Circulation journal : official journal of the Japanese Circulation Society · 2021
Evaluation of the Feasibility and Efficacy of a Novel Device for Screening Silent Atrial Fibrillation (MYBEAT Trial).
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Okubo Yousaku, Tokuyama Takehito, Okamura Sho, Ikeuchi Yoshihiro, Miyauchi Shunsuke, Nakano Yukiko, MYBEAT Trial Investigators
Аннотация
BACKGROUND: myBeat is a novel cutaneous patch device that continuously records electrocardiography and automatically detects atrial fibrillation (AF) by using a new algorithm based on RR intervals. We aimed to test the diagnostic ability of this novel device for screening silent AF in asymptomatic patients.
METHODS AND RESULTS: A multicenter randomized prospective clinical study was performed. To be eligible for inclusion in the study, patients had to be ≥65 years of age and have ≥1 of the following risk factors: hypertension, diabetes, heart failure, ischemic heart disease, stroke, and transient ischemic attack. Patients with prior AF, an implantable pacemaker, and previous palpitation or syncope were excluded. The 300 participants were divided into 2 groups, those using myBeat (n=150) or those undergoing 24-h Holter monitoring (control group; n=150), for AF screening. The rate of AF detection was significantly higher in the myBeat than control group (16 [10.7%] vs. 7 [4.7%], respectively; P=0.04). Multivariable logistic regression analysis revealed that prior heart failure was an independent predictor of silent AF (odds ratio 12.07; 95% confidence interval 1.67-86.27; P=0.01). A 7.7-fold difference in silent AF was found between subjects with CHA2DS2-VASc scores of 1 point and those with scores ≥4 points.
CONCLUSIONS: The novel patch device using an original algorithm was beneficial for screening of silent AF.
METHODS AND RESULTS: A multicenter randomized prospective clinical study was performed. To be eligible for inclusion in the study, patients had to be ≥65 years of age and have ≥1 of the following risk factors: hypertension, diabetes, heart failure, ischemic heart disease, stroke, and transient ischemic attack. Patients with prior AF, an implantable pacemaker, and previous palpitation or syncope were excluded. The 300 participants were divided into 2 groups, those using myBeat (n=150) or those undergoing 24-h Holter monitoring (control group; n=150), for AF screening. The rate of AF detection was significantly higher in the myBeat than control group (16 [10.7%] vs. 7 [4.7%], respectively; P=0.04). Multivariable logistic regression analysis revealed that prior heart failure was an independent predictor of silent AF (odds ratio 12.07; 95% confidence interval 1.67-86.27; P=0.01). A 7.7-fold difference in silent AF was found between subjects with CHA2DS2-VASc scores of 1 point and those with scores ≥4 points.
CONCLUSIONS: The novel patch device using an original algorithm was beneficial for screening of silent AF.