Good afternoon, everyone. I would like to thank the society for inviting us to talk. I'm a surgeon in a critical care conference, so please be gentle on me. I think part of my talk is going to be a little bit different. I'm not going to talk a little more about physiology and things like that, but what is the current state of pediatric WADs that we have, and where are we going, and from a surgical perspective, what the future holds for us. Some of the work that I'm going to talk about is a collaboration between us and Cincinnati Children's, and that's also where I trained, and then I moved to All Children's. I have no disclosures. Like I talked, we'll briefly discuss the current state of WADs in North America, the growing need, what are the innovative solutions that we have already started in some subset of populations, and what the future looks like. This is the PDMAX sixth annual report. People who are not familiar, PDMAX is the registry of all the pediatric WADs that are implanted and reported. Currently this is in press, but as of now, the registry was started in 2012, and as of now, there are over 1,300 devices that have been placed in over 1,100 patients, and hospitals, it says 42, but there are actually 47 hospitals to date in the registry. And the implant number by years have mostly have gone up, except the last two years. The graph here shows the survival based, if you stratify them by primary diagnosis, and this is cardiomyopathy and congenital heart disease, and as you can see, at six months after implant, congenital heart disease patients do worse, as was said in the previous talk as well, compared to cardiomyopathy. So why is that? And obviously, as you can see, 57% survival, so there's a lot of work that needs to be done. If you look at competing outcomes for cardiomyopathy patients, only 9% of these patients die on a device, which means that 91% of these patients have a positive outcome, and that means either alive on a device, transplanted, or recovered, as opposed to 32% of patients who have congenital heart disease die within six months who undergo a VAD, so remarkable difference. So with transplant supply being the same in the last decade or so, there's a growing need for children and young adults with congenital heart disease, and we have to do something different. And in this day and age, almost certainly, it can be done through technology, and in some areas, it has been shown that it can be done, and these are just the various devices that are available in this day and age. And the timing is right, because nowadays, VADs, as was used to believe, are no longer a means to an end. They are placed to help patients with medical-resistant heart failure to get out of the hospital and improve their quality of life and health, and we're trying to get away from phrases like bridge-to-transplant or destination therapy, and no longer do we need to know if they're transplant candidates as far as they can be recovered and be supported adequately. And these are just examples of a couple of patients that we have dealt with in the past. A subset of patients that we have tackled in the last few years is the Fontan population. This is a first analysis of STS that looked at all Fontan patients, and from 2012 to 2019, there were 55 patients who underwent a systemic VAD implantation, which means that the VAD was implanted in the ventricle to support the Fontan circulation, not in the Fontan circulation itself. Median age was 10 years, and median weight was 27 kilograms, and you can see about a third of these patients were in profile one, which means that they were in cardiogenic shock. Positive outcome, as I alluded to earlier, alive on a device, transplanted or recovered, were 81%, which is pretty remarkable considering what it was before. Most of the patients that died died within the first month after implantation, and of these patients, stroke was one of the highest morbidities of 5.5%. Eight patients out of these have been supported for more than one year, and five patients have been supported for more than two years. But the question is, how small can we go? Fontan patients are a little bit older, and what people often think about when implanting VADs into kids, right? But it can be pretty, I shouldn't say easy, but straightforward as long as it is well-planned. We still use, in some areas, BSA or weight, and to me, it looks like this game that was played before I was born, when we have this available. So we got to do something different. We have to use some new ways to figure out how different patients can be affected. This is the first generation, as we call it, and we use 3D rendering and just use virtual implantation. This is obviously not, as a surgeon, I was trained to do, and so this is a two-person job at least, where we have a dedicated imager who is well-versed in cardiac anatomy and also in technology, and we can both work together and use 3D modeling to see if a device would fit into a patient, and these are just examples. Now this was many years ago. We built onto this and went onto something called virtual reality implantation. Now on the left-hand side is what we did at Cincinnati, and then on the right is what we did at All Children's. We had two different patients, but what it shows is, using the VR headset and using the 3D data set that we have, we can really look at the heart and carve out and see where the device would fit, and if there is a septum in the way, if there's any valve or tissue in the way, what needs to be resected, or if it even would fit or not, and that I'll show you in the next few videos about the outflow graft as well. After this, we thought, okay, if we can do, use virtual reality, and if we can implant, how about using different institutions and collaborating as what we, for the lack of better word, in metaverse. This is a patient who was at All Children's, and we transferred the data set to Cincinnati, and obviously we both had, both institutions had the VR equipment and all the capabilities, and we got into this virtual reality atmosphere, or metaverse, as we want to call it, and looked at this patient together to see, yeah, to see if the device would fit in and how we can do it, and while doing so, you can go inside and in and out of the heart, you can move the heart around to see, get the views that you would not normally get in the operating room. These views that I'm showing here are very hard to get, because we always stand on the right side of the table, and this is from the left, which we never see this way. So it really has helped us to figure out how we can really precisely implant these devices and make sure that the morbidity, at least the technical part of the operation, gets less complicated. This is a very long video, I'm not going to show the whole thing, but it just shows that this is my senior partner, as you can see, he's having some trouble in the metaverse, pressing the button, but you can see a lot of different vessels, you can take them out, you can bring them in, you can take the blood out, you can take the ribcage away, you can kind of play with a lot of things around that to see how it will help you. And obviously there's been a learning curve, but in the last at least three to five years, we are at a point where we have started some international collaborations as well, and this has gone really well, and it's helped, I think, us as surgeons visualize how we can help or bring smaller patients into play. This is just another video, not really to show the implant, but for example, if someone has an intracardiac device, and this patient had a mitral valve ring placed in the past and had some subvalvular work done as well, and this was transferred from an outside facility, and we used the same method to see, okay, once we put this VAD in, is there going to be muscle or chordae in the way that's going to interfere with our VAD flow? And as you can see, we can really carve out the muscle and just look inside the ventricular cavity and reposition that inflow cannula to see how it would really direct towards the mitral inflow. And again, the outflow graft is another component of that. You can size it, you can bring it around, and patients who have had redo work done, you can bring it higher in the aorta, or if you want, in the inominate, all of these things that can be done. So this is an example of a patient with a 27-kilogram, BSA was 0.95, with decompensated heart failure, tachycardic, lethargic, was on multiple inotropic support, and we used the same technology to figure out, okay, if we can do this, because from a traditional standpoint it was already revealed that he would not be a candidate for, or she would not be a candidate for VAD implantation. But after this, we figured out that there are ways we can, you know, the VAD would fit in, but we have to be a little bit more creative from a surgical standpoint. So in these patients, what we usually do is take down the anterior attachments of the diaphragm to increase the AP diameter of these patients. Sometimes we have to placate that dome of the diaphragm and push it down to create more space. And then when you create more space, there is this fear that once the VAD is in place in the ventricular cavity, that's going to fall down into the left pleural space. And in order to prevent that, we create these what we call pillows, or pericardial wraps, so that it can be supported underneath the VAD. This patient was extubated within 36 hours, no blood products were given, was on some milrinone and then discharged and supported for three months. And then afterwards, was successfully transplanted a year ago. Now obviously, this is one of the examples, one of the very few examples, and for obviously reasons went very well. But this is not all, and we need to do a lot of more work. But having said that, I think this is an exciting time for pediatric mechanical support. I think we're caring for new cohorts of children who are only going to grow, we're only going to see them more and more. We're going to come out with medical resistant heart failure and we're going to need new and innovative solutions to treat and take care of these patients. Thank you very much.

pediatric ventricular assist devices

survival rates

congenital heart disease

virtual reality

medical-resistant heart failure