 Okay. Well, what an honor it is to be flanked by Dr. Frazier and Dr. Lore later. And then, of course, you know, following South footsteps, who I'm sure spent countless hours and evenings doing heart and liver transplants and lung transplants. So thank you, Kathy, for the introduction. Like I, like she said, my name is Blaine Johnson from the University of Chicago. And today I'll be presenting on the organ care system. I'm going to talk about the current concepts and new strategies. And I really want to look at what we think will be going into the next decade. I'm excited to kick off this transplant session and share with you some highlights of our research and this new and innovative technology. I have no disclosures or conflicts of interest. However, I'll state that I am a practicing perfusionist and I believe that perfusionist should be involved in OCS. I want to discuss the current trends and transplantation. We're going to review TransMedics OCS, evaluate the impact and clinical evidence of OCS. I want to address how perfusionists can get involved. And ultimately, I want to explore how OCS could evolve over the next decade. In 2021, we actually had more transplants than ever before. And this is despite ongoing challenges from the COVID-19 pandemic. While transplantation continues to increase substantially, we should continue to explore improvements that will increase utilization while also maintaining organ quality. Some current advances include the increased utilization of DCD donors that we'll talk about here in a little bit, but also the use of ex vivo organ perfusion. Now, one way we could expand the donor pool is to simply address the massive underutilization of the most cost effective treatment for an organ failure. Because remember, ultimately, for every organ wasted, it's a life not saved. So if we really analyze transplantation further, we can see that it's more of a supply constrained market. And that's primarily due to the limitations of cold storage preservation that you see there on the bottom. So the current limitations of cold storage preservation include cold ischemia in which donor organs are placed on ice may be viable for only a small limit of time. They're maintaining this ischemic state as we know, in which there's no blood supply. And for an extended amount of time, we can result in organ damage. There's no assessment, and there's also no ability to optimize the organ, which we'll see here that we can do a little bit differently. Right now there's three companies that really lead the way and innovation of ex vivo organ perfusion in the United States and there are across a modality of different things from currently implemented and FDA approval to clinical trials. The first one is Medics is Massachusetts base, they have the organ care system or OCS as we'll refer to it throughout this presentation, and they current have three platforms which include heart, lung and liver. There's organox, which is based in the UK and has developed the Metra transportable profusion device for liver, and also the Swedish headquartered ex vivo organ profusion, which offers the XPS lung profusion module. It's an interesting fourth company, and that's long bio engineering which is based on Maryland. Now they really have focused on making perfusion technology more widely available and more centralized which we'll talk about here in the future, but basically instead of creating their own platform they utilize the ex vivo XPS system. So let's talk about organ care system to overcome some limitations of cold storage the OCS is a transformative technology that was designed to better preserve, assess and maintain donor organs by potentially reducing the number of unused organs by addressing the key limitations that we talked about earlier. It has warm blood profusion in which they are maintained in a living functional state. It's perfused with warm, oxygenated and nutrient risk blood, it allows for organ assessment that we talked about, and also therapeutic intervention and optimization. I kind of think about it as like using a Fitbit or Apple Watch for an organ. So let's give an example here. Fitch at all, which is based out of Duke actually presented a case report of a 41 year old female wonder went bilateral or organ lung transplantation from ex vivo organ profusion and ventilation from over 4,700 miles away in Honolulu, Hawaii, which was transported all the way to Durham, North Carolina. Now the patient experienced no primary graft dysfunction, they state, and at one year of transplant they're doing great remained rejection free and presented excellent pulmonary function. I think this case highlights the challenge that active organ preservation systems pose, and also to the questions of organ allocation and different geographic sharing that we'll talk about later. As I mentioned, OCS comes in three different platforms. It's great because it's actually based on a flight attendant cart so it fits on any airplane mostly. It comes with detachable wheels, a lightweight construction carbon fiber base, and as integrated power and gas there's a little bit different than the other models that we talked about like ex vivo. It's more stationary and not able to be transplanted or transported. So the OCS you can see has a significant impact on donor organ utilization. If we specifically look at for instance the lung expand trial. You can see utilization of DVD and DCD donors that have been declined for transplantation. Actually, on average the you know data shows that for that study alone, every set of organ was declined on average 35 times from other centers before it reached an OCS trial center. But not only is it important for utilization but also for post transplant outcomes. We can see again as an example for the lung expand trial, it resulted in 91% patient survival at one year, which I think as we move towards the future will really be, you know in conjunction for instance for hearts, we're comparing a L bad, the Dr Frazier discussed, compared to the OCS model of ex vivo organ transplantation. That's really interesting because transplantation is really a condensed industry was only 50 to 55 transplant centers out there that drive over 70% of the allocation of abdominal and thoracic. So let's talk about it should perfusion is be involved in OCS. And my answer is always going to be yes, probably because I'm biased, but I think it fits very well within our scope of practice. You know it has extracorporeal circulation organ preservation. These are all standards that we see in today's scope of practice that you know we see in licensure. And in fact, in February 2020 and in the board. I think also saw the need for that to advocate for change as we move throughout our profession, and they actually moved up ex vivo organ perfusion cases from a category two only to a category one. I think that's great for our profession and really shows where we're moving towards in the future. So, once we kind of got approval for that. Some of our colleagues around here thought, you know, really who is utilizing these OCS devices and who is operating them. Michael Carl back there and some other colleagues throughout the United States we went and did a 2020 organ care workforce survey. And really we wanted to present an accurate representation of which healthcare professionals were primary, primarily operating the OCS platforms at that time. And what you can see was really exciting results we had 35 centers participate there are active centers which was actually 100% response at that time. And that accounted for 52 total platforms of that 35% used more than one platform that we saw at that time. Now you have to remember, lung was post market approved and heart and liver were in the clinical stages at that time. We saw about a 10% utilization for all transplants conducted on OCS. So now let's look and dive into that study, specifically, who were the personnel specifically a lot of perfusionist always laugh that there's probably some answering bias that only 89% of doctors were part of the transplants. I hope there was 100%. But also let's look at the different training levels for heart specifically which was recently, maybe two or three weeks ago, met their DCD authorization from the FDA. You see, perfusionists are most involved in those cases alone, simply because of the complexity but also because of the experience that we have and the scope of practice fits. Let's talk about the difference between the primary and secondary operators. You know, when we look at that, like we said, generally two operators were involved in the heart and liver, mainly probably due to the clinical trial at the time, but of those, only five to 28% handed off to another individual. I know we're going to talk about some interesting staffing models. In my institution, the same profusionist goes all the way throughout. I know here at THI, you know, one profusionist might go out on the run and hand off to another one. And then there's even, you know, other attributes that we'll talk about having transmedics through the entire public for you. There are some challenges and reluctance to participation. Overwhelmingly, most said that there are administrative hurdles, that there is their or demand was too high to fit in with their small staff, or even reluctance to staff. Now if we dig into that reluctance, we see that mainly it was from the length of transport times or concern of transport, a lack of incentive, and really a lack of backup support, because if you have a small team that we'll talk about here in a moment, it's really difficult to step that into your n plus one model that we use generally today. So after that, we concluded this national survey and we really started to hone down on our institution alone. And the interesting part is we took a two year observational quality improvement data. We looked at the interdisciplinary team that was involved over the two year process of every single OCS lung recovery. We documented specific challenges and benefits, and noted perceived barriers and suggested solutions. Now we came up with thematic analysis of four different main themes that we're going to talk about today. And those included clinical protocols, strategic restrictions, administrative needs and operational aspects. So let's talk about the administrative challenges. You know one really heavy hitting one that we might see from administrative would be reimbursement. Now the interesting thing, you know when we're talking about clinical trials is that there's not really a there's a lack of reimbursement from third parties and government insurance. So we're definitely moving towards the future of working to maintain right you can't have a program if you're just a cost center you always want to bring in revenue. So some things we've done at our institutions worked with different managed care partners to allow for third parties to include this in a bundle payment included in our cost. Another thing you know from administrative challenges marketing. One exciting thing that we got to do was, we actually published the first use of OCS recovered lungs and coven 19 pulmonary fibrosis, which is interesting because we beat Baylor. We also had operational challenges. More examples, you know you can see some survey results there feasibility respondents said having a small trained team can be challenging to the next days or schedule which totally makes sense. But what about like quality assurance. There are no really best practice recommendations out there that could be shared at the time. Strategic challenges again staffing was a big one for us, you'll see how we kind of organized our program over time over the two years of kind of having a hierarchical structure two different coordinators. But really like staffing again, you know there's no standardized staffing model or best best practice recommendation. One respondents said that they'd be doing probably up to 50 OCS cases a year if there are a more realistic staffing model behind it. But of course there's also clinical challenges right one and for instance that we are moving towards manuscript now is blood bank, and you know the use of banked blood for at least OCS. You know blood bank bank blood is used more for the lungs as opposed to exanglinated whole blood, which is used from the liver in the heart OCS platforms. But really there's no guidance or set up a protocol from a BB or anyone out there. And in fact when we when initiated our program we saw a loss of over $2,000 from simply nine units that were wasted over time. And of course let's talk about the benefits to right when we talk about the challenges we should look at the benefits. So we saw a significant reduction and primary graph dysfunction. 91% utilize interoperative ECMO, which is probably an anecdotal evidence that suggested a decreased inflammatory response. We have collaborative work with the community, instead of individual centers, and those again we could create best practices over time. With this research, we really saw that, you know, kind of a Steve job says, great things in business are never done by one person, they're done by a team of people. And you'll see that you know when establishing a program of this magnitude it really requires a thoughtful interdisciplinary collaboration and coordination. And this project provides vital data and statistics that we hope will assess with current OCS workforce, and really show how the technology can continue to transform transplantation. Let's go back to Transmanix as a company right, what is their strategy over the next decade. You'll see here that we've actually accomplished some of these near term things. We have adoption they want approval of the DCD heart, which like I said we had about three weeks ago. You'll see the national program which I'm going to talk about here in a second, but of course the long term goals to right. They want to increase our reimbursement as a whole so we can be profitable from these, but also what about other platforms such as OCS kidney, which should be really exciting. So there's a different transplant dynamics that you normally see right when you're the OR and a perfusion this you know you might not see the whole picture if you look at the you know 10,000 foot view. So there's really, you know an interdisciplinary collaborative practice right, we have pre transplantation coordinators. We're going to use the OCS technology in the operation. We have post marketing to right and post care transplantation coordination, but really, you know, Transmanix thinks that they're really uniquely positioned to deliver on these different results. You know they have multi organ technology, they have a team of OCS specialist, and also you know they're dedicated to establishing transplant program relationships. So you'll see that really the the ecosystem that they want to create is a little bit different in creating a national model or what we would think of you know as a future of more regional transplant centers. I mean they can do that by basically managing the entire inter, you know, OR process from start to finish, and then handing off the organ once it gets to the OR. Now this is really interesting because I think a big push came from COVID-19 right during COVID-19 a lot of opios or organ procurement organizations throughout the United States had to limit staff right because of infection and spreading and transmission. So, I mean, an example of this being Nashville right Vanderbilt said we're not offering any teams to come in, we will harvest for you, and we'll send it out in a box to you. So an interesting thing is that we're getting, you know, more and more movement, I think in the next decade towards regional procurement organization nationally throughout the United States. The national program wants to transform the way you know transplant is thought, they are going to provide in to end technology they want to partner with major opios. I can tell you our local opio was one of the first 10 to come out. And it was really exciting opportunity to be able to work with them as an institution and help pave their way to their success. And really, you know, over time I think you'll see a adoption of both right, but institutions that want to take them, you know, for more healthier donors and stuff like that, maybe for extended times or extended transport. But you're also see opios and they want to really focus on those marginal organs right because as you saw in the beginning only eight out of 10 lungs for instance are not used. So anything that we can do to increase that 20%, I think is a step forward in the future. So the national program where it's located right now at 11 centers throughout the United States, like I said, a gift of hope being in Illinois in Texas actually at the Southwest transplant alliance in Texas you can see that there's a high adoption in the Southwest as well. But really, if we talk about regional transplant centers and for instance having others go and procure organs organs, but you're also think about the legal implications right. I don't know if you know but Texas was the first state licensed in 1994 right so I gave an example here of the Illinois practice act where I practice, and you can see that within our scope of practice we have several different modalities that we talked about earlier. That really fit organ transplantation, but what are some of the hot topics for the next decade, should our profession allow EVOP and RP to follow the pathway. You know reminiscent of ECMO where other providers such as respiratory therapists and nurses are involved. Should we were in conjunction. You know another thing is should we our profession work to encourage licensing so that more states can protect their scope of practice within the OR. You know at a minimum, but when you get into that you also think that individual licensure, for instance in every state I would go to, could be really cost effective and I did spell state with the dollar sign there. Which is different than you know a national compact licensure, which is something that we may be able to move forward. You know, Shelly and the GRC from AMSEC gave a great talk this year about compact licensure and how we can move forward to that. And I hope that's something that our profession really seeks to adopt in the future. Nothing means more than examples so our institution like we said over two and a half years we did 35 organ transplant recoveries throughout the United States. You'll see here in red were states that we traveled to in which licensure was effective for perfusion us. And you'll see here in green or states where we traveled to that there was no licensure. In fact, this year in 2020 we have 18 states licensed throughout the United States, one titled which would be California. And as of the AMSEC conference that I discussed we had seven states are interested in the next steps. So you can see there that if we exclude for instance, our home state of licensed Illinois, that you see almost 45 to 50% going into other states that have legal obligations right. But you also see the number of recoveries is in increasing as well. Now go back for a second to one thing interesting about all 19 states that are titled or licensed that they have no explicit language that's expressively exempts interstate transport right. I think with COVID-19. Again, as an example of interstate transport of ECMO. You know it wasn't until COVID-19 that all these states with licensure for nursing, EMS for fusion really got involved and said hey we should do something to protect these people that are transporting across state lines. So I think you know that's a hot topic that we'll see eventually in the future, but overall I think it's a really exciting new horizon organ transplantation. I think we're going to increase utilization through dbd and dcd donors, we're going to have an improvement of post transplant outcomes, we're going to limit, eliminate ischemia time and of course the transplant logistics around and really hopefully we push towards no impact on allocations, which really means more lives saved by transplantation. I'd like to thank Deb and the conference planning committee for this opportunity, and I'll take any questions you may have. Thank you.