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Melanie Cole, MS (Host): Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole. And today, we're talking about avoiding surgery for patients with micrognathia with a novel oral airway appliance. Joining me is Dr. Henya Sandhaus. She's an Assistant Professor in the Department of Otolaryngology Head and Neck Surgery at the University of Florida College of Medicine.

Dr. Sandhaus, thank you so much for joining us. I'd like you to start by setting the stage for us. For providers who may not be as familiar, what is micrognathia and why can it be such a challenging condition to manage particularly in neonates?

Dr. Henya Sandhaus: So first of all, Melanie, I just want to say thank you for having me and thanks for letting me on your show. So, micrognathia is a small jaw, compare that with retrognathia being a pushed back jaw. Patients are often born with micrognathia where there is a change or challenge during development where these patients grow with an abnormal mandible. And the challenge overall with micrognathia is that that can cause some airway difficulties. Overall, the tongue is really connected to the front of the mandible. And with that connection, if the mandible is pushed back, that pushes the tongue back as well, and that blocks the airway, and patients are unable to bring their tongue forward the same way a patient without micrognathia would be able to bring it forward. And they're unable to manage their airway to different degrees.

Melanie Cole, MS: Thank you for that. So historically, what has been the standard approach to airway management for these patients? There's so little. And what are some of the key limitations or risks associated with those surgical interventions that made the novel approach so important?

Dr. Henya Sandhaus: So, overall, there have been a number of methods of treatment. There have been some non-surgical methods and some surgical methods. Trying initially the nonsurgical methods are usually for patients who have a mild form of micrognathia, and these are changes such as prone positioning or placing a nasopharyngeal airway to bypass that tongue, putting them on high flow or positive pressure ventilation, or even up to intubating these patients.

Historically, however, there have been some surgical approaches. And of course, we always want to avoid surgery in any patient if we can, because that is never without risk. And so, there's been the tongue-lip adhesion where the tongue has been attached to the lower lip to see if that pulls it forward a little bit. And that's been challenging because that makes the patient unable to eat or speak the way that patient without a tongue-lip adhesion would be able to. There've always been mandibular distractions. This is where the mandible is split surgically on either side and slowly advanced over a number of days to weeks.

And the goal of that is to allow a callous to form in that fracture line so that, hopefully, the anterior mandible can be pushed forward and that brings the tongue with it. Again, that being a surgery is risky, but also has some risks that there will be a non-union of the fracture. There's a risk to changes in facial growth. There's a risk to the jaw that the jaw will become ankylosed or that it won't move as well, and patients won't be able to open and close their mouth as well. And so, overall that risk is still there and that tends to be what is used for more moderate to severe micrognathia.

And of course, the most ultimate way of bypassing this obstruction is with a tracheostomy, which we try to avoid as much as possible. Now, with the novel approach, that brings us to an option where these patients can go home without changes to their positioning. It helps improve their growth of their mandible to catch up to what it should have been. Not necessarily completely will it get there, but it does get significant improvement. And it allows them to feed and avoid a surgery.

Melanie Cole, MS: Wow, this is so interesting. So, tell us a little bit about this oral airway appliance as an innovative alternative to surgery for these patients with Pierre Robin sequence and airway concerns. Tell us a little bit about the evolution or development and really how it works.

Dr. Henya Sandhaus: Of course. So, this was actually first discussed in 1968 by an Irish dentist who had thought that maybe putting an appliance to obstruct the palate and bring the tongue forward a little bit would help these patients. He tried to avoid putting them in what used to be known as a burp-and-cradle, to have them prone while they tried feeding. And this has slowly developed over the years with another physician over in Germany who in 2007 felt that maybe if he put a little extension on this to bypass not only the palate, but push the tongue forward a little bit, that would really improve the airway. And what he has come up with over time and that has been improved on and expanded on by physicians over in Stanford namely, Dr. Choo, who's an orthognatic dentist is that they put a prosthetic or an operator connected with an extension over to the velum or past the tongue into the vallecula. And this extends to push the tongue forward, but leave the epiglottis in place and therefore extend the airway and open the airway to the nasopharynx and the oropharynx as much as it can.

And with that, because that tongue is being pushed forward, there's a lot of pressure also to push forward on the mandible, and that has been inducing what we call catchup growth, like I've mentioned before. And over time, these babies will slowly grow out of their obstruction as that mandibular catchup growth occurs. And over a period of about six to eight months, they're able to now breathe without having this mandibular appliance or without having changes in positioning and adjust the same way a child without micrognathia would be able to.

Melanie Cole, MS: Wow. So, Dr. Sandhaus, how's it placed? Tell us a little bit about the design and functional elements that make it so effective. And from a physiological standpoint, how does this technique actually improve the airway patency and oxygenation for these little patients?

Dr. Henya Sandhaus: So, what happens is that these patients would initially be diagnosed at birth or sometimes even prenatally with the micrognathia, and they would be identified as having airway obstruction. These patients would then get a sleep study or some measurement of obstruction rather airway during sleep, while they're still in the ICU or in the newborn nursery.

At that point, if they're having significant obstruction as documented and their oxygenation is not able to be maintained appropriately, we would obtain a CT scan. The goal of the CT scan is that we can measure the length of the mandible from their lower lip all the way to the back of their throat or their oropharynx, as well as measure the angulation that we would need from their velum, which is the back of their soft palate down to the level of their epiglottis.

And then, once we would have that, then either a pediatric dentist or an orthodontist who is familiar with this would get an impression of the patient's palate, their hard and soft palate, and they'd be able to then conform and create a positive mold and an acrylic obturator and prosthesis that would then sit in place. There would be some wires in the prosthesis itself. That would curve around the upper lip to help hold it in place. Overall, it would be placed under direct visualization while the patient is still awake in the NICU. Direct visualization is usually done by ENT, and these ENTs would perform a flexible laryngoscopy the same way they would normally, and they would hold it in place as if a FIS was being done or a feeding evaluation were being done. And in the meantime, the pediatric dentist is able to insert this obturator in place. And once it's seated appropriately, then the ENTs can make sure that there is good improvement of the airway because their scope is in place. And that would then conclude the procedure. Patients would be monitored afterwards for a period of time, usually about one to two weeks still in the NICU, to make sure that their airway has improved, that their feeding is now okay, and then they'd be able to go home.

And overall, over the next six to eight months, adjustments are made about every three weeks as an outpatient so that these patients can have the obturator grow with them as they grow. And what it does is it changes the airway by pushing that tongue forward and really giving a widened airway. When the tongue is pushed back, there's not a lot of space in that oropharynx or that velopharynx. There's really very minimal airway space for oxygen or ear to get through. And when you pull that tongue forward, that space just widens so significantly. And so when you have the obturator in place, it really pushes that tongue forward to really widen that space in the oropharynx and really improve the airway.

Melanie Cole, MS: Dr. Sandhaus, what has early data shown in terms of success rates, patient outcomes? What have you seen?

Dr. Henya Sandhaus: Early data has been extremely successful on this. These patients have been able to avoid surgery. In fact, in Seattle where they've been doing this since 2019, they have recorded that, in every patient that they have tried using this oral airway appliance, not one of them has then proceeded on to have surgery.

Now, of course, there are some patients who may need surgery afterwards. These tend to be patients who are syndromic and have other causes to have airway dysfunction. But overall, in patients with isolated Pierre Robin, the data is pretty good that they would not require surgery afterwards and they'd be able to go home with a safe airway within a few weeks of life.

Melanie Cole, MS: Wow, that's really fascinating. Pretty exciting time in your field. And Dr. Sandhaus, speak about the multidisciplinary coordination that's required to identify candidates and implement this intervention safely for micrognathia.

Dr. Henya Sandhaus: Of course, this is definitely a multidisciplinary required approach. These patients who need to be identified in the NICU as having micrognathia or some sort of difficulty with breathing, they may need a scope from an ENT to help identify that this is the glossoptosis or the tongue falling back from that micrognathia as the cause of their airway obstruction and airway difficulties.

So firstly, we're needing that NICU team. We would need an ENT team. We would need a pediatric dentist or orthodontist to help to create the prosthesis. But importantly, we need also nursing care and speech therapy. We would need sleep medicine, helping us to make those diagnoses and help monitor the patient to help us determine when the patient has grown out of needing the prosthesis. We would need to have imaging or radiology involved as we're working on getting these CT scans and measuring the angulation. Overall, it's a pretty involved team to get these patients to where they need to be.

Melanie Cole, MS: Doctor, I just have a few more questions for you because this is really, really so interesting. Now, this device itself, how steep is the learning curve for clinicians? Is this something that could be readily adopted in tertiary centers? What do you see happening with this countrywide as far as adoption of this type of intervention?

Dr. Henya Sandhaus: So in terms of adoption and learning this technique, this is something that we've been working very closely with the team over in Seattle to help learn this. And what's been really interesting to see is that they've been able to have teams come to them and learn from them as they have these babies with Pierre Robin. So, providers have been taking maybe one or two trips to learn how to actually make the device, potentially one additional trip over to Seattle to see how the device is actually placed. But overall, the learning curve is not so significant. There are teams, the Seattle team, and both the Stanford team, which are the only two places in the U.S. who have been doing it since 2019, have helped other teams to help initiate the program in their tertiary care centers. And it seems to be that , if you have the teams available and the multidisciplinary approach while it takes a long time to get started, once it gets started, it's a pretty smooth transition.

Melanie Cole, MS: This has been such great information. And Dr. Sandhaus, how might this change the long-term outlook for patients who previously faced early surgical interventions? As we look forward, as it impacted feeding growth, neurodevelopmental outcomes compared to those who undergo surgical correction? When you look ahead, what do you think this represents as a paradigm shift in airway management for micrognathia or a bridge to more individualized treatment decisions? I'd like you to offer your advice to clinicians who are interested in learning more or participating in some of these early implementation studies.

Dr. Henya Sandhaus: Yeah, I think there is a lot of good data out there, and I think that this is really going to change and decrease the number of surgical interventions. I don't think it will take them away completely. There are patients who will not have enough improvement with this. But I do think that the patients who do become candidates and are appropriately placed with an oral airway appliance will have a significantly decreased rate of surgery. I don't think it will remove the surgical intervention overall, however. So for providers who are interested in learning, there's a lot of research out there. There's a lot of data out there already, even in its short period of time where it's been used in the states. And I think most of that is because there's been data from over in Europe and Germany where this has been implemented since 2007.

So, I think there's a lot of good data, a lot of good ways to learn about it. Reach out to anybody that you know, who does it if you're interested in learning more or any teams that you know. When I started learning about it, I reached out to the Seattle team. This was while I was still in training actually, just because that was something I was interested in. I think people who know about it and who use it are very eager to share about it, so just reach out. If that's something, send an email, reach out. I'm sure everybody who receives it learns that somebody is interested to know more about it, we'd be happy to teach.

Melanie Cole, MS: I'm sure they would as well. Thank you so much, Dr. Sandhaus, for joining us today and sharing your expertise on this topic that is not as familiar for many providers, but also so interesting and innovative. Thank you again. And to learn more, you can always visit ent.ufl.edu or to learn more about this and other healthcare topics at UF Health Shands Hospital. Visit innovation.ufhealth.org. That concludes today's episode of UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole.