Corsano Health: continuous monitoring with the CardioWatch
This is a translation of an article that was originally published on https://smarthealth.live/?on March 24, 2022, written by Sebas Eikholt
Smart wearables provide a wealth of health data. But consumer smartwatches and fitness trackers are not easily usable for application in the medical world. Dutch company Corsano Health developed the CardioWatch, which continuously measures patients' vital parameters. Several academic hospitals are using the watch for scientific research. In conversation with Raúl Bennis, Medical Business Development Manager at Corsano Health, about the need from the medical world to work with raw and reliable data.
The number of patients with cardiovascular diseases is increasing rapidly. Figures from the Heart Foundation show that the Netherlands has 1.5 million chronic cardiovascular patients. The non-profit organization expects this number to increase by 33 percent in ten years. So the call is greater than ever for devices that can determine heart rate, heart rate variability and atrial fibrillation with high accuracy. By monitoring that cardiovascular risk patient population, physicians hope to prevent exacerbation of symptoms and to preemptively deploy medication or treatments.
High blood pressure, sleep apnea and atrial fibrillation (AF) are considered major risk factors in these conditions. According to Corsano Health, untreated atrial fibrillation doubles the risk of heart-related deaths. It is also associated with a fivefold increased risk of stroke.
Telemetric surveillance
Monitoring and data collection on heart rate, heart rate variability and atrial fibrillation, among other things, are therefore important. A number of methods exist for this purpose.
One of the current methods is to monitor patients with telemetric monitoring. This involves effectively monitoring a patient during a hospital stay, based on an electrocardiogram (ECG), or heart monitor. However, telemetric monitoring has a number of disadvantages. This method is only applicable to patients who are staying in the hospital. Patients are hooked up to wires and restricted in their activity. ECG recordings from telemetry can be uploaded to the electronic patient record, but this usually does not apply to the raw data itself, such as heart rate. As a result, there is a delay between the time of measurement and the time to use the data for diagnosis or treatment.
Holter study
An alternative way to monitor the heart rhythm is through a holter examination, which takes one to several days. In a holter examination, the patient is given wires with sensors attached, wears a device on the body and leaves for home. This way, the heart rate is recorded continuously, while you can go about your daily activities at home.
Nevertheless, patients also experience obstacles here. The sensors may start to shift, or produce a skin reaction or feeling of discomfort. Those obstructions can reduce correct readings, reducing compliance. And that's especially detrimental. Studies show that monitoring longer than 14 days is desirable for the detection of atrial fibrillation (AF) in patients undergoing ambulatory external ECG monitoring. The first occurrence of AF is frequently missed during shorter monitoring. There are also long waiting lists for Holter monitoring, and the cost structure of the current technique leads to a strain on the healthcare system.
CardioWatch
Raúl Bennis is Medical Business Development Manager at Corsano Health and explains why the CardioWatch is a better alternative to the previously mentioned methods for monitoring heart rhythm in patients. "The Corsano CardioWatch 287 bracelet is the first device of its kind to accurately and continuously measure heart rhythm in the form of an easy-to-use application. The name suggests that this is a product within cardiology, but the CardioWatch can be used much more widely. The device can be used for intramural and extramural monitoring, for example also for patient groups within oncology or geriatrics," says Bennis.
The CardioWatch contains a PPG sensor, a technology that is also used in more and more fitness trackers and smartwatches to measure heart rate. The PPG sensor Corsano developed measures fluctuations in the light that arteries reflect into subcutaneous tissue. In doing so, it identifies heart rate variability and possible arrhythmias. That heart rhythm is analyzed, to detect atrial fibrillation. Atrial fibrillation, also known as atrial fibrillation, is the most common cardiac arrhythmia. In addition to the PPG sensor, the wearable also contains an accelerometer to measure the user's physical activity.
Background in Swiss watch industry
Of particular note is the focus on the design, quality, usability and functionality of the CardioWatch. The founders of Corsano Health have years of experience in the Swiss watch industry. "They know the importance of an ergonomic and aesthetic design, so that users enjoy wearing the bracelet 24/7. The CardioWatch is small, light and sits comfortably. In this way, it does not form any obstacle in their daily lives. As a result, we notice a high level of compliance and patients are satisfied with the wearable," said Bennis.
"Researchers and clinicians set up which parameters they want to record and examine through the app"
The rechargeable battery in the wearable lasts seven to fifteen days. The battery life can be even longer when not all parameters are on. On average, users charge the wearable only once a week. "The lack of a screen makes for a longer battery life. That was a deliberate choice. A screen makes the bracelet bigger, more expensive, more fragile and heavier," says Bennis. "Plus, a screen or interface with associated data is not always easy to understand with older patients. There is a risk that patients will start interpreting the medical data themselves, and we want to avoid that: it is precisely the researcher or the doctor who can interpret the data and give feedback to the patient."
In the accompanying app, however, a user can retrieve basic health information. The wearable originated as a research tool, with comfort and wearability as a starting point. Bennis: "The most important feature is that the accurately measured data from the CardioWatch goes to the cloud, securely. Researchers and clinicians can set which parameters they want to examine in the app, though."
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Clinical validation and reliability
Corsano Health works closely with cardiologists, scientists, hospitals, patients and research organizations. There are now six independent clinical validations to the CardioWatch, and as of November 2021, it has obtained EU MDR certification as a medical device.
Bennis: "To ensure clinical accuracy, we use algorithms from ourselves and from partners. This allows us to achieve data accuracy. Our technology has been clinically validated in major teaching hospitals at home and abroad. In addition to existing ISO 13485 and CE-MDR compliance, we have also started the process of FDA approval, which is required for the U.S. market."
Domestic and foreign clinical studies showed that the CardioWatch 287 could determine heart rate and heart rate variability (R-R interval) with high accuracy in a cardiovascular risk patient population. These studies compared ECG measurements with the PPG technology contained in the CardioWatch. Other vital signs that the CardioWatch monitors in real time were also clinically validated, including the user's respiratory rate, skin temperature, activity and sleep quality.
"To ensure clinical accuracy, we use proprietary algorithms"
Access to raw data
Major applications for the CardioWatch include clinical trials within hospitals, academic centers and university clinics. Clinicians and researchers can access all the raw, continuous high-frequency data collected by the wearable. Through Corsano's cloud platform, and APIs, that data can be used for research.
Bennis: "The heart rate and motion data - the PPG (photoplethysmogram) and ACC (accelerometer) data - are available in our research web portal. What is special is that we are one of the few companies to offer raw raw data with a data frequency of both 25, 32 and 128 Hz. Researchers and physicians are often amazed by this capability, which adds a lot of value for medical research."
Thanks to partners, Corsano Health supports hospitals with additional technology. "For example, we provide a link between the research platform and the hospital's electronic health record. We can also hang gateways in the department that pick up the Bluetooth signals from the wearable and put them into the system. Our Swiss partner Leitwert is helping with this. This enables academic research centers and research organizations to continuously monitor vital signs of subjects. Researchers can thus conduct large-scale clinical studies."
Cardiac arrest without witnesses
In addition to research, prevention is also a spearhead, now and in the future. The Dutch Heart Foundation recently chose RadboudMC and Corsano Health to develop smart watches. These are smartwatches that can detect cardiac arrest and alert the emergency services. Non-invasive, ergonomic wearables such as those offered by Corsano Health can contribute to this.
Since November 2021, the company has been participating in the Cardiac Arrest without Witnesses project, which is funded by the Dutch Heart Foundation. According to the non-profit organization, there are some 17,000 out-of-hospital cardiac arrests each year. In six out of 10 cases, no one else is present. Adequate assistance within 6 minutes is required.
This is important because many people who suffer cardiac arrest outside the hospital have no witnesses. And calling 112 is then not possible. These kinds of technological solutions can save lives in that case. That is why the Dutch Heart Foundation wants to use a newly developed version of the CardioWatch for the early detection of a cardiac arrest and the immediate alerting of the emergency services. The Radboudumc is leading the research and in addition to Corsano Health, the Reinier de Graaf Gasthuis, Erasmus MC, UMC, AMC and Isala are also participating.
Also measure blood pressure, oxygen saturation and stress
At the Corsano Health office, the team is now working on a new version of the smartwatch, which is expected to be certified in the third quarter of this year. This version also includes an ECG measurement and stress management technology. In addition, the wearable is capable of monitoring blood pressure, oxygen saturation (SpO2) and core body temperature in patients. This opens up even more possibilities for researchers and clinicians.
Corsano Health's CardioWatch 287 is currently being used in several clinical trials, with the goal of further validating its functionality. The company has set up a research page for researchers and clinicians. This lists the current studies and previously published scientific publications. Interested parties can also register here to participate in a clinical trial.