Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

BACKGROUND AND AIM: Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system. METHODS: This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604. RESULTS: 22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m-2) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h-1, a mean change of 10.8 events·h-1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h-1, a mean change of 9.3 events·h-1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period. CONCLUSIONS: Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

[Surgical treatment for obstructive sleep disordered breathing]. / Traitement chirurgical des troubles respiratoires obstructifs du sommeil de l'adulte.

The obstructive sleep apnea syndrome is a chronic condition characterized by repeated nocturnal pharyngeal collapse leading to poor-quality sleep and an increased risk of cardiovascular episodes. The classic management by continuous positive-pressure ventilation has its limitations and is not always well tolerated. The treatment alternative comprising an orthotic device is effective in 2/3 of cases, despite the dental limitations and risks inherent in long-term usage. Through a review of the literature, this paper describes the different surgical solutions used to correct obstructive sleep apnea syndrome in adults. The proposed corrections aim to maintain pharyngeal permeability during sleep either by reducing soft tissue volume or by enlarging the facial skeleton or, more recently, by acting on the tone of the pharyngeal dilator muscles. Among these different approaches, the highest success rate was reported for the maxillomandibular advancement procedure. This technique demands rigorous patient selection combined with an appropriate orthodontic work-up and management. Patient selection and the respective benefits and drawbacks of the different approaches are discussed. Indications are reported in the framework of current guidelines.

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea.

OBJECTIVES: This report describes the surgical implantation of a novel bilateral hypoglossal nerve stimulator (Genio system®, Nyxoah S.A., Belgium) and the successful treatment of a patient with moderate obstructive sleep apnea (OSA). STUDY DESIGN: Surgical technique description and case study report. METHODS: The bilateral implantable stimulator (IS) simultaneously stimulates both genioglossus (GG) muscles to reduce airway obstruction. At night, patients wear an activation chip under their chin that wirelessly transmits energy to the implant and enables the nerve stimulation. Surgical implantation of the IS is performed under general anesthesia by making a small incision above the hyoid bone and dissecting through the platysma, mylohyoid, and geniohyoid muscles to the GG muscle. The hypoglossal nerve branches are then identified, followed by suturing the IS in place. The system was evaluated in an otherwise healthy, 60-year-old woman with moderate OSA (apnea hypopnea index (AHI): 25/hr, nadir O2 saturation: 78%). Appropriate stimulation settings were determined at 2-, 3-, and 6-months post implantation during polysomnography (PSG) and changes in apnea and hypopnea events and oxygen desaturation recorded. RESULTS: The surgery was well tolerated by the patient with an uneventful recovery. The PSG at 6 months showed that AHI per hour, obstructive apnea events per hour, hypopnea events per hour, and oxygen desaturation index have been reduced by 88%, 92%, 88%, and 97%, respectively, and nadir O2 saturation improved to 91%. CONCLUSIONS: The absence of complications and considerable reduction of apnea and hypopnea events in this case study help demonstrate the potential safety and efficacy of the bilateral hypoglossal nerve stimulator. LEVEL OF EVIDENCE: 4.

Changes in facial profile after maxillomandibular advancement surgery for obstructive sleep apnea syndrome.

UNLABELLED: The aim of this study was to assess changes in the profile of adult male patients treated for obstructive sleep apnea syndrome (OSAS) with maxillomandibular advancement (MMA) surgery and to measure patient perception of changes compared with that of different panels. MATERIALS AND METHODS: Fifteen consecutive apneic patients displaying a wide variety of morphological types, mean age 42 years (20-59), a BMI of 26.60 kg/m(2) (22-29), a mean initial Apnea Hypopnea Index (AHI) of 50.9 (19-85), underwent MMA. Assessment was done by facial photography, lateral cephalographs (Tweed analysis modified by Riley and Delaire architectural analysis), polysomnographic records and a validated self-assessment questionnaire. Patients' pre- and postoperative profiles were taken from photographs using Photoshop 7™ software. Their darkened outlines were shown randomly in positions A or B (pre- and postoperative) to panels composed of orthodontists (n=40), fine arts students (n=50) and lay persons (n=50) who were requested to choose the most attractive profiles. RESULTS: The MMA success rate for OSAS was 80% (12/15) for an AHI less than 15, with no surgical complications. All patients reported a reduction of their symptoms and 14 out of 15 were satisfied with the esthetic outcome. Mean advancement was 8.4mm (3.0-10.0) for the maxilla and 10.8mm (10.0-13.0) for the mandible. Following MMA, 12 out of 15 exhibited maxillary protrusion and six out of 15 mandibular protrusion. The mean change in the nasolabial angle was -5.7° (-27°; 14°). The postoperative profiles were preferred by 85% of the combined panels (P=<0.001), showing no significant difference from one panel to another. No skeletal characteristic could be correlated with the esthetic preference. Upper lip retrusion, open nasolabial angle and dolichofacial type emerged as positive preoperative predictors of esthetic preference. CONCLUSION: The profile changes following MMA were favorably perceived in the majority of cases. However, specific orthodontic preparation could be offered to patients with pronounced preoperative protrusion.

Treatment of the obstructive sleep apnea syndrome in adults by mandibular advancement device: the state of the art.

The obstructive sleep apnea syndrome (OSAS) constitutes a non-negligible risk which requires management by specialists of the upper airways. When OSAS is diagnosed, it needs to be treated and different resources are listed. Different forms of treatment can be envisaged: positive pressure ventilation (VCPP), mandibular advancement devices (MAD), and surgery (soft and hard tissues). The authors focus especially the treatments for MAD, outlining their positive and negative impact on ventilation, TMJ, the bony base and interarch relationships.

Effects of mandibular advancement on upper airway dynamics in awake normal subjects: a pilot study with phrenic nerve stimulation.

BACKGROUND: Mandibular advancement (MA) can be an alternative to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea syndrome. This study was designed to describe its effects on upper airway mechanics. METHODS: Six awake healthy subjects (four men, 31+/-8 years, body mass index (BMI) 25+/-2kg/m2) were studied supine. Phrenic stimulation was used to measure pressure-flow relationships in response to diaphragm contractions without pre-activation of upper airway dilators during progressive MA. RESULTS: Phrenic stimulation consistently induced flow limitation (initial peak V'-t1, corresponding to the limiting pressure; reduction to a nadir V'-t2; reincrease to a second peak V'-t3). The upper airway resistances were negatively correlated with MA. Their values at 4mm were significantly lower than at baseline. Further MA reduced resistances. CONCLUSIONS: As with CPAP, MA in normal subjects decreases the propensity of the upper airway to collapse in response to a negative pressure pulse.

Mandibular advancement titration for obstructive sleep apnea: optimization of the procedure by combining clinical and oximetric parameters.

BACKGROUND: Oral appliances (OAs) have been used for the treatment of obstructive sleep apnea syndrome (OSAS), with different degrees of effectiveness having been shown in previous studies. But, in the absence of a consensual recommendation, the method of the determination of effective mandibular advancement varies from one study to another. STUDY OBJECTIVE: We prospectively evaluated an OA titration protocol based on a combined analysis of symptomatic benefit and oximetric recording to guide the progressive mandibular advancement. SETTING: University hospital sleep disorders center. PATIENTS: Forty patients with OSAS (mean [+/-SD] apnea-hypopnea index [AHI], 46 +/- 21 events per hour) found on baseline polysomnography, who were intolerant of nasal continuous positive airway pressure, completed all aspects of the study. METHODS: Two acrylic appliances connected by Herbst attachments were constructed. The mandible was advanced 1 mm every week until there was a resolution of the symptoms and a reduction in the oxygen desaturation index (ie, the number of desaturations yielding a > 3% fall in pulse oximetric saturation per hour of recording) [ODI] of <10 events per hour of recording or a maximum comfortable limit of advancement was obtained. The final response to OA was evaluated by full polysomnography recording. RESULTS: A complete response (ie, mean AHI, 5 +/- 3 events per hour; mean snoring reduction [SR], 91 +/- 13%; mean Epworth sleepiness scale [ESS] score, 5 +/- 3) was obtained in 63.6% of patients, and a limited response (ie, mean AHI, 21 +/- 11 events per hour; mean SR, 88 +/- 15%; mean ESS, 6 +/- 3) was obtained in 18.2% of patients. Twenty-five percent of mandibular advancements were motivated by an abnormal ODI (ie, 21 +/- 10 events per hour) despite resolution of the symptoms, while 20% were motivated by persistent symptoms with a normal ODI (ie, 6 +/- 2 events per hour). After a mean duration of 17 +/- 4 months, 34 patients declared that they had used the OA 5 +/- 2 days a week for 89 +/- 19% of their sleep time. CONCLUSIONS: A combination of the patient's subjective evaluation and oximetric score improves the effectiveness of the OA titration procedure.

Radiofrequency soft palate procedure in snoring: influence of energy delivered.

OBJECTIVE: We conducted a retrospective study to evaluate the influence of amount of energy delivered during radiofrequency procedure for soft palate reduction in snoring, to improve the cure rate. METHODS: Consecutive patients with chronic disruptive snoring presenting to our department were successively treated in an outpatient procedure. A visual analog scale was used to assess the severity of snoring by the bed partner and the pain by the patient, before treatment and after each treatment session. The soft palate was divided into 3 treatment sites: middle, lateral right, and lateral left. Any mucosal injury of the soft palate was classified as a complication. RESULTS: Forty-3 patients were classified into 2 groups according to energy assignment. The total amount of energy delivered was 1250 J in group 1 (n = 15) and 1500 J in group 2 (n = 28). Energy was predominantly distributed in the middle of the soft palate in group 1 (550 J) and group 2 (800 J). After each treatment session, the 1500-J delivery of radiofrequency energy (total per session) led to a better snoring grading reduction in comparison with the 1250-J delivery with a significant difference after 2 treatment sessions (P < 0.05). The mean pain score and the incidence rate of complications per treatment were not statistically different in comparing both groups. CONCLUSION: Better snoring scores can be expected by increasing radiofrequency energy applied to the soft palate. Further randomized long-term investigations are required to confirm that the cure rate can be improved when increasing energy with a suitable distribution and good clinical tolerance.

Clinical impact of somatostatin receptor scintigraphy in the management of paragangliomas of the head and neck.

UNLABELLED: Paragangliomas are neuroendocrine tumors expressing somatostatinergic receptors and, thus, may be imaged by somatostatin receptor scintigraphy (SRS). The purpose of the study was to assess the contribution of SRS in the management of paraganglioma of the head and neck. METHODS: (111)In-Pentetreotide (148 MBq) was intravenously administered to 3 groups of patients. Group A consisted of 9 patients with tumors of the head and neck that did not exhibit typical radiologic features of paragangliomas and required further diagnostic evaluation. Group B consisted of 28 patients with known paragangliomas or paraganglioma metastatic lymph node who required staging and assessment of multicentricity. Group C consisted of 5 asymptomatic relatives of affected individuals who required screening. All patients underwent clinical, laboratory, radiologic, and audiovestibular evaluation. RESULTS: In group A (n = 9), SRS was positive in 6 cases, 4 paragangliomas and 2 meningiomas, and negative in 3 patients in whom the initial diagnosis of paraganglioma was excluded. In group B (n = 28), SRS was strongly positive in all of the 34 head and neck masses diagnosed on conventional imaging to be paragangliomas; it localized 1 primary malignant paraganglioma and revealed 9 unexpected foci. In group C (n = 5), SRS was positive in 3 of the 5 relatives, CT or MR scan confirming the diagnosis of paraganglioma in all cases. CONCLUSION: Because of very high sensitivity in detecting paraganglioma, SRS should be included in a multiple-step strategy for patients' management. It could be useful in ruling out the diagnosis of schwannoma, but its major advantage may involve patients' staging. Once biologic genetic testing of affected patients' relatives evidenced the predisposing mutation, SRS could be proposed to identify individuals who express the disease.

One-night mandibular advancement titration for obstructive sleep apnea syndrome: a pilot study.

The effect of a dental appliance (DA) is usually evaluated in a single mandibular position reached after several weeks and corresponding to either improvement of symptoms or intolerance to any further advancement. The purpose of this study was to test the feasibility of one-night evaluation of the efficacy of a DA. The study population consisted of seven patients (six men) with obstructive sleep apnea syndrome (66.9 +/- 32.4 apneas and/or hypopneas per hour). Patients underwent two consecutive polysomnographies; first with a temporary DA (two arches connected by a hydraulic system) progressively adjusted during the night to correct sleep disordered breathing and second with a permanent DA (two arches connected by Herbst attachments) set to the effective degree of advancement during the titration night. All patients completed the protocol. The mean mandibular advancement reached during the titration night was 12.6 +/- 2.7 mm. Arousal was never observed during or for 60 seconds following advancement. The apnea-hypopnea index (AHI) was significantly reduced from 66.9 +/- 32.4 to 26.1 +/- 20.7 per hour during the titration night from the diagnostic night (p < 0.01). During the second night, the AHI was 19.6 +/- 20.2 per hour and was less than 20 per hour in 71.4% of patients and less than 10 per hour in 42.9% of patients. The efficacy of a DA can be evaluated during a single night of polysomnography.