Hypoglossal Nerve Stimulation and Innovations in the Management of Obstructive Sleep Apnea

Podcast Transcript

Paul Bryson: Welcome to Head and Neck Innovations, a Cleveland Clinic podcast for medical professionals exploring the latest innovations, discoveries, and surgical advances in otolaryngology - head and neck surgery.

Thanks for joining us for another episode of Head and Neck Innovations. I'm your host, Paul Bryson, Director of the Cleveland Clinic Voice Center. You can follow me on X, formerly Twitter, @PaulCBryson, and you can get the latest updates from Cleveland Clinic Otolaryngology-Head and Neck Surgery by following @CleClinicHNI on X. That's @CleClinicHNI. You can also find us on LinkedIn at Cleveland Clinic Otolaryngology - Head and Neck Surgery, and Instagram at Cleveland Clinic Otolaryngology.

Today I'm joined by Dr. Alan Kominsky, an otolaryngologist-head and neck surgeon who is our Section Head of Surgical Seep and Snoring. He is also boarded in sleep medicine and otolaryngology-head and neck surgery. Dr. Kominsky, welcome to Head and Neck Innovations.

Alan Kominsky: Thank you so much for having me.

Paul Bryson: Well, we've been working together in different capacities for a little while now, but let's start by having you share some of your background for our listeners, where you're from, where you trained, how you came to Cleveland Clinic, and maybe just a little bit of the evolution of your practice as you've started to, well not started to, but been investigating and managing surgical sleep.

Alan Kominsky: Sure, thanks. I am from the suburbs of Philadelphia, originally. Spent my growing years there, left for college at Penn State University Park in central Pennsylvania, then went on to Temple University for medical school, stayed there another five years for my otolaryngology residency. I worked for a couple of years in suburban Philadelphia and then came to Cleveland. That was about 30 years ago, and I was working in town at another institution and my wife, who's an internist, was working for Cleveland Clinic and she said, you have to come and work for the Clinic. So at that time, the chair was Marshall Strome and there was an opening and I came interviewed, and I've been here for the last 22 years.

Paul Bryson: We've got to work together with the residency program. You've built a very busy practice. When was the turning point for you and the decision to further specialize in surgical sleep?

Alan Kominsky: So this is what I think is a very funny story. I was practicing next to the Chair at the time, in the hallway in our clinic and he had a busy sleep practice and he walked out in the hallway. I was standing there and he turned to me and said, “Alan, how would you like do sleep? I've done enough of it.” I said, “Yes, sir.” And that's how it all started.

So I started seeing more sleep patients at that time. There was the opportunity to become board certified through a practice pathway, and so I went and learned to read sleep studies and learned from our excellent sleep medicine section here, our center, the Sleep Medicine Center, and I was able to become board certified, and that was 17 years ago and it's just grown ever since. I think this is a very exciting time in sleep surgery, and that's of course my interest being an otolaryngologist. And you see the evolution of what has been the traditional therapy transitioning to something brand new, which is hypoglossal nerve stimulation. I sort of compare this to the time when we were doing traditional sinus surgery with a microscope, and all of a sudden endoscopic sinus surgery came on the scene and made a huge difference and a big transition in what the practice had been, and I think that is what's going on right now in sleep surgery. So it's really exciting to be living my medical life during this transition.

Paul Bryson: And it hasn't been even that long. It's been a contained time period. I mean, even when I was finishing my residency training in the early part of the two thousands, it was mostly soft tissue surgery, UPPP implants. Just if you don't mind, indulge me, take me from when did you start to hear about and then start to actually do sleep neurostimulation, hypoglossal nerve stimulation? What did that look like?

Alan Kominsky: Yeah, so I'll take you back to soft tissue surgery. That has been the staple since the early 1980s. So for the past 40 years, we've been doing soft tissue surgery, variations of soft tissue surgery to try and make it more tolerable, better outcomes…

Paul Bryson: CPAP more tolerable? Is that what we're talking about?

Alan Kominsky: No, we're talking about soft tissue surgery. So uvulopalatopharyngoplasty with variations, whether it's completely removing the posterior soft palate, whether it is doing more of a throat lift, such as expansion sphincter pharyngoplasty. So these techniques have come along, but they've probably reached the apex of how good it's going to be.

Paul Bryson: And this is tongue-based reduction? This is genioglossus advancement, things like that.

Alan Kominsky: Right. So all of these, in addition to our traditional palate surgery, they came along and some of them were adopted and many of them sort of came and went. But 10 years ago, the FDA approved the Inspire® device, which is hypoglossal nerve stimulation. Our traditional surgeries have been trying to make the box bigger, so to make the oropharynx bigger, to make the retro lingual space bigger, retro palatal space, bigger hypoglossal nerve stimulation or nerve stimulation is a dynamic rather than a static therapy. So this is something that is very exciting because not only is it dynamic, but it's adjustable, and so we may be getting ahead of ourselves, but there's lots of ways to adjust what you've done. If you've done our traditional pharyngeal surgery or base of tongue reduction or hyoid suspension, I mean, that's pretty much it. You've done it. That's it. You got to go somewhere else with a nerve stimulator. There's lots of adjustments that you can make post-implant in order to adjust the efficacy.

Paul Bryson: We'll walk it back just a little step too. Who's the ideal candidate for this? How does somebody have their candidacy assessed? And then tell us a little bit about the outcomes.

Alan Kominsky: Yeah, so the ideal patient is a patient who has failed CPAP. I mean, that's bottom line. You've got to try CPAP first. People fail CPAP for a whole variety of reasons. Some people just can't tolerate the pressure. Some people are claustrophobic, they just cannot tolerate anything, even the smallest CPAP interface on their face touching their skin. And some people, a lot of people just take it off unknowingly while they're sleeping during the night and they don't achieve compliance, which is considered four hours a night for at least five nights per week. That's not very much sleep.

Paul Bryson: No, it's not a big bar. It's not a high bar.

Alan Kominsky: It's not a high bar, but a lot of people cannot tolerate even that. So the patient who fails that is somebody who should be assessed for an alternative therapy. So patients who have moderate or severe obstructive sleep apnea need to search for some alternative for mild to moderate sleep apnea, could consider an oral appliance, and I know you've had Dr. [Todd] Coy on from our Dentistry Section to talk about oral appliances, so I won't go over that too much at all. But for patients who are not candidates for an oral appliance or don't think that they could tolerate it or fail an oral appliance, then some sort of surgical intervention is usually considered.

So what are our surgeries? I'll put them in broad groups. We talked about soft tissue surgery, so that's been our mainstay for the past 40 years. Initially, it started out as a surgery just for snoring, but it sort of morphed into treatment for obstructive sleep apnea as sleep studies were coming online and people realized what the problem actually was.

It wasn't just snoring, it began just by taking out tonsils and removing a posterior rim of the soft palate. That morphed into saving some of the palate and having more of a tailored approach. You can add tongue-based reduction, hyoid suspension, and all of those things to try and increase the outcome. The problem is the outcomes really vary. The surgery can have regression, so we create surgery that does a lot of scarring and holds things together, but as the years go by, the scar tissue relaxes the tissue droops, for lack of a better term, and we get regression in the results. So that's soft tissue surgery. Another option would be “bony surgery,” which is maxillomandibular advancement, usually done by an oral surgeon. Some plastic surgeons do it as well. That's where the jaw is divided, sagittal split of the ramus of the jaws, and then there's a Le Fort 1. And so everything has slid forward several millimeters to try and move the upper and lower jaws together, maintain the bite and pull the tongue forward and pretty big deal. That is what I'd say is a big surgery.

There was a study in the early 2000s that showed at the time uvulopalatopharyngoplasty versus maximum mandibular advancement, the numbers, and it was a 30 to one ratio of patients who were getting uvulopalatopharyngoplasty because not everybody wants to sign up for the bony surgery, six weeks of healing and all of that. So a lot of this is certainly patient preference and patient driven, and so that's the second category of surgery that we usually talk about and to be considered. And then the third category is hypoglossal nerve stimulation, and that is basically like a pacemaker for the tongue, and we implant the device, which looks like a pacemaker in the upper chest, there's a sensor that goes between the ribs, and then in a second incision just in front of the submandibular triangle, we place the stimulation lead on the hypoglossal nerve.

It's the distal hypoglossal nerve. Now, this is from an ENT standpoint. This is also fascinating because when we learned about the hypoglossal nerve, it's just one thing, it's the hypoglossal nerve, that's it. But as you get more distal, it branches out into protrusions and retrusive. It's a very predictable branching, and that allows us to stimulate just the protrusions of the tongue in order to stiffen the tongue and bring it forward a little bit to dynamically open the airway. So when somebody comes in and they failed CPAP and they're not a candidate or a failed an oral appliance, this is the discussion that we have, letting them know that these are their options.

Paul Bryson: And then just as an airway person myself, I understand that you do have some airway evaluation as part of the candidacy selection process. Can you tell us a little bit about DISE? What does that mean? Are we looking at the tongue here? What's that look like?

Alan Kominsky: Yeah, so if somebody is in the office and they decide after hearing all the discussion that they want to proceed with hypoglossal nerve stimulation, the next step would be to do DISE, which is drug-induced sleep endoscopy. That is a sedated endoscopy. We take people to the operating room. We sedate them to mimic sleep, so we sedate them so that they're sleeping, but they don't need airway support, but they're breathing on their own.

Paul Bryson: The only other option would be to go into their house and scope them while they're asleep.

Alan Kominsky: Right. Well, there have been some studies where there is natural sleep endoscopy, but that's a commitment I don't think most of us…

Paul Bryson: Yeah, the house call era for sleep is small.

Alan Kominsky: Absolutely. Absolutely. So when we are taking a look with our flexible nasopharyngoscopy laryngoscope, we're taking a look at the pallet. How is the pallet closing for the Inspire® device? It has to close in a flat fashion. If you're closing in a complete concentric, collapsed circular type of fashion, then you're disqualified from, according to the FDA, disqualified from being a candidate for implantation…

Paul Bryson: Because those protrusions aren't going to address the rest of the area of collapse.

Alan Kominsky: Well, this is also very interesting. So the determination on that distinction between the flat eight anterior posterior collapse versus the circular collapse was decided on a very, very small number of patients. So it's really unclear at this point whether there's truly a distinction in the results. I believe that if there's not work happening now, there will be work on that in the future to try and determine whether the DISE is really needed for that.

But we also look further in DISE. We look in the oropharynx. Do they have lateral wall collapse? How much lateral wall collapse, base of tongue epiglottis? Is the epiglottis collapsing and on its own, or is it stuck against the base of tongue and the base of tongue and epiglottis are going together. So we're looking at all of these things. We do some maneuvers. We do a chin lift, which is a very gentle way of moving the tongue forward, and sometimes just closing the jaw and bringing the tongue a little bit forward just opens up the airway tremendously. For me, that's a great sign that hypoglossal nerve stimulation is going to have a tremendous effect. Sometimes you do that. You don't see much movement at all. We also do what's known as the S mark maneuver or a jaw thrust. We try not to thrust it so much, but you can see that that opens up the airway tremendously as well. So that also gives hope that if that works, that the hypoglossal nerve stimulation therapy may be successful as well.

Paul Bryson: What are the outcomes? What have they looked like for the people that go through the evaluation process?

Alan Kominsky: Yeah, so this is a very great area of interest. So measuring outcomes right now is based on apnea-hypopnea index. Are we decreasing the apnea-hypopnea index? That's probably not the best way to determine outcomes. We wanted to see if fatigue gets better. We want to see that there's less cardiovascular or neurovascular events. We don't have that data yet. In fact, we don't have that data for CPAP either, but that's a whole other podcast. So the results that we're seeing are reduction of apnea-hypopnea index, significantly either to the mild or many patients are in the normal range. After we do the implantation, we take them back for an Inspire® titration study. So here is where some work still needs to be done. How long of a time at a certain setting on the device do you need to say that this is a success?

And we're still working on that. That's something that really needs to be standardized, and we're not quite there yet, just because it's so new. We're only 10 years into this, and in medical terms, 10 years, that's a baby still. But given what we're seeing in our results, we're probably 75-80% successful in reducing the apnea-hypopnea index. Our results for time of usage is amongst the tops in the country. So we're getting almost six hours per night of use for our patients who are using the hypoglossal nerve stimulator, which is tremendous, really tremendous. And I have to say that we co-manage our patients with the Sleep Center. So I have partners over in the Sleep Center who are medical sleep medicine physicians, not surgeons, and they activate the device about a month after implantation, and they are following and adjusting. And I think this co-managing of patients has really led to a significant increase in our success rate.

Paul Bryson: It seems like there's a lot of variables when you're trying to, what is success and what is a meaningful success for the patient, and also with some of the objective measures that we have. So it seems like there's a lot of nuance.

Alan Kominsky: There is a lot of nuance, and that will continue to be refined as time goes forward. But I can't tell you the number of patients who have told me this has changed my life. That's a tremendous, tremendous success to hear that kind of feedback.

Paul Bryson: Yeah, I mean, it's just critical. I mean, you think about all the things that quality sleep provides. We didn't even really dig into the neurovascular, cardiovascular, cognitive things that we presume to be beneficial, and that's over years, whereas they otherwise would have some number of hours of night of worse sleep magnified over time.

Alan Kominsky: Right. This is a cumulative problem. When people come to me and they say, do I really have to treat this? I feel fine. I compare them to a car. You can get a car and never change the oil. It will run really, really well for many years, but after a while, things will start to go off track and break down, and treating sleep apnea is very much like that. As time goes on and it's cumulative and the inflammation and the vascular inflammation goes on, things will start to break down, and you get that increased risk of coronary artery disease, stroke risk, cognitive defects, hypertension. It just goes on and on.

Paul Bryson: Well, I really appreciate your time today, and as we wrap up, can you give us any final take home messages for the listener, looking ahead and for people or maybe colleagues that are interested in sending patients?

Alan Kominsky: I think that the take home message is that if you fail CPAP, there are alternative therapies, and we are living in a time where hypoglossal nerve stimulation is coming on board. I think it's in its infancy and it will continue to improve. There'll be other products that will hit the market besides the one that is FDA approved right now. And I think we're just going to get better and better and better.

Paul Bryson: Well, for more information on surgical sleep and snoring services at Cleveland Clinic, please visit ClevelandClinic.org/Sleepapnea. That's ClevelandClinic.org/Sleepapnea. And to speak with a specialist or submit a referral, please call 216.444.8500. That's 216.444.8500. Dr. Kominsky, thanks for joining Head and Neck Innovations.

Alan Kominsky: Oh, thanks so much for having me. I had fun.

Paul Bryson: Thanks for listening to Head and Neck Innovations. You can find additional podcast episodes on our website clevelandclinic.org/podcasts. Or you can subscribe to the podcast on iTunes, Google Play, Spotify, BuzzSprout, or wherever you listen to podcasts. Don't forget, you can access realtime updates from Cleveland Clinic experts in otolaryngology – head and neck surgery on our Consult QD website at consultqd.clevelandclinic.org/headandneck. Thank you for listening and join us again next time.