Key result
Screening for atrial fibrillation using a single-lead ECG at primary care visits did not significantly increase new AF diagnoses among individuals aged 65 years or older compared to usual care (1.72% vs 1.59%, RD 0.13%, p=0.38).
Why the study?
Undiagnosed AF may cause preventable strokes, and clinical guidelines differ regarding screening recommendations.
Does point-of-care screening with a handheld single-lead ECG increase diagnoses of atrial fibrillation in patients aged ≥ 65 years without prevalent AF?
RCT (n=30,715)
Open-label
Cluster randomization
Yes
Does point-of-care screening with a handheld single-lead ECG increase diagnoses of atrial fibrillation in patients aged ≥ 65 years without prevalent AF?
Effect estimate: RD 0.13% (95% CI -0.16-0.42)
Absolute Event Rate: 1.72% vs 1.59%
p-value: p=0.38
Single-lead ECG screening at primary care visits does not increase AF diagnoses in adults ≥65; challenges routine screening adoption.
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 electrocardiogram (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 aged ≥ 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 over one-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 one year versus 1.59% in the control group (risk difference [RD] 0.13%, 95% confidence interval [CI] −0.16–0.42, P=0.38). New AF diagnoses in the screening and control groups differed by age with the greatest effect observed for those aged ≥ 85 years (5.56% versus 3.76%, respectively, RD 1.80%, 95% CI 0.18–3.30). The difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening versus control group (0.32% versus −0.12%, RD 0.43%, 95% CI −0.01–0.84). The proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was similar in the screening (n=194, 73.5%) and control (n=172, 70.8%) arms (RD 2.7%, 95% CI −5.5–10.4). Conclusions Screening for AF using a single-lead ECG at primary care visits was not associated with a significant increase in new AF diagnoses among individuals aged 65 years or older compared to usual care. However, screening may be associated with an increased likelihood of diagnosing AF among individuals aged 85 years or older and warrants further evaluation. This study is registered with ClinicalTrials.gov, NCT03515057 Funding Bristol Myers Squibb-Pfizer Alliance
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Lubitz et al. (2021) conducted an RCT in Atrial fibrillation (n=30,715). Point-of-care screening with a handheld single-lead ECG vs. Usual care was evaluated on Incidence of newly diagnosed AF during the 12-month screening period (RD 0.13%, 95% CI -0.16-0.42, p=0.38). Screening for atrial fibrillation using a single-lead ECG at primary care visits did not significantly increase new AF diagnoses among individuals aged 65 years or older compared to usual care (1.72% vs 1.59%, RD 0.13%, p=0.38).
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