Apple recently announced that the latest version of its Apple Watch had received Food and Drug Administration clearance for its atrial fibrillation detection algorithm, which is built into its Series 4 device. The latest version…
Apple recently announced that the latest version of its Apple Watch had received Food and Drug Administration clearance for its atrial fibrillation detection algorithm, which is built into its Series 4 device. The latest version of the product also includes fall detection and other health-related features.
Atrial fibrillation, which affects nearly 6 million Americans, is the most common heart rhythm disorder in the world. AF can result in stroke, and it’s vital that patients are placed on blood thinners (called anticoagulants) when appropriate in order to prevent this devastating complication. AF is one of the more costly chronic cardiovascular diseases — medication, frequent hospitalizations and symptoms related to AF can significantly impact quality of life and lead to other cardiovascular complications.
Apple is not the first to develop a device that can monitor and detect AF. In 2017, Alive Cor developed the first FDA-cleared medical accessory for the Apple Watch. The band attaches to the watch (replacing the original manufacturer’s watchband) and can record a 30-second ECG with the touch of a sensor. Known as the Kardia band, this device utilizes artificial intelligence and proprietary algorithms for the detection of AF and other arrhythmias. This device has been validated by numerous published studies for its accuracy and utility in the management of AF.
Data from previous studies on high blood pressure and diabetes has demonstrated that when patients are engaged in their own health care through recording blood pressures or blood sugars and sharing these data with their health care providers, their outcomes are improved. Their blood pressure is better controlled and their diabetes remains in check. It stands to reason, then, that by allowing patients to monitor their own heart rhythm through the use of simple point-of-care ECG recordings via a personal device, outcomes with AF should also be improved.
In the coming years, we’re going to see more and more FDA-cleared, direct-to-consumer medical devices that will allow us to better monitor our own health status. Apple has led the way with the HealthKit, and the company is now beginning to innovate with devices that can produce data that can assist both doctor and patient with disease management. When a patient is able to alert a physician of a change in health status before a major medical event occurs, proactive and preventative changes to a treatment plan can be made, and an adverse outcome may be avoided. In the case of AF, the use of a device such as the Kardia Band or the Apple Watch can allow a physician to more appropriately use blood thinners to prevent a life alerting stroke. By monitoring your own ECG and working closely with your physician, a patient with AF may be able to avoid unnecessary hospitalizations and frequent clinic visits.
Other health-related applications, such as the fall detection feature on the Series 4 Apple Watch, can allow seniors to live independently and remain safe at home for much longer — averting the need for assisted living in many situations. The fall detection uses built in gyroscopes to determine if the wearer has fallen and gives them the opportunity to call 911 for assistance immediately once a fall is detected.
The U.S. Preventive Services Task Force does not recommend screening for AF in low-risk asymptomatic adults, and experts worry that the widespread availability of screening tools may result in overuse of the medical system. Opponents of direct-to-patient diagnostic technology are concerned that the devices will create a culture of the “worried well” and result in healthy individuals calling a doctor for an unnecessary visit. With any device like a mobile ECG, there’s always the concern that there will be false positives that may lead to further testing and over-utilization of health care resources. In addition, there is a concern that those who may benefit most may not have access to the Apple device due to its high price point. While these concerns are valid, I think that the potential benefits far outweigh the negatives.
In its clearance statement for the Apple Watch ECG, the FDA specifically mentions that those with AF should not use the device — and this is where I think the FDA got it wrong. Those are the people who could benefit most from self-monitoring. Medicine has long been a “paternalistic science” where the “doctor knows best.” This is an antiquated way of thinking, and medicine is now a partnership between doctor and patient. It is no longer feasible or acceptable for the health care provider to care for a patient in a vacuum. Successful outcomes require a partnership between the doctor and patient, and these technologies will allow for more interaction — albeit digital — that will ultimately improve outcomes. These digital touch points are not a replacement for an in-person doctor-patient interaction but will serve to supplement the time between office visits and reinforce healthy behaviors. The best way to decide if a medical monitoring device is right for you is to have a discussion with your health care provider and weigh the risks and benefits of home monitoring that are specific to your medical diagnosis and situation.
I believe that digital tools, telemedicine and remote monitoring technologies are the future of medicine. When medical professionals are able to have insight into the patient’s activities and health status when they’re at home, they’re better able to prescribe effective treatments and prevent disease. Data compiled from a meta-analysis of the remote monitoring of pacemakers and implantable cardioverter defibrillators demonstrates that for every 1000 patients monitored, we can prevent 53 deaths and 30 strokes. The culture of medicine in the U.S. must change from one of treatment to one of prevention in order to save money and improve patient outcomes. Technology is a big part of the answer. I expect that we’ll see many other direct-to-consumer medical devices in the market in the coming years, and I think we’ll all be healthier for it.