@article{353e847c5ce74978830c060cce24dbf2,
title = "Sleep apnea multi-level surgery trial: long-term observational outcomes",
abstract = "Study Objectives: The sleep apnea multi-level surgery (SAMS) randomized clinical trial showed surgery improved outcomes at 6 months compared to ongoing medical management in patients with moderate or severe obstructive sleep apnea (OSA) who failed continuous positive airway pressure therapy. This study reports the long-term outcomes of the multi-level surgery as a case series. Methods: Surgical participants were reassessed >2 years postoperatively with the same outcomes reported in the main SAMS trial. Primary outcomes were apnea-hypopnea index (AHI) and Epworth sleepiness scale (ESS), with secondary outcomes including other polysomnography measures, symptoms, quality of life, and adverse events. Long-term effectiveness (baseline to long-term follow-up [LTFU]) and interval changes (6 month to LTFU) were assessed using mixed effects regression models. Control participants were also reassessed for rate of subsequent surgery and outcomes. Results: 36/48 (75\%) of surgical participants were reevaluated (mean (standard deviation)) 3.5 (1.0) years following surgery, with 29 undergoing polysomnography. AHI was 41/h (23) at preoperative baseline and 21/h (18) at follow-up, representing persistent improvement of −24/h (95\% CI −32, −17; p < 0.001). ESS was 12.3 (3.5) at baseline and 5.5 (3.9) at follow-up, representing persistent improvement of −6.8 (95\% CI −8.3, −5.4; p < 0.001). Secondary outcomes were improved long term, and adverse events were minor. Interval change analysis suggests stability of outcomes. 36/43 (84\%) of the control participants were reevaluated, with 25 (69\%) reporting subsequent surgery, with symptom and quality of life improvements. Conclusion: Multi-level upper airway surgery improves OSA burden with long-term maintenance of treatment effect in adults with moderate or severe OSA in whom conventional therapy failed. Clinical Trial: Multi-level airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019\&isReview=true; ACTRN12614000338662.",
keywords = "cohort studies, follow-up studies, human, obstructive, patient satisfaction, polysomnography, sleep, sleep apnea, sleep surgical procedures, surveys and questionnaires, treatment outcome",
author = "Pinczel, \{Alison J.\} and Woods, \{Charmaine M.\} and Catcheside, \{Peter G.\} and Woodman, \{Richard J.\} and Carney, \{Andrew Simon\} and Chai-Coetzer, \{Ching Li\} and Michael Chia and Cistulli, \{Peter A.\} and Hodge, \{John Charles\} and Andrew Jones and Lam, \{Matthew E.\} and Richard Lewis and Nigel McArdle and Ooi, \{Eng H.\} and Rea, \{Siobhan Clare\} and Guy Rees and Bhajan Singh and Nicholas Stow and Aeneas Yeo and Nick Antic and McEvoy, \{Ronald Doug\} and Weaver, \{Edward M.\} and MacKay, \{Stuart G.\}",
note = "Funding Information: The main SAMS Trial was supported by a project grant from the National Health and Medical Research Council of Australia (1059510), with supplementary funding provided by Flinders University and The Repat Foundation Prabha Seshadri Research Grant. In addition, the LTFU study was supported by Flinders University and Flinders Foundation. Publisher Copyright: {\textcopyright} The Author(s) 2023.",
year = "2024",
month = jan,
day = "1",
doi = "10.1093/sleep/zsad218",
language = "English",
volume = "47",
journal = "Sleep",
issn = "0161-8105",
publisher = "Oxford University Press",
number = "1",
}