Update Course 2021: MAGNET THERAPY FOR ESOPHAGEAL ATRESIA

part of the update course uh and I'm going to turn things over to Von Alman in a second. part of the update course is to show all these new just like what Rohini just showed, all these new and exciting things that are brand new and great for pediatric surgery. But maybe part of the update course should also show things that we need to update ourselves that may not be as exciting as as we thought. So we're we are presenting uh a concept here that is very exciting, that is very new, but I think you're going to hear two sides to the story. So Dan, do you want to take it over from here? Sure, happy to happy to introduce it Todd. It is um uh we're going to finish up once again with a completely non controversial topic for which the therapy is very straightforward and that is long gap esophagial atresia. Um and and you know, this is a a challenge. It can be an incredibly difficult uh thing to treat. Um and people have done lots of work to try to figure out a better way to treat it. And one of those ways is to use magnets to pull the two ends of the esophagus together. And so we're going to have a couple presentations here. Uh first we're going to have Dr. Slater uh present on her experience with magnets and then we'll have the venerable Dr. Rothenberg present his experience with the magnets and we'll have a discussion about uh what the what the options are and the potential use for this uh for this new technology. So Bethany, take it away. All right. Well, thank you very much and um, thanks for staying for this last presentation. Um, of course, always fun for me to be talking before Dr. Rothenberg, but I'll do my best here. Um, I'll keep this fairly short as well so that we can have some robust discussion. Um, but we'll start with a poll here. So, um, this question is a three-month-old male who has a history of a cardiac anomaly with a type A esophageal atresia or a a pure esophageal atresia, who had a gastrostomy placed after birth and then had a gap study at again about three months of age demonstrating a 3 cm gap between the proximal and distal esophagus. What would the next step be for an operative plan? So A, either an openthoracotomy with esophageal repair, a thoracoscopic approach to esophageal repair, esophagtomy or placement of magnets. Um, while we're waiting for this poll, um, Dr. Harman, why don't you tell us what you would respond to this? Dr. Harman may have bailed on us. He he had an uh an emergency that came up and just had to leave. He was supposed to be moderating this with you and part of that is is because uh uh oh. Yeah, I do I do I I love the question. So uh I would 3 centimeters is overcomble. So I would try that thoracoscopically and uh uh uh get those two ends together and if you needed to do something different in the middle of the case, you could do that. Great. How about um the results from our poll here. Sure. Um, so more, it's changing, it's still changing by the minute, but more than half are saying the thoracoscopic repair and then some the next most common is placement of magnets and last would be an openthoracotomy. All right. Great. So I think most of these options are certainly um possibilities. But for the point of this particular talk here, we're going to use this to highlight the discussion about using magnets for esophageal atresia. Um so in general magnets have actually been used for many, many years and specifically for esophagial atresia. Um but they can be used as a non surgical alternative for esophageal anastomosis and they're able to promote lengthening and approximation of the proximal and distal end of the esophagus and then it uses compression and anastomosis to create continuity of the esophagus. So this picture here shows the flourish device. It's a catheter based magnet system and that's what I have experience with, but there are some other magnets that have been used in the past, including um Mike Harrison has one that's being used now primarily for strictures though. Um, so again this is, you know, one particular type that uses magnets as the device, um using catheters. But just in brief, again, the magnets go on the proximal and distal part of the esophagus, they um lengthen and attract one another and then the compression anastomosis works by causing ischemia of the tissue between the two and then that sluffs off and that creates the anastomosis. So just a little more specifically about the flourish device, um as I mentioned, I think that it's an FDA approved commercially available device. Um it is a humanitarian device exception from Cook Medical and it has both the esophageal and gastric catheters that have inner bullet shaped magnets on each end. And it does, which is very important to note that it does taper down to a 10 French coupling surface. Um, proximal catheter does have a suction port, so that can be used to suction the saliva for the patient while it's being used and the gastric port has a portion for feeds as well. Um, this is a table that just shows some of the studies that have been previously published with um flourish magnets. So there are a couple of case reports and some series that show um success with using the flourish device. Um, of note, almost all of these patients did have strictures post operatively. And then just um a tiny bit more detail about a study that we published about two years ago now, looking back back retrospectively at all the available data um using the flourish magnets. Um, there were 13 patients um over 17 years in a couple different countries and all of these patients were able to achieve anastomosis, um, although of note all of them did have a stricture as mentioned previously and two of the patients did require surgery for recalcitron strictures, um, post operatively after the magnet placement. Um, there is currently a sing a prospective single arm observational study. It's the uh post FDA approval study that is ongoing right now. Um it is a Cook sponsored study and currently there are about 12 patients or so that are enrolled in this study. Um, there have been more that have placed outside of the study as well. And um, I really wanted to focus um a little bit on the fact of the eligibility for both the study as well as for placements of the flourish magnets. So there needs to be a gap length of less than 4 centimeters and if the um lengths are greater than that, the magnets will not attract one another, so they can't be used. Additionally, and also very importantly, there needs to either be an absent fistula, so as in a pure esophageal atresia or a fistula that has been previously repaired and the patients do require a gastrostomy that can accommodate an 18 French catheter because that is the diameter of the gastric portion of the catheter. Um, of course, like with any device, it's important to note the indications for use and um to proceed with the caveats um and the recommendations, you know, from the company. Um and yes, I believe that is my last slide. So um we can move on to Dr. Rothenberg's case and to continued um conversation about it and I'm happy to answer any of the questions afterwards. Great, thank you. Uh Steve, why don't you present your case and then we'll uh maybe we can discuss it. Okay. Um, are my slides going to come up? Yeah. Yep, they will. Okay. So I, you know, I I I I I just to say at the beginning, I'm not convinced that there's not a role for magnets in this, but I thought it important to people be aware of of some of the issues. And this is a case that I um got presented with this last year that I think uh had significant consequences for the child and I think it it raises some of the questions about the protocol for for this device. Um, so this was a full-term uh male who was born with pure esophageal atresia. He had a gastrost me placed at birth and this was not at our institution. Um, at about, you know, five weeks of uh or about six weeks of age, they had a gap study that showed a three and a half centimeter gap uh, and then in uh about a little over six weeks later, so three months of age, patient had another gap study which uh showed a gap of 2.6 centimeters. And at this point the decision was used to make uh was made to use the flourish device. Um, I will say I'm not going to name the institution, but I will say this is not Cincinnati Children's Hospital or Chicago. Uh, this is a small institution that does some pediatric surgery uh but that yet somehow got approval to use this device. Um, this just shows the gap uh, you know, at the insertion of the magnets. They put the magnets in. I think it was over they had to reposition them once and I've not used the device so I'm not totally clear on on what all the implications are, but I know you have to have involvement of interventional radiology. The patient was heavily sedated. I think for 12 days. Um, and they got the device the esophagus together. Uh four days later the patient had an acute decompensation. He was transferred to another hospital. Uh the hospital where this was done did not have a full-time pediatric surgeon. And so when the patient decompensated, the uh there was no pediatric surgeon at this hospital. Uh he was transferred uh to another local uh Children's Center where the pediatric surgeon um worked him up and they identified a large fistula uh between the esophagus and the left main stem bronchus. At that point the surgeon felt the only way to salvage this was to take him to the OR, did an openthoracotomy, found severe inflammation. He had trouble difficulty in identifying any of the structures. He divided the fistula and then felt the only way that that he could safely manage the patient was actually to divide the esophagus again and now the patient ended up with a gap um of 5 centimeters. Uh, so the baby was stabilized and then the question was what to do. and you can imagine the parents were quite distraught at this point. Uh they started looking for answers and got on the internet um and contacted a couple centers, ours was one of them. Um, and I when I talked with the family, I told them, you know, I really wasn't sure what could be done. I didn't know if the esophagus could be salvaged. Um, they wanted to do a uh esophagtomy, um, locally and then do some sort of reconstruction later. And I told him I thought there was probably a 50/50 chance we could salvage the esophagus, um, and they eventually ended up deciding to come to our institution. Got a gap study, um, and when I did an esophagram of the upper pouch, uh, it showed that there was an upper pouch fistula which had not previously been diagnosed. Uh the question was whether this was traumatic or um, you know, uh a true upper pouch fistula. Uh, and when I scoped the patient, um, it was a true upper pouch fistula. So one of the contraindications to using the flourish device, I believe would be the presence of this fistula which was unfortunately uh not looked for, I think the initial institution and and was missed. Um, so what to do next? So I decided normally I would fix that upper pouch fistula through umscopy. Uh we all our upper pouch and H type nowscopically because I think the view is excellent, we get good control. But because this child's chest was a mess and he actually was with us, took us about four weeks to tune him up before we could do anything. Um I went I did a a neck um dissection went in and ligated that fistula, uh let him get over that for a week, talked with the parents and then we elected to go in, um and start and I don't know, can the will the video play? Should be. Should be, I loaded it. Um if it should I click again or is that uh yeah, click again. Okay. There it goes. Oh, there it goes. Sorry. So just I mean it took me it took me about two hours to get through all the adhesions scopically and find the ends. Um, I found um uh this is we found his upper pouch. Um, I also found a a uh traumatic fistula which I um ligated with 5 millimeter stapler. I dissected out his lower pouch um which uh there was still a persistent fistula we divided and then I was actually able to mobilize the two ends together and get them together. I think it was quite lucky. Um, and he's done quite well. He does have a stricture which is we're dilating about once a month, um, and he's now learning to eat. So he was in the hospital the first um almost six months of his life. And my basic comment here is this child had a gap at one point of two and a half centimeters that I think any any certainly anybody on the panel, whether you did it scopically or open could have fixed. Um, by classification, the International group, a gap of 4 centimeters, it you have to have a gap of at least 4 centimeters to be considered a long gap. So we should be able to get all those together. And and here's a case and the indications for the magnet is you have to have a gap of less than 4 centimeters and you're getting an incredibly high stricture rate and multiple strictures. And so I just wonder a bit and this is an after his repair. So I you know, I I have some concerns. I'm not completely against magnets, but I would argue that a patient who's got less than a 4 centimeter gap uh should be amenable to a primary anastomosis and we would of course do it scopically as I think most of the people on the panel would uh with maybe a 20% stricture rate. Uh and certainly this child because of this the the flourish device, this patient was taken care of in an institution where they should never have been treated, which is if that device had not been available, this patient would have been transferred to a center that could have treated it and you know, and and had all the modalities. So I'm concerned more around the ethics of the device and and how it's being applied than necessarily using the device and you know, it'll be great someday if we don't need to operate on kids and we can do all their anastomosis minimally invasively. But you know, I think this, you know, Bethany is something that maybe should have been done at your institution or at Dan's, but certainly not in the middle of nowhere that in a place that doesn't have a full-time surgeon. Um, you know, that's and and that's what really concerns me about this is that this device, people are going to think because you don't have to operate that we can do this. So anyway, that's my presentation. So if I could just comment, I would I would definitely agree with you on basically all of those points and I not I was not involved in this case directly, but after getting some feedback, I do my understanding is that there was some using of it, um, that was against the advice of some of the Cook reps, etc. Um so I do think that we do need to be responsible of using devices where you use it responsibly and in places where you'd be able to operate if there were a problem. Um I also do agree with your point that not everyone with, you know, a 2 centimeter gap should get a magnet. Um, I think it's, you know, something that can be used in select patients, particularly patients who have cardiac disease or who have had previous operations that might make them less of a candidate um for a reoperative surgery, you know, or an increased risks of the anesthetic for whatever reason. Um additionally, sometimes these have been used as a stage procedure. So rather than do, you know, internal attraction stitches if that's the practice, there is also a possibility of trying to get the two ends together closer surgically and then using a magnet just for the anastomosis portion as as a possibility. That's great, thanks Bethany. Um, thanks Steve. this, you know, we're 15 minutes I think past the end of the uh end of the the event um and we could spend the next four hours talking about this. Uh, I think it brings up a whole lot of issues, not the least of which is the preoperative workup to make sure that there isn't another fistula and whether that patient got bronze, you know, things that that uh there are lots of strong feelings about how to manage patients uh even before they they undergo any kind of treatment. I'll just tell you our experience with the magnets has been in the in the type of case that you just described where a patient um who had a complex uh airway reconstruction, median sternonomy uh where we attempted to salvage a previously operated upon esophagus and I was able to get a stitch to pull the two ends together, um, but could not get do an anastomosis because it was too tight. And so then rather post operatively after recovering from the airway reconstruction, rather than going back in, uh we used magnets, but the two we knew that the two ends of the esophagus were right next to each other and that prevented uh potentially a very difficult operation. Um I think Mac, I think you have some experience with the with the magnet as well. Yeah, just one and uh uh it it it worked sort of but there was a dead stricture that required uh lots of work. Never got another operation but did have to get dilated and GTube feeds for a long time. So again, I think we're it's a good concept and we're searching for the right patient. I would again, I totally I have a patient that's like what you just described and um, this this was actually it's a 23 week premy who was two who was um, you know, 340 grams when born and it's now it was a pure tria and every time I look at this kid, the kid gets sick, you know, and and we've done, we've actually gotten the ends together, but I'm sure it's going to be a problem and I'm thinking the magnets may be a good way to because every time I go in scopically but the kid decompensates for two weeks after I do it. And so I, you know, and we don't really know what the basic lung. And so I think that is probably an excellent case for this. My my biggest reason to present this was not to say that magnets, I I mean I do think that, you know, if you have a two or three centimeter gap, you know, if you can't sew that together then send it someplace that can because I think that's the best outcome for the child. But I I do think that that I'm concerned that I don't even know how a device like this could end up in the hands of the people who it ended up in and and I you know, I think centers like you that are doing complex things and and studying things, it's appropriate, but I am terrified that this is and and plus people need to know that this is one of the complications. If you put in magnets, you may get a fistula. And I've heard of other cases like this and I tried to identify them but I was not able to get specifics. But I think besides stricture formation, there are other complications and I just think this needs to be done in the right institution. It's not a license for people who say, well, you know, I'm not comfortable doing the operation but if I can put in magnets, I can do that and we can just keep the baby here. I think that's doing those kids a disservice. Yeah, it's a great comment and it gets back a little bit to Vic Garcia's earlier comment uh earlier this morning talking about the FDA process for getting devices into use.