 This is by Dr. Eric Grossman. Eric is a fellow in pediatric surgery at the Lurie Children's Hospital here in Chicago. We like to claim him as a product of the University of Chicago since he was an undergraduate here, went to medical school here, did his residency here, including his surgical ethics fellowship, and then we released him to go elsewhere. But we're hoping someday that he will come back. We're happy today he's speaking on ethical issues in pediatric surgery. Eric. Thank you very much for inviting me. It's a big honor to speak here. Thank you, Dr. Siegler, Dr. Angelos. And thank you everyone for sticking around for the last talk. I very much appreciate it. So when I initially thought about what I was going to talk about, I kind of left a broad ethical issues in pediatric surgery, which kind of encompasses pretty much anything I wanted. And I wanted to basically focus on ECMO and the ethics of ECMO. You could probably speak for hours or even a whole weekend. But in the next 10 minutes, what I was hoping to do is kind of give a quick introduction on what ECMO is. And then what I was hoping to do is kind of talk a little bit about how ECMO came about and the history of ECMO with a specific focus on the concept of equipoise. Equapoise being defined as the ethical standards, or excuse me, thinking about equipoise in the sense of ethical standards that were employed during the initiation of ECMO. Now when new treatment modalities are introduced, they're put upon such strict criteria. And I think it's really interesting to kind of see how ECMO came about. The other thing I want to talk about is how ECMO, the ECMO experience in relationship to justice, specifically social justice and distributive justice, and how we ethically distribute this resource, who is eligible, who is not eligible, and who makes those decisions and how they are executed. And then finally, when you come off ECMO, obviously it's easy when a patient is doing well and you come off ECMO. But the question is when a child or a specific relationship to children, when a child is not doing well, and the decision to come off ECMO has to be made, how that kind of spans the realm between autonomy and futility. So quickly an introduction. So ECMO stands for extracorporeal membrane oxygenation. It's used as support for patients with a reversible pulmonary and or cardiac failure in whom maximal conventional therapies have failed. I put two pictures up here. The cartoon is, if you Google ECMO, this is one of the pictures you'll get. And it's very benign looking and peaceful. This was the most graphic photograph I found on Google that was not too graphic. ECMO is by far a far stretch from benign. It's extremely invasive and comes at a large risk. And I put those two pictures up just because I think it's important for us to understand that what patients perceive and what they are about to go through, what their child is about to go through, is almost impossible. I mean, there's really no way a parent could appreciate what their child is about to go through when they elect to put their kid on ECMO. So Dr. Lantos, who I had the good fortune of when I was an ethics fellow hearing him speak, phrases it as such. ECMO is less a discrete intervention and then a commitment by a large group of skilled individuals to provide ongoing, high risk, high tech life support and extraordinary cost of time, energy, equipment, and money. And I think this really sums it up best. It is an enormous intervention about as big as we could do for a child. And it is costly both in resources, medical professionals, family buy-in, and then risk to the patient. And what's especially interesting with ECMO is that it's someone else who's undergoing the risk. As the parent, you purchase this for your child. I use the word purchase only in the sense of buying in. I mean, it's a big commitment to put someone through. So the final thing I wanted to say as far as an introduction is what are we offering with ECMO? I mean, the whole point of going on ECMO is you're likely to die without it. So what are we offering you? What are your chances of surviving? So this is from the ELSO database, which is the organization that compiles all of the ECMO data. And it's a little bit, it is what it is, but these are the total values, so the cumulative data. So if you just kind of look at surviving to discharge or surviving to transfer under the neonatal and the pediatric. And then if you look at either respiratory or cardiac, ECPRs is simply crashing onto ECMO, and those numbers are obviously lower. But the surviving to discharge or surviving to transfer range is between 49 and 75%. That 75%, in my opinion, is a misleading number because that is a product of the fact that neonatologists have become so good at treating meconium aspiration such that only the sickest go on ECMO. That number, I think, will change as neonatologists get better and better at treating respiratory problems. So fewer and fewer kids require ECMO for respiratory problems, and the vast majority of kids who go on ECMO are diaphragmatic hernias or kids with really just unusual problems. So the first topic I wanted to talk about was equipoise. So obviously there's lots of definitions. The definition I wanted to kind of focus on was genuine uncertainty in the expert medical community over whether a treatment will be beneficial. And then so kind of what were the ethical standards that the surgical community used when ECMO was introduced? So this is Dr. Bob Bartlett from the University of Michigan. So 1975 was the first successful application of ECMO in the neonatal respiratory failure. And this was his publication, Extra Corporal Circulation in Neonatal Respiratory Failure, A Perspective Randomized Study. So what did the randomization allocation entail? What it was was it was 12 children. And it was classified as what's called a play the winner, such that the first child was placed on a conventional ventilator and died. The next one was placed on ECMO and lived. And the way the study was designed that you were randomized to whatever the benefit was from the previous one. So in other words, as ECMO did better, more and more kids went on ECMO. So of these 12 patients, one was a conventionally ventilated, the following 11 were all placed on ECMO, and they all survived. So this was the beginning of our randomized studies in ECMO. This was followed up in 1989 by Dr. O'Rourke, looking at an extra ECMO in neonates with persistent pulmonary hypertension, another prospective randomized study. And this was not as skewed as the play the winner, this is what's called an adaptive patient allocation in which there was a randomized section and then a second section. So in the first trial, there was four, excuse me, 10 patients, four of whom died in the conventional ventilation and nine of whom all survived in the ECMO. And the second set, everyone went on ECMO and 19 of the 20 survived. So again, not exactly what we would call a randomized controlled study, but I bring it up to simply to kind of go through how ECMO came about. The counterpoint to this, also published in 1989, was a paper published saying, survival of infants with persistent pulmonary hypertension. So these are the majority of kids going on ECMO at the time, this plus meconium aspiration. And what they did is they basically looked at their results and compared them with the results of kids who would have qualified for ECMO. And they said, hey, you know, we're doing better with our ventilation. Obviously, 1989 is not the way we ventilate children now, but there were benefits. And they said, hey, we're ventilating kids better. Our survival is just as good as ECMO survival. We propose that a better randomized clinical trial should be undertaken before further expenditures on ECMO centers are made. So this was kind of a point, counterpoint, beginning to think about how ECMO poise was executed. Nonetheless, ECMO came and really exploded. So this is looking at 1985 to 1990, the ECMO registry as well as neonatal ECMO centers, this is out of the University of Michigan, which really is the birth of ECMO. And as you can see, the numbers just shot up exponentially over that 10-year period. So in retrospect, where are we? So this is a Cochrane view from 2008 that basically tried to say ECMO is here. The survival is what it is. How confident are we that there are randomized data to say ECMO is actually benefits to our patients? So there have basically been four randomized controlled studies that this Cochrane view looked at to compare ECMO, this is all in children, to conventional ventilation. And their conclusions was that a policy of using ECMO in mature instruments with severe but potentially reversible respiratory failure results in significant approval of survival without increased risk of severe disability. So whether or not it was executed or initiated with equipoise, this Cochrane view definitely would support the data, or assume the data would support its use for children. However, the benefit of ECMO for babies with diaphragmatic hernias remains unclear. And as I mentioned earlier, as neonatology improves, the majority of our children, or a larger percentage of them, and I'll show you the data in a minute, are diaphragmatic hernias no more than macronium aspirations or the primary pulmonary hypertension. And whether or not the data supports this, I think, is unknown. So changing gears a little bit, justice and the definition of distributive justice. So how goods are socially allocated in a society? This is the version of Plato's Republic that I read almost 20 years ago as a freshman in college, and I loved it. And I loved thinking about the concept of how to distribute goods in a society, and who gets what, and upon what merits do they get those goods? And I think it's such an interesting way to think about medicine and how we, who gets what treatment, who comes to the University of Chicago, who doesn't come, and then when they are there, how are they treated? And ECMO is one of the most exclusive things we have, and you have to qualify. And so the way that we decide who gets, who is even eligible for ECMO, so there's a few different criteria. So ELSO, who's the, as I mentioned earlier, they compile all the data and they credential ECMO centers, have specific center inclusion or exclusion criteria. Additionally, specific hospitals also have their own inclusion or exclusion criteria. And I just listed them here, not because I think they're wrong, but I think it's really interesting. So you have to be more than 34 weeks gestational age. You have to weigh more than either 1.7, 2.0, or 2.5, they should say kilograms. And the variability is there. I highlight that simply because that's center to center to center across the street where I'm at right now at Lori Children's. We are at 2.0, so you have to weigh more than two kilos to get on ECMO. And even that number is slightly fudgable, but that's different from every center. And I think that's a very interesting thing that it's a different number. You have to have what's called reversible lung disease. The concept of reversible lung disease is as ambiguous as it sounds. And it's very hard on who decides what reversible lung disease is and whether your lung disease is reversible. You can't be ventilated prior to ECMO for more than 7 or more than 10 or more than 14 days. All of these things kind of add to the ambiguity on whether or not you're a candidate. The bleeding and the coagulability, the coagulopathy is kind of self-evident because of the heparin. And then lethal condition incompatible with life, including trisomy 13 and trisomy 18. I put that there, and I'll come back to that in a second. Interestingly, this is Aetna, the insurance company's criteria for who goes on ECMO. You've got to be more than 34 weeks, and you have to weigh more than 2 kilos. And if you don't, they say this. Aetna considers ECMO for neonates experimental and investigational if you don't meet these criteria. I don't know if this means they won't pay for it. I doubt that. But it's definitely on their website. And this I stole from the internet as well. So these are pictures on trisomy 18 and trisomy 13 support group websites. So these are people who are excluded from ECMO. I was reminded of when I did my ethics fellowship, Dr. Oplogle would talk all about how children with Down Syndrome were treated when he was training. Obviously, the outcome for 18 and 13 is much worse than Down Syndrome. But these are children who are excluded from ECMO. And these are their pictures and their support groups. And they are definitely some of them live longer than we would anticipate. The final thing I wanted to say about justice in the sense of how is ECMO distributed? This is a chart, excuse me, this is a graph looking at who goes on ECMO. I just want to highlight the blue and the black. So the blue is white population. And then how often whites go on ECMO? And then black, both dotted and in a bar, is the African-American population as a percentage of the census, as well as a percentage of how often they go on ECMO. And basically neonates of ethnic minorities continue to disproportionately require ECMO in comparison to their birth rates. It's argued that maybe ethnic minorities get worse care prior to coming to tertiary centers and therefore require ECMO more. I'm not sure what this means, but it's definitely different as far as what you would expect simply from a numbers game. And then finally, coming off ECMO. So this is an article from the New England Journal by Dr. Siegler and Dr. Satter, who are still here, talking about how to come off ECMO and what to do when you're coming off ECMO and you know it's not going to end well and the patient doesn't want to and the family doesn't want to. And so does patient autonomy require medical professionals to comply with family requests and how does that differ in the withdrawal of support? So the two, what Dr. Siegler referenced was the Healthcare Decision Act of Virginia in which a physician shall not be construed to prescribe or render medical treatment to a patient that they determine to be medically or ethically inappropriate, as well as the Brody versus New England Sinai Hospital in 86, in which a hospital and staff should not be compelled to act contrary to their moral or ethical principles. And what this sounding board proposed was that if you think it's time and you think it's ethically appropriate, then to decannulate despite the disappointment of the family. So in conclusion, I think we kind of talked a little bit about how equipoise was used as ECMO came about, the justice of how ECMO was distributed and the issues of autonomy and futility on how we come off ECMO. Again, thank you very much for letting me speak. Thank you very much. That was great.