Early Discharge to Clinic-Based Therapy of Patients Presenting With Decompensated Heart Failure (EDICT-HF): Study Protocol for a Multi-Centre Randomised Controlled Trial.

BACKGROUND: Acute decompensated heart failure involves a high rate of mortality and complications. Management typically involves a multi-day hospital admission. However, patients often lose part of their function with each successive admission, and are at a high risk for hospital-associated complications such as nosocomial infection. This study aims to determine the safety and efficacy of the management of patients presenting with acute decompensated heart failure to clinic-based therapy vs usual inpatient care using a reproducible management pathway. METHOD: An investigator-initiated, prospective, non-inferiority, 1:1 randomised-controlled trial, stratified by left ventricular ejection fraction including 460 patients with a minimum follow-up of 7 days. This is a multi-centre study to be performed in centres across Victoria, Australia. Participants will be patients with either heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF), admitted for acute decompensation of heart failure. INTERVENTION: Early discharge to an outpatient-based Heart Failure Rapid Access Clinical Review (RACER) in addition to frequent medical/nursing at-home review for patients admitted with decompensated heart failure. RESULTS: The primary endpoint will be a non-inferiority assessment of re-hospitalisation at 30 days. Secondary outcomes include superiority assessment of hospitalisation at 30 days, a composite clinical endpoint of major adverse cardiac and cerebrovascular event (MACCE), hospital re-admission or mortality at 3 months, achievement of guideline-directed medical therapy, patient assessment of symptoms (visual-analogue scale quantified as area under curve and Kansas City Cardiomyopathy Questionnaire-12 [KCCQ-12]), attendance at 3-month outpatient follow-up, number of bed stays/clinics attended, proportion of patients free from congestion, change in serum creatinine level, treatment for electrolyte disturbances, time to transition from intravenous to oral diuretics, and health economics analysis (cost-benefit analysis, cost-utility analysis, incremental cost-effectiveness ratio). CONCLUSIONS: The Early Discharge to Clinic-Based Therapy of Patients Presenting with Decompensated Heart Failure (EDICT-HF) trial will help determine whether earlier discharge to out-of-hospital care is non-inferior to the usual practice of inpatient care, in patients with heart failure admitted to hospital for acute decompensation, as an alternative model of care.

Sex Differences in Radial Access for Percutaneous Coronary Intervention in Acute Coronary Syndrome Are Independent of Body Size.

BACKGROUND: Radial access reduces bleeding and is associated with improved survival following percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). We evaluated the association between sex, markers of body size and radial access, and its impact on bleeding and mortality following PCI for ACS. METHODS AND RESULTS: From 2013-2016, consecutive patients treated with PCI for ACS across 30 centres were prospectively entered into the Victorian Cardiac Outcomes Registry and followed for 30 days. Multivariate logistic regression was used to analyse predictors of the primary endpoint of PCI access site and secondary endpoints of major bleeding and mortality. A total of 16,330 ACS patients (40.9% ST elevation myocardial infarction [STEMI]) underwent PCI (23.5% female). Women were older with significantly lower weight and height compared to men. Women had lower radial access use (41.6% versus 51.0%, p<0.001), with higher 30-day major bleeding (2.4% versus 1.4%, p<0.001) and mortality (4.4% versus 3.4%, p<0.001) than men. Female sex independently predicted lower radial access use (OR 0.75, 95% CI 0.68-0.83, p<0.001) while body surface area, height and body mass index did not. Female sex was an independent predictor of higher 30-day major bleeding (OR 1.38, 95% CI 1.05-1.81, p=0.019) and mortality in STEMI patients (OR 1.31, 95% CI 1.01-1.70. p=0.039). Radial access was associated with lower major bleeding (OR 0.70, 95% CI 0.53-0.91, p=0.009) and mortality (OR 0.60, 95% CI 0.48-0.75, p<0.001). CONCLUSIONS: Radial access, despite being associated with lower bleeding and mortality, was used less frequently in women, independent of co-morbidities and objective markers of body size.

Artificial FLOwering plants in Reducing Anxiety and depressive symptoms following Acute Coronary Syndromes (A-FLORA-ACS): a randomised controlled trial.

Patients often experience emotional distress after acute coronary syndrome (ACS). These may lead to symptoms of depression or anxiety and greater morbidity/mortality. We sought to determine whether flowering plants in the coronary care ward reduced depressive and anxiety symptoms in these patients. Patients with ACS were randomly allocated to flowering plants (intervention) or no plants (control) in their room during index hospitalisation. Baseline data were collected. The primary outcome was the Hospital Anxiety and Depression Scale (HADS) depressive and anxiety symptom scores at discharge. Secondary outcomes were HADS depression and anxiety scores at 3 months. Both modified intention-to-treat (mITT) and per-protocol (PP) analysis were performed. 122 patients were included in the analysis after case exclusion, with all completing the HADS questionnaire at discharge and 89/122 (73%) patients completing the 3-month post-discharge HADS. At discharge, mean depressive symptom scores were lower in the intervention group, but only significantly so in the PP analysis (mITT 3.6/21 vs 4.6/21, p = 0.11; PP 3.5/21 vs 4.9/21, p = 0.04). There were no significant changes in between-group anxiety symptom scores (mITT 6.4/21 vs 6.1/21, p = 0.51; PP 3.3/21 vs 3.6/21, p = 0.67). The mean increase in depressive symptom scores at 3 months was smaller in the intervention group in both analyses (mITT 0.6 ± 3.6 vs 2.2 ± 2.6, p = 0.02; PP 0.8 ± 3.6 vs 2.4 ± 2.7, p = 0.03). Mean increase in anxiety symptom scores was not significantly different between groups (mITT 2.8/21 vs 2.5/21, p = 0.86; PP 3.3/21 vs 3.6/21, p = 0.67). Flowering plants during index hospitalisation for ACS reduced depressive symptoms in a per-protocol analysis but did not have a significant impact on anxiety symptoms. Increases in depression symptom scores were significantly smaller at 3 months post exposure to flowers compared to anxiety symptom scores.

Factors That Prevent Progression to Transcatheter Aortic Valve Implantation (TAVI).

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly used for intermediate- and high-risk patients with severe symptomatic aortic stenosis (AS). However, safe undertaking of the procedure may be precluded by various anatomic factors. This study sought to identify prevalence of factors that prevent progression to TAVI. METHODS: TAVI candidates with severe AS undergoing workup coronary angiography and iliac vessel angiography (±cardiac-gated CT) were identified and factors precluding TAVI were reviewed retrospectively from a single-centre cardiac database over a 10-year period. RESULTS: 197 patients were included; mean age was 81.5±6.5years (±SD); 46.2% were male. 26.9% of TAVI candidates could not proceed to femoral access TAVI due to various factors including unsuitable peripheral vasculature (13.2%), untreated coronary artery disease (CAD) deemed high risk for TAVI (8.1%), unfavourable aortic characteristics (4.1%), and low-lying coronary ostia (1.5%). Factors associated with unsuitable femoral vasculature included female gender (p<0.01) and any CAD (p=0.03). Factors associated with the presence of unrevascularised CAD included male gender (p<0.01), estimated glomerular filtration rate (eGFR)<30mL/min/1.73m2 (p=0.02), history of CAD (p<0.01), while prior percutaneous coronary intervention (PCI) or bypass surgery were protective (both p<0.01). Rates of progression to TAVI have increased over the last 10 years (p<0.01) from 58.3% prior to 2012 to 83.7% in 2016 and 2017, while incidence of unsuitable peripheral vasculature preventing TAVI (p=0.01) and CAD deemed unsuitable for TAVI (p=0.04) have both decreased. CONCLUSIONS: Non-progression to TAVI among higher risk patients with severe AS has become less common over the last 10 years with improvements in operator experience, lower profile devices, and wider ranges of valve sizes.

Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: A 16-Year Australian Single Centre Experience.

BACKGROUND: Alcohol septal ablation (ASA), is a well-established treatment for symptomatic hypertrophic obstructive cardiomyopathy (HOCM). We report the acute, short and long-term clinical and echocardiographic outcomes of our experience in a single Australian centre over 16 years. METHODS: We retrospectively analysed consecutive patients presenting to our centre for ASA between March 2000 and July 2016. Local databases were interrogated along with direct patient or physician contact occurred where required. RESULTS: Alcohol septal ablation was performed in 80 patients with symptomatic, medication refractory HOCM (mean age 61±15 years; range 22-84 years; 50% male). All patients had transthoracic echocardiography prior to the procedure, within 48hours of the procedure, 6 weeks, 6 months, 1 year and yearly thereafter to a median follow-up of 80±40months. At baseline, mean resting and provoked LVOT gradients were 80±49mmHg and 97±40mmHg respectively. Compared with baseline, ASA led to a reduction in resting LVOT gradients at all time points, particularly at 2 days-52±41mmHg, p<0.001; 12 months-29±34mmHg, p<0.001; and last follow-up 12±21mmHg, p<0.001. Provoked LVOT gradients were also reduced at 2 days-64±44mmHg and last follow-up of 19±29mmHg, p<0.001. Compared to baseline (19.8±4.2mm), ASA was associated with a reduction in interventricular septal (IVS) thickness at all time intervals with last echocardiographic follow-up at 80 months being 16.0±4.9mm, (

Cardiac implantable electronic device hematomas: Risk factors and effect of prophylactic pressure bandaging.

BACKGROUND: Cardiac implantable electronic device (CIED) hematomas are associated with many adverse outcomes. We examined the incidence and risk factors associated with hematoma formation post-CIED implantation, and explored the preventative effect of prophylactic pressure bandaging (PPB) in a large tertiary center. METHODS: 1,091 devices were implanted during October 2011-December 2014. Clinically significant hematomas (CSH) were those that necessitated prolonged admission, including those due to reoperation, and clinically suspicious hematomas were swellings noted by medical/nursing staff. We screened for variables affecting hematoma incidence prior to conducting multivariate logistic regression analyses, one for all hematomas and one for CSH. RESULTS: 61 hematomas were identified (5.6% of patients), with 12 of those clinically significant (1.1% of patients). Factors significantly increasing the odds of developing any hematoma were stage 2 (odds ratio [OR] = 2.93, 95% confidence interval [CI] [1.08-7.94], P = 0.034) and 3 chronic kidney disease (CKD) (OR = 3.39 [1.20-9.56], P = 0.021), unfractionated heparin/therapeutic enoxaparin (OR = 3.15 [1.22-8.14], P = 0.018), and dual antiplatelets-aspirin + clopidogrel (OR = 2.95 [1.14-7.65], P = 0.026) + other combinations. Body Mass index (BMI) 25.0-29.9 (OR 0.52 [0.28-0.98], P = 0.044) and >30 were associated with decreased hematoma risk (OR 0.43 [0.20-0.91], P = 0.028). Factors significant for CSH formation were unfractionated heparin/therapeutic enoxaparin (OR = 9.55 [1.83-49.84], P = 0.007) and aspirin + clopidogrel (OR = 7.19 [1.01-50.91], P = 0.048). PPB nonsignificantly increased the odds of total hematoma development (OR = 1.53 [0.87-2.69], P = 0.135), and reduced CSH (OR = 0.67 [0.18-2.47], P = 0.547). CONCLUSIONS: Heparin and dual antiplatelet use remain strong predictors of overall hematoma formation. CKD is a comparatively moderate predictor. BMI > 25 may decrease the risk of hematoma formation. PPB had nonsignificant effects on hematoma development.

Serotonin antidepressants and atrial fibrillation burden from cardiac implantable electronic devices.

Objective: Depression and anxiety show a bidirectional relationship with atrial fibrillation (AF). Antidepressant use is associated with a reduction in the incidence of AF. However, no studies have examined the relationship between antidepressant use and AF burden (time in AF). This retrospective cohort study examined cardiac implantable device-detected AF episodes and their relationship with antidepressant use, among other treatment factors. Methods: Consecutive patients from the Western Health Cardiology Department attending pacemaker checks between 2015 and 2021 were included. Patients with permanent AF were excluded, yielding 285 patients with no or paroxysmal AF, with a total of 772 patient encounters. Generalized estimating equations were used to model two processes: binary AF (present/absent) and the number of days in AF for patients with AF. Results: Each yearly increase with age was associated with an increase in the odds of developing AF (OR 1.03 [1.00-1.05], p = .027). Male gender conferred a reduction in AF incidence (OR 0.30 [0.13-0.68], p = .004). Digoxin use was associated with incident AF (OR 4.43 [1.07-18.4], p = .04). Sotalol and heart-failure beta blocker use were associated with a decrease in AF burden (IRR 0.30 [0.12-0.78], p = .013 and 0.33 [0.14-0.81], p = .015). Selective serotonin reuptake inhibitor antidepressant use was associated with reduced AF burden (IRR 0.27 [0.09-0.81], p = .019), as was selective serotonin/noradrenaline reuptake inhibitor use (IRR 0.07 [0.03-0.15], p < .001). Conclusions: Older age, female gender and digoxin are associated with a higher odds of developing incident AF. Sotalol, heart failure beta blockers and serotonin-based antidepressants are associated with reduced AF burden. Further prospective study into the effects of antidepressants on atrial arrhythmias is warranted.

Effect of Different Anthropometric Body Indexes on Radiation Exposure in Patients Undergoing Cardiac Catheterisation and Percutaneous Coronary Intervention.

BACKGROUND: Patient factors, such as sex and body mass index (BMI), are known to influence patient radiation exposure. Body surface area (BSA) and its association with patient radiation exposure has not been well studied. METHODS AND RESULTS: We analysed height, weight, BMI and BSA in consecutive patients undergoing cardiac catheterisation and percutaneous coronary intervention (PCI) at a high-volume Australian centre between September 2016 and April 2020 to assess their association with dose-area product (DAP, Gycm2). The mean age of the cohort was 64.5 ± 12.3 years with males comprising 68.8% (n = 8100, 5124 diagnostic cardiac catheterisation cases and 2976 PCI cases). Median male BMI was 28.4 kg/m2 [IQR 25.2-32.1] versus 28.8 kg/m2 [24.7-33.7] for females, p = 0.01. Males had higher BSA (2.0 ± 0.2 m2) than females (1.78 ± 0.2 m2), p = 0.001. Each 0.4 m2 increase in BSA conferred a 1.32x fold change in DAP (95% CI 1.29-1.36, p ≤ 0.001). Each 5 kg/m2 increase in BMI was linked to a 1.13x DAP fold change (1.12-1.14, p ≤ 0.001). Male sex conferred a 1.23x DAP fold change (1.20-1.26, p ≤ 0.001). Multivariable modelling with BMI or BSA explained 14% of DAP variance (R2 0.67 vs. 0.53 for both, p ≤ 0.001). CONCLUSIONS: BSA is an important anthropometric measure between the sexes and a key predictor of radiation dose and radiation exposure beyond sex, BMI, and weight.

Cardiovascular effects of caffeinated beverages.

Caffeine is the world's most popular 'drug', with tea and coffee a ubiquitous part of daily life. As a psychoactive stimulant, there are potential concerns regarding adverse cardiovascular squeal. Cardiovascular conditions, encompassing hypertension, coronary artery disease, rhythm disorders and heart failure affect billions of patients worldwide. We aim to provide a patient-centered comprehensive review of the cardiovascular effects of caffeinated beverages as they pertain to various common cardiovascular conditions. We conclude that intake of tea and coffee, particularly in moderate doses, does not appear to be harmful and may even be beneficial in a range of cardiovascular conditions, including coronary artery disease, heart failure and arrhythmias.

Does sex predict quality of life after acute coronary syndromes: an Australian, state-wide, multicentre prospective cohort study.

OBJECTIVE: Women have reported higher mortality and major adverse cardiovascular events (MACE) following acute coronary syndromes (ACSs) compared with men. With this in mind, we aimed to identify predictors of poor quality of life (QoL) post-ACS as our primary outcome. We examined predictors of MACE, major cerebrovascular events and major bleeding as our secondary outcome. DESIGN: Prospective cohort study. SETTING: 30 metropolitan centres across the Victorian Cardiac Outcomes Registry network. PARTICIPANTS: 16 517 patients treated with percutaneous coronary intervention (PCI) for ACS (22.9% females). Selection/inclusion criteria: consecutive patients with successful or attempted PCI for ACS from 2013 to 2016, alive at 30 days post-PCI. EXCLUSION CRITERIA: patients not fulfilling ACS criteria. At 30 days, 2497 (64.7% females) completed the QoL EQ-5D-3L instrument. PRIMARY AND SECONDARY OUTCOME MEASURES: QoL, assessed using the EuroQo-5Dimensions (EQ-5D-3L) instrument by telephone at 30 days. Independent predictors of QoL were identified by univariate and multivariate logistic regression analyses. RESULTS: Women were significantly older with more diabetes, cerebrovascular disease and renal failure. Regarding the primary outcome, female sex was independently associated with moderate/severe impairment in all EQ-5D-3L domains including mobility (OR 2.38, 95% CI 2.06 to 2.75, p<0.001), personal care (OR 2.14, 95% CI 1.73 to 2.66, p<0.001), activities of daily living (OR 1.84, 95% CI 1.63 to 2.08, p<0.001), pain/discomfort (OR 1.44, 95% CI 1.24 to 1.67, p<0.001) and anxiety/depression (OR 1.49, 95% CI 1.30 to 1.70, p<0.001). Women had significantly lower self-rated Visual Analogue Scale scores (80.0 for both groups, IQR 60-85 vs 70-90, p<0.001). There was no significant difference between the sexes in secondary outcomes. CONCLUSIONS: Female sex was a predictor of poorer QoL following PCI for ACS including significantly higher pain, anxiety and depression. This was independent of age, comorbidities and ACS presentation. There is a clinical need for a tailored approach in female ACS management, for example, emphasis on management of depressive and anxiety symptoms.

Barriers to Accessing Testing and Treatment for Chronic Hepatitis B in Afghan, Rohingyan, and South Sudanese Populations in Australia.

The burden of chronic Hepatitis B (CHB) infection and associated complications such as hepatocellular carcinoma is growing significantly in Australia due to increased migration from countries with a high prevalence of CHB. Significant barriers to screening and engagement with healthcare persist due to stigma and perceptions associated with CHB within these communities. Our study was a pilot intervention aimed at engaging Afghan, Rohingyan, and Sudanese populations into CHB care through an initial needs assessment. Twenty six patients from Afghan, Rohingyan, and Sudanese communities, identified in the Monash Health CHB database, participated in a combination of survey questionnaires and semi-structured interviews. Language and cultural barriers, lack of HBV knowledge, housing and family reunification priorities associated with new settlement, as well as previous experiences of healthcare engagement were all identified as obstacles to accessing CHB care. Healthcare and health promotion workers should be sensitive to the additional health barriers associated with seeking asylum, as these barriers can take priority over the often asymptomatic and chronic nature of CHB. Communities with high prevalence of CHB require culturally relevant education tools delivered at a community level in order to improve their knowledge.

Engaging new refugee in Australian communities at risk for chronic hepatitis B infection into care: A peer-educator intervention.

Chronic Hepatitis B (CHB) infection and subsequent liver complications are rising in prevalence in Australia due to increased migration from endemic regions. Nearly 50% of all those living with CHB in Australia are undiagnosed, leading to missed opportunities for liver cancer and cirrhosis prevention. Health literacy around CHB among refugee communities such as Afghan, Rohingyan, and Sudanese populations (all with a high prevalence of CHB) is low, partly due to a paucity of targeted health promotion programmes; despite the release of the Victorian Hepatitis B Strategy (2016-2020). We developed a peer-education intervention in these three communities to deliver CHB focused radio programmes and community forums in their own language, following a needs assessment consisting of semistructured interviews and surveys. Effectiveness of this intervention was measured through paired comparison of disease-knowledge assessment pre and post forum. Community forums were held between 2015 and 2016, with 25 attendees at the Rohingyan forum (68% male), 10 attendees at the Afghan forum (90% male) and 0 attendees at the Sudanese forum. Participants demonstrated a significant improvement in CHB knowledge between pre- and post-forum surveys (p-value < 0.05). A peer-educator approach was a cost-effective health promotion strategy in building CHB knowledge and dispelling misconceptions within the Afghan and Rohingya communities. There were significant barriers in the engagement of the South Sudanese community, which will inform future strategies for health promotion.