Khaldoun Tarakji, MD, MPH, an Electrophysiologist at the Cleveland Clinic, discusses a heart monitor that can easily be controlled by a smartphone.
Interview conducted by Ivanhoe Broadcast News in May 2017.
How was the heart monitored remotely traditionally?
Dr. Tarakji: Patients complain of palpitations or fluttering in the chest, these symptoms are very vague and could be very nonspecific. It could be your own normal heart rate just going faster. Not every palpitation or flutter in the chest translates into arrhythmia in particular. This is where you need to document what the rhythm is showing at the time when the patient is having those symptoms. That’s the critical part before you start talking about how you treat or how to manage, you need to establish a diagnosis and that’s the first step. That’s when it becomes challenging. If you have symptoms for example that are happening daily, constantly every single day; a halter monitor, which is basically a monitor that records every single beat for twenty four hours or forty eight hours, it records every single beat and you get the information. It becomes more challenging if these episodes happen infrequently, sporadically, you can’t predict when they’re going to happen. You don’t know the timing. We have longer term monitors that we use. Something that you can keep with you for a month for example, that gets activated when you’re having symptoms. But even a month sometimes is not good enough to capture episodes if they’re happening once every couple of months or three months. That’s the challenge, how can you catch these episodes. These episodes sometimes they’re short lived. Only a few minutes, so by the time they seek medical attention the episode is already over and then you go through the same cycle of halter monitors trying to figure out the diagnosis. That could be a process that you might get an answer quickly it, might take months or even years sometimes to establish a diagnosis. Many patients are labeled as being anxious or having anxiety problems now, when in reality they’re having arrhythmia. The opposite is also true, a lot of patients think they’re having arrhythmia, but they’re just simply their heart rate is going faster; they’re a little bit anxious. The lines are blurred up until you establish diagnosis and you do this by recording a rhythm strip at the time when you’re having symptoms.
You mentioned the halter monitor, what’s involved in that type of monitor?
Dr. Tarakji: We hook them up here in the clinic and it involves some electrodes and wires. You have to stay connected to the device that you can place in your pocket or on your belt. Everything gets recorded in the device and when the time is done then you’re done, the twenty four or forty eight hours, you basically disconnect the device and you send it by mail and this is when we receive it and we download the information.
No showers during that time, you sleep with it on, all the kind of stuff?
Dr. Tarakji: Therefore, you have it on, you are connected, and you take it off its done. Yes these are the drawbacks of these type of monitors.
How common is it for somebody to be assigned one of these monitors and have to monitor their heart?
Dr. Tarakji: We rely heavily on monitors in our specialty. Like I said sometimes we see patients they already come with a diagnosis that’s established, and they just need a further plan or management, discussion should I get this ablation done. But a lot of times we see these patients from the beginning when they’re just simply having symptoms and we don’t have a diagnosis. I can’t imagine practicing our specialty in electrophysiology, dealing with arrhythmia, without depending on monitors. We depend heavily on monitors, this is how we establish diagnosis before we start talking plans and treatment.
Let’s talk about this smart phone monitor. What is it and how does it work?
Dr. Tarakji: We’re all connected to smart phones right now and every day you have more applications, wearable devices that are out there in the market. Some of them do work, some of them are questionable. Our job and responsibility as physicians is to figure out the ones that are meaningful, that can actually affect your practice. Therefore, smart phone heart rhythm monitors, they were introduced a few years ago now and one of them got FDA approval. It’s very intriguing when you first see it the first time and it’s amazing when you show it to somebody for the first time. It gets you this wild moment about how accessible this is. You’re using your own smart phone but you attach it to a component that will record your rhythm strip and it talks to your phone. Not only do you get beats per minute, you actually get one lead rhythm strip with the current technology recorded on your smart phone. We’re all attached to our smart phones. The only reason you would turn around and go back home, is if you forget your mobile device or smart phone. We’re all attached to it, it’s available for us with easy access and if somebody feels something weird or palpitation they just hook themselves up. By hooking yourself up you just hold your phone and make sure your fingers are touching the metal plates in the back of the device and basically you record the rhythm strip. That’s how it’s used.
Do patients need to download an app or anything to get the phone to talk to the device?
Dr. Tarakji: There are two components. You need the actual device itself, which that’s what you the patient holds and that’s how you record your rhythm strip. You need to download an app on your smart device to download the rhythm strip, look at the interpretation, and save that rhythm recording at the time that you did.
Does it transmit it back to your electronic medical record or do you have to physically bring your phone in to your doctor?
Dr. Tarakji: This is where it’s a work in progress. Initially, what started as a simple recording that you can save with you, or you can e-mail it to your physician that will do the job but it’s not a sustainable model you know getting the random e-mails from different patients and you don’t know which e-mail belongs to whom. That is changing, that’s the work in progress and there’s a platform now that we’re going to hopefully start using soon. There’s no direct communication between you as a patient and us as physicians, but we can access your data through the cloud and we can see your recordings that you did over a certain period of time. That’s where you know it’s nice to have the technology, but making sure that the work flow works for everybody in a way that is safe and secured and doesn’t overwhelm health care providers also with random e-mails or random recordings. That developed or needed to take place in order to make this feasible and something we can adopt clinically.
What are some of the advantages and disadvantages of the new device?
Dr. Tarakji: I think just as with any other device or health care app as physicians we have responsibilities to check these products and to see what works and what does not. Just like you should not adopt any new technology you also should not dismiss technology just you’re just not familiar or it’s novel or new. We need to challenge these products and that’s what we did. So the smart phone heart rhythm recorder got FDA approval, but we actually also wanted to test this in our clinic at the Cleveland Clinic. We did the study and as you know atrial fibrillation is the most common arrhythmia in the world. We take care of a lot of patients with atrial fibrillation and we wanted to see, well how does this compare, this new technology using your smart phone to record your rhythm, how does it compare to our traditional transtelephonic monitor? Traditional transtelephonic monitor is basically a device that the patient will hook themselves up to. It relies on a land line to send the transmission at the time when they hook themselves up tothis device. This is when we get this recording and we download the information and we do the interpretation. So we do a lot of ablation for atrial defibrillation. This is when we go and provide catheter ablation to treat atrial fibrillation. Up until this moment it’s still practice in our routine. These patients after ablation, they go home with arrhythmia transmitter, transtelephonic monitor. We ask them to record at least once a week or anytime they have symptoms to record and send us a transmission. The patient from the patient’s end, they really don’t see anything they’re just hooking themselves up to this machine that will record and send a transmission to us. When they come back after three or four months, we look at these recordings and we see what do you know sinus rhythm, atrial fibrillation. As we get in these recordings, we do the interpretation so when the patient comes for a follow up after three or four months, we take a look at all our interpretation of these transmissions. You know you’re doing fine, everything looks normal, sinus rhythm or you had some fibrillation here and there. So we did the study, this was the beginning of adopting this technology, and for patients who had a smart phone that’s compatible, we told them to use this new smart phone recorder at the same time that they’re using the traditional transtelephonic monitor. We asked them to send simultaneous recordings. While we really needed to see does this work, is it feasible, how easy is it to read those recordings, but to tell you the truth we were also interested in getting the feedback of the patients. The average age of patients who enrolled in that study, these patients were in their early to mid-sixties and we were concerned, how easy is it to adopt this new technology, how easy is it to use your smart phone not only as a telephone but truly as a smart phone that has more applications. We wanted the patient’s feedback. That was equally important for us as much as knowing whether the device was going to work or not. So it turned out you know we published this in Heart Rhythm Journal and as far as the recording themselves, they have excellent sensitivity and specificity and so did the job. It correlated beautifully to the traditional transtelephonic monitors. So it does work. But I think the eye opener for us is the feedback that we got from patients. Patients loved it and they found it fun to use, easy access. Access is huge, so if you’re sitting at the restaurant and you start having symptoms, palpitations it’s not easy to have access to that machine that is sitting at your home but you already have your smart phone next to you so you can record it. Accessibility was a huge factor they gave us feedback about. It was fun to use and actually for the first time the patient is looking at the recording that she or he is doing at the time. They can see what they recorded. Patients are very smart, people in general, they can tell how atrial fibrillation looks like, what a sinus rhythm looks like. Therefore, that immediate feedback to the patient is also very important. Now, you get them engaged so now they’re not just a passive component in this transmission, they take an active role recording and looking at their transmission. If you have an engaged patient, you have a more compliant patient and the feedback that we got from them was great.
What was some of the disadvantages would you say?
Dr. Tarakji: I think one of the concerns that we have and we trying to provide solutions to is doing the recording is one thing, but having a work flow in how do you receive those recordings. How do you provide your interpretation, how do you store the data, how do you communicate back to the patient. This is what we’re working on right now. Because all these things, you can have a beautiful product, but if doesn’t generate an easy work flow for everybody both from patient standpoint and physician standpoint, it could be a nightmare. You don’t want random recordings coming from different people without attaching them to a specific patient. Privacy is always a concern, I think we live in an era of privacy, but the cloud and security is always a concern for everybody. You know having a secure cloud is something that is available now but it certainly continues to be a concern and we hear it from some patients. I think one of the major obstacles in adopting these technologies insurance companies are a little bit behind in recognizing these new products. Re-imbursement is an issue. Unfortunately the practice that we provide right now some of it is dictated by the fact that this is what you can bill for. The insurance companies, it’s time for them to recognize newer technology that probably doesn’t fit under certain code or billing code, but it provides an excellent way to care for patients. So that’s also, hopefully will be a work in progress to make sure that this is adopted more widely whether for this device or other devices in the future as well.
This device you did say it was FDA approved right?
Dr. Tarakji: Yes.
So it’s available for doctors to use anywhere. How often are we utilizing it right now?
Dr. Tarakji: Yeah these devices are available to the public. Patients are not under the mercy of physicians writing a prescription, they can just go online and buy the product. That’s why we have the responsibility, when these patients come to us with these devices and they’re asking for help, do you know the results or do you know the findings. We need to be ready to work with these devices. I think the model in the past used to be physicians working with industry to develop a product that you present to the patient, you offer to the patient whether it’s a test or device, or an intervention. The model has shifted and now you have biotech companies making a product, smart products, and selling it directly to the consumers. Not just patients but to anybody, whether you have any condition or not. The physicians now took the passive role and they’re nowhere to be found in this equation. Now we’re faced with patients coming to us with different type of devices and we need to be familiar with these devices. You can’t just stay dormant; you can’t just turn your back and not recognize these products or not at least know how to deal with them. Some of them are great products that you can find a lot of value in using them. Accordingly, I think that’s our obligation in accessing these products, seeing what works and what does not. Plus those that do work maybe you just create your in work flow how to adopt them and use them in your clinic.
Could you talk a little bit about Tom’s situation?
Dr. Tarakji: Tom certainly is a perfect example of how we’re transforming the way we care for patients, specifically patients with arrhythmia and probably atrial fibrillation in particular. I’ve been taking care of Tom for a few years now. He has atrial fibrillation and he’s very symptomatic and he had an ablation done a few years back. Tom was one of the early adopters for the smart phone technology to monitor his rhythm. He travels a lot. I don’t think Tom called me twice from the same city or same location in any particular period of time that’s just the nature of his job. For him, having that technology available to him; he’s not bound to a land line, something that is portable and with easy access any time he wants to record was extremely helpful for Tom. Tom was not only an early adopter of the new smart phone technology but Tom was one of the first patients who enrolled in a virtual visit clinic. So the combination actually worked perfectly for him. After his first ablation, he did very well for quite some time but then he started having symptoms again. When Tom called and I told him well why we don’t set up a time, we did that virtual visit. I received data from his smart phone recorded and it turned out he’s having atrial fibrillation again. We did the virtual visit when he was in a different state; he was out of state and it was very hard for him to come. We talked about what he’s feeling, what he’s going through, and we looked at all the recordings that he’s done through his smart phone independently. It was clear that he’s having atrial fibrillation and we talked about the management plan. Do we do drugs or should we proceed with a second ablation which a lot of patients do require after afib ablation. Tom wanted to pursue a second ablation. Therefore, when time came and he came for his actual visit he already came with a plan. He was scheduled for an ablation the following day so he came again and we talked about the procedure in more detail fashion. The following day was his scheduled appointment for the ablation. So his visit was more meaningful and he came with a clear plan in mind for both from my end with the schedule and for his end with his schedule and traveling all the time. It’s not easy to take time off from work and to come. He came and he had his second ablation and he’s been doing great since then. He’s using his smart phone. I’m under the microscope too, whether it works or not, because he will sure call me if he has atrial fibrillation again.
Anything else that you think we might have missed?
Dr.Tarakji: With all these wearable devices you have to worry about many things. Not only whether they work or; not the accuracy of the data, but at the end of the day what should we do with the information. A lot of consumers of these products actually stop using the wearable device or their health care app after a while for different reasons. Sometimes they don’t know what to do next; so now you have information what do I do with it. There are always concerns about how easy it is to adopt these technologies by the general public. I think often this is coming at a time they have a generation gap among physicians as well. Not everybody is comfortable using new technologies or including these technologies in their practices. The gap is not always from the patient’s side it could be also from the physician side. This is transforming the way we care for patients, cost is a major concern for a lot of people. Rightly at the time when we keep talking about healthcare cost, having something that’s affordable that provides value and provides you with the information is something we should all be eager to pursue for different types of conditions. If we can get good answers, accurate data, in a cheaper way; that should be a mutual goal from patients, physicians and healthcare policy in general.
Trusting these devices, do you see that as a barrier, not only adapting the technology but trusting what’s coming out of here for physicians or for patients?
Dr. Tarakji: Oh absolutely. That’s why I say that we have a responsibility as a medical community to challenge these products, and to test them and their accuracy. That’s a responsibility that we all share and it’s not going to be one set or one physician; it’s collaboration among different people from different specialties. Now I might develop a study to assess heart rhythm devices or apps, but probably would not be the best person to assess another device, to assess sleep apnea or gastroenterology issues. Therefore, we all work in silos but we all have responsibility when we need to break these silos and work together on different products and different wearable devices or healthcare apps.
What’s your message for folks?
Dr. Tarakji: It’s a great issue, do we trust these products and which one to trust and which one we should not. It’s a great question about the trust, is the information accurate, can I use it? That’s where our responsibility as physicians comes to play a role. Now we’re actually getting to be introduced to a lot of wearable devices from the patients. They come to us with these devices and our job is not to turn a blind eye, we have to challenge these products. The way we do this is through clinical studies. We can identify which one is accurate, which one is helpful, which one works and those that don’t. This is where it is a collaborative effort by multiple specialties because as you know each one of these devices or healthcare apps, they address a certain problem that belongs to certain specialties. So it’s collaboration among different people within the institution and among multiple institutions. Certainly we can shed some light for patients to guide them through these devices. And you can choose whatever works for them.
END OF INTERVIEW
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