Summary: | Background: Undiagnosed atrial fibrillation AF may cause preventable strokes. Guidelines differ regarding AF screening recommendations. We tested whether point-of-care screening with a handheld single-lead ECG at primary care practice visits increases diagnoses of AF. Methods: We randomized 16 primary care clinics 1:1 to AF screening using a handheld single-lead ECG AliveCor KardiaMobile during vital sign assessments, or usual care. Patients included were ages ≥65 years. Screening results were provided to primary care clinicians at the encounter. All confirmatory diagnostic testing and treatment decisions were made by the primary care clinician. New AF diagnoses during the 1-year follow-up were ascertained electronically and manually adjudicated. Proportions and incidence rates were calculated. Effect heterogeneity was assessed. Results: Of 30 715 patients without prevalent AF n=15 393 screening [91% screened], n=15 322 control, 1.72% of individuals in the screening group had new AF diagnosed at 1 year versus 1.59% in the control group risk difference, 0.13% [95% CI, -0.16 to 0.42]; P=0.38. In prespecified subgroup analyses, new AF diagnoses in the screening and control groups were greater among those aged ≥85 years 5.56% versus 3.76%, respectively; risk difference, 1.80% [95% CI, 0.18 to 3.30]. The difference in newly diagnosed AF between the screening period and the previous year was marginally greater in the screening versus control group 0.32% versus -0.12%; risk difference, 0.43% [95% CI, -0.01 to 0.84]. The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different in the screening n=194, 73.5% and control n=172, 70.8% arms risk difference, 2.7% [95% CI, -5.5 to 10.4]. Conclusions: Screening for AF using a single-lead ECG at primary care visits did not affect new AF diagnoses among all individuals aged 65 years or older compared with usual care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03515057. © 2022 American Heart Association, Inc.
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