Study Authors: Stuart MacKay, A. Simon Carney, et al.; Meghna P. Mansukhani, Eric J. Olson, Sean M. Caples
Target Audience and Goal Statement: Pulmonologists, ear, nose, and throat (ENT) surgeons, cardiologists
The goal of this study was to determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with obstructive sleep apnea (OSA) when conventional treatment failed.
Question Addressed:
- Was multilevel upper airway surgery effective in adults with moderate or severe OSA who could not tolerate or adhere to device use?
Study Synopsis and Perspective:
It is estimated that 22 million Americans suffer from sleep apnea, with 80% of the cases of moderate and severe OSA undiagnosed. OSA is characterized by repetitive upper airway collapse, hypoxemia, and sleep disruption, and is associated with cardiovascular disease and excessive daytime sleepiness. Other adverse effects of untreated OSA include decreased quality of life and an increased risk of motor vehicle crashes.
Action Points
- Palatal surgery combined with minimally invasive tongue volume reduction reduced the number of sleep apnea events and improved patient-reported sleepiness at 6 months compared with ongoing medical management in adults with moderate or severe obstructive sleep apnea, according to preliminary findings from a multicenter randomized trial.
- Note that, despite the observed benefits, 57% of patients still had moderate to severe residual sleep apnea on polysomnography at 6 months, and oxygen saturation continued to fall below 85% in some patients.
Continuous positive airway pressure (CPAP) delivered by mask and jaw advancement with an oral appliance are two treatment mainstays. However, there remains a need for alternate treatment options when patients are unwilling or unable to tolerate standard medical management.
Surgeons have modified the upper airway with procedures such as uvulopalatopharyngoplasty for decades to manage OSA. However, these surgeries have received little support within the sleep medicine community because of an evidence base that mainly includes studies with methodological limitations that reported low rates of benefit in managing OSA.
In a recent randomized trial, surgery to widen and stabilize the soft palate and reduce tongue size improved outcomes among patients with moderate-to-severe OSA for whom conventional treatments had failed.
In early findings from the multicenter trial, palatal surgery combined with minimally invasive tongue volume reduction reduced the number of sleep apnea events and improved patient-reported sleepiness at 6 months compared with ongoing medical management, reported Stuart MacKay, MD, of the Illawarra ENT Head and Neck Clinic in Wollongong, Australia, and colleagues in JAMA.
Patients who received the surgery had a nearly 60% reduction in the frequency of throat obstructions at night after 6 months versus a 20% decrease in patients who remained on medical treatment. In addition, the surgery patients had major added improvements in snoring, daytime sleepiness, and general health status.
The Sleep Apnea Multilevel Surgery (SAMS) trial — conducted at six sites across Australia — included 102 adults with symptomatic moderate or severe OSA for whom conventional treatments had failed. Participants were randomized to multilevel surgery (n=51) or ongoing medical management, which included advice on OSA-related lifestyle and health interventions such as sleep positioning, weight loss, and management of nasal obstruction (n=51). Eligible patients were middle-age (mean age 44.6 years) with overweight or obesity (mean body mass index 30.7 in the surgery group and 29.5 in the medical management group); 18% were women and 89% completed the trial.
Surgery consisted of modified uvulopalatopharyngoplasty to widen and stabilize the velopharynx and seven to nine submucosal insertions of a radiofrequency-in-saline wand to reduce tongue volume. The seven surgeons recruited to perform the multilevel procedure attended a training workshop designed to standardize the surgical technique.
The primary study outcomes were the apnea-hypopnea index (AHI: the number of apnea and hypopnea events per hour, with more than 30 indicating severe OSA) and the Epworth Sleepiness Scale (ESS: range of 0 to 24, with more than 10 indicating pathological sleepiness). The researchers assessed baseline-adjusted differences between the two treatment groups at 6 months.
The mean AHI was 47.9 at baseline and 20.8 at 6 months among the surgery group and 45.3 at baseline and 34.5 at 6 months among the medical management group (mean baseline-adjusted between-group difference at 6 months, -17.6 events/hr, 95% CI -26.8 to -8.4, P<0.001).
Similarly, the mean ESS decreased from 12.4 at baseline to 5.3 at 6 months in the surgery group and from 11.1 to 10.5 in the medical management group (mean baseline-adjusted between-group difference at 6 months -6.7, 95% CI -8.2 to -5.2, P<0.001).
There were also statistically significant mean between-group differences favoring surgery for secondary outcomes such as partner-reported snoring severity, sleep-specific quality of life, and self-rated general health status.
Two patients who underwent surgery (4%) were considered to have serious adverse events (AEs) possibly related to surgery. One had a myocardial infarction on postoperative day 5 and the other was hospitalized following hematemesis of old blood. None of the patients in the medical management group experienced a serious AE.
The researchers acknowledged that the results might not be generalizable to a larger OSA population, as the selected study sample excluded patients with severe obesity, patients older than 70 years, and patients with retrognathia and significant comorbidities.
Source References: JAMA 2020; DOI: 10.1001/jama.2020.14265
Editorial: JAMA 2020; DOI: 10.1001/jama.2020.9332
Study Highlights and Explanation of Findings:
In addition to reductions in the frequency of sleep apnea and hypopnea events and daytime sleepiness, other polysomnography measures of sleep apnea severity, including arterial oxygen saturation and cortical arousal frequency, as well as partner-reported snoring and patient-reported quality of life were also improved in the surgery patients at 6 months. However, 57% of patients still had moderate to severe residual sleep apnea on polysomnography at 6 months, and oxygen saturation continued to fall below 85% in some patients.
“This trial is the result of extensive prior research into the surgical treatment of sleep apnea and gives new hope to people who, without treatment, would each day continue to feel sleepy and depressed and may have their lives cut short by the detrimental effects of long-term interrupted sleep,” said senior author R. Doug McEvoy, MD, of Flinders University in Adelaide, Australia, in a press release.
However, further research is needed to confirm these preliminary findings in additional populations and to understand the clinical utility, long-term efficacy, and safety of multilevel surgery for the treatment of patients with OSA.
Writing in an accompanying editorial, Sean M. Caples, DO, and colleagues from the Mayo Clinic in Rochester, Minnesota, said the study “should be considered a platform for the new era in clinical trials of upper airway surgery for OSA.”
In an interview, Caples praised the rigorous design of the study, but called the findings “somewhat disappointing.”
“After surgery there was still a large group of patients with residual sleep apnea, so I suspect that this approach is probably not going to be the game changer everyone is looking for in the treatment of sleep apnea,” he told MedPage Today.
Caples and colleagues stated that several issues deserve consideration.
“First, surgery was effective at preventing upper airway collapse in some patients but not in others, suggesting that selection criteria will need to be refined in future trials,” they wrote. “Second, as in other treatment trials of OSA, women and minority populations were underrepresented, highlighting the importance of including patients from these groups in future trials. Third, because the follow-up time was only 6 months, longer-term data from this trial and future trials will be needed to test the durability of treatment effect over time. It is conceivable that with aging or weight gain, the surgical effect on soft tissue recedes.”
Caples and co-authors concluded that comparative efficacy trials are needed to compare outcomes from the multilevel surgical strategy with other surgical procedures, including maxillomandibular advancement and upper airway stimulation.
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco