Episode Transcript
Hi, everybody, this is Tom Salemi of DeviceTalks. Welcome to the AbbottTalks podcast. Over the past few years, the world has come to recognize Abbott as a company dedicated to helping people live happier and healthier lives. In this podcast series, we’ll talk with the healthcare leaders, the executives and the engineers who are working every day to develop new technologies to help people live their best lives.
I know you’ll enjoy this episode of the AbbottTalks podcast.
Welcome back to another episode of AbbottTalks. I’m Kayleen Brown, managing editor of DeviceTalks and I am joined by editorial director Tom Salemi. Welcome to the podcast, Tom.
Thank you, Kayleen. Great to be here. That was exciting.
Yeah, it’s a little nerve wracking being on the other side for our audience. I had three false starts, so if you thought that was good, it took some time. So thank you to our guest for his patience. But Tom, first, before we get into that, in our last episode of AbbottTalks, we unpacked Abbott’s structural heart business. And now in this episode, we get an opportunity to get a look inside Abbott’s heart failure business.
So I just have to ask before we dig into the episode, reflecting on season three, how much have you learned?
I always, every episode I learn a great deal about the technology. I’m excited about today’s too, because CardioMEMS™ is one of those med that we’ve all been following forever, from when it was CardioMEMS™ to when it became a part of Abbott. But I think what we both walk away from is just a real connection with the folks that we interview with and just a real sense of their passion and caring for the patient. I mean, honestly, I think every time we hang up, we like darn, that was great. We usually don’t say darn. We use a worse word than that.
So excited to unpack the story today.
I’m going to pause this here real quick before our keynote interview to bring you our conversation with this episode sponsor Tecan.
Hal Wehrenberg, Vice President, Digital Transformation for Tecan.
Welcome to the podcast.
Thank you so much. I’m happy to be here.
So, Hal, I want to dig right in.
Can you tell us about Tecan?
Of course. Tecan is a company that’s been around for a while. We’ve got 40 years of experience in life science business. MedTech, one of our growing areas. A lot of work with the clinical diagnostic areas. We work with most of the top 10 IBD players in the world. We also deal directly with laboratory automation, endpoint analysis, reagent creation for life sciences research. And yeah, we’re really excited about our mission about accelerating healthcare innovation globally.
And it’s something I’ve been doing with Tecan for almost 20 years now and I’m super proud of.
So Tecan very clearly has a strong reputation for partnering with leading healthcare companies. How can you share with us how your OEM services are evolving to meet the needs of today’s digital healthcare landscape?
Of course, when we think about classic OEM structures, it was often we’re looking at the device that we’re building, so a partner would come to us and it’s all about the device. What are the specifications, what’s it going to do, how much is it going to cost to build, what’s the cost of the development project? These are the kinds of things it was all about building the box, building the thing. And what we’re seeing with the digital healthcare landscape changes is that it’s really hitting it in multiple ways and it’s moving really fast.
The first one is the devices generally have an expectation of being connected so that the company that is bringing the device to the end user has the ability to do basic monitoring, checking the functionality. Are the instruments running, is the instrument running as much as it should be? Is the end user delighted by that instrument, which also in turn creates a platform for the back end. So some of the mundane stuff like the automation of the billing, the automation of the logistics, whether there are consumables that need to be shipped to the end user, that can be done through the monitoring platform, these are all things that also come with that.
But that’s just the first step. After that, we get into things like the ability to use that connection for remote service, for the remote diagnostics, that we can make sure the instrument is running as good as it can, that the results are as high quality as possible, the end user is getting the most out of that device at all times possible, and then taking all of that data that we have on the back end that we gather during the development phase, that we see from the real world application of it, to start using those service models, those usage models, to create predictive maintenance models that are actually even potentially AI driven, to understand how to make sure before the instrument actually is broken down, that we can change one part in advance of those issues to reduce the total amount of service that’s getting done over time to make sure that the customer is getting the most possible usage out of it. The data quality as good as it can possibly be.
A lot of people will talk about this in terms of total cost of ownership. I like to think of it as providing as much value as possible over the lifetime of the instrument, but I think that’s really how the OEM manufacturing of the things has really changed. It’s all about the connectivity and then all the value that you can bring with that connectivity.
That’s really helpful.
I’m going to pause this here really quickly and we will hear more from this episode’s sponsor, Tika, a little later on in the podcast. But if you want to find out more now, please Visit their website partnering.Tecan.com that’s P A R T N E R I N G.T E C A N.com and now we bring you the first part of our keynote interview with Dr. Finn Gustafsson, Chief Medical Officer for Abbott Heart Failure. I hope you enjoy.
So then, with that, our guest today actually joined Abbott in April this year, and I’m going to give a little teaser. I know you’re going to go into the background, but a little teaser. It wasn’t a traditional move. So our guests actually spent the past seven years as a professor at the University of Copenhagen and then joined Abbott’s heart failure business. So with that in mind, let’s stop the suspense and let’s bring in our guest, Dr. Finn Gustafsson, Chief medical officer for Abbott’s heart failure business.
Welcome to the podcast.
Well, thank you very much, Kayleen and Tom, and thanks for having me.
Our pleasure. And that’s why Kayleen got promoted. She does the research that I never do and knows the answers to the questions before we even ask. So I love to learn. I mean, whenever we have these conversations, we always want to understand the people we’re talking to before we get to know the technologies. So, Finn, how did you find your way into medicine? First of all, what, what made you decide to be a doctor?
Yeah, that’s a kind of an old story by now, Tom, I think dates back more than 30 years. But, but I, I was really interested in physiology and how the body works. So I think that really got me into medicine and med school. I, I really liked the heart, the circulatory system. I was very interested in physical training, exercise understanding. Yeah, I mean, probably the, the interest has become more theoretic over the years, but at that time, you know, it was also more practical.
But, you know, the physical exercise, understanding how the body works and really how the heart works, and that’s how I got into cardiology and eventually heart failure.
Did you see the heart and the cardiovascular system is more of an engineering sort of marvel than a medical one?
No, I think, I think those two go hand in hand. I think you have to understand the mechanics to become a good doctor. Obviously there are many others, many other layers than the pure mechanical ones to being a good doctor certainly. But you have to understand the mechanics. And I think the circulatory system is a really mechanical model in many ways. So I think they go hand in hand for sure.
And Kayleen had mentioned your time at university. How did you move from there? And then of course we’d love to unpack what led you to join Abbott earlier this year?
Essentially working with heart failure in cardiology for years drove a strong interest in research and understanding why patients trajectory is developed as they do. How can we impact them, how can we treat them? I was for years, you could say part of a journey where heart failure really transformed, formed from being a disease that could be treated with digoxin and diuretics. So really very limited 100 year old pills to suddenly being really main stage for in cardiology for treatment with multiple number of drugs and an emerging, you know, a number of devices that really spiked my research interest.
And I think, you know, in the end then combining clinical medicine with academia led me to taking the part time being a professor at the university while also being a consultant obviously in heart failure and cardiology at the Riggs Hospital in Copenhagen.
And the opportunity to join Abbott, how did that come to be and what led you to take the position?
So I’ve been working over the years with different device companies in the field of heart failure, in innovation, in clinical trials. And I worked with Abbott for years, Both with CardioMEMS™. And HeartMate 3™ and really enjoyed working with Abbott. I would say, I think after having spent 30 years in clinical medicine and probably last 22 or so in heart failure, you certainly will make a difference for individual patients over time. And I think I did.
I think at some point I realized that there was also an opportunity to make a difference in a different way than in the traditional physician patient encounter one to one on the daily clinical basis. But actually maybe help drive the field of heart failure and advancement for a greater number of patients in a different role. And then that this role to work with and in particular I would say Abbott Heart Failure, because it is the leading device company in heart failure for sure was a very attractive one to me.
I’d like to get a better understanding of what really heart failure is. So as I said in the introduction, our last episode of Abbott talks, we looked at structural heart and if I Know, if I was to go to my mom and say, hi, this really great interview on structural heart. And my next interview is on heart failure. She’s gonna say, what’s the difference? So for myself and those who aren’t in the know, can you first explain what heart failure is? And is it just the failure of the structure of the heart, or is it more than that? And how does heart failure impact the heart’s ability to function?
Right, right. So heart failure is, first of all, a very common disease. Right. We estimate that around 7 million people in the United States suffer from heart failure. It’s the most common cause for hospital admission. And essentially, all the heart diseases we know, they could be structural, they could be heart attacks, they could be arrhythmias, they could be, you know, all the things we talk about in cardiology can ultimately all lead to heart failure. That’s kind of the end station for all of these diseases. So it is, in the end, when the heart is not able to pump sufficient amount of blood to the organs, either at rest or when we exercise or stress the circulatory system, or can only do so at the expense of increased pressures inside the heart. And actually, the latter really relates to one of the Abbott devices that we’re talking about, namely cardiomems, the pressure sensor, because it really.
That’s the underlying physiology. So it is when the heart, for some reason, with multiple. The typical ones being high blood pressure or heart attacks, diabetes. So typically also lifestyle diseases lead to the failure of the pump to really pump blood to the organs and the muscles either at rest or when we exercise.
Spoken like an experienced professor. So I understand better than I have in a long time, so I really appreciate that. Let’s talk about the patients, the patients who are most commonly affected by heart failure. I know you touched on it a little bit, but are there specific risk factors or conditions that might make them more likely to. To require intervention?
Yeah. So when patients develop heart failure, Heart failure is a chronic disease that evolves over time. And there are, like, different stages. You could say, like early heart failure, you can be at risk for heart failure. And some of those we mentioned already, prior heart attack, diabetes, obesity, high blood pressure being, some of them, certainly also genetic diseases. So heart failure can run in families. We have.
You can get heart failure from, you know, when you’re only a few months old, if you have some of these inheritance diseases, and then, of course, until the end of life. So it is a spectrum. But when heart failure progresses, we typically start treating with drugs, and we have effective drugs nowadays that can treat many patients and actually give them an acceptable quality of life and also a much better prognosis than previously.
But as heart failure progresses, that’s typically when we start thinking about different devices that can help with the long term survival and also improve symptoms. Symptoms are typically tiredness and shortness of breath and the tendency to accumulate fluid, typically swollen legs, swollen belly. And patients typically show up that way at the initial time of diagnosis.
I wonder what the first symptoms were. Is there a percentage where it’s considered heart failure? Is it not failure at 85% of efficiency, but under 85 it is failure? Is there a number or is it more just a general diagnosis?
Yeah, that’s a good question. And actually it is a continuum. So there is no percentage. And also it is a combination of how the body, you know, the body composition. If you’re a very small person, you’ll need less heart function. If you’re a very big 200 pound fellow, your heart is going to need to be larger and stronger to meet the demands. So it is really when we see those compensatory mechanisms, as we call them, so the mechanisms where the heart starts, you know, the body strikes to try to alleviate some of the consequences of the impaired heart function, if you will, typically activation of hormones and other stuff that, that actually drag water back into the body. So that those are some of the consequences as and why we see the fluid buildup in the patient.
So from what I’m understanding, and I’m going to use these very general terms, so please feel free to correct me, but the sickest of patients require device intervention, which I feel like brings us beautifully over to Abbott’s heart failure portfolio. So we’ll deep dive into each of the products a little later on. But just for context, can you give us just an overview of Abbott’s heart failure portfolio?
Yeah. So the Abbott Heart failure division has right now three main products that we serve heart failure patients with. We have what we call a centromap, which is the pump that is used acutely for circulatory support in the hospital in critically ill patients, even patients who are suffering a cardiac arrest. But basically what we call patients in cardiogenic shock. So this is a temporary pump external to the body that can provide circulatory support and even also oxygenate the blood.
Supply the blood with oxygen to sustain life for a limited period of time while either the patient recovers or receives a heart transplant or receives one of the other products in the portfolio, namely the durable left ventricular assist device called HeartMate 3. That’s a pump that is surgically implanted into the patient where the driveline comes through the skin, driven by external batteries that the patient can go home with and live with for years, more than a decade, unless a transplantation is performed or is needed.
So those are the two circulatory support products. And the last product we use is in earlier stages of heart failure, not the very earliest stages, but typically patients who remain symptomatic despite the drug therapy. And that’s the cardiomems, and that’s a small center that is implanted under local anesthesia through the vein, a blood vessel, typically in the groin or in the neck. And it’s about the size of a quarter or so.
Actually smaller, but the size of a dime. Sorry. Still getting used to the US Currency. We don’t use coins much anymore, but it’s small. And it’s implanted in the lung artery through a catheter left there and without a battery, is able to transmit. Transmits the pressures from the vessel, which reflects, as we spoke about before, the pressures inside the heart, which are really critical. So when the pressures go up, this is a marker that fluid is starting to build up or will build up in a few days if you don’t do something.
And that gives us an opportunity to intervene early, prior to the patient feeling it, prior to anything happening and with medications, and then prevent, you know, fluid buildup, decompensation, and the need for going to the hospital. So this is a monitoring device. So those are the products in the portfolio.
I think we get very excited when we hear the word sensors and data, and they’re certainly the buzzwords. And as I mentioned earlier, cardiomems, I think, was one of the first to really bring this not only to light at MedTech, but also particularly within the heart. So how is the data sent to the doctor? How is a physician able to say, whoa, you’re beginning to. Your condition is getting slightly worse. You need to come in and see me.
What is that process like? What is the device the doctor’s looking at? How does that entire process work?
Essentially, the patient is implanted in the hospital, goes home same day, typically, and brings home a pillow.
And it’s not the most. You know, it doesn’t look a lot like a pillow, but that’s the best name right now. And that’s connected basically through a secure connection to the Internet. And we’ll transmit. The patient lie down. Lies down on the pillow for about 18 seconds every morning.
Press the button and then these pressure measurements go directly to a secure connection to a system that the physician or the nurse at the hospital will access a couple of times a week, three times a week, or alarm the scent if pressures are really high. And then that allows the physician or the nurse to check the pressures, contact the patient if need be, or say everything is fine. And that really is the way that this communication works.
I’ve heard about the pillow and I’ve kind of always tried to figure out, well, I put my head on the pillow, not my chest. I wondered how that works.
So this clears up so much for me.
I now understand the process and I understand also that it’s becoming more mainstream. I mean, we’re not the only ones recognize the value of data and sensors. I know CMS had a positive experience expansion of coverage earlier this year. How is the adoption for patients growing? How much more widely? How much more widely or how widely accepted are the car u mem sort of procedure becoming? Is it becoming available to more patients and how is it finding its way into patients and into the clinical decisions?
It is increasing, obviously, with the NCD being going through. That is an important milestone for more patients getting access to this therapy or monitoring device. It’s still only a few percent of heart failure patients that are being monitored with cardiomems. So there is a lot of patients that are still not, you know, being offered or treated with the device. It’s not for every patient. I mean, some patients do really well and have, you know, no symptoms on drug therapy.
And they probably don’t need this device, at least not to the extent of our current knowledge. Maybe in the future when we get more trials. Right now, it’s patients that remain symptomatic despite drug therapy or medications, appropriate medications. And for those, we’re still seeing a moderate uptake. And I think there is a lack of knowledge. There is probably a little bit of a lack of tradition to use devices unless you’re desperately sick in the hospital in heart. In heart failure in particular.
On behalf of patients or physicians, where’s the. Is it the physicians who don’t see the need for the patients who don’t want to go into the procedure? Maybe a combination of both.
Yeah, I think, I think, I think that there’s a combination of both. And I think part of this is to do with, you know, disseminate, you know, knowledge dissemination, understanding. And we know that for medical devices there is a slow and adoption in cardiology. In general, there’s a long lag time between devices being recognized as effective and useful for patients and the actual uptake. So I think there’s work to be done there.
What we see is that patients benefit from this not just by what we’ve shown in trials, that the risk of being having to be admitted to a hospital with fluid overload is dramatically reduced in subgroups. We also see improved survival with the device because you manage them better. And finally, and actually an interesting study just came out documenting that I’ve been working with the cardiomems and implanted cardiomems for years before I joined Abbott. And I’ve definitely seen this with patients.
But the sense of security, the sense that people know that somebody’s watching them, right? We have patients telling them we didn’t go on vacation, we didn’t go anywhere because I was always uncertain what was going to happen. Now with this monitoring device, I know I’m going to be fine because otherwise they will tell me. And actually led to, I would say, really fulfilling one of the visions for Apple in general, really empowering patients and letting them live their lives.
So I see that as an. An added benefit beyond the hard endpoints, if you will. And interestingly, a study just came out documenting them as a subset of tmoires trials where patients really voiced that. So I think that’s. So I think to your question, it’s only about 1 to 2% right now that are being monitored with this device. And there is Certainly, it’s not 100% should not be monitored, but there are certainly, and we’ll see, I’m sure, a greater uptake in the coming years.
That’s great. No, I mean, we joked about data before. I was speaking as a reporter or as a journalist, but as a patient, I love having data. I mean, I love knowing what’s. Because you don’t know when you’re going to see your physician again, honestly. I mean, obviously if you’re in a critical state, unfortunately you will, but there’s in between states where you’re kind of like, do I feel this way? Do I feel that way? You try to call. It’s just, it seems like this technology is coming in at just the right time. So excited to hear that adoption is ticking up, albeit a little slowly. But I’m sure you’ll take care of that.
We’re going to take a quick break from our keynote interview to bring you the conclusion of our conversation with this episode’s sponsor, Tecan.
But what about the devices themselves? I mean, are they being changed due to today’s healthcare landscape.
Yeah, I think we’re seeing a lot of movement in how can AI change diagnostic practices in general. Whether that’s personalized medicine, oncology, patient monitoring. These devices themselves are actually changing what their function is and how they do their work. And whether our devices that we’re building are preparing samples to flow into the type of endpoint analysis that are feeding those insights generated by AI or actually the analysis device themselves.
So these devices are infused with the cutting edge of technology, which is really exciting because that’s basically the manifestation of our mission statement, which is to scale healthcare innovation globally. And it’s been really exciting to help our OEM customers who are taking these devices out into the world to do exactly that, to have an impact across the globe.
So it’s always clear to me that Tecan has a value forward strategy, which leads me to wonder, how does Tecan support its partners in navigating the complex regulatory landscape, particularly when bringing new digital health solutions to market?
I mean, first and foremost, I have to give a shout out to our quality and regulatory teams. They are absolutely phenomenal. They are one of the strengths of the organization. And I think it’s exactly that strong team which is kind of at the core of our ethos, core of our identity, and we bring that to really everything we do. But as far as what does it mean for an individual partner or customer that’s working with us, we have a broad experience, so we work with most of the top 10 IBD companies that are out there. We work with huge pharma companies, we work in regulated spaces, and we do that across the world.
And we have a organization that gets audited quite frequently because of these products that we make and these services that we offer. And it means that this experience we gather, we internalize in terms of best practices, we internalize it in our standard operating procedure, in our product development. But it’s also something that we can gift to our customers. Because we work with so many customers, we actually have more experience in a wider range of topics and regulated environments than any single customer can.
And so when you work with a partner like us, it means that you actually get that brought to you. And so even startups love it because we can kind of bring that expertise to them, whether it’s a contract manufacturing thing and it’s their first device coming to market and they need a lot of advice. But even large organizations navigating new spaces, their first time developing a new type of device, or wondering how the European AI regulations might impact the product strategy that they’re developing.
These are all things that we bring an informed opinion on and it comes from our experience and our expertise.
Well, Hal, I’ve had so much fun with you today.
Hal Wehrenberg, Vice President, Digital Transformation at Tecan, and thank you so much for joining us on the podcast.
Once again, a huge thank you to this episode sponsor, Tecan, for allowing us the opportunity to share this conversation with our audience. To learn more about Tecan, please visit their website at partnering.Tecan.com and now we bring you the conclusion of our conversation with Dr. Finn Gustafsson, Chief Medical Officer for Abbott Heart Failure.
I think the the other side of adoption is adherence. So I’d be interested to know about patients adherence. Are they using cardiomemes the way they’re supposed to? Are you seeing the patient responsibility actually come to fruition in the way you need it to?
Yeah. So I think generally yes, patients are compliant and motivated to use it. And I think there’s a selection process as well. Right. You want to talk to patients prior to implanting a device in them that they are interested in using it. Otherwise it’s, it doesn’t do anything on itself, if you will. So it’s a really important point and an important point to discuss with the patient prior to, you know, having this making the decision of to implant.
Excellent.
So this is a good time for us to, I think, shift over to HeartMate 3. How has, how has HeartMate 3 changed the way clinicians think about using LVADs to treat advanced heart failure? So let’s maybe start there.
LVADs have had a long history, back from when devices were large and bulky with a short lifespan and then transitioning into what we call the current continuous flow devices. And now with the Heartbeat 3 introduced in 2020, 2015, we really see that the technological evolution has transitioned LVAD’s left ventricular assist devices, these implantable pumps, from being something we would use for a short time just prior to a transplant, when really needing a plan for transplantation, to devices that really treat advanced heart failure, irrespective of whether it’s for short term for cardiac heart transplantation or as what we call destination therapy, as the final therapy for heart failure ongoing.
And that transition happened probably with the second generation pump called HeartMate 2, but really took on after the the Momentum 3 trial, which compared HeartMate 3 to HeartMate 2 and showing a much improved outcomes with the current HeartMate 3 in particular, with respect to risk of some of the complications that were prevalent with earlier legacy pumps.
I’d like to talk a little bit more about the Momentum 3 study. So you gave a very high level of the results that you saw, but could you dig in a little bit more and like, what, what did you glean from it? How does it speak to HeartMate, HeartMate 3 and so on?
Yeah, so HeartMate 3. So the Momentum 3 trial compared the HeartMate 3, the current pump in use, with the HeartMate 2, which was in itself a tremendous step forward compared to the old pulsatile pumps. The study was a randomized trial in patients with advanced heart failure, and it’s the largest study ever done in advanced heart failure and mechanical circulatory support. This study showed after two years, similar survival, but much lower rate of stroke, of thrombosis. So clots inside the pump, which was a problem previously because then you have to exchange the pump, you have to open the patient’s chest again, put in a new pump, which is not necessarily a benign thing.
But so those endpoints were massively reduced with the HeartMate 3 after 5 years. Actually, recently a 5 year follow up was done. At that time, there was a difference in survival with the two devices as well in favor of HeartMate 3. And actually for the first time, we were able to see a median survival exceeding five years. So essentially with HeartMate 3. So essentially survival with this pump is on average more than five years.
As I mentioned, we have patients on these pumps for 10 years or more. The data from Momentum 3 was correlated by not just being trial data, patients selected for a trial, but also real world data from what we call the Intimax registry in the U.S. so a much larger cohort finding completely similar, actually 6, 60% five year survival, and a European registry as well of more than 400 patients, completely similar survival. So very robust data showing us that in these very, very sick patients who are prone to die within days to weeks if they’re not treated with mechanical circulatory support, we’re now extending lives well beyond five years in these patients. So from that perspective, Momentum 3 was really, really changed the landscape and the perception of durable mechanical circulatory support in the field.
I love that so much. You flagged my interest when you were talking about real world evidence and registry, so I’m going to circle back to that. But before we do that, I have to think about the patient experience. So what impact, and it could be anecdotal, but what impact has HeartMate 3 had on patients like their longer lifespan or a better quality of life. What have you seen?
So first of all, obviously for many of these patients, the initial goal is to survive because for most of these patients the alternative is essentially death within a very short time frame. So that’s typically the initial population. I think typically once you then survive, then you want quality of life and being able to do all the things, which makes complete sense fortunately. And that’s where we’ve seen a huge progress.
So clearly very large improvements in quality of life for these patients, both compared to prior to the pump implant in in patients, but also compared to earlier pump products. So better quality of life. 80% have minimal or no heart failure symptoms after treatment with the pump. A few still have some heart failure symptoms, but 80% are what we call class one or two symptoms. There is a tripling of the six minute walk distance with the pump and, you know, very significant improvements in quality of life. So is everything perfect?
No, not necessarily. I mean, you have to live with a pump. You have a driveline, you have batteries that you exchange every 16 hours or so, which is a small process. But of course if you travel or if you go out, you need to bring extra batteries. So you can’t go swimming, but you can shower. So there are some limitations, but overall we see that the quality of life is high and we certainly see that patients, even when presented with the option of being transplanted, getting rid of the driveline, if you will, in the batteries, we see patients that actually prefer to stay on the vat because they know it’s durable and they know that they don’t need to take drugs to suppress the immune system.
So I’m not saying that all patients would choose to stay on the vat, certainly not. But just as an example of the tremendous improvement in quality of life we’ve seen with, with the HeartMate 3 compared to, especially to earlier pumps. So it is transformative.
Absolutely. I promise to circle back to real world evidence and registries. So what role do they play in validating and expanding the use of Abbott’s heart failure technologies?
I think this is general to cardiovascular medicine and medicine in general that we, we typically test our drugs or devices in a selected population, right. Where we think that it needs to be safe. To test it in that population needs to be meaningful and we need to be able to measure outcomes. So we do that in selected group. And that’s helpful. It informs us whether the device is safe and effective. And we saw that with the Momentum 3 trial.
The challenge is of course that that selection process also creates a boundary for we can to extrapolate, to say, hey, can we use these results and talk about everybody else? What about that patient, that patient who might not have fitted exactly the inclusion criteria for the pivotal trial? And that’s why the real world evidence becomes crucial to extend the knowledge from the randomized clinical trial to the broader population. See, can you reproduce the findings that you saw in the clinical trial? Are there signals that we need to be aware of in the general population who typically have more comorbidities, have different profiles, maybe different age spans, et cetera.
And that’s where it’s been. So I would almost say surprisingly fantastic to see how the Intimax registry and the European Registry mirror the Momentum three trial results very, very, very narrowly.
One last thought about HeartMate 3™ and I’d be remiss if I didn’t mention there’s been some news around aspirin use with HeartMate 3. So what’s changing there and what could that mean for patients?
Yeah, that’s kind of the next chapter when we talk about mechanical circulatory support because we have clearly had tremendous technological development and that is continuing and more to come. But we also seeing that with the improvements we’ve seen with a one year survival of almost 90%, driving up survival just short term is probably not, is not going to be the goal for the next generations and for the total management package. So it’s also about how do we treat these patients because they’re not just surviving five, six months.
This is long term therapy, 10 years if you will. So how do we manage these patients? And one of the management pieces of having a HeartMate 3 is that you need to inhibit the coagulation system to avoid getting clots in the system. That’s like with mechanical heart valves and others. If you put things into the circulatory system you need to anticoagulate. Historically this was done with warfarin and aspirin together we knew that bleeding because of these needed treatments was a significant risk for these patients. So typically bleeding from the nose or bleeding from the stomach, which needed then attention and was a cause of morbidity in these patients.
Heartbeat 3 had very significant technological advances compared to earlier pumps in that it was much more compatible with the bloodstream. And that led to the hypothesis that maybe aspirin is not necessary. So that’s why we did a trial called the Aries trial where we randomized more than 500 patients just implanted with a HeartMate 3 to either receive standard therapy with warfarin, so coumadin, the classical anticoagulation drug, and aspirin to randomize them to receive either that or coumadin or warfarin plus placebo. So no aspirin. And the hypothesis was that you wouldn’t need it, that it would be just as good not to do it.
And we showed that very, very convincingly. But furthermore, we showed a 40% reduction in bleeding events if you did not use aspirin, if you got placebo, really leading to also associated very large decrease in hospitalization need in patients. So really was now is part of the label that you only need warfarin when you get a HeartMate 3. And that’s. I think it’s an example of how we are moving this field forward not just by improving the devices per se, but actually the entire patient treatment.
That’s fascinating. Just final question, sort of building off of that answer. And we open this up by you’re giving us a great sense of the large problem of heart failure. You’re seeing progress in cardiomems use in helping patients who are less sick. The LVAD information was startling. I never knew someone would choose to remain on the pump if an organ was available. And I know it’s not everybody, but still the fact that someone does that, I think speaks to what the pumps are able to do.
Where do we go from here? You’ve outlined the size of the problem, you’ve showed us some signs of progress. But what excites you about the future?
Well, I think there’s more work to be done on this whole, actually also doing very robust science around mechanical circulatory support, like the Aries trial. And we’ve just published another, I think, very important study called the Aspire study, which informed us that using chlorhexidine silver dressings for the exit site for the driveline was associated with almost 40% reduction in driveline infection. Which is one of the remaining issues that we unfortunately have with having the driveline but actually doing trials, doing real robust science, I like to call IT LVAD Science 2.0, because we’re really moving away from just registries, but doing real trials in the field, also showing that the field is maturing.
That’s going to, I think, really improve outcomes when we focus on the entire patient journey, not just the device per se. But obviously the future will also definitely include improvements of devices, the smaller devices that will deliver the same pump energy, if you will, and also at some point, technologies that will allow us to have not permanent time with the driveline going through the skin. So I see we’re going there.
Everybody recognizes that that’s going to take some more time, but we’re working on, I think, importantly, the entire management and treatment of these patients, not just isolated to the technology per se, but the whole treatment package. And I think that’s going to really transform outcomes for patients.
Remarkable. Well, I think this is one of the true MedTech stories where you’re building devices and tools that are keeping people alive and giving them a way to live a life as well at the same time. So remarkable stuff. Great conversation, Finn. I’m glad you’ve, you’ve joined us in the, in the MedTech industry. It’s great to have your, your expertise and your knowledge here, and we’re really grateful you chose to share it here on the podcast. Thanks for joining us.
Thanks for having me.
All right, well, that’s a wrap. Kayleen Brown, it’s time to play our favorite game. What did you learn? What did you learn from our conversation today with Finn Gustafsson?
Well, I definitely learned a lot. I think at the beginning, I had posed a question to you, reflecting on season three. How much did you learn? I didn’t actually think that I’d also be answering that question at the end of the interview. I learned a ton, so thank you so much, Finn. But one of the standouts out of the many standouts was the fact that some patients, not all patients, but some patients, when they’re given the opportunity, opportunity to have a transplant, instead of keep their LVAD, they’re choosing to keep the LVAD. And you don’t really -
Right. Like, we both had this, like, we both said, wow, and sat back and I saw our own reaction because you just, you don’t think about that. And I think it makes such a strong case for how impactful these devices really are on the patient experience. And Finn had mentioned that for those patients who are choosing to keep the LVAD, it’s because they know the device is reliable. They already know how the quality of their life is working for them and to risk that. And I’m using the word risk, not Abbott, not Finn, the patient.
They’re choosing not to risk the quality of life that they’ve gotten used to. Again, understanding the reliability of the device is a really good fit for them. It just is such a mark for how far we’ve come with LVADs. It’s pretty cool. What about you? What did you learn, Tom?
Well, I, as I said during the interview, I never knew what the pillow actually was. With the CardioMEMS™, I always had this image of why would someone lie on a pillow? How long do they have to lie on this pillow? Is it a pillow they sleep in for the whole night? And you’re uploading data the whole night? I’m glad we got some clarity on that. I’m sorry the MedTech world sees how dumb I am when it comes to some medical devices.
How dumb we are or we are. Thank you for taking the bullet with me. Like, oh, pillow. I imagine it’s a pillow, but there’s many different kinds of pillows. So I’m glad Finn enabled me to see the light on that. But just, I think also more broadly, just the problem that heart failure is, the progress that Abbott is making and the hope for the future. I think they’ll get a lot of other great products they’re working on, so be exciting to to track the space. So I learned MedTech is cool, but I knew that, so I don’t know if I actually learned it.
Reinforced might be a better way of saying it. It’s been reinforced that MedTech is really cool and we are very, very lucky to be part of this industry in our very dumb, small way. I want to emphasize it again. We are so dumb, but we are so lucky to learn from those who are much smarter than us.
Exactly. And we’re also very lucky to have the fine folks at Tecan sponsor this episode of AbbottTalks. They are great supporters of DeviceTalks. We’re very grateful. And you should go to Partnering.Tecan.com for more information. All right, Kayleen Brown, if folks have just discovered this, this podcast and the DeviceTalks podcast world, what should they do if they don’t want to miss a future episode?
My best recommendation would be to follow the DeviceTalks podcast network on their favorite podcast player. And if you’re going to ask me my favorite podcast players, all of them that play DeviceTalks, with the DeviceTalks podcast network, you’re going to get access to every single one of our podcast episodes. But if you want to follow AbbottTalks, pure and simple, AbbottTalks, you can do that as well. AbbottTalks, one word on all of your favorite players. And we hope that you do, because we love to provide these great MedTech stories.
Absolutely. And we also hope you’ll connect with us on LinkedIn. We love being part of your MedTech conversations. Tom Salemi, editorial director of DeviceTalks.
Kayleen Brown, managing editor for DeviceTalks. But please do. Really, please follow us. Please send us messages that really gives us the fire to continue to have these conversations and find our way through our email and all of the other parts of our job that is not as fulfilling as sitting down with people smarter than us. So please message us. Please give us those fires. And thank you so much to Abbott. Thank you, Finn, and thank you, Tecan, for allowing us to do well, my dream job.
So thank you.
Can’t say anymore.
Thanks everybody for joining us.
