthcare provider or payer perspective and employed Markov Models with the number of health states varying from 6 to 16. Cost-effectiveness results varied across studies. LAAC displayed a probability exceeding 50% of being the cost-effective option in six out of nine evaluations compared to warfarin, six out of eight evaluations when compared to dabigatran, in three out of five evaluations against apixaban, and in two out of three studies compared to rivaroxaban. The methodological quality scores for individual studies ranged from 10 to - 12 out of a possible 24. Most high-risk ratings were due to inadequate reporting, which was prevalent across various biases, including those related to data identification, baseline data, treatment effects, and data incorporation. Cost measurement omission bias and inefficient comparator bias were also common. CONCLUSIONS: While most studies concluded LAAC to be the cost-effective strategy for stroke prevention in AF, shortcomings in methodological quality raise concerns about reliability and validity of results. Future evaluations, free of these shortcomings, can yield stronger policy evidence.

Global, regional, and national burden of heart failure associated with atrial fibrillation.

BACKGROUND: Heart failure is a leading cause of mortality and morbidity worldwide, and Atrial fibrillation (AF) is among many modifiable risk factors for heart failure. No estimates are available on the magnitude of the burden of heart failure associated with AF, and this study estimated the global, regional, and national burdens associated with AF. METHODS: We used the comparative risk assessment method to estimate the disease burden in terms of prevalence and years lived with disability (YLD). The population-attributable fraction for heart failure and AF was calculated from prevalence estimates of AF and the recalculated relative risks of heart failure associated with AF from a systematic review summarising the longitudinal association between AF and outcomes. The burden of heart failure was retrieved from the Global Burden of Disease database. RESULTS: Globally, 2.6% (95% uncertainty interval 1.3 to 4.7%) of the burden of heart failure is associated with AF. This was 1.5 (95% UI 0.6 to 3.2) million people in 2019, a 49.8% increase from 1990. The highest prevalence was from South-East Asia, East Asia and Oceania. The highest YLD was estimated for Central Europe, Eastern Europe and Central Asia. High-income countries showed a sharp decline in the age standardised prevalence and YLD rates from 1990 to 2019. CONCLUSION: The burden of heart failure associated with AF has increased substantially over the past two decades despite the advances in AF management. However, falling prevalence and YLD rates of heart failure associated with AF in high-income countries over time indicate that reducing this burden is possible.

Developing an Australian utility value set for MacNew-7D health states.

BACKGROUND: A new preference-based measure (MacNew-7D) has recently been developed to allow condition-specific data to be used to capture the quality of life in health economic evaluations in cardiology; however, a general population value set has not yet been developed. This study developed a population utility value set for the MacNew-7D heart disease-specific instrument. METHODS: The discrete choice experiments (DCE) technique was chosen as the preference-elicitation method. The DCE asked respondents to compare two options and to state their preferences. The survey was conducted using an online panel of respondents, with quota sampling using age groups, sex and jurisdictions to achieve representativeness of the Australian population. The total design consisted of 200 choice sets, of which each respondent answered eight. Additionally, each respondent answered two quality control choice sets. The best-fitting models were selected on the basis of consistency, parsimony, and goodness of fit. RESULTS: In total, 1903 respondents were included in the analyses. The MacNew-7D utility value set ranged from -0.4456 to 1.000 for health states defined by the classification system. The best-fitting model retained all levels for five dimensions and collapsed one adjacent level for the other two dimensions. Findings were robust to sensitivity analyses related to the inclusion or exclusion of dominancy and repeat tasks. CONCLUSION: Findings indicated that the MacNew-7D utility value set is likely suitable for estimating quality-adjusted life years derived from the MacNew heart disease health-related quality-of-life questionnaire. This value set was derived from an Australian population-based sample and may not be generalisable to dissimilar populations.

Hybrid cardiac telerehabilitation for coronary artery disease in Australia: a cost-effectiveness analysis.

BACKGROUND: Traditional cardiac rehabilitation programs are centre-based and clinically supervised, with their safety and effectiveness well established. Notwithstanding the established benefits, cardiac rehabilitation remains underutilised. A possible alternative would be a hybrid approach where both centre-based and tele-based methods are combined to deliver cardiac rehabilitation to eligible patients. The objective of this study was to determine the long-term cost-effectiveness of a hybrid cardiac telerehabilitation and if it should be recommended to be implemented in the Australian context. METHODS: Following a comprehensive literature search, we chose the Telerehab III trial intervention that investigated the effectiveness of a long-term hybrid cardiac telerehabilitation program. We developed a decision analytic model to estimate the cost-effectiveness of the Telerehab III trial using a Markov process. The model included stable cardiac disease and hospitalisation health states and simulations were run using one-month cycles over a five-year time horizon. The threshold for cost-effectiveness was set at $AU 28,000 per quality-adjusted life-year (QALY). For the base analysis, we assumed that 80% completed the programme. We tested the robustness of the results using probabilistic sensitivity and scenario analyses. RESULTS: Telerehab III intervention was more effective but more costly and was not cost-effective, at a threshold of $28,000 per QALY. For every 1,000 patients who undergo cardiac rehabilitation, employing the telerehabilitation intervention would cost $650,000 more, and 5.7 QALYs would be gained, over five years, compared to current practice. Under probabilistic sensitivity analysis, the intervention was cost-effective in only 18% of simulations. Similarly, if the intervention compliance was increased to 90%, it was still unlikely to be cost-effective. CONCLUSION: Hybrid cardiac telerehabilitation is highly unlikely to be cost-effective compared to the current practice in Australia. Exploration of alternative models of delivering cardiac telerehabilitation is still required. The results presented in this study are useful for policymakers wanting to make informed decisions about investment in hybrid cardiac telerehabilitation programs.

Cost-Effectiveness of Screening to Identify Patients With Atrial Fibrillation: A Systematic Review.

BACKGROUND: Screening for Atrial Fibrillation (AF) is recommended for people aged above 65 years. Screening for AF in asymptomatic individuals can be beneficial by enabling earlier diagnosis and the commencement of interventions to reduce the risk of early events, thus improving patient outcomes. This study systematically reviews the literature about the cost-effectiveness of various screening methods for previously undiagnosed AF. METHODS: Four databases were searched to identify articles that are cost-effectiveness studies conducted on screening for AF published from January 2000 to August 2022. The Consolidated Health Economic Evaluation Reporting Standards 2022 checklist was used to assess the quality of the selected studies. A previously published approach was used to assess the usefulness of each study for health policy makers. RESULTS: The database search yielded 799 results, with 26 articles meeting the inclusion criteria. Articles were categorised into four subgroups: (i) population screening, (ii) opportunistic screening, (iii) targeted, and (iv) mixed methods of screening. Most of the studies screened adults ≥65 years of age. Most studies were performed from a 'health care payer perspective' and almost all studies used 'not screening' as a comparator. Almost all screening methods assessed were found to be cost-effective in comparison to 'not screening'. The reporting quality varied between 58% to 89%. The majority of the studies were found to be of limited usefulness for health policy makers, as none of the studies made any clear statements about policy change or implementation direction. CONCLUSION: All approaches of AF screening were found to be cost-effective compared with no screening, while opportunistic screening was found to be the optimal approach in some studies. However, screening for AF in asymptomatic individuals is context specific and likely to be cost-effective depending on the population screened, screening approach, frequency, and the duration of screening.

Application of High-Sensitivity Troponin in Suspected Myocardial Infarction.

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.).

Evaluation of the Atellica TnIH cardiac troponin I assay and assessment of biological equivalence.

OBJECTIVES: We evaluated the analytical performance characteristics and the biological equivalence of the Atellica TnIH assay. METHODS: Precision, detection capability, linearity, and sex specific 99th percentiles were determined de novo. Classification of patients relative to the 99th percentiles was used to assess biological equivalence. RESULTS: Analytical precision and detection capability of the Atellica TnIH assay is excellent with a limit of blank <1 ng/L and 62.5% of women and 93% of men had results above the limit of detection. The 99th percentiles (90% CI) in women were 49 ng/L (31-67) and 70 ng/L (48-121) in men. An asymmetrical distribution involving 5% of results was notable. Agreement was moderate (Kappa 0.58, 95% CI 0.53-0.63) with 20% of patients discordantly classified with Atellica TnIH below and Access hsTnI above the 99th percentiles. Serial results in 195 patients demonstrated good agreement (Kappa 0.84, 95% CI 0.77-0.90). Differences greater than the assay specific reference change values (z≥±1.96) occurred in 65% (95% CI 53-76%) of 99th percentile discordant patients compared to 2.7% (p<0.001) and 76% (p=0.17) of the concordant low and high cTnI groups respectively. CONCLUSIONS: The 99th percentile discordant and the concordantly elevated groups are more alike with respect to their z≥±1.96 rates. This favours an overestimated Atellica TnIH 99th percentile as more likely, and we hypothesize that antibody interference resulting in asymmetric scatter of nearly 5% samples may be the underlying mechanism. Analytical accuracy and interferences in cardiac troponin assays should be investigated and resolved with high priority.

Reducing waste in collection of quality-of-life data through better reporting: a case study.

PURPOSE: This study describes the reporting of the preference-based health-related quality-of-life (HRQOL) instrument, the EQ-5D, and proposes strategies to improve reporting and reduce research waste. The EQ-5D is a validated instrument widely used for health economic evaluation and is useful for informing health policy. METHODS: As part of a systematic review of papers reporting EQ-5D utility weights in patients with coronary artery disease, we noted the reasons data from some papers could not be reused in a meta-analysis, including whether health utility weights and sufficient statistical details were reported. Research waste was quantified using: (1) the percentage of papers and sample size excluded, and (2) researcher time and cost reviewing poorly reported papers. RESULTS: Our search strategy found 5942 papers. At title and abstract screening 93% were excluded. Of the 379 full text papers screened, 130 papers reported using EQ-5D. Only 46% (60/130) of those studies reported utility weights and/or statistical properties enabling meta-analysis. Only 67% of included papers had reported EQ-5D in the title or abstract. A total sample size of 133,298 was excluded because of poor reporting. The cost of researcher time wasted estimated to be between $3816 and $13,279 for our review. CONCLUSIONS: Poor reporting of EQ-5D data creates research waste where potentially useful data are excluded from meta-analyses and economic evaluations. Poor reporting of HRQOL instruments also creates waste due to additional time spent reviewing papers for systematic reviews that are subsequently excluded. RECOMMENDATIONS: Studies using the EQ-5D should report utility weights with appropriate summary statistics to enable reuse in meta-analysis and more robust evidence for health policy. We recommend authors report the HRQOL instrument in the title or abstract in line with current reporting guidelines (CONSORT-PRO and SPIRIT-PRO Extensions) to make it easier for other researchers to find. Validated instruments should also be listed in the Medical Subject Headings (MeSH) to improve cataloguing and retrieval of previous research.

Development of a preference-based heart disease-specific health state classification system using MacNew heart disease-related quality of life instrument.

PURPOSE: The MacNew Heart Disease Health-Related Quality of Life Instrument (MacNew) is a validated, clinically sensitive, 27-item disease-specific questionnaire. This study aimed to develop a new heart disease-specific classification system for the MacNew amenable for use in health state valuation. METHODS: Patients with heart disease attending outpatient clinics and inpatient wards in Brisbane, Australia, completed MacNew. The development of the new disease-specific classification system included three stages. First, a principal component analysis (PCA) established dimensionality. Second, Rasch analysis was used to select items for each dimension. Third, Rasch analysis was used to explore response-level reduction. In addition, clinician and patient judgement informed item selection. RESULTS: Participants included 685 patients (acute coronary 6%, stable coronary 41%, chronic heart failure 20%). The PCA identified 4 dimensions (restriction, emotion, perception of others, and symptoms). The restriction dimension was divided into physical and social dimensions. One item was selected from each to be included in the classification system. Three items from the emotional dimension and two symptom items were also selected. The final classification system had seven dimensions with four severity levels in each: physical restriction; excluded from doing things with other people; worn out or low in energy; frustrated, impatient or angry; unsure and lacking in self-confidence; shortness of breath; and chest pain. CONCLUSION: This study generated a brief heart disease-specific classification system, consisting of seven dimensions with four severity levels in each. The classification system is amenable to valuation to enable the generation of utility value sets to be developed for use in economic evaluation.

The Spectrum, Severity and Outcomes of Rheumatic Mitral Valve Disease in Pregnant Women in Australia and New Zealand.

BACKGROUND: Rheumatic heart disease (RHD) poses significant perinatal risks. We aimed to describe the spectrum, severity and outcomes of rheumatic mitral valve disease in pregnancy in Australia and New Zealand. METHODS: A prospective, population-based cohort study of pregnant women with RHD recruited 2013-14 through the hospital-based Australasian Maternity Outcomes Surveillance System. Outcome measures included maternal and perinatal morbidity and mortality. Univariable and multivariable logistic regression analyses were undertaken to test for predictors of adverse maternal and perinatal outcomes. RESULTS: Of 274 pregnant women identified with RHD, 124 (45.3%) had mitral stenosis (MS) and 150 (54.7%) had isolated mitral regurgitation (MR). One woman with mild MS/moderate MR died. There were six (2.2%) stillbirths and two (0.7%) neonatal deaths. Babies born to women with MS were twice as likely to be small-for-gestational-age (22.7% vs 11.4%, p=0.013). In women with MS, use of cardiac medication (AOR 7.42) and having severe stenosis (AOR 16.35) were independently associated with adverse cardiac outcomes, while New York Heart Association (NYHA) class >1 (AOR 3.94) was an independent predictor of adverse perinatal events. In women with isolated MR, use of cardiac medications (AOR 7.03) and use of anticoagulants (AOR 6.05) were independently associated with adverse cardiac outcomes. CONCLUSIONS: Careful monitoring and specialist care for women with RHD in pregnancy is required, particularly for women with severe MS, those on cardiac medication, and those on anticoagulation, as these are associated with increased risk of adverse maternal cardiac outcomes. In the context of pregnancy, contraception and preconception planning are important for young women diagnosed with RHD.

Emergency Department Assessment of Suspected Acute Coronary Syndrome Using the IMPACT Pathway in Aboriginal and Torres Strait Islander People.

OBJECTIVES: The Improved Assessment of Chest pain Trial (IMPACT) pathway is an accelerated strategy for the assessment of emergency patients presenting with suspected acute coronary syndrome (ACS). The objective of this study was to report outcomes for Aboriginal and Torres Strait Islander patients deemed low-, intermediate-, or high-risk according to this pathway. DESIGN: This was a prospective observational trial conducted between November 2017 and December 2019. SETTING: Regional hospital in Far North Queensland. PARTICIPANTS: Aboriginal and Torres Strait Islander people presenting to the Emergency Department with suspected ACS were asked to participate. Participants were stratified as low-, intermediate- or high-risk of ACS according to the IMPACT pathway. High-and intermediate risk patients were managed according to the IMPACT pathway. Management of low-risk patients included additional inpatient cardiac testing, which was not part of the original IMPACT pathway. MAIN OUTCOME MEASURES: The primary outcome was acute coronary syndrome within 30-days. Secondary outcomes included length of stay and prevalence of objective testing. RESULTS: A total of 155 participants were classified as either at low-risk (n=18 11.6%), intermediate-risk (n=87 56.1%), or high-risk (n=50 32.3%) of ACS. Thirty-day (30-day) ACS occurred in 29 (18.6%) patients, which included 26 (52.0%) high-risk patients and three (3.4%) intermediate-risk patients. No patients in the low-risk group were diagnosed with ACS during their index presentation or by 30-days. Median hospital length-of-stay was 11.9 hours (interquartile range [IQR] 5.3-20.2 hrs) for low- and 15.5 hours (IQR 5.9-29.2 hrs) for intermediate-risk patients. CONCLUSION: The IMPACT pathway, which has been associated with reduced LOS in other settings, could be safely implemented for patients of Aboriginal and Torres Strait Islander origin, classifying two-thirds as low- or intermediate risk. However, a clinically significant proportion of Aboriginal and Torres Strait Islander patients experience cardiac events, which supports the need to provide early objective testing for coronary artery disease.

Heart Disease and Pregnancy: The Need for a Twenty-First Century Approach to Care .

Pregnancy and childbirth present a specific challenge to the maternal cardiovascular system. Pre-existing cardiac diseases, or cardiac diseases that occur during pregnancy, are associated with a significant risk of morbidity and mortality for both mother and baby. In recent decades, cardiac disease has emerged as a leading cause of maternal death in most high income countries, including Australia and New Zealand. The burden of cardiac disease in pregnancy is likely to be growing due to an increase in adult survivors with congenital heart disease embarking on pregnancy coupled with demographic shifts in the age and cardiovascular risk factors of women giving birth and the persisting high incidence of acute rheumatic fever in First Nations women. There is widespread consensus that the best obstetric and neonatal outcomes in women with cardiac disease are delivered by a strategy of carefully coordinated multidisciplinary care. Australia and New Zealand currently lack nationally agreed strategies for clinical practice and service delivery for women with heart disease in pregnancy. This state-of-the-art review summarises some of the key issues faced in relation to prevention, diagnosis, treatment and health service delivery in this patient group and concludes with suggested priorities for policy and research.

Pregnancy Following Heart Transplantation: A Single Centre Case Series and Review of the Literature.

BACKGROUND: Maternal and fetal outcomes of pregnancy amongst cardiac transplant recipients are limited in the current literature. METHODS: We describe five pregnancies in three cardiac transplant recipients managed between a tertiary centre for obstetric medicine and an associated state-wide transplant centre between 2014-2018, and provide a narrative review of the literature. RESULTS: Pre-conception counselling was undertaken. There were no recent rejection episodes and all women demonstrated good baseline cardiac function. Median maternal age was 27 years (range 23-38 yrs.). Median time from transplantation to pregnancy was 5 years (range 2-14 yrs.). All women were managed with modified immunosuppressant regimens and multidisciplinary care. Cardiac function, tacrolimus levels and renal function were closely monitored with frequent monitoring for common complications of pregnancy. There were no maternal or fetal deaths. There was no evidence of graft rejection and no deterioration in cardiac function. Tacrolimus doses were increased to maintain therapeutic targets. Gestational diabetes occurred in three women and cholestasis of pregnancy occurred in one. Each infant was delivered by vaginal delivery. One mother had postpartum haemorrhage in both pregnancies. Pre-eclampsia did not occur. Median gestation at delivery was 37 weeks (range 35+4-40+5 days) with two preterm deliveries. One (1) infant was born with low birth weight. One (1) infant had jaundice requiring phototherapy. All infants were breastfed. CONCLUSION: Pregnancy in transplant recipients confers risk to the mother and fetus. Pre-conception counselling, immunosuppressant tailoring and regular monitoring are paramount to avoid rejection and possible teratogenic complications. Favourable pregnancy outcomes are achievable with specialist multidisciplinary care.

Mapping the Minnesota living with heart failure questionnaire (MLHFQ) to EQ-5D-5L in patients with heart failure.

BACKGROUND: Mapping algorithms can be used to convert scores from a non-preference based instrument to health state utilities. The objective of this study was to develop mapping algorithms which will enable the Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores to be converted into EQ-5D-5L utility scores that can be used in heart failure related cost utility studies. METHOD: Patients diagnosed with heart failure were recruited from Australia. Mapping algorithms were developed using both direct and indirect response mapping approach. Three model specifications were considered to predict the EQ-5D-5 L utility score using MLHFQ total score (Model 1), MLHFQ domain scores (Model 2), or MLHFQ item scores (Model 3). Six regression techniques, each of which has the capability to cope with either skewness, heteroscedasticity, ceiling effects and/or the potential presence of outliers in the data set were used to identify the optimal mapping functions for each of the three models. Goodness-of-fit of the models were assessed using six indicators. In the absence of an external validation dataset, predictive performance of was assessed using three-fold cross validation method. In the indirect response mapping, EQ. 5D 5 L responses were predicted separately using the MLHFQ item scores using ordered logit model. RESULTS: A total of 141 patients participated in the study. The lowest mean absolute error (MAE) was recorded from the multivariable fractional polynomials (MFP) model in all three-model specifications. Regarding the indirect response mapping, results showed that the performance was comparable with the direct mapping approach based on root mean squared error (RMSE) but was worse based on MAE. CONCLUSION: The MLHFQ can be mapped onto EQ-5D-5 L utilities with good predictive accuracy using both direct and indirect response mapping techniques. The reported mapping algorithms would facilitate calculation of health utility for economic evaluations related to heart failure.