Clinton Kemp, M.D., provides an depth presentation on LVADs. Dr. Kemp covers what are the indications for LVAD, who are the DT LVAD patients, what is the surgical technique for implantation and what are the outcomes.
Good morning, everybody. Thank you for joining us. I'm click Camp one of the cardiothoracic surgeons here. Tara, I am a consultant for Edwards and Medtronic Structural Heart as well as Paragon ICS. So the objectives of my part of the talk already go through a brief overview of L VADs to see where we've come from and where we are. Talk about the indications for l've at the three major who are DTL fad patients, the surgical technique for implantation of elves and then l vet outcomes. So first, to start with a brief overview of Al bods, we've come a long way. The earliest devices weren't even implantable. These a pair of corporeal devices like the Abbey Ahmed B Bs 5000 and 85,000. Um, I really enjoy the picture on the left because those of us who've taken care of these patients, no, they're not lying there comfortably and repose. They're very sick, and these are actually pumps that are attached or were attached to the bedside as well. The rial first generations of l VADs like we think about the implantable ones, were like the HeartMate, ex CEO of the Nova Corps left ventricular assist system. Um, these were implantable, but we're still rather quite large and actually implanted in the abdomen, making both implants as well as X plant during the time of transplant. Quite difficult. The rial modern era came with the heart made to the Jarvik 2000. Never really took off. But the HeartMate two was the major workhorse for left ventricular assist device therapy for quite some time. And this is one where you can start to actually hold it in your hand. Fast forward to the modern era, the third generation centrifugal flow devices. There's really two that we use the hardware, a chat on the left and the HeartMate three of these both. As you can see, you can literally hold in the palm of your hand. Now, there were two trials which compared both of these new modern devices against the slightly older HeartMate two, and showed that these were better. And these air pretty much what we use every day. This is an important trial, and this is actually taking a little bit set backwards. This is the rematch trial. This was a randomized controlled trial between the HeartMate XP, so that older, larger, implantable version versus maximum medical therapy. And this was actually the first study that showed that patients survived longer. 48% reduction in all cause mortality with l VAD therapy compared to maximum medical therapy. So this is really what gave us the impetus to be able to use l've ads in these patients as advanced surgical options. So now we'll talk about the indications for elves bridge to transplant. This is using the L VAD is durable support for a patient on the heart transplant. Wait list we take a patient like Dr Yahya had described his very sick, and we put them on an l VAD, which allows them to be supported while they're waiting a heart prior to 2018, when the unis allocation system changed and we'll talk about that in a little bit. This was the most common indication for implantation of L VADs. The second is what we call bridge to decision, or you may see it Tina's Bridge to candidacy. This is for a patient where there may be one or two yellow flags, maybe even a red flag, but possibly modifiable. So right now, they're not a candidate for transplant, but there's either a possibility or they're too sick right now for us to be able to determine definitively there are transplant candidate, so we implant thes, and these patients will either become bridge to transplant or become destination therapy. In the destination. Therapy is durable elves support for patients who are not a transplant candidate, and we'll go through some of the indications for that as well. So this slide here shows the changes that took place in you nose in October of 2000 and 18, and these changes had a big time effect, both on how we is the heart failure community. Treat patients with heart failure as well as how patients get allocated for transplants. Um, in both of these systems, the one in prior to October 2018 is on the left, and the new current one is on the right, and both of them. The goal is to get hearts to people who quote need them the most. Now, obviously, that is up to interpretation, and one of the things that the old system was criticized for was increased weightless mortality. So if you take a look at the flight on the left of the graph on the left. Rather, patients with l VADs were either one A or one B, right? So just even having an l VAD doing perfectly well at home, you were a status one B. Obviously, the lower the status or the the lower the number, the higher the status. More likely you were to get in Oregon, all you had to have is one device related complication, which could be a drive line infection, um, where the patients were relatively doing well. But we're on antibiotics for infection, and all of a sudden you were bumped up to the top of the list. This essentially meant that for those patients who were bridge to transplant if we implanted in, l bad say in January we would expect to transplant them that year, sometimes even within a couple of months. So what we noticed was that patients on the wait list were dying, and so the allocation system was changed so that truly the sickest of the patients would be the highest status. So you can see that the new status ones are patients in the hospital on ECMO. There they have non dischargeable surgically implanted by VADs. Um, even status to tandem. I mean, total artificial hearts are VADs by VADs. What you see is that now l've ads go for the most part two status for with some exceptions and some truly life threatening complications, we could go to Status three. But what we've seen as a community and as well it's in Terra is that it's very difficult to transplant somebody who's not a status one or two. It's not that we don't do it, but no longer can we say we're gonna put your all that in in January and get your heart this year. So therefore, the L VAD landscape has changed. This is data from the ts slash inter Max registry, published in 2020. So starting in 2014, the different colors represent the different indications for L VOD. So in 2014, 15, 16 and 17, destination therapy was less than or around 50%. As you can see, the bridge to transplant as well as bridge to decision, of which a lot of those patients went on a transplant was the other almost 50%. What's interesting is the allocation system in 2000 and 18 didn't change to October, but you can see already that year the number of bridge to transplant uh, L've at implants went down and the number of destination therapy went up. And then, in 2019, the majority of elves air implanted, now a destination therapy. So who are the DTL that patients? Well, the short answer is anyone who is not a transplant candidate, right? So, typically, folks who are slightly older most transplant programs will transplant folks up to 72 73. Um, current substance abuse. Um, mostly, this is tobacco. And surprisingly, when you tell patients you either have to stop smoking or you can't get a transplant. Not everybody wants to stop smoking, right? History of malignancy, even if they truly are, felt to be in remission if they're within the five year window there, technically, not a transplant candidate, but there would be a candidate for a destination therapy. L've odd patients with renal dysfunction who are not a candidate for concomitant renal transplant folks was elevated pulmonary vascular resistance and the inability to tolerate a heart transplant alone, necessitating a heart lung transplant. Patients with obesity currently in our program, we will transplant patients up to a B M I of 35 with exception up to a B M I of 38. But what about the patient with a B. M. I 40? And then, surprisingly, there are patients who choose not to pursue a transplant and would rather anel bad. Obviously, this is, um this is a minority of the DT patients, but, um, this is basically the snapshot of who we're looking at for destination therapy. L've odd, and the important thing to consider is to some of these destination therapy patients maybe later considered for transplant. Right? Somebody who is smoking but promises to quit, finds the substance abuse contract and gets their l that after a certain amount of time, they complete their contract and they are now a transplant candidate. We do have patients to who are above the B m. I cut off. Very motivated to lose weight. We've partnered with our bariatric surgery colleagues as well. Those folks who lose weight and now we're in range will become transplant candidates. And finally, the l VADs can help patients lower their pulmonary vascular resistance to where they would become transplant candidates. So now we'll go into the surgical technique. For the most part, these air typically implanted via medium stra nana me on cardiopulmonary bypass. Um, there are some centers that do perform this off pump. There are some centers that do perform this to authority. Khatemi approach. Um, we have terror, have tried all these approaches, and this is the one that works well for us in our patients. And I would say that by and large, this is the majority of implants today. Um, both pumps that we use the HeartMate three and the H fat, having inflow cannula attached into the left ventricle attached to the pump. And this blood flows from the pump to a graph stone to the ascending aorta. The important part to remember is there is an externalized drive line attached to a controller unit that's worn by the patient continuously. These patients are systemically anti coagulated, first with heparin as an in patient and then transition to Coumadin. So this is a diagram of the H bad. This is a truly inter pericardial pump. Is you can see it's implanted into the left ventricle, sits within the pericardial cavity itself, and blood flows from the left ventricle into the impeller. And then it's pushed through this graft out to the house ascending aorta. And as mentioned before, there's a perky team strive line attached to a controller that's worn by the patient. This design is very similar to the HeartMate three, which isn't truly an intra pericardial pump. There's some slight differences for those of us who implant them, but essentially to is attached. The left ventricle has a rotor and a motor in there, which pumps blood to a graph to the ascending aorta. Again with the drive line that comes out and has attached to a controller that's worn by the patient. Now this is a study we really want to see. Um, I didn't I just touched on it briefly. The endurance and the Momentum trial showed that both of these pumps are better than their predecessors. The HeartMate two. What we haven't seen and probably are unlikely to see is a true randomized control trial between the H fat and the heart made three. So now we'll talk about outcomes after elves, so we've gotten better at implanting these, and the technology has gotten better in terms of the pump and and the ability to take care of these patients afterwards, we've gotten and this is all Inter Max data. So this is all centers across the world. We've gotten 30 day mortality down to 5%. Okay, One year survival out to 82%. About 50% of patients are alive anywhere from 4 to 5 years, depending on which way in which part of the data you look at. Um, less than 5% of patients had my cardio recovery, but there are some patients who do get X planted from their L VOD. Not surprisingly, the survival is dependent on which category of patients you were in general, Bridge to transplant patients survive longer than bridge to decisions than destination therapy. And this makes sense because in general, the bridge to transplant patients are healthier. They have less home or bids. They're less old, they don't smoke or anything like that. And the interesting in some, a controversial thing that came out of the data is that I did tell you that we didn't have any data comparing the heart made three to the H fat head to head in a randomized fashion. But if you look at this large registry data, which essentially is almost all of the data from all elves and planted across the world. One year survival is better with the heart made three than the H fat. And interestingly, in this one year time period, it's comparable the heart transplantation adverse events. As with any surgery, any sort of device, there are events that happen to patients and their riel. Um, all of these complications are lower for the heart made threes in the age bad. This, combined with the previous slide, has led a lot of centers, including ours to preferentially used. The heart made three over the age bad G I bleeding. These patients can have a B M, both from the pump itself, as well as being at the coagulated can have G I bleed. This is anywhere from 12 to 20% and this could be something that happens. Is an outpatient with a slow downtrend in the hemoglobin. Or it could be a life threatening G. I bleed where patients here in the I. C U stroke does happen in 7 to 16% of patients, and again, this could be something that's picked up based on neuro deficits or it could be a devastating stroke here in the hospital. Infection is still the most common complication after an L VAD, and this typically is because there's a piece of foreign material, the drive line that's actually exiting the body. And we have protocols for not only how to attach these drive lines during the healing process, but also for the drive line change in the dressing change. This'll is still the Achilles heel for the L VADs, and this is something I know both companies they're working on. It would be fantastic if we could get some sort of power source that's either implanted or even have a per cutaneous transmission of electricity. So far, we have not been able to do that, and this infection can take many forms. It can again be a simple, say, allergic reaction. Or it could be a life threatening infection that actually gets back into the media. Sinem, which sometimes communications, not even eligible for transplant and be incurable, right Heart failure, um, is also common about a third of patients. Um, sometimes this is just diagnosed an echocardiogram and not clinically significant. Other times this is folks are home on in a truck therapy to support their right heart. And this makes sense, right, because you have a weak LV that's not getting blood back. And now all of a sudden you have an LV that's able to pump, which can overwhelm the right heart. That's why it's important when the patients are here in the hospital, especially after their implant, to find that sweet spot of flow on the left side so you don't over circulate and cause right heart failure. Yatra genetically eso in terms of quality of life, All this data is actually taken from the Mo Mentum HeartMate three trial and the Endurance H Bad trials. And again, these were trials comparing the newer, uh, pump design from the older HeartMate to pump design. Um, there were improvements in the n Y h a class, the numbers that the numbers of patients that were in class one or two in both of these trials, with zero prior to implant after implant, 77 to 80% of these patients had gone from class 342 class one and two, also an improvement in the six minute walk test right, folks went from anywhere from 100 to 164 m to 200 to 300 m. And then finally the Kansas City Cardio Myopathy questionnaire we had improvement in This is well with both pumps. So here's the Inter Max data for overall survival for all L VADs. Right. So this is every center, every type of l vod Um, the heart made to truly isn't implanted anymore. But some of these patients were still included in the data. The more modern data is again, the heart made three in the h bad. So what you can see is that at five years, almost 50% survival. We've gotten a lot better with our with our l vet implants. Survival by l Vet Indication. And I think this is interesting that they put up the heart transplant on there is. Well, um, I don't think there's anybody in the room or in the audience who wouldn't think that a heart transplant was better than an L VAD myself included? Patients with heart transplants tend to do better once they get out from the immediate surgical period. As I mentioned before, though, the survival of elves depends on the indication again, the bridge to transplant. That sort of royal blue line has the highest survival, followed by the bridge to candidacy, a bridge to decision and then followed by the destination therapy. Again. It's important to keep in mind, though. Even those destination therapy patients whose survival may not be as good as the bridge to decision or bridge to transplant is certainly not. Transplant is still better than maximal medical therapy alone, and this slides a little controversial. And it's interesting if you read the paper, um, sort of how they came to this conclusion. So we're now taking a look at survival based on the type of velvet. And again, this is not randomized data. But this is the largest collection of data on elves. So the CF continuous flow fully magnetically levitated pump. That's the heart mate. Three. You can not only see that that survival is higher than the C F h l or the hybrid levitation or the A chad, but it's also equal to transplant out to about 48 months. So this is This is very, very interesting, right? So for for once, we've been able to show at least in the registry data, that the newer generation. The pumps that we think is quote unquote better actually have survival. That's on par with transplants. And again, I don't think anybody would say, Let's not transplant somebody who's not a transplant candidate But keeping in mind we have about 3000 organs a year and that some patients aren't transplant candidates. This is a very good solution and a very good treatment for those patients who aren't transplant candidates. That's all I had from my portion of the talk, and I'm happy toe have back to back up here, and we can entertain some questions. If anybody has some, I'm not sure any how we actually get questions from the audience as well. But if we could do that, that'd be great. I mean, any suggestions and any suggestions as how we tap that population of patients that are candidates that we're just not finding are not coming to the table here? Yeah, one of, uh, initiatives Dr. Canceled myself are working on it. Looking at the Millennium list. We have our own 60 plus stations on the Miller and List. We've been political months and years, almost seven eso young over that. The basically some of these patients could be that or even transplant candidates. And we talked to the providers Other things is trying to do is reaching out Thio, doing more outreach events to within the system in house, basically and reach bullet, trying to get to our care of positions and trying to get more referrals for patients? Well, sometimes we see patients in their advanced age, and at that time, you know, the kidney function has significantly wars or way don't have haven't been establishing our program, and it might be too late to do anything for them. That's why we did. We're doing this grand zones and other events trying Thio, you know, partner with the physicians in our system and the community trying to get for the patients awesome in earlier states. Yeah, I mean, I think for me it's sort of a two pronged approach. One is, you know, if you see something, say something right. If you're a hospital is taking care of a patient, you get a spot echo. It's 20%. That's the time to refer to the Advanced Heart Failure Center, not necessarily when the patient's crashing and burning and is an inter max water zero in the I C. U and need something, and the other is just to get the information about elements out there. Um, as with anything on the Internet, there horror stories and their success stories. And when patients are faced with a choice, I get it. I would want a heart transplant, too. But these air patients specifically, you don't have that as an option, and I think pointing it out to them. Yes, this isn't a heart transplant. Yes, it's a little different. You'll have a drive line. There's other things to deal with. But pointing out that their survival is comparable up to the two year point with transplant, I think it's huge. Um, one of the things we've been doing is actually trying to use some of our patients who are willing thio as volunteers to talk to patients because it's one thing when you know you are hired, actually go in and talk to a patient at an l VAD. It's another when they meet in L VAD patient who's back working, doing everything they want to dio um, and so that's that's really what we're doing to but basically focusing on looking in and then also outreach. To get folks who have a patient who may be a candidate into the clinic would much rather see them well before they're ready. So we can have that talk, then have them at the point where they're non dischargeable. And it's either this or hospice. Yeah, I mean, I that was very interesting data like he shared about the, you know, the Eldad survivability in comparison to transplant. It gets in my mind, it does seem as you touched on is quality of life issues. And it's earlier that patient get some understanding in terms of maybe some of the hurdles and other things like that, the better they consider assess that. And obviously, you know, if you could get transition to everything being interested, drastic, that's where you don't have, that would be a huge it really a game changer in terms of if you could get similar survivability and it would, our presumption would be similar quality of life. If you don't have the external drive line, that would be tremendous. You know that. You know, working projects. Yeah. One thing I wanna ask Thio if you know, especially in the past two years since October 2018. It was just a big shift and, um, outlook and the culture for patients with advanced heart failure. Now, with the new national allocation, it seems everybody now should focus storage transplants and forgot little bit about the pads. And, you know, sometimes you know positions or providers can be a little bias, especially patients, too. You know our steak and let's get them transplanted, but sometimes transplant. Not the best options for patients who do not know. Especially, you know, they come into our service out of transfer from different centers, and you know they're crashing and burning. We have to act upon them. So I think bringing back the culture and dependent has switched in. What, too far. I think at this time it's always good to just remind everybody that bad is still an option. Sometimes, you know you can do patients this favor by keeping them on tropes, waiting for them to be a transplant candidates on by the time they potential transplant candidates waiting for them to be there might be interesting to get transplant or they might die. And we've seen that. So I think, you know, doing more of these talks in just reminding positions and colleagues. And that's you know, that viable option is that you can't do it. I mean survival rate for his part three or that patient is significantly high and that just providing patients with survival. We're providing patients with food quality of life and with seen it sometimes in the hospital position for nursing staff and to see patients who are potentially frequent flyers locations with complications like bleeding or infection. But they don't see patients out there in the community was driving, living in traveling, so it is important again to just bring it back in. And because treatment options for patients population, if you don't want to give it for transplant patients, that is a very viable options for picking else they're going to die, and I showed you the data on patients. And Honest wrote, Most patients will not survive 40 year old, too. But now we have an option, can make them live longer and feel better in the past. I can see it all the time for Marie Hypertension medicines have been approved because by the FDA because they can make patients walk maybe extra 50 steps for 50 m more on the six minutes five. But now we have a treatment option. That's not just can make them feel that would also live longer years and years and years. And we still hesitant about. So I think we just have Thio embrace it and send these patients expired and flushed out of the house and and getting better. I'm here, um, bridge to transplant. That put them further back on the list in terms of getting transplanted. Yes, it absolutely does. I'll go back to the allocation, uh, slide here. Essentially, if you put in Alberta and now is the bridge to transplant the best. They're gonna be a status three unless they have serious life threatening complications where they can't leave the hospital. So almost without exception, all centers have stopped doing bridge to transplant. Necessarily. No longer really, really think that's right. One thing I can add to that too, is that Terra, we are part off the a d c d. Don't the nation of the cross before you get basically and we're able hopefully with more hearts available for Monday able to transplant patients or status for plus, um, one thing again in the past couple of months, we transplant three patients towards status for on, like my intros at home, too. It's not pulling out from the picture. I think you know, if you wanna bring somebody who is to me 40 or 50 years old, give them four or five or six years on the device and then give them the transplant 45 or six years later, give them 15 or 20 years for transplant. I think it better than just, you know, giving them maybe 15 years and transmit them. They have to communicate more marks on the part. So because it doesn't usually work the other way around transplant, then get a L bet if you have, that's right. I mean that that's been done. But that generally is in practice. You know, it's interesting when when the allocation system first started, um, before people had kind of figured it out and figure out their own algorithm for taking care of patients. If you put some, if you even put a balloon pump in somebody that puts you to a status to we would get hearts often within a day or two. Put somebody on ECMO literally an hour after you listed them, you started to get offers. Now that that's commonplace, it's not that way. We've had patients on ECMO for a week, right? And every day on ECMO, as you well know, is a chance to get renal failure, liver failure, quite you obviously bleeding and everything. So it now, you know, presents itself with Simone with his own challenges, right? You can sit and wait for a heart, which is what we in a lot of Senators dio. But the interesting thing is, you know, should we at some day say, Okay, we haven't gotten a reasonable offer by day, you know, 34567 Let's put an l VAD and let's stabilize them. Let's do all this and then let's wait for them to get a transplant, knowing that it's obviously gonna put them down. And that's really I think, the next front here in terms of our management figuring out that part of the algorithm and also here, um, to be back on that we have a active, um, gardening stock program was involving state. I mean, we have a lot to do. A lot of activists to one of the options to is patients were coming in with cardiogenic shock requiring significant support. And these patients, we don't know their background and all the other compliance or not. Or there were smokers. These patients with the perfect or better candidates say, than heart transplant because again putting them in that in these patients, get them better, centralize them, get them home for them in clinics, see how they do it is another venue where way especially right. I mean, don't get me wrong. The allocation systems greatly changed, which is one patient that I know. Dr Perro does well, prior to 2000 and 18, patient came in in shock, got put on ECMO, recovered to the point where he got Anel. VOD then recovered to the point where he got translated. Now that patient would have come in on ECMO, would have gotten transplanted likely that week or early the next week and sort of cut the l VAD out andan. Also, we've got a family with familial cardiomyopathy. The brother gotta tell that a couple of years ago and I was consulted for the new younger brother who needed an l vod, and it was amazing. I mean, yes, obviously we went through all the education, But he said, I know what it's like. It saved my brother's life. He's out there doing what he wants to dio. I want one, too, about cost of transplant versus cost of Elvis, I mean from reimbursements and point towards patient. Both. Really? I guess. Yeah. I mean, I think all of our patients go through a, um, financial like counseling. We have a financial counselor, which is awesome, and help our patients through the process. And most of our patients are usually to go through the evaluation process. They should be cleared from finance standpoint from AL that perspective that most of the care is usually covered, especially clinic visits and observation based on their interests or from the medical medications. What they need mostly is take their warfarin, which is that one of, unless it happens, speaking, I believe. On the other hand, for example, transplant patients also they have to be approved. The medication transplants. They're more expensive speaking, for example, valve eyes or, you know, but this has before, like six months or a fine. So, um, patients have also, even though they might be expensive but they have also some other venues that can help with medications. Um, you know, coverage. So for patient perspective, you know, it's not all the medicines about transport patients come to the hospital to some for the visit them when they visit. Um, but all the other procedures, like biopsies echoed, usually should be covered by their insurance. Yeah, I mean, I don't have the numbers specifically, it's a great question, Don. I mean, the pumps themselves are not cheap. Um, I would imagine that uncomplicated transplant patient who leaves, you know after the first week or into the second week is going to be cheaper than l God patient. But all it takes is, you know, ECMO run for transplant or, um, some sort of prolonged today, And I would imagine to be comparable with the elves, the expenses up front with the pump and then, like I mean said, it's mostly warfarin. Afterwards, I think your question that Donna is more about sort of total cost of care over six months or 12 months or something like that, and that's a little bit harder to answer. But I think we could try toe, find the answer for you. All right. Thank you. Thank you. Come on,
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