Rate of AF diagnosis improves by self-applied ECG patch
A Digital End-to-End, Nationwide, Pragmatic Trial of Screening for Undiagnosed Atrial Fibrillation Within a Health Insurance System Using a Self-Applied ECG Patch: Primary Results of the mHealth Screening to Prevent Strokes (mSToPS) Trial
Presented at ACC.18 by Steven Steinhubl (La Jolla, CA, USA)News - Mar. 13, 2018
Introduction and methods
The lifetime risk of atrial fibrillation (AF) in adults >55 years is >37%, which is associated with a 5-fold increase in risk for stroke. Once AF is recognized, anticoagulation therapy can reduce the risk of stroke by 65% and mortality by 30%. Guideline-recommended opportunistic screening for AF is rarely done. Novel digital technologies do exist, but the clinical value and optimal method is currently unknown.
Therefore, the mHealth Screening to Prevent Strokes (mSToPS) trial was developed to determine if patient-generated data available through a wearable ECG patch can improve the identification of AF relative to routine care.
2655 eligible individuals without a diagnosis of AF were enrolled via a web-based platform to undergo active monitoring at home with an iRhythm Zio patch for an average of 12 days (cases) and for each case, 2 age-, sex- and CHA2DS2-VASc-matched observational controls were chosen. The primary endpoint was the number of participants with first diagnosis of AF at 1 year.
- 1- year new diagnosis of AF was 6.3% in 1738 participants who were actively monitored compared to 2.3% in 3476 matched controls (unadj OR 2.8; 95%CI:2.1-3.7, P<0.0001 and adj OR 3.0; 95%CI:2.2-4.0, P<0.0001).
- Median total AF burden during monitoring was 0.9% and median duration of longest AF period was 185.5 min (92.8% >5 minutes, 37.7% >6 hours).
- Active monitoring was associated with increased initiation of anticoagulation therapy compared to routine care (5.4% vs. 3.4%, P=0.0004)
- No differences in clinical outcomes (stroke, myocardial infarction, systemic thromboembolism) between the actively monitored participants and matched controls were observed.
In a digital clinical trial with patient-generated data, use of a wearable ECG patch showed an improvement in the rate of AF diagnosis compared to routine care. Follow-up is needed to understand the clinical impact of ECG monitoring.
In a press release dr. Steinhubl said: “In most cases, the only currently recommended method is to feel someone’s pulse or check an ECG for 30 seconds during a routine doctor’s visit. Based on our data, individuals have very short episodes of AF that would make it very difficult to catch in the way we routinely look for it today.”
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