Steven A Lubitz1,2, Steven J Atlas3, Jeffrey M Ashburner3,2, Ana T Trisini Lipsanopoulos4, Leila H Borowsky3, Wyliena Guan5, Shaan Khurshid1,2, Patrick T Ellinor1,2, Yuchiao Chang3,2, David D McManus3,6, Daniel E Singer2. 1. Demoulas Center for Cardiac Arrhythmias and Cardiovascular Research Center (S.A.L., S.K., P.T.E.), Massachusetts General Hospital, Boston. 2. Harvard Medical School, Boston, MA (S.A.L., J.M.A., S.K., P.T.E., Y.C., D.E.S.). 3. Division of General Internal Medicine (S.J.A., J.M.A., L.H.B., Y.C., D.E.S.), Massachusetts General Hospital, Boston. 4. Division of Cardiology (A.T.T.L.), Massachusetts General Hospital, Boston. 5. University of North Carolina, Chapel Hill (W.G.). 6. Department of Medicine, University of Massachusetts Medical School, Worcester (D.D.M.).
Abstract
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.
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.
Entities:
Keywords:
atrial fibrillation; digital health; electrocardiography; screening
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