European Archives of Oto-Rhino-Laryngology

https://doi.org/10.1007/s00405-020-06170-w

HEAD AND NECK

Safety and effectiveness in explantation and re‑implantation

of hypoglossal nerve stimulation devices
Philipp Arens1   · Thomas Penzel2 · Ingo Fietze2 · Alexander Blau2 · Bodo Weller2 · Heidi Olze1 · Steffen Dommerich1

Received: 10 April 2020 / Accepted: 23 June 2020

© Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract
Purpose  Since 2001, hypoglossal nerve stimulators have been implanted in patients with obstructive sleep apnea around
the world, initially in trial situations but more recently also in regular care settings. Medium term data indicate effectiveness
and tolerability of treatment. However, when assessing the safety of the procedure, the safe feasibility of explantation or
reimplantation must also be considered.
Patients and methods  Nine patients with an implanted respiratory-driven hypoglossal nerve stimulator. We have evaluated
the feasibility and safety of explantation or re-implantation with another stimulation system.
Results  In 2012, nine patients were implanted with a respiratory-driven hypoglossal nerve stimulator as part of the Apnex
Medical Pivotal Study. The study was ended in 2013. For a variety of reasons, the system was explanted from all nine patients
by the year 2019. Three of these patients were re-implanted with a different system with respiratory sensing during the same
session (mean incision to closure time for explantation 88.2 ± 35.01 min., mean incision to closure time for re-implantation
221.75 ± 52.73 min.). Due to extensive scar tissue formation, all procedures were technically challenging. Complication rate
was significantly higher when re-implantation was performed or attempted in the same surgical session (0 of 5 patients with
explantation versus 3 of 4 patients with attempted re-implantation; p = 0.018). There was no significant difference between
the AHI values before and after implantation in patients with re-implantation.
Conclusion  Explantation and re-implantation are technically challenging though possible procedures. The single-staged
equilateral reimplantation of another hypoglossal nerve stimulation system can, but need not, be successful.

Keywords  Hypoglossal nerve stimulation · Sleep apnea · Surgical treatment of obstructive sleep apnea · Neurostimulation

Introduction

Nocturnal electrical stimulation of the hypoglossal nerve

Part of the data has been presented at the 89th Annual General
Meeting of the German Society of Otorhinolaryngology, Head and
Neck Surgery as a lecture. Lübeck, Germany, 12.05.2018.
* Philipp Arens
philipp.arens@charite.de
1
Department of Otorhinolaryngology, Charité –
Universitätsmedizin Berlin, corporate member of Freie
Universität Berlin, Humboldt-Universität zu Berlin,
and Berlin Institute of Health, Charitéplatz 1, 10117 Berlin,
Germany
2
Department of Cardiology and Pulmonology, Center of Sleep
Medicine, Charité – Universitätsmedizin Berlin, corporate
member of Freie Universität Berlin, Humboldt-Universität
zu Berlin, and Berlin Institute of Health, Charitéplatz 1,
10117 Berlin, Germany
to treat obstructive sleep apnea in patients with CPAP non-
compliance is a relatively new treatment option.
It is important to note that various systems for hypoglos-
sal nerve stimulation are or have been available on the mar-
ket. One approach is continuous stimulation of the hypoglos-
sal nerve at the main trunk (ImThera Medical Inc/LivaNova
PLC). Nocturnal stimulation with this system tones the phar-
ynx at the base level of the tongue and results in slight pro-
trusion of the tongue. This method contrasts with nocturnal
stimulation of the hypoglossal nerve with respiratory sens-
ing. This approach involves stimulation of selective branches
of the hypoglossal nerve, inducing protrusion of the tongue
with consecutive openings of the upper respiratory tract. Ini-
tially, two such systems were available: Apnex Medical Inc.
and Inspire Medical Systems Inc. [1–3]. However, Apnex

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Medical discontinued operations in 2013. Recently there is
data available for a third therapy concept that stimulates the
hypoglossal nerve bilaterally via a small implanted electrode
activated by a unit worn externally (Nyxoah S.A.) [4].
Following initial trials and feasibility studies of the con-
cept of hypoglossal nerve stimulation over the previous two
decades [5–7], hypoglossal nerve stimulators have been
implanted worldwide in patients with obstructive sleep
apnea for the past 9 years. Initially in trial situations but
more recently also in regular care settings [8–15]. Medium-
term data indicate effectiveness and tolerability of the treat-
ment [16–19]. However, because of the short period of appli-
cation, longer-term data are lacking. The assessment of the
safety of the procedure also requires that the feasibility of
explantation or re-implantation be considered. A physician
needs to be aware of these options to be able to explicitly
explain the possible future events and incidents to a patient.
To answer this question, we examined a local cohort of
patients with a hypoglossal nerve stimulation system with
respiratory sensing with respect to the feasibility and safety
of explantation and re-implantation and the effectiveness of
re-implantation.
Patients and methods
The study consists of nine patients with an implanted hypo-
glossal nerve stimulator with respiratory sensing (Apnex
Medical HGNS System). The participation at the Apnex
Medical Pivotal Study was approved by the local ethics
committee. Retrospectively, we evaluated the following
variables: time with the implant, surgical explantation
time or re-implantation time, body mass index (BMI), the
apnea–hypopnea index (AHI) before and after implanta-
tion, complications and surgical and technical aspects of the
explantation or re-implantation with a different stimulation
system. The results were evaluated with IBM SPSS version
26 (Statistical Package for the Social Sciences). Nominal
variables were examined using the Chi square-test. Non-
parametric data were examined using the Wilcoxon test
for matched pairs with signs. The significance level was
p ≤ 0.05.
Results
In 2012 and 2013, nine patients in our clinic were implanted
with a respiratory-driven hypoglossal nerve stimulator as
part of the multicenter Apnex Medical Pivotal Study. All
surgeries were successful. From a sleep-medical perspec-
tive, all implantations yielded predominantly good results
(Table 1).
In 2013 Apnex had to cease all business operations. All
patients were given the option for immediate explantation
due to the lack of future support. All patients declined this
option because they experienced high personal satisfaction
with the treatment. In the years that followed, we cared for
these patients in our clinic with regular follow-up examina-
tions and re-titrations.
Ultimately, by 2019 all nine patients underwent complete
or partial explantation of the system. In some patients, we
performed a equilateral re-implantation of a different system
during the same surgical session; in this case, the system
with respiratory sensor made by Inspire Medical Systems
was used (Inspire II or IV System). This system was selected
because its operating principle is similar to the Apnex sys-
tem and hypoglossal stimulation had been proven effective
for the selected patients.
Technical aspects of explantation
Explantation was performed according to the explantation
specifications of the device and was adjusted according to
the intraoperative findings. The following components need

Table 1  Data for the implanted patients (SD standard deviation)

Pat. no. Pre-operative BMI Pre-operative AHI Mean postoperative Last AHI with work- Best postoperative AHI
AHI ± SD ing device

1 34.9 41.9 46.6 ± 15.5 54.8 33.8

2 30.5 45.1 42.9 ± 13.3 33.0 33
3 32.4 22.2 11.8 ± 6.3 19.4 4
4 27.8 59.1 15.2 ± 7.9 8.6 8.6
5 34.5 34 26.4 ± 7.8 36 16.8
6 29 17.3 8.2 ± 0.0 8.2 8.2
7 33.5 86.4 27.3 ± 3.0 24.3 24.3
8 31.6 20.7 9.2 ± 5.6 2.6 2.6
9 31.4 56.9 12.9 ± 0.0 12.9 12.9
Mean ± SD 31.73 ± 2.39 42.62 ± 22.39 22.3 ± 14.5 22.2 ± 16.71 16.02 ± 11.85

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European Archives of Oto-Rhino-Laryngology
to be removed during complete explantation of the system:
the stimulation lead including the cuff electrode on the hypo-
glossal nerve, the pulse generator, the sensor lead. Explanta-
tions were performed under general anesthesia. The patient
was aseptically cleaned and draped; a sharp incision was
then initiated along the previous submental access site. After
skin incision, a strict blunt-sharp dissection was performed,
taking care not to damage the lead material. In general, we
found the loop of the stimulation lead located a few mil-
limeters below the scar tissue, in front of the submandibular
gland. In all 9 patients, all foreign material was enclosed in
a transparent, solid scar tissue that was up to 1 mm thick. To
free the lead and dissect in the direction to the cuff electrode
without trauma, this scar tissue needed to be sharply severed.
For this procedure we used a fine blade from iris surgery (bvi
Beaver Optimum Knife, Straight 15°, Beaver-Visitec Inter-
national Inc.; see Fig. 1a). With the same scalpel, this tissue
also needed to be severed at the cuff around the hypoglossal
nerve. A surgical microscope was used to avoid damaging
the nerves. Once this scar tissue had been dissected, the cuff
could be freed from the nerve without injury and with only
minimal pulling.
Next, as described above, the former access site to the
chest pocket was opened. Again, all components were
enclosed in scar tissue (see Fig. 2a, b). Once the scar tis-
sue had been sufficiently and generously excised and the
pulse generator had been withdrawn, the sensor and stimula-
tion leads on the pulse generator could be identified. Next,
the cuff was cut off the stimulation electrode in the area
of the submental access site, allowing the stimulation lead
to be removed from the chest pocket of the patient. It is
Fig. 1  a Surgical microscope image of the incision into the fixed con-
nective scar tissue around the cuff electrode at the hypoglossal nerve
using an iris knife. b Location on the hypoglossal nerve during re-
implantation. The old cuff electrode from the Apnex system, which
important that any wire loops are always completely dis-
sected from the scar tissue, as the silicone sheath on the lead,
as well as the lead strands themselves, tend to tear easily
when pulled too hard and there is thus a risk that foreign
material remains in the patient. Use of a monopolar pulsed
radiofrequency blade (Peak Plasma Blade 3.0S, Medtronic
Advanced Energy LLC) significantly aided the speed and
reliability of explantation of the components in the chest
pocket and in the costal arch in Patient 3. The device has
previously been used in neurosurgery in explanting other
neuromodulators and allows incisions up to the leads with-
out destroying them [20]. In our case, the lead components
could be rapidly and reliably exposed. For safety reasons,
we did not use the device for excisions in the neck area near
the hypoglossal nerve.
Next, both access sites to the costal arch were opened as
described above. The sensor and lead were identified at both
sites and all parts wider than the actual lead were sharply
excised from the scar tissue. Any stay sutures that had not
been resorbed were also identified and detached. The lead
was then cut in the central portion between the two sensors.
The distal lead/sensor portion was removed via the lateral
access port. The proximal lead/sensor portion was then sepa-
rated and recovered again proximally from the lead to the
pulse generator. The lead remaining, connected to the pulse
generator, could then be removed completely from the chest
pocket together with pulse generator. This completed the
explantation. The explanted system was checked for com-
pleteness away from the surgical table. The surgical wounds
were closed in two layers (Vicryl, Ethilon). Drainage was not
necessary in any of the patients.
has been dissected from the nerve, can be seen. The electrode of
the new system (Inspire) is already wrapped around the hypoglossal
nerve
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Fig. 2  Explantation of the pulse generator at the chest. a, b The connective scar tissue that also firmly encases all components
Technique for explantation with simultaneous
re‑implantation (with a new, different stimulation
system with respiratory sensing)
In addition to the usual perioperative preparations, we
set up neuromonitoring of the hypoglossal nerve using
intraoral monitoring electrodes on the styloglossus and
genioglossus muscle. Explantation of all old system com-
ponents then followed as described above. The only dif-
ference was that when the old cuff was removed, the cuff
electrode of the new system was immediately wrapped
around the nerve at the same site (see Fig. 1b). Due to the
scarring and the restricted space conditions, we wanted
to avoid any unnecessary manipulations at the nerve that
was already at risk. Moreover, this site on the nerve had
already demonstrated suitability for a system with respira-
tory sensing and tongue protrusion. Once all old compo-
nents had been removed, a new subcutaneous tunnel to
the chest pocket was dissected for the new stimulation
lead, using a tunneling device (Inspire Tunneling Tool,
Inspire Medical Inc.); the lead was drawn through the tun-
nel towards the chest pocket using the tunneling device
or a hollow loop (Ethicon ETHILOOP EH389, 2.0 mm;
2 × 45 cm; Johnson & Johnson Medical GmbH). A new
access port was required only for the sensor of the Inspire
system, as that system, unlike the Apnex system, uses an
intercostal sensor between the fourth and fifth or fifth and
sixth rib between the external and internal intercostal mus-
culature. Re-implantation thus involved a new scar on the
chest wall. System functionality was tested according to
the manufacturer’s instructions. We also visually checked
for tongue protrusion upon stimulation. After the system
was deactivated using the programmer, all wounds were
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European Archives of Oto-Rhino-Laryngology
closed with a double layer (Vicryl, Ethilon). Drainages
were not required.
All explantations were successful (see Table  2). The
system was completely explanted in eight patients. In one
patient, only the pulse generator could be explanted from
the chest pocket under local anesthesia as the patient had
a new concomitant condition (relapsed coronary heart dis-
ease requiring intervention, heart failure) which meant he
had a high anesthetic risk. This explantation was able to
proceed as planned. We used a standard cardiac and neu-
rosurgery torque-limiting screwdriver (InterStim torque
wrench, Medtronic plc) to loosen the screws on the lead
conduits. During complete explantation in Patient 5, the sen-
sory lead was torn near the chest pocket. As recommended
for implantations, the lead was looped behind or beneath
the pulse generator. Despite care in pulling the lead during
explantation, the rigid scar tissue around the lead resulted in
self-strangulation and subsequent breakage of the lead. This
break was noticed immediately. All parts of the lead could be
removed. The explanted lead was checked for entirety again
prior to closure of the surgical wound. An X-ray following
surgery confirmed there was no residual material.
Re-implantations were difficult due to the fact that addi-
tional manipulation was required to place the new stimula-
tion electrode. Once the old simulation electrode had been
removed, the scarred hypoglossal nerve still required dis-
secting several more millimeters since the cuff of the Inspire
system is a few millimeters wider. This placed additional
stress on the nerve. Because there was considerable scar-
ring around the nerve, re-implantation was discontinued
in Patient 3 and the Apnex system was explanted only. In
neurophysiological monitoring, a reliable signal could not
be derived from the nerve impacted by the scarring at this
European Archives of Oto-Rhino-Laryngology
Table 2  Data for patients undergoing explantation (SD standard deviation)
Pat. no. Implanted time in months Reason for explantation
1 79.17 Device/battery defect
2 77 Device/battery defect, pectoral
distortion with shifting and scarring
around the pulse generator
5 58.53 Device/battery defect
8 42.67 Need for MRI examinations due to
paresis of the diaphragm associated
with suspected focal demyelinating
polyneuropathy
9 41.3 Dissatisfaction (hindrance during
athletic activities, altered sensations
in the chest when lying on the right
side)
Mean ± SD 59.73 ± 18.09
patient. However, the patient experienced no hypoglossal
paresis following surgery. In Patient 4, a revision of the cuff
electrode was performed due to suspected dislocation of the
electrode after 20,4 months following re-implantation. After
this second revision we measured an AHI of 9.6/h at the
latest sleep study.
At the Re-Implantation group there were significantly
more complications than at the explantation group (0 of 5
patients with explantation versus 3 of 4 patients with re-
implantation; p = 0.018). Success of the re-implantations
was quite variable (see Table 3). A comparison of the mean
AHI of the three patients under therapy with the Apnex
device with the mean AHI values after reimplantation
with the Inspire device showed no significant difference
(p = 0.109). Also in these patients a comparison between a
sleep study without therapy before re-implantation and the
most recent value after Ra-implantation showed no signifi-
cant difference in AHI values (p = 1.000).
Discussion
The cohort present here is unique. The Apnex HGNS sys-
tem is no longer on the market. Most of the data present
here were collected following termination of the multicenter
study during simple clinical follow-up outside of the trial
setting. Overall, the patients were very satisfied with treat-
ment. Only Patient number 9 complained in the end of an
impairment due to the implant. The post-surgery AHI values
presented in Table 1 corroborate the predominantly positive
results. It should be noted, that in addition to the average and
the last AHI value, we also list the best achieved AHI value.
This has the goal to give a better overview of the course
Surgery time (incision Notes/perioperative complications
to closure time in min)
101 No complications. CPAP follow-up
recommended
47 Partial explantation under local
anesthesia; pulse generator only.
No complications. CPAP follow-
up recommended
140 No complications. Continued CPAP
83 Continued BIPAP. No complications
70 No complications
CPAP follow-up recommended
88.2 ± 35.01
of the therapy and the variability of the measured values
under the therapy. This approach was also based on the fact
that after completion of the multicenter study, the patients
were measured at irregular and inconsistent intervals. Thus
there is only limited comparability with results previously
published for other cohorts using the Apnex HGNS system
[12]. Finally, patient treatment compliance could no longer
be recorded on a defective device. Nevertheless, to provide
a rough idea of the use of the device, we calculated the abso-
lute time with the implant for each patient (see Tables 2, 3).
To date, there have been no scientific reports published
that describe experiences with explantations after this length
of time following implantation of a hypoglossal nerve stimu-
lation system. Explantations proved to be certainly possible
but also challenging due to scarring. It is imperative to detect
all loops of the leads before pulling them out to avoid break-
ing them. In our view, EMG monitoring is not necessary for
explantations, since the nerve is reliably indicated by the
cuff. It appears useful for re-implantations, as the nerve may
need to be freed of scar tissue.
Re-implantation to a different hypoglossal nerve stimula-
tion system has the potential to be but is not always success-
ful. The reasons remain unclear. Due to the small size of
the cohort and the variability of the AHI values within the
groups, the power of the statistical analysis of complications
and effectiveness is clearly limited.
One explanation is the significant scarring that forms
around the nervus hypoglossus; in addition, the Inspire
system demands greater precision in placement of the cuff
electrode on the nerve. However, this requirement is cer-
tainly also the reason for the relatively greater success rates
in the standard of care now seen with this system [8]. In any
discussion of treatment with a hypoglossal nerve stimulator,
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 European Archives of Oto-Rhino-Laryngology

Table 3  Data for patients undergoing explantation with single-staged equilateral re-implantation (SD standard deviation)

Pat. no. Implanted Reason for re- Surgery time AHI without Mean post- Latest AHI Best postop- Complications
time in implantation (incision to stimulation operative with working erative AHI
months closure time in before Re- AHI ± SD device
min) implantation

3 82 Device/battery 147 40.4 – – – Explantation

defect only and dis-
continuation
of the new
implantation
in during the
same surgical
session
4 60.3 Device/battery 244 18.9 17.7 ± 11.5 9.6 9.6 Temporary
defect incomplete
hypoglossal
paresis
Cuff dislocation
with revision
20.4 month
later
6 49.7 Device/battery 269 30.3 8.5 ± 6.9 16.4 4.5 Temporary
defect incomplete
hypoglos-
sal paresis,
development
of seromas
(multiple
punctures
required)
7 62.13 Device/battery 227 21.3 36.5 ± 0.0 36.5 36.5 No complica-
defect tions
Mean ± SD 63.53 ± 13.48 221.75 ± 52.73 27.73 ± 9.77 20.89 ± 14.29 20.83 ± 13.99 16.87 ± 17.19

we recommend that a patient is informed of the potential
for a future explantation, for whatever reason. In particular,
consideration of the pros and cons of implantation should
include a potential deterioration of health. Our case for
Patient no. 2 demonstrated that certain conditions can make
explantation impossible or difficult.
Because scar tissue forms around the hypoglossal nerve,
we advise against a second surgery on the same side after
an interval following explantation of a system. Based on our
experiences, overall it is better to opt for placement of a new
system on the opposite side.
Conclusion
explantation or single-stage explantation with reimplan-
tation appear to be transferable to current or future sys-
tems with a with similar design and working principle.
Due to the lack of other published data on this topic,
the data shown here, and especially the results regarding
complications, may be helpful in strategic decisions on
the further treatment of patients with defective devices.
Author contributions  All authors contributed to the study conception
and design. Material preparation, data collection and analysis were
performed by PA, SD, IF, AB and BW. Supervision was done by TP.
The first draft of the manuscript was written by PA. Reviewing and
editing of the manuscript was done by SD, TP and HO. All authors
read and approved the final manuscript.

Funding  Apnex Medical Pivotal Study was financed by Apnex Medical

Explantation and re-implantation are technically chal-
lenging though possible procedures. Re-implantation
of a different hypoglossal nerve stimulation system has
the potential to be but is not always successful. Even if
the system reported here is no longer on the market, the
experiences and findings on the feasibility and safety of
Inc. Aftercare and evaluation of patient data in clinical follow-up—as
presented here—was not financed.
Availability of data and material (data transparency)  All data and mate-
rials support the published claims and comply with field standards.

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European Archives of Oto-Rhino-Laryngology
Compliance with ethical standards  Registry. Otolaryngol Neck Surg 159:379–385. https​: //doi.
Conflict of interest  Philipp Arens P, Thomas Penzel, Ingo Fietze, Al-
exander Blau, Heidi Olze and Steffen Dommerich received financial
support from ImThera Inc. and Apnex Medical Inc. within the frame-
work of research projects related to hypoglossal nerve stimulation
therapy. Philipp Arens received a speaker’s fee for an invited talk on
behalf of Inspire Medical Inc.
Ethical approval  Procedures performed within the Apnex Pivotal Study
were in accordance with the ethical standards of the national research
committee (LAGeSo Berlin, 11/0326-ZS EK 11) and with the 1964
Helsinki declaration and its later amendments or comparable ethical
standards.
Consent to participate  Informed consent was obtained from all indi-
vidual participants included in the study.
Consent for publication  Informed consent was obtained from all indi-
vidual participants included in the study.
Code availability (software application or custom code)  Not applicable.
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