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      Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

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          Abstract

          Objective/Hypothesis

          The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.

          Study Design

          Cohort Study.

          Methods

          Demographic and sleep study data collection occurred at baseline, implantation visit, post‐titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea‐Hypopnea Index (AHI) and AHI ≤20 at the 12‐month visit.

          Results

          The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6‐month follow‐up and 382 have completed the 12‐month follow‐up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6–45.0) to 9.5 (IQR, 4.0–18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7–16) to 7.0 (IQR, 4–11); mean, 11.4 ± 5.6 to 7.2 ± 4.8, P < .0001. Therapy usage was 5.6 ± 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.

          Conclusions

          Across a multi‐institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.

          Level of Evidence

          2

          Laryngoscope, 130:1333–1338, 2020

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          Most cited references11

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          The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome.

          This paper, which has been reviewed and approved by the Board of Directors of the American Sleep Disorders Association, provides the background for the Standards of Practice Committee's parameters for the practice of sleep medicine in North America. The intent of this paper is to provide an overview of the surgical treatment of obstructive sleep apnea syndrome, to provide the basis for the American Sleep Disorders Association's practice parameters on this subject and to share our findings of metanalysis of previously published studies regarding uvulopalatopharyngoplasty. We searched MEDLINE from January 1966 through April 1993, with an update in February 1995, to provide a review of the application of surgical modifications of the upper airway to treat adults with obstructive sleep apnea syndrome. Operations to treat obstructive sleep apnea syndrome include nasal septal reconstruction; uvulopalatopharyngoplasty; uvulopalatopharyngoglossoplasty; laser midline glossectomy; lingualplasty; inferior sagittal mandibular osteotomy and genioglossal advancement, with hyoid myotomy and suspension (the entire process is referred to as GAHM); maxillomandibular osteotomy and advancement, and tracheotomy. Papers included in metanalysis provided preoperative and postoperative polysomnographic data on at least nine patients treated with uvulopalatopharyngoplasty for their obstructive sleep apnea. Analysis of the uvulopalatopharyngoplasty papers revealed that this procedure is, at best, effective in treating less than 50% of patients with obstructive sleep apnea syndrome. The site of pharyngeal narrowing or collapse, although identified by different and unvalidated methods, has a marked effect on the probability of success of uvulopalatopharyngoplasty. Patients who achieve a favorable response with uvulopalatopharyngoplasty tend to have less severe obstructive sleep apnea than those who do not. For patients who demonstrate retrolingual narrowing or collapse, other surgical modifications have been described, such as lingualplasty, GAHM, and maxillomandibular osteotomy and advancement. The studies to support the use of the surgical treatment of obstructive sleep apnea syndrome contain biases related to small sample size, limited follow-up and patient selection.
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            Sensitivity and specificity of the multiple sleep latency test (MSLT), the maintenance of wakefulness test and the epworth sleepiness scale: failure of the MSLT as a gold standard.

            Excessive daytime sleepiness (EDS) is an important symptom that needs to be quantified, but there is confusion over the best way to do this. Three of the most commonly used tests: the multiple sleep latency test (MSLT), the maintenance of wakefulness test (MWT) and the Epworth sleepiness scale (ESS) give results that are significantly correlated in a statistical sense, but are not closely related. The purpose of this investigation was to help clarify this problem. Previously published data from several investigations were used to calculate the reference range of normal values for each test, defined by the mean+/-2 SD or by the 2.5 and 97.5 percentiles. The 'rule of thumb' that many people rely on to interpret MSLT results is shown here to be misleading. Previously published results from each test were also available for narcoleptic patients who were drug-free at the time and who by definition had EDS. This enabled the sensitivity and specificity of the three tests to be compared for the first time, in their ability to distinguish the EDS of narcolepsy from the daytime sleepiness of normal subjects. The receiver operator characteristic curves clearly showed that the ESS is the most discriminating test, the MWT is next best and the MSLT the least discriminating test of daytime sleepiness. The MSLT can no longer be considered the gold standard for such tests.
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              Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline

              Introduction: This guideline establishes clinical practice recommendations for positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA) in adults and is intended for use in conjunction with other American Academy of Sleep Medicine (AASM) guidelines in the evaluation and treatment of sleep-disordered breathing in adults. Methods: The AASM commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of clinically significant benefits and harms, patient values and preferences, and resource use. In addition, the task force adopted recommendations from prior guidelines as “good practice statements” that establish the basis for appropriate and effective treatment of OSA. The AASM Board of Directors approved the final recommendations. Good Practice Statements: The following good practice statements are based on expert consensus, and their implementation is necessary for appropriate and effective management of patients with OSA treated with positive airway pressure: Treatment of OSA with PAP therapy should be based on a diagnosis of OSA established using objective sleep apnea testing. Adequate follow-up, including troubleshooting and monitoring of objective efficacy and usage data to ensure adequate treatment and adherence, should occur following PAP therapy initiation and during treatment of OSA. Recommendations: The following recommendations are intended as a guide for clinicians using PAP to treat OSA in adults. A STRONG (ie, “We recommend…”) recommendation is one that clinicians should follow under most circumstances. A CONDITIONAL recommendation (ie, “We suggest…”) reflects a lower degree of certainty regarding the outcome and appropriateness of the patient-care strategy for all patients. The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources. We recommend that clinicians use PAP, compared to no therapy, to treat OSA in adults with excessive sleepiness. (STRONG) We suggest that clinicians use PAP, compared to no therapy, to treat OSA in adults with impaired sleep-related quality of life. (CONDITIONAL) We suggest that clinicians use PAP, compared to no therapy, to treat OSA in adults with comorbid hypertension. (CONDITIONAL) We recommend that PAP therapy be initiated using either APAP at home or in-laboratory PAP titration in adults with OSA and no significant comorbidities. (STRONG) We recommend that clinicians use either CPAP or APAP for ongoing treatment of OSA in adults. (STRONG) We suggest that clinicians use CPAP or APAP over BPAP in the routine treatment of OSA in adults. (CONDITIONAL) We recommend that educational interventions be given with initiation of PAP therapy in adults with OSA. (STRONG) We suggest that behavioral and/or troubleshooting interventions be given during the initial period of PAP therapy in adults with OSA. (CONDITIONAL) We suggest that clinicians use telemonitoring-guided interventions during the initial period of PAP therapy in adults with OSA. (CONDITIONAL) Citation: Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2019;15(2):335–343.
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                Author and article information

                Contributors
                erica.thaler@uphs.upenn.edu
                Journal
                Laryngoscope
                Laryngoscope
                10.1002/(ISSN)1531-4995
                LARY
                The Laryngoscope
                John Wiley & Sons, Inc. (Hoboken, USA )
                0023-852X
                1531-4995
                14 September 2019
                May 2020
                : 130
                : 5 ( doiID: 10.1002/lary.v130.5 )
                : 1333-1338
                Affiliations
                [ 1 ] Department of Otorhinolaryngology–Head and Neck Surgery University of Pennsylvania Philadelphia Pennsylvania
                [ 2 ] Penn Sleep Center, University of Pennsylvania Philadelphia Pennsylvania
                [ 3 ] Sleep Disorders Center, University Hospital Mannheim Mannheim Germany
                [ 4 ] Department of Otorhinolaryngology–Head and Neck Surgery University Hospital Mannheim Mannheim Germany
                [ 5 ] Department of Otolaryngology University of Pittsburgh Pittsburgh Pennsylvania
                [ 6 ] Department of Otolaryngology–Head and Neck Surgery University of Kansas Medical Center Kansas City Kansas
                [ 7 ] Department of Otolaryngology–Head and Neck Surgery Thomas Jefferson University Hospitals Philadelphia Pennsylvania
                [ 8 ] Cleveland Clinic Health System Cleveland Clinic Cleveland Ohio
                [ 9 ] Head and Neck Institute Cleveland Clinic Cleveland Ohio
                [ 10 ] Department of Otorhinolaryngology University of Lübeck Lübeck Germany
                [ 11 ] Department of Otolaryngology–Head and Neck Surgery Keck School of Medicine at University of Southern California Los Angeles California
                [ 12 ] Department of Otorhinolaryngology–Head and Neck Surgery Klinikum rechts der Isar, Technical University Munich Munich Germany
                [ 13 ] Department of Otolaryngology University of Alabama School of Medicine Birmingham Alabama
                [ 14 ] Department of Medicine Case Western Reserve University Cleveland Ohio U.S.A
                Author notes
                [*] [* ]Send correspondence to Erica Thaler, MD, Department of Otorhinolaryngology–Head and Neck Surgery, University of Pennsylvania Medical Center, 3400 Spruce Street, Philadelphia, PA 19104. E‐mail: erica.thaler@ 123456uphs.upenn.edu
                Author information
                https://orcid.org/0000-0002-7853-4307
                https://orcid.org/0000-0003-4637-3630
                https://orcid.org/0000-0002-1044-492X
                https://orcid.org/0000-0003-3808-4521
                https://orcid.org/0000-0002-3126-2877
                https://orcid.org/0000-0001-6301-2891
                Article
                LARY28286
                10.1002/lary.28286
                7217178
                31520484
                2ddbb8fd-e988-4d9b-9534-b0e6ffaaa77d
                © 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 25 March 2019
                : 15 July 2019
                : 19 August 2019
                Page count
                Figures: 3, Tables: 5, Pages: 6, Words: 4270
                Categories
                Sleep Medicine
                Sleep Medicine
                Original Reports
                Custom metadata
                2.0
                May 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.8.1 mode:remove_FC converted:12.05.2020

                Otolaryngology
                obstructive sleep apnea,surgery,upper airway stimulation,drug‐induced sleep endoscopy

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