Artificial intelligence-guided screening for atrial fibrillation using electrocardiogram during sinus rhythm: a prospective non-randomised interventional trial

Peter A. Noseworthy, Zachi I. Attia, Emma M. Behnken, Rachel E. Giblon, Katherine A. Bews, Sijia Liu, Tara A. Gosse, Zachery D. Linn, Yihong Deng, Jun Yin, Bernard J. Gersh, Jonathan Graff-Radford, Alejandro A. Rabinstein, Konstantinos C. Siontis, Paul A. Friedman, Xiaoxi Yao

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Previous atrial fibrillation screening trials have highlighted the need for more targeted approaches. We did a pragmatic study to evaluate the effectiveness of an artificial intelligence (AI) algorithm-guided targeted screening approach for identifying previously unrecognised atrial fibrillation. Methods: For this non-randomised interventional trial, we prospectively recruited patients with stroke risk factors but with no known atrial fibrillation who had an electrocardiogram (ECG) done in routine practice. Participants wore a continuous ambulatory heart rhythm monitor for up to 30 days, with the data transmitted in near real time through a cellular connection. The AI algorithm was applied to the ECGs to divide patients into high-risk or low-risk groups. The primary outcome was newly diagnosed atrial fibrillation. In a secondary analysis, trial participants were propensity-score matched (1:1) to individuals from the eligible but unenrolled population who served as real-world controls. This study is registered with ClinicalTrials.gov, NCT04208971. Findings: 1003 patients with a mean age of 74 years (SD 8·8) from 40 US states completed the study. Over a mean 22·3 days of continuous monitoring, atrial fibrillation was detected in six (1·6%) of 370 patients with low risk and 48 (7·6%) of 633 with high risk (odds ratio 4·98, 95% CI 2·11–11·75, p=0·0002). Compared with usual care, AI-guided screening was associated with increased detection of atrial fibrillation (high-risk group: 3·6% [95% CI 2·3–5·4] with usual care vs 10·6% [8·3–13·2] with AI-guided screening, p<0·0001; low-risk group: 0·9% vs 2·4%, p=0·12) over a median follow-up of 9·9 months (IQR 7·1–11·0). Interpretation: An AI-guided targeted screening approach that leverages existing clinical data increased the yield for atrial fibrillation detection and could improve the effectiveness of atrial fibrillation screening. Funding: Mayo Clinic Robert D and Patricia E Kern Center for the Science of Health Care Delivery.

Original languageEnglish (US)
Pages (from-to)1206-1212
Number of pages7
JournalThe Lancet
Volume400
Issue number10359
DOIs
StatePublished - Oct 8 2022

ASJC Scopus subject areas

  • Medicine(all)

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