Gabriel Loor, MD, surgical director of the Lung Transplant Program at Baylor St. Luke’s Medical Center and Associate Professor of Surgery at Baylor College of Medicine, talks about a device called Organ Care System that is like a portable ICU that help lungs that are harvested for transplants last longer.
Tell me a little bit about the problem that you’re trying to address with this device.
GABRIEL LOOR: In the field of lung transplant, one of the biggest obstacles that we have is donor shortage. People get placed on the wait list, but they’re very sick when they’re on the wait list. Up to 15 to 30 percent of people unfortunately die waiting for an organ. It’s very important to have enough organs available for them. So, a donor supply is very important. What’s interesting is that we have plenty of donors, but only 20 percent of the organs actually get used. We needed a technology that would allow us to investigate more donors so that we could hopefully use those that we thought weren’t usable. The other major issue that we have is quality. A lot of folks who are struggling with lung disease and know that they need a lung transplant worry a lot about the quality of that organ because they know that when an organ gets taken out of the body, travels and then is put back into another person, that’s not a natural phenomenon. The lungs sometimes don’t start up right away and they get what’s called graft dysfunction. And when you do get that, sometimes the lifespan of the organ isn’t as long. Right now, within 10 years the majority of patients are going to experience some form of rejection. The way to get the organ to last longer, we believe, starts at the time of the transplant to some degree. So, this technology addresses basically two issues. One is the quantity of organs and the second is the quality.
Tell me about what this device does.
GABRIEL LOOR: The device tries to achieve what we’ve always wanted to do in transplant, which is to have the donor right next to the recipient. There’s a lot of logical sense to that. When we remove the organ we don’t want it to be outside of the body for too long. We also don’t want to rush. But we want to have some time. In the past, we’ve cooled the organ down. We’ve been able to travel with the organ cold and that decreases the amount of oxygen that it actually needs. And we also believe the lung is privileged a little bit because it has oxygen in its airways. But we’ve relied on that to get an organ from point A to Point B, and that’s all we’ve had. What this device does is it basically takes the lung and keeps it as if it’s inside of the patient. It’s as if we’re bringing the patient directly to the recipient, the donor to the recipient. It keeps blood pumping through the lung, it keeps air going in and out of the lung, so it keeps the lung looking feeling and breathing just like a normal lung would, and it doesn’t change its characteristics. In that way we believe that we’re essentially bringing the donor directly to the recipient. The other thing that it does is it monitors the lungs, so it monitors how well oxygen is getting in, how well it’s functioning, how much resistance there is to the blood through the circuitry of the lung, and all of these things give us an indication of the quality of that organ. Two things happen when we get the lung. We’re confident that we have an organ with really good quality, and then the second thing is that we’ve limited the transit time. We’ve limited the time that the lung has been without oxygen. Both of those things we believe lead to more organs and a better quality organ.
What inspired the device?
GABRIEL LOOR: Well, the device was invented by an inventor in Boston who was actually a surgical resident, went into the lab to study how hearts could actually beat outside of the body for a longer period of time. As with most inventions, it takes a village and it takes a lot of investigators. We were really privileged to be among the first investigators involved in testing the lung platform. We went through some trial and error and a lot of thought and discussion into what the final protocol would look like for using it for lung transplantation. Since then, we’ve gone through several cycles of regulatory overview, several clinical trials to get to the point where we’re at now, which is kind of a fun time because now we can increase its use for whatever indication we feel is appropriate for the recipient. We use it for about 60 to 70 percent of all the lungs that we do.
Where is it used widespread?
GABRIEL LOOR: It received FDA approval for standard lungs last year, and then they increased its FDA approval clause to allow it to be used also for what we consider extended criteria lungs. Between those two approvals, you can use it fairly liberally to expand the number of donors that you have access to. We’re in an era now where we have the technology that we couldn’t have even thought of 10 or 20 years ago. And we’re using it now under a registry. We’re still keeping track of it. We’re trying to detect any harm and so far there doesn’t seem to be any. But we’re also trying to detect the benefits. As we learn more and more about benefits it’s important to really document that to understand if we need to apply this across the board. It’s approved in the US, it’s used up to 80 times so far since that approval in the U.S. Part of that use was within a clinical trial and the rest was just standard use. In total, it’s been used probably over 300 to 400 runs worldwide. That included some of the original clinical trials, as well as the work that was done in Europe that actually preceded a lot of the work that was done here.
What is the name of the device?
GABRIEL LOOR: The name of the device is called the Organ Care System and it’s kind of like a portable ICU. It keeps the lung treated with medicines and with blood flowing through it. The Organ Care System is the trade name for it. It’s also known as breathing lung transplant or some folks call it a lung in a box because that’s what it looks like as it’s travelling. The technical term for it is normothermic portable ex vivo perfusion. Normothermic means it keeps the lung at its regular temperature, portable because we can take it really anywhere. In fact, it’s even traveled from Hawaii to North Carolina. It was implanted in North Carolina as well as in Arizona from Hawaii, so it’s definitely portable. Ex vivo perfusion refers to the concept of having an organ outside of the human body. It’s not the only ex vivo perfusion platform, but it’s the only one that we are currently using that is portable.
How is this device better than the standard method?
GABRIEL LOOR: In terms of how is it better, this is a process that we’re continuing to evolve and continuing to understand. In a landmark clinical trial comparing ice to the device, what it showed was published last year in the Lancet. It showed that individuals who had their lung transplants after cold storage after the standard way had about 30 percent incidence of what we call graft dysfunction. The lungs’ oxygen levels were not quite as high as we would want them to be. That was within the first three days of transplant. Individuals who had the organ brought over on the device had half as much graft dysfunction, so the lungs woke up faster, within the first six hours after implantation. That was an important signal within a trial that was really designed to make sure that a new technology doesn’t do harm. It certainly showed that but then it also showed a positive signal in that regard. Now, we’re trying to study that across real world experience to see if we can extrapolate that to real world transplants outside of a clinical trial and see if we continue to see this positive signal. One of the things we’re really looking forward to is seeing the long term results too because if the theory of the quality the organ at the front end really dictates how long it lasts, then that’s very important for us and for the scientific community. We are eager to see what the long term results are as well. The other thing in terms of how good it is in comparison to the standard way is when we think about extended criteria organs. We did have another publication that came out in the Lancet last year and it showed the use of this device in 90 organs that were extended criteria. They were very far away and they were donors that had suboptimal oxygen levels for whatever reason and had a couple of other indications that normally we wouldn’t transplant with standard ice. At least less than 10 percent of transplants in the US would use this extended criteria. In this trial all of the transplants were extended criteria. What we saw was a 90 percent one year survival. So, that’s better than what we would expect with a standard transplant with a regular normal organ. That was very important. We did not compare it to ice because we weren’t sure how safe that would be. It did give us a strong hope that we’re going to be able to use it to investigate offers that we traditionally don’t use or that at least are being used less than 10 percent of the time in the US.
And you talked about the heart. What implications does this have for transplants, big picture?
GABRIEL LOOR: It’s a very important technology and I think it’s an important platform for organs outside of just the lung and lung transplant. For example, with hearts it’s gaining a lot of traction right now particularly in the field of donation after cardiac death donors. DCD donors is a sub population of donors, so ninety five percent of all donors in the US tend to fall under a standard brain death criteria. They have to be declared brain dead in order to donate the organ. But the body is still functioning and the heart is still pumping when the team goes to do the procedure. Donation after cardiac death is a situation where they can’t quite pronounce them. They’re not really brain dead, but they’re at a futile point in care and the family has reached a point where they would like to withdraw care. In that situation, they withdraw care and the team shows up to do the operation, but the heart is not beating anymore. The team has to start the procedure very quickly and procure the organs under what we would consider somewhat suboptimal conditions. DCD heart transplants were not being performed at all in the US and recently it has been performed in two to three centers in the US. This platform gives people confidence to study the heart and see how good it’s functioning before they transplant it into the individual. It’s going to be very important for heart transplant. For liver transplant, it’s being used also to try to increase the amount of time that the liver can be outside of the body. I see this as kind of a futuristic thing almost like the Jetsons where you’re traveling from point A to Point B in ways that you didn’t normally think you would be. It’s pretty exciting for the transplant community. It’s definitely something that’s very important for us.
When you talk to patients about this, like, what is – are they excited? Are people, you know, who weren’t able to have a transplant before, you’re able to tell them this is an option? You know, just in general what is the reaction?
GABRIEL LOOR: Patients, especially in the field of lung transplant are very savvy. By the time they’ve had a lung disease to the point that it requires a transplant, they’ve gone through many doctors from many facilities. They know what’s out there. They know what the odds are of getting a transplant. They know what the odds are of having a successful transplant. They know how the procedure is done. They know how the organ is cared for. They’re very, very smart about it, all the details of transplant. Oftentimes I’m surprised about some of the questions that they’ll ask. A lot of times they know about this technology before we even bring it up. Patients get so uplifted and so excited about something that is new, something that gives them hope. They see more hope in it, even oftentimes than sometimes the doctors do in the sense that it means so much to them, it’s so palpable to see that science and the medical community, the scientific community is heading in this positive, innovative direction that it means like the world to them. They love the idea. It made sense to patients far before we got regulatory approval. It made a lot of sense to patients that would come to get consents – why wouldn’t I sign this? Why wouldn’t I do this? Why were you doing it the other way? And it’s pretty fun to interact with patients about it. The patients are doing relatively well over all.
We need to understand the full spectrum of how it’s working. But I see this as an important start. We still have organs that we’re not able to quite make better. We see on the device if they’re not “good lungs” to use and then we screen them out and we don’t utilize them. Well, we’d like to get to the point where we really start to regenerate the lung. What that requires is a little more understanding about the biology of what’s going on as it’s being transported and using things like genetic therapy, stem cell therapy, or different medications that block or change the inflammatory system. The nice thing about having the organ outside of the patient is that we don’t give them medicines that are too toxic to the patient. We can give it directly to the lung and we can monitor its effect on the lung. That’s gonna be a very important next step which is not just utilize it as a platform to maintain oxygen and to keep it transported, which is very important, but also as a way to try to manipulate the genetics and the biology of the organ.
END OF INTERVIEW
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