Aims The aim of this study was to investigate the association between within-individual changes in physical activity and onset of atrial fibrillation (AF). Methods and results A total of 1410 participants from the general population (46.2% women, mean age 74.7 ± 4.1 years) with risk factors but with no prior AF diagnosis underwent continuous monitoring for AF episodes along with daily accelerometric assessment of physical activity using an implantable loop recorder during ≈3.5 years. The combined duration of monitoring was ≈1.6 million days, where 10 851 AF episodes lasting ≥60 min were detected in 361 participants (25.6%) with a median of 5 episodes (2, 25) each. The median daily physical activity was 112 (66, 168) min/day. A dynamic parameter describing within-individual changes in daily physical activity, i.e. average daily activity in the last week compared to the previous 100 days, was computed and used to model the onset of AF. A 1-h decrease in average daily physical activity was associated with AF onset the next day [odds ratio 1.24 (1.18–1.31)]. This effect was modified by overall level of activity (P < 0.001 for interaction), and the signal was strongest in the tertile of participants with lowest activity overall [low: 1.62 (1.41–1.86), mid: 1.27 (1.16–1.39), and high: 1.10 (1.01–1.19)]. Conclusions Within-individual changes in physical activity are associated with the onset of AF episodes as detected by continuous monitoring in a high-risk population. For each person, a 1-h decrease in daily physical activity during the last week increased the odds of AF onset the next day by ≈25%, while the strongest association was seen in the group with the lowest activity overall. Clinical Trial Registration ClinicalTrials.gov, identifier: NCT02036450.
ImportanceThere is increasing interest in heart rhythm monitoring and technologies to detect subclinical atrial fibrillation (AF), which may lead to incidental diagnosis of bradyarrhythmias.ObjectiveTo assess bradyarrhythmia prevalence and prognostic significance in persons screened for AF using implantable loop recorder (ILR) compared with unscreened persons.Design, Setting, and ParticipantsThis was a post hoc analysis of the Implantable Loop Recorder Detection of Atrial Fibrillation to Prevent Stroke (LOOP) randomized clinical trial, which took place in 4 sites in Denmark. Participants were 70 years or older without known AF but diagnosed with at least 1 of the following: hypertension, diabetes, heart failure, or prior stroke. Participants were recruited by letter invitation between January 31, 2014, and May 17, 2016. The median (IQR) follow-up period was 65 (59-70) months. Analysis took place between February and June 2022.InterventionsILR screening for AF with treatment of any bradyarrhythmia left to the discretion of the treating physician (ILR group) vs usual care (control group).Main Outcomes and MeasuresAdjudicated bradyarrhythmia episodes, pacemaker implantation, syncope, and sudden cardiovascular death.ResultsA total of 6004 participants were randomized (mean [SD] age, 75 [4.1] years; 2837 [47.3%] female; 5444 [90.7%] with hypertension; 1224 [20.4%] with prior syncope), 4503 to control and 1501 to ILR. Bradyarrhythmia was diagnosed in 172 participants (3.8%) in the control group vs 312 participants (20.8%) in the ILR group (hazard ratio [HR], 6.21 [95% CI, 5.15-7.48]; P &lt; .001), and these were asymptomatic in 41 participants (23.8%) vs 249 participants (79.8%), respectively. The most common bradyarrhythmia was sinus node dysfunction followed by high-grade atrioventricular block. Risk factors for bradyarrhythmia included higher age, male sex, and prior syncope. A pacemaker was implanted in 132 participants (2.9%) vs 67 (4.5%) (HR, 1.53 [95% CI, 1.14-2.06]; P &lt; .001), syncope occurred in 120 (2.7%) vs 33 (2.2%) (HR, 0.83 [95% CI, 0.56-1.22]; P = .34), and sudden cardiovascular death occurred in 49 (1.1%) vs 18 (1.2%) (HR, 1.11 [95% CI, 0.64-1.90]; P = .71) in the control and ILR groups, respectively. Bradyarrhythmias were associated with subsequent syncope, cardiovascular death, and all-cause death, with no interaction between bradyarrhythmia and randomization group.Conclusions and RelevanceMore than 1 in 5 persons older than 70 years with cardiovascular risk factors can be diagnosed with bradyarrhythmias when long-term continous monitoring for AF is applied. In this study, ILR screening led to a 6-fold increase in bradyarrhythmia diagnoses and a significant increase in pacemaker implantations compared with usual care but no change in the risk of syncope or sudden death.
BACKGROUND Patients with an implantable cardioverterdefibrillator (ICD) are at a high risk of malignant ventricular arrhythmias. The use of remote ICD monitoring, wearable devices, and patient-reported outcomes generate large volumes of potential valuable data. Artificial intelligence-based methods can be used to develop personalized prediction models and improve earlywarning systems.OBJECTIVE The purpose of this study was to develop an integrated web-based personalized prediction engine for ICD therapy Q6. METHODS This international, multicenter, prospective, observational study consists of 2 phases: (1) a development study and (2) a feasibility study. A total of 400 participants with an ICD (with or without cardiac resynchronization therapy) on remote monitoring will be enrolled: 300 participants in the development study and 100 in the feasibility study. During 12-month followup, electronic health record data, remote monitoring data, accelerometry-assessed physical behavior data, and patientreported data are collected. By using machine-and deep-learning approaches, a prediction engine is developed to assess the risk probability of ICD therapy (shock and antitachycardia pacing). The feasibility of the prediction engine as a clinical tool (SafeHeart Q7 Platform) is assessed during the feasibility study. RESULTS Development study recruitment commences in 2021 Q8 . The feasibility study starts in 2022 Q9 .CONCLUSION SafeHeart is the first study to prospectively collect a multimodal data set to construct a personalized prediction engine for ICD therapy. Moreover, SafeHeart explores the integration and added value of detailed objective accelerometer data in the prediction of clinical events. The translation of the SafeHeart Platform to clinical practice is examined during the feasibility study.
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