Wearable, long-term continuous heart monitors helped discover 52% more cases of atrial fibrillation in comparison with usual care, but that didn’t result in a discount in hospitalizations as a result of stroke, in response to a study led by the Duke Clinical Research Institute.
The findings, reported Sept. 1 on the European Society of Cardiology meeting and published within the Journal of the American College of Cardiology, provide inconclusive data about whether atrial fibrillation screening lowers stroke rates. The COVID pandemic led to an early halt of the study before fully enrolling, so it didn’t have enough participants to determine definitive results about stroke.
“Atrial fibrillation is commonly undiagnosed and may increase the chance of ischemic stroke, which is essentially reversible by oral anticoagulation,” said lead writer Renato Lopes, M.D., Ph.D., a professor of medication and member of the Duke Clinical Research institute.
“We still need definitive evidence that diagnosis of atrial fibrillation through systematic screening can result in subsequent treatment with oral anticoagulation and subsequently, lower stroke risk,” Lopes said.
The study enrolled roughly 12,000 patients within the U.S. who were no less than 70 years old with no history of atrial fibrillation. Roughly half the patients were randomly assigned to receive a long-term (14 days) continuous monitoring device, and the opposite half usual care.
Over a median of 15 months of follow-up, the study reported a 52% increase within the variety of cases of atrial fibrillation diagnosed among the many device-wearers in comparison with those in usual care. There was no increase in rates of hospitalization for bleeding, and no significant reduction in the speed of hospitalizations for all stroke compared with usual care.
The study was originally designed to enroll 52,000 patients, which might have given it the ability to find out whether screening reduces the numbers of strokes. A big study population is required because strokes occur in a subset of patients with atrial fibrillation.
“Despite the inconclusive results, we’ve lots of lessons learned which may inform future studies” Lopes said. He said the study’s design, which enabled patients to be enrolled and screened online in a virtual format with self-applied patch devices of their homes with only distant support, may very well be duplicated in future studies.
Along with Lopes, study authors include Steven J. Atlas, Alan S. Go, teven A. Lubitz, David D. McManus, Rowena J. Dolor, Ranee Chatterjee, Michael B. Rothberg, David R. Rushlow, Lori A. Crosson, Ronald S. Aronson, Michael Patlakh, Dianne Gallup, Donna J. Mills, Emily C. O’Brien, and Daniel E. Singer.
The study received funding support from the Bristol-Myers Squibb/Pfizer Alliance.
