The State of ECG / EKG Collection During COVID-19
ERT’s Brian Smith and AliveCor’s Dr. David Albert explore how technological advancements can not only offer solutions to problems caused by COVID-19, but change the landscape of clinical research even after the pandemic is over.
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Dr. David Albert of AliveCor explains how patient-collected data can solve some of the problems facing clinical trials during the COVID-19 pandemic, as well as the long-term outlook on changes in data collection for clinical research.
What is the AliveCor KardiaMobile 6L and how does it work? [01:43]
The AliveCor KardiaMobile 6L is a 6-lead device for patient-collected ECG/EKG reads.
How is the KardiaMobile 6L being used today in light of the COVID-19 pandemic and subsequent changes in FDA regulations? [03:21]
AliveCor received the FDA’s approval for emergency use of the KardiaMobile 6L. Some drugs being tested as treatments for COVID-19 may cause QT prolongation, potentially leading to a serious cardiac arrhythmia. The KardiaMobile 6L is capable of monitoring QTc and able to keep people safe while they’re using experimental COVID-19 treatments.
How can the KardiaMobile 6L make it easier for doctors to keep patients safe during COVID-19? [05:14]
Taking ECGs in hospitals treating patients with coronavirus requires staff to sterilize the machine and use personal protective equipment, when those resources may be better used on the “front lines” in hospitals. Now, using the KardiaMobile 6L, patients are able to complete their own ECGs / EKGs without having to use valuable PPE or put ECG/ EKG techs at risk.
How do you think we can solve the problem of successfully conducting clinical trials today during stay-at-home mandates?[07:15]
There are increasing demands from sponsors who want to do virtual trials or conduct trials within unique venues, like refugee camps. In these cases, the KardiaMobile 6L can provide a solution to measure the potential impacts of a treatment on a patient’s QT interval.
Should clinical trials sponsors have any concerns about the integrity of remote ECG / EKG data collection?[08:54]
The KardiaMobile technology has proven that a person if trained correctly and with practice, can collect clinical-quality ECGs at home by themselves. It’s also been demonstrated that this technology can be used even in difficult populations.
Do you think there’s going to be a permanent move towards at-home monitoring in clinical research following the changes put in place in response to COVID-19?[11:00]
COVID-19 has been the greatest catalyst to change in primary care; for example, telemedicine has become a standard way of providing care. Patients have responded positively to it. This sentiment will likely carry over into the clinical research industry.
What do you see as the benefits of at-home ECG / EKG collection by the patient?[12:28]
People are more relaxed and comfortable at home, which can lead to improved data (similar to the white coat effect in collecting blood pressure data at home.) Sometimes patients may experience conditions like atrial fibrillation at home; by the time they get to the hospital or doctor, it’s passed. With personal ECG/ EKG devices, patients can document their experiences without ever going to the doctor. Remote management and remote patient monitoring are trends that are here to stay following COVID-19.
How do you think remote data collection solutions will continue to evolve? What other trends do you see coming in the industry?[15:09]
“Digital health” is just becoming health. The smartphone is now incorporated into every part of our lives; that’s going to become the principal entry point for many people into healthcare. Smart devices keep becoming more and more sophisticated, and we’ll continue to see more remote monitoring and attempts to prevent illness by catching issues early and encouraging changes in lifestyle and healthcare.
Introduction speaker: [00:00:05] This is the greatest catalyst to the transformation of what I call primary care, ambulatory care because right now telemedicine has become the standard way for a regular physician visit and I know of cardiologists who really never used telemedicine are using it all over the world.
Announcer: [00:00:26] Welcome back to the Trial Better podcast. In this episode we’re discussing AliveCor’s KardiaMobile 6L. A device that patients can use to complete ECG assessments at home. We’ll discuss how the KardiaMobile supports social distancing and the surgeon virtual trials in response to Covid-19. Leading this conversation is host Brian Smith and guest Dr. David Albert, founder and chief medical officer at AliveCor. So let’s not waste time and jump into this edition of Trial Better.
Brian Smith: [00:00:53] Hi everyone and welcome to ERT’s Trial Better Podcast. I’m Brian Smith filling in for your host Jason Eger. Today I’m joined by Dr. Albert from AliveCor, who is the founder and chief medical officer. Dr. Albert is a physician, inventor and serial entrepreneur who has developed life-saving technologies and products for three decades. His latest Innovation AliveCor’s KardiaMobile personal ECG technology brings data collection directly to the patient’s hand. Dr. Albert welcome to Trial Better.
Dr. David Albert: [00:01:26] Well, thank you Brian for inviting me and unfortunately, I’ve been doing that inventing for 40 years. And then when I heard three decades I went yeah, I must have written that 10 years ago, so, but thank you for inviting me.
Brian Smith: [00:01:40] Well, thank you for joining us. So to start off our podcast my first question is could you explain to everyone what the AliveCor KardiaMobile 6L device is and how does it work?
Dr. David Albert: [00:01:51] Well our KardiaMobile 6L is a device that AliveCor introduced in 2019. And what it does is, in techno-nerd terms, it allows you to record Einthoven triangle. And what that means is that we have two kinds of EKG or ECG leads. We have the limb leads, which are made up of the left leg, the left arm, and the right arm, and then leads that are calculated from those measurements. And then we have the chest leads, the precordial leads and a 12-lead ECG what you’d get in a doctor’s office or a hospital involves often times putting sticking electrodes on, laying down all these wires connected to you. And what we wanted to do is bring at least half of that, 6 of those 12 leads, to anyone without having to take their clothes off, without having to do anything major but give both them and their healthcare providers, their doctors, their cardiologists significantly more information than you could get from our first generation KardiaMobile, which was a single lead, lead one ECG. And so the KardiaMobile 6L does lead one, lead two and then gives you leads three and then what we call the augmented lead. So it gives you a number of additional views which can be very helpful.
Brian Smith: [00:03:11] Now thank you and that’s fascinating, the ability to go from a single lead from your old device to the six lead. I think really changes the way we can collect ECGs at home. Now due to the Covid-19 pandemic and the recent changes in the FDA regulations, how is the KardiaMobile device being used today in doctors’ offices and households?
Dr. David Albert: [00:03:31] Well, there’s surely two ways. First of all as you may know we receive what’s called an emergency use, probably people listening on this podcast have heard about the malaria medicine that has gained a lot of attention, hydroxychloroquine. Along with a conventional antibiotic azithromycin z-pack and they’ve been used all over the world literally to treat Covid-19. And so the issue with those drugs are both of them can do something called, create a QT prolongation, and ERT is very familiar with that. What that means is when you take both of them or even just one of them you potentially can have a serious cardiac arrhythmia. And so the FDA, we went to them and said, we’ve been working for several years and I know ERT knows this, with Mayo Clinic and others on measuring QT using the KardiaMobile 6L. And what we did is we went and said listen, we’re getting ready, we have a lot of clinical data we’ve collected over the last several years. We published papers, but we think we could help keep people safe while they’re treated with these medicines. And so they granted us an emergency use literally in one day. And so since that time we’ve been helping Healthcare organizations, utilize the KardiaMobile 6L to monitor QTC in patients who are taking these two medicines that are now being used in a widespread way.
Brian Smith: [00:05:14] that’s great. I mean I know doctor about you shared with me, personal story about your son and collecting ECGs during, Covid-19. Can you share that with us and how the KardiaMobile makes it that much easier for our doctors?
Dr. David Albert: [00:05:27] Well sure because, my oldest son is a new attending physician at one of our largest hospital Cedars-Sinai in Los Angeles, and he was an attending on their teaching medicine service. So, he for three weeks had nothing but Covid patients. They were a hot spot at Cedars. Again it’s because it’s a very high-end world-famous hospital. And when they took an ECG, they would have to essentially sterilize the machine. They would have to use personal protective equipment another acronym PPE for the ECG techs to go into the room, the people who normally do this. And they said wait a second this is not a good idea because we need that PPE for the people are actually taking care of the patients. We don’t want to take those EKG machines out of service for who knows how long to get them clean. So they said is there another way we can do it and actually leave a device in the room and that’s where the idea of using our 6L came from. And it’s found use not only there but at other places like, let me just say major institutions. My son works at Cedars, but I have other people, but there are many other institutions that have purchased our devices and are using them including in other countries hotspots. France, Spain have all purchased our device and are using them for in patients without having to waste this personal protective equipment nor put those people at risk, those ECG techs nor having to sterilize or clean their ECG equipment.
Brian Smith: [00:07:05] It’s great to see your device making an immediate impact like that. So now moving into clinical research, obviously ERT is involved with our, conducting clinical trials around the world. How do you think we can solve problems in the clinical research today, especially with the stay-at-home mandates and patients unwilling or less likely to go into their doctor’s office for their clinical trials visit?
Dr. David Albert: [00:07:28] Well, we’ve been doing the validation research to show that we can be very close to a traditional 12-lead ECG with our device. And we’ve been talking to ERT about how to use this and as we’ve been told you have further and further demands of the sponsors, the Pharma companies wanting to do trials, virtual trials, trials for patients, stay-at-home, trials that are beyond the traditional Phase 1 Phase 2. And in addition to that you’re being asked to do these trials and what I like to call unique venues. Those things in the jungle or in a refugee camp and what the world knows is and we were contacted by the CDC, is that both multi-drug resistant tuberculosis and multidrug-resistant malaria, the drugs were using to treat them are all QT prolongers and you’re not going to be using these in regular clinic venues. And therefore the KardiaMobile 6L could potentially be useful for ERT and taking their expertise that QT measurement and data acquisition and taking it to these new venues. Whether it’s the home or whether it’s some place more remote than even a home.
Brian Smith: [00:08:46] No, definitely, we can definitely see ourselves, see the use for collecting ECGs at home with alternate methods. One question I know that our sponsors and people we’ve talked to, as we’ve talked about alternate collection of ECGs whether single lead or six lead, the question comes up should they have any concerns about the integrity of the data collected at patient’s home? What are your thoughts on your device? And also other home collection?
Dr. David Albert: [00:09:13] Well, I can’t speak to other home collection. People have been collecting blood pressures and blood glucoses for years, decades even. ECG we were kind of the pioneer at the home collection, at the personal collection and I can tell you we have over 90 peer-reviewed publications in every major cardiovascular journal. We presented at every major cardiovascular meeting both here and overseas and our technology has been put to the test against 12 lead ECGs , against ambulatory ECGs, and I think we’ve done well and have proven that a person if trained and who gets to practice can record clinical quality ECGs at home on themselves. And I think that’s important. I can tell you right now one of the things that we’re seeing is venues that are constant where people live together, like nursing homes where you have both close quarters and high-risk patients elderly people with other conditions, you’re going to need to keep track of those kinds of people and they often take many kind of medicines. Many of which probably prolong with QT. And so, I think having somebody there in a nursing home we’ve shown them that we can utilize our technology even in a difficult population such as serious seniors. So I’m confident that that will be able to generate high-quality data that will be acceptable to Pharma that is acceptable to the FDA and to other regulatory bodies and is acceptable to clinicians.
Brian Smith: [00:10:59] That’s great. So, I mean obviously, for all of us in the Covid-19 pandemic and stay at home mandates are temporary, do you think that what we’re going through now is going to lead to a permanent shift in how we’re collecting clinical data in the future?
Dr. David Albert: [00:11:17] No question, I didn’t bring that up when I talked about the QT issue in Covid, but the reality is this is the greatest catalyst to the transformation of what I call primary care, ambulatory care, because right now telemedicine has become the standard way for a regular physician visit. And I know of cardiologist who really never used telemedicine are using it all over the world. My wife’s a rheumatologist. She’s using it every day and patients like it. You don’t have to drive. You don’t have to take off work. You don’t have to sit in a waiting room around other potentially sick people if you’re good. And I think this will be a catalyst and everyone I’ve talked to, at every major institution agrees that telemedicine is here to stay and will be utilized much more and I think that same idea will carry over into the clinical research area where ERT is such a significant player. People like to be home, people like to be comfortable and they don’t like to travel. And if you’re here in LA I can tell you very few people like to get on the road.
Brian Smith: [00:12:29] I get it, I mean, it’s true. Obviously, we also see oncology patients that fly, coast-to-coast to get treatment and clinical trials and their ability to be able to collect patient, their own data at home, without their site being thousands of miles away. It’s truly beneficial to the patient and I think that’s what this pandemic is showing. Is that bringing that to the patient is beyond just the Covid-19 pandemic? You see any other benefits from being at home? Let’s say an ECG collection do we remove like well that’s white coat effects that we would see?
Dr. David Albert: [00:13:02] White coat effect, well that’s obviously been a big issue with blood pressures and I think it’s becoming very well understood that home blood pressures are probably more valuable in terms of patient management than office blood pressures. They may not be quite as good as an ambulatory blood pressure, but they’re much better than an office where you have the white coat syndrome, and I think the same things probably true of ECG collection. I don’t have data on this so I can’t tell you. I’ve got a peer-reviewed published manuscript, but people are more relaxed. They’ve got less of a flight or fright. I can tell you that we have lots of anecdotes of people who at home go into an arrhythmia such as atrial fibrillation. And by the time they get to an emergency room or doctor’s office they’re in sinus rhythm. And they go well doc trust me I was in atrial fibrillation I promise. And now with these personal ECG devices like Kardia you can document that and you don’t even have to go to the office. You just send it to your doctor and they go yeah, you’re right and let’s schedule whatever we need to schedule or let’s change or start a prescription. So I think remote management, remote patient monitoring are trends that are here to stay. I think they’ve been catalyzed by Covid-19, but we not going to go back Brian in a number of ways. We’re not going to go back. Do you feel really comfortable in a month getting on a plane? Going to a basketball game? I think the world’s going to change and with it the practice of medicine is going to change and maybe in some ways we can’t even see today now,
Brian Smith: [00:14:44] I agree and as much as I’d love to go watch a baseball game, I’ll be perfectly happy watching it from my home and not with a 50,000 other screaming fans.
Dr. David Albert: [00:14:52] Go Dodgers…
Brian Smith: [00:14:52] I could say go Yankees, but we’re going to leave this strictly scientific and not based on who has the most world series titles. So beyond what we’ve talked about today Dr. Albert, how do you think that this will continue to evolve? And what do you see as other trends in the industry?
Dr. David Albert: [00:15:16] I think the notion of having started AliveCor what I would say in the infancy, the Jurassic period of digital health. I’ve seen it as a matter of fact several people have said I’m the father of digital health, no more I’m the grandfather digital health. But I have watched the evolution to where digital health is really just becoming health. The smartphone is the remote control for our lives. That’s how we bank, it’s how we communicate, it’s how we take pictures, and it’s involved. You can’t see anybody even in Covid who don’t have their head down. In fact you worry about running into people right? Everywhere you go people are on their smartphone. And so that’s going to become the principal entry point for many people in the health care and I think those devices just keep getting more and more sophisticated, with more and more sensors and I think with devices such as blood pressure devices, pulse oximeters, ECG devices like Kardia we’ll continue to see more and more remote monitoring, more and more attempts to prevent. Because the best way to stay healthy is to prevent getting sick. And I think that’s where digital medicine has some tremendous opportunity, is to help people either catch issues early and change their lifestyle, change their health care or to address things in a more efficient way because cost is always been a huge issue. And, if you don’t have to go across town and miss work and things to the patient the cost is better. So I just going to change in a bunch of ways, Brian and some that probably I can’t even imagine.
Brian Smith: [00:17:09] Thank you; I really appreciate your insight on that Dr. Albert. And so thanks again for joining us today on Trial Better. We really had a great conversation on how AliveCor is being used today. It’s *inaudible* ECG collection during the Covid-19 pandemic and different environments in the hospital and how it can be used in the home. We really look forward to hearing more about AliveCor innovations and cardiac safety in the future. As I’m sure as an innovator as yourself for four decades as you corrected me, I’m sure you have more to come. To our listeners thank you for tuning in and as always leave a review for Trial Better on your favourite podcast channel and send us your feedback any time at email@example.com. And thanks again. Dr. Albert.
Dr. David Albert: [00:17:52] Thank you.
Announcer: [00:17:55] Special thanks to Dr. Albert and Brian for today’s discussion as technologies, like KardiaMobile become the new normal of clinical research, it’s important for sponsors and researchers to know the trailblazing tools available for virtual trials.
Before we go thanks again for tuning in and be sure to join us on May 20th for our next trial better briefing, an interactive webinar series where we dig deeper into the topics we cover on the podcast. Find information to register and upcoming briefings at trial better.com. Finally please remember to comment, rate or review Trial Better on Apple podcasts or your favourite podcast channel. You can also reach us at firstname.lastname@example.org. Thanks for listening and stay safe everyone.
Dr. David Albert
Founder and CMO, AliveCor
David E. Albert, MD, an Oklahoma native, is a physician, inventor and serial entrepreneur who has developed life-saving technologies and products over the last 40 years, turning a number of those innovations into tech startups. Today, he is a founder of three technology companies, InnovAlarm, Lifetone Technology, and AliveCor. His previous startups include Corazonix Corp (sold to Arrhythmia Research Technology) and Data Critical (sold to GE). Dr. Albert left GE in 2004 as Chief Scientist of GE Cardiology to disrupt several new markets.
His latest invention, AliveCor’s KardiaMobile personal ECG technology, became a global sensation via a YouTube Video in January 2011 around the Consumer Electronics Show and was featured on ABC, CBS, CNN and Fox News among many other media outlets. Dr. Albert has 32 issued US patents, a large number pending and several new “secret inventions” in development. He has authored or co-authored over 50 scientific abstracts and publications, principally in the cardiology literature. Dr. Albert has lectured at the Entrepreneurship programs at the MIT Sloan School and the University of Oklahoma. Dr. Albert graduated with Honors from Harvard College and from Duke University Medical School.