Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation

Abstract

BACKGROUND:Asymptomatic atrial fibrillation (AF) is increasingly common in the aging population and implicated in many ischemic strokes. Earlier identification of AF with appropriate anticoagulation may decrease stroke morbidity and mortality. METHODS:We conducted a randomized controlled trial of AF screening using an AliveCor Kardia monitor attached to a WiFi-enabled iPod to obtain ECGs (iECGs) in ambulatory patients. Patients ≥65 years of age with a CHADS-VASc score ≥2 free from AF were randomized to the iECG arm or routine care (RC). iECG participants acquired iECGs twice weekly over 12 months (plus additional iECGs if symptomatic) onto a secure study server with overread by an automated AF detection algorithm and by a cardiac physiologist and/ or consultant cardiologist. Time to diagnosis of AF was the primary outcome measure. The overall cost of the devices, ECG interpretation, and patient management were captured and used to generate the cost per AF diagnosis in iECG patients. Clinical events and patient attitudes/experience were also evaluated. RESULTS:We studied 1001 patients (500 iECG, 501 RC) who were 72.6±5.4 years of age; 534 were female. Mean CHADS-VASc score was 3.0 (heart failure, 1.4%; hypertension, 54%; diabetes mellitus, 30%; prior stroke/transient ischemic attack, 6.5%; arterial disease, 15.9%; all CHADS-VASc risk factors were evenly distributed between groups). Nineteen patients in the iECG group were diagnosed with AF over the 12-month study period versus 5 in the RC arm (hazard ratio, 3.9; 95% confidence interval=1.4-10.4; P=0.007) at a cost per AF diagnosis of $10 780 (£8255). There was a similar number of stroke/transient ischemic attack/systemic embolic events (6 versus 10, iECG versus RC; hazard ratio=0.61; 95% confidence interval=0.22-1.69; P=0.34). The majority of iECG patients were satisfied with the device, finding it easy to use without restricting activities or causing anxiety. CONCLUSIONS:Screening with twice-weekly single-lead iECG with remote interpretation in ambulatory patients ≥65 years of age at increased risk of stroke is significantly more likely to identify incident AF than RC over a 12-month period. This approach is also highly acceptable to this group of patients, supporting further evaluation in an appropriately powered, event-driven clinical trial.CLINICAL TRIAL REGISTRATION: URL: https://www.isrctn.com. Unique identifier: ISRCTN10709813. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial FibrillationThe REHEARSE-AF Study © 2017 American Heart Association, Inc. ORIGINAL RESEARCH ARTICLE A trial fibrillation (AF) is a common cardiac arrhythmia, affecting an estimated 33.5 million individuals worldwide. 1 AF is an important risk factor for stroke, being implicated in up to 1 in 3 cases 2-4 and often not diagnosed beforehand. 5 AF-related strokes commonly result in greater disability than ischemic stroke secondary to arterial disease. 6 The annual stroke risk conferred by AF increases with age and other common risk factors a...

Newer technologies for detection of atrial fibrillation

“…7 The participants were randomized to AliveCor KardiaMobile single lead electrocardiography screening twice weekly over 12 months (plus additional electrocardiography if symptomatic) or routine care. In this study, 19/500 patients in the screening group were diagnosed as having atrial fibrillation over the 12 month study period compared with 5/501 patients in the routine care group (hazard ratio 3.9; P=0.007).…”

“…Several studies have shown the efficacy of these devices for atrial fibrillation screening in populations at risk (table 3). 731323334353637383940…”

“…More than a third of patients diagnosed as having atrial fibrillation have no attributable symptoms,45 and many patients do not seek medical evaluation routinely; thus, the diagnosis of atrial fibrillation is often delayed. Data from studies of screening for atrial fibrillation in populations at risk confirm that it is diagnosed in people without symptoms 678. As patients with undiagnosed atrial fibrillation remain at increased risk of cardiovascular events such as stroke,4 which could be reduced with appropriate treatment, a clear need exists for an improvement in its detection and diagnosis.…”

Year in Review in Cardiac Electrophysiology

“…Among 1001 older patients in the REHEARSE-AF study (Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation), patients randomized to self-screening using a consumer, hand-held ECG device 1× to 2× weekly (and prn symptoms) demonstrated a hazard ratio of 3.9 for the detection of AF at 12 months, compared with patients receiving routine care. 11 And in the ASSERT-II study (Prevalence of SubClinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patient With Cardiovascular Risk Factors), the authors used implantable loop recorders to assess the prevalence of subclinical AF among 256 patients at increased risk of AF. 12 The investigators identified at least 5 minutes of subclinical AF among 34.4% of patients per year over mean follow-up of 16 months.…”

When Silence Isn’t Golden: The Case of “Silent” Atrial Fibrillation

“…However, while they may be useful as alternatives to older patient-applied recorders at the time of symptomatic periods, or as a means to detect long-lasting paroxysms of AF, because of the brief and intermittent nature of their monitoring capabilities they are not optimal options for the detection of silent AF in the overwhelming majority of patients who are at risk, or for adequately evaluating AF burden, and have yields that do not compare with those of the prospective trials discussed below that utilized insertable monitors. 31 Prospective studies of silent AF Notably, device-detected silent AF is not limited to studies in patients with pacemakers/ICDs or post-stroke patients. Recently, three prospectively performed trials have been reported that considered patients with risk markers for AF and for stroke who demonstrated no prior history of AF, incorporating long-term monitoring (in years) with an implanted/inserted cardiac monitor (ICM) ( Table 1).…”