Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study.

STUDY OBJECTIVES: Mandibular advancement device (MAD) outcome varies between patients. We hypothesized that upper airway collapse sites, patterns, and degrees assessed during baseline drug-induced sleep endoscopy (DISE) affect MAD outcome. METHODS: One hundred patients with obstructive sleep apnea (OSA) were included and underwent baseline type 1 polysomnography. MAD was fitted intraorally at fixed 75% maximal protrusion. A total of 72 patients completed 3-month follow-up polysomnography and baseline DISE. Response was defined as apnea-hypopnea index (AHI) reduction ≥ 50%, deterioration as AHI increases during MAD treatment compared to baseline. RESULTS: Adjusting for baseline AHI and body mass index, patients with tongue base collapse showed 3.69 higher odds (1.27-10.73; P = .0128) for response. Complete concentric collapse at the level of the palate (5.32 [1.21-23.28]; P = .0234) and complete laterolateral oropharyngeal collapse (6.62 [1.14-38.34]; P = .0330) related to deterioration. Results for tongue base collapse and complete concentric collapse at the level of the palate were confirmed in the moderate to severe OSA subgroup. Applying these results to this selected subgroup increased response rate with 54% and decreased deterioration rate with 53%. These results were confirmed using other response and deterioration definitions. CONCLUSIONS: Three baseline DISE phenotypes identified during drug-induced sleep were significantly related to MAD treatment outcome: one beneficial, tongue base collapse, and two adverse, complete concentric collapse at the level of the palate and complete laterolateral oropharyngeal collapse. If confirmed in future prospective studies, these results could guide patient selection for MAD outcome. CLINICAL TRIAL REGISTRATION: This prospective clinical trial (PROMAD) was registered on Clinicaltrials.gov with identifier: NCT01532050. CITATION: Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic labelling using drug-induced sleep endoscopy improves patient selection for mandibular advancement device outcome: a prospective study. J Clin Sleep Med. 2019;15(8):1089-1099.

European position paper on drug-induced sleep endoscopy: 2017 Update.

BACKGROUND: The first edition of the European position paper (EPP) on drug-induced sleep endoscopy (DISE) was published in 2014 with the aim to standardise the procedure, to provide an in-depth insight into the main aspects of this technique and to have a basis for future research. Since 2014, new studies have been published concerning new sedative agents or new insights into the pattern/levels of the obstruction depending on the depth of sedation. Therefore, an enlarged group of European experts in the field of sleep breathing disorders (SBD), including the most of the first DISE EPP main authors, has decided to publish an update of the European position paper on DISE, in order to include new evidence and to find a common language useful for reporting the findings of this endoscopic evaluation in adult population affected by SBD. METHODS: The authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centres in order to provide an update regarding the standardisation of the DISE procedure and an in-depth insight into the main aspects of this technique. RESULTS: After the first European Position Consensus Meeting on DISE and its update, consensus was confirmed for indications, required preliminary examinations, where to perform DISE, technical equipment required, staffing, local anaesthesia, nasal decongestion, other medications, patient positioning, basics and special diagnostic manoeuvres, drugs and observation windows. So far, no consensus could be reached on a scoring and classification system. However, regarding this aim, the idea of an essential classification, such as VOTE with the possibility of its graded implementation of information and descriptions, seems to be the best way to reach a universal consensus on DISE classification at this stage. A common DISE language is mandatory, and attempts to come to a generally accepted system should be pursued.

Adverse skin reactions following percutaneous bone conduction implant surgery using the linear incision technique with and without subcutaneous tissue reduction.

CONCLUSIONS: Adverse skin reactions were equally distributed among age groups, surgical technique, or presence of a retroauricular incision. Implant loss was observed more frequently in children when compared to adults and elderly. OBJECTIVE: A bone conduction (osseointegrated) implant can be used for rehabilitation of patients with conductive hearing loss or single-sided deafness. The surgical technique has been modified to minimize adverse skin reactions and other complications. Two commonly used techniques are the linear incision technique with subcutaneous tissue reduction and the technique without tissue reduction. The primary aim is to compare the complication rate between the two surgical techniques. METHODS: Retrospective study on all bone conduction implant cases implanted between April 1990 and July 2014 at a tertiary referral center. Skin reactions were graded by Holgers' scale (grade 0-1: 'normal', grade 2-3: 'adverse'). The worst follow-up available was reported. RESULTS: Of the 289 bone conduction implants, 25 were implanted in children, 220 in adults, and 44 in elderly. Implant loss occurred in 2.8% of all cases: 8.0% in children, 2.3% in adults, and 2.3% in the elderly. Skin overgrowth was seen in 4.2%: 4% in children, 4.8% in adults, and 3.5% in the elderly. No differences were observed in the amount of adverse skin reactions (16.8% vs 14.7%) or skin overgrowth (4.6% vs 2.9%) between the surgical techniques. There was no difference in adverse skin reactions if the patient had a retroauricular incision (14.4% with vs 17.8% without prior incision).

The Use of Remotely Controlled Mandibular Positioner as a Predictive Screening Tool for Mandibular Advancement Device Therapy in Patients with Obstructive Sleep Apnea through Single-Night Progressive Titration of the Mandible: A Systematic Review.

STUDY OBJECTIVES: To perform a review of the current evidence regarding the use of a remotely controlled mandibular positioner (RCMP) and to analyze the efficacy of RCMP as a predictive selection tool in the treatment of obstructive sleep apnea (OSA) with oral appliances that protrude the mandible (OAm), exclusively relying on single-night RCMP titration. METHODS: An extensive literature search is performed through PubMed.com, Thecochranelibrary.com (CENTRAL only), Embase.com, and recent conference meeting abstracts in the field. RESULTS: A total of 254 OSA patients from four full-text articles and 5 conference meeting abstracts contribute data to the review. Criteria for successful RCMP test and success with OAm differed between studies. Study populations were not fully comparable due to range-difference in baseline apneahypopnea index (AHI). However, in all studies elimination of airway obstruction events during sleep by RCMP titration predicted OAm therapy success by the determination of the most effective target protrusive position (ETPP). A statistically significant association is found between mean AHI predicted outcome with RCMP and treatment outcome with OAm on polysomnographic or portable sleep monitoring evaluation (p < 0.05). CONCLUSIONS: The existing evidence regarding the use of RCMP in patients with OSA indicates that it might be possible to protrude the mandible progressively during sleep under poly(somno)graphic observation by RCMP until respiratory events are eliminated without disturbing sleep or arousing the patient. ETPP as measured by the use of RCMP was significantly associated with success of OAm therapy in the reported studies. RCMP might be a promising instrument for predicting OAm treatment outcome and targeting the degree of mandibular advancement needed.

On the connection between the tympanic membrane and the malleus.

BACKGROUND: The tympano-mallear connection (TMC) is the soft-tissue connection between the tympanic membrane (TM) and the manubrium of the malleus. Some studies suggest that its mechanical properties may have a substantial influence on the mechanics and transfer function of the middle ear. However, relatively little is known about the dimensions of the TMC and its variability among individuals. METHOD: Thirteen samples were collected from human temporal bones, consisting of only the malleus and the TM. They were imaged using µCT without contrast enhancing agent. From the µCT images, the TMC dimensions were measured in both anterior-posterior direction (TMC width) and medial-lateral direction (TMC thickness). Three selected samples were examined using histological microscopy. RESULTS: Both TMC width and thickness featured a large variability among individuals. The minimal TMC width along the manubrium for different individuals covered a range between 83 and 840 µm. The minimal thickness ranged from 48 to 249 µm and the maximal thickness from 236 to 691 µm. Histological sections showed that the TMC consists of a narrow core of dense regular connective tissue, surrounded by loose connective tissue. In some samples, either of these two components was absent in the TMC at some manubrium locations. The configuration of these components varied among the samples as well. CONCLUSION: Our data confirm that a large inter-individual variability exists in the properties of the TM-malleus connection in humans in terms of its dimensions, tissue composition and configuration. Average data and their variability margins will be useful input for testing the importance of the TMC in finite element models.

Endoscopic versus transcranial procurement of allograft tympano-ossicular systems: a prospective double-blind randomized controlled audit.

Allograft tympano-ossicular systems (ATOS) have proven their use over many decades in tympanoplasty and reconstruction after resection of cholesteatoma. The transcranial bone plug technique has been used in the past 50 years to procure en bloc ATOS (tympanic membrane with malleus, incus and stapes attached). Recently, our group reported the feasibility of the endoscopic procurement technique. The aim of this study was to assess whether clinical outcome is equivalent in ATOS acquired by using the endoscopic procurement technique compared to ATOS acquired by using the transcranial technique. A double-blind randomized controlled audit was performed in a tertiary referral center in patients that underwent allograft tympanoplasty because of chronic otitis media with and without cholesteatoma. Allograft epithelialisation was evaluated at the short-term postoperative visit by microscopic examination. Failures were reported if reperforation was observed. Fifty patients underwent allograft tympanoplasty: 34 received endoscopically procured ATOS and 16 received transcranially procured ATOS. One failed case was observed, in the endoscopic procurement group. We did not observe a statistically significant difference between the two groups in failure rate. This study demonstrates equivalence of the clinical outcome of allograft tympanoplasty using either endoscopic or transcranial procured ATOS and therefore indicates that the endoscopic technique can be considered the new standard procurement technique. Especially because the endoscopic procurement technique has several advantages compared to the former transcranial procurement technique: it avoids risk of prion transmission and it is faster while lacking any noticeable incision.

Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial.

IMPORTANCE: The main reported reasons for discontinuation of oral appliance therapy for sleep-disordered breathing (SDB) are the presence of self-perceived adverse effects and self-appreciated lack of efficacy. However, these conclusions rely only on subjective compliance data. OBJECTIVE: To determine which parameters are correlated with objectively measured data on compliance with oral appliance therapy. DESIGN, SETTING, AND PARTICIPANTS: For 51 outpatients with SDB, a prospective clinical trial using oral appliance therapy was conducted at Antwerp University Hospital from February 7, 2011, to October 8, 2013 (38 [75%] males; mean [SD] age, 49.3 [9.0] years; mean [SD] apnea-hypopnea index, 14.9 [9.3] events per hour of sleep; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 26.3 [2.8]). Analysis was performed November 5, 2014. INTERVENTION: Oral appliance therapy with a custom-made, titratrable mandibular advancement device (OAm). MAIN OUTCOMES AND MEASURES: Possible correlations were assessed between objective compliance and patients' anthropometric characteristics, polysomnographic parameters, and answers to 3 subjective questionnaires (the visual analog scale for snoring, the Epworth Sleepiness Scale, and an adverse effects questionnaire). RESULTS: Median oral appliance use was 6.4 hours per night (range, 4.7-7.2 hours per night) at the 3-month follow-up. None of the anthropometric and polysomnographic parameters were correlated with compliance. No correlation was found between objective compliance and reports of excessive daytime sleepiness. However, a significant inverse correlation was found between objective compliance and posttreatment visual analog scale values for snoring (P = .006; ρ = ­.40). In addition, objective compliance was correlated significantly with a more pronounced decrease in socially disturbing snoring (P = .005; ρ = 0.39). The presence of dry mouth was the only adverse effect that was negatively correlated with objective compliance at the 3-month follow-up (P < .05; ρ = ­.31). CONCLUSIONS AND RELEVANCE: Neither the anthropometric and polysomnographic parameters nor reports of excessive daytime sleepiness correlated with compliance during oral appliance therapy. The 2 parameters that were correlated with higher objective compliance during oral appliance therapy were a more pronounced decrease in snoring and the presence of dry mouth during treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01284881 and NCT01532050.

Endoscopic procurement of allograft tympano-ossicular systems: valuable to replace the Schuknecht bone plug technique?

Recently, our group demonstrated the technical feasibility of allograft tympano-ossicular systems (ATOS) procurement directly through the external auditory canal by using a rigid endoscope. This novel technique has several advantages compared to the traditional transcranial Schuknecht bone plug technique: it avoids contact with the dura mater, it is less time-consuming and it doesn't require a thorough reconstruction of the donor. In our tissue bank, we are currently transitioning from the transcranial procurement technique to the endoscopic procurement technique. The learning curve to master the endoscopic technique is steep but our preliminary results suggest that the percentage of good quality endoscopically procured ATOS is at least similar to the percentage of good quality transcranially procured ATOS dissected from the temporal bone plug. Additionally, the number of donations has increased significantly. By avoiding contact with the dura mater and therefore eliminating the risk of potential prion disease transmission, this technical evolution in procurement technique might allow dedicated tissue banks to (re-)introduce ATOS procurement and implantation.

European position paper on drug-induced sedation endoscopy (DISE).

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.

Drug-induced sleep endoscopy in sleep-disordered breathing: report on 1,249 cases.

OBJECTIVES/HYPOTHESIS: To describe upper airway (UA) collapse patterns during drug-induced sleep endoscopy (DISE) in a large cohort of patients with sleep-disordered breathing (SDB) and to assess associations with anthropometric and polysomnographic parameters. STUDY DESIGN: Observational study. METHODS: A total of 1,249 patients [age 47 ± 10 y; apnea-hypopnea index (AHI) 18.9 ± 15.3/h; body mass index (BMI) 27.2 ± 3.7 kg/m(2)] underwent polysomnography and DISE. DISE findings were categorized to the following UA levels: palate, oropharynx, tongue base, and hypopharynx. The degree of collapse was reported as complete, partial, or none. The pattern of the obstruction was described as anteroposterior, lateral, or concentric. Associations between DISE findings and anthropometric and polysomnographic parameters were analyzed. RESULTS: Palatal collapse was seen most frequently (81%). Multilevel collapse was noted in 68.2% of all patients. The most frequently observed multilevel collapse pattern was a combination of palatal and tongue base collapse (25.5%). Palatal collapse was seen most frequently (81%). The prevalence of complete collapse, multilevel collapse, and hypopharyngeal collapse increased with increasing severity of obstructive sleep apnea (OSA). Multilevel and complete collapse were more prevalent in obese patients and in those with more severe OSA. Both higher BMI and AHI values were associated with a higher probability of complete concentric palatal collapse. CONCLUSION: The current study provides an overview of UA collapse patterns in a large cohort of SDB patients who underwent DISE. The associations found in this study may indicate that UA collapse patterns observed during DISE cannot be fully explained by selected baseline polysomnographic and anthropometric characteristics.

Tongue suspension: an evidence-based review and comparison to hypopharyngeal surgery for OSA.

OBJECTIVES/HYPOTHESIS: Our first objective was to perform a systematic review of suture-based tongue suspension procedures as a stand-alone therapy for hypopharyngeal obstruction in obstructive sleep apnea (OSA). A second objective compared outcomes of tongue suspension as part of a multilevel approach to OSA surgery to genioglossus advancement (GA) with uvulopalatopharyngoplasty (UPPP), and to genioglossus advancement with hyoid suspension (GAHM) with UPPP. STUDY DESIGN: Systematic review. METHODS: The PubMed database was queried for English-language studies published after 1997 to create four cohorts: tongue suspension alone, tongue suspension with UPPP, GA + UPPP, and GAHM with UPPP. Chi-squared test was used to compare outcomes between cohorts. RESULTS: Twenty-seven studies were included, broken down into cohorts based on our selection criteria. Six studies qualified for the tongue suspension-alone group with a surgical success rate of 36.6%. Eight studies qualified for our cohort of tongue suspension with UPPP with a surgical success rate of 62.3%. Eighteen studies qualified for our remaining two cohorts: GA + UPPP, and GAHM + UPPP. Their surgical success rates were both 61.1%. A chi-squared test to compare surgical outcomes showed that there was no difference between tongue suspension with UPPP, GA + UPPP, and GAHM + UPPP. CONCLUSION: Tongue suspension is effective and safe as part of a multilevel surgical approach for patients with OSA. As a stand-alone procedure, its success rate is 36.6%, comparable to UPPP procedures for OSA success rates across the board. Tongue suspension should be considered in patients with OSA who demonstrate tongue base obstruction.

Observer variation in drug-induced sleep endoscopy: experienced versus nonexperienced ear, nose, and throat surgeons.

STUDY OBJECTIVE: To determine variations in interobserver and intraobserver agreement of drug-induced sleep endoscopy (DISE) in a cohort of experienced versus nonexperienced ear, nose, and throat (ENT) surgeons. DESIGN: Prospective, blinded agreement study. SETTING: Ninety-seven ENT surgeons (90 nonexperienced with DISE; seven experienced) observed six different DISE videos and were asked to score the upper airway (UA) level (palate, oropharynx, tongue base, hypopharynx, epiglottis), direction (anteroposterior, concentric, lateral), and degree of collapse (none; partial or complete collapse). Findings were collected and analyzed, determining interobserver and intraobserver agreement [overall agreement (OA), specific agreement (SA)] and kappa values per UA level. MEASUREMENT AND RESULTS: In the nonexperienced group, overall interobserver agreement on presence of tongue base collapse (OA = 0.63; kappa = 0.33) was followed by the agreement on epiglottis (OA = 0.57; kappa = 0.23) and oropharynx collapse (OA = 0.45; kappa = 0.09). Low overall interobserver agreement in this group was found for hypopharyngeal collapse (OA = 0.33; kappa = 0.08). A similar ranking was found for degree of collapse. For direction of collapse, high interobserver agreement was found for the palate (OA = 0.57; kappa = 0.16). Among the experienced observers, overall interobserver agreement was highest for presence of tongue base collapse (OA = 0.93; kappa = 0.71), followed by collapse of the palate (OA = 0.80; kappa = 0.51). In this group, lowest agreement was also found for hypopharyngeal collapse (OA = 0.47; kappa = 0.03). Interob-server agreement on direction of collapse was highest for epiglottis collapse (OA = 0.97; kappa = 0.97). Concerning the degree of collapse, highest agreement was found for degree of oropharyngeal collapse (OA = 0.82; kappa = 0.66). Among the experienced observers a statistically significant higher interobserver agreement was obtained for presence, direction, and degree of oropharyngeal collapse, as well as for presence of tongue base collapse and degree of epiglottis collapse. Among the nonexperienced observers, high intraobserver agreement was found in particular for tongue base and epiglottis collapse. Among the experienced observers, high agreement was found for all levels but to a lesser extent for hypopharyngeal collapse. Intraobserver agreement was statistically significantly higher in the experienced group, for all UA levels expect for the hypopharynx. CONCLUSION: This study indicates that both interobserver and intraobserver agreement was higher in experienced versus nonexperienced ENT surgeons. Agreement ranged from poor to excellent in both groups. The current results suggest that experience in performing DISE is necessary to obtain reliable observations.

Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea.

STUDY OBJECTIVES: 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). METHODS: 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. 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/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. 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.

Endoscopic procurement of tympano-ossicular allografts: alternative to the transcranial or retroauricular technique.

A tympano-ossicular tissue bank complying with European Union regulations on human allografts is feasible and critical to assure that the patient receives tissue which is safe, individually checked and prepared in a suitable environment. The transcranial procurement technique has become the standard approach to procure tympano-ossicular allografts since the 1970s because it can provide en bloc allografts. Over the last 10-20 years, en bloc allografts have been abandoned and only the malleus (hammer) is left attached to the tympanic membrane. This modification enables introduction of the transmeatal procurement technique. Transmeatal procurement using readily available nasal 0° and 30° endoscopes is a feasible alternative which avoids contact with the dura mater and is not esthetically invasive to the donor. It involves a more time-consuming procurement but avoids the need for preparation of the temporal bone plug and is therefore generally more time-efficient.

Allograft tympanoplasty: a historical perspective.

OBJECTIVE: To present the rise and decline of allograft tympanoplasty and investigate how the challenges it has faced may inform us of its future. DATA SOURCES: Articles and books published over the last 48 years that refer to allograft tympanoplasty or its historical roots. HISTORY: The first published account of allograft tympanoplasty is by Ned Chalat in 1964; however, whether he was the first to use the technique is controversial. In 1966, Jean Marquet published the first clinically successful use of allograft tympanic membranes. Since that time, a number of surgeons have trialed both en bloc tympano-ossicular techniques and tympanomeatal techniques with separate ossicle interposition or columellar reconstruction, often with considerable success. The advent of the human immunodeficiency virus and Creutzfeldt-Jakob's disease resulted in a reduction in its application; however, a number of centers are still successfully using the technique in their current practice. CONCLUSION: Whether allograft tympanoplasty will have a place in the future of otology remains to be seen, but an understanding of the history of this technique is essential in evaluating its merit.

Hyoid expansion as a treatment for obstructive sleep apnea: a pilot study.

OBJECTIVES: Hyoid expansion is a novel procedure that was developed to widen and stabilize the lateral walls of the hypopharynx in order to improve obstructive sleep apnea. This study was conducted to evaluate the safety, efficacy and feasibility of hyoid expansion. STUDY DESIGN: A prospective, non-randomized multicenter pilot study with a follow-up of 6 months was conducted. METHOD: An implantable device (the Air-Frame system) was used to surgically expand the hyoid bone. Subjective and objective outcome measures were evaluated. RESULTS: The procedure was successfully performed in all patients without technical adverse events. There were three clinical adverse events, and tolerance was good. Although there was a significant improvement in snoring and excessive daytime sleepiness, there was no objective improvement of the apnea-hypopnea index as measured by polysomnography. CONCLUSION: Hyoid expansion did not provide objective improvement of obstructive outcome measures in patients with obstructive sleep apnea syndrome.

A study of the new generation of the advance system tongue implants: three- and six-month effects of tongue to mandible tethering for obstructive sleep apnea.

OBJECTIVES/HYPOTHESIS: Treatment of hypopharyngeal collapse of upper airway is a surgical challenge in obstructive sleep apnea (OSA) patients who fail continuous positive airway pressure (CPAP). STUDY DESIGN: A prospective, nonrandomized, multicentered, feasibility study. METHODS: Nineteen OSA patients with an apnea-hypopnea index (AHI) between 15 and 50 with CPAP intolerance were included in the study. Baseline polysomnography (PSG) was measured, and 3- and 6-month postoperative PSGs were recorded. Preoperative and postoperative home sleep studies, cephalographs, and videoendoscopy were performed. Additionally, the subjects completed the Epworth Sleepiness Scale (ESS), Patient and Bed Partner Snoring Questionnaire, Functional Outcomes of Sleep Questionnaire, and Throat Questionnaire. RESULTS: AHI dropped from 33.8 at baseline to 18.6 at 3-month follow-up and to 24.3 at 6-month follow-up, respectively. Overall surgical success was 38.9% as defined by a 50% drop in AHI to a score below 20 at 6 months. ESS decreased from 11.4 to 6.1 and 7.4 at 3 months and 6 months, respectively. Snoring intensity was reduced from 7% to 3.8% at 3 and 6 months, respectively. Quality of life was improved from 15.6 to 17.9 (14.3%) and 18.1 (15.6%) at 3 months and 6 months, respectively. CONCLUSIONS: The rates of surgical success, feasibility, and safety were satisfactory. Further technical device improvement is necessary and must be based on a new understanding of tongue forces.

Adjustable tongue advancement for obstructive sleep apnea: a pilot study.

OBJECTIVES: Surgical treatment of obstructive sleep apnea (OSA) caused by hypopharyngeal collapse of the upper airway can be considered in patients who are intolerant to continuous positive airway pressure (CPAP). The present procedures addressing the hypopharynx are invasive and have substantial morbidity and limited efficacy. METHODS: Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway. RESULTS: The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred. CONCLUSIONS: Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.