iRhythm Technologies has announced the results of the SCREEN-AF study, led by researchers at Sunnybrook Health Sciences Centre in Toronto, Canada and University Hospital in Leipzig, Germany, published in JAMA Cardiology.
The transatlantic clinical trial found that the use of the Zio (iRhythm) ambulatory cardiac monitor 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 AF and, as a result, 75% 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, iRyhthm said in a press release, and 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 results enabled some 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.
Commenting on the news, Justin Hall, GM and VP EMEA at iRhythm, said:“AF is currently the leading independent risk factor of stroke, with more than 886,000 new people being diagnosed across Europe each year. As with many heart conditions, the key to improving the outcome of AF—and therefore the associated risk of stroke—is through earlier and more accurate detection. The sooner an individual is diagnosed; the sooner medical practitioners can deploy the best course of treatment. This is something that Zio can help to achieve, even during the ongoing pandemic, through accurate, remote monitoring.”
“The big challenge is that atrial fibrillation is often a silent risk factor that can be difficult to detect with current methods,” says 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 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.
In recent months, iRhythm has also been awarded a positive recommendation from the National Institute for Health and Care Excellence (NICE), as well as being named a recipeint of the UK government’s AI in Health and Care Award.