Use of Imaging-guided Decongestion for Reducing Heart Failure Readmission and Death in High-risk Patients: A Multi-site Randomized Trial of a Nurse-led Strategy at the Point of Care.

BACKGROUND: Nurse-led disease management programs (DMPs) decrease readmission after acute decompensated heart failure (HF). We sought whether readmissions could be further reduced by lung ultrasound (LUS)-guided decongestion before discharge and during DMP. METHODS AND RESULTS: Of 290 patients hospitalized with acute decompensated HF, 122 at high risk for readmission or mortality were randomized to receive usual care (UC) (n = 64) or UC plus intervention (DMP-Plus) (n = 58), comprising LUS-guided management before discharge and during at-home follow-up. Residual congestion was identified by ≥10 B-lines detected in 8 lung zones. The outcomes included a composite of readmission and/or mortality at 30 and 90 days, and 90-day HF readmission. Residual congestion was detected equally among the patient groups. The 30-day composite outcome occurred in 28% DMP-plus patients and 22% UC patients (odd ratio [OR], 1.36; 95% confidence interval [CI], 0.59-3.1; P = .5) and the 90-day HF readmission outcome occurred in 22% and 31%, respectively (odds ratio, 0.63; 95% CI, 0.28-1.43; P = .3). Residual congestion, identified at predischarge LUS examination in high-risk patients, was associated with early (<14-day) HF readmission (relative risk, 1.19; 95% CI, 1.06-1.32; P = .002) and multiple (≥2) readmissions over 90 days of follow-up (relative risk, 1.09; 95% CI, 1.01-1.16; P = .012), independent of demographics and comorbidities. CONCLUSIONS: Readmission in patients with incomplete decongestion before discharge occurs within the first 2 weeks. However, our DMP-plus strategy did not improve the primary outcome.

Cardiovascular disease hospitalizations among women who undergo fertility treatment.

RESEARCH QUESTION: Are women who receive fertility treatment at increased risk of cardiovascular disease (CVD) hospitalization compared with women who do not? DESIGN: A retrospective cohort study of all women registered for fertility treatment at Monash IVF between 1998 and 2014. This cohort was linked to the Victorian Admitted Episodes Dataset, which contains records of all hospital admissions in the Australian state of Victoria. Age- and Index of Relative Socioeconomic Disadvantage (IRSD)-adjusted relative risks of CVD hospitalization for women who did or did not undergo fertility treatment were determined using Poisson regression. Risks were calculated overall by CVD subtype and stratified by area-based social disadvantage using IRSD fifths, number of stimulated cycles and mean oocytes per cycle. RESULTS: Of 27,262 women registered for fertility treatment, 24,131 underwent treatment and 3131 did not. No significant difference was found in risk of CVD hospitalization between treated and untreated women overall (adjusted RR 0.93, 95% 0.82 to 1.05) or by CVD subtype. The admission risk for CVD was significantly lower in treated women who had a mean of fewer than five oocytes per cycle (adjusted RR 0.80, 95% CI 0.70 to 0.92) compared with untreated women. Treated women residing in areas within the second IRSD fifth were less likely to be hospitalized for CVD compared with untreated women (age-adjusted RR 0.66, 95% CI 0.49 to 0.89). CONCLUSIONS: Fertility treatment is not associated with increased risk of CVD hospitalization. Lower risk among some subgroups of treated women may be explained by social disadvantage.

Optimising the implementation of digital-supported interventions for the secondary prevention of heart disease: a systematic review using the RE-AIM planning and evaluation framework.

BACKGROUND: mHealth technologies are now widely utilised to support the delivery of secondary prevention programs in heart disease. Interventions with mHealth included have shown a similar efficacy and safety to conventional programs with improvements in access and adherence. However, questions remain regarding the successful wider implementation of digital-supported programs. By applying the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework to a systematic review and meta-analysis, this review aims to evaluate the extent to which these programs report on RE-AIM dimensions and associated indicators. METHODS: This review extends our previous systematic review and meta-analysis that investigated the effectiveness of digital-supported programs for patients with coronary artery disease. Citation searches were performed on the 27 studies of the systematic review to identify linked publications that reported data for RE-AIM dimensions. All included studies and, where relevant, any additional publications, were coded using an adapted RE-AIM extraction tool. Discrepant codes were discussed amongst reviewers to gain consensus. Data were analysed to assess reporting on indicators related to each of the RE-AIM dimensions, and average overall reporting rates for each dimension were calculated. RESULTS: Searches found an additional nine publications. Across 36 publications that were linked to the 27 studies, 24 (89%) of the studies were interventions solely delivered at home. The average reporting rates for RE-AIM dimensions were highest for effectiveness (75%) and reach (67%), followed by adoption (54%), implementation (36%) and maintenance (11%). Eleven (46%) studies did not describe relevant characteristics of their participants or of staff involved in the intervention; most studies did not describe unanticipated consequences of the intervention; the ongoing cost of intervention implementation and maintenance; information on intervention fidelity; long-term follow-up outcomes, or program adaptation in other settings. CONCLUSIONS: Through the application of the RE-AIM framework to a systematic review we found most studies failed to report on key indicators. Failing to report these indicators inhibits the ability to address the enablers and barriers required to achieve optimal intervention implementation in wider settings and populations. Future studies should consider alternative hybrid trial designs to enable reporting of implementation indicators to improve the translation of research evidence into routine practice, with special consideration given to the long-term sustainability of program effects as well as corresponding ongoing costs. REGISTRATION: PROSPERO-CRD42022343030.

Use of coronary computed tomography or polygenic risk scores to prompt action to reduce coronary artery disease risk: the CAPAR-CAD trial.

BACKGROUND: The traditional primary prevention paradigm for coronary artery disease (CAD) centers on population-based algorithms to classify individual risk. However, this approach often misclassifies individuals and leaves many in the 'intermediate' category, for whom there is no clear preferred prevention strategy. Coronary artery calcium (CAC) and polygenic risk scoring (PRS) are 2 contemporary tools for risk prediction to enhance the impact of effective management. AIMS: To determine how these CAC and PRS impact adherence to pharmacotherapy and lifestyle measures in asymptomatic individuals with subclinical atherosclerosis. METHODS: The CAPAR-CAD study is a multicenter, open, randomized controlled trial in Victoria, Australia. Participants are self-selected individuals aged 40 to 70 years with no prior history of cardiovascular disease (CVD), intermediate 10-year risk for CAD as determined by the pooled cohort equation (PCE), and CAC scores >0. All participants will have a health assessment, a full CT coronary angiogram (CTCA), and PRS calculation. They will then be randomized to receive their risk presented either as PCE and CAC, or PCE and PRS. The intervention includes e-Health coaching focused on risk factor management, health education and pharmacotherapy, and follow-up to augment adherence to a statin medication. The primary endpoint is a change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months. The secondary endpoint is between-group differences in behavior modification and adherence to statin pharmacotherapy. RESULTS: As of July 31, 2021, we have screened 1,903 individuals. We present the results of the 574 participants deemed eligible after baseline assessment.

Long term all-cause and cardiovascular disease mortality among women who undergo fertility treatment.

OBJECTIVES: To compare age-adjusted all-cause and CVD mortality, relative to the general female population, for women registered for fertility treatment who received it and those who did not. DESIGN: Prospective cohort study; analysis of Monash IVF clinical registries data, 1975-2018, linked with National Death Index mortality data. PARTICIPANTS: All women who registered for fertility treatment at Monash IVF (Melbourne, Victoria), 1 January 1975 - 1 January 2014, followed until 31 December 2018. MAIN OUTCOME MEASURES: Standardised mortality ratios (SMRs) for all-cause and CVD mortality, for women who did or did not undergo fertility treatment; SMRs stratified by area-level socio-economic disadvantage (SEIFA Index of Relative Socioeconomic Disadvantage [IRSD]) and (for women who underwent treatment), by stimulated cycle number and mean oocytes/cycle categories. RESULTS: Of 44 149 women registered for fertility treatment, 33 520 underwent treatment (66.4%), 10 629 did not. After adjustment for age, both all-cause (SMR, 0.58; 95% CI, 0.54-0.62) and CVD mortality (SMR, 0.41; 95% CI, 0.32-0.53) were lower than for the general female population. All-cause mortality was similar for women registered with Monash IVF who did (SMR, 0.55; 95% CI, 0.50-0.60) or did not undergo fertility treatment (SMR, 0.63; 95% CI, 0.56-0.70). The SMR was lowest for both treated and untreated women in the fifth IRSD quintile (least disadvantage), but the difference was statistically significant only for untreated women. CVD mortality was lower for registered women who underwent fertility treatment (SMR, 0.29; 95% CI, 0.19-0.43) than for those who did not (SMR, 0.58; 95% CI, 0.42-0.81). CONCLUSION: Fertility treatment does not increase long term all-cause or CVD mortality risk. Lower mortality among women registered for fertility treatment probably reflected their lower socio-economic disadvantage.

Association between arthritis and cardiovascular risk factors in community-based adults: an opportunity to target cardiovascular risk.

BACKGROUND: Undertreated risk factors are major contributors to the burden of cardiovascular disease (CVD). Those with arthritis have an increased prevalence of CVD risk factors. CVD risk factors are often asymptomatic, which may be a barrier their treatment. Arthritis causes pain and immobility, and is a common reason for individuals to seek healthcare. Our aims were to (1) examine the relationship between arthritis and CVD risk factors in Australian adults, and (2) calculate the proportion of CVD risk factors that could be reduced if individuals with arthritis were targeted. METHODS: This cross-sectional study uses data from the 2017-18 Australian National Health Survey which included 13,776 participants, categorised into young (18-39 years), middle aged (40-64 years) and older (≥ 65 years) adults. Hypertension, height and weight were measured. Arthritis, dyslipidemia and diabetes were self-reported. The associations between arthritis and CVD risk factors were examined using logistic regression, and the population attributable fraction (PAF) of arthritis for each CVD risk factor was calculated. RESULTS: Arthritis was reported by 4.0% of young adults, 28.8% of middle-aged adults and 54.5% of older adults. Those with arthritis were at increased odds of obesity (2.07 fold in young, 1.75 fold in middle-aged and 1.89 fold in older adults), increased odds of diabetes (5.70 fold in young, 1.64 fold in middle-aged and 1.37 fold in older adults), increased odds of hypertension (2.72 fold in young, 1.78 fold in middle-aged and 1.48 fold in older adults) and an increased odds of dyslipidaemia (4.64 fold in young, 2.14 fold in middle-aged and 1.22 fold in older adults) compared to those without arthritis. This elevated chance remained significant even after adjusting for obesity, with the exception of diabetes in the older population. This elevated chance remained significant even after adjusting for obesity, with the exception of diabetes in the older population. The PAF of the presence of arthritis for having at least one CVD risk factor was 30.7% in middle-aged adults and 70.4% in older adults. CONCLUSION: Australian adults of all ages with arthritis are at increased odds of having CVD risk factors. For young and middle-aged adults, this increased odds remains significant even when adjusted for obesity. Presentation to healthcare practitioners with arthritis is an opportunity to screen for asymptomatic CVD risk factors with the potential of improving outcomes for both diseases. By adopting an approach of managing arthritis and CVD risk factors in parallel, rather than in silos, we could reduce the burden of CVD risk factors by 20-30%.

Improved sleep efficiency is associated with reduced cardio-metabolic risk: Findings from the MODERN trial.

Poor sleep increases cardio-metabolic risk, but limited information on the impact of sleep for the improvement of cardio-metabolic health exists. This analysis examined the impact of sleep on a health and lifestyle modification programme to reduce cardio-metabolic disease risk factors. Secondary analysis of the MODERN randomised controlled trial to reduce cardio-metabolic risk was undertaken at baseline and 24-month follow-up. Participants aged 40-70 years (n = 121) with three or more cardio-metabolic risk factors were randomised to a health and lifestyle modification intervention (n = 59) or usual care (n = 62), and underwent 7 day/night actigraphy to assess total sleep time, sleep efficiency (%), number of awakenings/night and physical activity levels. Blood pressure, blood lipid and glycaemic levels, anthropometric and diet measures were collected. The mean age was 59 ± 7 years and 37% were male. Baseline sleep measures were not different between groups. At the 24-month follow-up, both groups showed improvements in cardio-metabolic risk factors, albeit the change in blood pressure was greater in the intervention compared with the usual care group (systolic blood pressure: -11 versus -4 mmHg, p = .014). There were no differences between groups for diet, physical activity or sleep parameters. An increase in sleep efficiency was independently associated with lower systolic blood pressure (ß = -2.117, p = .002) and higher high-density lipoprotein levels (ß = 0.040, p = .033); an increase in total sleep time was associated with lower low-density lipoprotein levels (ß = -0.003, p = .038) at 24 months. Overall, improvement in sleep quality over time was beneficial to reduce blood pressure and lipid levels. These findings highlight sleep as a potential target to reduce cardio-metabolic risk.

Sleep quantity and quality and cardiometabolic risk factors in Indigenous Australians.

Poor sleep is associated with increased risk of cardiovascular disease (CVD). Indigenous Australians have 1.3 times higher risk of CVD compared to non-indigenous Australians. However, there are limited data describing sleep problems and cardiometabolic risk in this population. This study aimed to investigate sleep quantity and quality in indigenous Australians and assess its association with cardiometabolic risk. Two hundred and forty-five indigenous Australians aged > 18 years were recruited via convenience sampling from communities in the Northern Territory and Queensland. Sleep quantity and quality was assessed subjectively with questionnaires including the Epworth Sleepiness Scale. In a sub-population (n = 46), objective sleep assessment was performed over three nights of actigraphy. Cardiometabolic risk measures included glycated haemoglobin, lipids, anthropometric measurements and sitting blood pressure. Sleep duration measured subjectively and objectively averaged 7.5 ± 2.0 hr/night; however, over one-third of participants (self-report 35%; actigraphy 39%) obtained < 7 hr/night. Overall, more than a third of participants experienced poor-quality sleep, with 27% reporting severe daytime sleepiness (ESS score > 10) and a high number of objectively measured awakenings/night (6 ± 4). Short sleep duration (<6 hr/night) measured both subjectively and objectively was an independent predictor of diastolic (ß = 5.37, p = .038) and systolic blood pressure (ß = 14.30, p = .048). More objectively measured night-time awakenings were associated with increased glycated haemoglobin levels (ß = 0.07, p = .020) and greater sleep fragmentation was associated with lower high-density lipoprotein levels (ß = -0.01, p = .025). A large proportion of indigenous Australians experienced short sleep durations and had significant sleep disruption. Poor sleep quantity and quality may contribute to heightened cardiometabolic risk in this population.

Imaging-guided evaluation of subclinical atherosclerosis to enhance cardiovascular risk prediction in asymptomatic low-to-intermediate risk individuals: A systematic review.

Carotid intima-media thickness (cIMT), plaque quantification and coronary artery calcium (CAC) scoring have been suggested to improve risk prediction of cardiovascular disease (CVD), particularly for asymptomatic individuals classified as low-to-intermediate risk. We aimed to compare the predictive value of cIMT, carotid plaque identification, and CAC scoring for identifying sub-clinical atherosclerosis and assessing future risk of CVD in asymptomatic, low-to-intermediate risk individuals. We conducted a comprehensive search of Ovid (Embase and Medline), Cochrane Central Register of Controlled Trials (CENTRAL) and Medline complete (EBSCO health). A total of 30 papers were selected and data were extracted. Comparisons were made according to the cIMT measurement (mean, maximum), carotid plaque evaluation (presence or area), and CAC scoring. CVD event rates, hazard ratios (HR), net reclassification index (NRI), and c-statistic of the markers were compared. There were 27 studies that reported cIMT, 24 reported carotid plaque, and 6 reported CAC scoring. Inclusion of CAC scores yielded the highest HR ranging from 1.45 (95% CI, 1.11-1.88, p = 0.006) to 3.95 (95% CI, 2.97-5.27, p < 0.001), followed by maximum cIMT (HR 1.08; 95% CI, 1.06-1.11, p < 0.001 to 2.58; 95% CI, 1.83-3.62, p < 0.001) and carotid plaque presence (HR 1.21; 95% CI, 0.5-1.2, p = 0.39 to 2.43; 95% CI, 1.7-3.47, p < 0.001). The c-statistic enhanced predictive value by a minimum increase of 0.7. Finally, the NRI ranked higher with CAC (≥11.2%), followed by carotid plaque (≥2%) and cIMT (3%). CAC scoring was superior compared to carotid plaque and cIMT measurements in asymptomatic individuals classified as being at low-to-intermediate risk.

The Gut Microbiota and Their Metabolites in Human Arterial Stiffness.

AIM: Gut microbiota-derived metabolites, such as short-chain fatty acids (SCFAs) have vasodilator properties in animal and human ex vivo arteries. However, the role of the gut microbiota and SCFAs in arterial stiffness in humans is still unclear. Here we aimed to determine associations between the gut microbiome, SCFA and their G-protein coupled sensing receptors (GPCRs) in relation to human arterial stiffness. METHODS: Ambulatory arterial stiffness index (AASI) was determined from ambulatory blood pressure (BP) monitoring in 69 participants from regional and metropolitan regions in Australia (55.1% women; mean, 59.8± SD, 7.26 years of age). The gut microbiome was determined by 16S rRNA sequencing, SCFA levels by gas chromatography, and GPCR expression in circulating immune cells by real-time PCR. RESULTS: There was no association between metrics of bacterial α and ß diversity and AASI or AASI quartiles in men and women. We identified two main bacteria taxa that were associated with AASI quartiles: Lactobacillus spp. was only present in the lowest quartile, while Clostridium spp. was present in all quartiles but the lowest. AASI was positively associated with higher levels of plasma, but not faecal, butyrate. Finally, we identified that the expression of GPR43 (FFAR2) and GPR41 (FFAR3) in circulating immune cells were negatively associated with AASI. CONCLUSIONS: Our results suggest that arterial stiffness is associated with lower levels of the metabolite-sensing receptors GPR41/GPR43 in humans, blunting its response to BP-lowering metabolites such as butyrate. The role of Lactobacillus spp. and Clostridium spp., as well as butyrate-sensing receptors GPR41/GPR43, in human arterial stiffness needs to be determined.

The Baker Biobank: Understanding Cardiovascular Outcomes.

BACKGROUND: Cardiovascular diseases (CVDs) and diabetes are two of the most important public health problems. Outcomes for patients with these disorders vary considerably, likely due to the added influence of a range of interacting clinical, metabolic, environmental, lifestyle, genetic and psychosocial risk factors associated with these diseases. The Baker Biobank study was designed to characterise these factors to inform better risk prediction, earlier diagnosis and better treatment of CVDs and diabetes. METHODS: This paper describes the detailed methods for the establishment of the Baker Biobank. The study collected extensive phenotypic detail about the participants recruited from Victoria, Australia. Data and samples were collected at the Departments of Cardiology and Respiratory Medicine at the Alfred Hospital and Healthy Hearts Program at the Baker Institute. RESULTS: A total of 6,530 adults with age 18-69 years were recruited into the Biobank. The majority of these participants (63%) were male. The mean (standard deviation [SD]) age of the Biobank Cohort at the time of data collection was 57(15) years. The study collected data on socio-demographic characteristics, behavioural and lifestyle factors, anthropometric measurements, medical and medication history, and blood levels of various biomarkers. The study also collected and stored Guthrie cards, serum, plasma, buffy coat, whole blood collected in Tempus tubes (for RNA extraction). For some samples extracted DNA and RNA is stored. The Biobank data is also linked to echocardiogram, hospital admission, pathology and mortality datasets. The Baker Biobank data and samples are available for health researchers with approval of Biobank Steering Group and Human Research Ethics Committee. CONCLUSION: The Baker Biobank provides valuable data and samples into the study of the interplay among cardiovascular diseases risk factors and their impact on morbidity and mortality in Australia.

May Measurement Month 2017: an analysis of blood pressure screening results from Australia-South-East Asia and Australasia.

Increased blood pressure (BP) is the single biggest contributing risk factor to the global disease burden. May Measurement Month (MMM) is a global initiative of the International Society of Hypertension aimed at raising awareness of high BP. In Australia, hypertension affects around six million adults and continues to remain the greatest attributable cause of cardiovascular mortality and morbidity (48.3%), stroke deaths (28%), and kidney disease (14%). An opportunistic cross-sectional survey was carried out during May 2017 predominantly in capital cities across Australia which included adult volunteers. Blood pressure measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. Additional information obtained included anthropometric data and responses to questionnaires on demographic, lifestyle, and environmental factors. Data were collected from 3817 individuals. After multiple imputation, of the 3758 individuals for whom a mean of the second and third BP reading was available, 1188 (31.2%) had hypertension. Of 3213 individuals not receiving antihypertensive treatment, 591 (18.4%) were hypertensive, and 239 (40.1%) of the 596 individuals receiving treatment had uncontrolled BP. Adjusted BP was higher in association with antihypertensive medication, cerebrovascular disease, smoking, and alcohol consumption. Blood pressure was higher when measured on the right arm and on Tuesdays. MMM17 was one of the largest BP screening campaigns undertaken in Australia using standardized BP measurements. In line with previous surveys, around one-third of screened adults had hypertension and approximately 40% of treated individuals remained uncontrolled. These results suggest that opportunistic screening can identify significant numbers with raised BP.

Multimorbidity and the Risk of All-Cause 30-Day Readmission in the Setting of Multidisciplinary Management of Chronic Heart Failure: A Retrospective Analysis of 830 Hospitalized Patients in Australia.

BACKGROUND: Multimorbidity has an adverse effect on health outcomes in hospitalized individuals with chronic heart failure (CHF), but the modulating effect of multidisciplinary management is unknown. OBJECTIVE: The aim of this study was to test the hypothesis that increasing morbidity would independently predict an increasing risk of 30-day readmission despite multidisciplinary management of CHF. METHODS: We studied patients hospitalized for any reason with heart failure receiving nurse-led, postdischarge multidisciplinary management. We profiled a matrix of expected comorbidities involving the most common coexisting conditions associated with CHF and examined the relationship between multimorbidity and 30-day all-cause readmission. RESULTS: A total of 830 patients (mean age 73 ± 13 years and 65% men) were assessed. Multimorbidity was common, with an average of 6.6 ± 2.4 comorbid conditions with sex-based differences in prevalence of 4 of 10 conditions. Within 30 days of initial hospitalization, 216 of 830 (26%) patients were readmitted for any reason. Greater multimorbidity was associated with increasing readmission (4%-44% for those with 0-1 to 8-9 morbid conditions; adjusted odds ratio, 1.25; 95% confidence interval, 1.13-1.38) for each additional condition. Three distinct classes of patient emerged: class 1-diabetes, metabolic, and mood disorders; class 2-renal impairment; and class 3-low with relatively fewer comorbid conditions. Classes 1 and 2 had higher 30-day readmission than class 3 did (adjusted P < .01 for both comparisons). CONCLUSIONS: These data affirm that multimorbidity is common in adult CHF inpatients and in potentially distinct patterns linked to outcome. Overall, greater multimorbidity is associated with a higher risk of 30-day all-cause readmission despite high-quality multidisciplinary management. More innovative approaches to target-specific clusters of multimorbidity are required to improve health outcomes in affected individuals.

Impact of Nurse-Led, Multidisciplinary Home-Based Intervention on Event-Free Survival Across the Spectrum of Chronic Heart Disease: Composite Analysis of Health Outcomes in 1226 Patients From 3 Randomized Trials.

BACKGROUND: We sought to determine the overall impact of a nurse-led, multidisciplinary home-based intervention (HBI) adapted to hospitalized patients with chronic forms of heart disease of varying types. METHODS AND RESULTS: Prospectively planned, combined, secondary analysis of 3 randomized trials (1226 patients) of HBI were compared with standard management. Hospitalized patients presenting with heart disease but not heart failure, atrial fibrillation but not heart failure, and heart failure, as well, were recruited. Overall, 612 and 614 patients, respectively, were allocated to a home visit 7 to 14 days postdischarge by a cardiac nurse with follow-up and multidisciplinary support according to clinical need or standard management. The primary outcome of days-alive and out-of-hospital was examined on an intention-to-treat basis. During 1371 days (interquartile range, 1112-1605) of follow-up, 218 patients died and 17 917 days of hospital stay were recorded. In comparison with standard management, HBI patients achieved significantly prolonged event-free survival (90.1% [95% confidence interval, 88.2-92.0] versus 87.2% [95% confidence interval, 85.1-89.3] days-alive and out-of-hospital; P=0.020). This reflected less all-cause mortality (adjusted hazard ratio, 0.67; 95% confidence interval, 0.50-0.88; P=0.005) and unplanned hospital stay (median, 0.22 [interquartile range, 0-1.3] versus 0.36 [0-2.1] days/100 days follow-up; P=0.011). Analyses of the differential impact of HBI on all-cause mortality showed significant interactions (characterized by U-shaped relationships) with age (P=0.005) and comorbidity (P=0.041); HBI was most effective for those aged 60 to 82 years (59%-65% of individual trial cohorts) and with a Charlson Comorbidity Index Score of 5 to 8 (36%-61%). CONCLUSIONS: These data provide further support for the application of postdischarge HBI across the full spectrum of patients being hospitalized for chronic forms of heart disease. CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au. Unique identifiers: 12610000221055, 12608000022369, 12607000069459.

Better Indigenous Risk stratification for Cardiac Health study (BIRCH) protocol: rationale and design of a cross-sectional and prospective cohort study to identify novel cardiovascular risk indicators in Aboriginal Australian and Torres Strait Islander adults.

BACKGROUND: Of the estimated 10-11 year life expectancy gap between Indigenous (Aboriginal and Torres Strait Islander people) and non-Indigenous Australians, approximately one quarter is attributable to cardiovascular disease (CVD). Risk prediction of CVD is imperfect, but particularly limited for Indigenous Australians. The BIRCH (Better Indigenous Risk stratification for Cardiac Health) project aims to identify and assess existing and novel markers of early disease and risk in Indigenous Australians to optimise health outcomes in this disadvantaged population. It further aims to determine whether these markers are relevant in non-Indigenous Australians. METHODS/DESIGN: BIRCH is a cross-sectional and prospective cohort study of Indigenous and non-Indigenous Australian adults (≥ 18 years) living in remote, regional and urban locations. Participants will be assessed for CVD risk factors, left ventricular mass and strain via echocardiography, sleep disordered breathing and quality via home-based polysomnography or actigraphy respectively, and plasma lipidomic profiles via mass spectrometry. Outcome data will comprise CVD events and death over a period of five years. DISCUSSION: Results of BIRCH may increase understanding regarding the factors underlying the increased burden of CVD in Indigenous Australians in this setting. Further, it may identify novel markers of early disease and risk to inform the development of more accurate prediction equations. Better identification of at-risk individuals will promote more effective primary and secondary preventive initiatives to reduce Indigenous Australian health disadvantage.

Comparison of the EQ-5D-3L and the SF-6D (SF-12) contemporaneous utility scores in patients with cardiovascular disease.

PURPOSE: Multi-attribute utility instruments (MAUIs) are widely used to measure utility weights. This study sought to compare utility weights of two popular MAUIs, the EQ-5D-3L and the SF-6D, and inform researchers in the selection of generic MAUI for use with cardiovascular (CVD) patients. METHODS: Data were collected in the Young@Heart study, a randomised controlled trial of a nurse-led multidisciplinary home-based intervention compared to standard usual care. Participants (n = 598) completed the EQ-5D-3L and the SF-12v2, from which the SF-6D can be constructed, at baseline and at 24-month follow-up. This study examined discrimination, responsiveness, correlation and differences across the two instruments. RESULTS: Both MAUIs were able to discriminate between the NYHA severity classes and recorded similar changes between the two time points although only SF-6D differences were significant. Correlations between the dimensions of the two MAUIs were low. There were significant differences between the two instruments in mild conditions but they were similar in severe conditions. Substantial ceiling and floor effects were observed. CONCLUSIONS: Our findings indicate that the EQ-5D and the SF-6D cover different spaces in health due to their classification systems. Both measures were capable of discriminating between severity groups and responsive to quality of life changes in the follow-up. It is recommended to use the EQ-5D-3L in severe and the SF-6D in mild CVD conditions.

Nurse health and lifestyle modification versus standard care in 40 to 70 year old regional adults: study protocol of the Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) randomized controlled trial.

BACKGROUND: Metabolic syndrome (MetS), the clustering of multiple leading risk factors, predisposes individuals to increased risk for developing type 2 diabetes and/or cardiovascular disease (CVD). Cardio-metabolic disease risk increases with greater remoteness where specialist services are scarce. Nurse-led interventions are effective for the management of chronic disease. The aim of this clinical trial is to determine whether a nurse-implemented health and lifestyle modification program is more beneficial than standard care to reduce cardio-metabolic abnormalities and future risk of CVD and diabetes in individuals with MetS. METHODS: MODERN is a multi-centre, open, parallel group randomized controlled trial in regional Victoria, Australia. Participants were self-selected and individuals aged 40 to 70 years with MetS who had no evidence of CVD or other chronic disease were recruited. Those attending a screening visit with any 3 or more risk factors of central obesity, dyslipidemia (high triglycerides or low high density lipoprotein cholesterol) elevated blood pressure and dysglycemia were randomized to either nurse-led health and lifestyle modification (intervention) or standard care (control). The intervention included risk factor management, health education, care planning and scheduled follow-up commensurate with level of risk. The primary cardio-metabolic end-point was achievement of risk factor thresholds to eliminate MetS or minimal clinically meaningful changes for at least 3 risk factors that characterise MetS over 2 year follow-up. Pre-specified secondary endpoints to evaluate between group variations in cardio-metabolic risk, general health and lifestyle behaviours and new onset CVD and type 2 diabetes will be evaluated. Key outcomes will be measured at baseline, 12 and 24 months via questionnaires, physical examinations, pathology and other diagnostic tests. Health economic analyses will be undertaken to establish the cost-effectiveness of the intervention. DISCUSSION: The MODERN trial will provide evidence for the potential benefit of independent nurse-run clinics in the community and their cost-effectiveness in adults with MetS. Findings will enable more nurse-led clinics to be adopted outside of major cities and encompassing other chronic diseases as a key primary preventative initiative. TRIAL REGISTRATION: MODERN is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12616000229471 ) on 19 February 2016 (retrospectively registered). Secondary identifiers: MODERN is an investigator-initiated trial funded by the National Health and Medical Research Council of Australia from 2014 to 2017 via a Project Grant (ID No. APP1069043) and was approved by the Australian Catholic University Human Research Ethics Committee (Project No: 2014 244 V) and the Department of Health Human Research Ethics Committee (Project No:38/2014) for the release of Medicare claims information.

Risk Factor Management and Atrial Fibrillation Clinics: Saving the Best for Last?

Atrial fibrillation (AF) is a leading cause of cardiovascular morbidity and mortality worldwide. Management of AF is a complex process involving: 1) the prevention of thromboembolic complications with anticoagulation; 2) rhythm control; and 3) the detection and treatment of underlying heart disease. However, cardiometabolic risk factors, such as obesity, hypertension, diabetes mellitus, and obstructive sleep apnoea, have been proposed as contributors to the expanding epidemic of atrial fibrillation (AF). Thus, a fourth pillar of AF care would include aggressive targeting of interdependent, modifiable cardiovascular risk factors as part of an integrated care model. Such risk factor management could retard and reverse the pathological processes underlying AF and reduce AF burden.

Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Patients are increasingly being admitted with chronic atrial fibrillation, and disease-specific management might reduce recurrent admissions and prolong survival. However, evidence is scant to support the application of this therapeutic approach. We aimed to assess SAFETY--a management strategy that is specific to atrial fibrillation. METHODS: We did a pragmatic, multicentre, randomised controlled trial in patients admitted with chronic, non-valvular atrial fibrillation (but not heart failure). Patients were recruited from three tertiary referral hospitals in Australia. 335 participants were randomly assigned by computer-generated schedule (stratified for rhythm or rate control) to either standard management (n=167) or the SAFETY intervention (n=168). Standard management consisted of routine primary care and hospital outpatient follow-up. The SAFETY intervention comprised a home visit and Holter monitoring 7-14 days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed. Clinical reviews were undertaken at 12 and 24 months (minimum follow-up). Coprimary outcomes were death or unplanned readmission (both all-cause), measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital. Analyses were done on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTRN 12610000221055). FINDINGS: During median follow-up of 905 days (IQR 773-1050), 49 people died and 987 unplanned admissions were recorded (totalling 5530 days in hospital). 127 (76%) patients assigned to the SAFETY intervention died or had an unplanned readmission (median event-free survival 183 days [IQR 116-409]) and 137 (82%) people allocated standard management achieved a coprimary outcome (199 days [116-249]; hazard ratio 0·97, 95% CI 0·76-1·23; p=0·851). Patients assigned to the SAFETY intervention had 99·5% maximum event-free days (95% CI 99·3-99·7), equating to a median of 900 (IQR 767-1025) of 937 maximum days alive and out of hospital. By comparison, those allocated to standard management had 99·2% (95% CI 98·8-99·4) maximum event-free days, equating to a median of 860 (IQR 752-1047) of 937 maximum days alive and out of hospital (effect size 0·22, 95% CI 0·21-0·23; p=0·039). INTERPRETATION: A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital (but not prolonged event-free survival) relative to standard management. Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation. FUNDING: National Health and Medical Research Council of Australia.

A metabolic syndrome severity score: A tool to quantify cardio-metabolic risk factors.

Metabolic syndrome is a cluster of cardio-metabolic risk factors and is associated with increased mortality. There is no standard, validated way to assess the severity of aggregated metabolic syndrome risk factors. Cardiovascular and diabetes risk factor data came from two studies conducted in Australia from 2006 to 2010 in adults aged 18 or above. In medication free adults, sex-specific clinical thresholds and Principal Component Analysis were used to develop a formula to calculate a metabolic syndrome severity score (MetSSS). These scores were compared to scores derived using the same process in subgroups by sex, age, medication status, and time. We also examined the MetSSS in relation to other known risk factors. In 2125 adults (57.6±14.7years of age), the MetSSS ranged from 0 to 8.7 with a mean of 2.6. There were strong correlations (.95-.99) between the MetSSS in medication free adults and the MetSSS calculated from subgroups. MetSSS predicted medication initiation for hypertension, hyperlipidemia and hyperglycemia over six months (OR=1.31, 95% CI [1.00-1.70], per MetSSS unit, p=.043). Lower education, medication prescription, history of smoking and age were associated with higher MetSSS (all p<.05). Higher physical but not mental health quality of life was associated with lower MetSSS (p<.001). A standardized formula to measure cardio-metabolic risk factor severity was constructed and demonstrated expected relations with known risk factors. The use of the MetSSS is recommended as a measure of change within individuals in cardio-metabolic risk factors and to guide treatment and management.