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.

Main results

- 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).

Conclusion

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 -