Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association.

AIMS: The aim is to describe the rationale, design, delivery, and baseline characteristics of the Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European society of cardiology in a cluster-Randomized trial in patients with Atrial Fibrillation (STEEER-AF) trial. METHODS AND RESULTS: STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomized in six countries (France, Germany, Italy, Poland, Spain, and UK; 2022-23). The STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with a mean age of 68.9 years (SD 11.7), CHA2DS2-VASc score of 3.2 (SD 1.8), and 647 (37%) women. Eight hundred and forty-three patients (49%) were in AF at enrolment and 760 (44%) in sinus rhythm. Oral anticoagulant therapy was prescribed in 1543 patients (89%), with the majority receiving direct oral anticoagulants (1378; 89%). Previous cardioversion, antiarrhythmic drug therapy, or ablation was recorded in 836 patients (48.3%). Five hundred fifty-one patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomized to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers. CONCLUSION: The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice and evaluate if a structured educational programme for healthcare professionals can improve patient-level care. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT04396418.

Participation of women in clinical studies of atrial fibrillation in the Northern Netherlands.

INTRODUCTION: Concerns exist of women underrepresentation in atrial fibrillation (AF) studies, potentially limiting the generalisability of study findings to women with AF. We assessed the participation of women in AF clinical studies performed at a tertiary care centre in the Northern Netherlands. METHODS: Eight AF clinical studies with screening logs were available for analysis. To identify sex-specific differences, patient inclusion and exclusion and reasons for exclusion were assessed. Participation-to-prevalence ratios (PPRs) were calculated to evaluate the representation of women in the studies relative to the AF sex distribution of the general population in the Netherlands (2019 Global Burden of Disease study). RESULTS: We included 1739 screened patients with AF in the analysis, of whom 722 (41.5%) were women. Of the patients screened, 161 (9%) were enrolled. Median age of screened patients was 69 years (interquartile range (IQR): 61-77), and women were older than men (71 years; IQR: 63-79 vs 68 years; IQR: 60-75; p < 0.001). Women were not underscreened compared with men (PPR: 1.09; 95% confidence interval (CI): 1.08-1.10), disproportionally excluded (92% vs 90%; p = 0.10) or less willing to participate (17% vs 15%; p = 0.36). Women had an overall PPR of 1.05 (95% CI: 1.05-1.06) compared with the general AF population. CONCLUSION: At our tertiary hospital in the Northern Netherlands, women appeared to be well-represented in AF studies. The current study advocates for the adoption of a more comprehensive measure of equity, such as the PPR, and screening log evaluation to improve the generalisability of study findings to the entire clinical AF population.

Multimorbidity in patients with atrial fibrillation.

There is an escalating trend in both the incidence and prevalence of atrial fibrillation (AF). AF is linked to numerous other comorbidities, contributing to the emergence of multimorbidity. The sustained rise in multimorbidity and AF prevalences exerts a significant strain on healthcare systems globally. The understanding of the relation between multimorbidity and AF is essential to determine effective healthcare strategies, improve patient outcomes to adequately address the burden of AF. It not only begins with the accurate identification of comorbidities in the setting of AF. There is also the need to understand the pathophysiology of the different comorbidities and their common interactions, and how multimorbidity influences AF perpetuation. To manage the challenges that rise from the increasing incidence and prevalence of both multimorbidity and AF, such as adverse events and hospitalisations, the treatment of comorbidities in AF has already gained importance and will need to be a primary focus in the forthcoming years. There are numerous challenges to overcome in the treatment of multimorbidity in AF, whereby the identification of comorbidities is essential. Integrated care strategies focused on a comprehensive multimorbidity management with an individual-centred approach need to be determined to improve healthcare strategies and reduce the AF-related risk of frailty, cardiovascular diseases and improve patient outcomes.

Atrial fibrillation: better symptom control with rate and rhythm management.

Atrial fibrillation (AF) is often associated with limiting symptoms, and with significant impairment in quality of life. As such, treatment strategies aimed at symptom control form an important pillar of AF management. Such treatments include a wide variety of drugs and interventions, including, increasingly, catheter ablation. These strategies can be utilised either singly or in combination, to improve and restore quality of life for patients, and this review covers the current evidence base underpinning their use. In this Review, we discuss the pros and cons of rate vs. rhythm control, while offering practical tips to non-specialists on how to utilise various treatments and counsel patients about all relevant treatment options. These include antiarrhythmic and rate control medications, as well as interventions such as cardioversion, catheter ablation, and pace-and-ablate.

Orally Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm: INSTANT Phase 2 Trial.

BACKGROUND: INSTANT (INhalation of flecainide to convert recent-onset SympTomatic Atrial fibrillatioN to sinus rhyThm) was a multicenter, open-label, single-arm study of flecainide acetate oral inhalation solution (FlecIH) for acute conversion of recent-onset (≤48 hours) symptomatic atrial fibrillation (AF) to sinus rhythm. OBJECTIVES: This study investigated the efficacy and safety in 98 patients receiving a single dose of FlecIH delivered via oral inhalation. METHODS: Patients self-administered FlecIH over 8 minutes in a supervised medical setting using a breath-actuated nebulizer and were continuously monitored for 90 minutes using a 12-lead Holter. RESULTS: Mean age was 60.5 years, mean body mass index was 27.0 kg/m2, and 34.7% of the patients were women. All patients had ≥1 AF-related symptoms at baseline, and 87.8% had AF symptoms for ≤24 hours. The conversion rate was 42.6% (95% CI: 33.0%-52.6%) with a median time to conversion of 14.6 minutes. The conversion rate was 46.9% (95% CI: 36.4%-57.7%) in a subpopulation that excluded predose flecainide exposure for the current AF episode. Median time to discharge among patients who converted was 2.5 hours, and only 2 patients had experienced AF recurrence by day 5. In the conversion-no group, 44 (81.5%) patients underwent electrical cardioversion by day 5. The most common adverse events were related to oral inhalation of flecainide (eg, cough, oropharyngeal irritation/pain), which were mostly of mild intensity and limited duration. CONCLUSIONS: The risk-benefit of orally inhaled FlecIH for acute cardioversion of recent-onset AF appears favorable. FlecIH could provide a safe, effective, and convenient first-line therapeutic option. (INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm [INSTANT]; NCT03539302).

Previous Exercise Levels and Outcome in Patients with New Atrial Fibrillation: "Past Achievements Do Not Predict the Future".

INTRODUCTION: Long-term endurance exercise is suspect to elevate the risk of atrial fibrillation (AF), but little is known about cardiovascular outcome and disease progression in this subgroup of AF patients. We investigated whether previous exercise level determines cardiovascular outcome. METHODS: In this post hoc analysis of the RACE 4 randomized trial, we analyzed all patients with a completed questionnaire on sports participation. Three subgroups were made based on lifetime sports hours up to randomization and previous compliance to the international physical activity guidelines. High lifetime hours of high dynamic activity patients were defined as more than 150 min·wk -1 of high-intensity physical exercise. The primary endpoint was a composite of cardiovascular death and hospital admissions. RESULTS: A total of 879 patients were analyzed, divided in 203 high lifetime hours of high dynamic activity, 192 high lifetime hours of activity, and 484 low lifetime hours of activity patients. Over a mean follow-up of 36 months (±14), the primary endpoint occurred in 61 out of 203 (30%) high lifetime hours of high dynamic activity, 53 out of 192 (27%) high lifetime hours of activity, and 135 out of 484 (28%) low lifetime hours of activity patients ( P = 0.74). During follow-up, 42 high lifetime hours of high dynamic activity (35%), 43 high lifetime hours of activity (32%), and 104 low lifetime hours of activity patients (34%) with paroxysmal AF received electrical or chemical cardioversion or atrial ablation ( P = 0.90). CONCLUSIONS: In patients included in the RACE 4, there seems to be no relation between previous activity levels and cardiovascular outcome and the need for electrical or chemical cardioversion or atrial ablation. Cardiovascular outcome was driven by AF-related arrhythmic events.

Women have less progression of paroxysmal atrial fibrillation: data from the RACE V study.

BACKGROUND: Sex differences in atrial fibrillation (AF) are observed in terms of comorbidities, symptoms, therapies received, AF progression and cardiovascular complications. METHODS: We assessed the differences in prevalence and the determinants of AF progression, as well as the clinical characteristics and quality of life (QoL), between women and men with paroxysmal AF included in the RACE V (Reappraisal of Atrial Fibrillation: Interaction between hyperCoagulability, Electrical remodeling, and Vascular Destabilisation in the Progression of AF) study. At baseline, extensive phenotyping was done. To assess AF progression, implantable loop recorder (ILR) monitoring was used throughout follow-up. AF progression was defined as (1) progression to persistent or permanent AF or (2) progression of paroxysmal AF (>3% burden increase). RESULTS: 417 patients were included, 179 (43%) of whom were women. Women were older (median 67 years vs 63 years, p<0.001), less often had coronary artery disease (n=11 (6%) vs n=36 (16%), p=0.003), had more obesity (n=57 (32%) vs n=50 (21%), p=0.013), had less epicardial and pericardial fat (median 144 (interquartile range [IQR] 94-191) mL vs 199 (IQR 146-248) mL, p<0.001; and median 89 (ICQ 61-121) mL vs 105 (IQR 83-133) mL, p<0.001, respectively) and had more impaired left atrial function. The median follow-up was 2.2 (1.6-2.8) years. 51 of 417 patients (5.5% per year) showed AF progression (15/179 (8.4%) women and 36/238 (15.1%) men, p=0.032). Multivariable analysis showed tissue factor pathway inhibitor, N-terminal prohormone brain natriuretic peptide (NT-proBNP) and PR interval being associated with AF progression in women and factor XIIa:C1 esterase, NT-proBNP and proprotein convertase subtilisin/kexin type 9 in men. QoL was not different between sexes. CONCLUSION: Despite older age, the incidence of AF progression was lower in women. Parameters associated with AF progression varied in part between sexes, suggesting different underlying pathophysiological mechanisms.