Steve Macaleese : Remote Cardiac MonitoringHello everyone. Good afternoon. It's a pleasure to be at the EBME conference. So thank you, John, for the invitation. I've worked for many years now in monitoring both with Welch Allyn, in fact, and then Omron. Now I work for a company called Qardio. And I'm sure you’ve all heard of it? Perhaps not. So let me tell you a bit more about us. So there are many challenges, and we've heard already in Scott's presentation actually before, that data is very much easier, more accessible and there are issues with integration certainly into systems and EPRs. What I'd like to do is look at the main problems the NHS are facing. If we think about the NHS generally, what are the conditions that are really causing big problems?

So I want to talk about stroke. Now, we know stroke is really quite, well, probably the number one issue that we have. And the condition which is one of the major causes of stroke, of course, is atrial fibrillation. So currently in the UK 1.3 million people have AF. Now that is the equivalent of the population of Birmingham. So it's a huge problem. And if you imagine that all those people are potentially at risk of complicated stroke or other complications. That means in the UK every 18 minutes somebody suffers from an AF-related stroke. So a huge issue, it equals about 30,000 people a year. OK. Another problem with AF is that it's, in 80% of the cases, completely asymptomatic. So people don’t have a problem. They wouldn’t necessarily go to primary care because they don’t know. And that’s 80% of them, so they're essentially completely asymptomatic. Cost to the UK, and this is quite considerable, the NHS, £3 billion a year, OK, to look after post-stroke patients, and £4 billion, in fact, loss of productivity. So for the UK as a whole it's an enormous issue.

How do we address that? Obviously, this has been a problem for many years and technology is making this much, much easier. So typically a patient presents with chest pain, goes to their GP. They’ll do a rest ECG in the surgery. Now, if that person has got persistent AF or very high-burden AF, you can pick it up straightaway on a 12 lead ECG. However, unfortunately that’s not the case with most of these patients. In fact, you might have one event a month. So if you imagine, if you don’t monitor that patient for a full month, you may never pick up his AF condition.

Looking a bit more into AF, I can show you here on the chart. You see the blue line at the bottom there. You’ve got the axis along the bottom shows time, so that’s 1-31 days. That is a month there of monitoring time. And the other axis is the diagnostic yield, OK, so who we actually pick up over that time period. Now, if you're at the top there in the sort of purple line you can see, you can see that, yeah, people who have quite persistent AF who are between 75% and 100% of the time, easy to find. OK, not a problem. You can put them on a Holter for 24 hours, 48 hours; you'll pick up that patient's AF. However, if it's low burden, you would potentially have to monitor that patient, as you can see in the blue line at the bottom, which goes up the top, 100% diagnostic yield, to find everybody in that category, you have to monitor for 30 days. Clearly, that’s an issue.

Why is it an issue? Because you can't put somebody in hospital for 30 days. What you would do is fit them with Holter. The Holters have limitation in wear time. New advances are coming along which are making that wear time maybe 14 days, but still we don’t have a very good solution for those patients. The other interesting point to make is that obviously your person in the blue line at the bottom who doesn’t have regular events. They have two or three events a month. You may fit them up with a fantastic, expensive recorder to go home. And guess what, they might experience AF within the first day, but they're still having to wear the device for 30 days, which is pretty uncomfortable. OK. So what we want to do is also have that device, whatever it may be, send the data constantly, continuously back to the hospital remotely monitoring the patient. The minute the patient experiences AF, it's picked up by the hospital, received the notification, you can call the patient up and say please come in, we've found out what's wrong with you.

So, to address this, what is available? What is existing currently on the market to facilitate the diagnosis? Well, I've broken this into two sides here. You’ve got up-to-14-days monitoring, OK, and then you’ve got more-than-14-days remote monitoring. If you look at the left-hand side, very commonplace in secondary care but also primary care, is traditional Holter monitoring. Holter monitors will typically be used for 24 hours. OK. So, as we've seen from the previous chart, you're going to pick up very few patients who have very low burden AF. Then you have wearable patches. Now, these are fairly recent on the market. They're good products. You can wear them for 14 days maximum though a month. I don't think there's one out there yet that does actually 30 days. And the limitation there is you’ve got some skin preparation to do. You adhere onto the chest. I'm sure I've been in a situation where they’ve had to shave my chest to put a device on, not very comfortable. But wearing it for 14 days can be challenging as well. Those devices do not communicate real-time back to the hospital. So if you have an event after two hours of wearing it, nobody knows that. You have to wait for the full 14 days, go back to the hospital, download at the hospital.

On the right-hand side, the other options, OK, implantable loop recorders. Again, this technology is very good. You can leave them in a patient for up to here years, but it is a procedure. There are injectable devices now which are incredibly fast to implant. I think it takes a couple of minutes just to inject it into the chest. However, patient cost is £1,000 per patient. It could be more than that actually. I've heard it varies between £1,000 to £2,000. If you then look at the permanent pacemaker, obviously that’s a person who's really had an established arrhythmia that you're correcting with, the cost of that is £2,000, but it provides monitoring and it provides remote monitoring. However, cost is prohibitive. OK. Looking at the slides, so it's 1.3 million people, you can't entertain that sort of audience with the ILR or the pacemaker.

So what's the solution? Well, we have a product called the QardioCore. And the QardioCore is a reusable, wearable device. It doesn’t look like a medical device. I walked around today and there are some fantastic stands and a lot of really complex medical products. This is quite, we see it as revolutionary, because it looks very much like a heart rate monitor, if you will, that you'd wear in the gym. Now, I have one with me in my pocket just to show you the device. Normally, I wear the device. I take my shirt off and put it on. I won't do that. I'll just show you what it looks like. OK. It's very much like if you imagine a Polar-type heart rate monitor. You just put it on. It sits just under the pectoralis muscles, if I had some, just about there, and straps around the back and it just basically locks in like that. You see the green light. As simple as that, that is done.

So if you're a nurse and you fit somebody with this, it's extremely easy. Everyone's chest is a bit different, so we appreciate that sometimes you need to wear it in different positions so you can actually invert this and wear it upside down, and we can invert in the software, the ECG, to make it as comfortable as possible. I assume a lot of people probably have had a go with the heart rate monitor, but I used to have one for the gym. I kind of gave up on doing at the moment, but they're not too uncomfortable compared to say a Holter, where you’ve had your hair shaved, your skin abraded and electrodes put on and you're wearing a big box on your belt somewhere. So it's wireless. As you can see that is basically it.

What does it do? Well, obviously ECG. You're getting three leads of ECG. This is working with a smartphone. Now, when I say smartphone, people say they need a phone and somebody will steal it or take it or lose it. Yes, that can happen. But people can lose a Holter monitor and I'm sure that they don’t get returned and they're £1,500 apiece. So this will work as of April. It works on iPhone at the moment and Android as well. Android phones are quite inexpensive. Streaming the data via low energy Bluetooth to the device; from the device it goes into our cloud. We are doing analysis all the time in the cloud, OK, and a doctor can log in to any PC or Mac to our portal, basically our doctor portal, and the doctor portal will triage your patient. So, for example, if you have 1,000 patients all wearing this device - that’s my hope in the near future - then you can imagine that it may pick up AF on a patient. That will be recorded, so it will put it into the red bucket on your screen. So you'll red flag the patients where there is something detected. If nothing is detected they stay in green. So with one screen you can see which patients you’ve got to look at and which you don’t.

If I can go and show you a bit more detail about this. This is, on the left-hand side, your traditional monitor. I think we’re all pretty familiar with that. Skin electrodes, wires, uncomfortable certainly, you wouldn’t want to wear that for a month. I mean I'd find that uncomfortable for a day, so for a month it's not great. You're limited to wear time, as I mentioned, to about 48 hours maximum. OK. And you have quite a low diagnostic yield because you're missing the low-burden patients. So what we want to do is to say OK we have a solution now for up to 30 days or more in fact. This device is sold to consumers. There's a different product, different version, if you will, for medical, but the consumer version of the product we've been selling for quite a long time. And people who have an established arrhythmia or a problem, they're sitting, watching TV. Suddenly they get a run of tachycardia. They get panicked, they go to their doctor, but they can't capture the event. There's some people out there wear this every day. You know, I wouldn’t do it every day, but trust me we're getting millions of hours of ECG coming in to us, to our server, from consumers wearing this on a regular basis. So it's possible to wear really long term, so unlimited monitoring time.

The hardware is reusable. Your setup time is very simple, very quick. No skin preparation. I know I mentioned this earlier, but I used to work with a colleague and I won't tell you his name, but he was extremely hairy. He had a lot of hair on his chest. And normally he would have to have hair shaved, electrodes put on. This device worked over hair, so really no skin prep is required at all with this device, so in terms of setting up the patient incredibly simply. Also, a lot of monitors which are being used for seven-day recording, you expect the patient to take some of the electrodes off at home and replace those. They put them in the wrong place; they forget to put some on. The trace quality is quite horrible. OK. So it gets away from all that. The patient can easily take this off and put it back on, very easy. So if they're showering, by the way it is waterproof, so it's not a problem. But we recommend take it off, plug it in to charge. It needs one hour charge for 24 hours' battery life. So you effectively lose an hour within 24, but of course you can wear it indefinitely.

OK. And also the data, we spoke about data and integration. We work with Cerner, Epic, Validic and various systems. I know we’re a US business as well as in the UK, so there are some systems which are used more or less in either market. But certainly we can integrate and we can do a cloud-to-cloud API to electronic patient record systems. OK. So we work with the hospital to provide that interface. It gives you the ability to also have unlimited download reports from the software. And we can show you a bit more in detail what the software looks like. So, on the left here, well, the big blue screen, you can see a typical screen which you'd expect to see for a Holter-type device. We provide all of the same tools and arrhythmia identification within the software. We have a stand outside where we have this live and my colleague's wearing it, so you can see this actually operating here. And you can then look around the portal, CardioMD, which is our doctors' portal.

If you have a patient, for example, who’s fitted up in the hospital and they are just leaving - and we've had this happen quite a few times actually - by the time they reach the carpark, guess what? We've seen AF or something that we’re looking for already in the electrophysiology lab. We've already picked them up. So by remote monitoring, you can see it straightaway. I think the lag time between seeing the trace on the phone and getting it to your PC, depending on obviously the connection you're on, but you're looking at two minutes with a reasonable connection. So you immediately get the information back at the hospital. OK.

So I want to show you what the trace looks like on the phone. So hopefully this will work. There you go. You can see the trace on the phone. However, for patients we have a dedicated kit with the device and the phone. We lock the phone down and we use guided access in the phone and lock the phone down so the patient just sees a black box basically. This one here - I’ll just put one up as an example - was done in the UK at Russells Hall Hospital comparing our device with a 12 lead ECG. We have other studies which compare our device to a 24-hour Holter device and also to a patch-type device for longer periods of time. So we are working on more and more studies, of course, and we're happy to engage any hospital who wants a free demonstration of the product to put this in, test it out.

Talking about data, I know we talk a lot about data and integration, but what really is important is the quality of that data. We know that a percentage of patients come back with regular Holter devices with extremely poor data, so you just have to bin it and retest the patient. This device is a completely different technology to traditional ECG. It's unique to Qardio. And it has four electrodes, as you can see, on the base of this device, and it’ll give you basically a derived lead one, two and three. But the trace quality from what we've heard back from the hospitals, it seems to be much better than a traditional Holter, less artefact than you'd expect with say a 24-hour device. OK.

So, just moving on from that, just to sort of recap in terms of the market and the costs of devices, on the left-hand side we've got percentage diagnostic yield and, as I mentioned, there are many devices in the market at the moment. But if you want to look at getting 100% diagnostic yield, there are very few that'll do the job. In fact, you're looking at ILRs, which are implanted devices, and Qardio. QardioCore will also transmit data because it's remote monitoring. So you don’t have to leave it on the patient for 30 days if they have the event after two weeks or after a week. So you'll bring that patient in early. But really there's nothing else comparable on the market which will achieve that. So what we’re trying to do is say OK we have a potential alternative to an implantable device which will cost you £1,000 to £2,000 per patient, this is £450 and it's reusable. OK.

Other devices on there, of course, at the bottom there, you’ve got the 12 lead traditional in-office ECG, but, of course, very low diagnostic yield. There are a number of devices on the market which use phones now. There's one where you have a 30-second rhythm strip. You’ve probably seen that and it's worked very well. Because there is a reluctance when I speak to doctors and hospitals about giving patients phones; however, that’s already sort of happening in primary care with a lot of devices to measure 30-second rhythm strips for symptomatic patients. Of course, for asymptomatic, it's not going to work. But if you look at the other options, your 24-hour ECGs, seven-day recorder, you can see you're not achieving that 100% diagnostic yield.

OK. So just really to summarise on the presentation, solutions for stroke, we know that AF is a major cause of stroke. So to find those patients and do it within a budget, because we know costs are very important of course for the NHS, this is a local solution, which is easy to use, very comfortable for the patient because you're not preparing the skin at all and a cloud-based solution so you can constantly monitor those patients. The other ambition here is that patients who have long-term conditions who you want to monitor, you can give them the device and they can hang onto the device and then you can tell them, you can phone them up and say we need to monitor you, just put it on. They put it on. The data comes straight back to you. Obviously, we comply with GDPR and all of the standards required for data in the UK and throughout the EU and US. OK.

This is not the only device in the range which we make. We also make a blood pressure monitor and a body fat scale. So the blood pressure monitor, this is not an ABPM, it's a standard blood pressure device which can be used at any time. And the unique feature is it's extremely small. So you could fit it in the inside pocket of your jacket and use it anywhere. So it's very portable and wherever you measure yourself, the data goes back to the QardioMD, to the doctor's screen. Heart failure patients who require routine measurement of weight, we have the QardioBase 2 Scale. The patients just take it home. They put it on the floor. They don't need to touch it. By the way, nothing has an on-off button. You literally just put the devices on and they work. They work on your Bluetooth to your phone and then transmit across to the portal.

 

 Steve Macaleese's presentation at the EBME Expo -- Remote Cardiac Monitoring.