Rationale and design of the early valve replacement in severe asymptomatic aortic stenosis trial.

BACKGROUND: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of 'watchful waiting'. METHODS: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary. Exclusion criteria include other severe valvular disease, planned cardiac surgery, ejection fraction <50%, previous aortic valve replacement or life expectancy <2 years. The primary outcome is a composite of cardiovascular mortality or heart failure hospitalization. The primary analysis will be undertaken when 663 primary events have accrued, providing 90% power to detect a reduction in the primary endpoint from 27.7% to 21.6% (hazard ratio 0.75). Secondary endpoints include disability-free survival, days alive and out of hospital, major adverse cardiovascular events and quality of life. RESULTS: Recruitment commenced in March 2020 and is open in the UK, Australia, New Zealand, and Serbia. Feasibility requirements were met in July 2022, and the main phase opened in October 2022, with additional international centers in set-up. CONCLUSIONS: The EASY-AS trial will establish whether a strategy of early aortic valve replacement in asymptomatic patients with severe aortic stenosis reduces cardiovascular mortality or heart failure hospitalization and improves other important outcomes.

Multimorbidity impacts cardiovascular disease risk following percutaneous coronary intervention: latent class analysis of the Melbourne Interventional Group (MIG) registry.

BACKGROUND: Multimorbidity is strongly associated with disability or functional decline, poor quality of life and high consumption of health care services. This study aimed (1) To identify patterns of multimorbidity among patients undergoing first recorded percutaneous coronary intervention (PCI); (2) To explore the association between the identified patterns of multimorbidity on length of hospital stay, 30-day and 12- month risk of major adverse cardiac and cerebrovascular events (MACCE) after PCI. METHODS: A retrospective cohort study of the Melbourne Interventional Group (MIG) registry. This study included 14,025 participants who underwent their first PCI from 2005 to 2015 in Victoria, Australia. Based on a probabilistic modelling approach, Latent class analysis was adopted to classify clusters of people who shared similar combinations and magnitude of the comorbidity of interest. Logistic regression models were used to estimate odd ratios and 95% confidence interval (CI) for the 30-day and 12-month MACCE. RESULTS: More than two-thirds of patients had multimorbidity, with the most prevalent conditions being hypertension (59%) and dyslipidaemia (60%). Four distinctive multimorbidity clusters were identified each with significant associations for higher risk of 30-day and 12-month MACCE. The cluster B had the highest risk of 30-day MACCE event that was characterised by a high prevalence of reduced estimated glomerular filtration rate (92%), hypertension (73%) and reduced ejection fraction (EF) (57%). The cluster C, characterised by a high prevalence of hypertension (94%), dyslipidaemia (88%), reduced eGFR (87%), diabetes (73%) and reduced EF (65%) had the highest risk of 12-month MACCE and highest length of hospital stay. CONCLUSION: Hypertension and dyslipidaemia are prevalent in at least four in ten patients undergoing coronary angioplasty. This study showed that clusters of patients with multimorbidity had significantly different risk of 30-day and 12-month MACCE after PCI. This suggests the necessity for treatment approaches that are more personalised and customised to enhance patient outcomes and the quality of care delivered to patients in various comorbidity clusters. These results should be validated in a prospective cohort and to evaluate the potential impacts of these clusters on the prevention of MACCE after PCI.

Data-driven collaborative QUality improvement in Cardiac Rehabilitation (QUICR) to increase program completion: protocol for a cluster randomized controlled trial.

BACKGROUND: Coronary heart disease (CHD) is the leading cause of deaths and disability worldwide. Cardiac rehabilitation (CR) effectively reduces the risk of future cardiac events and is strongly recommended in international clinical guidelines. However, CR program quality is highly variable with divergent data systems, which, when combined, potentially contribute to persistently low completion rates. The QUality Improvement in Cardiac Rehabilitation (QUICR) trial aims to determine whether a data-driven collaborative quality improvement intervention delivered at the program level over 12 months: (1) increases CR program completion in eligible patients with CHD (primary outcome), (2) reduces hospital admissions, emergency department presentations and deaths, and costs, (3) improves the proportion of patients receiving guideline-indicated CR according to national and international benchmarks, and (4) is feasible and sustainable for CR staff to implement routinely. METHODS: QUICR is a multi-centre, type-2, hybrid effectiveness-implementation cluster-randomized controlled trial (cRCT) with 12-month follow-up. Eligible CR programs (n = 40) and the individual patient data within them (n ~ 2,000) recruited from two Australian states (New South Wales and Victoria) are randomized 1:1 to the intervention (collaborative quality improvement intervention that uses data to identify and manage gaps in care) or control (usual care with data collection only). This sample size is required to achieve 80% power to detect a difference in completion rate of 22%. Outcomes will be assessed using intention-to-treat principles. Mixed-effects linear and logistic regression models accounting for clusters within allocated groupings will be applied to analyse primary and secondary outcomes. DISCUSSION: Addressing poor participation in CR by patients with CHD has been a longstanding challenge that needs innovative strategies to change the status-quo. This trial will harness the collaborative power of CR programs working simultaneously on common problem areas and using local data to drive performance. The use of data linkage for collection of outcomes offers an efficient way to evaluate this intervention and support the improvement of health service delivery. ETHICS: Primary ethical approval was obtained from the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH01093), along with site-specific governance approvals. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623001239651 (30/11/2023) ( https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386540&isReview=true ).

Long-Term Pattern and Associated Costs of Re-hospitalisations in Patients After Index Atrial Fibrillation Admission in Western Australia, 2011-2017.

AIMS: This study aimed to determine total and cardiovascular-specific re-hospitalisation patterns and associated costs within 2 years of index atrial fibrillation (AF) admission in Western Australia (WA). METHOD: Patients aged 25-94 years, surviving an index (first-in-period) AF hospitalisation (principal diagnosis) from 2011 to 2015 were identified from WA-linked administrative data and followed for 2 years. Person-level hospitalisation costs ($ Australian dollar) were computed using the Australian Refined Diagnosis Related Groups and presented as median with first and third quartile costs. RESULTS: The cohort comprised 17,080 patients, 59.0% men, mean age 69.6±13.3 (standard deviation) years, and 59.0% had a CHA2DS2-VA (one point for congestive heart failure, hypertension, diabetes mellitus, vascular disease or age 65-74 years; two points for prior stroke/transient ischaemic attack or age ≥75 years) score of 2 or more. Within 2 years, 13,776 patients (80.6%) were readmitted with median of 2 (1-4) readmissions. Among total all-cause readmissions (n=54,240), 40.1% were emergent and 36.6% were cardiovascular-related, led by AF (19.5%), coronary events (5.8%), and heart failure (4.2%). The median index AF admission cost was $3,264 ($2,899-$7,649) while cardiovascular readmission costs were higher, particularly stroke ($10,732 [$4,179-23,390]), AF ablation ($7,884 [$5,283-$8,878]), and heart failure ($6,759 [$6,081-$13,146]). Average readmission costs over 2 years per person increased by $4,746 (95% confidence interval [CI] $4,459-$5,033) per unit increase in baseline CHA2DS2-VA score. The average 2-year hospitalisation costs per patient, including index admission, was $27,820 (95% CI $27,308-$28,333) and total WA costs were $475.2 million between 2011 and 2017. CONCLUSIONS: Patients after index AF hospitalisation have a high risk of cardiovascular and other readmissions with considerable healthcare cost implications. Readmission costs increased progressively with baseline CHA2DS2-VA score. Better integrated management of AF and coexistent comorbidities is likely key to reducing readmissions and associated costs.

Sex- and Age-Specific Differences in Risk Profiles and Early Outcomes in Adults With Acute Coronary Syndromes.

BACKGROUND: Adults <55 years of age comprise a quarter of all acute coronary syndromes (ACS) hospitalisations. There is a paucity of data characterising this group, particularly sex differences. This study aimed to compare the clinical and risk profile of patients with ACS aged <55 years with older counterparts, and measure short-term outcomes by age and sex. METHOD: The study population comprised patients with ACS enrolled in the AUS-Global Registry of Acute Coronary Events (GRACE), Cooperative National Registry of Acute Coronary Syndrome Care (CONCORDANCE) and SNAPSHOT ACS registries. We compared clinical features and combinations of major modifiable risk factors (hypertension, smoking, dyslipidaemia, and diabetes) by sex and age group (20-54, 55-74, 75-94 years). All-cause mortality and major adverse events were identified in-hospital and at 6-months. RESULTS: There were 16,658 patients included (22.3% aged 20-54 years). Among them, 20-54 year olds had the highest proportion of ST-elevation myocardial infarction compared with sex-matched older age groups. Half of 20-54 year olds were current smokers, compared with a quarter of 55-74 year olds, and had the highest prevalence of no major modifiable risk factors (14.2% women, 12.7% men) and of single risk factors (27.6% women, 29.0% men), driven by smoking. Conversely, this age group had the highest proportion of all four modifiable risk factors (6.6% women, 4.7% men). Mortality at 6 months in 20-54 year olds was similar between men (2.3%) and women (1.7%), although lower than in older age groups. CONCLUSIONS: Younger adults with ACS are more likely to have either no risk factor, a single risk factor, or all four modifiable risk factors, than older patients. Targeted risk factor prevention and management is warranted in this age group.

Utilisation of Chronic Disease and Mental Health Management Services and Cardioprotective Medication Prescriptions in Primary Care for Patients With Cardiovascular Diseases and Cancer: A Cross-Sectional Study.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality among cancer survivors. Mental health is considered an important risk factor affecting the treatment of cardiovascular disease. However, little is known about the use of secondary prevention strategies for CVD in patients with both cancer and CVD. This study aimed to compare the utilisation of primary care chronic disease management plans, mental health care and guideline-indicated cardioprotective medications among CVD patients with and without cancer. METHODS: Retrospective cross-sectional study utilising clinical data of patients with CVD from 50 Australian primary care practices. Outcomes included the use of chronic disease management plans, mental health care, guideline-indicated cardioprotective medications and influenza vaccination. Logistic regression, accounting for demographic and clinical covariates and clustering effects by practices, was used to compare the two groups. RESULTS: Of the 15,040 patients with CVD, 1,486 patients (9.9%) concurrently had cancer. Patients with cancer, compared to those without, were older (77.6 vs 71.8 years, p<0.001), more likely to drink alcohol (62.6% vs 55.7%, p<0.001), have lower systolic (130.3±17.8 vs 132.5±21.1 mmHg, p<0.001) and diastolic (72.2±11 vs 75.3±34 mmHg, p<0.001) blood pressure. Although suboptimal for both groups, patients with cancer were significantly more likely to have general practice management plans (GPMPs) (51.4% vs 43.2%, p<0.001), coordination of team care arrangements (TCAs) (46.2% vs 37.0%, p<0.001), have a review of either GPMP or TCA (42.8% vs 34.7%, p<0.001), have a mental health treatment consultation (15.4% vs 10.5%, p=0.004) and be prescribed blood pressure-lowering medications (70.1% vs 66.0%, p=0.002). However, there were no statistical differences in the prescription of lipid-lowering or antiplatelet medications. After adjustments for covariates and multiple testing, patients with cancer did not show a difference in GPMPs, TCAs, and a review of either, but were more likely to receive mental health treatment consultations than those without cancer (odds ratio 1.76; 95% confidence interval 1.42-2.19). CONCLUSIONS: Less than half of patients with CVD had a GPMP, TCA or review of either. Although those patients with cancer were more likely to receive these interventions, still around half the patients did not. Medicare-funded GPMPs, TCAs and a review of either GPMP or TCA were underutilised, and future studies should seek to identify ways of improving access to these services.

Clinical outcomes and health care costs of transferring rural Western Australians for invasive coronary angiography, and a cost-effective alternative care model: a retrospective cross-sectional study.

OBJECTIVES: To examine the severity of coronary artery disease (CAD) in people from rural or remote Western Australia referred for invasive coronary angiography (ICA) in Perth and their subsequent management; to estimate the cost savings were computed tomography coronary angiography (CTCA) offered in rural centres as a first line investigation for people with suspected CAD. DESIGN: Retrospective cohort study. SETTING, PARTICIPANTS: Adults with stable symptoms in rural and remote WA referred to Perth public tertiary hospitals for ICA evaluation during the 2019 calendar year. MAIN OUTCOME MEASURES: Severity and management of CAD (medical management or revascularisation); health care costs by care model (standard care or a proposed alternative model with local CTCA assessment). RESULTS: The mean age of the 1017 people from rural and remote WA who underwent ICA in Perth was 62 years (standard deviation, 13 years); 680 were men (66.9%), 245 were Indigenous people (24.1%). Indications for referral were non-ST elevation myocardial infarction (438, 43.1%), chest pain with normal troponin level (394, 38.7%), and other (185, 18.2%). After ICA assessment, 619 people were medically managed (60.9%) and 398 underwent revascularisation (39.1%). None of the 365 patients (35.9%) without obstructed coronaries (< 50% stenosis) underwent revascularisation; nine patients with moderate CAD (50-69% stenosis; 7%) and 389 with severe CAD (≥ 70% stenosis or occluded vessel; 75.5%) underwent revascularisation. Were CTCA used locally to determine the need for referral, 527 referrals could have been averted (53%), the ICA:revascularisation ratio would have improved from 2.6 to 1.6, and 1757 metropolitan hospital bed-days (43% reduction) and $7.3 million in health care costs (36% reduction) would have been saved. CONCLUSION: Many rural and remote Western Australians transferred for ICA in Perth have non-obstructive CAD and are medically managed. Providing CTCA as a first line investigation in rural centres could avert half of these transfers and be a cost-effective strategy for risk stratification of people with suspected CAD.

Evidence-based medication adherence among seniors in the first year after heart failure hospitalisation and subsequent long-term outcomes: a restricted cubic spline analysis of adherence-outcome relationships.

PURPOSE: Non-adherence to heart failure (HF) medications is associated with poor outcomes. We used restricted cubic splines (RCS) to assess the continuous relationship between adherence to renin-angiotensin system inhibitors (RASI) and ß-blockers and long-term outcomes in senior HF patients. METHODS: We identified a population-based cohort of 4234 patients, aged 65-84 years, 56% male, who were hospitalised for HF in Western Australia between 2003 and 2008 and survived to 1-year post-discharge (landmark date). Adherence was calculated using the proportion of days covered (PDC) in the first year post-discharge. RCS Cox proportional-hazards models were applied to determine the relationship between adherence and all-cause death and death/HF readmission at 1 and 3 years after the landmark date. RESULTS: RCS analysis showed a curvilinear adherence-outcome relationship for both RASI and ß-blockers which was linear above PDC 60%. For each 10% increase in RASI and ß-blocker adherence above this level, the adjusted hazard ratio for 1-year all-cause death fell by an average of 6.6% and 4.8% respectively (trend p < 0.05) and risk of all-cause death/HF readmission fell by 5.4% and 5.8% respectively (trend p < 0.005). Linear reductions in adjusted risk for these outcomes at PDC ≥ 60% were also seen at 3 years after landmark date (all trend p < 0.05). CONCLUSION: RCS analysis showed that for RASI and ß-blockers, there was no upper adherence level (threshold) above 60% where risk reduction did not continue to occur. Therefore, interventions should maximise adherence to these disease-modifying HF pharmacotherapies to improve long-term outcomes after hospitalised HF.

Unplanned 30-day readmissions, comorbidity and impact on one-year mortality following incident heart failure hospitalisation in Western Australia, 2001-2015.

BACKGROUND: Readmissions within 30 days after heart failure (HF) hospitalisation is considered an important healthcare quality metric, but their impact on medium-term mortality is unclear within an Australian setting. We determined the frequency, risk predictors and relative mortality risk of 30-day unplanned readmission in patients following an incident HF hospitalisation. METHODS: From the Western Australian Hospitalisation Morbidity Data Collection we identified patients aged 25-94 years with an incident (first-ever) HF hospitalisation as a principal diagnosis between 2001 and 2015, and who survived to 30-days post discharge. Unplanned 30-day readmissions were categorised by principal diagnosis. Logistic and Cox regression analysis determined the independent predictors of unplanned readmissions in 30-day survivors and the multivariable-adjusted hazard ratio (HR) of readmission on mortality within the subsequent year. RESULTS: The cohort comprised 18,241 patients, mean age 74.3 ± 13.6 (SD) years, 53.5% males, and one-third had a modified Charlson Comorbidity Index score of ≥ 3. Among 30-day survivors, 15.5% experienced one or more unplanned 30-day readmission, of which 53.9% were due to cardiovascular causes; predominantly HF (31.4%). The unadjusted 1-year mortality was 15.9%, and the adjusted mortality HR in patients with 1 and ≥ 2 cardiovascular or non-cardiovascular readmissions (versus none) was 1.96 (95% confidence interval (CI) 1.80-2.14) and 3.04 (95% CI, 2.51-3.68) respectively. Coexistent comorbidities, including ischaemic heart disease/myocardial infarction, peripheral arterial disease, pneumonia, chronic kidney disease, and anaemia, were independent predictors of both 30-day unplanned readmission and 1-year mortality. CONCLUSION: Unplanned 30-day readmissions and medium-term mortality remain high among patients who survived to 30 days after incident HF hospitalisation. Any cardiovascular or non-cardiovascular readmission was associated with a two to three-fold higher adjusted HR for death over the following year, and various coexistent comorbidities were important associates of readmission and mortality risk. Our findings support the need to optimize multidisciplinary HF and multimorbidity management to potentially reduce repeat hospitalisation and improve survival.

Improving prioritization processes for clinical practice guidelines: new methods and an evaluation from the National Heart Foundation of Australia.

BACKGROUND: Releasing timely and relevant clinical guidelines is challenging for organizations globally. Priority-setting is crucial, as guideline development is resource-intensive. Our aim, as a national organization responsible for developing cardiovascular clinical guidelines, was to develop a method for generating and prioritizing topics for future clinical guideline development in areas where guidance was most needed. METHODS: Several novel processes were developed, adopted and evaluated, including (1) initial public consultation for health professionals and the general public to generate topics; (2) thematic and qualitative analysis, according to the International Classification of Diseases (ICD-11), to aggregate topics; (3) adapting a criteria-based matrix tool to prioritize topics; (4) achieving consensus through a modified-nominal group technique and voting on priorities; and (5) process evaluation via survey of end-users. The latter comprised the organization's Expert Committee of 12 members with expertise across cardiology and public health, including two citizen representatives. RESULTS: Topics (n = 405; reduced to n = 278 when duplicates removed) were identified from public consultation responses (n = 107 respondents). Thematic analysis synthesized 127 topics that were then categorized into 37 themes using ICD-11 codes. Exclusion criteria were applied (n = 32 themes omitted), resulting in five short-listed topics: (1) congenital heart disease, (2) valvular heart disease, (3) hypercholesterolaemia, (4) hypertension and (5) ischaemic heart diseases and diseases of the coronary artery. The Expert Committee applied the prioritization matrix to all five short-listed topics during a consensus meeting and voted to prioritize topics. Unanimous consensus was reached for the topic voted the highest priority: ischaemic heart disease and diseases of the coronary arteries, resulting in the decision to update the organization's 2016 clinical guidelines for acute coronary syndromes. Evaluation indicated that initial public consultation was highly valued by the Expert Committee, and the matrix tool was easy to use and improved transparency in priority-setting. CONCLUSION: Developing a multistage, systematic process, incorporating public consultation and an international classification system led to improved transparency in our clinical guideline priority-setting processes and that topics chosen would have the greatest impact on health outcomes. These methods are potentially applicable to other national and international organizations responsible for developing clinical guidelines.

Unplanned Readmissions and Long-Term Mortality Risk After Incident Heart Failure Hospitalisation in Western Australia, 2001-2015.

AIMS: To investigate the frequency and predictors of unplanned readmissions after incident heart failure (HF) hospitalisation and the association between readmissions and mortality over two years. METHODS: We performed a retrospective cohort study using Western Australian morbidity and mortality data to identify all patients, aged 25-94 years, who survived an incident (first-ever) HF hospitalisation (principal diagnosis) between 2001-2015. Ordinal logistic regression models determined the covariates independently associated with unplanned readmission(s). Cox proportional hazards models with time-varying exposures determined the hazard ratios (HR) of one or more readmissions for mortality over two years after incident HF. RESULTS: Of 18,693 patients, 53.4% male, mean age 74.4 (standard deviation [SD] 13.6) years, 61.3% experienced 32,431 unplanned readmissions (39.7% cardiovascular-related) within two years. Leading readmission causes were HF (19.1%), respiratory diseases (12.6%), and ischaemic heart disease (9.6%). All-cause death occurred in 27.2% of the cohort, and the multivariable-adjusted mortality HR of 1 (versus 0) readmission was 2.5 (95% confidence interval [CI], 2.3-2.7) increasing to 5.0 (95% CI, 4.7-5.4) for 2+ readmissions. The adjusted mortality HR of 1 and 2+ (versus 0) HF-specific readmission was 2.0 (95% CI, 1.8-2.1) and 3.6 (95% CI, 3.2-3.9), respectively. Coexistent cardiovascular and other comorbidities were independently associated with increased readmission and mortality risk. CONCLUSION: This study underlines the high burden of recurrent unplanned cardiovascular and other readmissions within two years after incident HF hospitalisation, and their additive adverse impact on mortality. Integrated multidisciplinary management of concomitant comorbidities, in addition to HF-targeted treatments, is necessary to improve long-term prognosis in HF patients.

A Clinical Guide for Assessment and Prescription of Exercise and Physical Activity in Cardiac Rehabilitation. A CSANZ Position Statement.

Patients with cardiovascular disease benefit from cardiac rehabilitation, which includes structured exercise and physical activity as core components. This position statement provides pragmatic, evidence-based guidance for the assessment and prescription of exercise and physical activity for cardiac rehabilitation clinicians, recognising the latest international guidelines, scientific evidence and the increasing use of technology and virtual delivery methods. The patient-centred assessment and prescription of aerobic exercise, resistance exercise and physical activity have been addressed, including progression and safety considerations.

The New South Wales Sudden Cardiac Arrest Registry: A Data Linkage Cohort Study.

BACKGROUND: Sudden cardiac arrest (SCA) in young people aged 1 to 50 years often occurs with no presenting symptoms or risk factors prompting screening for cardiovascular disease prior to their cardiac arrest. Approximately 3,000 young Australians suffer from sudden cardiac death (SCD) each year, making this a major public health issue. However, there is significant variation in the way incidence is estimated resulting in discrepancy across reporting which impacts our ability to understand and prevent these devastating events. We describe the New South Wales (NSW) Sudden Cardiac Arrest Registry: a retrospective, data linkage study which will identify all SCAs in the young in NSW from 2009 through to June 2022. OBJECTIVE: To determine the incidence, demographic characteristics and causes of SCA in young people. We will develop an NSW-based registry that will contribute to a greater understanding of SCA including risk factors and outcomes. METHODS: The cohort will include all people who experience a SCA in the NSW community aged between 1 to 50 years. Cases will be identified using the following three datasets: the Out of Hospital Cardiac Arrest Register housed at NSW Ambulance, the NSW Emergency Department Data Collection, and the National Coronial Information System. Data from eight datasets will be collected, anonymised and linked for the entire cohort. Analysis will be undertaken and reported using descriptive statistics. CONCLUSIONS: The NSW SCA registry will be an important resource for the improved understanding of SCA and inform the widespread impacts it has on individuals, their families and society.

A National Survey of Patient Data Capture, Management, Reporting Practice in Australian Cardiac Rehabilitation Programs.

BACKGROUND: Lack of service data for cardiac rehabilitation limits understanding of program delivery, benchmarking and quality improvement. This study aimed to describe current practices, management, utilisation and engagement with quality indicators in Australian programs. METHOD: Cardiac rehabilitation programs (n=396) were identified from national directories and networks. Program coordinators were surveyed on service data capture, management systems and adoption of published national quality indicators. Text responses were coded and classified. Logistic regression determined independent associates of the use of data for quality improvement. RESULTS: A total of 319 (81%) coordinators completed the survey. Annual patient enrolments/programs were >200 (31.0%), 51-200 (46%) and ≤50 (23%). Most (79%) programs used an electronic system, alongside paper (63%) and/or another electronic system (19%), with 21% completely paper. While 84% knew of the national quality indicators, only 52% used them. Supplementary to patient care, data were used for reports to managers (57%) and funders (41%), to improve quality (56%), support funding (43%) and research (31%). Using data for quality improvement was more likely when enrolments where >200 (Odds ratio [OR] 3.83, 95% Confidence Interval [CI] 1.76-8.34) and less likely in Victoria (OR 0.24 95%, CI 0.08-0.77), New South Wales (OR 0.25 95%, CI 0.08-0.76) and Western Australia (OR 0.16 95%, CI 0.05-0.57). CONCLUSIONS: The collection of service data for cardiac rehabilitation patient data and its justification is diverse, limiting our capacity to benchmark and drive clinical practice. The findings strengthen the case for a national low-burden approach to data capture for quality care.

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

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

Conventional Glycaemic Control May Not Be Beneficial in Diabetic Patients Following Cardiac Surgery.

INTRODUCTION: Stress hyperglycaemia is common following cardiac surgery. Its optimal management is uncertain and emerging literature suggests that flexible glycaemic control in diabetic patients may be preferable. This study aims to assess the relationship between maximal postoperative in-hospital blood glucose levels (BSL) and the morbidity and mortality outcomes of diabetic and non-diabetic cardiac surgery patients. METHODS: A retrospective cohort analysis of all patients undergoing cardiac surgery at a tertiary single centre institution from 2015 to 2019 was undertaken. Early management and outcomes of hyperglycaemia following cardiac surgery were assessed via multivariable regression modelling. Follow-up was assessed to 1 year postoperatively. RESULTS: Consecutive non-diabetic patients (n=1,050) and diabetic patients (n=689) post cardiac surgery were included. Diabetics with peak BSL ≤13.9 mmol/L did not have an increased risk of morbidity or mortality compared to non-diabetics with peak BSL ≤10.0 mmol/L. In non-diabetics, stress hyperglycaemia with peak BSL >10.0 mmol/L was associated with overall wound complications (5.7% vs 8.8%, OR 1.64 [1.00-2.69], p=0.049) and postoperative pneumonia (2.7% vs 7.3%, OR 2.35 [1.26-4.38], p=0.007). Diabetic patients with postoperative peak BSL >13.9 mmol/L were at an increased risk of overall wound complication (7.4% vs 14.8%, OR 2.47 [1.46-4.16], p<0.001), graft harvest site infection (3.7% vs 11.8%, OR 3.75 [1.92-7.30], p<0.001), and wound-related readmission (3.1% vs 8.8%, OR 3.11 [1.49-6.47], p=0.002) when compared to diabetics with peak BSL ≤13.9 mmol/L. CONCLUSION: In non-diabetics, stress hyperglycaemia with peak BSL >10.0 mmol/L is associated with morbidity. In diabetic patients, hyperglycaemia with peak BSL ≤13.9 mmol/L was not associated with an increased risk of morbidity or mortality compared to non-diabetics with peak BSL ≤10.0 mmol/L. Further investigation of flexible glycaemic targets (target BSL ≤13.9 mmol/L) in diabetic patients is warranted.

Validation of ICD-10-AM Coding for Myocardial Infarction Subtype in Hospitalisation Data.

BACKGROUND: International Classification of Disease (ICD) codes are central for identifying myocardial infarction (MI) in administrative hospitalisation data, however validation of MI subtype codes is limited. We measured the sensitivity and specificity of ICD-10-AM (Australian Modification) codes for ST-elevation MI (STEMI) and non-STEMI (NSTEMI). METHODS: A sample of MI admissions was obtained from a dataset containing all MI hospitalisations in Western Australia (WA) for 2003, 2008 and 2013. Clinical data were collected from hospital medical records (n=799 patients). Cases were classified by ICD-10-AM codes for STEMI, NSTEMI and unspecified MI, and compared to clinical classification from review of available electrocardiographs (ECGs) and cardiac biomarkers (n=660). Sensitivity and specificity for ICD-10-AM coding versus clinical classification was measured, stratified by calendar year of discharge. RESULTS: The majority of classifiable cases had MI recorded in the principal diagnosis field (STEMI n=293, 84.2%; NSTEMI n=202, 74.3%; unspecified MI n=20, 50.0%). Overall sensitivity of the ICD-10-AM STEMI code was 86.3% (95% CI 81.7-90.0%) and was higher when restricted to MI as a principal versus secondary diagnosis (88.8% vs 66.7%). Comparable values for NSTEMI were 66.7% (95% CI 61.5-71.6%), and 68.8% vs 61.4% respectively. Between 2003 and 2013, sensitivity for both MI subtypes increased: 80.2-89.5% for STEMI, and 51.2-73.8% for NSTEMI. Specificity was high for NSTEMI throughout (88.2% 95% CI 84.1-91.6%), although improving over time for STEMI (68.1-76.4%). CONCLUSIONS: The sensitivity and specificity of ICD-10-AM codes for MI subtypes in hospitalisation data are generally high, particularly for principal diagnosis cases. However, the temporal improvement in sensitivity in coding of MI subtypes, particularly NSTEMI, may necessitate modification to trend studies using administrative hospitalisation data.

Applying a framework to assess the impact of cardiovascular outcomes improvement research.

BACKGROUND: Health and medical research funding agencies are increasingly interested in measuring the impact of funded research. We present a research impact case study for the first four years of an Australian National Health and Medical Research Council funded Centre of Research Excellence in Cardiovascular Outcomes Improvement (2016-2020). The primary aim of this paper was to explore the application of a research impact matrix to assess the impact of cardiovascular outcomes improvement research. METHODS: We applied a research impact matrix developed from a systematic review of existing methodological frameworks used to measure research impact. This impact matrix was used as a bespoke tool to identify and understand various research impacts over different time frames. Data sources included a review of existing internal documentation from the research centre and publicly available information sources, informal iterative discussions with 10 centre investigators, and confirmation of information from centre grant and scholarship recipients. RESULTS: By July 2019, the impact on the short-term research domain category included over 41 direct publications, which were cited over 87 times (median journal impact factor of 2.84). There were over 61 conference presentations, seven PhD candidacies, five new academic collaborations, and six new database linkages conducted. The impact on the mid-term research domain category involved contributions towards the development of a national cardiac registry, cardiovascular guidelines, application for a Medicare Benefits Schedule reimbursement item number, introduction of patient-reported outcome measures into several databases, and the establishment of nine new industry collaborations. Evidence of long-term impacts were described as the development and use of contemporary management for aortic stenosis, a cardiovascular risk prediction model and prevention targets in several data registries, and the establishment of cost-effectiveness for stenting compared to surgery. CONCLUSIONS: We considered the research impact matrix a feasible tool to identify evidence of academic and policy impact in the short- to midterm; however, we experienced challenges in capturing long-term impacts. Cost containment and broader economic impacts represented another difficult area of impact to measure.

Antithrombotic Therapy in Atrial Fibrillation Management in Western Australia: Temporal Trends and Evidence-Treatment Gaps.

OBJECTIVE: To describe temporal trends in appropriate antithrombotic therapy use in hospitalised atrial fibrillation (AF) patients and identify evidence-treatment gaps in clinical practice. DESIGN: Retrospective cohort study from January 2009-March 2016. SETTING: Tertiary and secondary teaching hospitals in Perth, Western Australia. PARTICIPANTS: Hospitalised adults with non-valvular AF. RESULTS: We identified 11,294 index AF admissions, with a mean age of 76.9 years, 45.8% women and 86.3% at high risk of stroke (CHA2DS2-VASc score ≥2 in men and ≥3 in women). In high risk subjects use of appropriate antithrombotic therapy improved over time with increasing oral anticoagulant (OAC) use and declining sole antiplatelet use (both trend p<0.001). However, by study end only 45.3% of high-risk patients were receiving OAC therapy. In low risk patients, receipt of OAC therapy was steady throughout the study at 40.5% (trend p=0.10). The gender gap in OAC use narrowed over time, with no significant difference between high risk men and women by study end. Use of OAC therapy in elderly patients (age ≥75 years) remained lower than younger patients (age <65 years) over the entire period, with only 31% of elderly patients receiving OAC therapy at study end. From 2012 onwards use of non-vitamin K oral anticoagulants (NOACs) doubled each year with declining warfarin use (both trend p<0.001). CONCLUSION: Despite substantial uptake of NOACs, OAC therapy in AF patients at high risk of stroke remains under-utilised in Western Australia and over-utilised in low risk patients. Further work is required to reduce treatment-risk mismatch for stroke prevention in AF patients.

A Versatile Big Data Health System for Australia: Driving Improvements in Cardiovascular Health.

Cardiovascular diseases (CVD) are leading causes of death and morbidity in Australia and worldwide. Despite improvements in treatment, there remain large gaps in our understanding to prevent, treat and manage CVD events and associated morbidities. This article lays out a vision for enhancing CVD research in Australia through the development of a Big Data system, bringing together the multitude of rich administrative and health datasets available. The article describes the different types of Big Data available for CVD research in Australia and presents an overview of the potential benefits of a Big Data system for CVD research and some of the major challenges in establishing the system for Australia. The steps for progressing this vision are outlined.