[Show abstract][Hide abstract] ABSTRACT: Objective. To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures. Study Design. A randomized controlled therapy withdrawal study. Setting. Industry-supported multicenter academic and clinical setting. Subjects. A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants. Methods. Participants were randomized to either therapy maintenance ("ON'') group or therapy withdrawal ("OFF'') group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed. Results. Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months. Conclusion. Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.
Otolaryngology Head and Neck Surgery 09/2014; 151(5). DOI:10.1177/0194599814544445 · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Upper-airway stimulation (UAS) using a unilateral implantable neurostimulator for the
hypoglossal nerve is an effective therapy for obstructive sleep apnoea patients with continuous positive
airway pressure intolerance. This study evaluated stimulation effects on retropalatal and retrolingual
dimensions during drug-induced sedation compared with wakefulness to assess mechanistic relationships in
response to UAS.
Patients with an implanted stimulator underwent nasal video endoscopy while awake and/or during
drug-induced sedation in the supine position. The cross-sectional area, anterior–posterior and lateral
dimensions of the retropalatal and retrolingual regions were measured during baseline and stimulation.
15 patients underwent endoscopy while awake and 12 underwent drug-induced sedation endoscopy.
Increased levels of stimulation were associated with increased area of both the retropalatal and retrolingual
regions. During wakefulness, a therapeutic level of stimulation increased the retropalatal area by 56.4%
(p50.002) and retrolingual area by 184.1% (p50.006). During stimulation, the retropalatal area enlarged in
the anterior–posterior dimension while retrolingual area enlarged in both anterior–posterior and lateral
dimensions. During drug-induced sedation endoscopy, the same stimulation increased the retropalatal
area by 180.0% (p50.002) and retrolingual area by 130.1% (p50.008). Therapy responders had larger
retropalatal enlargement with stimulation than nonresponders.
UAS increases both the retropalatal and retrolingual areas. This multilevel enlargement may explain
reductions of the apnoea–hypopnoea index in selected patients receiving this therapy.
European Respiratory Journal 09/2014; 45(1). DOI:10.1183/09031936.00059414 · 7.13 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background Although drug-induced sedation endoscopy
(DISE) represents the most widespread diagnostic tool for
upper airway endoscopic evaluation of snoring and obstructive
sleep apnea hypopnea syndrome (OSAHS), many controversies
exist about how to perform the sedation, the
indications for DISE, and how to report DISE findings. The
present position paper reports on a consensus as proposed by a
group of European experts in the field of DISE after discussion
during a recent dedicated meeting.
Methods The authors have evaluated all the available evidence
reported in the literature and have compared experience
among various departments in leading European centers in
order to provide a standardization of the DISE procedure and
an in-depth insight in the main aspects of this technique.
Results A proposal of the DISE procedure standardization has
been achieved with a general agreement concerning the terminology,
indications, contraindications, required preliminary
examinations, setting, technical equipment required, staffing,
local anesthesia and nasal decongestion, patient positioning,
basis and special diagnostic maneuvers, and the applied sedation
drugs and observation windows.Otherwise, no consensus
has been reached on a scoring and classification system.
Conclusions Although consensus has been reached on several
aspects of the DISE procedure, some topics remain open to
future research, such as a better analysis of the importance of
positional aspects during DISE and a further comparison of
the differences in degree, level and pattern of upper airway
collapse observed during DISE versus during natural sleep
and awake endoscopy. Finally, a universally accepted scoring
and classification system is lacking
Sleep And Breathing 05/2014; 18(3). DOI:10.1007/s11325-014-0989-6 · 2.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND
Obstructive sleep apnea is associated with considerable health risks. Although continuous
positive airway pressure (CPAP) can mitigate these risks, effectiveness can
be reduced by inadequate adherence to treatment. We evaluated the clinical safety
and effectiveness of upper-airway stimulation at 12 months for the treatment of
moderate-to-severe obstructive sleep apnea.
Using a multicenter, prospective, single-group, cohort design, we surgically implanted
an upper-airway stimulation device in patients with obstructive sleep apnea
who had difficulty either accepting or adhering to CPAP therapy. The primary
outcome measures were the apnea–hypopnea index (AHI; the number of apnea or
events per hour, with a score of ≥15 indicating moderate-to-severe apnea)
and the oxygen desaturation index (ODI; the number of times per hour of sleep that
the blood oxygen level drops by ≥4 percentage points from baseline). Secondary
outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes
of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen
saturation less than 90%. Consecutive participants with a response were included
in a randomized, controlled therapy-withdrawal trial.
The study included 126 participants; 83% were men. The mean age was 54.5 years,
and the mean body-mass index (the weight in kilograms divided by the square of
the height in meters) was 28.4. The median AHI score at 12 months decreased 68%,
from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased
70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome
measures showed a reduction in the effects of sleep apnea and improved quality of
life. In the randomized phase, the mean AHI score did not differ significantly from
the 12-month score in the nonrandomized phase among the 23 participants in the
therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score
was significantly higher (indicating more severe apnea) among the 23 participants
in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI
results followed a similar pattern. The rate of procedure-related serious adverse
events was less than 2%.
In this uncontrolled cohort study, upper-airway stimulation led to significant improvements
in objective and subjective measurements of the severity of obstructive
sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number,
New England Journal of Medicine 01/2014; 370(2):139-49. DOI:10.1056/NEJMoa1308659 · 54.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The treatment of diseases of the lingual tonsils is still under debate, and surgical interventions are often associated with significant morbidity and complications. The aim of the present study was to evaluate the safety of lingual tonsillectomy using cold ablation (coblation) as a new treatment of lingual tonsil diseases. In this retrospective, bicentric study, we included all patients between 2005 and 2012 who underwent cold ablation (Coblation(®)) of the lingual tonsils. We assessed the frequency of postoperative complications based on the patients' charts. A total of 108 patients (47 ± 13, 6 years) underwent lingual tonsillectomy using coblation. All patients were operated on under general anesthesia as inpatients. Intraoperative complications did not occur. Three patients (2.8 %) needed revision surgery due to postoperative hemorrhage, and in one of those cases, three revisions were necessary. There was no postoperative airway compromise and no need for tracheostomy. There was no hypoglossal nerve paralysis, but in the case needing multiple revisions, a weakness of the hypoglossal nerve persisted. In all the cases, oral intake was possible with adequate analgesia. Coblation of the tongue base is a safe procedure with a relatively low rate of postoperative complications. Postoperative hemorrhage is the most relevant complication that occurred in our series of patients. Future studies are needed to evaluate the efficacy of the procedure in the treatment of obstructive sleep apnea.
Archives of Oto-Rhino-Laryngology 01/2014; 271(6). DOI:10.1007/s00405-013-2845-x · 1.61 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: These guidelines aim to facilitate high quality medical care of adults with snoring problems. The guidelines were devised for application in both in- and outpatient environments and are directed primarily at all those concerned with the diagnosis and therapy of snoring. According to the AWMF three-level concept, these represent S2k guidelines.A satisfactory definition of snoring does not currently exist. Snoring is the result of vibration of soft tissue structures in narrow regions of the upper airway during breathing while asleep. Ultimately, these vibrations are caused by the sleep-associated decrease in muscle tone in the area of the upper airway dilator muscles. A multitude of risk factors for snoring have been described and its occurrence is multifactorial. Data relating to the frequency of snoring vary widely, depending on the way in which the data are collected. Snoring is usually observed in middle-aged individuals and affected males predominate. Clinical diagnosis of snoring should comprise a free evaluation of the patient's medical history. Where possible this should also involve their bed partner and the case history can be complimented by questionnaires. To determine the airflow relevant structures, a clinical examination of the nose should be performed. This examination may also include nasal endoscopy. Examination of the oropharynx is particularly important and should be performed. The larynx and the hypopharynx should be examined. The size of the tongue and the condition of the mucous membranes should be recorded as part of the oral cavity examination, as should the results of a dental assessment. Facial skeleton morphology should be assessed for orientation purposes. Technical examinations may be advisable in individual cases. In the instance of suspected sleep-related breathing disorders, relevant comorbidities or where treatment for snoring has been requested, an objective sleep medicine examination should be performed. Snoring is not-at least as we currently understand it-a disease associated with a medical threat; therefore there is currently no medical necessity to treat the condition. All overweight patients with snoring problems should strive to lose weight. If snoring is associated with the supine position, positional therapy can be considered. Some cases of snoring can be appropriately treated using an intraoral device. Selected minimally invasive surgical procedures on the soft palate can be recommended to treat snoring, provided that examinations have revealed a suitable anatomy. The choice of technique is determined primarily by the individual anatomy. At an appropriate interval after the commencement or completion a therapeutic measure, a follow-up examination should be conducted to assess the success of the therapy and to aid in the planning of any further treatments.
[Show abstract][Hide abstract] ABSTRACT: Objectives: Upper airway stimulation (UAS) is a potential therapy for continuous positive airway pressure (CPAP)-refractory obstructive sleep apnea by hypoglossal stimulation using an implantable, programmable neurostimulator. We tested the hypothesis whether changes in stimulation amplitude would modulate palatal and tongue-base airway size during wakefulness and sedation.
Otolaryngology Head and Neck Surgery 08/2013; 149(2 Suppl):P272-P273. DOI:10.1177/0194599813496044a394 · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objectives: Determine safety and effectiveness of upper airway stimulation for treatment of obstructive sleep apnea (OSA) in a prospective, multi-center trial; with subsequent randomized, controlled therapy withdrawal evaluation.
Otolaryngology Head and Neck Surgery 08/2013; 149(2 Suppl):P140-P140. DOI:10.1177/0194599813495815a315 · 1.72 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: patients undergoing UAS therapy, a large interindividual differ-ence in response to stimulation is obser ved. 13,14 A recent study by Van de Heyning et al. examined a set of factors predictive for therapy response to UAS. 13 Study Objectives: To study the possible predictive value of drug-induced sleep endoscopy (DISE) in assessing therapeu-tic response to implanted upper airway stimulation (UAS) for obstructive sleep apnea (OSA). Methods: During DISE, artifi cial sleep is induced by midazol-am and/or propofol, and the pharyngeal collapse patterns are visualized using a fl exible fi beroptic nasopharyngoscope. The level (palate, oropharynx, tongue base, hypopharynx/epiglot-tis), the direction (anteroposterior, concentric, lateral), and the degree of collapse (none, partial, or complete) were scored in a standard fashion. Results: We report on the correlation between DISE results and therapy response in 21 OSA patients (apnea-hypopnea index [AHI] 38.5 ± 11.8/h; body mass index [BMI] 28 ± 2 kg/m², age 55 ± 11 y, 20 male/1 female) who underwent DISE before implantation of a UAS system. Statistical analysis revealed a signifi cantly better outcome with UAS in patients (n = 16) without palatal complete concentric collapse (CCC), reducing AHI from 37.6 ± 11.4/h at baseline to 11.1 ± 12.0/h with UAS (p < 0.001). No statistical difference was noted in AHI or BMI at baseline between the patients with and without palatal CCC. In addition, no predictive value was found for the other DISE collapse patterns documented. Conclusions: The absence of palatal CCC during DISE may predict therapeutic success with implanted UAS therapy. DISE can be recommended as a patient selection tool for implanted UAS to treat OSA. de Vries N; Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med 2013;9(5):433-438. http://dx.doi.org/10.5664/jcsm.2658
Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 05/2013; 9(5):433-8. · 2.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To study the possible predictive value of drug-induced sleep endoscopy (DISE) in assessing therapeutic response to implanted upper airway stimulation (UAS) for obstructive sleep apnea (OSA).
During DISE, artificial sleep is induced by midazolam and/or propofol, and the pharyngeal collapse patterns are visualized using a flexible fiberoptic nasopharyngoscope. The level (palate, oropharynx, tongue base, hypopharynx/epiglottis), the direction (anteroposterior, concentric, lateral), and the degree of collapse (none, partial, or complete) were scored in a standard fashion.
We report on the correlation between DISE results and therapy response in 21 OSA patients (apnea-hypopnea index [AHI] 38.5 ± 11.8/h; body mass index [BMI] 28 ± 2 kg/m(2), age 55 ± 11 y, 20 male/1 female) who underwent DISE before implantation of a UAS system. Statistical analysis revealed a significantly better outcome with UAS in patients (n = 16) without palatal complete concentric collapse (CCC), reducing AHI from 37.6 ± 11.4/h at baseline to 11.1 ± 12.0/h with UAS (p < 0.001). No statistical difference was noted in AHI or BMI at baseline between the patients with and without palatal CCC. In addition, no predictive value was found for the other DISE collapse patterns documented.
The absence of palatal CCC during DISE may predict therapeutic success with implanted UAS therapy. DISE can be recommended as a patient selection tool for implanted UAS to treat OSA.
Vanderveken OM; Maurer JT; Hohenhorst W; Ha-mans E; Lin HS; Vroegop AV; Anders C; de Vries N; Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med 2013;9(5):433-438.
Journal of clinical sleep medicine: JCSM: official publication of the American Academy of Sleep Medicine 01/2013; 9(5):433-438. DOI:10.5664/jcsm.2658 · 2.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The low success rates for current surgical treatments for obstructive sleep apnea highlight the need for new methods for treating the disorder. This manuscript describes the novel Inspire upper airway stimulation method that through stimulation of the hypoglossal nerve leads to concomitant contraction of the innervated tongue protrusor musculature and increased airway patency. Three components, a stimulating electrode lead, an implantable pulse generator, and a respiration sensing lead, are surgically implanted at 3 separate sites. Detailed descriptions of the surgical method and accompanying illustrations clarify the procedure. Finally, the protocols for activating and titrating the system are detailed. Preliminary clinical investigations on carefully selected patients suggest that the Inspire Upper Airway Stimulation system is an efficacious therapy for treating obstructive sleep apnea.
Operative Techniques in Otolaryngology-Head and Neck Surgery 09/2012; 23(3):227–233. DOI:10.1016/j.otot.2012.07.002