"Updates in Upper Airway Stimulation for Obstructive Sleep Apnea" Yan Lee, MD and Bruno Cardoso, MD (01/19/2022)

February 04, 2022

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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.