Manual Chest PRESSURE During Direct Current Cardioversion for Atrial Fibrillation: A Randomized Control Trial (PRESSURE-AF).

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).

Fasting vs no fasting prior to catheterisation laboratory procedures: the SCOFF trial.

BACKGROUND AND AIMS: Current guidelines recommend 6 hours of solid food and 2 hours of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no fasting strategy to fasting prior to cardiac catheterisation procedures which require conscious sedation. METHODS: This is a multicentre, investigator-initiated, non-inferiority randomised trial conduced in Australia with a prospective open label blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention or cardiac implantable electronic device (CIED) related procedures were enrolled. Patients were randomised 1:1 to fasting as normal (6 hours solid food and 2 hours clear liquid) or no fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. RESULTS: 716 patients were randomised with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 versus 3.0 hours, Bayes factor >100 indicating extreme evidence of difference) and clear liquid fasting times (7.0 versus 2.4 hours, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no fasting arm. The estimate of the mean posterior difference in proportions in the primary composite outcome was -5.2% (95% CI -9.6 to -0.9, ) favouring no fasting. This result confirms non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36 to 4.67, Bayes factor >100). Secondary outcome events were similar. CONCLUSIONS: In patients undergoing cardiac catheterisation and CIED related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterisation laboratory procedures that require conscious sedation.

2023 Cardiac Society of Australia and New Zealand Expert Position Statement on Catheter and Surgical Ablation for Atrial Fibrillation.

Catheter ablation for atrial fibrillation (AF) has increased exponentially in many developed countries, including Australia and New Zealand. This Expert Position Statement on Catheter and Surgical Ablation for Atrial Fibrillation from the Cardiac Society of Australia and New Zealand (CSANZ) recognises healthcare factors, expertise and expenditure relevant to the Australian and New Zealand healthcare environments including considerations of potential implications for First Nations Peoples. The statement is cognisant of international advice but tailored to local conditions and populations, and is intended to be used by electrophysiologists, cardiologists and general physicians across all disciplines caring for patients with AF. They are also intended to provide guidance to healthcare facilities seeking to establish or maintain catheter ablation for AF.

Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial).

Aims: Cardiac catheterization procedures are typically performed with local anaesthetic and proceduralist guided sedation. Various fasting regimens are routinely implemented prior to these procedures, noting the absence of prospective evidence, aiming to reduce aspiration risk. However, there are additional risks from fasting including patient discomfort, intravascular volume depletion, stimulus for neuro-cardiogenic syncope, glycaemic outcomes, and unnecessary fasting for delayed/cancelled procedures. Methods and results: This is an investigator-initiated, multicentre, randomized trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomized 1:1 to fasting (6 h solid food and 2 h clear liquids) or to no fasting requirements. The primary outcome will be a composite of hypotension, hyperglycaemia, hypoglycaemia, and aspiration pneumonia. Secondary outcomes will include patient satisfaction, contrast-induced nephropathy, new intensive care admission, new non-invasive or invasive ventilation requirement post procedure, and 30-day mortality and readmission. Conclusions: This is a pragmatic and clinically relevant randomised trial designed to compare fasting verse no fasting prior to cardiac catheterisation procedures. Routine fasting may not reduce peri-procedural adverse events in this setting.

Impact of an outpatient telestroke clinic on management of rural stroke patients.

OBJECTIVE: Report on feasibility, use and effects on investigations and treatment of a neurologist-supported stroke clinic in rural Australia. DESIGN: Data were collected prospectively for consecutive patients referred to atelehealth stroke clinic from November 2018 to August 2021. SETTINGS, PARTICIPANTS AND INTERVENTIONS: Patients attended the local hospital, with a rural stroke care coordinator, and were assessed by stroke neurologist over videoconference. MAIN OUTCOME MEASURES: The following feasibility outcomes on the first appointments were analysed: (1) utility (a) change in medication, (b) request of additional investigations, (c) enrolment/offering clinical trials or d) other; (2) acceptability (attendance rate); and (3) process of care (waiting time to first appointment, distance travelled). RESULTS: During the study period, 173 appointments were made; 125 (73.5%) were first appointments. The median age was 70 [63-79] years, and 69 patients were male. A diagnosis of stroke or transient ischemic attack was made by the neurologist in 106 patients. A change in diagnosis was made in 23 (18.4%) patients. Of the first appointments, 102 (81.6%) resulted in at least one intervention: medication was changed in 67 (53.6%) patients, additional investigations requested in 72 (57.6%), 15 patients (12%) were referred to a clinical trial, and other interventions were made in 23 patients. The overall attendance rate of booked appointments was high. The median waiting time and distance travelled (round-trip) for a first appointment were 38 [24-53] days and 60.8 [25.6-76.6] km respectively. CONCLUSION: The telestroke clinic was very well attended, and it led to high volume of interventions in rural stroke patients.

First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial.

BACKGROUND: Pulsed field ablation (PFA) is a novel form of ablation using electrical fields to ablate cardiac tissue. There are only limited data assessing the feasibility and safety of this type of ablation in humans. METHODS: PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; https://www.clinicaltrials.gov; unique identifier: NCT04198701) is a nonrandomized, prospective, multicenter, global, premarket clinical study. The first-in-human pilot phase evaluated the feasibility and efficacy of pulmonary vein isolation using a novel PFA system delivering bipolar, biphasic electrical fields through a circular multielectrode array catheter (PulseSelect; Medtronic, Inc). Thirty-eight patients with paroxysmal or persistent atrial fibrillation were treated in 6 centers in Australia, Canada, the United States, and the Netherlands. The primary outcomes were ability to achieve acute pulmonary vein isolation intraprocedurally and safety at 30 days. RESULTS: Acute electrical isolation was achieved in 100% of pulmonary veins (n=152) in the 38 patients. Skin-to-skin procedure time was 160±91 minutes, left atrial dwell time was 82±35 minutes, and fluoroscopy time was 28±9 minutes. No serious adverse events related to the PFA system occurred in the 30-day follow-up including phrenic nerve injury, esophageal injury, stroke, or death. CONCLUSIONS: In this first-in-human clinical study, 100% pulmonary vein isolation was achieved using only PFA with no PFA system-related serious adverse events. Graphic Abstract: A graphic abstract is available for this article.

Investigating the efficacy of chest pressure for direct current cardioversion in atrial fibrillation: a randomised control trial protocol (Pressure-AF).

INTRODUCTION: Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. Direct current cardioversion is commonly used to restore sinus rhythm in patients with AF. Chest pressure may improve cardioversion success through decreasing transthoracic impedance and increasing cardiac energy delivery. We aim to assess the efficacy and safety of routine chest pressure with direct current cardioversion for AF. METHODS AND ANALYSIS: Multicentre, double blind (patient and outcome assessment), randomised clinical trial based in New South Wales, Australia. Patients will be randomised 1:1 to control and interventional arms. The control group will receive four sequential biphasic shocks of 150 J, 200 J, 360 J and 360 J with chest pressure on the last shock, until cardioversion success. The intervention group will receive the same shocks with chest pressure from the first defibrillation. Pads will be placed in an anteroposterior position. Success of cardioversion will be defined as sinus rhythm at 1 min after shock. The primary outcome will be total energy provided. Secondary outcomes will be success of first shock to achieve cardioversion, transthoracic impedance and sinus rhythm at post cardioversion ECG. ETHICS AND DISSEMINATION: Ethics approval has been confirmed at all participating sites via the Research Ethics Governance Information System. The trial has been registered on the Australia New Zealand Clinical Trials Registry (ACTRN12620001028998). De-identified patient level data will be available to reputable researchers who provide sound analysis proposals.

Position Statement on the Management of Cardiac Electrophysiology and Cardiac Implantable Electronic Devices in Australia During the COVID-19 Pandemic: A Living Document.

The COVID-19 pandemic poses a significant stress on health resources in Australia. The Heart Rhythm Council of the Cardiac Society of Australia and New Zealand aims to provide a framework for efficient resource utilisation balanced with competing risks when appropriately treating patients with cardiac arrhythmias. This document provides practical recommendations for the electrophysiology (EP) and cardiac implantable electronic devices (CIED) services in Australia. The document will be updated regularly as new evidence and knowledge is gained with time.

Comparison of Outcomes Using the First and Second Generation Cryoballoon to Treat Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation using cryoballoon ablation is an effective treatment for patients with atrial fibrillation. We sought to compare outcomes with the first and second generation cryoballoon, with the second generation balloon incorporating the Achieve Lasso catheter, in terms of freedom from symptomatic recurrence and major complications. METHODS: The first 200 patients who underwent cryoballoon ablation with the first generation balloon were compared with the first 200 patients using the second-generation balloon. All patients had symptomatic atrial fibrillation and had failed at least one antiarrhythmic drug. The primary efficacy endpoint was freedom from symptomatic recurrence of atrial fibrillation (AF) after a single pulmonary vein isolation (PVI) procedure using the cryoballoon. The primary safety endpoint was major procedural complications. RESULTS: At 12 months, freedom from symptomatic AF after a single procedure in the first generation cohort was 64.3% compared with 78.6% in the second-generation cohort (p = 0.002). At 24 months, freedom from symptomatic AF in the first generation cohort was 51.3% compared with 72.6% in the second-generation cohort (p < 0.001). Procedural time (150 min vs 101 min; p < 0.001) and fluoroscopy time (32.5 min vs 21.4 min; p < 0.001) was lower in the second-generation group. The rate of major complications was comparably low in both groups. CONCLUSIONS: The second-generation cryoballoon was associated with improved freedom from symptomatic AF with reduction in procedure and fluoroscopy time, with a similar low rate of major complications.

Sleep habits, insomnia, and daytime sleepiness in a large and healthy community-based sample of New Zealanders.

STUDY OBJECTIVES: To determine the relationship between sleep complaints, primary insomnia, excessive daytime sleepiness, and lifestyle factors in a large community-based sample. DESIGN: Cross-sectional study. SETTING: Blood donor sites in New Zealand. PATIENTS OR PARTICIPANTS: 22,389 individuals aged 16-84 years volunteering to donate blood. INTERVENTIONS: N/A. MEASUREMENTS: A comprehensive self-administered questionnaire including personal demographics and validated questions assessing sleep disorders (snoring, apnea), sleep complaints (sleep quantity, sleep dissatisfaction), insomnia symptoms, excessive daytime sleepiness, mood, and lifestyle factors such as work patterns, smoking, alcohol, and illicit substance use. Additionally, direct measurements of height and weight were obtained. RESULTS: One in three participants report < 7-8 h sleep, 5 or more nights per week, and 60% would like more sleep. Almost half the participants (45%) report suffering the symptoms of insomnia at least once per week, with one in 5 meeting more stringent criteria for primary insomnia. Excessive daytime sleepiness (evident in 9% of this large, predominantly healthy sample) was associated with insomnia (odds ratio [OR] 1.75, 95% confidence interval [CI] 1.50 to 2.05), depression (OR 2.01, CI 1.74 to 2.32), and sleep disordered breathing (OR 1.92, CI 1.59 to 2.32). Long work hours, alcohol dependence, and rotating work shifts also increase the risk of daytime sleepiness. CONCLUSIONS: Even in this relatively young, healthy, non-clinical sample, sleep complaints and primary insomnia with subsequent excess daytime sleepiness were common. There were clear associations between many personal and lifestyle factors-such as depression, long work hours, alcohol dependence, and rotating shift work-and sleep problems or excessive daytime sleepiness.

Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.

BACKGROUND: A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality. OBJECTIVE: To test the association of FDA advisory status with long-term mortality. METHODS: The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advisories on ICD generators were identified. Mortality was determined by using the Social Security Death Index. RESULTS: In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were class I and 532 (32.3%) were class II. ICDs were explanted before advisory notifications in 14.0% of class I and 10.1% of class II advisories. Among ICDs under advisory, 28 (4.0%) advisory-related and 15 non-advisory- related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival rate was 65.6% overall, and 64.2, 61.1, and 69.3% in patients with no, class I, and class II advisories, respectively (P = .17). CONCLUSIONS: ICD advisories impacted 43% of the patients. Advisory-related malfunctions affected 4% within the combined advisory group. Based on a conservative management strategy, ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.