Sleep apnea multi-level surgery trial: long-term observational outcomes

Alison J. Pinczel, Charmaine M. Woods, Peter G. Catcheside, Richard J. Woodman, Andrew Simon Carney, Ching Li Chai-Coetzer, Michael Chia, Peter A. Cistulli, John Charles Hodge, Andrew Jones, Matthew E. Lam, Richard Lewis, Nigel McArdle, Eng H. Ooi, Siobhan Clare Rea, Guy Rees, Bhajan Singh, Nicholas Stow, Aeneas Yeo, Nick AnticRonald Doug McEvoy, Edward M. Weaver, Stuart G. MacKay

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

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.

Original languageEnglish
Article numberzsad218
Number of pages12
JournalSLEEP
Volume47
Issue number1
Early online date22 Aug 2023
DOIs
Publication statusPublished - 1 Jan 2024

Keywords

  • cohort studies
  • follow-up studies
  • human
  • obstructive
  • patient satisfaction
  • polysomnography
  • sleep
  • sleep apnea
  • sleep surgical procedures
  • surveys and questionnaires
  • treatment outcome

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