Fostering the Future of Wearable Biosensors for Congenital Heart Disease

The technology for wearable devices and biosensors continues to improve, enabling companies to incorporate more sensing modalities, says Animesh (Aashoo) Tandon, MD, MS, Vice Chair for Innovation and Director of Cardiovascular Innovation at Cleveland Clinic Children’s. “This is especially relevant in congenital heart disease because we are now seeing medical-grade biosensors being made,” he says.

These novel technologies and their growing medical applicability in pediatric and congenital heart disease prompted a recent science advisory from the American Heart Association to advance this field.

“We wanted to highlight how we can make these technological innovations useful in the next five years in our patient population of children with heart disease and adults with congenital heart disease,” explains Dr. Tandon, who was Vice Chair and lead author of the writing committee.

Some of the currently available wearables include wristwatches that can monitor health measures such as heart rate, oxygen saturation level, number of steps taken and sleep quality. There are also chest-worn sensors used for cardiac electrophysiology, heart rate, movement/step count, and to measure chest vibration. New, noninvasive technologies are being investigated as well, including using light to measure blood glucose.

“There are a number of cool devices out there, but just because we can measure something doesn’t mean we know what it indicates for a specific patient,” Dr. Tandon says. “In this advisory, we were trying to outline what we need to think about, from the clinician and patient perspective specifically, to make sure these technologies are being developed in a way that will actually be meaningful instead of just being a fad.”

Existing challenges

The biggest gap in the current wearables landscape is that there aren’t many technologies made specifically for children, nor are there many designed for people with congenital heart disease. “That means we need to understand what the unique opportunities and challenges are for these patients,” says Dr. Tandon.

A substantial advantage of wearables is that they can give clinicians real-life data collected over extended periods. “We can do a bunch of testing in the hospital or clinic, but what’s going on the other 99.9% of the time that they’re not here?” Dr. Tandon says. However, there are clinical challenges to greater adoption of wearables, including data integration into the electronic health record, as well as making that data actionable.

Several steps are needed to meet these challenges, including designing the right hardware-software combination, as well as a data transmission architecture to bring it into the clinical workflow. “Then we have to do studies to make sure we understand how to interpret that data,” says Dr. Tandon.

He believes performing these studies is the biggest challenge. “A heart rate variability number or a step count number likely means something different for everybody, so it’s even more important to know what it means for that particular patient,” he says. “My guess is that a more powerful approach will be to compare a patient’s data to themselves rather than to a population-level ‘normal value.’”

Ethical considerations

Children and patients with congenital heart disease are underserved by technology “because companies don’t make as much money off them,” says Dr. Tandon. “When we’re talking about health technologies being equitably distributed, we have to make sure that companies are making technology for these populations.”

One ethical consideration the advisory points out is the reality that light-utilizing sensors have significantly reduced accuracy in people with darker skin. Another is that infants may need to wear wrist-worn devices on their thighs due to their small wrist size, meaning that the devices need to be “wearable” for a particular patient.

Digital health literacy is another consideration. “We need to make sure that these technologies are designed so that everybody who needs to be able to use them can use them,” says Dr. Tandon. In the pediatric context, this includes parents, guardians or caretakers.

Additionally, there is the issue of accessibility. For example, if wearable technology is only accessible to families with higher incomes, those with lower incomes will not be able to take advantage of it. “There are a lot of potential ethical challenges in making sure that the technology is accessible to everyone,” Dr. Tandon acknowledges.

Future directions

The most effective way to overcome these challenges and show the utility of wearable devices for congenital heart disease is to continue to perform studies, Dr. Tandon says. As part of Cleveland Clinic Children’s Center for Artificial Intelligence (C4AI), he is involved in one such study that uses wearables to detect low cardiac output syndrome (LCOS) after surgery in congenital heart disease. He is also implementing two studies looking at using wearable biosensors at home for patients with congenital heart disease.

“We are designing and leading studies to help companies realize that they should be making wearable technologies for kids,” says Dr. Tandon. He says the obstacle here is that if many of these companies are consumer-facing, they simply don’t have the same incentives as healthcare professionals do.

Advocating with health insurance companies and health systems for better reimbursement is another step to making wearable technology available for patients with congenital heart disease. “If we change the financial incentives, then companies are more likely to make stuff for kids,” Dr. Tandon says.

There is great promise in wearable technology, and it will become increasingly useful over time as both sensors and the ability to interpret data continue to improve, Dr. Tandon believes. “This technology is here to stay. We just have to do the science to show that it’s useful for everyone and work with companies to make sure that they understand its utility,” he says.