Sleep Apnea Multi-level Surgery (SAMS) Trial: Long-term Observational Outcomes
Alison J Pinczel, Charmaine M Woods, Peter G Catcheside, Richard J Woodman, A 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 Antic, R Doug McEvoy, Edward M Weaver, Stuart G MacKay- Physiology (medical)
- Neurology (clinical)
Abstract
Study objectives
The Sleep Apnea Multi-level Surgery (SAMS) randomised 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 >2years post-operatively 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) and interval changes (six-month to long-term follow-up) 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 re-evaluated (mean [SD]) 3.5 [1.0] years following surgery, with 29 undergoing polysomnography. AHI was 41/hour [23] at pre-operative baseline and 21/hour [18] at follow-up, representing persistent improvement of -24/hour [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 re-evaluated, 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.