Home screening for detection of atrial fibrillation in elderly hypertensive patients with left atrial enlargement using hand-held medical device, the DEFINE-AF clinical study

Abstract Background Proper diagnosis of silent atrial fibrillation(AF) remains a significant challenge. The occasional paroxysmal character and asymptomatic course of the condition can hamper detection, with major consequences. Currently developed medical devices suitable for home screening provide additional opportunities for increased AF detection. Purpose This study sought to evaluate home screening for silent asymptomatic AF with the use of a handheld single-lead ECG recorder, as well as to assess arrythmia presence with concomitant self-test of pulse palpation. Methods DEFINE-AF was a multicenter, nationwide, low-interventional, prospective study in Greece, conducted in 7 university cardiology departments as well as in 49 private cardiology practices. Participants were elderly(≥65 years) with a history of hypertension and echocardiographic signs of left atrial(LA) enlargement (LA diameter40mm). Subjects were excluded if there was a history of AF. Eligible patients used a handheld medical device at home, twice daily (morning and evening) for 2 weeks. The device, MyDiagnostick, was capable to record ECG Lead I tracings. Moreover, prior to each device recording, all participants were instructed to self-test their radial pulse (regular/irregular) and record it in a diary. After 2 weeks the recorded ECG strips were interrogated, and diagnosis of AF was established following investigators’ review and confirmation. A stepwise multivariable logistic regression model was used to investigate possible risk factors for AF. Results From June 09, 2022, to May 18, 2024, 900 individuals were enrolled in the study and 886 valid recordings were received. The mean(SD) age was 73.9 years(6.3), BMI was 28.2kg/m2(4.5) and CHA2DS2VASc score was 3.5(1.0). In summary, 80% had a history of dyslipidemia, while 25% and 28% of thyroid disease and other arrythmias respectively (Table 1). In total, 63 new cases of AF were detected by the device and confirmed by the investigator (63/886-diagnosis rate:7.1%, 95%C.I.: 5.55-9.06). More than 2/3 of new AF cases were detected within the first week of home screening (Table 2). Of these cases, 37 had been reported by the participants as an "irregular pulse" (37/63, 58.7%). Age≥75(OR:8.577, p= 0.008) and history of prior arrhythmias (excluding AF) (OR:2.106, p=0.006) were positively associated with AF detection. Interestingly, BMI30 kg/m2 had an almost 5-fold likelihood of having AF compared to ≥30 (OR:4.89, p=0.034); although, the effect was minimized for the ages≥75y (OR:1.03 p=0.999). The majority of patients and investigators (94% and 89%, respectively) found the experience of home screening extremely or quite satisfying. Conclusion Home screening with a user-friendly technology for a period of 2 weeks demonstrates a 7.1% prevalence of silent AF in elderly hypertensive patients with LA dilation. Moreover, self-test of radial pulse at home may reveal irregular rhythm and thus lead to further investigation for AF.