Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Sleep (New York, N.Y.), 2024-01, Vol.47 (1), p.1

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2024

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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.