Upper Airway Hypoglossal Nerve Stimulation - 2019 - Atlas of The Oral and Maxi
Upper Airway Hypoglossal Nerve Stimulation - 2019 - Atlas of The Oral and Maxi
Upper Airway Hypoglossal Nerve Stimulation - 2019 - Atlas of The Oral and Maxi
KEYWORDS
Obstructive sleep apnea Upper airway stimulation Hypoglossal nerve stimulation Sleep surgery
Drug induced sleep endoscopy Implant
KEY POINTS
Obstructive sleep apnea is a multilevel process consisting of physiologic and anatomic obstructive patterns leading to
partial or complete collapse of the upper airway and resulting comorbidities.
Studies have shown apnea-hypopnea index (AHI) response rate of 75% (AHI less than 20 events per hour and overall >50%
reduction) and improvement in quality of life in patients treated with upper airway stimulation (UAS).
UAS is indicated in patients with positive airway pressure failure, who are 22 years of age or older, with AHI 15 to 65, with
body mass index less than or equal to 32 and anatomy amenable to implantation and likelihood of high success.
Drug-induced sleep endoscopy is an essential evaluation step to exclude patients with retropalatal concentric collapse.
Preparation of cranial nerve XII and determination of functional breakpoint to exclude the lateral XII branches and include
the medial XII branches are critical to optimize surgical success.
years, with the technology subsequently modified.15 Most recently, radiograph, fluoroscopy, ultrasonics, defibrillation, or radi-
Inspire Medical Systems (Maple Grove, Minnesota) has obtained tion can adversely affect the UAS system.
Food and Drug Administration approval for a UAS device, and a 5-
year Stimulation Therapy for Apnea Reduction (STAR) outcome Preparation and patient positioning
study showed improvement in sleepiness (Epworth Sleepiness
Scale [ESS]) and quality of life (Functional Outcomes of Sleep
1. The patient is taken to the operating room and is placed in
Questionnaire [FOSQ]), with normalization of scores increasing
the supine position, and short-acting muscle relaxers are
from 33% to 78% and 15% to 67%, respectively, and showed an
used prior to intubating orally or nasally.
apnea-hypopnea index (AHI) response rate of 75% (AHI <20 events
2. Patient is given dexamethasone and preoperative antibiotics,
per hour and overall >50% reduction).16
such as IV cefazolin, within 60 minutes of first incision.
Surgeons need to have thorough understanding of the pre-
3. Nerve Monitoring System (NIM) (Medtronic, Minneapolis,
operative and surgical protocols to optimize postoperative
Minnesota) monitors the tongue response by utilizing sensor
outcomes. This article describes the steps required for preop-
leads (Xomed 82273049) and bipolar simulating probe
erative assessment, diagnostic work-up, performance of im-
(Xomed 8225401).
plantation of the UAS device, and postoperative management.
a. Inclusion: NIM blue electrode is placed using a Debakey
forceps right of the midline and in the floor of the mouth
Surgical technique by plunging into the genioglossus muscle (avoid frenulum
and salivary duct). This ensures inclusion of the protru-
Diagnostic work-up sive muscles (genioglossus oblique [GGo] and genio-
glossus horizontal [GGh]) and of the tongue narrowing/
A baseline polysomnography (PSG) or home sleep study is ob- flattening muscles (transverse and vertical [T/V]), which
tained to first diagnose the severity of OSA. After confirmation of are innervated by the medial branches of XII.
OSA, comprehensive clinical, radiographic, and endoscopic b. Exclusion: NIM red electrode is placed using a Debakey
diagnostic work-up is performed to determine the appropriate 5 cm from the tip of the tongue and inserted into the
selection of sleep surgical options. The clinical examination ventrolateral and submucosal surface of the tongue. This
consists of evaluation of the nasal passages, oropharyngeal ensures exclusion of the retractor muscles (styloglossus
space, and retroglossal area. DISE is performed to characterize [SG] and hyoglossus [HG]), which are innervated by the
airway collapse pattern. The pattern and degree of collapse is lateral branches of XII.
scored according to the velum, oropharyngeal, tongue base, and 4. Bite block is placed to hold the mouth open to visualize the
epiglottis classification.14,17 tongue during device testing at the end of the case.
UAS indications: 5. Shoulder roll and jelly donut used to extend the head to the
left for optimal surgical access. Keep the arm on the
implant side free of IV, pulse oximetry, and blood pressure
1. PAP failure
cuff and loosely tuck.
2. 22 years of age or older
6. The 3 surgical sites are then marked at the stimulation lead
3. AHI 15 to 65
incision (neck), implantable pulse generator (IPG) pocket
4. Body mass index (BMI) 32
incision (superior chest), and sense lead incision (infero-
5. Anatomy amenable to implantation and likelihood of high
lateral chest).
success
a. Stimulation lead incision: 4-cm to 6-cm incision is
marked midway along the length of the right mandible
UAS contraindications: and midway between the hyoid and mandible while
staying 1 cm from the midline.
1. Sleep study showing greater than 25% central or mixed apneas b. IPG pocket incision: 5.5-cm incision is marked 5 cm
2. Concentric palatal collapse seen on DISE11,13,14 inferior to clavicle and midway between the sternum
3. Unable to operate the therapy and deltopectoral groove.
4. Pregnancy c. Sense lead incision: palpate the 5th (1) rib using
5. Preexisting anatomic alterations or neurologic disorders inferolateral margin of pectoralis major as a landmark;
6. Patients who require MRI 4-cm to 6-cm incision marked following the curvature of
a. Inspire Model 3024: MRI is contraindicated because it may the rib approximately 5 cm lateral from a line straight
cause tissue damage and/or damage to the UAS device. down from the nipple.
b. Inspire Model 3028: if certain conditions are met, pa- 7. The face, neck, and chest are then prepped with betadine.
tients may undergo an MRI scan on head and extremities. Sterile towels are secured with staples to isolate surgical sites.
Adhesive drape (Ioban [3M, St. Paul, Minnesota]) is placed over
exposed skin to maintain aseptic technique at all 3 surgical
UAS precautions:
sites. A transparent drape (1012 [3M]) is then placed across the
loban to cover the oral cavity while ensuring visual access to
1. BMI greater than 32 may be associated with decreased
the tongue. A split sheet is then secured over the drapes.
likelihood of surgical success.
2. Diathermy (primarily used in physical therapy): do not use
shortwave diathermy, microwave diathermy, or therapeutic Surgical procedure
ultrasound diathermy on patients with a neurostimulation
system. 1. Neck incision is carried through the skin, platysma, and
3. Electromagnetic compatibility and interference, electro- superficial layer of the deep cervical fascia while avoiding
cautery, irradiation, lithotripsy, radiofrequency ablation, the marginal mandibular branch of the facial nerve. The
Upper Airway (Hypoglossal Nerve) Stimulation 55
submandibular gland is located, carefully dissected at the cuff are free from adhesions or other trapped tissue
inferior and anterior aspect away from the mylohyoid (Fig. 2).
muscle, and retracted posteriorly. 7. Pass the anchor of the stimulator cuff under digastric
2. Identify the anterior belly of digastric muscles and trace tendon. Secure the anchor to the anterior belly of the
back to the digastric tendon. Tunnel under the digastric digastric muscle by placing two 3-0 silk sutures on RB-1
tendon toward the mylohyoid muscle to provide a path for needle and positioning the suture into the grooves on the
the stimulating lead. Place a vessel loop around the anchor. Place moist gauze into the surgical site and pro-
digastric tendon and retract inferiorly. Free the posterior ceed to the next incision.
margin of the mylohyoid muscle and retract the muscle 8. IPG pocket incision is carried through the skin and subcu-
anteriorly. taneous tissue and superficial to the pectoralis major fas-
3. By retracting the submandibular gland posteriorly, the cia. Bluntly dissect superficially to the fascia and avoid
mylohyoid muscle anteriorly, and the digastric tendon vessels. The pocket should be approximately 4 cm deep
inferiorly, the hypoglossal nerve (cranial nerve [CN] XII) and should be oriented to support arm motions and daily
can be visualized, which lies superficial to the HG muscle activities. Place moist gauze into the surgical site and
and deep to the mylohyoid muscle. Surgeons must be proceed to the next incision.
careful not to injure important structures in the field, such 9. Inferolateral chest incision is carried through the skin,
as the lingual nerve and submandibular duct. Once the subcutaneous tissue, and either through or working be-
hypoglossal nerve is identified, the ranine vein may need tween the anterior serratus muscle fibers. Surgeons must
to be ligated and divided because it often lies over the avoid the intercostal neurovascular bundle located
nerve. beneath each rib. A dissector is used to make a small
4. Identify the hypoglossal nerve (CN XII) and the functional opening through the external intercostal fibers until the
breakpoint using stimulation and NIM monitoring. The goal internal intercostal fibers are visualized. A narrow
is to separate the branches of XII that produce a uniform malleable retractor is tunneled 6 cm between the internal
protrusive and stiffened tongue motion from the branches and external intercostal muscles to accommodate the
of XII that cause tongue retraction. Surgeons should work sensor lead. Surgeons must be cautious to not proceed
counterclockwise along the hypoglossal nerve from inferior through the internal intercostal muscle and violate the
to posterior (geniohyoid [GH], GGh, GGo, T/V, HG, and SG) plural space. The sensor lead is positioned facing the in-
and stimulate the individual branches within the main ternal intercostal muscle by only grasping the tapered,
trunk to exclude the lateral XII branches (HG and SG) and honeycomb area to prevent damage to the sensor lead.
include the medial XII branches (GGh, GGo, and T/V) and, Maintain sensor lead parallel to the ribs. Secure the fixed
when possible, the C1 branch from XII to the GH muscle anchor to the fascia with four 2-0 silk sutures (Fig. 3).
(Fig. 1). 10. Assemble the tunneling device by screwing the collet and
5. Use a fine vessel loop to isolate the inclusion branches of sleeve apparatus to the shaft. Prebend the shaft and guide
XII and validate with NIM. It is important to minimize the tunneling device in the subcutaneous plane from the
dissection on the nerve to prevent neuropraxia. While inferolateral chest incision site to the IPG pocket incision
placing gentle traction on the nerve, the surrounding tis- site. Stay superficial to the pectoralis major and avoid
sue is teased away from the nerve to form a path for the involvement of breast tissue. Once the tip of the tunneling
placement of the simulator cuff. device has reached the destination incision, attach the
6. Nerve stimulator lead cuff is placed around the inclusion opposite end of the sensor lead into the collet of
branches of XII. The corner of the outer flap of the cuff is the tunneling device and lock into place by gently sliding
held with a right-angled dissector and positioned beneath the sleeve. Pull the tunneling device from the destination
the nerve. The outer flap is gently positioned past the incision site, which results in positioning of the opposite
nerve so the shorter, superior flap of the cuff wraps on to end of the sensor lead at the IPG site. Release the sensor
all isolated branches of the nerve. The right-angled lead from the tunneling device by sliding the sleeve.
dissector is then released, allowing both flaps to Secure the movable anchor to the fascia at the infero-
completely wrap around nerve XII. Ensure both flaps of the lateral incision site with four 2-0 silk sutures and provide
excess sensor lead length between the fixed and movable
anchors to accommodate for chest motion (Fig. 4).
Potential complications
nerve. Mixed activation of the HG and GG indicates that effectiveness of UAS compared with no treatment. UAS sub-
the final l-XII stantially reduced clinical events, such as 10-year reductions in
HG branch is in the cuff and must be excluded. cardiovascular events by 25% to 37%, and reduced motor
vehicle collisions projected over a patient’s lifetime and
6. Do not place pressure or bend the collet when passing the resulted in gain in total quality-adjusted life expectancy of
leads because this may lead to breakage of the collet. 1.7 years.21 Untreated obstructive sleep apnea (OSA) syndrome
can lead to increased cardiovascular disease, stroke, metabolic
disease, excessive daytime sleepiness, workplace errors,
Immediate postoperative care traffic accidents and death, which are associated with signifi-
cant economic burden.22 Although UAS is less cost effective
1. Obtain postoperative radiograph to document implant than PAP therapy in treating OSA, patients who remain un-
placement and rule-out pneumothorax (anterior-posterior treated after PAP therapy trial would lead to a significant
for all 3 implant sites and lateral for stimulator lead, which economic burden on society. As a result, the short-term costs
includes chin-to-cervical vertebrae) associated with UAS should be accepted, with the potential
2. Plan for same-day discharge or overnight observation per significant long-term savings with reduction in comorbidities,
surgeon discretion. traffic accidents, and loss of workdays.
3. Place arm in sling on the same side as IPG pocket to restrict A study out of Cleveland Clinic showed that although both
range of motion of arm and shoulder for days 1 to 2. traditional surgery and UAS are effective treatments for patients
4. Normal diet and light activities after day 1. with moderate to severe OSA with CPAP intolerance, UAS is
curative in normalizing the AHI to less than 5 in a majority of
Rehabilitation and recovery patients.23 For patients who underwent UAS, mean AHI
decreased significantly from 38.9 12.5 to 4.5 4.8, and all
1. One week posteimplant placement: patients achieved an AHI less than 20 postimplant, with 65% (13/
a. Surgical evaluation and suture removal. Pain and swelling 20) with an AHI less than or equal to 5. For patients who under-
should begin to resolve 7 days to 10 days postoperatively. went traditional airway surgery, mean AHI decreased from
b. Resume activities of daily living. 40.3 12.4 to 28.8 25.4. Additional studies are needed that
c. Avoid strenuous activities that require arm/shoulder compare the effectiveness of various sleep surgical procedures
motion and no shoulder abduction greater than 90 . with the UAS.
2. One month posteimplant placement: Patients with multilevel obstruction may be treated with
a. Resume vigorous activities with appropriate protections traditional Stanford protocol phase 1 consisting of nasal,
for IPG and leads. palatal, and tongue base surgery; MMA, or UAS. DISE is a
b. Activate device and teach patient how to use remote critical diagnostic tool in aiding surgeons in selection of the
and device at home. Patient uses therapy at home for a appropriate surgical intervention as the primary treatment.24
few months for acclimation and up-titration of simula- Each of these surgical techniques also may serve as and
tion level as tolerated. adjunctive therapy to further treat residual or relapse OSA.
3. Two to 3 months post implant placement: DISE evaluation of patients who have recently undergone MMA
a. Optimize nerve stimulator settings during PSG with and of patients presenting with long-term OSA relapse has
presence of sleep medicine and Inspire Medical Systems shown minimal velum and lateral pharyngeal wall collapse.25
technicians. As a result, based on the current inclusion criteria for UAS, it
4. Every 5 months to 12 months posteimplant placement: is highly likely that patients previously successfully treated
a. Routine checks of simulator and surgical sites. with MMA who later present with relapse would be good
candidates for hypoglossal stimulation.26
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