A large-scale study has provided some evidence that the Apple Watch could be used to detect atrial fibrillation (AFib) and provide a potentially life-saving early warning for the condition – although the result suggests the tech isn’t quite ready for prime time. The ‘virtual’ Apple Heart Study allowed subjects with an iPhone and Apple Watch to enrol online, download an app and use it for several months to see if it was possible to detect AFib remotely, cross-checking the app findings with conventional testing using an electrocardiogram. One out of every four people will experience AFib at some point in their lifetime, raising their risk of stroke and heart failure, although the condition often goes undiagnosed. Having AFib gives a four- to five-fold increased risk of stroke, and it kills around 130,000 people in the US every year. “The study’s findings have the potential to help patients and clinicians understand how devices like the Apple Watch can play a role in detecting conditions such as atrial fibrillation,” said Minang (Mintu) Turakhia, co-principal investigator and associate professor of cardiovascular medicine at Stanford Medical School. “We don’t have to bring people into a brick and mortar clinic and give the study intervention.” In the study, the Apple Watch app used an algorithm that gauged if the watch wearer’s heart was beating irregularly, and if so stepped up the monitoring rate. If five out of six checks indicated an irregularity in the heart beat, the subject would receive a warning via the app, and be given the chance to connect with a doctor employed by telemedicine company American Well. After a consultation, the subjects would either be advised to visit a doctor immediately, receive an ECG patch (ePatch) that would be worn for several days, or were excluded because they had already been given a diagnosis of AFib. Apple and its collaborators at Stanford University reported preliminary results at the American College of Cardiology (ACC) conference in New Orleans over the weekend showing that the Apple Watch app was able to predict AFib effectively with an 84% success rate from a sample of almost 420,000 subjects. Around 0.5% of the sample – a little over 2,000 people – received an alert that they may have AFib and were referred to the telemedicine service, which the investigators said indicated that there wasn’t an excess of false positives. The alert was acted on by 945 people – which raised questions about how to motivate people to engage with the process – and around 650 of them were subsequently sent an ePatch. All told, AFib was identified in around 34% of the latter group. Marrying the two data sets did throw up a discrepancy, with the app showing a positive predictive value (PPV) of 71% when its diagnosis of AFib was compared directly to the ePatch readings. That shows that its accuracy is “still far short of more traditional and currently used monitoring techniques”, according to ACC.org editor-in-chief Kim Eagle. Turakha says however that AFib can come and go, particularly early on in the course of the disease, so “it’s not surprising for it to go undetected in subsequent ECG patch monitoring.” “While only 34% of people were still having AFib on the ambulatory ECG, that doesn’t mean that 66% didn’t have AFib,” he adds. “It just means that AFib may not have been there at the time.” It’s also worth noting that the Apple Watch used in the study was an earlier generation without the built-in ECG tech of the most up-to-date model, which was recently the subject of an alliance between Apple and Johnson & Johnson that will focus on AFib detection. Patient recruitment is due to start in late 2019 for the J&J-backed HEARTLINE study, which will put the new Apple Watch through its paces in the early detection and diagnosis of AF and the potential to improve outcomes, including myocardial infarction, stroke and death.<doc-sep>Two months ago, Apple CEO Tim Cook said his company's "greatest contribution to mankind" would be in health. A new study led by Stanford researchers provides a glimpse at how that vision is beginning to take shape. The preliminary analysis suggests that the Apple Watch can accurately detect some heart problems. But there are caveats. For one, the study didn't include the most recent Apple Watch, which has an extra feature that helps detect heart problems. The study looked at whether the watch can detect atrial fibrillation, or afib, a common but potentially serious disorder. Other tech companies like Fitbit are also trying to detect it. Roughly two months after Apple CEO Tim Cook said his company's "greatest contribution to mankind" would be in health, a new study provides the first glimpse at how that vision is beginning to take shape. The unprecedented analysis, known as the Apple Heart Study, involved teaming up with cardiologists at Stanford University and studying more than 400,000 people. Their aim was to learn whether the Apple Watch and its heart-rate sensor could properly pick up on irregularities in people's heartbeat. An early look at the work suggests it can. Of course, there are caveats. The researchers are scheduled to present a summary of the Apple-sponsored study at the American College of Cardiology's annual meeting on Saturday in New Orleans. The full study has not yet been published. According to their presentation, the watch appeared capable of picking up on abnormalities linked with a common but serious condition called atrial fibrillation or afib. Afib is an irregular heart beat, and people with the condition can experience shortness of breath and poor blood flow. The condition can also increase the risk of more serious problems like stroke and heart failure . "The study's findings have the potential to help patients and clinicians understand how devices like the Apple Watch can play a role in detecting conditions such as atrial fibrillation, a deadly and often undiagnosed disease," Mintu Turakhia, the study's lead author and an associate professor of cardiovascular medicine at Stanford, said in a statement. While the research offers a hopeful glimpse at the power of the Apple Watch to improve people's health, there is also potential for the device to overburden the healthcare system, according to some researchers. That could happen if the device tells too many people that they have a health problem when they actually don't. Here's what you need to know. An example for tech giants with their eyes on health Apple isn't the only Silicon Valley tech giant with its eye on health. In recent years, companies such as Facebook, Google parent company Alphabet, and Fitbit have all made an effort to detect and prevent illness — whether it's picking up on someone who might be at risk of suicide or diagnosing a condition like afib or sleep apnea. Still, ailments like afib — which is equal parts common, serious, and preventable — are a kind of holy grail. Outside experts who reviewed Apple's latest study see strengths and weaknesses in how it was done. Some major bright spots include the fact that it was done in collaboration with a well-respected university like Stanford, included lots of people, and took place over a fairly long time period. Additionally, the study design was kept separate from Apple, who funded it. "This study is a great example for tech of how to design future studies," Mohamed Elshazly, an assistant professor of medicine at Weill Cornell Medical College who reviewed the study's design and saw its preliminary results, told Business Insider. The Apple Watch's optical sensor uses light to measure your heart rate. Hollis Johnson One big caveat: The study did not include the latest Apple Watch with its ECG Still, Elshazly and other experts warn that the study had some important caveats. The biggest? It didn't include the most recent Apple Watch, the series 4. That watch, released after the study began, features a built-in electrocardiogram or ECG, the medical test typically used to detect heart-rhythm problems. The series 4 was also the source of some controversy: experts worried that the device would over-diagnose irregularities, sending a lot of healthy people running to their doctors. "Imagine the impact on a health care system as thousands of young, healthy people suddenly want to schedule appointments with cardiologists," Larry Husten, the former editor of TheHeart.Org, wrote in a recent opinion piece for Stat News. But previous versions of the Apple Watch still have something else that can be used to check on your heart. The series 1, 2, and 3 versions of the watch contain what are known as optical heart-rate pulse sensors. They use lights to take your pulse. So for the Stanford study, Turakhia and his co-investigators studied 400,000 people with one of these Apple Watches. The researchers also had the participants use a corresponding heart health app on their iPhones. When people's Apple Watches picked up on an irregularity, they notified the participant with a pop-up and asked them to schedule a video chat with a doctor involved in the study. Then, to check that the irregular readings were correct, the researchers sent those participants ECG patches. The Apple Watch identified heart problems in a small number of people The study came away with some positive findings. They suggest that the Apple Watch does a fairly good job of detecting heart problems in people who have them, especially in cases where the problem also happens to be afib. But in some cases, the devices also detect problems when there aren't any. This phenomenon, known in clinical parlance as a false-positive, is most concerning when it affects a large number of people. At first glance, this doesn't seem to be an issue with Apple's study: out of its more than 400,000 participants, only 0.5% (or 2,000 people) got notifications indicating they had an irregular heart rate. However, when you consider that several million people are already wearing Apple Watches, that 0.5% figure could actually be quite troubling, Elshazly said. It's especially troubling when you also consider the fact that sometimes the notifications are wrong. Hollis Johnson According to comparisons with ECG patch recordings taken at the same time, the watches were correct in flagging a problem 71% of the time. In other words, in roughly seven out of 10 cases in which the watches told someone they had a problem, that problem turned out to be real. Additionally, in about eight out of every 10 abnormal cases, people were found to have afib at the time of the alert, suggesting that the Apple Watch is good at flagging people with that serious condition. But those findings also mean that roughly a third of people who got flagged had nothing wrong with their hearts. And some of them still went on to seek medical care. Those are the people Elshazly and Husten are worried about. "These are people who are pursuing care when they shouldn’t have," Elshazly said. Another problem the study doesn't address is what happens to the people with afib whose symptoms are not picked up by the Apple Watch. In contrast to the people without a problem who the Apple Watch flags incorrectly, the people with a problem that get missed by the Apple Watch might never get the care they need. In other words, they might "feel falsely reassured by the absence of any alert," Husten wrote. Despite these issues, researchers like Elshazly still think wearables like the Apple Watch could play an important role in helping to predict and prevent serious illnesses like afib — especially if they're provided to populations who are known to face a higher risk of those illnesses. With afib, the risk increases dramatically with age, suggesting to Elshazly that perhaps the watches should be given primarily to older people. Detecting heart problems is just the start "Atrial fibrillation is just the beginning," Lloyd Minor, the dean of the Stanford School of Medicine, said in a statement about Apple's study. "This study opens the door to further research into wearable technologies and how they might be used to prevent disease before it strikes," he said. Other tech companies are working on similar applications for their devices in healthcare. Fitbit, for example, has been exploring the idea of using its fitness trackers to detect both afib and sleep apnea. Two years ago, the company enrolled in a new precertification program with the Food and Drug Administration that's designed to help speed the approval process for new digital health products. "The billion dollar question is, does using the Apple Watch — with all its features — actually lead to me living longer and having better health?" Elshazly said. "We don’t know yet. We don't have the data."<doc-sep>
(CNN) — Has a new bar been set for wearable technologies? An Apple Watch may detect heart rate irregularities that subsequent medical tests confirm to be atrial fibrillation, according to preliminary findings from a new study. AFib is often undiagnosed since it might not cause noticeable symptoms, but it contributes to 130,000 deaths and 750,000 hospitalizations in the United States each year. New results from the Apple-funded study, which have not been published or peer-reviewed, were presented Saturday at the American College of Cardiology Scientific Session in New Orleans. “The study’s findings have the potential to help patients and clinicians understand how devices like the Apple Watch can play a role in detecting conditions such as atrial fibrillation,” Dr. Mintu Turakhia, co-principal investigator and associate professor of cardiovascular medicine at Stanford Medical School, said in a statement. Preventive medicine enabled by technology Turakhia and his colleagues conducted a virtual study with more than 400,000 participants to understand whether a mobile app using data from a heart rate pulse sensor can identify atrial fibrillation. Participants had both an iPhone and an Apple Watch, though not the most recent version, which features built-in electrocardiography (ECG), because it was released after the study’s launch. Intermittently, a special app checked each participant’s heart-rate pulse sensor for an irregular pulse, and if it was detected, the participant would receive a notification and was asked to schedule a telemedicine consultation with a study doctor. Next, the participant would be sent ambulatory (walking) ECG patches to record the rhythm of their heart for up to a week. The findings suggest how wearables might help to detect conditions before they strike, the researchers say. Overall, only 0.5% of participants received irregular pulse notifications indicative of possible AFib. This is important, the researchers say, given concerns about potential over-notification – a kind of false positive. And about a third (34%) of the participants who received irregular pulse notifications and followed up were found to have atrial fibrillation. Comparing the irregular pulse detection on Apple Watch with the longer-duration ECG patch recordings, the Apple Watch’s pulse detection algorithm showed a 71% positive predictive value; in other words, only 29% of those participants given a warning had received a false positive. Finally, 57% of those who received irregular pulse notifications sought medical attention, the study showed. “The performance and accuracy we observed in this study provides important information as we seek to understand the potential impact of wearable technology on the health system,” Dr. Marco Perez, co-principal investigator and associate professor of cardiovascular medicine at Stanford Medicine, said in a statement. What these preliminary results can tell us Dr. Mitesh Patel, an assistant professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, emphasized that “the results are preliminary.” Still, he gives kudos to both the team and Apple for doing a scientific study. “I think this could represent kind of a turning point in how we think about wearables,” said Patel, who was not involved in the new research. “There are lots of wearable devices that try to track lots of different behaviors and biometrics, and very few of them are actually tested in a well-designed, large-scale clinical trial. “A lot of people get excited by the 400,000 number” of participants, he said, and although this is impressive, he noted that only 0.5% had AFib. A study targeting higher risk populations – for example, people with heart failure over age 65 – might help to reduce the false positive rate, he said. “You might think” it is surprising that almost half of the people identified as having AFib didn’t seek medical care, but “it’s actually not,” Patel said. A lot of his own research has shown that while wearable devices may be really good at monitoring and detecting behaviors or biometrics, they need to be “combined with something else to really motivate people to change their behavior,” he said. In one of his studies, people discharged from the hospital after a heart attack or stroke were given either a wearable or a wearable plus a personalized activity goal and a financial incentive: $14 a week, with $2 deducted each day they didn’t meet the goal of walking a certain number of steps.