Technological advancements such as portability, advanced AI algorithms, advanced reporting novel electrodes and sensors, and smartphone integration is expected to contribute to growth.
There is a shift occurring in remote ECG monitoring technology used in Holters and cardiac event recorders that may help speed or enhance the diagnosis of arrhythmias. As already seen in business and consumer information technologies, there has been a revolution in recent years for how much and how fast digital data can be transmitted wirelessly. Data storage also has greatly expanded and the costs have significantly dropped. Lastly, complex software algorithms can now sort through large volumes of data to pull out specific, useful information to greatly reduce the amount of time it would take to review it manually. These components have come together in cardiac monitoring devices to enable real-time, 24/7 monitoring on all data. The future standard of care will likely be online, real-time monitoring combined with smart algorithms or artificial intelligence.
Previously, most devices only recorded segments of data during events, or when the patient initiated recording on a device. Holters only recorded data over a couple days at most. In both cases, these devices had to be brought back to the doctor by the patient and the data downloaded and analyzed by a doctor. If no cardiac events occurred during the recording period, or were not symptomatic so the patient did not initiate recording, no diagnosis could be made. Additionally, most of these systems only recorded a snapshot of cardiac activity and did not offer a complete picture of what was going on with the patient’s heart. Even if an event is recorded, many conditions cannot be diagnosed based on one ECG from a short-term event. Accurate diagnosis may require longer-term monitoring over days or weeks.
Today’s new generation of remote ECG monitoring technologies now enables 24/7 data recording. Some systems also enable real-time, wireless data analysis, which offers advantages over the old process of reviewing recorded data after a patient turns in a device.
Recording all cardiac data 24/7 enables a complete picture of the patient’s cardiac activity to establish a better diagnosis, rather than depending on a small sampling of short duration recording strips. Some intermittent smaller events that might not be recorded can be a sign of underlying disease and can be missed with only a small snapshot of recordings. Vendors offering continuous recording monitors refer to the increased diagnostic yield of having the additional data.
For monitoring systems that use more advanced algorithms, this additional data from continuous recording enables better statistical analysis. This might include recording the complete number of heart beats, the patient’s average heart rate and the number of minor and significant events over a given time period to calculate better, quantifiable assessments. The comparison in statistical accuracy can be made with clinical trials that only have 50 patients, as opposed to the same trial powered with 10,000 patients.
Constant Holter recording over one or two days offers detailed data, but the limitation is the duration of the data collection. A large number of clinically significant, symptomatic arrhythmias are recorded after the first 48 hours of monitoring, beyond the typical wear period for Holter monitors. This has led to the creation of longer term monitoring solutions.
Real-time 24/7 recording. A differentiation needs to be made between systems offering continuous recording and continuous monitoring. If a system does not have a way to wirelessly connect to the monitoring company, clinicians will not be notified of any critical events. Also, if enough data is collected to make a diagnosis, the patient can be notified to come back to the doctor’s office for consultation, rather than waiting days or weeks for a future schedule appointment. This can speed patient therapy and potentially cut the time needed to monitor patients. Systems offer real-time 24/7 monitoring, constantly recording and sending data to a third-party service. The monitoring service system software watches for and flags significant cardiac events, and can alert clinicians via e-mail. The patient’s data is also accessible at any time by doctors through a web connection. Recent remote cardiac rhythm monitors offer mobile cardiac telemetry, cellular event, and Holter functionality. They can be used for up to 30 days of continuous monitoring. They use Wi-Fi or cellular remote wireless access to enable immediate transmission of arrhythmia events. The monitors use data analysis software that enables event triage. The system auto-triggers and auto-transmits any significant events.
Advanced AI algorithms are now entering the market. AI will operate in the background of the monitoring software, constantly reviewing real-time streamed patient data, or quickly reviewing days or weeks of recorded data in seconds. This will likely be a big help in triaging cardiac events. However, AI is not a perfect one-size-fits-all solution. AI might be extremely helpful, but physicians need to understand its limitations. Also, not all patients have the exact same clinical presentations that neatly fit into pre-defined software grading categories.
Consider battery duration. One of biggest limiting factors with newer generation, continuous monitoring systems is battery life. While a device can record continuous data for long periods, vendors do not usually advertise the fact that the device’s battery needs to be changed out after just a few days of operation.
Recently, vendors have developed systems that can operate up to 72 hours on a single AAA battery. Some systems can operate for 7 days before the patient needs plug into power for its built-in rechargeable battery.
Another thing to think about when evaluating these devices is how many components are required. A single device that records and transmits data is ideal because it simplifies patient use/compliance and maintenance.
The increase in cardiovascular diseases has a direct impact on demand for ECG devices. The opportunity and concerns lie in the estimate made by WHO that 23.3 million people may die from cardiovascular disorders by the end of 2030. This forecast is expected to be a major propelling factor in the cardiac assist devices market, in the coming years. India, which has high geriatric population, is expected to show a major increase in demand with the geriatric population being more susceptible to cardiac diseases. In addition, technological advancements of ECG devices such as their portability, novel electrodes and sensors, and smartphone integration is expected to contribute to market growth. Emergence of novel ECG devices such as handheld ECG devices and ECG devices integrated with AI systems will be key drivers.