For patients suffering from narrowed or non-opening aortic valves, transcatheter aortic valve replacement (TAVR) is an option. Patients with aortic regurgitation are fitted with a new valve through a catheter inserted in their leg or chest and guided to the heart, where it is inserted into the diseased aortic valve.

For a long time, cardiology has been a specialty known for its openness to new ideas and rapid adoption of medical breakthroughs that have been the result of extensive research. It’s no surprise that people with chronic cardiovascular diseases like congestive heart failure (HF), coronary artery disease (CAD), and peripheral vascular disease (PVD) are interested in exploring digital devices and wearable technology.

Individual physiologic data can be transmitted to sophisticated computer platforms armed with complex algorithms by wearables and sensors that have been developed in recent years. Individual data can be placed in the context of data from thousands or even millions of patients thanks to advanced computational science capabilities, such as artificial intelligence and prediction analysis.

Precision medicine and risk stratification for public health is now possible thanks to the development of a big data predictive model. There has been an increase in the use of mHealth, a subcategory of eHealth that makes use of mobile and wireless technology, as a way to support the growing field of digital health for cardiovascular diseases.

From 2011 to 2018, disease management appeared to be the primary focus of digital health firms. Predicting disease earlier, including detection and prevention, has become more important recently.

The first question to ask is, “Why now?” What’s the big deal about this issue?

There is a lot of interest in the field of cardiology from a variety of stakeholders long before adoption begins at the practice or doctoral level. Medical professionals would be wise to take notice if innovators, investors, policymakers, and payers all paid attention.

In the last decade, there has been an explosion of interest in digital health across the health care spectrum.

Since the FDA launched its new expedited pathways for digital device approval, venture capital funds have invested billions of dollars, launching thousands of new digital health startups that focus on every aspect of the patient and provider health journey.

A solid economic foundation for digital health ventures, which will no doubt be of great interest in 2021 and beyond, has been laid by the CMS, which began paying for remote physiologic monitoring (RPM) in 2019. In 2020, this decision was expanded even further.

In the year 2020, the results of the COVID-19 study will have profound effects on the way health care is delivered nationwide. The desire of patients to avoid unnecessary exposure to the novel coronavirus, as well as the desire to reduce travel costs and avoid long waits while increasing communication with clinicians, sparked the development of innovative care solutions.

For starters, fewer doctor-patient encounters have led to a greater demand for remote services and telemedicine. Compared to January 2019, telemedicine adoption is expected to rise from 50 to 175 times in the next two years.

In addition, CMS waivers for specific telehealth regulations have significantly boosted the increase.

It is imperative that vital signs and other physiologic measurements that are difficult to obtain via remote interactions be improved and facilitated in light of this newly accepted form of doctor-patient communication.

That’s where wearable medical devices and platform solutions come into play.

What gadgets should I keep in mind?

There has been a massive increase in the number of wearable devices over the last five years. Fitness trackers, digital blood pressure cuffs, weight scales, and arrhythmia monitoring systems are all examples of cardiology-related wearable devices. Some are connected to a proprietary mobile app, while others are part of a digital solution that facilitates communication between patients and healthcare providers via a digital platform.

The FDA has not approved many devices that are sold directly to consumers. There is an emphasis on reliable devices with accurate data confirmed through rigorous FDA approval because many are not considered medical grade (but are widely popular).

Some basic parameters should be present from the clinician’s point of view when considering the adoption of physiologic monitoring devices. If so, what is the platform that the monitoring device is part of? What about disease-based physiologic measurements like blood pressure cuffs, body mass index (BMI), or oxygen sensors for congestive heart failure?

The digital device must be used with a proprietary application (app) if it wants to measure a single parameter without being integrated into a larger EHR system or another device.

Wearable devices and systems currently on the market include:.

The ZioPatch from iRhythm Technologies; CAM patch from Bardy Diagnostics; Bioflux monitor by Biotricity, and so on.

It is possible to detect atrial fibrillation (AFib) with wristwatch devices like Apple Watch and Livmor Halo+ System and smartphone apps such as Pulse-Smart and Kardia Mobile and ECG Check, among many others

Heart rate, respiratory rate, SpO2, accelerometers (walk speed), heart rate variability, and skin temperature are just a few of the sensors that can be used to track one’s physiological state.

These remote monitoring systems for cardiovascular-focused conditions like those from IntelliJ, Biofourmis, CareMindr, Current Health, and Hello Heart among others provide actionable data to stratify patient information and inform clinicians in real time.

Clinicians using digital stethoscopes like the Coala and EKO can improve the quality of their telemedicine visits by using digital stethoscopes like these. Smart socks developed by Siren Care can detect temperature changes in the lower extremities before they become clinically evident, which is particularly useful for patients with vascular disease.

Patients and your practice’s processes demand that all of these devices and the platforms or apps they run on be tailored to your specific needs.

Is there a device out there that is best suited for each individual patient? If you have congestive heart failure, you should monitor your condition with an IntelliH blood pressure cuff, a Vivify Health O2 sensor, and a weight scale.

FDA-approved solution platforms should be used for AFib detection in order to reduce false alarms, which can cause patients to be confused.

If you have an asymptomatic patient, you can use the Livermore Halo system or a short-term monitor patch like iRhythm to keep an eye on your heartbeat, but you’ll still need a clinician to determine the best course of action for your individual situation.

What should I do with all this information?

Heart Magazine Cover Photo

With an ageing population comes an increased risk of developing a chronic illness. As in other business sectors like banking and commerce, younger, tech-savvy generations are turning to mobile and remote devices to interact with the health care system.

In addition, improved wireless connections and the introduction of 5G technology for cellular connections enable patients and providers to share large amounts of data almost instantly.

Patients at risk are proactively identified through more frequent physiological monitoring devices, such as wearables and other devices, using this real-time information exchange.

Many systems have adopted color-coded alerts in their interface to distinguish between high and low levels of data such as blood pressure and oxygen saturation. These alerts are the best way to ensure that medical assistants, nurse practitioners, and physicians are all aware of any abnormalities in the patient’s vital signs.

I have found that large panels of patients followed by RPM can effectively deal with a significant amount of data when using this set up.

  1. Is digital health a cost-effective method of improving health outcomes?

It is possible to determine the impact of digital health on the cost of treatment in cardiology using various methods, including direct and indirect methods of analysis. Decision analytic health technology is one widely accepted model.

An intervention’s impact can often be gauged by looking at its cost-effectiveness and the incremental cost per additional year of quality life-adjusted life (QALY). HF and stroke are two of the more common topics of research in this area.

Many digital interventions are delivered via telehealth and telemedicine, including massage services, phone support, mobile apps, video conferencing, wearable medical devices, as well as remote monitoring of physiologic functions.

Data from the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) in patients with severe HF provides some information on the effect of the collaboration between general practitioners and an HF clinic on mortality and hospitalization rates.

Telemonitoring patients had lower all-cause mortality, fewer follow-up days lost to hospitalization, dialysis, or death, and fewer HF hospitalizations per patient compared to the usual care group (p=0.01), according to a study published in the Journal of the American College of Cardiology (JACC).

Since then, a growing number of outcomes trials have shown that remote monitoring for chronic disease can both improve patient care and lower overall healthcare costs.

How are these wearable devices going to be funded?

Heart Magazine Cover Photo

Manatt has given us permission to use their work here. For a closer look, click on the image above.

The inevitable question is, of course, who will foot the bill. Since January 2019, Medicare and commercial payers have agreed to pay RPMs using CPT codes.

In 2020, CMS announced that the agency would pay for several new CPT codes that would not only reimburse providers for various types of care they may already provide, but also open up new potential revenue streams to help ease the transition to value-based care.

In an episode of care and patient education, code 99453 covers the set-up of devices, while code 99454 covers the cost of the device(s) with daily recording(s) or pre-programmed alert(s). To qualify for reimbursement, a patient must be given a device as defined by the Food and Drug Administration (FDA).

In 2021, CMS may narrow the scope of the device definition, but for the time being, it is as broad as it can be. Patients and caregivers can expect to pay for the first 20 minutes each calendar month for RPM treatment management services provided by qualified healthcare professionals, such as clinical staff, physicians, or other qualified healthcare providers.

CPT code 99458 was first reimbursed by CMS on January 1st of 2020. Each additional 20 minutes (per calendar month) of treatment management services are now covered by the new code. Also starting on January 1, 2020, CMS has designated CPT codes 99457 and 99458 as care management services, which means that they can be provided under general rather than direct supervision of the billing provider.

There is no need for a physician or other qualified health care professional to be physically present at the same location as the clinical staff providing RPM services.

Conclusion

Cardiologists no longer face significant challenges in implementing remote monitoring and digital health. There are now solutions to the concerns about increased workload and lack of workflow integration crippling cardiology practise efficiencies due to increased data volumes.

Patients’ concerns about their health information’s privacy can be alleviated using secure portals; doctors and patients can better understand how to support research that proves quality of care through data and science by using remote monitoring devices.

There is no doubt that the future of cardiology and cardiovascular care will include wearable devices, remote monitoring, machine learning, artificial intelligence, and algorithms for risk stratification of patients as the health care system shifts from fee-for-service to a more value-based method. And the digital revolution in cardiology will only begin in earnest in 2021.