Barriers and Opportunities for Digital Wearables in Heart Failure Management

At the American Heart Association Scientific Sessions 2025 in New Orleans, Biykem Bozkurt, MD, PhD, FACC, discussed the critical need for objective activity monitoring in heart failure care and the challenges that currently limit widespread adoption of digital wearables in clinical practice. She highlighted that symptom assessment tools—such as questionnaires or six-minute walk tests—may be unreliable, biased, or impractical for patients with sedentary lifestyles, whereas wearables provide continuous data that reflect real-world functional capacity changes over time. However, she emphasized significant barriers, including the variability of wearable platforms, lack of clinical validation for outcomes-based coverage, difficulties with integration into electronic health records, and the overwhelming volume of data requiring interpretation. Bozkurt noted that while AI-driven solutions may ultimately support monitoring, further research and implementation strategies are necessary to ensure accuracy, usability, and clinical benefit across health systems.

Pharmacy Times: Given the increasing role of digital health tools, what barriers remain before accelerometry-based endpoints can be validated and adopted for regulatory or clinical decision-making?

Biykem Bozkurt, MD, PhD, FACC: Several barriers. One, there are numerous different platforms for digital wearables: smart watches and apps. I think the competition in this field is also creating noise and, from the consumer’s as well as the patient’s perspective, confusion as to which one is more reliable or validated. There is always the cost as well as the burden that is reflected to the consumer. Most of these currently are at limited coverage levels and thus require validation in a clinical trial setting for better outcomes association for them to be covered.

The other limitation is integration into electronic health records or a patient’s chart, because this data may be present here but will need to be visible both to the patient as well as their caregivers. How to do that? Health system integration with wearables currently requires both understanding of privacy data protection and integration into electronic health records.

The third barrier is the magnitude of data being so large. Who is to monitor and interpret this data is also a challenge. For example, in heart failure, we have implantable monitors that monitor the pressures inside the heart, which generate a large volume of data, and systems are overstretched for assigning clinicians to be able to monitor that data. Yes, one could envision the AI and/or other algorithms being able to detect the differences and alert the patients and the clinicians, but again, until we have these validated, this data—as to who interprets it, who receives it, which gadget, and which combinations of variables or biomarkers—is still a question.

Because, as I mentioned at the beginning, there are smartwatches as well as wearables that look at heart rate, that look at rhythm, irregular heart rate, that look at position, steps, and O₂ saturation. Then there are other wearables, patches that one could put on the chest wall that look at fluid collection inside the chest through impedance. Which one of these is with higher validity and precision, both for prediction of outcomes as well as responsiveness to therapy without a burden, but with integration to the health system, is to be determined.

Pharmacy Times: From a pharmacist or clinician perspective, how can continuous, real-world activity data complement current approaches to monitoring heart failure progression or treatment response?

Bozkurt: As I mentioned in my former responses, the objectivity of activity assessment is truly very valuable for the pharmacist as well as all other clinicians due to the limitations of our other tools. Symptom assessment can be limited, especially for sedentary lifestyles. A 6-minute walk distance requires the individual to be able to ambulate, and the standardization of that over time is potentially challenging. And, of course, there is always an individual bias regarding what people feel that they are doing when you are doing questionnaires such as KCCQ or quality-of-life questionnaires.

So, this adds objectivity, accuracy, sensitivity, and the ability to track people in their regular life context, not just in a hospital setting in only a 15-minute time frame when they are asked to walk. It gives us an idea of what happens at nighttime or during daytime, because in a heart failure patient, they do have these periods when things may be really bad, and then there may be periods when things may be better. So, that snapshot during the clinical time is very limited, and this adds the whole conglomerate of data over a larger period of time, which would add to giving a reflection of overall functional capacity changes over time.