Background:Patient-reported outcomes (PROs) are increasingly used as endpoints in clinical trials. However, the magnitude of observed changes in control arms attributable to placebo effects, as compared with other benefits of trial participation, has not been described.This study seeks to estimate the magnitude of the placebo effect by calculating changes in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) scores, which quantify the impact of heart failure on patients' symptoms, function, and quality of life, after participants were unblinded to treatment. Methods:REDUCE LAP-HF II randomized participants to atrial shunt or sham procedure, with unblinding after 2 years. The KCCQ was collected at baseline, 2, and 3 years after randomization. KCCQ-OS change from baseline to 2 years (placebo effect plus other benefits from trial participation) and the change from 2 to 3 years (placebo effect loss after unblinding) were calculated in sham-treated patients using mean±SD, as were changes from 2 to 3 years in shunt-treated patients (placebo effect benefit). Results:The analytic cohort included 421 participants (median age 72 years, 65.6% female). Among sham-treated participants (N=182), the mean±SD KCCQ-OS 2-year improvement from baseline was +9.3±22.4 points, with a decrement after unblinding of -1.7±18.2 points from 2 to 3 years. Among shunt-treated patients (N=239), mean±SD KCCQ-OS 2-year improvement was +12.7±22.8 points, with an improvement after unblinding of +1.9±18.2 points. In a hypothetical unblinded trial where placebo effect benefit would be expected in the active intervention arm, and none in the untreated arm, the combined effects would be 3.6 points. Conclusions:In a sham-controlled device trial that collected PRO data during blinded allocation to treatment or sham and after unblinding, the estimated mean placebo effect benefit and loss on the KCCQ-OS were small (≤2 points). Finding a modest placebo effect on PROs may increase confidence in their use as clinical trial outcomes.
Introduction:Mental health disorders are common among people with heart failure (HF). The Enhanced HF Care program is a digital health intervention designed to remotely monitor and support the wellbeing of patients discharged with acute decompensated HF via online modules and surveys. This qualitative study explores participants' experiences, engagement with and feedback on the program. Methods:The design was a qualitative in-trial sub-study. Participants were recruited pre-discharge from two public hospitals in New South Wales, Australia. Semi-structured telephone interviews were conducted one- and/or six-months post-recruitment with a sample of participants who received the intervention to understand their experience of the program. Transcripts were analysed based on a qualitative descriptive approach and content analysis. Results:Twenty-four interviews were conducted with 18 participants (3 female, 15 male; age range 39-87 years). Four overarching themes were identified: program engagement; program benefits; additional information needs; and multidimensional perspectives on health. Most participants reported the program as beneficial, comprehensive and detailed enough for their needs, particularly valuing the opportunity for self‑reflection on mental and physical health. However, engagement was variable, with competing priorities and feeling overwhelmed after discharge limiting uptake for some participants. Easy post‑discharge access to information and the ability to share it with family were also valued. Discussion:Patient feedback highlighted the acceptability and positive impacts of the program, though some challenges remain for uptake including information overload and competing time priorities. These findings underscore the importance of timing, tailoring, and responsiveness to individual patient contexts within digital health interventions.
Purpose To reduce risk of cardiovascular disease (CVD) in adults, as assessed by primary care doctors in rural NSW, Australia. Medical nutrition therapy (MNT) was delivered by Accredited Practicing Dietitians (APDs) using telehealth. Methods The study was a 12-month pragmatic cluster randomised controlled trial. All primary care practices (PCPs) within a large rural region were invited to participate, with enrolled practices stratified based on rurality and practice size. Patients at moderate to high CVD risk were recruited via practices. Usual care (UC) was provided by the patient’s general practitioner (GP). In addition to UC, the intervention group received two hours of MNT telehealth (video calls) consultations from an APD during five sessions over 6 months. The primary outcome was total serum cholesterol. Secondary outcomes included LDL cholesterol, triglycerides, blood glucose control, blood pressure, weight and waist circumference. Changes were analysed using Bayesian linear mixed models and posterior probability. Findings Sixteen PCPs recruited 132 eligible participants ( n = 91 intervention, n = 41 UC), with 79% (72/91) and 80% (33/41) respectively completing a primary or secondary outcome. No significant differences were found between groups for total cholesterol, LDL cholesterol or blood pressure at 12-months. However, the intervention group had significant improvements in blood glucose control (HbA1c: -0.16%, 95%CI: -0.32, -0.01) and decreased body weight (-2.46 kg, 95%CI: -4.54, -0.41) compared to UC at 12-months. Conclusions Results indicate that two hours of MNT delivered by an APD via telehealth is a synergistic adjunct therapy to support the usual care provided by GP, with benefits continuing to 12-months.
Background: The psychological impact of surviving an admission to an intensive care unit (ICU) with COVID-19 is uncertain. The objective of the study was to assess the prevalence of anxiety, depression and post-traumatic stress disorder (PTSD) symptoms in ICU survivors treated for COVID-19 infection, and identify risk factors for psychological distress. Methods: This observational study was conducted at 52 ICUs in the United Kingdom. Participants, treated for COVID-19 infection during an ICU admission of ⩾24 h, were recruited post-ICU discharge. Self-report questionnaires were completed at 3, 6 and/or 12 months. Symptoms of anxiety and depression were identified using the Hospital Anxiety and Depression Scale. PTSD was assessed using the Impact of Events Scale-6. Demographic, clinical, physical and psychosocial factors were considered as putative predictors of psychological distress. Results: 1620 patients provided consent and 1258 (77.7%) responded to at least one questionnaire, with responses at 3 months ( N = 426), 6 months ( N = 656) and 12 months ( N = 1050) following ICU admission. The following prevalence rates were found at 3, 6 and 12 months, respectively: anxiety in 28.8% (95% CI 24.6–33.1), 30.4% (95% CI 27.0–33.8) and 29.3% (95% CI 26.5–32.1); depression in 25.1% (21.0–29.3), 25.9% (22.7–29.3) and 24.0% (21.5–26.6); and PTSD in 43.5% (38.8–48.2), 44.3% (40.6–48.0) and 43.2% (40.2–46.1) of patients. Risk factors for psychological distress included a previous mental health diagnosis, unemployment or being on sick leave, and a history of asthma or COPD. Conclusion: Clinically significant symptoms of anxiety, depression and PTSD were common and persisted up to 12 months post-ICU discharge.
Background:Distal transradial artery (dTRA) access offers benefits to patients and operators. Aims:We sought to determine the feasibility and safety of the dTRA as a first-line vascular access site and to evaluate predictors of dTRA approach success. Methods:This retrospective cohort study analysed consecutive patients from three Australian centres who underwent coronary angiography and percutaneous coronary intervention via the dTRA (from November 2019 to December 2023). The primary outcome was procedural success (completion of a case using the dTRA puncture site). Secondary outcomes were access site crossover, procedural safety, arterial patency at follow-up, and predictors of procedural success. Results:A total of 1,692 patients were included (mean age 70.6±10.5 years, 59% male [n=993], mean body mass index [BMI] 31.0±7.0 kg/m2, right dTRA 85%, ultrasound guidance 99%). First pass success was achieved in 92.2% (n=1,560) of patients, and 1.5% had success on the second puncture of the ipsilateral dTRA. Crossover was required in 6.3% (n=107; proximal transradial [n=78; 4.6%], contralateral dTRA [n=22; 1.3%], femoral [n=6; 0.4%], ulnar [n=1; 0.1%]). There were no major vascular complications. Access site bleeding requiring treatment occurred in 0.3% (n=5) of cases. Proximal and distal radial occlusion occurred in 0.1% and 0.4%, respectively. Thirty-day major adverse cardiovascular events occurred in 1.4% (n=24). Radial artery patency was 98% (630/641) at follow-up. Hypertension (odds ratio [OR] 1.73; p=0.029), an experienced operator (attending/consultant and ≥4 years' experience with dTRA; OR 2.80; p<0.001), and a low BMI (OR 1.48 per 10 unit decrease in BMI; p=0.012) were predictors of technical success. Conclusions:The "distal radial first" approach is feasible and safe for coronary procedures. Factors associated with procedural success include increased operator experience, a low BMI, and hypertension.
BACKGROUND:Clozapine has demonstrated superiority in improving both positive and negative symptoms of treatment-resistant schizophrenia; however, there are associated treatment-limiting side effects, including myocarditis, cardiomyopathy and agranulocytosis. AIM:This retrospective cohort study describes the prevalence of myocarditis, left ventricular (LV) dysfunction, cardiovascular risk factors and outcomes in a cohort of patients maintained on clozapine therapy. METHODS:Data were retrospectively collated from patients who had a diagnosis of schizophrenia, had been managed with clozapine at any stage during their care and undergone at least one echocardiogram. RESULTS:Between March 2020 and September 2021 674 patients were identified, 71% were male, with a mean age of 47 years old (interquartile range (IQR) 40-57). The mean duration of clozapine use was 7 years (IQR 4-13). The overall mortality was 5.54% during the follow-up period. Myocarditis was identified in one patient (0.15%) within the first 30 days, and an additional five cases were identified over the follow-up period (0.89%). The combined incidence of heart failure (HF) and myocarditis was 1.6% during the follow-up period. There was no association between LV size and function at baseline or during follow-up and adverse cardiac outcomes (comprising death, myocarditis, HF). Older age at initiation of therapy and baseline E/e' ratio were associated with risk of HF and myocarditis. CONCLUSION:The overall incidence of myocarditis and HF during follow-up was low, with surveillance echocardiography offering limited predictive value. Patients maintained on clozapine are at risk of significant cardiovascular sequelae, likely reflecting an adverse risk factor profile.
Objective:Eosinophils have been implicated in mediating the inflammatory response after ST-elevation myocardial infarction (STEMI), but its role as a biomarker predicting major adverse cardiovascular events (MACE) remains unclear. We aimed to evaluate the predictive value of eosinophil response on 30-day and 1-year MACE post primary percutaneous coronary intervention (PCI) after STEMI. Methods:Single centre retrospective cohort study of STEMI patients undergoing PCI. Eosinophil response was defined as the change in peripherally circulating eosinophils cell count at admission minus 48 h post primary PCI. Primary endpoints were 30-day and 1-year MACE. Receiver operating characteristic (ROC) curves were created to identify optimal cut-off predicting MACE. Multivariate logistic regression analyses were used to determine if the ROC cut-off was an independent predictor of MACE. Results:Of the 366 patients in this study (median age 61 years [53.0-71.0]; 267 males [73 %]), 41 patients (11.2 %) and 78 patients (21.3 %) developed MACE at 30-days and 1-year. The optimal ROC curve cut-off predicting MACE was an eosinophil response of greater than -0.05 × 10^9/L (ΔEos > -0.05). It had a sensitivity, specificity, and positive and negative predictive value of 83, 39, 6 and 98 % for 30-day MACE, and 74, 39, 19 and 88 % for 1-year MACE. An ΔEos > -0.05 change was associated with a threefold higher likelihood of MACE at 30-days (OR 3.1, 95 % CI 1.04-9.07, p=0.042), but not 1-year. Conclusion:An eosinophil response of -0.05 × 10^9L at 48 h following primary PCI post STEMI is highly sensitive at predicting 30-day MACE, and in its absence, holds a high negative predictive value.
Background: The Enhanced HF Care study is a prospective randomised open blinded endpoint (PROBE) design trial comparing the effectiveness of a digital health intervention --Enhanced HF Care -- to usual care, in increasing health related quality of life for patients hospitalised with acute decompensated heart failure (ADHF). The study aims to evaluate effectiveness in (i) improving emotional and physical wellbeing, and (ii) decreasing healthcare utilisation. This statistical analysis plan outlines the pre-specified statistical principles and procedures for analysing data from the trial, which has been updated from as described in the trial protocol to reflect lower than anticipated recruitment rates. Methods: The co-primary outcomes are emotional and physical wellbeing measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) domains at 6-months post-recruitment. Secondary outcomes include MLHFQ emotional and physical well-being at 1-month post-recruitment, unplanned hospital readmissions, and emergency department presentations. Statisticians conducting analyses are blind to treatment allocation. Analysis: Bayesian hierarchical mixed effects models will be used to estimate treatment effects for all outcomes, with uninformative prior distributions specified for effect parameter and half-Cauchy priors on the random effect standard deviation and the within person standard deviation. For each outcome, the analysis will present mean differences between treatment groups with 95% credible intervals (highest posterior density) and posterior probabilities of treatment effect. All randomised participants will be analysed according to their assigned treatment group following an intention-to-treat framework, excluding only those who withdraw consent for data use. Intercurrent events will be handled using the estimands framework. For MLHFQ outcomes, a composite strategy will be employed where participants who die will be assigned the maximum value reflecting worst possible quality of life. Healthcare utilisation outcomes (unplanned hospital readmissions and emergency department presentations) will be analysed using a 'while alive' strategy, with follow-up extending until either death or 6 months post-randomisation, whichever occurs first. For handling missing data, we will use multiple imputation by chained equations (MICE) under a missing at random assumption when participants drop out. For completed MLHFQ subscales specifically, if only one item is missing within a subscale, we will use mean imputation for that item. However, if more than one item is missing form a subscale, the total score will be set to missing and MICE will be used to impute the total subscale score. Additional analyses will estimate the posterior predictive probability of trial success had the target sample size been achieved. Conclusion: Publication of this statistical analysis plan prior to data analysis ensures transparency in the analytical approach and minimises potential bias in the interpretation and reporting of trial results, particularly given the adaptation to Bayesian methods necessitated by lower-than-expected recruitment. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ACTRN12622001289707 ### Clinical Protocols ### Funding Statement This work is funded by a National Heart Foundation of Australia 2021 Mental Health & Heart Disease Strategic Grant (ID: 106532). BH is supported by an Australian Rotary Health Colin Dodds Postdoctoral Fellowship (#1801108). AL Sverdlov is supported by the National Heart Foundation Future Leader Fellowship (Award ID: 106025). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/IRB of Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee gave ethical approval for this work (2022/ETH00502 and H20220227, respectively) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data from this study will not be openly available. Results will be published in peer-reviewed journals and presented at national and international conferences. Additionally, participating hospitals will receive a de-identified report of results specific to their recruited patients. Researchers interested in further details may contact the study authors for inquiries.
Distal transradial artery (dTRA) access offers benefits to patients and operators. We sought to determine the feasibility and safety of the dTRA as a first-line vascular access site and to evaluate predictors of dTRA approach success. This retrospective cohort study analysed consecutive patients from three Australian centres who underwent coronary angiography and percutaneous coronary intervention via the dTRA (from November 2019 to December 2023). The primary outcome was procedural success (completion of a case using the dTRA puncture site). Secondary outcomes were access site crossover, procedural safety, arterial patency at follow-up, and predictors of procedural success. A total of 1,692 patients were included (mean age 70.6±10.5 years, 59% male [n=993], mean body mass index [BMI] 31.0±7.0 kg/m2, right dTRA 85%, ultrasound guidance 99%). First pass success was achieved in 92.2% (n=1,560) of patients, and 1.5% had success on the second puncture of the ipsilateral dTRA. Crossover was required in 6.3% (n=107; proximal transradial [n=78; 4.6%], contralateral dTRA [n=22; 1.3%], femoral [n=6; 0.4%], ulnar [n=1; 0.1%]). There were no major vascular complications. Access site bleeding requiring treatment occurred in 0.3% (n=5) of cases. Proximal and distal radial occlusion occurred in 0.1% and 0.4%, respectively. Thirty-day major adverse cardiovascular events occurred in 1.4% (n=24). Radial artery patency was 98% (630/641) at follow-up. Hypertension (odds ratio [OR] 1.73; p=0.029), an experienced operator (attending/consultant and ≥4 years' experience with dTRA; OR 2.80; p<0.001), and a low BMI (OR 1.48 per 10 unit decrease in BMI; p=0.012) were predictors of technical success. The "distal radial first" approach is feasible and safe for coronary procedures. Factors associated with procedural success include increased operator experience, a low BMI, and hypertension.
BACKGROUND:Historically, high-risk percutaneous coronary intervention (PCI) procedures such as rotational atherectomy (RA) required on-site surgical backup. However, advancements in PCI techniques, coupled with the geographic realities of Australia's dispersed population, warrant a reassessment of RA in the context of contemporary clinical practice. AIM:We aimed to establish the safety and outcomes after RA at non-surgical centres. METHOD:Consecutive RA PCI cases from September 2012 to February 2024 at seven Australian hospitals without on-site cardiac surgery were analysed. Primary outcomes were referrals for emergency cardiac surgery (bailout) and 30-day mortality. RESULTS:A total of 943 patients (1,010 lesions) were included, with a mean age of 74.4±9.6 years. A total of 72.6% were male and the average body mass index was 28.7±7.1 kg/m2. Common comorbidities included diabetes (35.1%), a history of smoking (48.7%), and acute coronary syndrome or emergency presentation (32.9%). Off-site surgical bailout was necessary for four patients (0.4%) (temporary pacing wire-related right ventricular perforation with tamponade [n=2]; burr entrapment not retrievable percutaneously [n=2]). Major coronary perforations occurred in 0.8% (n=8; Ellis III). Minor perforations occurred in 2.3% (n=22). Tamponade occurred in eight (0.8%) patients. Burr entrapment occurred in six (0.6%) patients. A total of 32 patients (3.4%) died within 30 days of the procedure; 13 cases (1.4%) were PCI-related, but only eight of these (0.8%) were directly attributable to RA (significant ischaemia, e.g., no/slow reflow [n=4]; perforation with tamponade unable to be temporised percutaneously [n=2]; burr entrapment [n=1]; extensive coronary dissection [n=1]). Female sex and acute coronary syndrome presentation were predictors of poorer outcome. CONCLUSIONS:RA can be safely conducted without on-site surgical backup, including in regional Australian areas. In geographically dispersed populations, regional access to RA-assisted PCI is critical. Immediate percutaneous management remains the mainstay of management of rare but potentially severe complications such as tamponade, perforations, and burr entrapment.
Sex-based differences in the development of obesity-induced cardiometabolic dysfunction are well documented, however, the specific mechanisms are not completely understood. Obesity has been linked to dysregulation of the epitranscriptome, but the role of N6-methyladenosine (m6A) RNA methylation has not been investigated in relation to the sex differences during obesity-induced cardiac dysfunction. In the current study, male and female C57BL/6J mice were subjected to short- and long-term high-fat/high-sucrose (HFHS) diet to induce obesogenic stress. Cardiac echocardiography showed males developed systolic and diastolic dysfunction after 4 mo of diet, but females maintained normal cardiac function despite both sexes being metabolically dysfunctional. Cardiac m6A machinery gene expression was differentially regulated by duration of HFHS diet in male, but not female mice, and left ventricular ejection fraction correlated with RNA machinery gene levels in a sex- and age-dependent manner. RNA-sequencing of cardiac transcriptome revealed that females, but not males may undergo protective cardiac remodeling early in the course of obesogenic stress. Taken together, our study demonstrates for the first time that cardiac RNA methylation machinery genes are regulated early during obesogenic stress in a sex-dependent manner and may play a role in the sex differences observed in cardiometabolic dysfunction.NEW & NOTEWORTHY Sex differences in obesity-associated cardiomyopathy are well documented but incompletely understood. We show for the first time that RNA methylation machinery genes may be regulated in response to obesogenic diet in a sex- and age-dependent manner and levels may correspond to cardiac systolic function. Our cardiac RNA-seq analysis suggests female, but not male mice may be protected from cardiac dysfunction by a protective cardiac remodeling response early during obesogenic stress.
BACKGROUND:Direct current cardioversion is frequently used to return patients with atrial fibrillation (AF) to sinus rhythm. Chest pressure during cardioversion may improve the efficacy of cardioversion through decreasing transthoracic impedance and increasing cardiac energy delivery. OBJECTIVES:This study aimed to assess the efficacy and safety of upfront chest pressure during direct current cardioversion for AF with anterior-posterior pad positioning. METHODS:This was a multicenter, investigator-initiated, double-blinded, randomized clinical trial. Recruitment occurred from 2021 to 2023. Follow-up was until hospital discharge. Recruitment occurred across 3 centers in New South Wales, Australia. Inclusion criteria were age ≥18 years, referred for cardioversion for AF, and anticoagulation for 3 weeks or transesophageal echocardiography excluding left atrial appendage thrombus. Exclusion criteria were other arrhythmias requiring cardioversion, such as atrial flutter and atrial tachycardia. The intervention arm received chest pressure during cardioversion from the first shock. The primary efficacy outcome was total joules required per patient encounter. Secondary efficacy outcomes included first shock success, transthoracic impedance, cardioversion success, and sinus rhythm at 30 minutes post cardioversion. RESULTS:A total of 311 patients were randomized, 153 to control and 158 to intervention. There was no difference in total joules applied per encounter in the control arm vs intervention arm (355.0 ± 301 J vs 413.8 ± 347 J; P = 0.19). There was no difference in first shock success, total shocks provided, average impedance, and cardioversion success. CONCLUSIONS:This study does not support the routine application of chest pressure for direct current cardioversion in atrial fibrillation (PRESSURE-AF [Investigating the Efficacy of Chest Pressure for Direct Current Cardioversion in Atrial Fibrillation: A Randomized Controlled Trial]; ACTRN12620001028998).
BACKGROUND:At a global level, regional variation in the management of ST-elevation myocardial infarction (STEMI) is influenced by patient demographics and geography. Rural patients with STEMI are disadvantaged in reaching timely care owing to distance and limited ambulance and healthcare resources. Optimising models of STEMI care is key to overcoming the excess rural vs metropolitan cardiovascular morbidity and mortality. In this descriptive study, we compare patient characteristics and STEMI management in three Local Health Districts (LHDs) across NSW: a rural LHD (Western NSW [WNSWLHD]), a regional LHD (Hunter New England), and a metropolitan site (Sydney LHD). METHOD:Data were collected from file audits conducted from 2019 to 2020 in a rural LHD with a single rural 24/7 cardiac catheter laboratory (WNSWLHD), a regional LHD with a part-time rural cardiac catheter laboratory, and a large regional 24/7 cardiac centre (Hunter New England LHD), and a metropolitan site (Sydney LHD), with two 24/7 cardiac centres. Patients with STEMI presenting in the three geographic regions were compared on demographics, differences in presentation, time to reperfusion treatment, time to percutaneous coronary intervention (PCI) centre, distances travelled, proportion of angiograms within 24 hours, and in-hospital mortality. RESULTS:During 2020, there were 675 recorded STEMI across the three regions. The rural site in WNSWLHD had the highest rate of STEMI per capita, with patients more likely to identify as Indigenous, less likely to call an ambulance, and more likely to present to a non-PCI hospital and to receive thrombolysis. Only 14% of these rural patients received primary PCI (PPCI), with patients presenting a median of 153 km from the PCI centre, vs 69% PPCI in the regional and 89% in metropolitan LHD. Thrombolysis was the main reperfusion treatment in WNSWLHD (76%), and the proportion of patients receiving no treatment was the same in all LHDs at 10%. The percentage of patients receiving angiography within 24 hours in the rural site was 84%. There was no substantial difference in in-hospital mortality among the three LHDs. CONCLUSIONS:We document large differences in the demographic profiles, use of ambulance, and access to PPCI in patients with STEMI across the three NSW centres. Current NSW health and ambulance protocols in a large, sparsely populated rural NSW LHD were able to deliver thrombolysis at the point of contact and facilitate "hot" transfer of patients with STEMI to a PCI centre. Long distances and transfer times mean that PPCI is a limited option in rural NSW, with scope for further improvement in models of care.
The Corvia atrial shunt is a novel treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF) and Farapulse Pulse Field Ablation is a new treatment for atrial fibrillation (AF). Both involve intervention across the interatrial septum. We present a patient with a pre-existing Corvia atrial shunt, treated using Farapulse Pulse Field Ablation for pulmonary vein isolation (PVI) and cavotricuspid isthmus (CTI) line ablation.
BACKGROUND Cardiovascular disease (CVD) is a leading cause of morbidity and mortality and residing in a rural and remote region is associated with an increased risk. The impact of rurality on CVD outcomes needs to be fully elucidated. OBJECTIVES The purpose of this study was to assess the difference in mortality, readmission within 30 days, total readmissions, survival, and total emergency department (ED) presentations following an index CVD admission among patients from rural or remote areas as compared to metropolitan areas. METHODS This retrospective observational study included all index hospitalizations with heart failure (HF), atrial fibrillation (AF), or acute coronary syndrome (ACS) within the Hunter New England region of Australia, between January 1, 2008, and December 31, 2021. RESULTS There were 27,995 ACS admissions, 15,586 HF admissions, and 16,935 AF admissions. Patients from a rural or remote area presenting with CVD presentations had increased 30-day readmission (OR: 1.19; P < 0.001), an increased number of readmissions (incident rate ratio: 1.19; P < 0.001), and more ED presentations (incident rate ratio: 1.39; P < 0.001) as compared to patients from metropolitan areas. This was consistent across patients presenting with ACS, HF, and AF. There was no difference in mortality (HR: 1.01; P = 0.515). However, in the ACS subgroup, there was increased mortality in the rural and remote population (HR: 1.05; P = 0.015). CONCLUSIONS This study highlights the increased incidence of ED presentations and hospital readmissions, for those living in rural Australia, illustrating the disparity in health care provided, and the ongoing need for interventions that address poorer access to specialized health care in the early discharge phase of hospitalization.
OBJECTIVES:. Lower tidal volume ventilation (targeting 3 mL/kg predicted body weight, PBW) facilitated by extracorporeal carbon dioxide removal (ECCO2R) has been investigated as a potential therapy for acute hypoxemic respiratory failure (AHRF) in the pRotective vEntilation with veno-venouS lung assisT in respiratory failure (REST) trial. We investigated the effect of this strategy on cardiac function, and in particular the right ventricle. DESIGN:. Substudy of the REST trial. SETTING:. Nine U.K. ICUs. PATIENTS:. Patients with AHRF (Pao2/Fio2 < 150 mm Hg [20 kPa]). INTERVENTION:. Transthoracic echocardiography and N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements were collected at baseline and postrandomization in patients randomized to ECCO2R or usual care. MEASUREMENTS:. The primary outcome measures were a difference in tricuspid annular plane systolic excursion (TAPSE) on postrandomization echocardiogram and difference in NT-proBNP postrandomization. RESULTS:. There were 21 patients included in the echocardiography cohort (ECCO2R, n = 13; usual care, n = 8). Patient characteristics were similar in both groups at baseline. Median (interquartile range) tidal volumes were lower in the ECCO2R group compared with the usual care group postrandomization; 3.6 (3.1–4.2) mL/kg PBW versus 5.2 (4.9–5.7) mL/kg PBW, respectively (p = 0.01). There was no difference in the primary outcome measure of mean (sd) TAPSE in the ECCO2R and usual care groups postrandomization; 21.3 (5.4) mm versus 20.1 (3.2) mm, respectively (p = 0.60). There were 75 patients included in the NT-proBNP cohort (ECCO2R, n = 36; usual care, n = 39). Patient characteristics were similar in both groups at baseline. Median (interquartile range [IQR]) tidal volumes were lower in the ECCO2R group than the usual care group postrandomization; 3.8 (3.3–4.2) mL/kg PBW versus 6.7 (5.8–8.1) mL/kg PBW, respectively (p < 0.0001). There was no difference in median (IQR) NT-proBNP postrandomization; 1121 (241–5370) pg/mL versus 1393 (723–4332) pg/mL in the ECCO2R and usual care groups, respectively (p = 0.30). CONCLUSIONS:. In patients with AHRF, a reduction in tidal volume facilitated by ECCO2R, did not modify cardiac function.
OBJECTIVE:To perform a systematic review of completion rates of cardiac rehabilitation (CR) in adults aged 18 to 50 yr and describe how core components were reported, measured, and tailored to those under 50 yr. REVIEW METHODS:Database search of MEDLINE, Embase, Emcare, PsycINFO, CINAHL, Scopus, and the Cochrane Library based on keywords, including articles from January 1, 1990. The last search was performed on April 21, 2023. Following the Preferred Reporting Items for Systematic Review and Meta-Analyses protocol, eligible articles contained adults (aged between 18 and 50 yr) who had participated in a CR program. SUMMARY:Out of the articles screened (n = 24,517), 33 reports across 31 independent studies were considered eligible (n = 1958 patients aged ≤50 yr). Cardiac rehabilitation completion rates ranged from 64% to 100%; however, only 5 studies presented a completion rate definition. The length of the program ranged from 7 d to 20 wk, with most (65%) ranging between 6 and 12 wk. While the studies included in this systematic review indicated relatively high rates of completing CR, these are likely to overrepresent the true completion rates as few definitions were provided that could be compared to completion rates used in clinical practice. This systematic review also found that all interventions prescribed exercise (eg, aerobic alone or combined with resistance training or yoga) but had very limited inclusion or description of other integral components of CR (eg, initial assessment and smoking cessation) or how they were assessed and individualized to meet the needs of younger attendees.