Originally Broadcast December 10, 2020
Hear key opinion leaders from around the world share their experience in mechanical circulatory support. Join us for a discussion exploring data and trends in surgical approach, right heart failure and patient management to achieve excellent outcomes for patients implanted with the HVAD System.
Featured Faculty
Stephan Schueler, MD, PhD, FRCS - Moderator
Anson Cheung, MD
Erika Feller, MD
Prof. Dr. med. Evgenij V. Potapov
Christopher T. Salerno, MD, FACS, FACC
This is an independent event and is not an official part of ISHLTv
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U.S. Brief Statement: Medtronic HVAD System Indications For Use: The Medtronic HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy(DT) in patients for whom subsequent transplantation is not planned.Contraindications: The HVAD System is contraindicated in patients who cannot tolerate anticoagulation therapy.Warnings/Precautions: Proper usage and maintenance of the HVAD System is critical for the functioning of the device. Serious and life-threatening adverse events, including stroke, have been associated with use of this device. Blood pressure management may reduce the risk of stroke. Never disconnect from two power sources at the same time (batteries or power adapters) since this will stop the pump, which could lead to serious injury or death. At least one power source must be connected at all times. Always keep a spare controller and fully charged spare batteries available at all times in case of an emergency. Do not disconnect the driveline from the controller or the pump will stop. Avoid devices and conditions that may induce strong static discharges as this may cause the VAD to perform improperly or stop. Magnetic resonance imaging (MRI) could cause harm to the patient or could cause the pump to stop. The HVAD Pump may cause interference with automatic implantable cardioverter-defibrillators (AICDs), which may lead to inappropriate shocks, arrhythmia and death. Chest compressions may pose a risk due to pump location and position of the outflow graft on the aorta -use clinical judgment. If chest compressions have been administered, confirm function and positioning of HVAD Pump post CPR. Potential Complications: Implantation of a VAD is an invasive procedure requiring general anesthesia and entry into the thoracic cavity. There are numerous known risks associated with this surgical procedure and the therapy including, but not limited to, death, stroke, neurological dysfunction, device malfunction, peripheral and device-related thromboembolic events, bleeding, right ventricular failure, infection, hemolysis and sepsis. Refer to the “Instructions for Use” for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions and potential adverse events prior to using this device.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.Disclaimer: This content is provided for general educational purposes only and should not be considered the exclusive source for this type of information. This training does not replace or supersede approved labeling. The content will be shared with physicians and allied health professionals who seek a deeper understanding of the operation and use of Medtronic products and therapies with the intent of enhancing their knowledge of features and operations described in the HVAD System labeling. Patient information (names, serial numbers, date, etc.) has been changed or removed to protect the privacy of the patients used in this content. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features and results may vary.Important Reminder Compensation MCS EU Brief Statement: TM System instructions for use for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.eu .
UC code: UC202112043 EE
ladies and gentlemen. Good morning. Good afternoon or good evening. Wherever you're listening to us, we would like to welcome you to this afternoon on the terror therapy off. L've at support. So we just heard that we have about 250 participants from 30 countries. So we try to give you the best possible information on data on Elbert therapy. Andi, first of all, let me introduce the fantastic faculty we have collected for you today on Let's start with Doctor Erika Feller. She is a world well known heart failure cardiologist and expert in Elvir therapy. On she works at the University of Maryland. Andi, our second distinguished speaker is Dr Chris Salerno from Indianapolis, a surgeon on Dwan of the pioneers in especially certain aspect off surgical implement techniques in H bad Professor Anderson Chung is a surgeon in Vancouver who also made his name in developing specialized surgical aspect off H vat implantation and is a famous representative off L VAD therapy in our community. And finally Dr Yevgeny, put up off from Berlin on Berlin is he is representing the L VAD program, M. C s program as a whole in Berlin for quite some time and has contributed significantly to the development off this field. So, first of all, I have to apologize that Dr Mark Slaughter cannot be with us today. Unfortunately, he became ill a few days ago, and obviously we wish him all the very best to recover as soon as possible. So, Mark, we miss you, just in case you're listening. Um, So what we thought we'll do today since we get so many listeners. First of all, you can send us questions for on whatever topic you want us to talk about. We will. We will address a few sort of issues around. Elevate therapy, hard advanced heart failure, management of patients, selection of patients and maybe a couple of surgical aspect as well. Andi, please feel free to send us as many questions as you want. We've got 60 minutes, so it's not such a long time, and we'll crack on straight away. And I would just just to pave the way to the discussion with a few slides on heart failure in general. So my first my first slide, would be, um can I have that first slide? There you go. So, basically what it shows you, I think, is most of you will recognize that slide. It's so it shows you the quiet but slow and steady death off the patients with advanced heart failure, you could see it's a chronic downhill course. There is not much to do. You have episodes where there's a where there seems to be a slight risk recovery. But overall is downhill and there is no end to this. The patients will quietly die. If you don't do anything else, I'll take the next slide. So just to talk about a few numbers to give you a few numbers from the U. K. Where I'm coming from from Newcastle in the UK, so you get a huge number of patients suffering from heart failure. The Survival and Dr Fellow will address that later on. The native survival with advanced stage of heart failure is terrible, and it's worse than breast and prostate cancer. In fact, on, do you have a high risk of sudden death? You have prolonged depressive illness, and in fact, your quality of life is terrible, and it costs the taxpayer a huge amount of money. As we all know, a lot of those admissions to emergency rooms are based on sort of deterioration with advanced heart failure. So the moment we had these, uh, sort of very fancy heart problems available, this was like, I would say, probably 15 2012 to 15 years ago, when this technology came on, we were able to demonstrate fantastic survival, at least short term I e. One year on, we were able to produce 85% plus survival at one year. And when you compare this in simple terms to the Net show history at survival of the patients with John Salvi is terrible. So just to show you just as a quick glimpse on what has happened in the past, So these air almost historic data on. We will talk about this a little bit more about the outcomes in a second. And if you really look at the full spectrum off the heart transplant scenario, then we have to say that more than 50% off all patients listed for heart transplantation they have to go go through a mechanical circular to support device are durable. L've odd before they get transplanted. Otherwise, if they wouldn't have had the device before, they would no longer be on the waiting list because they would have passed away. So clearly you can see from these few slides from this information where we stand today. Heart advanced heart failure is a terrible disease, and we haven't even top tapped into the surface as yet as you know, because the number of L that's implanted worldwide is still fairly limited. So I would like to get into the the other aspect, which which we all also with the address, is a long term outcome. We have now kind off long term data. We have, for example, seven years survival rates for the age, that which is quite impressive. Andi, if you compare this even to heart transplant outcomes in comparable patients. So let me hand over Thio Afghani to bring him in because he did a study based on your remarks data, and he compared H versus Heart made three data because, you know, there's always this discussion, whether it's a device related issue or whether one device is better than the other or whether it's basically our advances in therapy. And I would like to bring Dr Potapov here because this is his trial and maybe he can introduce a few of the conclusions of it. Yeah, Thank yourself. On bond to this trial, you know, the publication which issued to maybe two years ago. And it was analysis based off inter marks data comparing hardware and heart made three. I waas honestly un satisfied with this study, and I found that their methodology and statistical analysis waas super optimal. Therefore, I just, um e was Soto. Use our European data and we have over over 2000 patients in order marks included, with hardware and heart Made three. And then, um, we perform analysis, propensity, image, propensity, midge comparison. We have 303 161 patients in this in this cohort in each cohort. And then it's propensity matched and importantly, that the matching is based on pre operative a diagnosis, civility off cardiogenic shock, intermix, level, age, and also very important their diseases which influence long term outcome on device like diabetes Milito's and prefer arterial disease and so on and so on that results are quiet. Express impressive. On the left side, you see that the number off adverse events is similar. You see, the number of adverse events is, um, blue on black line. It is pretty high. It is approximately 2.4 events pair patient year, but it is similar between two groups. No. Any difference? PBL you 0.97 If you look on the survival on the right side, the survival is upto four years again similar between these two groups Heart made three and hardware and this is a result off our analogies again. Propensity Mitch to patients from oil remarks 361 patient in each group. So you have Guinea can ask U s. So when when you compare the two groups off patient populations, are there any difference in inter max classifications? Or is this is this very much the same? Or, you know, I'm kind of looking at the decision making process. Which device they're using, Maybe, for which patient population Do you have any preference here? Yeah, it is. It was very impressive on that was the reason we used propensity image analysis because if you look on the undamaged population, it's a clearly that patients who are who vote there supported with hardware there much sicker. In a not not imaged a cohort, hardware patients have higher or lower inter marks. The difference is more than one point. They are older. They are. They have more previous mechanical secretary support, mawr, ventilation and so on and so on and all parameters, including creating in and liver function. They are sicker compared Toa Hartnett. Three patients. Therefore, we need to perform one toe. One comparison we went down from 700 plus seven. Founded, uh, patients not matched or more than 1,000,000 patient not matched were well down to 361 because it was not easy to find as patients as seek in the heart made three population as sick as a heart rare population. So conclusion heart via is implanted cross over Europe in much mawr. Sicker patients. That's a pretty difference in the decision making process. Eso device. Can I Can I just come back to these? The question concerning sicker versus No, not not as sick patients. And I I would like to bring the other Panelists in here. Maybe Erica, I would just you know, I was wondering if you compare our present state to 10 years ago where we weren't as good an ECMO, and we had no m paellas, etcetera way kind of, you know, the conclusions of the old trials were rather to exclude patients who are very sick and focus on the slightly better ones. How has this changed from urine And you as a cardiologist? How would you approach the scenario today? Cases like Yevgeny just mentioned. Yeah, it's a great question, and we do think about it differently than we did a couple of years ago. And also, of course, 10 years ago. So the plan that we do now and what I would recommend, especially in these sicker patients, is as a cardiologists, you're really looking for what is modifiable in these patients that are with with very poor es that May, and most of them have many other co morbidity ease what's modifiable in the short term in the long term. And how are they best going to dio with l VAD therapy, not just intra op, but also post operatively and long term. So what can we dio to not only improve our patient selection but improve how they do early on and after that? So what? What we commonly do is have some of those patients, especially the sicker ones that maybe even Inter max one. Um, come into the hospital or they may already be there. And we're getting consulted from another service or things like that. And you're looking very carefully again at what is modifiable, Um, and many times, if it's just really their heart failure or their heart disease, we put a swan in pretty much right away. We get the fluid off we use in a tropic therapy, sometimes vase oppressor therapy, um, to improve their their end organ function, which is really one of the markers of end stage and advanced heart failure, as everyone knows occasionally will use balloon pumps and less occasionally. But we still do use VA ECMO to optimize thes patients to become better bad implant and post bad care patients. And so it it years ago, va ECMO was you rarely use it. It was used in Children much more. It had a very high mortality and morbidity rate way. Don't use it all the time because of that, still, but we've used it electively to get patients in really proof profound shock with end organ dysfunction, Um, in a in a more stable situation with better profusion to then become um, durable bad patients. Um so if I understand, if I don't understand everything, so we're not We're not. And I'm sure that's the same for all of us. We don't exclude those very sick patients anymore as we used to do we find different ways off having them on turn them into patients where we can actually use durable Albats. Is that the same for you? Chris? You have the same view? Yeah. I actually think that in the current situation with the world pandemic, the number of IMAX foreign higher patients have even see are smaller because people's hesitation to come to the hospital. So I think that we actually push really hard to do pre op optimization in terms of Afghan is point about pump selection. I think the one thing about th bad it's given its smaller footprint and really the smaller out programs as a surgeon and offers some versatility options. So I think that maybe one of the reasons why you see it being used in, uh, more sick patients the operation. Although I don't know of any direct comparison between the two commonly used pumps today, eyes actually quite expeditions with the H back, So I I totally concur with Erica. Pre op optimization helps busy programs have to be prepared to do an IMAX wanted to patients and perform the most expeditions operation as possible. Yeah, so I think that's that's an important message. I think that maybe answer You want to add something to what has been said Thio Thio. You know, making making therapy accessible for inter Max Class one patients. Yeah, I think I agree. We have the same similar situation, actually a matter of fact in our program, 80% off. Our patients are in inter maximum and to when we implant them being the hub on B. You know, the results we have is really very similar to all the intermix results published out there. And is there is it like you go straight on to durable devices or you bridge to bridge. Let's say using an impeller or whatever you like. Erika said using, you know, even simple things. Like a balloon pump or something. Yeah, we we tend to use va ECMO, and in Pella, we don't use very much balloon pump at all. Um, you know, with the whole center, we have maybe 10 but income a year. We're we're really shine away from that, you know, due to you know, some of the data that they published out there and and also the three effective. That's just, you know, sometimes questionable in some of those patients. And the other thing I wanted to redress is the one thing which, from our end has been very successful. We have a very, very low threshold in putting temporary Are VADs in because we have seen, you know, the in the early years where we tried to do everything to avoid the temporary are bad that has been detrimental to the outcomes. And since we have, we're using them quite frequently. They're very easy to win. After a week off our support on, then the patients do much better. I don't I don't know whether you guys have any strong feelings on this. Yeah. What do you think? 1st, 1st, I would like to commend to the first question tow the inter marks. Just the numbers I own this year, I almost doubled the number off until a used to announce institution of the temporary device almost doubled from 50 to 90. And it is very good device to bring the patient to recover the patient from multi organ failure and prepare him for long term device. Second, it's a very good device to recognize right heart failure. The patient is good on and Tele he will, uh, uber is the same good on long term device. If it's it's not a case we have timeto discuss by ventricular supporter. Total artificial heart on Impeller. Plus it's a less on Akmola. So, uh, and again it's the use of temporary support. A rise up in our institution to we have still 20% off inter marks, four class, still 20% but it z growing, but very, very slow growing. The second question about a robot Yes, we are very liberal with a robot and especially very like the duel Lumen Kenya So places through the jugular rain the patient could be mobilized with this, uh d o a cannula. Or did it? How how we use it in a robot and very liberal to inter operatively with the graft, pulmonary artery and jugular cannula for Venus, uh, supply off the air E g, Or if it's post operatively, dokey, Aniela. It's very nice solution and we can get. Fantastic. So So I think we all have the same view on this. So don't let Erica you want to add something. I do. I just wanted Thio. Add to the discussion. Um what? What I think has been helpful in our program to allow mawr of the inter max ones and twos to to be candidates for durable l've at at our program is really the inter max threes and fours you you have to hit a home run on. So those patients as well, even though they may be coming in from home from or elective bad placement, we still bring them in early thio, optimize their fluid balance, optimize their forward flow, optimize their diabetes, things like that. So once you have a nice process for those patients that are less sick, all those still quite sick with advanced heart failure, it allows your program Thio, you know, go into the higher inter max, you know, ones and twos to be successful with those patients as well, so didn't want to forget those other patients. I think it's a very important message, Erica, I think because they sit at home for quite some time and they could be completed congested, and their RVs really struggle around the implant. I totally agree with you. And I would which I would be very cautious and taking them on just from coming home. There was a question from the audience. Coming. What do you guys feel about maybe starting with Erica? What do you guys feel about at Intermix class Five and six. Yeah. Uh, the at our program, we typically do not implant for five and six. We watch, we watch closely. We look just like the graft you put up. Ah, little bit earlier showed we look for that progression into mawr advanced heart failure so that maybe end organ dysfunction. That may be hyponatremia. It may be slow and steady progression. It may be quick progression. We watch those patients carefully, but at this time, we do not implant for fives and sixes. Press any any different view? No, not really. I think those patients require very close follow up, and if they have anything from my i c d shot to a frequent hospitalization will move forward occasionally, occasionally for quality of life issues. We've considered those patients. But to use Erika's turn you have to make sure you hit a home run with those people. Short hospital, Excellent optimization. Yeah. So let's move on in terms of just looking at talking about data on good data. So we have a kind of an update on what has your Guinea has presented to us? We have additional good outcomes produced by the lateral trial. So this is kind of a surgical, a new surgical development within the age bad application. And I've I've got to representatives of this trial here as Panelists and sing Chang and Chris Salerno and I would like to maybe. And so would you like to introduce the sort of the idea behind the trial? And what's the this significant feature? Apart from the fantastic outcomes? Absolutely. You know, one of the, you know, things we talked about, we have a huge population of patients with end stage heart failure. Only a tiny, small fraction of the patient and having a device or transplant. Why is that? I mean, why is this so so little patient? I think one of the barrier off is that patient themselves and also preferring cardiologists looking at how invasive the surgery itself. ISS and I've been looking at it and say, Well, you know, can we actually lower the surgical trauma initially? And hopefully we'll, you know, take the fear out off people and I just starting in 2000 and seven, I've been implanting hobby to actually minimally invasively, and I did find that it's the the length of stay. And also the amount of bleeding requiring transfusion has decreased significantly with that. And then in 2010, when actually had has become available to myself, I implied that my first one actually full two tiny minister for economy, off pump and actually find a patient did not even need transfusion, period. So that spark that a lot of interest among all my colleagues and and start doing the palm, the implanted minimum basically on we get together and finalized. Well, why wouldn't we started trial and see? You know, this is not just ah limited utility in a few hands on and could be widely used by by other surgeons. So m a G and myself and, you know, letter This trialing in North America started with 144 patients and we initially fought off while we could look at short term and medium term outcome up to six months and see if they have improvement to our surprise. Actually, the effect is not just to six months, actually up to two years we have 87% off survival at two years in the lateral trial. In addition, some of the effect that we thought we would lower, such as bleeding, stroke and all that in the short short term, however, we actually find a persistent even beyond up to a year and a half with strict rhythm off quarter. What we thought would be compared to Intermix and also that bleeding risk have decreased significantly to our third what it should be. So we actually pleasant is very surprised that we have not just short and medium term improvement. We also have long term improvement in that. And the other thing is that you probably see on the slide that we actually also decreased the recovery period for patients Short hospital states off course, you know, definitely inm or off our cost conscious environment had decreased. You know, the, you know, the whole total cost for patients in hospital. Hopefully that will improve well. The number of referral on. Also, the number of patients could be held with the device. Yeah, fantastic. And so that's great. I mean, you have to be congratulated for the outcome. And, Chris, you want to add something to this? I dio a couple important things. I think the first thing is the stroke. That is pretty impressive. My bias is this may be really to the pump position and the fact that through the lateral approach, we may actually achieving better Palm position, which may lead, ultimately tow our strokes. The other thing is that although it wasn't study this part of this trial, there's a hint from other investigators that there might be less RV failure. Associate ID With this surgical approach, I think that's going to be uh, continued to be investigated. But it's, uh, something that multiple centers have have reported on an individual basis on, and I think the last part about this is it's a great tool for re operation because it allows access to the apex of the heart without having to do a complete media style re dissection. So I think for most centers that have experienced with the economy approach, they've gone to it as the primary approach for re operation or for pump exchange. So I think that is a great point. And in addition to your point is that when you come back to transplant those patient, I mean absolutely much more easier. It is the blood loss, the amount of Haitians. It's actually way less Onda just recently that I had a congenital patient that have, you know, fifth time re to with transposition. And so you just have to hate went to the left chest and did everything on the left chest on. It is remarkable. The patient did not even receive a single unit. The blood, I think one of and I got extra baited within three hours, and I think that's one of those utility abusing that approach. I mean, you know, I think it's it's really fantastic and mentioning the adults in general, we have We have quite a number of those, and as you said they have with their 3rd 4th Sonata me, they're fairly complex. Patients surged, simply speaking from the surgical standpoint, if what would you say if somebody says from you know to be the devil's advocate here? If they would say Hang on a minute. This is a trial which is very recent on. Basically, your low number of adverse events is just because you have become better on the last 10 years and it has nothing to do with the surgical approach. Apart from the bleeding, that stroke and all this kind of stuff is simply better. Because you know how to do things in a better way as compared to 10 years ago. What would you say? Well, I think that, you know, it comes hand in 10. I think No doubt that, you know, for the management posts up, we have definitely better. And maybe we have some even improvement in may be optimizing the patient prior to the implant. No doubt about that. But you have to look at the contemporary data. This is pretty contemporary. Compared to what? The Internet in general, that people are still implant them, you know, maximum evasively on. We do have a better outcome. I mean, unless you do a head to head randomized trial. I mean, we would never really solve that. You know that question. But I mean, for people that who incentives, actually you have surgeons that who to do only one versus the other. Even within their own center, there is actually outcome differences. You can you can detect. No, I think the only I think the only downside of this approach is if you are in a situation where you have a single surgeon. So not to surgeons or not a surgeon and a training the operation probably takes slightly longer, but if that's at the expense of improve patient outcomes, it's well worth it. And I think toe add to that we we used the lateral thoracotomy in the in the vast majority of our cases. From a cardiologists perspective, having the RV seemed to not struggle as much. Not just early post op, but for months. You know, after implant, it's been a It's been a huge success in our program. It's very difficult, as everyone realizes, to treat a bad recipient with RV dysfunction that isn't a transplant candidate, very difficult. So we we've had very similar outcomes to what's what's been presented in the lateral trial here, other than an atomic reasons to not do authority. Khatemi. That's our choice procedure. We do look at things like C. T. Angio is pre and post implant Tiu. Look at how the bad looks in the LV. That helps our management long term, Andi. That seems to be different as well, compared to just the purest Ternana me cases again not head to head, but our historical control. So we've been very pleased, not just with the surgical outcomes but also the long term medical outcomes of these patients. So, Erica, let me ask you, there was a question from the audience concerning I mean, what we know from from thoracic surgery that obviously through a thoracotomy, are much more painful as we know, for example, from lung transplant. You know, if you do a thoracotomy, it's it's actually a long term pain issue. Potentially. How does that look to you when you see those patients in outpatient clinics? Yeah, it's It's a great question we we've because we do the lateral lateral thoracotomy approach so frequently. We've adapted a protocol for the pain management because as we we've noticed that as well. So our patients prior to implant get Neurontin gabapentin the day or two prior to implant during the operation. Towards the end, they do get a nerve block an anesthesia does that for us in the O. R. That has helped quite a bit. Occasionally our patients get the nerve block again when their post op day one or two or or right before they get X debated. They stay on Neurontin for quite some time, sometimes months. So since we've we've adapted or adopted that procedure and protocol, we've had a much better pain issue that that's we've really been able to control that. And very few patients have long term pain eso it actually with with that protocol with the neuron. And of course, they also get narcotics for the first couple days or week after, you know, post op. But the Neurontin and the nerve block really helps in the post operative recovery on pain control as well. So the pain pain is not the pain issue is not a trivial one. A zit looks. I mean, I'm just looking at, for example, we switched in lung transplantation. We moved away from bilateral thoracotomy is and moved to stir, not a me because we think we know from general cardiac surgeon that is less painful and thoracotomy. Ease. Yeah, we haven't. We did early on with a thoracotomy see patients with more pain than a typical stern on a me with that for that implant. But with the nerve block as well as the neuron tonight it's It's really about equal, and we do pay attention to it, and we stick to our protocol pretty much 100% of the time. So with that, I think it's very tolerable. It also allows patients to ambulance and and use their incentives perama t speranza tree a little bit faster and things like that, which is also improves their post operative care. Fantastic. Brilliant. Eso just just to continue with you, Erica, I think we need to move on, move away from the surgical aspect of it and move towards patient after after care long term care. And I just wanted Thio maybe hand over to you to give us a little bit off idea what you think are your immediate long term issues. How you see how you know how you manage patient, general. Maybe a quick word on anti coagulation. How you monitor them, how often you see them in clinics. What are you key moments? How do you look after Dr Lines on things like this? would you? Would you mind just giving a few little ideas to this? Of course. Um what I what I really wanted Thio in part to everyone watching is what we do is really a lot of the same things over and over again. So we have a process. We stick to our process. We look at our protocols, we adapt our protocols based on what we're seeing from the patients. So what I really wanted to underline is we do a similar process for every single patient, and we stick to the basics. So we look at their blood pressure and that's really one of the cornerstones of bad care. So if you can control the blood pressure, if you can keep them in that sweet spot 65 to 85 somewhere in there depends a little bit on the center you're taking. You know, one of the key parts of bad care on getting that into a situation is as well controlled as you can. So, blood pressure control, we have, ah, inpatient and outpatient regimen and protocol for that. We also are very careful about their i n r. And they're anti platelet therapy. So So typically based on the patient. But typically the N. R is 2 to 3, and we have a process for that to start that in the hospital post implant, but also long term. And I'll talk about that in a minute. How we monitor these patients. We also look at their anti platelet therapy, and I understand not every center has the ability to look at from Bow Alaska grams and platelet function, assays and things like that. We do look at that and we follow it carefully, and we titrate and wean based on the results of how well or not, well, they're platelets are working. So we do look, but can I just Can I just come in here? Because I think this is one of the crucial issues, which I still haven't really got my head round. You know, we've We've been doing this amongst probably hundreds of centers worldwide. Everybody believes in something, but we don't have any. Not a single prospective randomized trial, not even on aspirin. Why do you think, uh, we are so poorly but performing in this respect, So nobody, neither you nor any of the other Panelists knows what is the best one. Nobody knows. So is that something we should be setting up? I do think so. It's sometimes and we've talked about this a lot in the bad space about the anti platelets. Even what dose of aspirin, like Like you said, we don't know the best dose. We don't know what the best test is to monitor platelets and I platelet function, and I think that's another question that we all have. I do think for what we have right now. What's important is that every center not just looks at the data that's starting to come out, but also that they stick to their own protocol and change it based on their own situation in their own, their own outcomes. I do think it and we've talked about this it. It begs for a bigger study to look at how anti platelets affect VADs and bad patients, how to test them on along with a lot of people. So, like I suggested, tags and PFCs aren't available to everyone. Our protocol is at times hard to follow and hard for every center to adapt to that. But I think even if we nail down the aspirin dose I think that would be a step in the right direction. Um, it, you know, just moving on thio other ways. We follow these patients. What's been helpful to us is looking at their log files on really a protocal ized basis. So we don't want to know just what the log file shows when the power is going. Hi. We want to look at a patient's sort of footprint or thumbprint of the log file on an ongoing basis. So we look at these for patients when they come into clinic. We have community clinics that we can look at the log files. It gives us an insight onto how the patients that is functioning long term. It allows the patient also to be a better. Um, you know, in they get more involved in their care by looking at the log files, which which, actually, when you teach patients that it becomes a little easier for them, but to see you know what's important when their power goes up, even if it's a spike. So we look at that long term. We are very careful with the wound care and the drive line care. Aziz. Well, I know every center has somewhat of their own protocol. What's been helpful to us is again to stick with our protocol and change it on Lee if we have a spike in Dr Line infections were pretty stingy on showers, which not patients don't really love that. But we tell our patients not to shower for months after implant. Um, but you know that early on, preventing water from getting towards the drive line, which can set you up for an infection, I think is really important. Eso again, I wanted to underscore sort of the what I would call the low hanging fruit of of long term bad care, which is blood pressure control, I in our control, platelet control and infection control. And we do that by lab draws, log files on bond monitoring, our patient's blood pressure carefully as outpatients. So, Erica, just just and maybe to the other Panelists as well, So this is wonderful option off having way forms. I you know, I think this is an untapped treasure, which is which we haven't really fully understood and way have a lot discussion here. Yeah, we do. And essential part off our out off our voluntary service and also in the clinic. Uh, first, what I look on is the monitor of hardware To understand what happens to the patient, and it's even, it's no need to look at the money to your bedside monitor. If the way former is good and monitor shows me something the first that they look your arterial line is does not working on. But I can definitely say you you have to do something to change or whatever it is the force of the I C U. Yeah, I think that we're all waiting for that, isn't it? That that seems quite exciting If it comes around, um, we I think we got 5 to 10 minutes maximum left. So I just, you know, since we've gone through a lot, I would like to I would like to ask one questions to all of you, So way discuss that initially. So So we all know that we're still dealing with a niche product here. We're still doing maybe 5000 implants. I don't know. 2500 in the U. S. Per year. Onda. We have thousands and thousands sense of patients struggling with their heart failure around, probably even in your own community. So what do you think is the main reason why this therapy has not penetrated our medical community, especially our heart failure community? You know, they're talking about the big cardiology societies where it actually has no space at the moment. What do you guys feel is the main reason for this? Shall we start with Erica? Sure. I think you hit the nail on the head. I think Ah, lot of it is education. Ah, lot of it is a perceived, really niche product, which which I think we're working towards not being that way. I think it's easier now than it was even a couple years ago to take care of these patients that air in the community so further away from the implanting center. And we can do that better by not just things like this telehealth and things like that. But having clinics that air in the community, reaching out thio cardiologists and internal medicine folks that are in the community that have an interest in helping their advanced heart failure patients, but also adapting processes that allow us to keep that patient in the community and not having to commute Thio, the implanting center. I think that's huge. I think we're so much better at taking care of bad patients, long term with these these ways that we're doing that, that it really can start to become so much less of a niche product. But what's worked quite well with us is is having the patient that that is in the community that's done really well and sending them back to the community and meeting with our with our colleagues in the community and saying, Listen, this this guy that we implanted six months ago is doing great, you don't need, You know, you see him six every six months. I see him every two months. We can co manage him as yet as an outpatient. I'm sure you have other patients just like this that we can accommodate, so that's worked quite well with us. I think it's moving into the community on did and looking for these patients on DNA, not relying on the referral from the in patient cardiology team solely that will that will really further this field in this product. Christs. You know, I, I A lot of America says I agree with I think just a few other things. I think there's still in inability to really promote the excellent outcomes that are there. Your point, that it's just not part of the large cardiology meetings is is important to keep in mind. We speak of the h of a C. C. It tends to be ah ah, smaller session. I think number two is. We have to realize that there are some new competing therapies in this space, whether that be to push for more heart donors through hep C or through D. C. D and the improvement with medical therapy. So there are other ways to treat some of these patients which may have an impact. I think to other things are really important. One is we have to continue to focus on decreasing adverse events. You know, the pumps are what we have right now, and I think the surgical implants is actually pretty well refined, and the postoperative care decreases adverse impacts. But to really make this universally accepted, we have to make this a forgettable device in The last point I would make is I think when we get to the point and and most companies are in the space or focusing on this, that we have a pump that does not have a drive line. We may see a greater adoption of the technology. Hanson. Yeah, could be everything said. I think this point of hit the nail on the head is the, you know, medical industry had to improve the pump. I think you have to make it more user friendly. You have to make the controller, if not smaller or disappearing. Ah, battery had to be smaller or internal on the drive line. I think the drive line issues that we have to deal with it ihsaa nuisance for patients and also for, you know, petitioner cardiologist nurses on outpatient basis is ongoing Problem. I mean that I mean, that was the You know, we have technology out there. We just have to put the, uh, effort in it. And I think we have that problem solved very soon. Yevgeny, Anything dead? Yeah, I think I completely agree with previous speakers, and they have nothing to add. But just a number that 2.4 major adverse events, including created me unexpectedly admission 2.4 per year. Year independent off the pump is just too much. And, uh, Dr Hansen completely agree with you that Dr Klein it makes in our analysis and or remarks that makes over 30% off major adverse events so we can read it Just the dry abandoning off the drive line. You reduce a major adverse events significantly reduce. So did it. It's very important point. So if I I gather if I if we all had one wish Thio for this kind of therapy, I think we would probably all would want the drive line to G O as the prime as our main priority. I'm sure you all will. Not your heads on this, I guess. S Oh, yeah, I think I think Listen, I think we're almost We're almost done here. I think we've got five more minutes. Anything. Anything we haven't addressed today. Anything important of anybody wants to add to what to artists get. And the audience is, as hopefully not fallen asleep over our discussion. I think there is a fascinating getting a fascinating combination off statements today. I think we've tried Thio address as much as possible. Andi, I think maybe maybe one final short comment. Is there any specific aspect for Elbert therapy during this terrible covert crisis to can to consider any any comments on it. Maybe Maybe, Erica, you have something to say from your end? Yeah, it's interesting. I have not had any patients, UH, that had a co vid related cardio myopathy that required either transplant or VAT implant. I've seen a lot of patients on ECMO V V and V A with co vid eso. I don't know how that might look long term. I think if that if something came up where a patient didn't recover, I think we would be more apt to think about that versus heart transplant for a co vid cardio myopathy type of patient. Just really, because we don't know what the what the long term effect of co vid would be on transplant. So I'm not that I'm looking forward to that. But I'm interested to see if any other participants may have had that has had that happen to the in their in their center. Any comments way have not seen the actual covert related kind democracy that require mechanical support in our center. But we see an indirect effect of covert, though we have seen more people have delayed. Am I who came in with a proposed Am I complication? I've done like three V s l in the last, you know, 2 to 3 months which, you know, we might see when one every 22 years off of it. Blown mitral valve. The three of them again in the last little while and which is again, Not that common anymore. So I think that there's something direct effect Not not very direct. I have I have not nothingto, uh it is the same situation in Germany. No one Kobe to my card itis no one out off 18 Telus and planted this year, but significantly less patients scheduled and much mawr acute accusations for temporary mechanical support. Wonderful. So I think I'm supposed to summarize, but I think it's all has been very self explanatory. I don't think there's much to add from my end to what we have discussed. I think we're on a good We are on a good track here for improving our therapy. We have learned so much in the last 10 years we have demonstrated that within our community we are very clear about where we want to go and step wise, we have improved our results, as demonstrated by your remarks trials by the lateral trial, with small little steps, we have demonstrated how we can improve with improved technology. I think we might get even better. And I think the other thing, I think what we should be doing, as as Chris has said, we should try it to be more upfront with our success rates, because way are very quiet, and it has become very quiet. Lots of our colleagues have become almost a little bit depressed because there is no breakthrough, including our companies who are selling the devices because the numbers don't go up as they did with defibrillators and other implantable devices. So I think we all need to have a fresh, fresh start on be optimistic in what is coming around because there will be fantastic technology coming around our way. I have to think all of you, it was wonderful to have you. And I hope you stay safe. I hope you have a wonderful Christmas amongst your family on to the to the audience and listeners. I would like to thank them to sign up for this for this great great event. Thank you all for participating. Bye bye. For now. Thank you. Uh huh. Hi. Bye bye. All right,
