Evan Nadler, MD - 2024 Pediatric Bariatric Surgery Update Course

OK, well, at 11:05, um, we are at time and 12:05 eastern. Oh yes, right, um, so Mark or Steph, do you wanna kick us off with this next one? Sure. So, next, uh, Evan is gonna, Evan's gonna take us on a little journey on some clinical controversies, uh, to stir some discussion cause obviously we're a quiet group and we need this to prompt us to get going. Uh, but Evan, you wanna go ahead and, uh, kick us off? Thanks, Mark. Um, So, for those of you who don't know me, um, my name's Evan Nadler. I used to be at DC Children's where I was a pediatric, bariatric surgeon starting in, well, 1515 years ago. And um I wish I actually had Manisha's uh unanswered question slide because the first unanswered question is, is how do we bring more care to the masses. So, I gave up my clinical practice because it occurred to me after performing 750 bariatric operations in children that I could operate all day every day cause I don't use the robot. I still never, um, I would still never make any dent in the overall population problem, uh, that, you know. We have access to the kids who need surgery. Uh, we, we treat about what, 005% of them or some number that's well below, uh, the adult numbers. Um, and then his second question was, I think, about the low BMI kids. And then the third question was about the kids with uh intellectual disabilities, etc. And he talked about data. And so, I'm gonna show you some of the data. And then, um, at the end, you'll see my email address. So, uh, at ProCare, what we're trying to do is Uh, uh, program building nationally, internationally, and whether it's starting from scratch or just getting your numbers up or whatever uh. That's what we're, we're aiming to do. Um, and I think I should also just touch on one controversy that's not, it's not part of my slides, which is, um, we talked about earlier today, accreditation versus not. And in Karen's slide, she said a program coordinator was optional. It's not optional for MBSA Quip. And then in the chat, someone talked about free-standing children's hospitals, the requirements for a verified surgeon, and since Makowski's not here, I'm, I'm answering this for him. Um, the requirements for, um, Verified surgeon at a freestanding children's hospital is actually 100 lifetime cases, 75 of which can be when you are a fellow, and then, uh, 20 stapled cases a year. So, it's, um, they're not nearly. Um, as restrictive as they used to be, and Mark has, uh, worked diligently to, to get those, um, number of requirements down. Similarly, the question about why to join, I've been working with him or pushing him to make the data collection and MBSA quit more relevant because it's not relevant to us and uh as pediatric surgeons. So I think if that happens, that would be a real reason to join. So with that, um, these are data that are published in preteens, they're published in obesity, we presented them in obesity Week. Um, and I'm not gonna go through all the data, uh, but, uh, Janie and I and, um, Jeff Seitzman at Columbia, we are 3 of the NBSA quip centers that have a bunch of preteen experience. So we got together to write this paper. In response to the AAP clinical guidelines that unfortunately introduced that cutoff of 13, whereas in 2019, they didn't have an age cutoff. So, in my mind, they actually moved backwards with the, the CGP, um, and we wanted to prove to them that there actually were data out there, they just didn't find them. Um, so, anyway, if you look at the teens in general that are in Uh, database of about 4800, but they're only about 50 preteens. And so, we compared, we sort of compared the two, and based on the MBSA quick data, the kids that we were operating on, uh, in the preteen age, you would, as you would expect, are actually sicker than the teens cause we're not doing operations in preteens because we're just trying to, you know, beat each other's lowest number, age number. We're doing it for patients who need care. Um, and so, we, we, we found that more had insulin-dependent diabetes, more had sleep apnea, um, and the rest were somewhat similar. And then, you know, in terms of safety, um, The, you know, the, the preteens, as you would expect, were the same or better because the younger the better, which is gonna be the overall theme here. And um The, we take some. Propensity score matching that showed that the Decrease in BMI in the MBSA uP data were the same between the two groups, but because the numbers are so low, we actually gathered our center-specific data, and these are not great, and they're not because the three centers were doing this in their own individual, um, databases and we didn't have standardized time points or anything standardized, um. This is, you know, sort of bare bones, not great data. But the point is, and, and again, I would argue that the kids who are having surgery as preteens probably have a more aggressive phenotype or even genotype of their obesity compared to the kids who can who get surgery much later. But as you can see, you know, the results were, were decent. Maybe not awesome, but decent. Uh, and so, you know, for me, Um, in DC before I left, I had no age cutoff. Youngest patient I've ever done was, I have two patients who were 4 who had bariatric surgery. One who was a hetero uh homozygote for MC4R, uh, receptor deficiency, and one who had Rohat's syndrome. I have a bunch of others who were 5. Not maybe not a bunch, but a small handful who were 5 who had either MC4R, uh, homozygous deficiency, or, um, Uh, some other genetic form of obesity. Um, and then actually, I did have some 8 and 9 year olds who are more into the, just low BMI with a With a uh comorbidity, and one of the tricks that With all the insurance companies is when you start using the percentiles instead of um just straight up BMI. So the, the um insurance companies don't really, can't really understand, frankly, I can't even understand the percentile of ninety-fifth percentile. But when you throw that in there, um, it confuses everybody and they just look at the diabetes and they say, OK, we'll approve that. Um, so, for preteens, that's where we're moving. There's no reason to exclude them from surgery if they meet criteria. You just have to support them more. I hope that the AAP removes that age limitation at some point because there are always unintended consequences of, uh, Uh, publishing guidelines, and I think one of them is gonna be insurance denials for patients under the age of 13, now that it's in writing somewhere that, um, That uh That, you know, that that's a cutoff suggested by a national society. So, moving on to the other sort of. Set of controversial kids. So should we, should we stop and maybe just chat about that a little bit and let's talk about the young patients because I, I think it's uh You know, gosh, you, you've got, I mean, I, the youngest I've done, I think, was 11 or 12. I've got, it's maybe like 11 of each or a couple 12-year-olds and 11-year-old. I don't know if anyone else has done any of these younger. I bought my own 8-year-old, um, with a syndrome of obesity. How are you guys getting approval? Or are they self-pay, or is it just easier where you're at? How, how did you get approval for that? Because, you know, um, with insurance companies, they don't want to do anything less than 13. So that's that again, that's sort of, that's a regional thing, right? So like I've spent my lifetime in DC, the 14 years, 15 years I was there working with the local Medicaids, educating them. Uh, so there are no age cutoffs in the DC area. Actually, I take that back. There are, there are in a couple of the Medicaids, but the others have removed them, and all of these are insurance approved. Not all of them, but I would say 90. Yeah, Kenneka, you have to, you just have, you have to make the case and you have to justify the clinical, uh, justification for why you're doing what you're doing. And fortunately, insurance companies, they, you know, they're not, uh, they don't have a, a, a great deal of clinicians that are in this space and so they defer to the people that are in this space more commonly than not when you have rare cases. So, like, for, you know, for my Rohag kid, it didn't even take an appeal, I don't think. I think I just got it approved cause the kids, you know, 4 with uh type 2 diabetes and obstructive sleep apnea, you know, what are, what are they, they know most, most of the Medicaids know that their cost-benefit ratio is gonna be far greater with surgery than any other therapy. Janie's done it, you know, like, when we looked at these data, I think they're like 10 or so came from Janie, 10 or so came from Jeff, and the other 30 or so, 40 or so came from me. So, Janie, do you have any comments? Yeah, I, I mean, I, I do them whenever they're ready. They don't usually come to me, unfortunately, when they're younger and, and lighter, and I could actually get them to a normal weight. Um, those that do, we do a lot of 12-year-olds, we do a lot of 11-year-olds. Um, now, I mean, and, um. You know, I, I, I honestly think the ideal age to operate is somewhere between 12 and 14 because those kids still listen to their parents and they're still developing habits, and they, they actually, I think they do better than any of the other kids. Um, I don't know about the younger groups because I don't have that many, but yeah, I would argue that the 10 and 11 year olds are even better because they, uh, going through puberty at a normal weight. Or at least a lower weight is way better for them, both physically and mentally. And they definitely listen to their parents, and they definitely don't have access to get any food or anywhere or any anything else without their parents' help. So, um, in my experience, actually, the younger the better. What about meds during this age group though? I mean, I for sure, 100% so you just have to. Like throw everybody on Binance. Yeah. So, you know, we started, you know, one of these days I'll get, you know, I'll get Nazreth to, to join one of these things. But yeah, we would just, we, we, for years have just been throwing anything, everything at any patient at any age because our philosophies have always which is You know, the disease needs to be treated. So, yeah, we use all these drugs off label. The, the Rohad patient was on Vyvanse pre-op, for sure. I don't, I think she got restarted on it post-op as well, um, you know, but it doesn't have to be, you know, that's obviously one of the easier ones to get in the youngest of young kids. But, you know, phentermine, topiramate, off-label, uh, generic versions, um, The GLP1s are obviously harder to get, but again, with your patients, if they have type 2, easier. But yeah, do it all. And, and it goes to actually to what Dave was talking about with the GCPs and the, or yeah, GCP. Like, we should be doing all of it. We should be trying all of it. Robotic joking aside, yeah, do that too. Do whatever it takes to get these kids care and, you know, study it if you can and publish it if you. I was about to say let's just don't do it. Let's learn from it, right, right, right, yeah, but learn from it so that, you know, the next generation of this, you know, global cast 2054, they can actually move on to something else that's different, that's not the same old, like, you know. We changed the lay public's view of obesity stigma, which frankly, I'm not sure we're ever gonna solve. So you're not, you're not arguing about Rulim links anymore, you know, yeah, exactly. We'll, we'll we'll, we'll find something else to talk about whether like it's the, you know, the Titan stapler versus the, the robotic stapler. We'll talk about that for like 10 years. I, I would, I would argue, I would argue that meds are no safer than surgery. And in fact, we have less long term data on these medications in children. We have less, uh, we know that it causes gallstones the same way as our surgeries do. And, um, you know, honestly, the, the weight regain is going to be higher because they're going to stop using them. So it's, uh, I think in a lot of ways surgery we know is safe for obesity. We don't know that these meds are safe. I think that might be true for the GLP-1 agonist, but some of the other meds have been around forever, and I think that there's a place to start treating kids earlier in general, and that's one of the things I really try to talk about with other pediatricians is you gotta treat the hunger. And if you don't handle some of this hyperphagia, these kids are just gonna get heavier. So even if they're heavier when they're younger, if you can start, and, and this is why I always say the ADD meds because that's what pediatricians are used to. So they feel more comfortable starting that. So, you know, and the joke used to be that, uh, even if their BMIs, then we could see them at 42 versus at 62, right? I mean like. It doesn't necessarily change the overall process as much as it will hopefully get them at a better place. The, the joke used to be that statins should be in the water cause we all could use a little bit. I think that's the same is true for Vyvanse. I think that everybody from age 2 to age 102 could do well with a little, um, with a little ADD medication, whether it's to treat your ADD like me, or to treat your, uh, addiction suppression, your, you know, your drug addiction, your appetite suppression. Uh, all of it, it's just a great drug. I just, I, I seriously, and phentermine is less addictive than. Um, has less addictive properties than the ADD meds too, so just throwing it out there. I wanna echo the part about compliance in the younger patients. I, we have a, a, a small cohort of patients that we see in our, in our non-surgical weight and wellness management clinic, and then we have them ready to go for surgery when they turn of age, and they're, they're better to follow instructions, and they have their mental health issues addressed appropriately in a timely manner. So dealing with that aftermath is a lot easier for in that population. Yeah. I also think it's interesting to think about the prospects of some, of, of making sure that somebody is on lifelong pharmacotherapy. I mean, that's like a, that's a real thought, right? Like, we're telling people you should take these medications and in order to maintain your weight loss, you are going to be on medications for the rest of your life. And I don't know if that's a, that's a great lesson to be teaching. So, it's interesting. Ted Kyle just posted, uh, Ted Kyle, if you guys know from Consent Health, he posts all these interesting things on LinkedIn every, every day. And, and about a week or two ago, he posted some epic data that showed that actually a large number of patients after GLP-1 cessation in real-world clinical data, actually don't regain their weight, which I found interesting, and uh, you know, who knows if that'll hold true as more data come alive. Uh, uh, I don't know that they, you know, and, and Tom showed in his data, they don't all need to be on lifelong medication, right? There were, there were, um, basically 50% who did pretty well or did really well, and then 50% who did not so great or did terribly. So, I think the key to all of it, as we don't know, is we still, and probably will never be able to predict who's gonna fall into what category until we start looking at like genetic data or some other. Um, something that we haven't looked at before, it's not preoperative exercise. The successful ones are on, are on meds. They're just on endogenous meds. Exactly. So, so I, I know we're, uh, you know, you've got a couple, you, yeah, you've got a couple more, uh, controversial topics, and we've taken up 60% with this one. We can come back to it if we want to, or, uh, just why don't we keep moving on. Cool. All right. Well, so the other controversy was sort of the, the kids who can't assent. And, um, you know, we had published about this back in 2019 in, um, Pediatrics, which is that, uh, publication to the left and on the right is, uh, actually from Cincinnati, but I think after Tom left. Um, and so, the, the, the guidelines they recommend. Not changing your care algorithms based on children, whether they have um uh special health care needs or not. But they actually didn't provide any data to support that even though the data had been published. Um, so, Address that, we actually went back, we went and basically redid the same study. We had done previously, uh, with our, our recent cohort. And so, The first publication was up until 2017. So we went from 2018 to 2022, 490 patients, 34 with special health care needs, this autism spectrum disorder, and IDD, which is basically just developmental delay or low IQ, we're not sure or unspecified. And then a few with Trisome 21 and then one Prader-Wie. And there was a question and to talk about Prader-Willi. Uh, it's a whole another topic for another day, and there's a publication from In Sworded by Steven Meyers that addresses, uh, Prader-Willi patients, so I'm not gonna talk about them today. We compared these two groups, and you guys can see that pretty, all that well. But basically, the blue is the special healthcare needs and the orange is the, um, Typical neurodevelopment. And so, the, the, the blue didn't do quite as well as the orange, but they still lost weight. And my question, my, I always sort of put it, put it back to the Pediatricians or other naysayers and say, well, we know what would happen if we didn't do surgery, so even though the outcomes may not be. Quite as good, if they're better than what the control would be, which is, you know, doing nothing or, or trying medications. Um, but what, what our data, because of data combined, Autism, others. The real signal may have been lost, so. If you look here, we separated out our spectrum disorder kids and the um IDD kids. And because the numbers are so low, the 16 versus 13, none of these data other than I think the um excess weight loss at 6 months were statistically significant, but you can certainly get a sense that the autism spectrum kids may do better than the IDD kids. And the reasons for that are probably. Multiple, one being that there are more males with autism spectrum disorder, and so we all know males tend to do better with uh obesity surgery than, than females. So that might be part of it. Um, also, um, You guys all know that, uh, Some of these kids with spectrum disorders are super black and white. Mm You know, you tell them some rules post-op, and they follow those rules like nobody's business, plus they're, they're all, um, both sets are under the care of their, um, families usually. So, some of the spectrum kids have, um, really structured, uh, life, um, you know, school, etc. after that. Um, so anyway, I think if the numbers, uh, were increased, this might be statistically different, even though it wasn't in this particular slide. So, again, I'm trying to leave a lot of time for discussion. There's my email if anybody has any questions about program development or other, and I hope I didn't talk too long. Never, never, Evan. So, yeah, you know, I think your, your observations and the data that you showed with the autism spectrum disorders probably mirrors what a lot of us have suspected anecdotally. And I think that some of the, some of the kids with neurodevelopmental or, you know, with, with neurocognitive challenges, um. You know, again, our, our impression is that they do better. I mean, it may, it may warrant us, you know, I wonder if we should all sort of pool our kids that, that have these disorders and, and actually show that they do pretty well because I think You know, getting back to the ethics of it, why would you withhold the therapy and especially if it's efficacious in that patient population? Yeah, and, and I was going to say we never put a flag in the Teen Labs database for this, but the subtle flag by its absence would be self-report forms that, you know, that some patients cannot do. I mean, I love this part of the DEI part of this uh of this day is, is right here. Yeah. So, you know, the, um, the big ethical question that came to me a couple of times right before I left, which You know, my, actually, my medical team threw back at me saying, why, why are you worried about this? It's because their, their argument was Tom's argument, which is why would you withhold therapy. But it's for the non-verbal, um, spectrum disorder kids, uh, like, you know, it, it even gave me pause to To operate on a patient who couldn't even like nod their head, yes. So there are some ethical considerations, but I think if we could prove through pulling our data how how safe and efficacious it is, the 2 year old for TNA or the 5-year-old with appendicitis, right? Yeah, yeah. We're, we're not there yet. I don't think we're quite there yet. We're making the exact same, you know, points, but, um, the, the, the, the point is clear that these therapies that we are incredibly, uh, demonstrating are safe and effective, um, have to be at some point seen in that light. And I think too, remember, I think this is where we get into sort of what's offered and sort of equity. These are usually with extremely high functioning families who have resources, who can bring their kids to multiple visits. And so are we selecting, self-selecting a group of kids who have all these additional supports to make this successful? I would argue that not all my Not, not all my, I know, I can tell, I, that's not true with my patients that are in this study. Some of them had parents who could barely, barely care for their kid, and that was actually one of the considerations of doing the surgery is because it would make the care of the kid easier than the current care of the kid. So, not all of them have high resources, um. So, um, I think selective eating, which Karen just put in the chat, is another super fascinating thing that needs to be studied because these kids actually did better with their selective eating after surgery than they were before surgery, cause after surgery, you tell them protein, water, multivitamin, and that's selective eating, and it fits right into their brain. Their selective eating is just their brain function, not because they actually like canned foods or whatever their selective eating was pre-op. So you just have to give them a new choice for their selective eating, and they tend to do awesome. So, again, totally unexpected. So, you know, my philosophy, which is why I was probably chosen for the controversies topic, I was, I've always been willing to try anything on anyone because the alternative is so crappy. The alternative is just letting these kids live a lifetime with, you know, we are recording this, right? Yeah, the reality, again, it's reality. As long as you, Tom, you made the, the really important point, which is as long as you sort of try to do it in a way that you can publish it or share the knowledge, which has always been my, my, my aim. So there was a commission. I was just gonna say as long as there's, as long, even if you make an error of commission, in my opinion, at least you're trying, I'd rather make an error of commission than an error of omission. Yeah, so somebody, so on a related topic, there was a question from a while back that I sort of remembered and was gonna bring up now, and that was Prader Willy. Somebody asked about what about Prader-Willi patients. And so what, what, what are your thoughts, Evan? I mean, we, we've operated on a few, and they, they don't do as well, but they do better than if you didn't operate on them, I think. Yeah, my, my personal. And this is more anecdotal than it's based, is that these, these syndromic kids, with your syndrome, genetic obesity kids, they all need everything. They all need meds, they all need surgery, and they all need meds. And that's gonna be, that's how the, those, uh, the top 11% in Tom's slide are gonna need, are gonna need the same thing, and these syndromic patients fall into that. And so, You know, yeah, I haven't had great success with Prader-Wie. I think Steve Myers's paper suggests BPD is the best of the operations, but obviously, we're not psyched to do that on young kids. So, maybe that's a sleeve, maybe it's meds, sleeve, meds, BPD meds or something like that. Yeah, you know, those patients are tough, and I was just gonna say about that, about that 11%, you know, we didn't genotype any of these, and uh we do have the genes and we are, um, we are in the process of getting that data looked at, um, because I said we haven't didn't genotype, we didn't do it in real time, but we saved it, we've done it, and uh. I think the, the full story is yet to be written on Teen labs and what defines them uh in that category um is gonna be really important and there will be some social, there'll be behavioral, but they'll be biological, um, it'll be all of the above that we're sorting through. So, we are getting close to time. Somebody else was speaking, I don't know who it was, um, but, um, why don't we have one more comment and then, uh, we're gonna pivot to the exciting part of, uh, hot topics on the research side. So, I guess my parting shot, because it's right before Justin's talk, is that I think, you know, obviously, I have my opinions about what The optimal treatment regimen might end up being, but it obviously needs to be studied. Like, I think, uh, you know, and, and, and doing a study where, you know, if Jamie's concerned about GLP-1's pre-op, so a study, you know, an ethically constructed study with, uh, GLP1s versus not pre-op and then surgery to sort of answer that question, obviously would help a ton. And, and, and same thing with post-op and. You know, I think the question is gonna become when post-op, not post-op. Uh, I don't personally think it's ever gonna be surgery versus medicine because I don't think they're even close to being comparable. One, you can, you get 50% of patients who need nothing after 10 years, and then you have another group that probably is way higher. You may eat your words, Evan. I might, I might, but. I think, I think to suggest otherwise. I think that surgery will end up winning out if nothing else because like someone had mentioned before, it's really hard to take a medication every day for the rest of your life or or even for a year consistently or 2 years consistently. So, so yeah, um, and also but the weeklies or the monthlies or the annual. Tools, don't, don't think, don't think that they're not insurance companies are also going to have their thumbs on the scales because, you know, one surgical operation is $50,000 which is what, 3 years of GLP-1 agonist therapy right now or maybe 4 years of GLP-1 agonists, about $1000 out of pocket for our patients in the DC area. So the insurance company is gonna have their thumbs on the scales too. I'm glad somebody's going to study it because by the time that. it's time to move on. Thank you, as always, lots of great conversation and um it just goes to show how important all these conversations are. We bring up these topics that you kind of spend all day with a lot of them.