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BACKGROUND Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known. METHODS We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding. RESULTS The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-y

01 juni 2023, Item does not contain fulltext, BACKGROUND: Sleep-disordered breathing (SDB) is prevalent in up to 50% of patients referred for atrial fibrillation (AF) catheter ablation (CA). Currently, it remains unclear how to improve pre-selection for SDB screening in patients with AF. AIM: We aimed to (1) assess the accuracy of the STOP-Bang screening questionnaire for detection of SDB within an AF population referred for CA; (2) derive a refined, AF-specific SDB score to improve pre-selection. METHODS: Consecutive AF patients referred for CA without a history of SDB and/or SDB screening were included. Patients were digitally referred to the previously implemented Virtual-SAFARI SDB screening and management pathway including a home sleep test. An apnoea-hypopnoea index (AHI) of ≥ 15 was interpreted as moderate-to-severe SDB. Logistic regression analysis was used to assess characteristics associated with moderate-to-severe SDB to refine pre-selection for SDB screening. RESULTS: Of 206 included patients, 51% were diagnosed with moderate-to-severe SDB. The STOP-Bang questionnaire performed poorly in detecting SDB, with an area under the receiver operating characteristic curve (AUROC) of 0.647 (95% Confidence-Interval (CI) 0.573-0.721). AF-specific refinement resulted in the BOSS-GAP score. Therein, BMI with cut-off point ≥ 27 kg/m(2) and previous stroke or transient ischaemic attack (TIA) were added, while tiredness and neck circumference were removed. The BOSS-GAP score performed better with an AUROC of 0.738 (95% CI 0.672-0.805) in the overall population. CONCLUSION: AF-specific refinement of the STOP-Bang questionnaire moderately improved detection of SDB in AF patients referred for CA. Whether questionnaires bring benefits for pre-selection of SDB compared to structural screening in patients with AF requires further studies. TRIAL REGISTRATION NUMBER: ISOLATION was registered NCT04342312, 13-04-2020.

Item does not contain fulltext, OBJECTIVE: Atrial fibrillation (AF) is associated with adverse events including conduction disturbances, ventricular arrhythmias and sudden death. The aim of this study was to examine brady- and tachyarrhythmias using continuous rhythm monitoring in patients with paroxysmal self-terminating AF (PAF). METHODS: In this multicentre observational substudy to the Reappraisal of Atrial Fibrillation: interaction between hyperCoagulability, Electrical remodelling and Vascular destabilisation in the progression of AF (RACE V), we included 392 patients with PAF and at least 2 years of continuous rhythm monitoring. All patients received an implantable loop recorder, and all detected episodes of tachycardia ≥182 beats per minute (BPM), bradycardia ≤30 BPM or pauses ≥5 s were adjudicated by three physicians. RESULTS: Over 1272 patient-years of continuous rhythm monitoring, we adjudicated 1940 episodes in 175 patients (45%): 106 (27%) patients experienced rapid AF or atrial flutter (AFL), pauses ≥5 s or bradycardias ≤30 BPM occurred in 47 (12%) patients and in 22 (6%) patients, we observed both episode types. No sustained ventricular tachycardias occurred. In the multivariable analysis, age >70 years (HR 2.3, 95% CI 1.4 to 3.9), longer PR interval (HR 1.9, 1.1-3.1), CHA(2)DS(2)-VASc score ≥2 (HR 2.2, 1.1-4.5) and treatment with verapamil or diltiazem (HR 0.4, 0.2-1.0) were significantly associated with bradyarrhythmia episodes. Age >70 years was associated with lower rates of tachyarrhythmias. CONCLUSIONS: In a cohort exclusive to patients with PAF, almost half experienced severe bradyarrhythmias or AF/AFL with rapid ventricular rates. Our data highlight a higher than anticipated bradyarrhythmia risk in PAF. TRIAL REGISTRATION NUMBER: NCT02726698.

Item does not contain fulltext, AIMS: In this quality improvement project, a care pathway for patients considered for atrial fibrillation (AF) ablation was optimized with the goals to improve the patient journey and simultaneously integrate prospective data collection into the clinical process. METHODS AND RESULTS: The Lean Six Sigma approach was used to map the pre-existing process, identify constraints, and formulate countermeasures. The percentage of patients going through the full pre-ablation preparation that eventually underwent AF ablation, number of hospital visits and consultations, pathway compliance, and completeness of scientific data were measured before and after pathway optimization. Constraints in the process were (i) lack of standardized processes, (ii) inefficient use of resources, (iii) lack of multidisciplinary integration, (iv) lack of research integration, and (v) suboptimal communication. The impact of the corresponding countermeasures (defining a uniform process, incorporating 'go/no-go' moment, introducing a 'one-stop-shop', integrating prospective data collection, and improving communication) was studied for 33 patients before and 26 patients after pathway optimization. After optimization, the percentage of patients receiving a full pre-ablation preparation that eventually underwent AF ablation increased from 59% to 94% (P < 0.01). Fewer hospital visits (3.2 ± 1.2 vs. 2.3 ± 0.8, P = 0.01) and electrophysiologist consultations (1.8 ± 0.7 vs. 1.0 ± 0.3, P < 0.01) were required after pathway optimization. Pathway compliance and complete collection of scientific data increased significantly (3% vs. 73%, P < 0.01 and 15% vs. 73%, P < 0.01, respectively). CONCLUSION: The optimization project resulted in a more efficient evaluation of patients considered for AF ablation. The new more efficient process includes prospective data collection and facilitates easy conduct of research studies focused on improvements of patient outcomes.

Recent preclinical and observational cohort studies have implicated imbalances in gut microbiota composition as a contributor to atrial fibrillation (AF). The gut microbiota is a complex and dynamic ecosystem containing trillions of microorganisms, which produces bioactive metabolites influencing host health and disease development. In addition to host-specific determinants, lifestyle-related factors such as diet and drugs are important determinants of the gut microbiota composition. In this review, we discuss the evidence suggesting a potential bidirectional association between AF and gut microbiota, identifying gut microbiota-derived metabolites as possible regulators of the AF substrate. We summarize the effect of gut microbiota on the development and progression of AF risk factors, including heart failure, hypertension, obesity, and coronary artery disease. We also discuss the potential anti-arrhythmic effects of pharmacological and diet-induced modifications of gut microbiota composition, which may modulate and prevent the progression to AF. Finally, we highlight important gaps in knowledge and areas requiring future investigation. Although data supporting a direct relationship between gut microbiota and AF are very limited at the present time, emerging preclinical and clinical research dealing with mechanistic interactions between gut microbiota and AF is important as it may lead to new insights into AF pathophysiology and the discovery of novel therapeutic targets for AF.

Contains fulltext : 283525.pdf (Publisher’s version ) (Open Access), INTRODUCTION: Continuous progress in atrial fibrillation (AF) ablation techniques has led to an increasing number of procedures with improved outcome. However, about 30-50% of patients still experience recurrences within 1 year after their ablation. Comprehensive translational research approaches integrated in clinical care pathways may improve our understanding of the complex pathophysiology of AF and improve patient selection for AF ablation. OBJECTIVES: Within the "IntenSive mOlecular and eLectropathological chAracterization of patienTs undergoIng atrial fibrillatiOn ablatioN" (ISOLATION) study, we aim to identify predictors of successful AF ablation in the following domains: (1) clinical factors, (2) AF patterns, (3) anatomical characteristics, (4) electrophysiological characteristics, (5) circulating biomarkers, and (6) genetic background. Herein, the design of the ISOLATION study and the integration of all study procedures into a standardized pathway for patients undergoing AF ablation are described. METHODS: ISOLATION (NCT04342312) is a two-center prospective cohort study including 650 patients undergoing AF ablation. Clinical characteristics and routine clinical test results will be collected, as well as results from the following additional diagnostics: determination of body composition, pre-procedural rhythm monitoring, extended surface electrocardiogram, biomarker testing, genetic analysis, and questionnaires. A multimodality model including a combination of established predictors and novel techniques will be developed to predict ablation success. DISCUSSION: In this study, several domains will be examined to identify predictors of successful AF ablation. The results may be used to improve patient selection for invasive AF management and to tailor treatment decisions to individual patients.

Contains fulltext : 252127.pdf (Publisher’s version ) (Closed access), AIMS: In atrial fibrillation (AF) patients, untreated sleep-disordered breathing (SDB) is associated with lower success rates of rhythm control strategies and as such structured SDB testing is recommended. Herein, we describe the implementation of a virtual SDB management pathway in an AF outpatient clinic and examine the utility and feasibility of this new approach. METHODS AND RESULTS: Prospectively, consecutive AF patients accepted for AF catheter ablation procedures without previous diagnosis of SDB were digitally referred to a virtual SDB management pathway and instructed to use WatchPAT-ONE (ITAMAR) for one night. Results were automatically transferred to a virtual sleep laboratory, upon which a teleconsultation with a sleep physician was planned. Patient experience was measured using surveys. SDB testing was performed in 119 consecutive patients scheduled for AF catheter ablation procedures. The median time from digital referral to finalization of the sleep study report was 18 [11-24] days. In total, 65 patients (55%) were diagnosed with moderate-to-severe SDB. Patients with SDB were prescribed more cardiovascular drugs and had higher body mass indices (BMI, 29 ± 3.3 vs. 27 ± 4.4kg/m2, P < 0.01). Patients agreed that WatchPAT-ONE was easy to use (91%) and recommended future use of this virtual pathway in AF outpatient clinics (86%). Based on this remote SDB testing, SDB treatment was recommended in the majority of patients. CONCLUSION: This novel virtual AF management pathway allowed remote SDB testing in AF outpatient clinics with a short time to diagnosis and high patient satisfaction. Structured SDB testing results in a high detection of previously unknown SDB in AF patients scheduled for AF ablation.