Advancements in Surgical Sleep and Snoring Treatment

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 am excited to be joined by guest Dr. Vaibhav Ramprasad, an otolaryngologist-head and neck surgeon who specializes in surgical sleep and snoring treatment. Dr. Ramprasad, welcome to Head and Neck Innovations.

Vaibhav Ramprasad: Thanks so much. I'm really excited to be here.

Paul Bryson: Dr. Ramprasad, let's start by having you share some background on yourself for our listeners, where you're from, where you trained, and how you came to Cleveland Clinic.

Vaibhav Ramprasad: Sure. So I actually sort of have roots stemming from Ohio. I was actually born in Cleveland, Westlake to be specific. Moved around a lot when I was younger, so spent some time in California and India as well. But I eventually finished my undergraduate degree at Miami of Ohio and went to medical school at Duke and completed my residency in otolaryngology at the University of Pittsburgh. I took the less traditional path of actually doing a sleep medicine fellowship at the University of Colorado before coming here to the Cleveland Clinic. And one of the things that really got me interested in sleep was really the technology as well as the advancements in surgical intervention for obstructive sleep apnea over the last decade or so. I wanted to be in a field within otolaryngology that was on the cutting edge and really evolving throughout my anticipated career trajectory. So sleep and sleep surgery proved to be a pretty good fit for me.

Paul Bryson: Yeah, thanks for that. I mean, there really are a lot of exciting things happening in sleep. Anyone listening, it can be so frustrating to wake up after a night of sleep and feel unrested, and obstructive sleep apnea affects millions of people in the United States each year, as you know, and our listeners probably do too. There's several long-term complications. One of the methods I'm hoping that you'll talk about is the hypoglossal nerve stimulator, the Inspire upper airway stimulation device. Can you tell us a little bit more about this technology and also, I am hoping that you'll maybe give us some sense of where other technologies might be going? This seems like a very effective first step, but I think there's more.

Vaibhav Ramprasad: Yeah, you're absolutely right. So nerve stimulation has been sort of the most exciting recent development in the treatment of obstructive sleep apnea. And really it was sort of the culmination of decades of research evaluating the utility and stimulating the hypoglossal nerve. So the nerve that sort of controls the movement of the tongue treatment for obstructive sleep apnea. A lot of this research started in the early 2000s, and it really sort of resulted in the landmark trial that led to the subsequent FDA approval of Inspire, which was the STAR trial. So this was a trial that was sort of institutional. It actually prospectively followed around 126 patients that were CPAP intolerant. So they had tried CPAP for various reasons, they were not able to tolerate it, but they had moderate to severe obstructive sleep apnea and they underwent implantation of the hypoglossal nerve stimulator. That initial trial actually showed that overall 66% of patients had response to therapy.

So they were cured of their sleep apnea and their median a HI, the hypopnea index, which is sort of the main measure of severity of obstructive sleep apnea, actually decreased by around 68%. So the median baseline for these patients was around 29.3 events an hour, and it came down to nine events an hour. So what 29.3 is close to severe obstructive sleep apnea and nine events an hour becomes mild sleep apnea. So it was actually very effective. And the nice thing that we've seen with this type of therapy is we've actually been very systematic in collecting outcomes data to see how patients have been doing longitudinally. And we found that over the last decade or so with modifications and technique also changes in how we've been selecting patients that 66% that responded to therapy has now become a little better up to 70 to 75% of patients that are responding to hyperglossal nerve therapy.

The surgery itself, it's really evolved over the last decade as well. Initially the first iteration of the surgery actually involved three incisions. So it was one incision in the neck, one incision in the chest, and one incision in the flank. And over the last three or four years or so, we've now sort of consolidated that into a more minimally invasive approach with only two incisions. So it's just one incision in the neck and one incision in the chest and essentially through the incision in the neck, it involves the surgical implantation of the electrode cuff on the hypoglossal nerve. And the electrode cuff is then connected to a wire that's actually tunneled from the neck into the chest that actually interfaces with a generator with a sensor. And that sensor is able to sort of detect your inhalation and expiration. It actually times stimulation to the hypoglossal nerve with each inhalation essentially in a rough sense, you can imagine that protruding the tongue sort of improves the upper airway in terms of increasing the space behind the tongue with obstructive sleep apnea. But we've actually found through further investigation that hypoglossal nerve stimulation not only affects the space behind the base of tongue, but it actually ultimately improves the retro palatal airway too. So essentially it stabilizes the entire upper airway from the palate to the base of tongue and even the epiglottis. So one of the sort of reasons why this therapy has been so successful is we've found that just doesn't really move the tongue. It's, that's sort of a simplistic way to look at it, but it actually provides multilevel airway dilation.

Paul Bryson: That's exciting. That last little piece I have to say. I was not aware of that, but it makes sense. The pharynx, as you know, is very much involved with sleep and the tone. And so tell me a little bit more. So in the present day, what are the steps or the qualifications to become a candidate to get a hypoglossal nerve stimulator? You mentioned CPAP intolerance, but there's probably more.

Vaibhav Ramprasad: Absolutely. Yeah. So yeah, CPAP intolerance is sort of the main criteria in patients with obstructive sleep apnea. And I just want to emphasize also that while this is really exciting therapy, for patients that really are able to tolerate CPAP, CPAP is still sort of the gold standard for obstructive sleep apnea, we know we have a great body of evidence that suggests that it improves the daytime symptoms associated with sleep apnea as well as some of the real cardiovascular risk factors that you see associated with it. So obviously there are patients that try it and aren't able to tolerate it. And from a criteria standpoint, we initially, actually when the therapy first came out, there was A BMI cutoff, so it was A BMI of less than 35 and a HI, which is the apnea hypopnea index between 15 and 65 per hour. That's actually been very recently over the last couple months or so have been liberalized. So the BMI cutoff is now 40 or below, and the a HI is 15 to 100. I think at this juncture though, from a practical standpoint, insurance companies have not really caught up to that new FDA guideline or the new FDA change in inclusion criteria. So they're still relying on the older criteria, but I'm thinking hopefully soon it'll be liberalized from an insurance standpoint to be able to cover patients for the surgery as well.

Paul Bryson: Yeah, thanks for that. I wanted to ask, what about those, we talked about CPAP, we talked about the stimulator. What about those patients maybe on the milder side, what are some other options other than the CPAP and the stimulator?

Vaibhav Ramprasad: Absolutely. Yeah, I'm glad you brought it up. The stimulator is great for treatment of sleep apnea, but like you said, it's good for moderate to severe sleep apnea. There are a host of other procedures and surgeries we can offer to patients with mild obstructive sleep apnea. For example, it ranges from something as simple as a tonsillectomy, especially in mild obstructive sleep apnea and patients that have larger tonsils and patients that qualify for or have the anatomy for it, something like palate surgery for instance. So there's various sort of techniques that you can use including the expansion sphincter pharyngoplasty, which is basically where you increase the retro palatal airway with surgery. Some of the other soft tissue surgeries that we can do, and this would depend on sort of the in-office evaluation on physical exam would be if patients have an enlarged uvula, could involve a partial uvulectomy, a lingual tonsillectomy for patients with larger base of tongues or bases of tongue, and OID suspension, which would be sort of just suspending the hyoid bone to improve some of the retro epiglottic airway as well as surgery of the epiglottis as well. There's also patients that do qualify for it. Skeletal surgery can also be performed. Things like maximum mandibular advancements and maxillary expansions. I personally don't perform these surgeries, but can certainly evaluate for them and refer patients for these types of surgery if it's indicated.

Paul Bryson: You mentioned about the evaluation in the office and then I've also heard of drug induced sleep endoscopy. Definitely. What's that look like for the patient in the office and then what's your sort of approach when you do drug induced sleep endoscopy?

Vaibhav Ramprasad: Sure. From an office exam standpoint, it's usually pretty straightforward. It's a head and neck exam sort of geared towards looking at the palate, the tongue sort of occlusion from a dental standpoint and the drug-induced sleep endoscopy is actually a procedure that we then pursue, and I actually like doing the drug-induced sleep endoscopy for as a precursor for most sleep surgery because it really does give us a lot of data in terms of where exactly some of this collapse related to obstructive sleep apnea may be taking place. So that is actually also a procedure that's required before we get approval for a hypo nerve stimulation as well. And essentially it involves going to sort of a procedure suite or an operating room setting and the presence of an anesthesiologist and using some sedative medications such as propofol to put patients in a sedated state. And once in that sedated state in this controlled setting, we're actually able to do a flexible endoscopy, much like what we do in the office, like a flexible laryngoscopy where we put a endoscope in the nose and take a look at the various different levels of the airway.

So I think we sort of talked about it a little bit relating to hypoglossal nerve stimulation, but we look at the retro palatal area behind the palate, we look at the retro gloss area, so the base of tongue. We also look at the lateral walls of the pharynx, and then we look at the epiglottis and we look for patterns of collapse. So there are certain patterns of collapse that are not really amenable for hyperlocal nerve stimulation, but are amenable for say, palate surgery. So it gives us a lot of information as to what types of surgery patient might be a candidate for.

Paul Bryson: I appreciate you taking me through that. I think there's a lot that you can get from that information. I sometimes forget about all the palatal stuff and even some of the tonsil base of tongue stuff, but yeah, the sleep is probably your best estimate as to what it might look like while the patient's sleeping.

Vaibhav Ramprasad: Definitely.

Paul Bryson: Well, I really appreciate your time today. As we wrap up, can you give us some final take home messages for our listeners?

Vaibhav Ramprasad: For sure. Yeah, I think it's sort of an exciting time right now, as I alluded to, for patients that are looking for alternative therapies for obstructive sleep apnea, and while hypoglossal nerve stimulation is one of the mainstay treatments as an alternative for CPAP, we have a wide array of surgeries we can offer. And even as a corollary to that, even in patients that would like to continue with CPAP but are not tolerating pressures, sometimes it's useful to be evaluated by an ENT to see if there's any sort of nasal obstruction, for instance. And correcting nasal obstruction by doing a septoplasty or nasal surgery can actually improve CPAP adherence and bring down the level of pressure that you might need with your CPAP as well. So any patients that are having trouble with CPAP would be great candidates to sort of come in and see either one of my partners or I, since we're both trained and sleep medicine as well as sleep surgery, we'd be happy to help in terms of trying to troubleshoot and see how we can alternatively potentially treat sleep apnea.

Paul Bryson: Well, this is great and it's great to have you here at the Cleveland Clinic, and it's nice that it's a bit of a homecoming for you and for the folks that are interested. I understand you see people in your old hometown.

Vaibhav Ramprasad: I do, yeah. Mostly in Westlake, as well as Independence.

Paul Bryson: Yeah. Fantastic. 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. Ramprasad, thanks for joining Head and Neck Innovations.

Vaibhav Ramprasad: Thanks for having me.

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.