The first question to ask for any medical device is whether the results are accurate. While alerts generated by pacemakers and implantable defibrillators tend to be quite accurate, the same cannot always be said for the small, implantable cardiac monitors used for diagnosing abnormal heart rhythms. These “Implantable Loop Recorders (ILRs)” have represented a major step forward in the diagnosis of intermittent heart rhythm problems, but they can be plagued by frequent false positive alerts, which strain the resources of cardiology clinics. While the accuracy of the Apple Watch in the study was encouraging, much work is yet to be done, and even a small percentage of false positives applied to a huge population could create tremendous increased utilization of healthcare resources. Improved algorithms, careful programming, and proper patient selection can all reduce the number of false positives for ILRs, and similar principles should apply to consumer wearables.
The next question to ask is, given that the data is accurate, is it actionable? One of the biggest controversies in cardiology is how to best minimize the risk of stroke in patients with afib, caused by development of blood clots in the heart. We know that blood thinning medication is effective in preventing stroke in patients with afib, but no one knows how long a patient has to be in afib before development of a blood clot is a risk.
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Data from remote monitoring of patients with pacemakers and defibrillators has, for the first time, given us an almost continuous view of how many episodes of afib patients have and how long they last. What isn’t known is whether treating patients based on these episodes that often occur without symptoms is any better than treatment based on symptoms or diagnosis that occurs during a physical examination. More data is probably better, but we still need to prove it.
Next, assuming these devices generate important data, are there people available to view and act on the results? Alerts for implantable cardiac devices are largely directed toward clinicians, as opposed to the patients themselves. However, there may not be dedicated staff or workflows designed to consistently review the data that is sent by devices remotely. Although clinical trials clearly demonstrate improved outcomes with remote monitoring, none of these benefits are realized if no one is looking at the data.
Many consumer-oriented technologies focus on delivering information to the patient instead of the physician. In the Apple Watch study, users were notified of possible afib if their pulse was irregular. It was then incumbent on the individual to contact a physician for further evaluation. While this example removes the burden of having clinical staff continuously monitor the patients’ heart rhythm, it remains to be seen how much more effective that will be than the pacemaker audible alert. In the Apple Watch study, only 57% of patients who received a notification actually sought medical attention.