New Cardiovascular Risk Assessment Techniques for Primary Prevention: JACC Review Topic of the Week.

Risk factor-based models fail to accurately estimate risk in select populations, in particular younger individuals. A sizable number of people are also classified as being at intermediate risk, for whom the optimal preventive strategy could be more precise. Several personalized risk prediction tools, including coronary artery calcium scoring, polygenic risk scores, and metabolic risk scores may be able to improve risk assessment, pending supportive outcome data from clinical trials. Other tools may well emerge in the near future. A multidimensional approach to risk prediction holds the promise of precise risk prediction. This could allow for targeted prevention minimizing unnecessary costs and risks while maximizing benefits. High-risk individuals could also be identified early in life, creating opportunities to arrest the development of nascent coronary atherosclerosis and prevent future clinical events.

Nurse-Provided Lung and Inferior Vena Cava Assessment in Patients With Heart Failure.

BACKGROUND: Residual congestion detected using handheld ultrasound may be associated with increased risk of readmission and death after hospitalization for acute decompensated heart failure (ADHF). However, effective application necessitates routine use by nonexperts delivering clinical care. OBJECTIVES: The objective of this study was to determine the ability of heart failure (HF) nurses to deliver a predischarge lung and inferior vena cava (IVC) assessment (LUICA) to predict 90-day outcomes. METHODS: In this multisite, prospective, observational study, HF nurses scanned 240 patients with ADHF (median age: 77 years; 56% men) using a 9-zone LUICA protocol. Obtained images were reviewed by independent nurses who were blinded to clinical characteristics and outcomes. Based on a B-line cut-off of 10, patients were dichotomized as congested (n = 115) or not congested (n = 125). RESULTS: Congested patients were more likely to have previous cardiac operations, long-standing HF (>6 months), and renal impairment. At 90 days, HF readmission or mortality occurred in 42 congested patients (37%) compared with 18 noncongested patients (14%). Pulmonary congestion increased at 30-day (OR: 3.86; 95% CI: 1.65-8.99; P < 0.01) and 90-day (OR: 3.42; 95% CI: 1.82-6.4; P < 0.01) HF readmission or mortality risk and 90-day mortality (OR: 5.18; 95% CI: 1.44-18.69; P < 0.01). Pulmonary congestion increased the 90-day odds of HF readmission and/or death by 3.3- to 4.2-fold (P < 0.01), independent of demographics, HF characteristics, comorbidities, and event risk score. Over 90 days, days alive out of hospital were fewer (78.3 ± 21.4 days vs 85.5 ± 12.4 days; P < 0.01) in congested patients. CONCLUSIONS: LUICA can be a powerful tool for detection of predischarge residual congestion. HF nurses can obtain images and provide diagnostic reports that are predictive of ADHF outcomes.

Economic evaluation of a nurse-led home and clinic-based secondary prevention programme to prevent progressive cardiac dysfunction in high-risk individuals: The Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) randomized controlled study.

OBJECTIVE: The objective of this study was to assess the cost-effectiveness of a long-term, nurse-led, multidisciplinary programme of home/clinic visits in preventing progressive cardiac dysfunction in patients at risk of developing de novo chronic heart failure (CHF). METHODS: A trial-based analysis was conducted alongside a pragmatic, single-centre, open-label, randomized controlled trial of 611 patients (mean age: 66 years) with subclinical cardiovascular diseases (without CHF) discharged to home from an Australian tertiary referral hospital. A nurse-led home and clinic-based programme (NIL-CHF intervention, n = 301) was compared with standard care ( n=310) in terms of life-years, quality-adjusted life-years (QALYs) and healthcare costs. The uncertainty around the incremental cost and QALYs was quantified by bootstrap simulations and displayed on a cost-effectiveness plane. RESULTS: During a median follow-up of 4.2 years, there were no significant between-group differences in life-years (-0.056, p=0.488) and QALYs (-0.072, p=0.399), which were lower in the NIL-CHF group. The NIL-CHF group had slightly lower all-cause hospitalization costs (AUD$2943 per person; p=0.219), cardiovascular-related hospitalization costs (AUD$1142; p=0.592) and a more pronounced reduction in emergency/unplanned hospitalization costs (AUD$4194 per person; p=0.024). When the cost of intervention was added to all-cause, cardiovascular and emergency-related readmissions, the reductions in the NIL-CHF group were AUD$2742 ( p=0.313), AUD$941 ( p=0.719) and AUD$3993 ( p=0.046), respectively. At a willingness-to-pay threshold of AUD$50,000/QALY, the probability of the NIL-CHF intervention being better-valued was 19%. CONCLUSIONS: Compared with standard care, the NIL-CHF intervention was not a cost-effective strategy as life-years and QALYs were slightly lower in the NIL-CHF group. However, it was associated with modest reductions in emergency/unplanned readmission costs.

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.

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.

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.

Long-term cost-effectiveness of home versus clinic-based management of chronic heart failure: the WHICH? study.

BACKGROUND: The cost-effectiveness of a heart failure management intervention can be further informed by incorporating the expected benefits and costs of future survival. METHODS: This study compared the long-term costs per quality-adjusted life year (QALY) gained from home-based (HBI) vs specialist clinic-based intervention (CBI) among elderly patients (mean age = 71 years) with heart failure discharged home (mean intervention duration = 12 months). Cost-utility analysis was conducted from a government-funded health system perspective. A Markov cohort model was used to simulate disease progression over 15 years based on initial data from a randomized clinical trial (the WHICH? study). Time-dependent hazard functions were modeled using the Weibull function, and this was compared against an alternative model where the hazard was assumed to be constant over time. Deterministic and probabilistic sensitivity analyses were conducted to identify the key drivers of cost-effectiveness and quantify uncertainty in the results. RESULTS: During the trial, mortality was the highest within 30 days of discharge and decreased thereafter in both groups, although the declining rate of mortality was slower in CBI than HBI. At 15 years (extrapolated), HBI was associated with slightly better health outcomes (mean of 0.59 QALYs gained) and mean additional costs of AU$13,876 per patient. The incremental cost-utility ratio and the incremental net monetary benefit (vs CBI) were AU$23,352 per QALY gained and AU$15,835, respectively. The uncertainty was driven by variability in the costs and probabilities of readmissions. Probabilistic sensitivity analysis showed HBI had a 68% probability of being cost-effective at a willingness-to-pay threshold of AU$50,000 per QALY. CONCLUSION: Compared with CBI (outpatient specialized HF clinic-based intervention), HBI (home-based predominantly, but not exclusively) could potentially be cost-effective over the long-term in elderly patients with heart failure at a willingness-to-pay threshold of AU$50,000/QALY, albeit with large uncertainty.

Systematic review of trial-based analyses reporting the economic impact of heart failure management programs compared with usual care.

BACKGROUND: The cost-effectiveness of heart failure management programs (HF-MPs) is highly variable. We explored intervention and clinical characteristics likely to influence cost outcomes. METHODS: A systematic review of economic analyses alongside randomized clinical trials comparing HF-MPs and usual care. Electronic databases were searched for English peer-reviewed articles published between 1990 and 2013. RESULTS: Of 511 articles identified, 34 comprising 35 analyses met the inclusion criteria. Eighteen analyses (51%) reported a HF-MP as more effective and less costly; four analyses (11%), and five analyses (14%) also reported they were more effective but with no significant or an increased cost difference, respectively. Alternatively, five analyses (14%) reported no statistically significant difference in effects or costs, and one analysis (3%) reported no statistically significant effect difference but was less costly. Finally, two analyses (6%) reported no statistically significant effect difference but were more costly. Interventions that reduced hospital admissions tended to result in favorable cost outcomes, moderated by increased resource use, intervention cost and/or the durability of the intervention effect. The reporting quality of economic evaluation assessed by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist varied substantially between 5% and 91% (median 45%; 34 articles) of the checklist criteria adequately addressed. Overall, none of the study, patient or intervention characteristics appeared to independently influence the cost-effectiveness of a HF-MP. CONCLUSION: The extent that HF-MPs reduce hospital readmissions appears to be associated with favorable cost outcomes. The current evidence does not provide a sufficient evidence base to explain what intervention or clinical attributes may influence the cost implications.

Cost-Effectiveness of a Home Based Intervention for Secondary Prevention of Readmission with Chronic Heart Disease.

The aim of this study is to consider the cost-effectiveness of a nurse-led, home-based intervention (HBI) in cardiac patients with private health insurance compared to usual post-discharge care. A within trial analysis of the Young @ Heart multicentre, randomized controlled trial along with a micro-simulation decision analytical model was conducted to estimate the incremental costs and quality adjusted life years associated with the home based intervention compared to usual care. For the micro-simulation model, future costs, from the perspective of the funder, and effects are estimated over a twenty-year time horizon. An Incremental Cost-Effectiveness Ratio, along with Incremental Net Monetary Benefit, is evaluated using a willingness to pay threshold of $50,000 per quality adjusted life year. Sub-group analyses are conducted for men and women across three age groups separately. Costs and benefits that arise in the future are discounted at five percent per annum. Overall, home based intervention for secondary prevention in patients with chronic heart disease identified in the Australian private health care sector is not cost-effective. The estimated within trial incremental net monetary benefit is -$3,116 [95% CI: -11,145, $4,914]; indicating that the costs outweigh the benefits. However, for males and in particular males aged 75 years and above, home based intervention indicated a potential to reduce health care costs when compared to usual care (within trial: -$10,416 [95% CI: -$26,745, $5,913]; modelled analysis: -$1,980 [95% CI: -$22,843, $14,863]). This work provides a crucial impetus for future research to understand for whom disease management programs are likely to benefit most.

Cost-effectiveness of home versus clinic-based management of chronic heart failure: Extended follow-up of a pragmatic, multicentre randomized trial cohort - The WHICH? study (Which Heart Failure Intervention Is Most Cost-Effective & Consumer Friendly in Reducing Hospital Care).

OBJECTIVE: To assess the long-term cost-effectiveness of two multidisciplinary management programs for elderly patients hospitalized with chronic heart failure (CHF) and how it is influenced by patient characteristics. METHODS: A trial-based analysis was conducted alongside a randomized controlled trial of 280 elderly patients with CHF discharged to home from three Australian tertiary hospitals. Two interventions were compared: home-based intervention (HBI) that involved home visiting with community-based care versus specialized clinic-based intervention (CBI). Bootstrapped incremental cost-utility ratios were computed based on quality-adjusted life-years (QALYs) and total healthcare costs. Cost-effectiveness acceptability curves were constructed based on incremental net monetary benefit (NMB). We performed multiple linear regression to explore which patient characteristics may impact patient-level NMB. RESULTS: During median follow-up of 3.2 years, HBI was associated with slightly higher QALYs (+0.26 years per person; p=0.078) and lower total healthcare costs (AU$ -13,100 per person; p=0.025) mainly driven by significantly reduced duration of all-cause hospital stay (-10 days; p=0.006). At a willingness-to-pay threshold of AU$ 50,000 per additional QALY, the probability of HBI being better-valued was 96% and the incremental NMB of HBI was AU$ 24,342 (discounted, 5%). The variables associated with increased NMB were HBI (vs. CBI), lower Charlson Comorbidity Index, no hyponatremia, fewer months of HF, fewer prior HF admissions <1 year and a higher patient's self-care confidence. HBI's net benefit further increased in those with fewer comorbidities, a lower self-care confidence or no hyponatremia. CONCLUSIONS: Compared with CBI, HBI is likely to be cost-effective in elderly CHF patients with significant comorbidity.

Economic implications of cardiovascular disease management programs: moving beyond one-off experiments.

Substantial variation in economic analyses of cardiovascular disease management programs hinders not only the proper assessment of cost-effectiveness but also the identification of heterogeneity of interest such as patient characteristics. The authors discuss the impact of reporting and methodological variation on the cost-effectiveness of cardiovascular disease management programs by introducing issues that could lead to different policy or clinical decisions, followed by the challenges associated with net intervention effects and generalizability. The authors conclude with practical suggestions to mitigate the identified issues. Improved transparency through standardized reporting practice is the first step to advance beyond one-off experiments (limited applicability outside the study itself). Transparent reporting is a prerequisite for rigorous cost-effectiveness analyses that provide unambiguous implications for practice: what type of program works for whom and how.

Composite outcome measures in a pragmatic clinical trial of chronic heart failure management: A comparative assessment.

BACKGROUND: A number of composite outcomes have been developed to capture the perspective of the patient, clinician and objective measures of health in assessing heart failure outcomes. To date there has been a limited examination in the composition of these outcomes. METHODS AND RESULTS: Three commonly used scoring systems in heart failure trials: Packer's composite, Patient Journey and the African American Heart Failure Trial (A-HeFT) scores were compared in assessing outcomes from the Which heart failure intervention is most cost-effective & consumer friendly in reducing hospital care (WHICH(?)) Trial. Comparability and interpretability of these outcomes and the influence of each component to the final outcome were examined. Despite all three composite outcomes incorporating mortality, hospitalisation and quality of life (QoL), the contribution of each individual component to the final outcomes differed. The component with the most influence in deteriorating condition for the Packer's composite was hospitalisation (67.7%), while in Patient Journey it was QoL (61.5%) and for A-HeFT composite score it was mortality (45.4%). CONCLUSIONS: The contribution made by each component varied in subtle, but important ways. This study emphasises the importance of understanding the value system of the composite outcomes to enable meaningful interpretation of results.

Systematic review of model-based analyses reporting the cost-effectiveness and cost-utility of cardiovascular disease management programs.

BACKGROUND: The reported cost effectiveness of cardiovascular disease management programs (CVD-MPs) is highly variable, potentially leading to different funding decisions. This systematic review evaluates published modeled analyses to compare study methods and quality. METHODS: Articles were included if an incremental cost-effectiveness ratio (ICER) or cost-utility ratio (ICUR) was reported, it is a multi-component intervention designed to manage or prevent a cardiovascular disease condition, and it addressed all domains specified in the American Heart Association Taxonomy for Disease Management. Nine articles (reporting 10 clinical outcomes) were included. RESULTS: Eight cost-utility and two cost-effectiveness analyses targeted hypertension (n=4), coronary heart disease (n=2), coronary heart disease plus stoke (n=1), heart failure (n=2) and hyperlipidemia (n=1). Study perspectives included the healthcare system (n=5), societal and fund holders (n=1), a third party payer (n=3), or was not explicitly stated (n=1). All analyses were modeled based on interventions of one to two years' duration. Time horizon ranged from two years (n=1), 10 years (n=1) and lifetime (n=8). Model structures included Markov model (n=8), 'decision analytic models' (n=1), or was not explicitly stated (n=1). Considerable variation was observed in clinical and economic assumptions and reporting practices. Of all ICERs/ICURs reported, including those of subgroups (n=16), four were above a US$50,000 acceptability threshold, six were below and six were dominant. CONCLUSION: The majority of CVD-MPs was reported to have favorable economic outcomes, but 25% were at unacceptably high cost for the outcomes. Use of standardized reporting tools should increase transparency and inform what drives the cost-effectiveness of CVD-MPs.

A multicenter, randomized trial of a nurse-led, home-based intervention for optimal secondary cardiac prevention suggests some benefits for men but not for women: the Young at Heart study.

BACKGROUND: We examined the impact of a prolonged secondary prevention program on recurrent hospitalization in cardiac patients with private health insurance. METHODS AND RESULTS: The Young at Heart multicenter, randomized, controlled trial compared usual postdischarge care (UC) with nurse-led, home-based intervention (HBI). The primary end point was rate of all-cause hospital stay (31.5±7.5 months follow-up). In total, 602 patients (aged 70±10 years, 72% men) were randomized to UC (n=296) or HBI (n=306, 96% received ≥1 home visit). Overall, 42 patients (7.0%) died, and 492 patients (82%) accumulated 2397 all-cause hospitalizations associated with 10,258 hospital days costing >$17 million. There were minimal group differences (HBI versus UC) in the primary end point of all-cause hospital stay (5405 versus 4853 days; median [interquartile range], 0.08 [0.03-0.17] versus 0.07 [0.03-0.13]/patient per month). There were similar trends with respect to all hospitalizations (1197 versus 1200; P=0.802) and associated costs ($8.66 versus $8.58 million; P=0.375). At 2 years, however, more HBI versus UC (39% versus 27%; odds ratio, 1.67; 95% confidence interval, 1.15-2.41; P=0.007) patients were assessed as stable and optimally managed. For women, HBI outcomes were predominantly worse than UC outcomes. In men, HBI was associated with reduced risk of cardiovascular hospitalization (adjusted hazard ratio, 0.68; 95% confidence interval, 0.46-0.99; P=0.044) with less cardiovascular hospitalizations (192 versus 269; P=0.054) and costs ($2.49 versus $3.53 million; P=0.046). CONCLUSIONS: HBI did not reduce recurrent all-cause hospitalization compared with UC in privately insured cardiac patients overall. However, it did convey some benefits in cardiac outcomes for men. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Unique Identifier: 12608000014358. URL: http://www.anzctr.org.au/trial_view.aspx?id=82509.

Patient preferences and willingness-to-pay for a home or clinic based program of chronic heart failure management: findings from the Which? trial.

BACKGROUND: Beyond examining their overall cost-effectiveness and mechanisms of effect, it is important to understand patient preferences for the delivery of different modes of chronic heart failure management programs (CHF-MPs). We elicited patient preferences around the characteristics and willingness-to-pay (WTP) for a clinic or home-based CHF-MP. METHODOLOGY/PRINCIPAL FINDINGS: A Discrete Choice Experiment was completed by a sub-set of patients (n = 91) enrolled in the WHICH? trial comparing home versus clinic-based CHF-MP. Participants provided 5 choices between hypothetical clinic and home-based programs varying by frequency of nurse consultations, nurse continuity, patient costs, and availability of telephone or education support. Participants (aged 71±13 yrs, 72.5% male, 25.3% NYHA class III/IV) displayed two distinct preference classes. A latent class model of the choice data indicated 56% of participants preferred clinic delivery, access to group CHF education classes, and lower cost programs (p<0.05). The remainder preferred home-based CHF-MPs, monthly rather than weekly visits, and access to a phone advice service (p<0.05). Continuity of nurse contact was consistently important. No significant association was observed between program preference and participant allocation in the parent trial. WTP was estimated from the model and a dichotomous bidding technique. For those preferring clinic, estimated WTP was ≈AU$9-20 per visit; however for those preferring home-based programs, WTP varied widely (AU$15-105). CONCLUSIONS/SIGNIFICANCE: Patient preferences for CHF-MPs were dichotomised between a home-based model which is more likely to suit older patients, those who live alone, and those with a lower household income; and a clinic-based model which is more likely to suit those who are more socially active and wealthier. To optimise the delivery of CHF-MPs, health care services should consider their patients' preferences when designing CHF-MPs.

Atrial fibrillation: profile and burden of an evolving epidemic in the 21st century.

BACKGROUND: Atrial fibrillation (AF) represents an increasing public health challenge with profound social and economic implications. METHODS: A comprehensive synthesis and review of the AF literature was performed. Overall, key findings from 182 studies were used to describe the indicative scope and impact of AF from an individual to population perspective. RESULTS: There are many pathways to AF including advancing age, cardiovascular disease and increased levels of obesity/metabolic disorders. The reported population prevalence of AF ranges from 2.3%-3.4% and historical trends reflect increased AF incidence. Estimated life-time risk of AF is around 1 in 4. Primary care contacts reflect whole population trends: AF-related case-presentations increase from less than 0.5% in those aged 40 years or less to 6-12% for those aged 85 years or more. Globally, AF-related hospitalisations (primary or secondary diagnosis) showed an upward trend (from ~35 to over 100 admissions/10,000 persons) during 1996 to 2006. The estimated cost of AF is greater than 1% of health care expenditure and rising with hospitalisations the largest contributor. For affected individuals, quality of life indices are poor and AF confers an independent 1.5 to 2.0-fold probability of death in the longer-term. AF is also closely linked to ischaemic stroke (3- to 5-fold risk), chronic heart failure (up to 50% develop AF) and acute coronary syndromes (up to 25% develop AF) with consistently worse outcomes reported with concurrent AF. Future projections predict at least a doubling of AF cases by 2050. SUMMARY: AF represents an evolving, global epidemic providing considerable challenges to minimise its impact from an individual to whole society perspective.

The Green, Amber, Red Delineation of Risk and Need (GARDIAN) management system: a pragmatic approach to optimizing heart health from primary prevention to chronic disease management.

BACKGROUND: A sustained epidemic of cardiovascular disease and related risk factors is a global phenomenon contributing significantly to premature deaths and costly morbidity. Preventative strategies across the full continuum of life, from a population to individual perspective, are not optimally applied. This paper describes a simple and adaptable 'traffic-light' system we have developed to systematically perform individual risk and need delineation in order to 'titrate' the intensity and frequency of healthcare intervention in a cost-effective manner. METHODS: The GARDIAN (Green Amber Red Delineation of Risk and Need) system is an individual assessment of risk and need that modulates the frequency and intensity of future healthcare intervention. Individual assessment of risk and need for ongoing intervention and support is determined with reference to three domains: (1) clinical stability, (2) gold-standard management, and (3) a broader, holistic assessment of individual circumstance. This can be applied from a primary prevention, secondary prevention, or chronic disease management perspective. RESULTS: Our experience with applying and validating GARDIAN to titrate healthcare resources according to need has been extensive to date, with >5000 individuals profiled in a host of clinical settings. A series of clinical randomized trials will determine the impact of the GARDIAN system on important indices of healthcare utilization and health status. CONCLUSIONS: The GARDIAN model to delineating risk and need for varied intensity of management shows strong potential to cost effectively improve health outcomes for both individuals at risk of heart disease and those with established heart disease.

Impact of home versus clinic-based management of chronic heart failure: the WHICH? (Which Heart Failure Intervention Is Most Cost-Effective & Consumer Friendly in Reducing Hospital Care) multicenter, randomized trial.

OBJECTIVES: The goal of this study was to make a head-to-head comparison of 2 common forms of multidisciplinary chronic heart failure (CHF) management. BACKGROUND: Although direct patient contact appears to be best in delivering CHF management overall, the precise form to optimize health outcomes is less clear. METHODS: This prospective, multicenter randomized controlled trial with blinded endpoint adjudication comprised 280 hospitalized CHF patients (73% male, age 71 ± 14 years, and 73% with left ventricular ejection fraction ≤45%) randomized to home-based intervention (HBI) or specialized CHF clinic-based intervention (CBI). The primary endpoint was all-cause, unplanned hospitalization or death during 12- to 18-month follow-up. Secondary endpoints included type/duration of hospitalization and healthcare costs. RESULTS: The primary endpoint occurred in 102 of 143 (71%) HBI versus 104 of 137 (76%) CBI patients (adjusted hazard ratio [HR]: 0.97 [95% confidence interval (CI): 0.73 to 1.30], p = 0.861): 96 (67.1%) HBI versus 95 (69.3%) CBI patients had an unplanned hospitalization (p = 0.887), and 31 (21.7%) versus 38 (27.7%) died (p = 0.252). The median duration of each unplanned hospitalization was significantly less in the HBI group (4.0 [interquartile range (IQR): 2.0 to 7.0] days vs. 6.0 [IQR: 3.5 to 13] days; p = 0.004). Overall, 75% of all hospitalization was attributable to 64 (22.9%) patients, of whom 43 (67%) were CBI patients (adjusted odds ratio: 2.55 [95% CI: 1.37 to 4.73], p = 0.003). HBI was associated with significantly fewer days of all-cause hospitalization (-35%; p = 0.003) and from cardiovascular causes (-37%; p = 0.025) but not for CHF (-24%; p = 0.218). Consequently, healthcare costs ($AU3.93 vs. $AU5.53 million) were significantly less for the HBI group (median: $AU34 [IQR: 13 to 81] per day vs. $AU52 [17 to 140] per day; p = 0.030). CONCLUSIONS: HBI was not superior to CBI in reducing all-cause death or hospitalization. However, HBI was associated with significantly lower healthcare costs, attributable to fewer days of hospitalization. (Which Heart failure Intervention is most Cost-effective & consumer friendly in reducing Hospital care [WHICH?]; ACTRN12607000069459).

Exploring the potential to remain "Young @ Heart": initial findings of a multi-centre, randomised study of nurse-led, home-based intervention in a hybrid health care system.

BACKGROUND: Disease management programs have been shown to improve health outcomes in high risk individuals in many but not all health care systems. METHODS: Young @ Heart is a multi-centre, randomised controlled study of a nurse-led, home-based intervention (HBI) program vs. usual care (UC) in privately insured patients in Australia aged ≥ 45 years following an acute cardiac admission. Intensity of HBI is tailored to an individual's clinical stability, management and risk profile. The primary endpoint is the rate of all-cause stay during a mean of 2.5 years follow-up. RESULTS: A target of 602 adults (72% men) were randomised to HBI (n=306) or UC (n=296); their initial profiles being well matched. At baseline, 71% were overweight (body mass index 29.7 ± 3.9 kg/m(2)) and 66% had an elevated blood pressure (153 ± 18/89 ± 7 mm Hg). Over half had a history of smoking and 39% had a sub-optimal total cholesterol level >4 mmol/L. Overall, 62% (376 cases) were treated for coronary artery disease (27% with multi-vessel disease and 39% underwent cardiac revascularisation). A further 20% (120 cases) were treated for a cardiac arrhythmia (predominantly atrial fibrillation) and 19% type 2 diabetes mellitus. At 7-14 days post-discharge, 293 (96%) HBI patients received a home visit triggering urgent clinical review and/or enhanced clinical management in many patients. CONCLUSIONS: The Young @ Heart intervention is a well accepted and potentially effective intervention to reduce recurrent hospital stay in privately insured cardiac patients in Australia.