Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute stressor (e.g. medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common occurrence (\>40% in some intensive care settings), but there is a lack of evidence to guide its management and guidelines have called for further research in this area. Retrospective data suggest that many patients with AFOTS (\>50%) will experience recurrent AF. These estimates were obtained without using sensitive methods for AF detection, which raises the possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF increases, it becomes increasingly likely that AFOTS is just the first detection of typical "clinical" AF. Objective To use a sensitive strategy to determine the rate of recurrent AF among patients who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to matched controls. Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac surgery (Cohort 1) or medical illness (Cohort 2). Controls will be patients without a history of AF who are matched for age (within 5 years), sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months after discharge. The endpoint is detection of AF. Impact If the incidence of AF after AFOTS is \>80%, clinicians could be advised to treat AFOTS like "clinical" AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of surveillance for AF would be advised. Hypothesis 1. Patients who experience AFOTS will have a higher future incidence of AF and of stroke compared to patients exposed to a similar stressor but who did not develop AF. 2. The risk of recurrent AF after AFOTS will be sufficiently high (\> 80%) to warrant routine initiation of long-term OAC in all cases.
Study Type
OBSERVATIONAL
Enrollment
281
The ZIO XT Patch (http://www.irhythmtech.com/zio-solution/zio-patch/) is an ultra-portable wearable adhesive patch monitor that provides continuous single-lead ECG recording for up to 14 days. It has been cleared by the FDA for arrhythmia detection and is in current clinical use in the U.S.\[87\]. It will be used in this study under an investigational testing authorization by Health Canada. The ZIO XT Patch is a single-use device worn over the left pectoral region with a skin adhesive (Figure 4). Its small, lightweight, water-resistant, patch-based design has advantages for patients compared with traditional ECG screening methods (e.g. Holter, event loop recorders, mobile outpatient telemetry systems), which are all more cumbersome and require detachable wired leads, two or more removable skin contact electrodes, plus separate recording units (+/- smartphone attachment).
Hamilton General Hospital
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
St. Joseph's Health Centre
Hamilton, Ontario, Canada
Atrial Fibrillation >/=30 s
Time frame: 1 year
Time to Atrial Fibrillation
Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: time to first detection of AF \>30 s.
Time frame: 1 year
Daily and total AF burden
Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: daily and total AF burden.
Time frame: 1 year
Average duration per AF episode
Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: average duration per AF episode
Time frame: 1 year
Other durations of Atrial Fibrillation
Among AFOTS patients, occurence of any AF episode lasting ≥30 seconds, ≥30 seconds to 5 minutes, \>5 hours, and \>24 hours (to facilitate comparison with other studies in the literature).( within 12 months post-enrolment)
Time frame: 1 year
Atrial Fibrillation at 1 and 6 months
Detection of the primary outcome at 1 and 6 months post enrolment.
Time frame: 1 and 6 months
Other clinical outcomes
Incidence of Clinical outcome events within 12 months post-enrolment (death, stroke, bleeding, embolism and hospitalization for heart failure or myocardial infarction), physician visits, hospitalizations and medication prescriptions.
Time frame: 1 year
OAC Use
Oral anticoagulant therapy use
Time frame: 1 year
Cost-effectiveness
Cost-effectiveness (cost per life year saved)
Time frame: 1 year
Cost-utility
cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening
Time frame: 1 year
Patient adherence
Patient adherence with the monitoring devices (defined as the average number of monitoring days completed and reasons for non-adherence)
Time frame: 1 year
Patient satisfaction
patient satisfaction with the monitoring devices (as measured by user satisfaction surveys),
Time frame: 1 year
Sensitivity and Specificity
Estimated sensitivity, specificity of non-patch ECG monitoring(i.e. monitoring done outside of the study protocol), with ZioXT ECG patch monitor as the gold standard
Time frame: 1 year
Other arrhythmias
Incidence of Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause \>3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation. ( within 12 months post-enrolment)
Time frame: 1 year
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