Khaldoun Tarakji, MD, MPH, Associate Section Head of Electrophysiology at the Heart and Vascular Institute at the Cleveland Clinic, talks about how direct pacemaker monitoring via smartphone enables high rates of transmission success.
Can you explain how the remote monitoring works?
Dr. Tarakji: Millions of people are living with pacemakers or defibrillators, and these are called cardiac implantable electronic devices and remote monitoring is part of their routine care. It has been in our practice for decades now. The concept is that we must monitor these patients while they are at home living their own life. We have plenty of data to show that remote monitoring of the data from their own devices, whether it is a pacemaker, or a defibrillator improves outcomes. That is mainly from early detection of arrhythmia or prompt identification of any problems with the leads, the battery or with the health of the system itself. That is what the concept of remote monitoring is about. Now, the technology that makes this happen has truly evolved over the years. This started many years ago as a patient-activated process, where they had to place a wand over the device, and then the data got transmitted through a telephone landline. That evolved into using a bedside console, or transmitter, that lived in the patient’s bedroom. Once the patient was near the transmitter, it communicated with the console, which transmitted the signals through a secure network. As physicians and health care providers, we could access that secured network and get all the data. That is what the technology has evolved into today, using the patient’s own smart device, whether it is a smart phone or smart tablet. The device itself directly communicates with the smart device, and the smart device acts as a vehicle to transmit the data to the secured network.
I’m guessing when you first started doing this, you were looking at more machinery, and a patient would have to come to the office, obtain it and then have some assistance setting it up at home. Now you can just do it from someone’s personal device.
Dr. Tarakji: Exactly. Again, the in-person visit is still an essential part of the care of these patients. There are certain things you cannot achieve remotely. But as far as the regular checkup, which we do almost every three months, it happens behind the scenes. And now you really do not need any extra hardware if you have your phone, which we are all attached to our smart devices these days. And if you have the phone on and the Bluetooth is on, that communication happens totally seamlessly without any interaction, without anything that needs to be initiated by the patient himself or herself.
What would you say are the biggest benefits to using this type of technology and are there any drawbacks?
Dr. Tarakji: I think that that was the main goal of the BlueSync study that we conducted. This was a multi-center international study that included centers in the United States, U.K., France, and Italy. What we truly look for is the technology itself and is it going to work. The way remote monitoring happens is there are scheduled dates when this automatic remote transmission needs to occur. We looked for an outcome, and we looked at the success rate of these scheduled remote monitoring transmissions. We found with this new technology, the success rate was as high as 94.6%, which was remarkably higher than a comparative cohort that we looked at using the old models of remote monitoring. It outperformed all the existent technologies for remote monitoring. As far as the main goal of the study and the true benefit of remote monitoring…mission accomplished. We know remote monitoring is important. We know that it improves outcomes. So to have a technology that will actually increase the success rate of remote monitoring to happen and to take place is a welcome news by the medical community because despite all the evidence about the importance of remote monitoring adoption and adherence, they’ve remained suboptimal. To have the technology that improve the success rate of remote monitoring that by itself is the main outcome of the study. And it is a welcome finding to the medical community and for our patients as well. Now, the other aspect of this new technology is that this process happens through the device and through a dedicated app. Through this app, for the first time ever, patients have some visibility to data from their own devices. As you can imagine, you have millions of people living with these devices and they never had an ability to see anything of what is going on. Even folks that are using remote monitoring, they will come to the office, and say, I know you are receiving my data, but I have no idea whether this is happening or not. So through the app, they actually have some eyes towards the data from their own devices, whether it’s the battery life, the type of device that they have, some educational material about the device that they have in addition to a diary and a calendar of all the scheduled transmissions with a check mark of when these transmissions took place. The ability to have visibility to the data I think is extremely important for our patients to get more engaged in their care and hopefully it will lead to better outcome.
Has patient compliance with this type of measure been good?
Dr. Tarakji: This was not a randomized trial. So, we were probably biased by the fact that they happened to have a smart device to begin with. And sure, that is a limitation for the study because you are already biased towards the patient population that have a smart device, and they are comfortable using it. But if you look around you that is where we are all headed. We are all attached to our devices. And this is not just for the care of the patient of today, but this is also for the care of the patient of tomorrow. We learned from this study and from many other studies using similar technologies do not underestimate our seniors and our older patients and their ability to adopt and use these new technologies successfully. They will. You probably need a little bit of education at the time of the setup to download the app. But beyond this, surprisingly, our older patients – they do better as far as adherence and compliance than the younger ones. The differences are small, but it is a testament for our older patients’ ability to adapt to these new technologies and use it successfully.
What kind of implications do you think that this might have going forward for future use of technology like this?
Dr. Tarakji: The goal of the study itself was to see if the technology works. It was a simple goal, but it is an important goal for any other future hopes or objectives. In the future, I think about it in two aspects. From clinical care, it certainly provides us with the ability to achieve remote monitoring more successfully, including our patients who are traveling. If you’re not at home, if you’re in an environment where you’re not close to your bedside console, as long as you have that smart device in close proximity, the remote transmission will happen, and it will take place. I think for the future, we really need to see outcome studies. Does this technology improve patients’ outcome, or number of hospitalizations? I think this is yet to be seen. We have plenty of evidence to suggest that remote monitoring in general will achieve this. But whether this added benefit from technology can improve this outcome that is yet to be determined. From a research standpoint, the sky is the limit. We conduct a lot of large trials using these devices, and the major bulk of the cost to get meaningful research is the cost of the follow-up of patients coming back to the clinic, answering questionnaires – all the elements through the app. You can potentially achieve a lot of this remotely. Telemedicine is the center of all that we talk about, especially considering COVID-19. We have been preaching about telemedicine and its value even before the pandemic. I think the pandemic was a wakeup call about its importance. But it is not going to go away even post-pandemic. It is here to stay. But for telemedicine to be successful, you really need to equip it with the right tools to get the data remotely and make telemedicine not just an exotic way of providing care but a really meaningful and impactful way to care for our patients.
How do you think that this type of technology in this global pandemic that we are dealing with is beneficial considering the circumstances that we were thrust upon?
Dr. Tarakji: We thought about potential advantages of this new system. And frankly speaking, pandemic was not one of them back in the days when we were planning the trial. One of the things that surfaced up during COVID-19 is the care for the patients who get admitted with COVID-19. For example, they have an implantable device and how can we achieve remote monitoring? Because now they are not at home. They are not close to that console. And when you think about it, as long as they have their smartphone with them or smart tablet, this could be easily achieved as long as they have Internet access through Wi-Fi or cellular network, which most hospitals provide. This is a perk that we learned post-crisis and not before. But it goes to show you how technology can help us, not only for our routine care but also during the caregiving crisis.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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If you would like more information, please contact:
Andrea Pacetti
Cleveland Clinic
216-316-3040
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