Personal wellness devices are becoming increasingly popular among consumers for monitoring their heart rate and electrocardiogram (ECG) readings.
While these devices offer several benefits, they also come with some drawbacks, and may not be the ideal solution for those individuals who have been previously treated for, or who are at-risk for developing atrial fibrillation (AFib). The purpose of this article is to compare the differences between a consumer-based ECG device and medical-grade, FDA-cleared device, and allow you to be the judge for whether ECG data from a smartwatch is suitable for you.
What is Atrial Fibrillation?
AFib is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. According to the American Heart Association, AFib can happen a few times a year or as often as every day. As many as one-third of patients who are diagnosed with Afib, never experienced related symptoms. It often becomes a permanent condition that needs regular treatment.
According to the CDC, over 6 million Americans suffer from AFib each year, with this number expected to double by 2030. Research indicates the global electrocardiogram (ECG) market is projected to reach $18 billion by 2030, growing at a compound annual growth rate of 8.3% (from $8 billion in 2020).
ECG Data from a Smartwatch: Understanding the Basics of Leads
Personal, consumer-based ECG devices like a smartwatch, may track or monitor your heart rate, but may lack the accuracy needed for AFib detection, which is a critical component to those at risk-for AFib. There are different types of readings for ECG equipment and devices, from 12-lead to single-lead. An ECG lead can be thought of as a representation of the electrical activity or signal that is conducted between two or more electrodes (sensors) that make contact with the body. A 12-lead ECG provides a more comprehensive evaluation of the heart’s electrical activity and is most commonly used within the hospital or health provider’s office. A single-lead (or single channel) has two electrodes to detect a single ECG signal. Handheld ECG devices are commonly known as single-lead ECG devices, where the thumbs or wrist are the points of contact for the sensors.
Consumer-Based Wearable Data
Hypothetically, let’s say you have purchased a smartwatch, or sporty, wearable device for the wrist to help improve your personal health. Most of these wearables require a smartphone to pair or sync with the device to fully reap all the benefits. Within the smartphones are apps that include features for monitoring your daily and weekly wellness, such as hydration and calorie trackers, sleep patterns, and the number of daily steps. The apps can track your activity over long periods of time, which presents trends and a broader view of your progress, or lack of progress in some cases.
Many of the personal wearables also provide heart rate monitoring and can produce ECG readings that transfer to the app on your smartphone. While many of these devices state that they can “detect” AFib, smartwatch devices have as low as 70% accuracy. While personal consumer-based ECG devices can give a wealth of information, they cannot diagnose AFib. If a consumer receives a message from their smartwatch that their heart rhythm is indeed irregular, then what?
A user will need to capture or save the data as a pdf file, connect to their email application, then email or “share” with their doctor. This also requires the doctor to monitor their email inbox and recognize if there’s urgency to the message, view the message, download the pdf, then analyze the data. A patient would likely call their physician as well, alerting them of the email and concern for their well-being. This is a lot to ask of a user in a high-stress scenario, and not realistic for a timely patient-to-provider workflow.
Medical-Grade ECG Device Data
There are a few options for handheld devices on the market that provide a more accurate reading, with more in-depth analysis than a consumer-based wearable. For some of the devices, readings are, again, sent to an app on the consumer’s smartphone (which requires a recent version of smartphone and updates software) using a Wi-Fi connection. These devices are often FDA-cleared and in some cases provide in-app messaging for communicating to a crowdsourced group of cardiologists to review your data for anything alarming. It’s still up to the user to make sure their data is sent and delivered to their personal care provider.
The primary advantages to choosing a medical-grade device is the quality of data, connectivity, and the interoperability within the healthcare provider’s workflow.
Eliminating the Need for a Smartphone
According to Pew Research, roughly a quarter of Americans who earn less than $30,000 a year don’t own a smartphone. Even more compelling, for individuals over the age of 65, only 61% own a smartphone.
The HomECG+ solution from Lohman Technologies has embedded cellular technology which eliminates the need for patients to sync with a smartphone or manage complex apps or to navigate local Wi-Fi networks. This device helps close the health equity gap by providing access to care for all patient types, including rural health, underserved populations, geographic disparities, and low-income populations.
Choosing the Right ECG Device
The first question to ask yourself is, are you looking for an ECG monitoring device or are you looking for an AFib detection device? This is a critical question for obtaining the right device for the right patient scenario.
Consider these three factors when choosing the right device:
ACCURACY: How accurate is the data which provides both the provider and patient the confidence with treatment and future readings?
SPEED: How quickly can the patient take a reading and send it to the provider to analyze?
TIMING: How close to the time of the AFib detection can the provider take action for treatment?
The HomECG+ solution is an example of an FDA-cleared, medical grade device which serves both the provider and the patient. The device checks all the boxes of speed, accuracy, and timing. The HomECG+ is a complete solution, designed for its ease-of-use, simplicity, embedded cellular connectivity, and integration capabilities. The algorithm used to detect AFib is 94.6% accurate and produces medical-grade ECG tracings. Two of the largest obstacles for patients capturing data (the need for a smartphone) and how quickly their providers receive that data (no direct connection) are eliminated by the HomECG+ design.
Integrating Directly to the Provider
Integration into the provider’s existing systems eliminates the need for the provider to check their email or rely on the patient to capture and send their data. Once a patient takes a reading with the HomECG+ device, within minutes the data is sent directly to their care provider. The data then resides within their EHR (electronic medical records) or RPM (remote patient monitoring) platform. This eliminates the uncertainty for the patient for when or how the provider is receiving their ECG data. Moreover, this allows for the required documentation needed for timely reimbursements.
How to Purchase the HomECG+
The HomECG+ solution is a provider-based solution. If you are among the millions of patients who are at-risk for developing AFib, make your healthcare provider aware of HomECG+ or contact us through our website and our team can help introduce the HomECG+ solution to your healthcare provider. If you’re a healthcare provider, please reach out to our integration team through our website here https://www.homecg.com .
For more information about the HomECG+ solution, click here.