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Data from the VITAL-AF trial indicate universal screening with single-lead ECGs among patients 65 years and older in primary care settings did not significantly increase in new atrial fibrillation diagnoses, but was more effective in patients aged 85 years or older.
A recent study is providing insight into the effectiveness of universal point-of-care screenings with a single-lead electrocardiogram (ECG) in primary care settings for diagnosis of atrial fibrillation (AF) in older adults.
A randomized trial with more than 30,000 participants from 16 primary care clinics, results of the VITAL-AF trial indicate routine screening of AF in all individuals aged 65 years and older did not result in a significant increase in newly diagnosed cases at 12 months but suggest the approach could prove useful in patients aged 85 years or older.
“Our work affirmed that single-lead devices generate information for the physician that is actionable, though the proportion of newly detected AF cases using a point-of-care ECG screening approach is likely to be very small. For that reason, we think handheld devices are best deployed for people at the highest risk of AF and stroke, and age is an excellent surrogate for that determination,” said lead investigator Steven Lubitz, MD, MPH, a cardiologist, electrophysiologist, and physician investigator with the Cardiovascular Research Center at Massachusetts General Hospital (MGH), in a statement from MGH.
Few prospects have captivated the attention of cardiovascular care professionals as the potential for digital health interventions in the diagnosis of AF in recent years. A pragmatic cluster randomized controlled trial, VITAL-AF was designed with the aim of assessing whether use of such an intervention in primary care settings could improve the diagnosis rates and prescription of oral anticoagulants.
The trial was conducted in 16 of the 22 practices within the MGH Primary Care Practice Based Research Network and enrolled patients aged 65 years and older from July 31, 2018-October 8, 2019. A total of 30,715 patients were enrolled in the trial and underwent cluster randomization in a 1:1 ratio to AF screening using a single-lead AliveCor KardiaMobile ECG device during vital sign assessments or usual care.
The primary outcome of interest for the investigators’ analyses were new diagnoses of AF during a 1-year screening period, which was ascertained through electronic or manual adjudication. Secondary outcomes of interest included incidence proton of AF during the 12-month screening window.
Of the 30,715 patients included in the study, 15,393 underwent screening with the single-lead ECG device and 15,322 were included in the control arm. All patients included in the study had at least 1 eligible visit at a study practice during the study period, which corresponded to 38,880 encounters among those who underwent screening with single-lead ECG device and 40,450 encounters among the control group. The median patient-level length of follow-up was 279 days in the screening arm and 282 days in the control arm. Investigators pointed out patient features in both arms were well-balanced.
Upon analysis, results indicated 1.72% of those in the screening arm and 1.59% of those in the control arm had newly diagnosed AF at 1 year (risk difference [RD], 0.13% [95% CI, -0.16 to 0.42]; P=.38). In subgroup analyses, results suggested the screening approach could be more effective in patients aged 85 years or older, with rates of diagnosis of 5.56% among the screening arm and 3.76% among the control arm (RD, 1.80% [95% CI, 0.18 to 3.30]). Investigators also pointed out the difference in newly diagnosed AF between the screening period and the prior year was marginally greater in the screening vs control group (0.32% vs -0.12%, respectively; RD, 0.43%, [95% CI -0.01 to 0.84])and the proportion of individuals with newly diagnosed AF who were initiated on oral anticoagulants was not different among the screening and control arms (73.5% vs 70.8%, respectively; RD, 2.7% [95% CI -5.5 to 10.4]).
“Considering that advanced age is associated with a substantially increased risk of both AF and stroke, point-of-care screening might be an efficient use of single-lead, handheld electrocardiograms for adults 85 and over,” Lubitz added. “The technology simply requires patients to place their fingers on the device to record an electrocardiogram and can be easily embedded in the routine clinical practice of primary care physicians.”
This study, “Screening for Atrial Fibrillation in Older Adults at Primary Care Visits: the VITAL-AF Randomized Controlled Trial,” was published in Circulation.