iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced that the results of the “SCREEN-AF” study led by researchers at Sunnybrook Health Sciences Centre in Toronto, Canada and University Hospital in Leipzig, Germany were published today in JAMA Cardiology.
The transatlantic clinical trial found that Zio by iRhythm, an ambulatory cardiac monitoring solution, led to a tenfold increase in the detection of atrial fibrillation (AF) versus patients receiving standard clinical care. One out of every 20 patients in the heart monitoring group was found to have a new diagnosis of atrial fibrillation and, as a result, 75 percent of those patients were subsequently prescribed a blood thinner medication for protection against strokes.
The study results lend support for Zio as a screening tool for early detection of AF. The results have important implications for stroke prevention, especially as the prevalence of AF and AF-associated strokes is increasing with the aging of the population. Zio was found to be well-tolerated and effective, and the service’s diagnostic reports enabled appropriate patients to receive anticoagulant therapy (anti-clotting medication) which has the potential to avert future strokes.
“Approximately one-third of those who have AF are not aware that they have it, leaving them at a significantly elevated risk of stroke,” said Michael Coyle, CEO at iRhythm. “The clinical validation that iRhythm has seen through its recent trials – mSToPS and SCREEN-AF – demonstrates that Zio proactively identifies arrhythmias based on risk factors, helping undiagnosed populations remotely monitor their symptoms and effectively seek treatment before more serious problems can occur.”
Unlike handheld ECGs, watches, and blood pressure monitors, wearable continuous ECG devices can serve as both a screening tool and a diagnostic test, likely reducing the need for confirmatory testing. When compared with implanted cardiac monitors, wearable ECG devices are noninvasive, less costly, more accessible, and can be self-applied by patients at home.
“The big challenge is that atrial fibrillation is often a silent risk factor that can be difficult to detect with current methods,” says Dr. David Gladstone, the study’s principal investigator and stroke neurologist from Sunnybrook Health Sciences Centre and Department of Medicine in the University of Toronto Temerty Faculty of Medicine. “If we are able to better detect atrial fibrillation, then more people could receive treatment for it earlier, and more strokes ought to be prevented,” adds Dr. Gladstone, who recently presented the research findings at the World Stroke Congress.
“These results are an important step towards stroke prevention by early detection of atrial fibrillation,” said Dr. Rolf Wachter, co-principal investigator, cardiologist at the University Hospital in Leipzig, Germany and scientist at the German Center for Cardiovascular Research.
The study recruited 856 individuals from 48 primary care clinics between 2015 and 2019. It involved participants aged 75 years or older who had high blood pressure but no previous diagnosis of AF. Half of the participants were given Zio monitors to wear at home for up to four weeks, while the other half of participants received standard medical care. All participants were observed for six months.
Clinical collaboration was supported through Sunnybrook Health Sciences Centre, the German Center for Cardiovascular Research, the Heart Center in Göttingen, and the Population Health Research Institute. Read more.