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Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep ApneaThe SAMS Randomized Clinical Trial

Educational Objective
To learn whether multilevel airway surgery is effective for the management of moderate or severe obstructive sleep apnea.
1 Credit CME
Key Points

Question  Is multilevel airway surgery effective in adults with moderate or severe obstructive sleep apnea (OSA) who cannot tolerate or adhere to device use?

Findings  In this randomized clinical trial of 102 adults, modified uvulopalatopharyngoplasty and radiofrequency in saline tongue reduction, compared with ongoing medical management, significantly improved the apnea-hypopnea index (mean baseline-adjusted between-group difference, −17.6 events per hour of sleep) and patient-reported sleepiness (mean baseline-adjusted between-group difference in Epworth Sleepiness Scale, −6.7; range, 0-24; higher score indicates greater sleepiness) at 6 months.

Meaning  In this preliminary study of adults with moderate or severe OSA who failed conventional treatment, combined palatal and tongue surgery improved patient-reported sleepiness and polysomnographic measures of OSA severity at 6 months, although further research is needed to confirm these findings in additional populations and to evaluate the safety, clinical utility, and long-term efficacy of multilevel upper airway surgery for treatment of individuals with OSA.

Abstract

Importance  Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated.

Objective  To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed.

Design, Setting, and Participants  Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018.

Interventions  Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51).

Main Outcomes and Measures  Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS.

Results  Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, −17.6 events/h [95% CI, −26.8 to −8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, −6.7 [95% CI, −8.2 to −5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood).

Conclusions and Relevance  In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA.

Trial Registration  Australian New Zealand Clinical Trials Registry: ACTRN12614000338662

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Article Information

Corresponding Author: Stuart MacKay, MD, Illawarra ENT Head and Neck Clinic, Suites 1&2, 8-10 Victoria St, Wollongong, NSW 2500, Australia (sgmackay@ozemail.com.au).

Accepted for Publication: July 15, 2020.

Published Online: September 4, 2020. doi:10.1001/jama.2020.14265

Author Contributions: Drs McEvoy and Woodman had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: MacKay, Carney, Catcheside, Chai-Coetzer, Chia, Cistulli, Hodge, Weaver, Woods, Yeo, McEvoy.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: MacKay, Carney, Catcheside, Chia, Cistulli, Hodge, Jones, Woodman, Woods, Yeo, McEvoy.
Critical revision of the manuscript for important intellectual content: MacKay, Catcheside, Chai-Coetzer, Chia, Cistulli, Hodge, Jones, Kaambwa, Lewis, Ooi, Pinczel, McArdle, Rees, Singh, Stow, Weaver, Woodman, Woods, Yeo, McEvoy.
Statistical analysis: Catcheside, Kaambwa, Weaver, Woodman, Woods, Yeo.
Obtained funding: MacKay, Carney, Catcheside, Chai-Coetzer, Cistulli, Ooi, Weaver, Woods, McEvoy.
Administrative, technical, or material support: MacKay, Carney, Catcheside, Chai-Coetzer, Chia, Jones, Ooi, Pinczel, McArdle, Rees, Stow, Woods.
Supervision: MacKay, Chai-Coetzer, Chia, Cistulli, Hodge, Jones, Ooi, Rees, McEvoy.
Other - Trial PI: McEvoy.

Conflict of Interest Disclosures: Dr MacKay reported receiving grants from National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation 2013 Prabha Seshadri Research Grant during the conduct of the study and nonfinancial support from Genio-Nyxoah and grants from Garnett-Passe Rodney Williams Foundation and Illawarra Health and Medical Research Institute outside the submitted work. Dr Carney reported receiving grants from National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study. Dr Catcheside reported receiving grants from National Health and Medical Research Council of Australia and from Flinders University during the conduct of the study; receiving grants from the Cooperative Research Centre for Alertness, Safety and Productivity, the National Health and Medical Research Council of Australia, and the Flinders Foundation Health Seed Grant and nonfinancial support from Philips Respironics, Air Liquide Healthcare, and Gorman Promed outside the submitted work; having a patent to Sleep Disorder Diagnosis, App No. AU 2018904007, US 62/812066 pending and a patent to decision support software for sleep disorder identification, February 28, 2019, US 61/815562 Sleep Disorder Data Fidelity Management System, March 8, 2019, pending. Dr Chai-Coetzer reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation during the conduct of the study. Dr Cistulli reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study and nonfinancial support from ResMed Inc; nonfinancial support from Zephyr Sleep Technologies; personal fees from SomnoMed, Signifier Medical, Wolter Kluwers, and Quintessence Publishing; and a provision of clinical trial services from Bayer outside the submitted work. Dr Jones reported receiving grants from Illawarra Sleep Medicine Centre during the conduct of the study. Dr Kaambwa reported receiving grants from the Australian National Health and Medical Research Council during the conduct of the study. Dr Lewis reported receiving consulting fees for Nyxoah SA (Belgium) as an investigator in 3 trials of a new hypoglossal nerve stimulator for obstructive sleep apnea. Dr Ooi reported receiving grants from the National Health and Medical Research Council and Flinders University during the conduct of the study and personal fees from Medtronic outside the submitted work. Dr Pinczel reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation during the conduct of the study. Dr McArdle reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study and grants from Oventus (Brisbane, Australia), Nyxoah (Mont-Saint Guibert, Belgium), and Zelda Therapeutics (Australia) outside the submitted work. Dr Weaver reported being a research consultant for Nyxoah SA outside the submitted work and practicing sleep surgery. Dr Yeo reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study. Dr McEvoy reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation during the conduct of the study and grants from Philips Respironics and ResMed outside the submitted work. No other disclosures were reported.

Funding/Support: This study is supported by a project grant from the National Health and Medical Research Council of Australia (1059510). Supplementary trial funding was provided by Flinders University and The Repat Foundation Prabha Seshadri Research Grant. Dr McEvoy was supported by a practitioner fellowship of the National Health and Medical Research Council (GNT 1079785). Dr Catcheside was supported by an Australian Research Council Future Fellowship (FT120100510). Dr. Weaver’s effort was supported by the Unites States National Institutes of Health (R01 HL084139, PI Weaver) and the Veterans Affairs Puget Sound Health Care System.

Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The contents of this article do not represent the views of the US government.

Group Information: The Sleep Apnea Multilevel Surgery (SAMS) Trial Group Investigators: Stuart MacKay, MD; A. Simon Carney, DM; Peter G. Catcheside, PhD; Ching Li Chai-Coetzer, MD, PhD; Michael Chia, MD; Peter A. Cistulli, MD, PhD; John-Charles Hodge, MD; Andrew Jones, MD; Billingsley Kaambwa, PhD; Richard Lewis, MD; Eng H. Ooi, MD, PhD; Alison Pinczel, PhD; Nigel McArdle, MD; Guy Rees, MD; Bhajan Singh, MD, PhD; Nicholas Stow, MD; Edward M. Weaver, MD, MPH; Richard J. Woodman, PhD; Charmaine M. Woods, PhD; Aeneas Yeo, MD; Nick A. Antic, PhD; R. Doug McEvoy, MD. Data and safety monitoring board: Matthew Naughton, MD (sleep and respiratory medicine specialist; Alfred Hospital and Monash University, Melbourne, Australia); Nathaniel Marshall, PhD (clinical trialist, epidemiologist, sleep disorders specialist; University of Sydney and The Woolcock Medical Institute, Sydney, Australia); and William Coman, AM, MD (consultant ENT surgeon; University of Queensland). Sleep laboratory managers: Jeremy Mercer, PhD (Flinders Medical Centre); Terry Sands, MD (Wollongong Hospital); Pam Singh, BSc(Hons) (Royal Adelaide Hospital); Neill Madeira, BHealthSc (Sir Charles Gairdner Hospital); Gary Cohen, PhD (for Sydney site). Corelab manager: Jeremy Mercer, PhD. Corelab scoring: Laura Bandick, BPsych(Hons); Michaela O’Keefe, BPsych(Hons). Additional site coordinators: Alison Teare, BSc, BEd; Kelsey Johnson, BPsych(Hons); Natasha Umrigar, BmedHlthSciAdv(Hons); Sue-Ellen Holmes, BSc(Hons); Kate Sutherland, PhD; Aimee Lowth, BSc(Hons); Clare Rea, BSc, BA.

Meeting Presentation: This study was presented at the Australasian Sleep Association Conference; October 19, 2018; Brisbane, Australia, and at the virtual European Respiratory Society International Congress; September 7, 2020.

Data Sharing Statement: See Supplement 3.

Additional Contributions: This work would not have been possible without both the late Samuel Robinson, MD (Flinders Medical Centre), who pioneered the surgical technique and the late Nick Antic, PhD (Flinders University). Dr Antic brought together the collaboration of sleep physicians and surgeons, led the funding proposal, and was the study’s principal investigator before his untimely death (in 2016). We thank the patients who participated in this trial; the various clinical and research teams of the Sleep and Respiratory, and Otolaryngology Head and Neck Surgery departments; and the technicians in the core sleep laboratory at the Adelaide Institute of Sleep Health for their work on the study.

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