2020 was the year when regulators, clinicians, and patients had no choice but to embrace the concept of wearable monitoring devices. But it’s been a long time coming for the technology class.
For years now, the mean global population and the prevalence of cardiovascular disease have risen steadily together. In some estimates, heart failure rates among US adults jumped 9% in just 4 years.
Other data show death from cardiovascular disease—already the greatest killer in modern society—has risen 21% since 2003.
During this troubling trend, the healthcare industry has geared itself toward improved preventive care: better diagnostics and mitigating therapies that could shrink the growing numbers.
Some of these more popular advances, first embraced by consumers before being vetted for clinical use, have been cast into starring roles during an unprecedented scenario.
This year in cardiovascular care has been defined by an increased need for and reliance on remote diagnostic and wearable technologies to ensure patients stay on the very needed pathway of cardiovascular disease prevention.
Such a need was answered by the US Food and Drug Administration (FDA), which in its capacity as regulator all but acknowledged the demand for telehealth and remote monitoring-complementary devices in 2020. They granted 510(k) clearance to AliveCor’s AI-based personal ECG, Nanowear’s SIMPLESense wearable heart and lung monitoring platform, and LIMVOR’s Halo atrial fibrillation detection system, to name a few.
Though recent lockdown and social distancing measures have coincided neatly with the approvals of such services and platforms, the narrative of this technology class had been unfolding well before the start of the pandemic.
The onset of sudden restrictions in healthcare access has merely precipitated the inevitable, and brought it under a microscope of scrutiny.
What has long been perceived as a badge of the health-conscious and affluent is—over time and particularly in recent months—being further accepted as the next frontier in popular cardiovascular care.
Remote Technologies: A Digital Picture of the Self
Wearable and remote technologies have long been expected to harness untapped potential in cardiovascular health. As Venk Varadan put it to HCPLive®, the expectation since the first generation of devices has been to create a “digital picture” of patients.
“Where we are in 2020 is a [closer movement] to that reality—that wearables are a device, but it really is an enabler of data that produces a digital signature of the body,” Varadan, MBA, CEO and Co-Founder of Nanowear, said.
Even with the pronounced reliance on telemedicine this year, the increasing supply of wearable and remote diagnostics has always been an undercurrent pointing to cardiology’s inevitable future.
Varadan explained that the market for these technologies has long existed, albeit on a more limited scale, and the idea of connected care between physician and patient is a concept that steadily gained traction pre-pandemic.
In addition to their recent approval of SIMPLESense, Varadan and his team also received FDA clearance in 2016 for a related technology called SimpleECG, a cloth-based device that collects heart and respiratory rate data and transfers it to a web-based portal for a physician to review.
Nanowear’s successes speak largely to this carving out of space within cardiovascular care—and healthcare as a whole—that is slowly but steadily becoming even more populated by physicians and patients alike.
The programs of this year’s American Heart Association (AHA) 2020 Scientific Session and the European Society of Cardiology Congress (ESC) 2020 speak for themselves. Specific sessions focused on the clinical effectiveness of wearables, as well as studies on personal ECGs and atrial fibrillation screening.
Hours of discussion dedicated to these topics reflect a growing acknowledgement that these devices can, and should, play a role in aiding healthy and ailing patients.
2020: An Affirmation and an Exposé
In spite of this inexorable march of wearables, the challenges of this year have exposed their limitations just as much as they have underscored their great potential.
On one hand, remote technologies serve to fill this gap within telemedicine practice. Varadan discussed how these technologies may complement video visits and allow physicians to perform the basic vital measurements that would otherwise be impossible.
Furthermore, he suggested that these technologies may effectively bypass “white-coat syndrome.”
“This is important for physicians, because they are making therapeutic determinations based on that blood-pressure reading over 60 seconds that they are taking once a year at your annual physical,” he said. “What if they are talking to you over telehealth for 30 minutes, and they’ve got hundreds of blood pressure calculations over that [time]? That’s a pretty accurate assessment of that one biomarker.”
However, with the promise of accurate and robust datapoints comes the potential for inconsistent data reporting and reading.
In his recent review article, “Guidelines for wrist-worn consumer wearable assessment of heart rate in biobehavioral research,” Benjamin Nelson, PhD, a research specialist in behavioral medicine and mobile, wearable, and smart home technologies at the University of North Carolina, laid out the current shortcomings of these devices—most notably in direct-to-consumer wearables such as Apple Watch and Fitbit.
His article expressed concern regarding the lack of standardization of data collection and processing procedures. It further developed a guideline prototype to assist future studies and, ultimately, clinical care. Yet, such a guideline would only move the needle incrementally towards progress in this domain.
“From what I have seen in the literature, in my own work and others, I don’t think we are quite at the space yet with wearables where they have an accuracy to be the sole medical device that’s driving patient healthcare decisions,” Nelson told HCPLive®.
Nonetheless, he acknowledged that technologies with electrocardiogram devices can be highly accurate, especially when aggregated within a large period of time for a single individual. But he is skeptical of the current validity of data when such technology is used on a basis where more movement is involved.
Varadan echoed Nelson’s sentiment that the future of wearables remains in its infancy; however, he opined that the technology has made great strides in recent months.
Varadan stressed this past year in cardiology has demonstrated the increasing importance of “the right data” over big data. He believes that this increasing demand and desire for more holistic, broad, and multiparameter diagnostics—which go beyond any single measurement—has shaped the trajectory of wearable technologies.
Of course, in a field as robust and data-driven as cardiology, filtering the data generated from these devices into more meaningful, purposeful, and actionable items is the next step in this march towards a full embracing of wearable technologies.
The lockdowns have certainly shone light on the potential of these wearables to enhance remote care, but that same light has revealed a mosaic of cracks that require patching.
So, what next?
There are many questions that will dictate the progress of the wearable market, and its reception within the healthcare industry.
The first is a matter of definition. Of course, wearables may be designed with a particular purpose, for a specific audience, and using a certain technology.
Even more, wearable technologies may refer both to mainstream direct-to-consumer products like Apple Watch and FitBit as well as products with the healthcare industry as the primary consumer, like Nanowear’s SimpleSENSE.
Both types demonstrate a degree of accuracy, and studies in recent years have verified that fact—but as Nelson noted, the vast range of wearables and brands has exacerbated this issue in inconsistency with data collection and utilization.
While he has acknowledged that wrist-worn and direct-to-consumer wearables are considerably limited in their clinical role, he nonetheless expressed a belief that these technologies can further elucidate the cardiovascular psychophysiological processes related to mental and physical outcomes—one of his research focuses.
Varadan himself has expressed doubt that mainstream devices should adopt the same categorical space as the “clinical-grade” wearables.
As it stands, the latter technologies are designed for physician/patient consumers, while direct-to-consumer technologies skew towards a broader, healthier, and more privileged socio-economic base.And yet, FDA Class II clearances span across products in both categories.
There is a potential, then, for clinicians, researchers, and product developers to better understand how mainstream wearables and the clinical-grade products can more productively co-exist and work together for the betterment of health outcomes.
Suffice it to say, then, that 2020 has been a year of growing pains for digital cardiology. With the steady proliferation of wearables in all types of consumers—mainstream or not—and the FDA’s expedited approvals of new technologies comes a stark exposé of its shortcomings, questions, and potential for moving forward.
Varadan was optimistic that this trend towards wearables is here to stay—he suggested it may perhaps become one of the main “chair-legs” of primary care, acute illness, and chronic disease.
Nelson emphasized all of this is still in the early chapters of a grander narrative.
“The past decade there has been a big increase in the importance of wearable devices,” he said. “And I would assume that as we move forward in the coming years—and especially as we move forward in the context of global pandemics, like COVID or next the next pandemic that may happen—wearables will be even more relevant than they are today.”