"Technology is a useful servant but a dangerous master." – Christian Lous Lange
The recent FDA approval of the AliveCor Apple Watch accessory KardiaBand highlights a next step toward expansion of the possibility of wearable medical device technology. Under ideal settings, patients may use this device to acquire single-lead ECG data via a wrist-worn device/Apple Watch accessory. This represents an incremental improvement to AliveCor's currently available device that works in conjunction with a smartphone app. The previous device, which was also FDA approved, requires patients to hold a credit card-sized device with two ECG leads while ECG data are acquired and transmitted to a device-connected smartphone or tablet. With the wrist-worn-enabled device, time to data acquisition can theoretically be at least minimally shortened. Additionally, the imminently available SmartRhythm algorithm can notify asymptomatic patients to initiate ECG data acquisition when discrepancies are detected between expected and measured heart rates. This has the potential to increase sensitivity in detecting arrhythmias.
Much enthusiasm and press have justifiably accompanied the long-awaited FDA approval of the KardiaBand device. This newly available wearable device acquires patient-initiated, intermittently transmitted episodic ECG data streams that may inform heart rhythm-related clinical decision support. No doubt this technology has the potential to make or confirm cardiac rhythm diagnoses. Additionally, the possibility of this technology has investors, futurists, prognosticators, marketers and even some clinicians enthusiastic about its potential for improved diagnosis, patient engagement and, perhaps, even chronic disease management. However, these data still require human review and diagnosis verification before it can be considered safely actionable.
Unfortunately, difficult to explain and arguably arcane concepts like artificial intelligence, deep neural networks and other charged descriptors of advanced data analytics have been invoked to conjure an overly grandiose vision for the use of wearable patient data of a new science of anticipatory medicine. Exuberant enthusiasm and industry and investor-driven optimism may overstate the potential value of KardiaBand and other developing medical technologies while also superseding the scientific method and undervaluing the investigation of novel technologies in less glamorous but real-world practical uses. As with most all patient data, clinical context and personalized interpretation inform clinicians of the value of any data. Real-world questions must be asked of these data, like: When much of clinical cardiology and medical care focuses on chronic disease management in patients with known diagnoses, how valuable is a patient-directed tool for arrhythmia diagnosis? How can millions of ECG data points most effectively be analyzed and displayed for clinical use? What is the cost of acquisition, analysis, storage and security of millions of ECG data streams? Who or what bodies will manage and pay for the stewardship and housing of these data? What are the unintended consequences and costs of the inevitable burden of incidental diagnoses detected in healthy populations?
Technology and innovation in biological data acquisition are inevitable. As clinicians and consumers of limited and shared resources, prioritizing data streams and data types and maintaining disciplined approaches to the assessment of novel technologies may stem the tendencies of technologies and advancement to increase overall costs without providing meaningful clinical benefits. As physicians and scientists, we can partner with industry to ask relevant clinical questions that leverage innovative technologies to search for these answers. Consumer-directed wearable patient data has the potential to provide the answer — an abnormal heart rhythm, an out-of-range pulse rate or BP, unusual accelerometer data, etc — without an a priori clinically meaningful question. This possibility may inevitably create conflicts with the pursuit of virtuous science.
KardiaBand offers potentially enhanced access to more immediate ECG data for patients, clinicians and investigators. This enhanced access has the potential for novel opportunities to better understand human physiology. Increased accessibility to ECG data as a tool to better understand the human condition on an individual and population level may be the most meaningful application of the KardiaBand. The mobile and regular access to ECG data serially acquired over time in ambulatory patients with varying baseline physiologies and under differing states of health and stress may better inform normal and abnormal variability. This may provide new insights about various cardiac and even noncardiac disease states and treatments.
Ilan Kedan, MD, MPH
Cedars-Sinai Heart Institute
Disclosures: Kedan reports no relevant financial disclosures.