Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening—mHealth Screening to Prevent Strokes (mSToPS)

Abstract

Background Atrial fibrillation (AF) is common, often without symptoms, and is an independent risk factor for mortality, stroke and heart failure. It is unknown if screening asymptomatic individuals for AF can improve clinical outcomes. Methods mSToPS was a pragmatic, direct-to-participant trial that randomized individuals from a single US-wide health plan to either immediate or delayed screening using a continuous-recording ECG patch to be worn for two weeks and 2 occasions, ~3 months apart, to potentially detect undiagnosed AF. The 3-year outcomes component of the trial was designed to compare clinical outcomes in the combined cohort of 1718 individuals who underwent monitoring and 3371 matched observational controls. The prespecified primary outcome was the time to first event of the combined endpoint of death, stroke, systemic embolism, or myocardial infarction among individuals with a new AF diagnosis, which was hypothesized to be the same in the two cohorts but was not realized. Results Over the 3 years following the initiation of screening (mean follow-up 29 months), AF was newly diagnosed in 11.4% (n = 196) of screened participants versus 7.7% (n = 261) of observational controls (p<0.01). Among the screened cohort with incident AF, one-third were diagnosed through screening. For all individuals whose AF was first diagnosed clinically, a clinical event was common in the 4 weeks surrounding that diagnosis: 6.6% experienced a stroke,10.2% were newly diagnosed with heart failure, 9.2% had a myocardial infarction, and 1.5% systemic emboli. Cumulatively, 42.9% were hospitalized. For those diagnosed via screening, none experienced a stroke, myocardial infarction or systemic emboli in the period surrounding their AF diagnosis, and only 1 person (2.3%) had a new diagnosis of heart failure. Incidence rate of the prespecified combined primary endpoint was 3.6 per 100 person-years among the actively monitored cohort and 4.5 per 100 person-years in the observational controls. Conclusions At 3 years, screening for AF was associated with a lower rate of clinical events and improved outcomes relative to a matched cohort, although the influence of earlier diagnosis of AF via screening on this finding is unclear. These observational data, including the high event rate surrounding a new clinical diagnosis of AF, support the need for randomized trials to determine whether screening for AF will yield a meaningful protection from strokes and other clinical events. Trail registration The mHealth Screening To Prevent Strokes (mSToPS) Trial is registered on ClinicalTrials.gov with the identifier NCT02506244.

Feasible approaches and implementation challenges to atrial fibrillation screening: a qualitative study of stakeholder views in 11 European countries

“… 19 The partly randomised mHealth Screening to Prevent Strokes (mSToPS) study suggested that active monitoring with a rhythm patch in high-risk individuals with AF without symptoms may reduce adverse outcomes over 3 years follow-up. 24 Outcome data of the currently published systematic screening trials Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden (STROKESTOP) 20 and Danish Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP) show controversial results. 25 Ongoing studies examine stroke rates, major bleeding, and mortality with different AF screening approaches.…”

“…Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF study randomised ambulatory patients ≥65 years of age with stroke risk factors to twice-weekly single-lead iECG for 1 year and demonstrated the acceptance of this screening method and a possible benefit for stroke risk 19. The partly randomised mHealth Screening to Prevent Strokes (mSToPS) study suggested that active monitoring with a rhythm patch in high-risk individuals with AF without symptoms may reduce adverse outcomes over 3 years follow-up 24. Outcome data of the currently published systematic screening trials Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden (STROKESTOP)20 and Danish Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP) show controversial results 25.…”

“…32 The interview participants stated that the most effective approach to detect new AF cases would possibly be prolonged screening (online supplemental file 1: scenario 2 or 3). Continuous 2-week patches as in (mSToPS study), 24 or intermittent ECG snapshot screening over a few weeks as used in the STROKESTOP 20 and Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) studies could be applied in primary care. However, these approaches were considered too expensive to implement with existing resources in healthcare settings across European regions.…”

In-ear infrasonic hemodynography with a digital health device for cardiovascular monitoring using the human audiome

“…The present study of cardiac rhythms focused specifically on SR and AF provides a basis for IH earbuds and for longer-term arrhythmia monitoring. The high sensitivity to detect AF during short time segments is especially critical for identifying and characterizing paroxysmal AF that may be particularly relevant in asymptomatic AF and for AF screening [21][22][23][24][25][26] . Future studies are underway to validate these findings in larger datasets and to include a variety of cardiac arrhythmias (Supplementary Fig.…”

Wearable Devices in Cardiovascular Medicine

“…However, the impact of early AF diagnosis on these findings remains unclear due to the observational nature of the study. 68 Two large studies investigated the ability of an irregular pulse notification from a photoplethysmogram-enabled smartwatch or band to identify a new diagnosis of AF in a predominantly middle-aged population. 33,34 These studies demonstrated a low prevalence of HR irregularity, and the diagnostic algorithms performed well with a positive predictive value of 0.84 to 0.92 for AF.…”