Smartphone-based screening increases detection rate of AF
Smartphone-based screening for atrial fibrillation (eBRAVE-AF) – A pragmatic siteless digital randomized clinical trial
Presented at the ESC congress 2022 by: Prof. Axel Bauer, MD- Innsbruck, Austria
Introduction and methods
eBRAVE-AF was a siteless, digital, randomized trial that aimed to investigate whether a smartphone-based screening method improves the detection rate of AF. A total of 67,488 policyholders of a large German health care insurance who met inclusion criteria (50- 90 years, CHA2DS2-VASc ≥1 for men, ≥2 for women, free of known AF, not on oral anticoagulation) received an invitation by mail to download a study app. In the app, they could provide informed consent. The app randomized 5551 participants to a digital screening arm (n=2860) or usual care arm (n=2691). In the digital screening arm participants could perform repetitive 1-minute measurements using a PPG smartphone app. Participants were advised to do this frequently, following a provided schedule. In case of abnormal findings, patients received a wearable ECG loop recorder which they were advised to wear for 14 days. The usual care arm mirror daily clinical practice with no study-related interventions.
The study consisted of two phases, both with a duration of 6 months. After the first 6 months (phase 1), participants who had not met the primary endpoint were invited to cross over in phase 2 (participants in the usual care arm entered the digital screening arm and visa versa). The primary endpoint was newly diagnosed AF treated with oral anticoagulation by an independent physician.
- The primary endpoint occurred in 38 participants (1.33%) in the digital screening arm and 17 (0.63%) in the usual care arm (odds ratio [OR] 2.12, 95% CI 1.19–3.76, P = 0.010).
- A total of 4,752 (85.6%) entered phase 2 of the study. After crossover, the findings could be replicated (OR 2.95, 95% CI 1.52–5.72, P = 0.001).
Prof. Bauer concluded that this digital screening strategy using normal smartphones more than doubles the detection rate of AF. This implies that anyone with a smartphone could screen themselves for AF. Whether improved AF screening through digital technologies translates to better outcomes needs to be investigated in future studies.
- Our reporting is based on the information provided at the ESC Congress -