"Updates in Upper Airway Stimulation for Obstructive Sleep Apnea" Yan Lee, MD and Bruno Cardoso, MD (01/19/2022)
February 04, 2022ID7412
To CiteDCA Citation Guide
- 00:03Alright, let's.
- 00:12Excellent, we see some folks joining us.
- 00:16And so we'll give it another
- 00:18minute or two. Let's see.
- 00:23Doctor yagi doctor Corwin. Excellent.
- 00:31Alright, so I think as folks are
- 00:34joining we're gonna get started.
- 00:36Good afternoon everyone.
- 00:37My name is Andres it Rick and I welcome
- 00:40you to the Yale Sleep Center seminars.
- 00:45And just a few announcements before
- 00:48I introduce today's speakers,
- 00:49there are two first, please take a
- 00:52moment to ensure that you are muted.
- 00:54If you'd like to receive CME credit,
- 00:57please see the chat room for instructions
- 00:59that we posted there by Debbie.
- 01:01And if you're not registered with the
- 01:03LC any you will first need to do that
- 01:05and recording of this session will
- 01:08eventually be available within two
- 01:10weeks on the link provided in the chat.
- 01:12And if you do have questions during the talk,
- 01:14please make use of the chatroom
- 01:16throughout this hour I'll be moderating.
- 01:18So I'll be making sure that
- 01:20your questions are answered,
- 01:21and if you do wanna have answer.
- 01:24Ask a question person,
- 01:25let me know and I'll have you need it.
- 01:27So without further ado,
- 01:29I wanted to introduce today's speakers and
- 01:32we are pleased and honored to have two,
- 01:35not one doctors from the Yale.
- 01:39Surgical Department,
- 01:40division of auto Laryngologist in head
- 01:42and neck surgery and first speaker
- 01:45today is Doctor Bruno Cardoso and he
- 01:48is a UConn graduate with a degree
- 01:51in plant Sciences and where he also
- 01:54earned his RN and worked as a nurse.
- 01:56Prior to earning his MD at University
- 01:59of Vermont where he was also selected
- 02:01into the Gold humanism Art Societies
- 02:03which was the great accomplishment
- 02:05and I'm sure that alright experience
- 02:07was an incredible asset to him and
- 02:09those who worked with Burnell.
- 02:10As he completed his surgical residency and
- 02:12E NT at Yale and served as a chief resident.
- 02:16And so yeah,
- 02:17I was lucky enough to recruit.
- 02:18Brown was an assistant professor
- 02:19with areas of expertise that include
- 02:21surgery for obstructive sleep apnea,
- 02:23which will be the topic of today's
- 02:25discussion and so Bruno's published
- 02:27papers and journals such as cancer
- 02:29Medicine Laryngoscope and his partner
- 02:31crime today is Doctor Yang Lee,
- 02:34who is also an assistant professor at the.
- 02:37Of surgery at the yield division of
- 02:40oral head and neck surgery and Jen
- 02:43received her bachelor science in
- 02:45Biomedical Engineering from Colombia
- 02:47and then her MD from Penn State,
- 02:49and then she moved on to Aiken
- 02:52School of Medicine, Mount Sinai,
- 02:53where she completed her hand T
- 02:55residency and a fellowship and facial
- 02:58plastic and reconstructive surgery,
- 02:59and eventually she was recruited by Yale
- 03:02and has since been on faculty and fix
- 03:04since 2017 and is a gifted educator.
- 03:06I haven't received a.
- 03:08Faculty teaching award.
- 03:09In section of Eulerian Colegi and
- 03:12so Jen conducts research and has
- 03:14over 30 original publications in
- 03:16the domains of facial reconstruction
- 03:18in trauma and medical education.
- 03:20In all Rangala G and has published
- 03:22in journals like JAMA Surgery and
- 03:24Laryngoscope and a personal note.
- 03:26Both Bruno and Jen are kind,
- 03:28funny and outstanding clinicians and
- 03:30they have been amazing partners in
- 03:32initiating collaborative upper airway
- 03:34stimulation program here at Yale.
- 03:35Where you have had some early successes
- 03:37and also important learnings for this
- 03:39therapy in OSA so that further do you.
- 03:41I'm going to hand the conference over to
- 03:44Jen and Bruno who will talk to us today
- 03:46about upper airway stimulation updates.
- 03:51Excellent, thanks, Andre.
- 03:53Thank you Andre. To your credit,
- 03:55if we we can't do this without you, so so.
- 03:59Thanks for the warm introduction.
- 04:01Alright, so let's move on.
- 04:02OK, so today what we want to talk about
- 04:04and we're going to tag team a little
- 04:06bit and switch back and forth so that
- 04:07we keep you guys entertained and not
- 04:09bored like like doctors in Chuck said.
- 04:12This is kind of in the lull
- 04:13of the sleep circadian rhythm,
- 04:15so we want to keep things energized.
- 04:18So we're talking about hypoglossal
- 04:20nerve stimulation today.
- 04:21And this is a surgical treatment
- 04:23that is possible for some patients
- 04:26when PAP isn't working.
- 04:28Today we'll talk a little bit we
- 04:30we understand completely that
- 04:31this is a Sleep Medicine talk,
- 04:33and so we're going to just briefly go
- 04:35over the diagnosis and epidemiology
- 04:37of OSA and really focus in on the
- 04:41advantages of hip nerve stimulation.
- 04:43We're going to talk about the
- 04:44history and the development and
- 04:46some of the evidence that supports
- 04:48hypoglossal nerve stimulation.
- 04:49And then lastly,
- 04:49we'll talk about the surgery,
- 04:51what it entails,
- 04:52and then of course the the criteria
- 04:55and the complications from surgery.
- 04:57Diagnosis of OSA can be through
- 04:59two different types of tests.
- 05:01As you know there's a polysomnography PSG
- 05:03and it could be a full or split night,
- 05:06or it could be a home sleep
- 05:08apnea test or an age sat,
- 05:09and so based on you know where you are,
- 05:12what,
- 05:13what types of numbers that you're looking at.
- 05:15You can have a calculation of an AHI,
- 05:18which is an apnea hypopnea index,
- 05:20or an RDIOK,
- 05:22which is the respiratory disturbance index.
- 05:25All these are our measurements of sleep.
- 05:27Fragmentation as well as the number
- 05:29of times throughout the night
- 05:31that your oxygen level drops,
- 05:32or that the air flow decreases
- 05:35through the upper airway.
- 05:36For the home sleep apnea test,
- 05:38they measure similar things,
- 05:40but because they most hopes home
- 05:42sleep tests don't include an EEG,
- 05:44you can't actually have a total sleep time.
- 05:48In fact,
- 05:49they all of their respiratory events are
- 05:52measured and divided over the recording time.
- 05:55OK, so it's that's the denominator
- 05:57is different between the.
- 05:58Yes,
- 05:58she and the home state test
- 06:01essentially what's diagnostic of OSA.
- 06:05Is an HI or an Rd or REI?
- 06:09That's over 15 if you have no other symptoms,
- 06:12but if you have any symptoms like
- 06:15fatigue or headaches or any kind
- 06:18of cardiovascular comorbidity,
- 06:19then anything over 5 so 5 and over is
- 06:23diagnostic for obstructive sleep apnea.
- 06:25There are different criteria for mild,
- 06:27moderate and severe,
- 06:28but essentially it is 5 to 14
- 06:30would be considered mild.
- 06:3215 to 29 is moderate and then anything
- 06:3430 or above would be considered severe.
- 06:37OSA and I only mentioned these
- 06:39numbers because it's.
- 06:40Important for figuring out the criteria
- 06:42for patients when you're trying to
- 06:44figure out if they're good candidates
- 06:46for hypoglossal nerve stimulation.
- 06:49So in terms of epidemiology
- 06:51for obstructive sleep apnea,
- 06:53we know that it's a very common disease.
- 06:55We know that it's on the rise overtime.
- 06:58Several population based studies have
- 07:01shown prevalence of HI over 5 in the
- 07:04population to be anywhere from 9 to 38%,
- 07:06and differences in that number and that the
- 07:09variability in that number can be related
- 07:12to the diagnostic testing that was employed.
- 07:14The definitions of OSA used in the
- 07:17studies and also population demographics.
- 07:20Prevalence studies have also shown
- 07:21that the HI over 15 in a population
- 07:24could be anywhere from 6 to 17%,
- 07:27so just taking a conservative number,
- 07:29say 10% of the population with an H,
- 07:32I / 15% in the US would be about 33
- 07:34million people in Connecticut alone,
- 07:37about 350,000 people,
- 07:39so quite a significant number of patients.
- 07:43Prevalence increases with older age
- 07:45in male gender and with higher BMI.
- 07:48I just want to highlight the
- 07:50older age factor here.
- 07:52The prevalence really seems to go up
- 07:56significantly after the age of 60,
- 07:58with some studies showing patients in
- 08:01this age range with an HI over 5 to
- 08:04be 90% in males and up to 78% females,
- 08:07and the risk of obstructive sleep apnea
- 08:09and females increases significantly
- 08:11in women after menopause.
- 08:15This slide is a little busy,
- 08:17but once I explain the colors I think it
- 08:20will start to make a little bit more sense.
- 08:22So we want to emphasize that positive
- 08:24airway pressure is the gold standard
- 08:26for therapy for OSA patients.
- 08:28But just in case the patient
- 08:31can't tolerate it,
- 08:32or for some reason it's just not working,
- 08:34then we have to consider hey,
- 08:36can we offer something sortable
- 08:38for these patients and what I
- 08:40want to highlight in this chart
- 08:41is that the blue the blue boxes?
- 08:44Are the different areas that we're
- 08:46looking at in terms of anatomy in
- 08:48terms of things that we want to assess
- 08:50and diagnose before we consider
- 08:52what kind of surgery we want to do.
- 08:55The yellow boxes or the different
- 08:57types of surgeries that we can
- 08:59consider to help treat OSA?
- 09:01It may not help it completely
- 09:02or cure them from their OSA,
- 09:04but it could make it more tolerable for
- 09:06them to use PAP or to use a dental device,
- 09:09etc.
- 09:11And.
- 09:11You'll see this chart kind of going
- 09:14from top left to bottom right and
- 09:17the yellow from the top to bottom.
- 09:20In general,
- 09:21OK goes from the least morbid or
- 09:24the the best tolerated to the
- 09:27least tolerated so nasal surgery
- 09:29so septal rhinoplasty.
- 09:31Zoar Turbinectomy's are very well tolerated.
- 09:34The hypoglossal nerve stimulator
- 09:36again very well tolerated,
- 09:37although it is an implant and
- 09:39then you go on to these other
- 09:41surgeries which are EU Triple P's.
- 09:42Or you willo palafrugell, plasties?
- 09:45That, or the glass ectomy's what?
- 09:47What that does is just remove
- 09:49excess tissue from the upper
- 09:50airway to create more space.
- 09:52Sometimes it works, sometimes it doesn't,
- 09:54but it's certainly very
- 09:55painful for the patient.
- 09:56OK for at least three weeks,
- 09:58really bad sore throat for like the worst
- 10:00sore throat they've ever had for three weeks,
- 10:02even on narcotics, so these are.
- 10:04And then you go onto the most
- 10:06or the least well tolerated,
- 10:08which are orthognathic surgeries,
- 10:09which where you're essentially
- 10:11expanding the facial skeleton,
- 10:12so that requires a lot of Bony work.
- 10:14A lot of soft tissue maneuvering and
- 10:16it changes the way the patients look.
- 10:19So so this is kind of in the order of
- 10:22what we think patients can tolerate.
- 10:25And in general,
- 10:26if they fail PAP,
- 10:27what we would try to do is figure out
- 10:29a way for them to get a surgery that
- 10:32will allow them to use their PAP.
- 10:33OK,
- 10:34so if they have any kind of
- 10:35nasal airway obstruction,
- 10:36that's what we go for first,
- 10:37because it's it's effective.
- 10:39It's easy to tolerate and you
- 10:41can then have the patient try
- 10:43Pap again to see if it works.
- 10:45If it doesn't work,
- 10:46then we have to assess whether it
- 10:49is an excess tissue problem or if
- 10:51it's a pharyngeal tone problem.
- 10:53We can figure this out using
- 10:54something called dice.
- 10:55Which is a drug induced sleep endoscopy?
- 10:58That's what we gave him medicine
- 10:59to put them to
- 11:00sleep. Then we assess their upper
- 11:02airway when they're sleeping,
- 11:03and I'll have videos of
- 11:04this later and in this.
- 11:06Through this dice, we can tell whether
- 11:08they have a fringe real tone problem,
- 11:10and if they do, which way they collapse.
- 11:13And this is important to to figure
- 11:14out if they're a good candidate
- 11:16for heavy loss in or stimulation.
- 11:18If these types of surgeries work,
- 11:21then great, they can just go
- 11:22on to using their either their
- 11:24stimulator or their PAT machine,
- 11:26but if they don't improve,
- 11:27that's when they have to go get
- 11:29the more painful surgeries which
- 11:31was Orthodox orthognathic surgery
- 11:33where they advance the job board.
- 11:38The why so why they have glossner?
- 11:40So just to review they have glossner comes
- 11:43out of the brain stem out of the medulla.
- 11:46Until they have a glass of canal.
- 11:48And it comes out of the frame of
- 11:50Magnum and then it helps to stimulate
- 11:52different muscles of the tongue.
- 11:53Not all of them, but the major ones.
- 11:56The ones that we are focused on are the
- 11:59the ones that advance the tongue forward
- 12:01and the the the ones that retrieves
- 12:05basically retract the tongue backwards.
- 12:07The Genioglossus is in the geniohyoid
- 12:10our attachments to the mantle itself and
- 12:12it helps to pull that tongue forward.
- 12:15So these are the branches that
- 12:16were focused on that.
- 12:17We want to include the ones that pull
- 12:20the tongue backwards and the pallet
- 12:21backwards is the style of losses and
- 12:24the higher losses and you can see these.
- 12:26In red and you can see the direction
- 12:28of that pole will just retract
- 12:30that tongue backwards.
- 12:31These are the ones that we
- 12:32do not want to stimulate.
- 12:36And this is just a a table that
- 12:38outlines the ones the divisions that
- 12:41help to bring the tongue backwards,
- 12:43which is the style losses
- 12:45in the higher glasses.
- 12:46And then there's the medial
- 12:47division that helps to stimulate
- 12:49the tongue to come forward.
- 12:50And these are the ones
- 12:51that we want to target.
- 12:53That's right, so
- 12:54like yeah and said so.
- 12:56The Genioglossus is really the the muscle
- 12:58that we're targeting here with hypoglossal
- 13:01nerve stimulation and that's really,
- 13:03you know, been shown in neuro
- 13:06anatomical studies to really be the main
- 13:09airway dilator of the upper airway.
- 13:10So I just want to step back and change
- 13:13gears a little bit here to history and
- 13:15development of hypoglossal nerve stimulation.
- 13:18So pilot studies really started in the
- 13:20late 1980s and they really looked at.
- 13:23You know three ways in which they
- 13:25were going to stimulate the tongue
- 13:27in order to open the upper airway.
- 13:29So the first was they focused on
- 13:33submental transcutaneous stimulation.
- 13:34This was with electrodes on the outside
- 13:36of the neck, stimulating the tongue,
- 13:38muscles, and several studies in
- 13:41this area showed some improvements
- 13:43in air flow dynamics,
- 13:44but other studies showed minimal
- 13:46improvements in the AHI,
- 13:48and certainly, as you can imagine,
- 13:49there were quite a few arousals
- 13:52occurring during stimulation, so.
- 13:53They decided to take a different approach
- 13:56and researchers started to look at
- 13:59direct fine wire stimulation at this point.
- 14:01So this was transmucosal
- 14:03electrode stimulation of the
- 14:06individual muscles of the tongue,
- 14:09and these studies showed a more
- 14:11pronounced improvement in muscle
- 14:12contraction and airway dilation,
- 14:14specifically of the genioglossus muscle,
- 14:17and they also at this time started
- 14:20to develop synchronous stimulation
- 14:22with inspiration at the same time.
- 14:24In 1997,
- 14:25the first human study involving direct
- 14:29type glossal nerve stimulation took
- 14:31place by researchers and this was just
- 14:37an illustration of that of that study,
- 14:39and so they actually have an
- 14:40electrode cuff in two different
- 14:42locations on the hypoglossal nerve.
- 14:44The first is on the main trunk right
- 14:46after the branching point with the anti
- 14:49placy and the next cuff that they put
- 14:52on was on the distal branches of the nerve.
- 14:55Going specifically to the genioglossus
- 14:57muscle and so this was really an
- 15:00airflow dynamics study that did not
- 15:02do a polysomnogram in this study,
- 15:04but they looked at they.
- 15:05What they found was basically that
- 15:08this increased airflow velocity by
- 15:11stimulating the hypoglossal nerve
- 15:13and decrease to the airflow velocity
- 15:15when they stopped stimulating it.
- 15:17In these patients,
- 15:18I think they had eight patients
- 15:21enrolled in this study,
- 15:22so from there they started several
- 15:25companies started to develop loop systems,
- 15:28so synchronous closed loop stimulation
- 15:30systems which timed the hypoglossal
- 15:33nerve stimulation with inspiration,
- 15:36and this is similar to the current
- 15:39modern day inspire system and one
- 15:41company in Thera actually started
- 15:44to develop an asynchronous open
- 15:46loop stimulation system which.
- 15:49In this picture, in the upper right here,
- 15:51there's actually this.
- 15:52This is what the electrode cuff look like.
- 15:56There's actually six different electrode
- 15:58arrays that they put around the main
- 16:00trunk of the nerve for continuous
- 16:02hypoglossal nerve stimulation,
- 16:04and So what this did was basically
- 16:07stimulate different branches and
- 16:08fibers of the nerve continuously,
- 16:10but in different timing and pattern.
- 16:14So like I said,
- 16:16several companies were were involved
- 16:18in research in the early 90s up
- 16:21until the early 2000s
- 16:23trying to develop a stimulator implant,
- 16:26including Medtronic app next Inspire,
- 16:29which was an offshoot of Medtronic.
- 16:31And then in Thera,
- 16:34the app Nicks and Inspire devices
- 16:37were both closed loop systems,
- 16:40and the Anthera was a open loop system.
- 16:43So this is a a graph just showing the
- 16:48early feasibility data on all these
- 16:51different implants that we're done,
- 16:53and so it shows significant reduction
- 16:56in the HI from baseline compared to
- 17:00the six month follow-up polysomnogram.
- 17:04And so they all you know were
- 17:06showing that they worked clinically
- 17:09in these feasibility studies.
- 17:11And this is a polysomnogram recording
- 17:13that you're all probably familiar with,
- 17:15but so in this on the left you have
- 17:19the patient having obstructive
- 17:21apneic events where air flow is
- 17:23being restricted here and you see
- 17:26a drop in the oxygen saturation and
- 17:28then when the stimulation is turned
- 17:31on you have a plateau in the oxygen
- 17:34saturation and you have continuous
- 17:36air flow in the upper airway.
- 17:40So.
- 17:42Again, several companies were trying to get
- 17:46FDA approval in the early and mid 2000s,
- 17:50and Inspire was the only company
- 17:52that actually was able to get FDA
- 17:55approval and then occurred in 2014.
- 17:57So I'll just go through
- 17:58that a little bit with you.
- 18:00So it started with a proof of
- 18:05principle trial in 2001 that had
- 18:07about 8 patients and then they do
- 18:10two separate feasibility trials.
- 18:13In 2009 through 2011,
- 18:15basically working on patient selection
- 18:19and implant technique and then looking
- 18:22at their preliminary safety and
- 18:24efficacy data and this culminated with
- 18:27the Inspire Star trial in 2012 and 2013,
- 18:31which led to FDA approval.
- 18:34So I'm just going to go through
- 18:36that trial with you a little bit,
- 18:38so star stands for stimulation
- 18:40therapy for apnea reduction trial.
- 18:43This was published in the
- 18:44New England Journal in 2014,
- 18:46and this trial was a multicenter,
- 18:48prospective trial.
- 18:50They enrolled 126 patients
- 18:52who were eventually implanted
- 18:55with the Inspire 2 device.
- 18:57Their primary outcomes were ajy
- 19:00and oxygen D saturation index.
- 19:03After a 12 month period of
- 19:06therapy in these patients,
- 19:0846 patients were randomized into two groups,
- 19:11so one being a maintenance therapy
- 19:13group and one being a pause in therapy
- 19:16group where they actually stopped
- 19:18their therapy for about 5 days and
- 19:21then had another polysomnogram at
- 19:23that time before restarting it.
- 19:26So in terms of characteristics
- 19:28of the the participants,
- 19:30these were a majority white males in
- 19:34their middle age around their 50s.
- 19:37BMI was in the in the high 20s.
- 19:42In terms of the primary outcome,
- 19:44there was a 68% decrease in the
- 19:46median age I in these patients and
- 19:48a 70% decrease in the median ody.
- 19:52In terms of surgical response rates,
- 19:55in terms of which patients were
- 19:58considered to be responders,
- 19:59which we consider a 50% reduction
- 20:02in the HI and then hi less than
- 20:0520 which was used in this study,
- 20:0866% of the participants were
- 20:11considered responders surgically.
- 20:14This is the portion of the study in
- 20:16which the patients were randomized
- 20:18after 12 months into two different groups,
- 20:21and so you say 23 patients continued
- 20:24their therapy for another five days
- 20:26and 23 actually stopped for five days,
- 20:29and then a repeat study was performed.
- 20:32So at the 12 month mark you see
- 20:34that the POLYSOMNOGRAM data in their
- 20:37age I and ODI was very similar.
- 20:40But after the five day randomization period.
- 20:43You see that the patients who stopped
- 20:46their therapy actually regressed
- 20:48back to close to their pre therapy
- 20:51age I and ODI levels.
- 20:55So another large study
- 20:57that's that's been published,
- 20:59and this was published in 2018,
- 21:01is the Adhir registry,
- 21:03and this is a very large multicenter
- 21:07registry of patients who have had
- 21:10hypoglossal nerve stimulation implants
- 21:13and so at the time of publication,
- 21:17301 patients were enrolled in
- 21:18this registry over two years,
- 21:20so it was a very large
- 21:22database for these patients.
- 21:24And it was nice because it was
- 21:26collecting outcomes in demographics,
- 21:28surgical outcomes, complications,
- 21:29quality of life and patient
- 21:32reported outcomes.
- 21:33And it was really the largest
- 21:35registry of these patients that
- 21:37had been published at the time.
- 21:40So in that registry the the reduction
- 21:43in HI was also very significant from
- 21:47a baseline of around 35.6 to 10.2 in
- 21:51terms of their Epworth sleepiness scale,
- 21:54they went from close to 12 down to 7.5.
- 21:59In terms of patient reported outcomes,
- 22:0394% of patients had positive
- 22:05feedback after surgery,
- 22:0790% of them preferred having this
- 22:10surgery and using this therapy
- 22:12over CPAP and 96% would choose
- 22:15upper airway stimulation.
- 22:17Again,
- 22:17if they could.
- 22:21The star trial participants were
- 22:23followed for five years and then
- 22:26that data was also published in 2018.
- 22:29And So what you can see in terms
- 22:32of age I Epworth sleepiness,
- 22:34scale the FOSCUE scores and also
- 22:38the responder rates is that.
- 22:41Patients who continued to use this for
- 22:44five years had a durable, lasting effect.
- 22:47In in all these measures,
- 22:50and so this really, you know,
- 22:52proved that this was not just a
- 22:56kind of a fluke, it was, you know,
- 22:57they continued to use this therapy.
- 22:59It was really had a durable,
- 23:00lasting effect.
- 23:03Great so so here we want to transition
- 23:06to just talk about what the surgery
- 23:08entails and this is just a diagram of
- 23:10what we want to have happen on the left.
- 23:13You can see that without stimulation
- 23:15that the base of tongue is so this
- 23:17is a flexible fiber optic scope
- 23:19and we're looking into the nose
- 23:21down onto the onto the airway,
- 23:23and these little lumpy bumpy's
- 23:24on the bottom of the screen.
- 23:26That's the back of the tongue with the
- 23:28base of the tongue and then you can
- 23:29barely see the tip of the epiglottis and
- 23:31then the the small airway the pallet.
- 23:33Also, we're looking through the nose
- 23:35at this view and you can see the soft
- 23:38palate on the bottom of the screen
- 23:40and it is almost touching the back
- 23:42of the throat with mild stimulation.
- 23:44You can see that the base of tongue.
- 23:47Pulls forward,
- 23:48which means it goes down on the bottom
- 23:50of the screen and you can see the larynx.
- 23:52You can finally see the vocal cords
- 23:54and the unwritten noise that help
- 23:56helped open up the airway and then on
- 23:58the right you can see the pallet view
- 24:00and the soft palate has been pulled
- 24:02down or forward on on the screen here
- 24:04and then you can see the epiglottis
- 24:06and so there's plenty of space in
- 24:08the oral fairing oral fairings.
- 24:11It is a procedure that used to
- 24:13require 3 incisions,
- 24:14but now we have a 2 incision technique
- 24:16which is even better and it is
- 24:19outpatient procedure which means
- 24:20patients as as soon as we're done.
- 24:22We'll go to the pack.
- 24:23You get a chest X ray to confirm its
- 24:25placement, and they can go home OK.
- 24:27The the stimulation is again synchronized
- 24:31to the the muscles of respiration and
- 24:34I'll show you what these electrodes do.
- 24:38In this diagram you can see
- 24:40that the computer.
- 24:41Is.
- 24:41Implanted into the chest soft
- 24:43tissues of the chest wall along
- 24:45with the electrode that senses
- 24:47the respirations and then it has a
- 24:50other a second electrode that is
- 24:52tunneled in the soft tissues of
- 24:53the neck and then it's connected.
- 24:54The hypoglossal nerve branches on the right.
- 24:57You can see the small little remote
- 24:59control that you use to turn this this
- 25:01mechanism on and off and when you turn
- 25:03it on it doesn't turn on immediately.
- 25:06It waits about 30 minutes and
- 25:08you can change that duration,
- 25:09but it allows for the patient to
- 25:11fall asleep before it starts working.
- 25:12And kicking in.
- 25:13When they travel,
- 25:15they don't have to take the
- 25:16CPAP machine with them,
- 25:17it will just be this remote control.
- 25:21The criteria that is important.
- 25:24The indications for this type of surgery.
- 25:26There are several number one.
- 25:28They are for adults.
- 25:29OK,
- 25:30so anybody that's 22 or over is a candidate.
- 25:34People who are 18 to 21 though they can,
- 25:37they can qualify,
- 25:38but only after they've had their tonsils out.
- 25:41The they have to have a
- 25:43diagnosis of obstructive sleep
- 25:45apnea with an age I range between 15 to 65.
- 25:47OK, so there are people with an HI
- 25:50that's over 65 that will not qualify,
- 25:52so they must have moderate to
- 25:54severe sleep apnea but not over 65.
- 25:58They have to have either failure or
- 26:01unwillingness to to tolerate PAF treatment,
- 26:04so it used to be that they have to have
- 26:06tried a certain duration of time to qualify.
- 26:08But at this point,
- 26:10if they're just unwilling to to try it,
- 26:13they can still be candidates and then the
- 26:16next step would be for us to do a dice.
- 26:18Which is this drug induced
- 26:20sleep endoscopy and all.
- 26:21It is is a quick little nap and
- 26:23we bring him to the operating we
- 26:25bring them to the operating room.
- 26:26For this we give them propofol.
- 26:29To for them to drift off to sleep,
- 26:30and as they're sleeping, we can see.
- 26:33When they're snoring we can see what
- 26:34their upper airway is looking like when,
- 26:36when their oxygen level drops
- 26:40during the sleep endoscopy.
- 26:41What we can find out is the collapse,
- 26:44the pattern of collapse.
- 26:48And here is a video.
- 26:49OK, so I'm going to pause this one for now.
- 26:51OK,
- 26:51so on the left you can see that
- 26:53there is complete AP or front to
- 26:55back collapse at the soft palate
- 26:57and this is what we're looking for
- 26:59is the level of soft palate and
- 27:02you can tell that when they're
- 27:04collapsing it squeezes front and back.
- 27:06OK.
- 27:07But here's an example on the right
- 27:09for a complete concentric collapse,
- 27:12which means it's just squeezing
- 27:13from all different directions.
- 27:15This is not a good candidate for Inspire,
- 27:17because the whole idea is that you're trying
- 27:19to stimulate the tongue to move forward,
- 27:21which opens the airway up in an AP diameter.
- 27:25But if you have concentric collapse,
- 27:28these are the people that we
- 27:29want to rule out.
- 27:30These will not.
- 27:30This person will not be a
- 27:31good candidate for surgery.
- 27:36There are some contraindications,
- 27:38some absolute and some relative.
- 27:40For those that have greater than
- 27:4325% central or mixed apneas,
- 27:44these are not going to be great
- 27:47candidates because not enough of their
- 27:49apneas are considered obstructive.
- 27:50Again, those people with complete
- 27:53concentric collapse are not good
- 27:55anatomic candidates for this type of
- 27:57surgery just because of the way that
- 27:59they collapse and narrow if they have
- 28:01a BMI of skip to the 4th bullet point.
- 28:04If they have a BMI greater than 35,
- 28:07they're not good candidates.
- 28:08There are some states where you can
- 28:10appeal and make special circumstances
- 28:12and exceptions for certain patients,
- 28:14but not in Connecticut.
- 28:15In Connecticut, they're pretty strict.
- 28:16You have to have a BMI less than 35.
- 28:18Some insurances will be.
- 28:20Even stricter,
- 28:21and they will require BMI less than 32,
- 28:24so it's just there are all the major
- 28:27care carriers essentially are.
- 28:29As long as their BMI is less than 35,
- 28:31they're fine.
- 28:32There are two major carriers that
- 28:34require the BMI BMI to be less than 32.
- 28:36If patients will need routine MRI scans
- 28:39or any kind of MRI scans of the chest,
- 28:42abdomen and pelvis,
- 28:42they will not be able to get this implant.
- 28:45It used to be the earlier models
- 28:48for Inspire did not allow any MRI's
- 28:50but at least at this point I think
- 28:52they're on their third or fourth
- 28:53model that they are MRI compatible,
- 28:55but only for the arms, legs, head and neck.
- 28:59Eventually I at least they've been
- 29:00talking about this for a while.
- 29:02They're looking for a device that
- 29:03will be completely MRI compatible,
- 29:05but they they have not yet come
- 29:07up with this yet.
- 29:08OK,
- 29:09next one is it is compatible with
- 29:11certain types of pacemakers,
- 29:13but not all,
- 29:13and the only way to tell is to
- 29:15ask the cardiologist what kind of
- 29:17pacemaker they have and whether
- 29:19it's compatible or not.
- 29:21Of course you want to have the
- 29:23patients or somebody who is a
- 29:24caregiver for them that can turn
- 29:26the machine on and off.
- 29:27And of course patients who are
- 29:28pregnant or plan to become pregnant
- 29:30are not eligible until afterwards.
- 29:34OK, these are incisions,
- 29:35they are so you can on the left you
- 29:38can see that this is an incision
- 29:405 centimeter incision just right
- 29:42underneath the chin off the midline,
- 29:45and then in the chest.
- 29:46It's just another 5 centimeter incision
- 29:48about a few centimeters below the clavicle.
- 29:51It's important that that we ask
- 29:53whether or not they shoot rifles
- 29:54or they do a lot of backpacking,
- 29:56because that will impact the
- 29:57placement of this this generator.
- 30:01OK. The most critical part of the surgery
- 30:05is finding the right branches of the
- 30:07nerve and This is why we take multiple
- 30:09steps to try to figure out which branches
- 30:12to include and which ones to exclude.
- 30:14So we put these little electrodes
- 30:15on the top OK and don't worry,
- 30:17they're they're asleep.
- 30:18When we do this, so we don't feel this,
- 30:20but the red channels are the
- 30:21ones that we want to exclude,
- 30:23and these are going to be the ones
- 30:25that that they're more lateral.
- 30:27These are the lateral divisions.
- 30:29And the ones that we include OK
- 30:32are the genioglossus and the TTV.
- 30:35Just means transverse and
- 30:37vertical fibers of the tongue.
- 30:40OK, so after we put those in then
- 30:43we do the neck dissection part
- 30:45where we identify that digastric
- 30:46tendon OK and if you guys remember
- 30:48from anatomy there's an anterior
- 30:50belly and the posterior belly.
- 30:52But right in the middle is a tendon.
- 30:53So we find this which is really easy to
- 30:56find because it's white and then we can
- 30:58retract it using these little rubber bands.
- 31:00Next there are two major things
- 31:02that we have to retract and then we
- 31:04can look at the nerve right away.
- 31:05One is to some individual and
- 31:08you see those fatty fatty.
- 31:10Polypoid looking thing here that's cemented
- 31:12your plan and we can retract it backwards.
- 31:14And then there's the mylohyoid,
- 31:16which is in a different muscle
- 31:18right underneath the chin and
- 31:19we retract that forward,
- 31:20and so you can see our two little
- 31:22retractors here and right away you
- 31:23can see the hubs loss on Earth.
- 31:26And then once we find the hypoglossal nerve,
- 31:29it's important that we find the inclusion
- 31:32fibers and the exclusion fibers,
- 31:34and we find the break point,
- 31:36which is what divides the two.
- 31:39And as you can see,
- 31:40sometimes there's a very clear separation.
- 31:42We know exactly where to go
- 31:44and and isolate these fibers.
- 31:46But then on the right on
- 31:47the picture on the right,
- 31:48you can tell that the there is
- 31:50an exclusion fiber that's really
- 31:51close to the top of the screen,
- 31:53and then we have to dissect along
- 31:55that nerve to literally set spread
- 31:57out those fibers and split the
- 32:00nerve a little bit so that we can
- 32:02exclude the appropriate fibers.
- 32:05Once we find them then we put this
- 32:08little cuff around the entire nerve
- 32:11fiber the entire nerve bundle.
- 32:13And we make sure that it's sitting
- 32:16nicely along the entire nerve,
- 32:17and then we suture it in place.
- 32:21Next is the chest incision and we
- 32:22make a little soft tissue pocket.
- 32:24Usually we put a couple of little 2
- 32:26segments of our of our feelings into
- 32:29the the chest wall and this is going to
- 32:31be in the fatty pocket, so it doesn't.
- 32:34It's not going to endanger
- 32:35anything around it.
- 32:36This is superficial to the pectoralis muscle.
- 32:40Third part of the surgery is to find
- 32:43the intercostals so that we can put
- 32:45the pressure sensor so that we can
- 32:47sense the inspirations and just a
- 32:49review of the chest wall layers.
- 32:51You've got your skin,
- 32:52your subcutaneous fat,
- 32:53which can be really sick for some patients.
- 32:56And then there's a pectoralis
- 32:57major which are thicker and males
- 32:59and thinner and females and then
- 33:01you get to the external and the
- 33:03internal intercostal muscles.
- 33:05If you remember they're really thin muscles,
- 33:07but they crisscross,
- 33:08they go in direct that completely.
- 33:10Opposite directions,
- 33:11and so that makes it really easy for us
- 33:14to find so you can see that the EIC,
- 33:16the external intercostals run
- 33:18in this direction,
- 33:19and then as soon as you go through them,
- 33:21you will see the internal intercostal
- 33:23muscles going the other way and as
- 33:25soon as you can see that then you'll
- 33:27know that your pressure sensor is
- 33:29going to go right between those layers.
- 33:33OK, and this is the picture of us
- 33:36putting in that pressure sensor.
- 33:38After surgery,
- 33:38I mean after those part we we hook
- 33:40it up and we tested just to make
- 33:41sure it works and it's super cool
- 33:43'cause you can see the the tongue
- 33:45coming out during during just
- 33:48right after your surgery.
- 33:49You can already tell that it
- 33:51works in the pack.
- 33:52You will take an X ray of the
- 33:53chest and X ray of the neck just
- 33:55to make sure that the electrodes
- 33:57are in the right place.
- 33:58And then
- 33:59of course there's no new thorax.
- 34:02And Bruno's gonna talk about the risks. So
- 34:05in terms of risks of the surgery,
- 34:08these are things that Jen and I
- 34:10talked to our patients about.
- 34:11You know, before the surgery.
- 34:13Obviously you can break them down
- 34:16into bleeding risks, infection, risk,
- 34:19injury to nerve risk, new thorax.
- 34:23OK, so tongue weakness from either
- 34:26temporary or permanent injury to the
- 34:29hypoglossal nerve, tongue numbness.
- 34:30So that'll be injury to the lingual nerve.
- 34:33And read to the marginal mandibular nerve,
- 34:35which is a small little branch of
- 34:37the facial nerve that makes your
- 34:40the corner of your mouth droop.
- 34:42If it's injured,
- 34:43a new more thorax is obviously
- 34:45a collapsed lung,
- 34:46and that can occur when placing sensing
- 34:49lead between those intercostal muscles,
- 34:52hematoma, bleeding,
- 34:53and infection are always concerns
- 34:55when you know operating in the
- 34:58neck and chest and therapy related
- 35:00risks can be due to unfavorable.
- 35:03Tongue protrusion obviously an
- 35:06inadequate response to therapy.
- 35:08Patients having poor sleep quality
- 35:10due to discomfort or arousals from
- 35:13stimulation and tongue irritation.
- 35:15So if we look at data from the STAR
- 35:19trial and the five year start trial,
- 35:22you can see that the majority of adverse
- 35:26events that were reported in that study
- 35:29were in the 1st 12 months and these were,
- 35:32you know,
- 35:32mostly related to.
- 35:34Discomfort related to the incisions.
- 35:36Discomfort related to the therapy itself,
- 35:39there were quite a few temporary
- 35:42tongue weaknesses that were reported,
- 35:45but these obviously resolved
- 35:47with time as you would expect
- 35:49temporary weakness or to resolve.
- 35:52There was one case of mild infection.
- 35:55There were no cases of pneumothorax.
- 35:58There were no cases of permanent
- 36:01nerve injury and no cases of.
- 36:05Major infection or sepsis or death.
- 36:09And so you can see that overtime
- 36:11you know the number of adverse
- 36:13events were were very low,
- 36:15and so overall this is a very safe
- 36:19surgery if you look at data from the
- 36:23adhere registry with quite a few
- 36:26larger number of patients who have
- 36:29been implanted the adverse events
- 36:30again are very low in terms of the
- 36:33percentage and in terms of tongue
- 36:36weakness less than 1% of speech and
- 36:39swallowing dysfunction less than 1%.
- 36:41There were no infections reported
- 36:43in in that registry at all,
- 36:46and so most of the the adverse
- 36:49events in that registry that have
- 36:52been reported have been related
- 36:54to stimulation related discomfort
- 36:57or activation related discomfort.
- 36:59And so overall is a very safe surgery
- 37:02in terms of surgical procedures.
- 37:05That again and I performed in
- 37:08terms of the patients pathway after
- 37:10their implantation,
- 37:11so we would see them about a week after
- 37:14surgery to make sure their surgical
- 37:17incision sites are healing up nicely.
- 37:19Typically,
- 37:20wait a month after the surgery
- 37:22in order to activate the patient.
- 37:25This is typically done in the
- 37:27office with the patient.
- 37:29And you know you teach them
- 37:30how to use their remote.
- 37:32You actually program their
- 37:34device in the office with them,
- 37:37and you actually turn it on
- 37:39with them awake in the office,
- 37:40and they get to actually
- 37:42experience and and see what
- 37:43it feels like and see what it looks like,
- 37:45and you get to see that too.
- 37:46So it's pretty cool.
- 37:48About a month after that,
- 37:49you checked in with them that can
- 37:51be through a Tele health visit and
- 37:52just see how things are going,
- 37:54see how they're feeling,
- 37:55see how their sleep quality is,
- 37:57see how they're you know snoring is, or if.
- 38:00It's if it's been resolved per their partner.
- 38:03And then usually around the three
- 38:06to four month Mark is when you would
- 38:08typically get a follow-up sleep
- 38:10study and do any of your fine tuning
- 38:13that you need to do in terms of,
- 38:15you know, reprogramming the software
- 38:17in terms of the implant itself.
- 38:20And certainly these patients are
- 38:22not patients that you want to,
- 38:24just you know,
- 38:24see in those first few months
- 38:26and then never see again.
- 38:27They they need to be, you know,
- 38:29have routine follow up at least once or
- 38:31twice a year to see how they're doing.
- 38:33See if they're still using there.
- 38:35Their device to,
- 38:37similar to a CPAP.
- 38:38See how their quality of life
- 38:40is while they're using therapy.
- 38:44And you know just to give you
- 38:46a sense of what we've been
- 38:48doing here at Yale is we we.
- 38:50It's a very expensive implant.
- 38:51And so in the beginning stages,
- 38:53a lot of hospitals aren't
- 38:55are very reluctant to.
- 38:57Allow implants,
- 38:58but in January or in March of 2019
- 39:01is when we got approval to to do
- 39:03them at GAIL and in November of 2020
- 39:05is when we did our first implant,
- 39:07so it took us a little bit of time
- 39:09to even find the right candidate
- 39:11for this surgery and then.
- 39:12But since then, for the past 14 months or so,
- 39:14we have had 10 implants already
- 39:17and at various stages of activation
- 39:19and we have 7 already scheduled
- 39:22in the upcoming two months.
- 39:24We are building this who also
- 39:26nerve stimulation program.
- 39:27Of course with the help of doctors in Chuck.
- 39:28And we have monthly meetings that
- 39:31a multidisciplinary we are doing.
- 39:33Physician outreach events where
- 39:34we're reaching out to pulmonologist
- 39:36as well as primary care doctors and
- 39:39probably eventually cardiologist as
- 39:41well to to see if we can increase
- 39:42everyones knowledge about hypoglossal
- 39:44nerve stimulation to so that they
- 39:46can keep an eye out for.
- 39:48For patients that may may benefit from this.
- 39:50And we're also planning on
- 39:52some community outreach talks.
- 39:53We are also I forgot to put this
- 39:55on the the list here,
- 39:57but we're also reaching out to some patients.
- 39:59Who have tried CPAP,
- 40:01who are not compliant,
- 40:03and so from we have a database.
- 40:05Thank you to doctors and
- 40:06Chuck for providing it,
- 40:08but but essentially we're trying
- 40:09to find out patients who are not
- 40:12tolerating the PAP machine and then
- 40:14screening them to to see if they
- 40:16would be interested in inspire.
- 40:18Because we think that it would
- 40:19benefit them greatly, of course,
- 40:21and these are our media outlets and you know,
- 40:24Doctor Cardoso.
- 40:25Doctors in shock was in a couple
- 40:27articles and of course there
- 40:29was a tiny little interview.
- 40:3020 years eve.
- 40:32To help promote,
- 40:33we're actually not necessarily to promote
- 40:36this necessarily for industry purposes,
- 40:38but really to to spread the word on
- 40:41this possible therapy for a small
- 40:44population of patients with OSA.
- 40:46With that I will kind of turn
- 40:49this over to to you guys for
- 40:51any questions or comments,
- 40:52and I know that.
- 40:55There's a chat box that you
- 40:57can post questions.
- 41:00Great, thank you so much guys.
- 41:01I appreciate the nice journey through the.
- 41:06Through the history of the
- 41:08hypoglossal nerve stimulation,
- 41:09the failed and successful attempts,
- 41:10and also where we are now.
- 41:13And absolutely great to have
- 41:15a partnership with you guys.
- 41:17So I'm just going to turn and see.
- 41:19Is there any questions or comments?
- 41:20And so I have a comment from Doctor Kumar.
- 41:23It says it's not a question but I
- 41:25wish while advertising about its
- 41:26fire as a non secret solution.
- 41:28They included the BMI exclusion
- 41:31and so I think.
- 41:33Speaks to the statement about awareness
- 41:36of for whom the therapy is appropriate
- 41:40and one of the comments that I'll make
- 41:43is that BMI is a modifiable factor,
- 41:45and so we do have some individuals who
- 41:49really want the uproar stimulation,
- 41:51device implantation,
- 41:52and so therefore,
- 41:53are working on losing weight and we're
- 41:55working with our weight management
- 41:57colleagues in GI to do that with them.
- 41:59And so there's also comment from Doctor Yagi.
- 42:02In committee is excellent talk.
- 42:04In addition to dice,
- 42:05what other ways may we be able to
- 42:08predict nonresponders to this therapy?
- 42:12That's a great question in
- 42:14terms of let's go backwards.
- 42:16So Doctor Yagi the.
- 42:18The reason why they keep the criteria
- 42:21so strict at this point is because
- 42:23we want to make sure that we don't
- 42:25put the implant into patients who are
- 42:27have a very very low success rate,
- 42:30and so these are the people
- 42:32with BMI greater than 35.
- 42:33Especially because when they
- 42:35have just a lot of fatty tissue
- 42:37in the upper airway or just a
- 42:38lot of weight and neck girth,
- 42:40it's really difficult.
- 42:41Like no matter how much you try to stimulate,
- 42:43the tongue is not going to
- 42:45expand the upper airway,
- 42:46so that's that's a really important one.
- 42:49I also in general like to make sure that
- 42:52my patients are very motivated there are,
- 42:55you know,
- 42:55surgery in general is not without risk.
- 42:57I mean you saw all the the list of yes,
- 42:59they're not that common,
- 43:00but it is possible for them to
- 43:02get those adverse outcomes.
- 43:03And I want to make sure that they
- 43:06understand the risks and they are
- 43:08motivated to to have the surgery
- 43:10even though they understand that
- 43:12things bad things can happen.
- 43:13There are and then back to
- 43:17Toshiba Kumar question the BMI,
- 43:19so there are a lot of patients
- 43:21with obstructive sleep apnea who
- 43:24doesn't respond completely to PAT,
- 43:26but we also want to make sure that they,
- 43:28even if they don't come,
- 43:29if they,
- 43:30even if they come in and they don't
- 43:32end up being candidates for inspire,
- 43:34it is still a great opportunity
- 43:35for us to talk to them about all
- 43:37the other things that they can do,
- 43:38like weight loss.
- 43:39There's a,
- 43:40there's a really funny story from one
- 43:42of our colleagues who does inspire at the VA.
- 43:44He's just saying that there was
- 43:46a patient with a really high VMI
- 43:48and really high hi and but he
- 43:50really wanted this implant 'cause
- 43:52he thought it was cool and so he
- 43:54ended up losing all this weight.
- 43:55He lost £50 and then at the end of
- 43:57the day they repeated the PSG and he
- 44:00didn't have sleep apnea anymore and
- 44:01so he he was really mad that he was
- 44:04really bummed that he couldn't get
- 44:05inspired by at least his OSA was cured.
- 44:07So it's a good way for us to at least
- 44:09bring patients in and even talk to
- 44:11them about their OSA and what the
- 44:13different strategies are to treat it.
- 44:15Yeah, great thank you.
- 44:16And so and and I just add that
- 44:19it is a multidisciplinary effort.
- 44:21A lot of these individuals.
- 44:23Don't just have sleep apnea,
- 44:25they have other sleep problems and
- 44:28there are some other predictors
- 44:30that are in the works for food.
- 44:32May I mean not be responded to
- 44:34stimulation so there's a recent
- 44:36paper published in a blue journal.
- 44:38Looking at these physiologic traits so
- 44:40people with easier as ability or high
- 44:43loop gain tend to be poor responders.
- 44:46Even among those who were in
- 44:47Star trial so and just as a,
- 44:49it's a highlight, you know,
- 44:51one up to 1/3 of patients in the start
- 44:53trial were nonresponders in terms
- 44:55of hi and upward sleepiness scale,
- 44:58so it's not a panacea.
- 45:01But with the right candidates we
- 45:03can have a successful therapy,
- 45:05and so Doctor Stewart meant is
- 45:07mentioning that what is the logic
- 45:09for allowing hi have 60 but not
- 45:1170 for this procedure,
- 45:13knowing how variable this number
- 45:15can be at this level.
- 45:17So
- 45:19the star trial the the age I cut off was
- 45:22actually 50 in that trial, so you know.
- 45:27And so several of the other
- 45:28studies around that time,
- 45:30they actually had similar cut offs and
- 45:33so then in getting FDA approval they
- 45:37initially made it slightly above that to 65.
- 45:41It's sort of an arbitrary number,
- 45:42but I think the thought was
- 45:45that you know the higher.
- 45:48That number went the the less likelihood of
- 45:52success in terms of of the device working.
- 45:56There have been a couple kind of
- 45:58studies out there that have been done.
- 46:01As for implants in patients kind of
- 46:04off label in patients who have either
- 46:08high BMI or age I above the cut off
- 46:12of 65 and it's been quite successful,
- 46:15but it's in the it's in the 62.
- 46:18Maybe 70% efficacy range similar
- 46:22to the original star trial.
- 46:25So I think that that criteria is
- 46:27probably going to change eventually,
- 46:30but it's it's not there yet.
- 46:32Yeah, we've been seeing in general just
- 46:35strict criteria in the in the beginning,
- 46:38but then as they demonstrate
- 46:40the effectiveness overtime,
- 46:41they've been expanding the criteria.
- 46:43For example, the BMI it used to be
- 46:45very strict, has we less than 32,
- 46:46but then they realized that they
- 46:48can go up to 35 and still these
- 46:50patients had good response rates.
- 46:51And so now most carriers will allow
- 46:54for BMI is to be as high as 35. Right,
- 46:57so Medicare is covers it for BMI up to 35.
- 47:02But you know, many of the other private
- 47:05insurance companies in Connecticut,
- 47:07at least, like Blue Cross Blue
- 47:09Shield have a strict 32 cut offs.
- 47:13Great, thanks guys.
- 47:14There's another question from
- 47:16Doctor Thappa and thank you for an
- 47:18excellent talk and if the patient
- 47:20gets implanted and then gains weight
- 47:23where the BMI goes up to above 35,
- 47:25does the efficacy of therapy decline?
- 47:31So excellent question. I don't know
- 47:34if we have much data on that yet,
- 47:38so I think time will tell on that. Yeah,
- 47:42it's a great idea. In fact, I'm.
- 47:44I'm hoping to to actually study
- 47:47this once we get enough patience.
- 47:49But wait, Andre, do you have
- 47:50something to say about that?
- 47:52Yeah no, I. I mean I think that BMI
- 47:55is one of the stronger predictors
- 47:57of upper escalation efficacy,
- 47:59and so whether that.
- 48:02BMI is at time of the plantation
- 48:05or time postimplantation.
- 48:06I'm not sure if it makes a
- 48:08difference that's unknown.
- 48:09You know it's possible that
- 48:11as you stimulate the tongue,
- 48:12there is a lower amount of tongue
- 48:14fat that ends up being deposited,
- 48:16which we know from recent work is
- 48:19one of the major causes of sleep
- 48:22apnea is the actual tongue fat
- 48:24rather than hypotonia necessarily?
- 48:26And so it's possible that with
- 48:29lower content of fat and a muscle
- 48:32that's repeatedly stimulated.
- 48:33Might be not as bad for you,
- 48:35but I I think the verdict is still
- 48:38out and I see Doctor Mayer Krieger is
- 48:41hoping to make comment and so I'll
- 48:43certainly we have some time to do that.
- 48:45So let me see if I can find you mayor OK.
- 48:49Meanwhile I had I have a direct
- 48:52message from Doctor Cynthia career
- 48:55and it was four known patients with
- 48:57OSA on CPAP and compliant and now
- 48:59want to have inspire since this
- 49:00type of therapy wasn't available
- 49:02when patient was diagnosed with.
- 49:04USA, would this be a consideration
- 49:05or for this type of patient to
- 49:07be included in the criteria?
- 49:08Yes, in fact we have several patients
- 49:10that we've seen who've been on.
- 49:12CPAP tolerating it using it very
- 49:15with a lot of compliance but just
- 49:19didn't want to carry it around with
- 49:21them anymore or travel with it or
- 49:23just have the maintenance of the
- 49:25tubing and everything and so so they
- 49:27are certainly candidates because.
- 49:31Because they you know they,
- 49:32they just wanna try something else.
- 49:34That might be a little bit more
- 49:36conducive to their lifestyle.
- 49:37But the same counseling applies.
- 49:39We always let them know that you
- 49:41know there's still strict criteria.
- 49:43We still have to do the dice and
- 49:44make sure that they're going to be.
- 49:45They're going to have good anatomy and
- 49:47there are all these other surgical
- 49:49considerations to to be aware of.
- 49:51For example,
- 49:52every 11 years the battery runs out,
- 49:54so after 11 years we have to replace
- 49:56the CPG which is in the chest pocket.
- 49:59The electrodes will stay, so they don't have.
- 50:01Risk from that, but yes,
- 50:02we do have to subject these
- 50:04patients to a surgery,
- 50:06a small surgery every 11 years
- 50:07and so if it's a young patient,
- 50:10they need to know that.
- 50:11Otherwise they they'll.
- 50:11You know,
- 50:1211 years later that their battery
- 50:13runs out and you're going to say,
- 50:15Oh yeah, oh, by the way,
- 50:16we have to replace that,
- 50:18right?
- 50:19Along those same lines,
- 50:21you know those patients who have
- 50:23been on CPAP for a long time.
- 50:25They would need an updated
- 50:27sleep study within two years.
- 50:29That's also part of the criteria.
- 50:31That's not typically mentioned. No,
- 50:34and so those are all all great points
- 50:36and they'll think would add too.
- 50:38Is that you know, we in our program
- 50:40we have all our patients go through
- 50:42this Sleep Medicine consultation
- 50:44to make sure that potential
- 50:45factors that are making C PAP and
- 50:48tolerable are actually addressed.
- 50:50And we've had several patients
- 50:51who came in for a consultation,
- 50:52and now we love their CPAP
- 50:55and so sorry and Bruno. Yeah.
- 51:00You gotta help the C PAP lovers and so
- 51:03it's important to address those other,
- 51:06possibly other modalities.
- 51:07So some people are switched to oral
- 51:09appliance therapy and other people are
- 51:12added positional therapy and they do quite
- 51:14well without having to undergo surgery.
- 51:16And let's see. So let me unmute Doctor
- 51:20Mayer Kreger mayor, can you hear us?
- 51:25Can you guys hear me?
- 51:27We can, yes, OK, I'm in a car
- 51:29so that's why I sound so crazy.
- 51:32So there's an interesting
- 51:34history before the history.
- 51:37So in the very early days
- 51:40of sleep apnea Medtronic,
- 51:42the the Pacemaking company
- 51:44actually bought the patents for
- 51:48CPAP from the original inventor.
- 51:51They saw that this was a big business.
- 51:54And they decided that they
- 51:56were going to use their pacing
- 51:59technology to treat sleep apnea.
- 52:01And when I was in Winnipeg at
- 52:03the time which was close to
- 52:05Minneapolis to their headquarters,
- 52:07we actually at that time
- 52:09with Medtronic we tried.
- 52:11Very early to stimulate the tongue,
- 52:15and I had a fellow who was an EMT surgeon
- 52:19actually stick electrodes through,
- 52:21you know, through here,
- 52:23right into his tongue.
- 52:24And we did CT scans and then and then
- 52:28stimulated and it hurts like hell
- 52:31and Medtronic very quickly decided
- 52:33that that was not going to work and
- 52:36they needed to do something different.
- 52:38What then happened is that the guy
- 52:42in charge of the program died and and
- 52:45the the entire painting program died.
- 52:48His name was Don Erik Erikson.
- 52:51And but right before that,
- 52:53Medtronic was so convinced
- 52:55that pacing was gonna work,
- 52:58that they sold the the the C PAP division.
- 53:03To one of its people,
- 53:06and it became rest Med and the
- 53:08rest is history so that those
- 53:12people became billionaires.
- 53:14So that's a part of the history
- 53:17that not many people know
- 53:18about. Very interesting.
- 53:20Thanks, thanks mayor.
- 53:22The lesson is don't jump
- 53:24ship too early. Yeah.
- 53:29Alright, let's see.
- 53:30There's a comment from Doctor Anthony.
- 53:32Guardi is successful or appliance
- 53:33treatment or predictor of
- 53:35hypoglossal nerve stimulation?
- 53:38Well I I'm not sure if that data is.
- 53:40I'm just going to take it 'cause
- 53:42I don't know how much exposure you
- 53:44guys have to to oral plants therapy.
- 53:46But in the day that I've looked at,
- 53:50I have not found a whole lot that
- 53:52has been used to predict HNS therapy.
- 53:55Following oral appliance.
- 53:58Have you guys seen anything that?
- 54:00To that effect, no.
- 54:02It's conceptually it might.
- 54:04Might make sense, but I think it's hard to.
- 54:07It's hard to know that that's
- 54:09a study to be done.
- 54:10Perhaps so,
- 54:11but do you worry if you're interested
- 54:13in we are happy to take on some
- 54:16patients or willing to change.
- 54:17Let us know.
- 54:21OK, then there's also
- 54:22another comment from Toshiba.
- 54:23Kumar is a sleep position.
- 54:25I am able to refer to Yale EMT
- 54:27directly for Inspire or they need
- 54:30a sleep consult at Yale first.
- 54:32And so you can refer to Ian
- 54:36and Bruno for our program.
- 54:38We do prefer to see them in clinic
- 54:40first to explore their sleep history.
- 54:43There's some other predictors like
- 54:45increased central propensity for events,
- 54:47and we can do some of the these
- 54:49more additional analysis and traits
- 54:51to help predict who might or might
- 54:54not respond ahead of his time.
- 54:56But you're welcome to refer them to.
- 54:59Doctor Lee and Doctor Carissa.
- 55:01Absolutely we
- 55:02can give us. We can give our
- 55:05contact information for, you know,
- 55:07referrals following the talk absolutely
- 55:09absolutely have patience.
- 55:10We have patients in in kind of both camps
- 55:14that that get all their care through
- 55:16the Sleep Medicine Center at Yale.
- 55:18And then we also have patients that
- 55:20have their own Sleep Medicine,
- 55:22doctors and as a sleep physician.
- 55:25If you you have the choice.
- 55:27So we we all we want to.
- 55:30Make it easy for for patients and for
- 55:33physicians to take care of the patients,
- 55:35and so if you're interested in learning how
- 55:38to activate the so so after the implant,
- 55:41OK, the someone needs to activate and kind
- 55:44of keep track and titrate the machine.
- 55:47It it requires a little bit
- 55:48of training in the beginning,
- 55:49but if you're interested in doing so,
- 55:51it's definitely possible.
- 55:52But let's say you have 0 interest
- 55:55in learning how to activate it.
- 55:57Don't worry,
- 55:57we can still implant a doctor's
- 55:59interest can help to activate.
- 56:00And as soon as they're stabilized,
- 56:02we can send the patient back
- 56:03to to to the referring back.
- 56:10OK, great, well I thank you
- 56:12all for a wonderful talk.
- 56:15Thanks Dan and Bruno and
- 56:17thanks all in the audience.
- 56:19Please feel free to refer patients to us.
- 56:21You can just send an email to myself,
- 56:24Jen or Bruno or send us a message.
- 56:26Will be happy to see your patients
- 56:28evaluate them and and hopefully
- 56:30there might be a therapy for them.
- 56:32Alright, take care everyone.
- 56:34Thanks again for a wonderful session
- 56:36and we'll see you next week.
- 56:37Alright, thank you guys.
- 56:38Thanks guys, appreciate it.