In this feature interview, EP Lab Digest speaks with Avi Fischer, MD, FACC, FHRS, Medical Director (CRM) and Divisional Vice President, Medical Affairs, about the Confirm Rx™ Insertable Cardiac Monitor (ICM) from Abbott.
How do you see the increased use of ICM affecting cardiac monitoring as a whole?
ICMs have been commercially available for many years, so in some ways, the ICM is not a new concept. The candidate patient population is fairly broad, and includes patients with suspected arrhythmias or those at risk of developing arrhythmias. ICMs are used for conditions such as unexplained syncope, palpitations, atrial fibrillation, and cryptogenic stroke. Technological advances have enabled industry to develop smaller forms of these implantable monitors and use available communication schemes to change the landscape of ICM use. The miniaturization of the devices, along with the ability to rapidly and remotely obtain patient data, has been a revolution. We are now at a point in time where devices are tiny, the implant procedures take minutes and can be done in the outpatient/office setting, and data can be transmitted using Bluetooth/Wi-Fi. An app (myMerlin™ mobile app, Abbott) on a patient’s smartphone or handheld device is available for both iOS and Android devices for use with the ICM. There is little doubt that these features, along with the future incorporation of other biologic sensors, are increasing the adoption and use of these technologies in medicine.
How does this product change ICM for doctors and their patients?
For the first time, we have an implantable device that directly engages the patient using their own handheld/smartphone, via a very simple and intuitive app created specifically for this device. A patient can use the handheld device (their own smartphone) to record and transmit events, episodes, and symptoms to their healthcare provider. Patients also know immediately that the recording and transmission have occurred. Importantly, this new approach enables the patient to verify and view past transmissions, including recorded symptoms and symptom history, and reduces unnecessary inquiries to confirm successful data transfers. This is extremely important to ensure peace of mind for patients, as they know that the event has been recorded and sent to their healthcare professional. Patients will no longer need to search their purse, backpack, or pockets for a separate transmitter or recording device, or worry if their episode was recorded and sent — these simple issues can have major consequences for patients. There is also a built-in “demo” feature on the app so that in advance of the Confirm Rx™ ICM implant, the patient can begin to use and appreciate the smartphone connectivity and workflow associated with the device.
From the doctor’s perspective, the ability to use the implantable device with a high degree of compliance makes this particular device attractive, and the acquisition of data has also been made simple. The device allows for immediate pairing with the handheld and use of the app begins immediately after implant even before the patient goes home. There is no uncertainty about how to use the system once the patient leaves the doctor’s office or hospital. The feedback that we have received from doctors and patients around the world who have used this device has been uniformly positive.
How is this product different from the loop recorders that have already been in use?
The most apparent and important difference is the size of the device and the communication scheme. The algorithms used for detection of arrhythmias are based on predicate devices and are relatively unchanged from previous versions of our ICM. The most apparent difference is the miniaturization of the device and the use of Bluetooth Low Energy (BLE), along with a smartphone app as a means for communication and data transmission. These features, along with the patient engagement to a degree that has not been done before with a device of this type, make the Confirm Rx™ ICM device unique. Using this approach, we now provide a means for patients to send patient-triggered symptoms to the clinic without the need to wait for the nightly sync, as with other systems. When needed, the system also provides patients with gentle, automatic notifications when patients miss device checks or scheduled transmissions, saving follow-up burden for clinic staff.
When developing the technology, we interviewed both physicians and patients to identify the unmet needs with the current generation of ICMs. The insertion procedure has been further simplified, making the implant quite painless and rapid. On the patient side, we obtained feedback from a broad group of patients, including elderly patients, to ensure that the technology would not be limited to just the young and “tech-savvy” generation. In a nutshell, we designed an app that is automatic and designed for use across all indications and patient demographics. It is also translated into 37 different languages for convenience and global use.
How would you describe the insertion procedure for the Confirm Rx™ ICM?
The implant procedure has been streamlined and simplified. It is performed using a very small amount of local anesthesia, and takes only a few minutes. We have developed a very simple, easy to use, and intuitive implant system. Again, the miniaturization of the device has been important in allowing for the procedure to be simple, quick, and painless (for both the patient and the doctor). Once implanted, connectivity can be demonstrated and education about the device for the patient and family can occur immediately. The device can be used immediately with the smartphone app, with confirmation of function and connectivity prior to the patient going home.
The main change here is the inclusion of Bluetooth capabilities. How does this impact the cardiac monitoring of patients?
BLE communication allows for the integration of a smartphone app as well as the use of a patient’s smartphone for data acquisition and transmission. Patient-triggered symptoms can be transmitted immediately to the clinic without the need to wait for the nightly sync required with other ICMs currently available.
From a data security perspective, this is more secure than other forms of data communication. We have worked with third-party experts to ensure that the security of the data is state of the art and similar to that used when performing online banking and other transactions via an app and smartphone. The widespread availability and use of smartphones, along with the easy-to-use app, has been very well received, and we believe it will impact patient compliance and patients’ overall quality of life.
What are some of the advantages for remote follow-up with Bluetooth?
One of the most apparent advantages of this system is the all-in-one integrated transmitter and symptom recorder, functional via the myMerlin™ mobile app. This eliminates the need for a traditional radiofrequency-based bedside transmitter, which can be intrusive and cumbersome for patients and limits their mobility. The app automatically connects with the device via BLE wireless technology, informing patients of successful device checks and clinic-scheduled transmissions, without the requirement of additional equipment or an interruption in their daily lives. Quite simply, the Confirm Rx™ ICM offers convenient, connected, and continuous monitoring.
Perhaps equally important is the level of security associated with use of Bluetooth as a means for data communication. Similar to banking, credit card purchases, and other secure transactions that are now commonplace with app-based technology, Bluetooth has become the standard secure means of data transfer with handheld devices.
Describe the monitoring app, and how that interacts with the monitor.
When BLE and Wi-Fi are enabled on a patient’s smartphone, the device continuously monitors the patient’s heart rhythm. If and when arrhythmias are detected, the episodes are automatically recorded and timestamped, and the electrograms (EGMs) are transmitted to the Merlin.net™ remote monitoring database and sent to the patient’s healthcare provider. Episodes are then available for review, and communication can occur between the healthcare professional and patients as needed. In the event that a patient has symptoms, a patient-triggered event can take place. The app allows for identification of symptoms from a dropdown menu, and timestamped EGMs that are linked to symptoms are sent via Wi-Fi to the Merlin.net™ server and made available to the healthcare professional.
In what ways can the app enhance patient compliance?
We believe that there is great value in enabling a patient to verify and view past transmissions, including recorded symptoms and symptom history. This reduces unnecessary patient inquiries to ensure successful data transfers. The app also allows patients to send patient-triggered symptoms to the clinic without the need to wait for a nightly sync with a traditional transmitter. Through the provision of gentle, automatic notifications when patients miss device checks or scheduled transmissions, one saves time, decreases the follow-up burden for clinic staff, and increases patient compliance.
How does this improve the doctor/patient relationship?
Features such as continuous monitoring, automatic as well as symptom-driven events that are rapidly sent to a healthcare professional, and verification of the transmission to the healthcare professional, provides a degree of comfort for patients. Patients know that their healthcare professional is rapidly made aware of events after they occur and that they are always “under the care” of their healthcare professional.
In terms of accuracy, how effective is the Confirm Rx™ ICM in regards to detecting AFib and other arrhythmias?
The Confirm Rx™ ICM device is based on the predicate Confirm™ ICM, so we have a lot of data on the ability of this device to accurately detect both bradyarrhythmias and tachyarrhythmias. As is the case with every product we develop, we always look for ways to enhance and improve our products, and our efforts continue in this regard with the Confirm Rx™ ICM device. This device remains the world’s first and only smartphone-enabled ICM, and we will continue to look for ways to improve the device, as well as the patient and doctors’ experience when using it.
Do ICMs improve clinical workflow?
ICMs themselves may not necessarily improve clinical workflow. The effect on workflow relates to patient compliance, automatic and continuous monitoring, and the streamlined approach made possible with the Confirm Rx™ ICM device.
How does the Confirm Rx™ ICM facilitate better patient management?
The continuous, convenient, and easy-to-use app-based connectivity make this device attractive to patients and healthcare professionals. App-based reminders add to the ease of use and compliance, which translates into better patient management.
The obvious goal is to improve patient outcomes. What do patients gain through this technology vs other monitors?
The advantage of this monitor versus others is that the device is small, the battery lasts for years, the device communicates continuously with the easy to use and intuitive smartphone-based app, and data is transmitted immediately to healthcare professionals. Troubleshooting, reminders, and symptom-driven transmissions can occur seamlessly, and the immediate feedback to the patient about the data transfer instills confidence in patients and healthcare professionals.
Disclosure: Dr. Fischer reports that he is a paid full-time employee of Abbott.
This article is published with support from Abbott.