Original Research Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study Otolaryngology– Head and Neck Surgery 1–7 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599816683378 http://otojournal.org Clemens Heiser, MD 1 , Joachim T. Maurer, MD 2 , Benedikt Hofauer, MD 1 , J. Ulrich Sommer, MD 2 , Annemarie Seitz, MD 3 , and Armin Steffen, MD 3 Sponsorships or competing interests that may be relevant to content are dis- closed at the end of this article. Abstract Objective. Selective stimulation of the hypoglossal nerve is a new surgical therapy for obstructive sleep apnea, with proven efficacy in well-designed clinical trials. The aim of the study is to obtain additional safety and efficacy data on the use of selective upper airway stimulation during daily clinical routine. Study Design. Prospective single-arm study. Setting. Three tertiary hospitals in Germany (Munich, Mannheim, Lu ¨beck). Subjects and Methods. A multicenter prospective single-arm study under a common implant and follow-up protocol took place in 3 German centers (Mannheim, Munich, Lu ¨beck). Every patient who received an implant of selective upper airway sti- mulation was included in this trial (apnea-hypopnea index 15/ h and 65/h and body mass index \35 kg/m 2 ). Before and 6 months after surgery, a 2-night home sleep test was per- formed. Data regarding the safety and efficacy were collected. Results. From July 2014 through October 2015, 60 patients were included. Every subject reported improvement in sleep and daytime symptoms. The average usage time of the system was 42.9 6 11.9 h/wk. The median apnea-hypopnea index was significantly reduced at 6 months from 28.6/h to 8.3/h. No patient required surgical revision of the implanted system. Conclusion. Selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment. Keywords obstructive sleep apnea, surgical treatment, hypoglossal nerve, selective upper airway stimulation, German postmar- ket study Received June 30, 2016; revised September 23, 2016; accepted November 18, 2016. O bstructive sleep apnea (OSA) has an increased preva- lence over the prior decades, present in 6% of women and 13% of men in the United States. 1 Continuous posi- tive airway pressure (CPAP) is the gold standard therapy; how- ever, it is limited by adherence and acceptance issues. Alternative treatment options have been developed, including upper airway stimulation (UAS) per the unilateral respiration-synchronized sti- mulation of the hypoglossal nerve. 2,3 This approach to electrical stimulation based on implanted neuromodulation technology was demonstrated to be a safe and effective treatment for OSA in a recent large clinical trial. 3 For selected patients with moderate to severe OSA who were CPAP intolerant, the UAS system reduced OSA severity both objectively, as measured by apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), and subjec- tively, through improved quality-of-life measures—namely, the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ)—all evaluated at 12 months postim- plantation. 3 Randomized withdrawal of therapy for 1 week at 13 months resulted in return of AHI, ODI, ESS, and FOSQ to base- line levels, and reactivation reestablished therapeutic efficacy as measured at 18 months. 4 More recently, long-term follow-up of the study cohort reported sustained treatment effects and therapy adherence after 24 and 36 months of implantation. 5,6 In addition, 2 single-center studies in a clinical practice setting demonstrated that UAS was associated with high adherence, low morbidity, and significantly decreased AHI. 7,8 Previous studies have identified specific selection criteria for patients who are likely to respond to UAS. 9-13 Individuals with body mass index \32 or \ 35 kg/m 2 had a lower AHI at 6 1 Department of Otorhinolaryngology–Head and Neck Surgery, Klinikum rechts der Isar, Technische Universita ¨t Mu ¨nchen, Munich, Germany 2 Department of Otorhinolaryngology–Head and Neck Surgery, University- Hospital Mannheim, Mannheim, Germany 3 Department of Otorhinolaryngology, University of Lu ¨beck, Lu ¨beck, Germany This article was presented at the 2016 AAO-HNSF Annual Meeting & OTO EXPO; September 18-21, 2016; San Diego, California. Corresponding Author: Clemens Heiser, MD, Department of Otorhinolaryngology–Head and Neck Surgery, Klinikum rechts der Isar, Technische Universita ¨t Mu ¨nchen, Ismaninger Str 22, 81675 Munich, Germany. Email: [email protected]
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Original Research
Outcomes of Upper Airway Stimulationfor Obstructive Sleep Apnea in aMulticenter German Postmarket Study
Otolaryngology–Head and Neck Surgery1–7
� American Academy ofOtolaryngology—Head and NeckSurgery Foundation 2016Reprints and permission:sagepub.com/journalsPermissions.navDOI: 10.1177/0194599816683378http://otojournal.org
Clemens Heiser, MD1, Joachim T. Maurer, MD2,Benedikt Hofauer, MD1, J. Ulrich Sommer, MD2,Annemarie Seitz, MD3, and Armin Steffen, MD3
Sponsorships or competing interests that may be relevant to content are dis-
closed at the end of this article.
Abstract
Objective. Selective stimulation of the hypoglossal nerve is anew surgical therapy for obstructive sleep apnea, withproven efficacy in well-designed clinical trials. The aim of thestudy is to obtain additional safety and efficacy data on theuse of selective upper airway stimulation during daily clinicalroutine.
Study Design. Prospective single-arm study.
Setting. Three tertiary hospitals in Germany (Munich,Mannheim, Lubeck).
Subjects and Methods. A multicenter prospective single-armstudy under a common implant and follow-up protocol tookplace in 3 German centers (Mannheim, Munich, Lubeck). Everypatient who received an implant of selective upper airway sti-mulation was included in this trial (apnea-hypopnea index �15/h and �65/h and body mass index \35 kg/m2). Before and 6months after surgery, a 2-night home sleep test was per-formed. Data regarding the safety and efficacy were collected.
Results. From July 2014 through October 2015, 60 patientswere included. Every subject reported improvement in sleepand daytime symptoms. The average usage time of the systemwas 42.9 6 11.9 h/wk. The median apnea-hypopnea index wassignificantly reduced at 6 months from 28.6/h to 8.3/h. Nopatient required surgical revision of the implanted system.
Conclusion. Selective upper airway stimulation is a safe andeffective therapy for patients with obstructive sleep apneaand represents a powerful option for its surgical treatment.
Keywords
obstructive sleep apnea, surgical treatment, hypoglossalnerve, selective upper airway stimulation, German postmar-ket study
Received June 30, 2016; revised September 23, 2016; accepted
November 18, 2016.
Obstructive sleep apnea (OSA) has an increased preva-
lence over the prior decades, present in 6% of women
and 13% of men in the United States.1 Continuous posi-
tive airway pressure (CPAP) is the gold standard therapy; how-
ever, it is limited by adherence and acceptance issues. Alternative
treatment options have been developed, including upper airway
stimulation (UAS) per the unilateral respiration-synchronized sti-
mulation of the hypoglossal nerve.2,3 This approach to electrical
stimulation based on implanted neuromodulation technology was
demonstrated to be a safe and effective treatment for OSA in a
recent large clinical trial.3 For selected patients with moderate to
severe OSA who were CPAP intolerant, the UAS system reduced
OSA severity both objectively, as measured by apnea-hypopnea
index (AHI) and oxygen desaturation index (ODI), and subjec-
tively, through improved quality-of-life measures—namely, the
Epworth Sleepiness Scale (ESS) and the Functional Outcomes of
Sleep Questionnaire (FOSQ)—all evaluated at 12 months postim-
plantation.3 Randomized withdrawal of therapy for 1 week at 13
months resulted in return of AHI, ODI, ESS, and FOSQ to base-
line levels, and reactivation reestablished therapeutic efficacy as
measured at 18 months.4 More recently, long-term follow-up of
the study cohort reported sustained treatment effects and therapy
adherence after 24 and 36 months of implantation.5,6 In addition,
2 single-center studies in a clinical practice setting demonstrated
that UAS was associated with high adherence, low morbidity,
and significantly decreased AHI.7,8
Previous studies have identified specific selection criteria for
patients who are likely to respond to UAS.9-13 Individuals with
body mass index \32 or \35 kg/m2 had a lower AHI at 6
1Department of Otorhinolaryngology–Head and Neck Surgery, Klinikum
rechts der Isar, Technische Universitat Munchen, Munich, Germany2Department of Otorhinolaryngology–Head and Neck Surgery, University-
Hospital Mannheim, Mannheim, Germany3Department of Otorhinolaryngology, University of Lubeck, Lubeck,
Germany
This article was presented at the 2016 AAO-HNSF Annual Meeting & OTO
EXPO; September 18-21, 2016; San Diego, California.
Corresponding Author:
Clemens Heiser, MD, Department of Otorhinolaryngology–Head and Neck
Surgery, Klinikum rechts der Isar, Technische Universitat Munchen,
Figure 3. Primary outcomes of the clinical trial in terms of apnea-hypopnea index (AHI), oxygen desaturation index (ODI),Functional Outcomes of Sleep Questionnaire (FOSQ), andEpworth Sleepiness Scale (ESS) between baseline and 6-monthvisit. All results were statistically significant (P \.05 vs baseline).
Heiser et al 5
OSA, who would probably not opt for this treatment, given
the moderately invasive surgical procedure and permanent
in-dwelling electrotherapeutic device system. Our data sup-
port the already-published UAS study results showing that
patients nonadherent to CPAP can be adherent to UAS if
properly selected.
Of further interest as it pertains to hypothesis generation,
a recent systematic review found that a 1-hour-per-night
increase in CPAP use was associated with an additional
reduction of systolic blood pressure of 1.5 mm Hg.25 The
improved UAS therapy use may have clinical implications
for reducing cardiovascular risks associated with untreated
OSA. This area, of course, needs to be studied through fur-
ther clinical trials.
In comparing the surgical treatment of UAS and its
safety profile with other OSA operations, the procedure
seems to be safe and without long-lasting side effects for
typical patients. Two cases (3%) were reported with bleed-
ing during tunneling, both of which were resolved without
any sequelae. Another instance occurred during previous
phases of UAS study and was similarly resolved. Numbness
of tongue and dysarthria for a few days after surgery were
reported in 2 other cases. As compared with similar types of
nerve dissection/surgery, the incidence numbers are accepta-
bly low. In parotid surgery, the temporary facial palsy rate
is around 40.2% on the first postoperative day and 1.6% at
12 months.26 If the subjective dysarthria is a result of a
palsy of the hypoglossal nerve, then the equivalent risk is
\2% for the first postoperative days and 0% for the long
term, representing a suitably low morbidity for essential
hypoglossal nerve functioning in the postsurgical and
chronic settings. The small numbers of reported numbness
of the tongue cannot readily be explained by the UAS sur-
gery, due to its widely accepted functions for efferent-only
motor innervation; yet, perhaps the lingual nerve may occa-
sionally be encountered (eg, ptotic sublingual gland and
accompanying nerve) and traumatized through retraction or
other elements of accessing, visualizing, and placing the sti-
mulation cuff around the hypoglossal nerve.
Furthermore, this clinical trial shows that even the self-
reported outcomes of the patients significantly improved (as
measured by the ESS and FOSQ). Polysomnography mea-
sures alone do not capture important aspects of OSA. The
quality of life depending on daytime sleepiness could be
enhanced. This effect has clinical and economic relevance.
Overall, surgical treatment with a fully implanted electro-
therapeutic device system for selective UAS appears to be a
safe procedure in the clinical setting. Additionally, in the
event that the therapy is ultimately unsuitable for a particular
patient, there is no overt anatomy-altering element to this
procedure, and it is essentially reversible for such patients
who may choose to have an underperforming system com-
pletely explanted (ie, reversible vs a failed UPPP).
Conclusion
Selective UAS reduced OSA severity and improved patient-