This video is part of the 2020 Sentara Cardiac Grand Rounds, "Heart in a Box: The Future is Now," originally broadcast September 15, 2020. Dr. Jonathan Philpott provides organ donation expectations about performing transplant surgery when utilizing the OCS Heart device.
When I first started getting into this, I thought that we could take a heart out that was really sick, and he would just keep getting better and you know it. Four hours we would look at it and say, Okay, let's give it another few hours and the eight hours Boy, it's even better. It doesn't work that way. After about two hours, it's about as good as it's gonna get. So understand that it's not like we can take that, uh, contused heart from trauma Victim and bring it back and watch it for a couple of days. And when it's completely healed and resuscitated, we can use it that maybe one day that's certainly on the horizon. But that is not today. And what that means is that there's this concept that I think we all had, that we could go out and get one of these hearts. And if it arrived at 12 midnight while we just let it stay on the pump because it would be happy, it would just be getting better and we would do the transplant seven in the morning. That would be great. Let me tell you, that's a narrative we all wanted to jump into, but unfortunately, that's not the case. The longer these things are on the pump them or diminished they get and the worst some of them become, uh, injured from the pump to the point of Dr. Baron said that about 30% of them are gonna need short term M. C s, and that means ECMO. Now, the good news is that the M. C s runs appear to be super short, usually just today so and that's also true for lungs. If these organs come back and their demand, it's usually after about a day, they're ready to go. So it's gonna be a different ECMO experience in terms of our ability, ability to get it. You can see this is our working board. We're down to number 10 here, which is successful recovery. We've got to do two of these practice runs. We started getting DCD calls already. We have one that we almost executed on. But we cannot implant until we get two of these done successfully and they do a debrief for us. And that is the tricky part. This trial is hot, it's red hot, and that's a good sign when it comes to trials. When you see trials enrolling this fast, particularly once they're this complicated, that's a good sign there. 90 that air in their 82 are enrolled with a couple enrolled just last week. And there is a big chance that we're gonna get everything ready to go on. The trial is gonna close. There is a chance that if we can sneak in under the radar, are right before the gate will be able to do. Maybe one of these are two, and then the trial is gonna close, and at that point, it's not over. The company will then apply to the FDA for a cap or continuing access protocol, which will be great because it won't have random ization. You know, how long is that gonna take? Well, that's an interesting question. If you ask the company, they'll say, like a month or two. The reality is it's probably gonna be about three or four months. So what to expect? There's a chance we'll get one of these under our belt and then be prepared for a big pause. There is a chance that we're gonna get all locked and loaded and ready to go and the trial is gonna close and there's gonna be a big pause. So I would say be prepared that there may be one or so, but really be prepared that this is probably gonna be a January or February launch. It would be nice to get the first one out. Really? Because just personally, I wanna beat M. C. V. Um, I trained there, so there's a good collaboration we've had with them and a healthy one healthy competition. But at the end of the day, this is also about this is the guiding principle for us. This is stewardship Administration has put this in our hands. Uh, this is a precious resource and a precious technique, and it is the future, and we cannot have a major stumble with this. This has to roll out its flawlessly as we can do it. We can't overwhelm the system with the whole rush of these. We've got a crawl, walk and run. There will be a debrief after each one of these runs, just like we do transplants where we take all the lessons and put rapid cycle improvement plants in place and learn. We've got to get to this learning curve as smoothly as we can. There will be hiccups, particularly early on. When we talked to all the centers in Europe, they definitely had these. And after about 10 or 15 they really kind of got it down. So we need the right amount of speed where we have a good cadence, a good healthy cadence, but one that's not too slow in one that's not too fast and that we optimize safety questions. Jonathan, have a question from the O. R team. Texted. So, Dr Philpott, how long can a patient in a vegetative state continues to be a donor? Because usually a vegetative patients on a lot of oppressors Lifesaving meds. So will those meds ultra how well the heart works in the box. They can. They can be in a chronic vegetative state for years. I mean, we're gonna get some donors that have been in a chronic vegetative state for five years, and finally the family says, Okay, we've had enough. You can have a trauma victim who is young and has a absolutely catastrophically severe traumatic brain injury that, on all scores, shows that the patient is not gonna wake up that's on some pressers that's gonna come to the O. R. And days. So it's gonna be the full gamut of these things. The question is an excellent one. You would prefer to come to the dying process without a bunch of cattle. Cola means on board and pharmacologic agents like epinephrine, because guess what that's in the prime and all those drugs and get put right into your prime that you're gonna go with on the run. The question also is a good one, because part of the learning curve is gonna be us looking and learning the right D c d donor to say yes to, um And there's a little bit of an art to that. Any other questions? Yes, a technical question. What if your aorta leaks when you cook it up? Thio that all your measurements are off, you move it and you wouldn't remove it. But you try to be able to troubleshoot it and get something around it to seal it. Okay, that is a problem. That happens. And you really have to make sure that when you are putting that cannula in that it's in deep and that your initial cardio pledges stick is completely solid. If not cut out of the way, it has to be sealed now. If it's not completely sealed, you still may be able to use the heart, but you're flying blind there. That's like kind of taking care of a nice to you patient where your your Swan Ganz catheter no longer works. It's probably the best way to think about it. Surgical duct tape doesn't it? Doesn't. It always scares you when they say Bring bone wax in case you get a leak. I'm not making that up, by the way. And then is the patient in the O. R. When they pass, you have a lot of passes. The bed song. It's completely variable. Sometimes they pass in the EU, and then once they they're declared dad, they whisk him off to the O. R. There are other times where they let it happen right outside the O. R. And in some places they let it happen Inside the O. R. The one consistent thing is the one part in the process that I would say we have just a little bit of, uh, involvement in is that the patient has given happen, Okay, question you mentioned before that sometimes gonna do runs and the heart home good or you bring the heart over and you turn it down. So all these runs that you might go and don't end up well, who, discovering these costs by from a mystery stand. Fortunately, the Medicare costs report allows this to go on that side of it. So I and I think that's why it's financially viable. The pump, I want to say cost about $50,000. So this is not cheap. Yes, I have several Sorry for our dads that have been on the you knows for 1300 days. Would we consider the idea of these marginal hearts for that? Like, what is our guess? Programmatic standpoint? What are we willing to accept for somebody? We think it's never going to get transplants. I would hope that we would use this technology to get them the 18 year old heart. They're gonna be turndowns. But the thing about this is the pool. It's so massive that we're gonna have access to that 18 year old heart where the patient does die correctly and we can bring them that heart home. Um, this also does not preclude them from the usual brain death. Like if we got a beautiful brain death donor and they lit up for it, they would get it either outside the trial or inside the trial. But the hope that I have for this is that we get access to much better donors than we currently have access to. The ones we have now are older. Um, they're drug laden. Um, many times exposed to chronic usage of very toxic drugs like cocaine. Um, that alter the heart over time. You know, like you do it once or twice. It's probably not that big a deal. You do it every day. You know, for years, the heart starts to change. For me, at least I want to get that 18 year old heart that's gonna go 20 or 30 years, and that's what I hope this is going to open the door for us to the bad players air the most difficult. They're the hardest to get out. And when you think about this, I think that those were the patients that don't get a marginal heart either way because it's a tough dig out and they're in shock and they've got to have an organ that's gonna work. So I think we're gonna be particularly picky for them. So how do we time it? Where Say we're doing a bad dig out, like sometimes we bring them to the are great Question s Oh, this is beautiful. This is where it can wait so you can bring it back and look at it and say, Hey, we like it And then bring the patient in and it the hearts to locate the key that the sad part for me was I had this idea that I could sleep. You know what I say? I say it over and over again. No matter what they tell you, it will be in 0 300 in the morning, you know? So I had this idea that you could bring it back and get a good night's sleep and do that case when you're arrested. We're not there yet, but for the tough redo. Yeah, it's not. You're not under a time gun at this point. And what they tell you out of the gate actually is. Don't get too hot with your recipient. Don't bring them into the over. Don't do any of that. But then if you've done 20 of these, if you're flying back on the airplane and the heart looks absolutely fabulous yeah, then you can go ahead and say, Let's go. We're gonna use this one. Um, And then what do we have programmatic wise infrastructure in place for the amount of transplants you could potentially be doing That's also like double. Yeah, that's also a good question. And we're not going to ram into that. We're gonna just gradually accelerate. We have got How many repetitions have we done? We've gone through three or four. It's like building a sandcastle. When you get real big and the whole thing comes down, you can't build too fast here. You've got to really build and then have checkpoints where you stop and say, How are we manpower wise? Because if not, if you overbuild their body burns out and get a big mass exodus of folks or you, you run into a bunch of bad outcomes, and we really just can't do that. So one of the other initiatives that we put in place is, um, just kind of closely called the Guardian Initiative, which is we're really going to start paying attention to that waitlist every week going through those patients and deciding who were gonna light up for D C. D. So we really kinda have our hand on the throttle there with a very controlled rollout. And if we do a couple of cases and we've got a couple of sick patients in the I C U, they're probably gonna back off and let those patients get on through so they can get the attention they deserve and the focus they need before we move on to somebody else. All right, well, thank you very much.
