Optimal duration of dual antiplatelet therapy after stent implantation in patients with or without diabetes

Editoria

Current and projected burden of heart failure in the Australian adult population: A substantive but still ill-defined major health issue

Background: Comprehensive epidemiological data to describe the burden of heart failure (HF) in Australia remain lacking despite its importance as a major health issue. Herewith, we estimate the current and future burden of HF in Australia using best available data

Women versus men with chronic atrial fibrillation: insights from the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY)

BACKGROUND: Gender-based clinical differences are increasingly being identified as having significant influence on the outcomes of patients with cardiovascular disease (CVD), including atrial fibrillation (AF). OBJECTIVE: To perform detailed clinical phenotyping on a cohort of hospitalised patients with chronic forms of AF to understand if gender-based differences exist in the clinical presentation, thrombo-embolic risk and therapeutic management of high risk patients hospitalised with chronic AF. METHODS: We are undertaking the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY) - a multi-centre, randomised controlled trial of an AF-specific management intervention versus usual care. Extensive baseline profiling of recruited patients was undertaken to identify gender-specific differences for risk delineation. RESULTS: We screened 2,438 patients with AF and recruited 335 into SAFETY. Of these, 48.1% were women who were, on average, 5 years older than their male counterparts. Women and men displayed divergent antecedent profiles, with women having a higher thrombo-embolic risk but being prescribed similar treatment regimens. More women than men presented to hospital with co-morbid thyroid dysfunction, depression, renal impairment and obesity. In contrast, more men presented with coronary artery disease (CAD) and/or chronic obstructive pulmonary disease (COPD). Even when data was age-adjusted, women were more likely to live alone (odds ratio [OR] 2.33; 95% confidence interval [CI] 1.47 to 3.69), have non-tertiary education (OR 2.69; 95% CI 1.61 to 4.48) and be symptomatic (OR 1.93; 95% CI 1.06 to 3.52). CONCLUSION: Health care providers should be cognisant of gender-specific differences in an attempt to individualise and, hence, optimise the management of patients with chronic AF and reduce potential morbidity and mortality.Jocasta Ball, Melinda J. Carrington, Kathryn A. Wood, Simon Stewart (the SAFETY Investigators

Optimising the management of patients with atrial fibrillation

Background: Atrial fibrillation (AF) is the most common form of cardiac arrhythmia found in clinical practice and indeed the adult population. Although AF can present in an acute and non-sustained (paroxysmal AF) form, it typically progresses into a chronic and often silent disorder. Over a prolonged period, chronic AF is associated with detrimental mechanical changes that result in progressive cardiac dysfunction. An enhanced thrombo-embolic state coupled with blood stasis in the atria leads to increased thrombus formation. Consequently, AF is closely linked to thromboembolic stroke and chronic heart failure; two of the most deadly and disabling forms of cardiovascular disease. Chronic AF is, therefore, commonly associated with recurrent hospitalisations and poor patient outcomes overall; including a poor prognosis. Overall, despite the known risks, health outcomes associated with AF continue to be sub-optimal within the context of predominantly older patients who require a careful assessment of risk and individualised management to ensure the benefit-to-risk ratio of often complex therapeutic regimes are optimised. Aims: In addition to understanding the true extent of the global burden of AF, the primary aim of this research was to establish enhanced and potentially effective methods for the assessment of risk in order to direct more individualised AF patient management in an attempt to improve outcomes. More specifically, the influence of gender, mild cognitive impairment and effective rate/rhythm control on patients with AF and as methods for risk delineation was assessed. Methods: The framework for this research was the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY), a multi-centre randomised controlled trial of a nurse-led AF-specific intervention involving home-based assessment, extensive risk profiling (over and above conventional profiling) and individualised management compared to usual post-discharge care. Participants included were those > 45 years of age with documented chronic AF for which this has been the cause of hospitalisation. For this research program, quantitative analysis to assess risk delineation strategies was undertaken using data collected at the baseline time point. Results: In a comprehensive review and meta-analyses of the literature, the prevalence of AF was found to be greater than commonly reported. Here, the population prevalence was found to be between 2.5% and 3.5%, substantially higher than the reported 1.0% to 2.0%. Furthermore, the economic consequences were found to be equally as large, with up to 2.5% of health care costs in Europe, North America and Australia spent on AF alone. When a detailed evaluation of gender differences was undertaken, key differences in the clinical presentation, thrombo-embolic risk and therapeutic management of women compared to men were detected. Most importantly, women were, on average, older than their male counterparts and were also more likely to report depressive symptoms and have poorer quality of life. There were also potentially important social, clinical and treatment differences that might adversely influence health outcomes in women. The prevalence of cognitive impairment within this cohort was found to be substantially higher than expected, with 65% of the SAFETY cohort demonstrating mild cognitive impairment (MCI) on initial assessment. Those with MCI were less educated but at a higher thrombo-embolic risk with multiple cognitive domains being affected. When cardiac rate and rhythm were assessed on Holter monitoring in intervention patients post-discharge, a substantial divergence between intended and detected control was found. Of those intended for rhythm control, 43% had reverted back to AF and an uncontrolled heart rate was identified in 26% of all patients. A novel method for classifying heart rate control was determined with three phenotypes being described. Patients who were more clinically complex with diagnosed coronary artery disease (CAD) and/or renal disease/dysfunction were less likely to display heart rate stability. Conclusions: In addition to providing a more contemporary and accurate description of an evolving global epidemic of AF, this research has the potential to enhance and extend current risk delineation strategies to optimise clinical management and outcomes in high risk individuals. Specifically, by focussing on gender differences, the common presence of MCI and a frequent disconnect between intended versus achieved rate/rhythm control target this research identified a number of practical ways to enhance risk delineation in AF. Ongoing research will evaluate the cost-effectiveness of enhanced risk delineation in AF via more proactive management

Optimising the management of patients with atrial fibrillation

Background: Atrial fibrillation (AF) is the most common form of cardiac arrhythmia found in clinical practice and indeed the adult population. Although AF can present in an acute and non-sustained (paroxysmal AF) form, it typically progresses into a chronic and often silent disorder. Over a prolonged period, chronic AF is associated with detrimental mechanical changes that result in progressive cardiac dysfunction. An enhanced thrombo-embolic state coupled with blood stasis in the atria leads to increased thrombus formation. Consequently, AF is closely linked to thromboembolic stroke and chronic heart failure; two of the most deadly and disabling forms of cardiovascular disease. Chronic AF is, therefore, commonly associated with recurrent hospitalisations and poor patient outcomes overall; including a poor prognosis. Overall, despite the known risks, health outcomes associated with AF continue to be sub-optimal within the context of predominantly older patients who require a careful assessment of risk and individualised management to ensure the benefit-to-risk ratio of often complex therapeutic regimes are optimised. Aims: In addition to understanding the true extent of the global burden of AF, the primary aim of this research was to establish enhanced and potentially effective methods for the assessment of risk in order to direct more individualised AF patient management in an attempt to improve outcomes. More specifically, the influence of gender, mild cognitive impairment and effective rate/rhythm control on patients with AF and as methods for risk delineation was assessed. Methods: The framework for this research was the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY), a multi-centre randomised controlled trial of a nurse-led AF-specific intervention involving home-based assessment, extensive risk profiling (over and above conventional profiling) and individualised management compared to usual post-discharge care. Participants included were those > 45 years of age with documented chronic AF for which this has been the cause of hospitalisation. For this research program, quantitative analysis to assess risk delineation strategies was undertaken using data collected at the baseline time point. Results: In a comprehensive review and meta-analyses of the literature, the prevalence of AF was found to be greater than commonly reported. Here, the population prevalence was found to be between 2.5% and 3.5%, substantially higher than the reported 1.0% to 2.0%. Furthermore, the economic consequences were found to be equally as large, with up to 2.5% of health care costs in Europe, North America and Australia spent on AF alone. When a detailed evaluation of gender differences was undertaken, key differences in the clinical presentation, thrombo-embolic risk and therapeutic management of women compared to men were detected. Most importantly, women were, on average, older than their male counterparts and were also more likely to report depressive symptoms and have poorer quality of life. There were also potentially important social, clinical and treatment differences that might adversely influence health outcomes in women. The prevalence of cognitive impairment within this cohort was found to be substantially higher than expected, with 65% of the SAFETY cohort demonstrating mild cognitive impairment (MCI) on initial assessment. Those with MCI were less educated but at a higher thrombo-embolic risk with multiple cognitive domains being affected. When cardiac rate and rhythm were assessed on Holter monitoring in intervention patients post-discharge, a substantial divergence between intended and detected control was found. Of those intended for rhythm control, 43% had reverted back to AF and an uncontrolled heart rate was identified in 26% of all patients. A novel method for classifying heart rate control was determined with three phenotypes being described. Patients who were more clinically complex with diagnosed coronary artery disease (CAD) and/or renal disease/dysfunction were less likely to display heart rate stability. Conclusions: In addition to providing a more contemporary and accurate description of an evolving global epidemic of AF, this research has the potential to enhance and extend current risk delineation strategies to optimise clinical management and outcomes in high risk individuals. Specifically, by focussing on gender differences, the common presence of MCI and a frequent disconnect between intended versus achieved rate/rhythm control target this research identified a number of practical ways to enhance risk delineation in AF. Ongoing research will evaluate the cost-effectiveness of enhanced risk delineation in AF via more proactive management

Post-discharge electrocardiogram Holter monitoring in recently hospitalized individuals with chronic atrial fibrillation to enhance therapeutic monitoring and identify potentially predictive phenotypes

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia managed in clinical practice. Maintenance of intended rate or rhythm control following hospitalisation is a key therapeutic goal. Aims: The purpose of this study was to assess post-discharge maintenance of intended AF control and classify potentially predictive heart rate (HR) phenotypes via electrocardiogram (ECG) Holter monitoring. Methods: In a sub-study of a multicentre randomised controlled trial comparing AF-specific management with usual care, 24-hour ECG Holter monitoring was undertaken in 133 patients 7–14 days post-discharge. Intended rate and rhythm control were compared to Holter data. Analysis of the frequency distribution of mean hour-to-hour differences identified those with labile HRs. Results: Mean age was 71±10 years, 67 (50%) were male and mean HR was 72±14 bpm. Most (89%) had persistent AF (median time in AF=39% (IQR 0–100%)). Uncontrolled HR (>90 bpm for >10% of recording) occurred in 35 (26%) patients and 49 (37%) patients did not achieve their intended rate (n=26) or rhythm control (n=23). Patients in the upper quartile of mean hour-to-hour HR variability were identified as persistently labile (n=33). A further group (n=22) with periodically labile HRs was identified. Those with coronary artery disease (OR 0.34; 95% CI 0.13–0.91, p=0.033) or renal disease/dysfunction (OR 0.24; 95% CI 0.06–0.98, p=0.047) were less likely to demonstrate HR stability (n=78). Conclusion: Post-discharge ECG Holter monitoring of AF patients represents a valuable tool to identify deviations in intended rhythm/rate control and adjust therapeutic management accordingly. It may also identify individuals who demonstrate labile HRs

Mild cognitive impairment impacts health outcomes of patients with atrial fibrillation undergoing a disease management intervention

Objective: Mild cognitive impairment (MCI) is prevalent in atrial fibrillation (AF) and has the potential to contribute to poor outcomes. We investigated the influence of MCI on survival and rehospitalisation in patients with chronic forms of AF undergoing a home-based, AF-specific disease management intervention (home-based intervention (HBI)) or standard management (SM). Methods: The Montreal Cognitive Assessment tool was administered at baseline (a score of Results: Of 260 patients (mean age 72±11, 47% female), 65% demonstrated MCI on screening (34% in SM; 31% in HBI). Overall, the number of days spent alive and out-of-hospital during follow-up (P=0.012) and all-cause rehospitalisation were influenced by MCI during follow-up (OR 3.16 (95% CI 1.46 to 6.84)) but MCI did not influence any outcomes in the SM group. However, survival was negatively influenced by MCI in the HBI group (P=0.036); those with MCI in this group were 5.6 times more likely to die during follow-up (OR 5.57 (95% CI 1.10 to 28.1)). Those with MCI in the HBI group also spent less days alive and out-of-hospital than those with no MCI (P=0.022). MCI was also identified as a significant independent correlate of shortest duration of event-free survival (OR 3.48 (95% CI 1.06 to 11.4)), all-cause rehospitalisation (OR 3.30 (95% CI 1.25 to 8.69)) and cardiovascular disease (CVD)-related rehospitalisation (OR 2.35 (95% CI 1.12 to 4.91)) in this group. Conclusions: The effectiveness of home-based, disease management for patients with chronic forms of AF is negatively affected by comorbid MCI. The benefit of adjunctive support for patients with MCI on CVD-related health outcomes requires further investigation

Within trial cost-utility analysis of disease management program for patients hospitalized with atrial fibrillation: Results from the SAFETY trial

Background: The potential impact of disease management to optimize quality of care, health outcomes, and total healthcare costs across a range of cardiac disease states is unknown. Methods: A trial-based cost-utility analysis was conducted alongside a randomized controlled trial of 335 patients with chronic, non-valvular AF (without heart failure; the SAFETY Trial) discharged to home from three tertiary referral hospitals in Australia. A home-based disease management intervention (the SAFETY intervention) that involved community-based AF care including home visits was compared to routine primary healthcare and hospital outpatient follow-up (standard management). Bootstrapped incremental cost-utility ratios were computed based on quality-adjusted life-years (QALYs) and total healthcare costs. Cost-effectiveness acceptability curves were constructed to explore the probability of the SAFETY intervention being cost-effective. Sub-group analyses were performed based on age and sex to determine differential cost-effectiveness. Results: During median follow-up of 1.75 years, the SAFETY intervention was associated with a non-statistically significant increase in QALYs (0.02 per person) and lower total healthcare costs (–$4,375 per person). Although each of these findings were not statistically significant, the SAFETY intervention was found to be dominant (more effective and cost saving) in 58.8$50,000 per QALY gained) in 61.5% of the iterations. Males and those aged less than 78 years achieved greater gains in QALYs and savings in healthcare costs. The estimated value of perfect information in Australia (the monetized value of removing uncertainty in the cost-effectiveness results) was A$51 million, thus demonstrating the high potential gain from further research. Conclusions: Compared with standard management, the SAFETY intervention is potentially a dominant strategy for those with chronic, non-valvular AF. However, there would be substantial value in reducing the uncertainty in these estimates from further research