This is the current release of this guideline.

This guideline updates a previous version: American Sleep Disorders Association. Practice parameters for the treatment of obstructive sleep apnea in adults: the efficacy of surgical modifications of the upper airway. Sleep - Europe. 1996 Feb;19(2):152-5.

Obstructive sleep apnea (OSA)

To provide recommendations for the practice of sleep medicine regarding the role of surgical procedures in the treatment of obstructive sleep apnea in adults

Adults diagnosed with or at high risk for obstructive sleep apnea (OSA)

Diagnosis

1. Detailed criteria of obstructive sleep apnea (OSA) utilized
2. Polysomnography
3. Discussion of treatment alternatives

Treatment

1. Tracheostomy
2. Maxillo-mandibular advancement (MMA)
3. Uvulopalatopharyngoplasty (UPPP)
4. Multi-level or stepwise surgery (MLS)
5. Laser assisted uvulopalatoplasty (LAUP) (Note: considered, but not routinely recommended)
6. Radiofrequency ablation
7. Palatal implants
8. Follow-up including sleep-disordered breathing, oxygen saturation, and clinical assessment

Search Strategy

Study eligibility was predicated upon the reporting of the apnea-hypopnea index (AHI) before and after surgical intervention. Acceptable study methodologies included randomized and non-randomized controlled trials, cohort studies and case series (sample size >1) published in English. Those papers that only reported surgical "success" without precise outcomes data on individual study subjects were excluded.

Study Identification

An expert reference librarian designed and conducted the electronic search strategy with input from study investigators with expertise in conducting systematic reviews. To identify eligible studies, we searched electronic databases (MEDLINE, EMBASE, Current Contents, and Cochrane CENTRAL through the Ovid interface) from 1966 through June, 2008, cross-referencing the key words sleep, sleep apnea AND surgery with UPPP, uvulopalatopharyngoplasty, hypopharynx, tongue, tongue base, tongue volume reduction, epiglottis, genioglossus, advancement, mortised, genioplasty, glossectomy, tongue radiofrequency, hyoid, suspension, stabilization, maxillomandibular, osteotomy, laser assisted uvuloplasty, LAUP, palatoplasty, pharyngoplasty, palatopharyngoplasty, tracheostomy, maxillary advancement, myotomy, septoplasty, polypectomy, adenoidectomy, tonsillectomy, adenotonsillectomy, soft palate, implant, uvula, positive airway pressure, CPAP, oral appliance, mandibular advancement device, sclerosis, sclerotherapy.

Task force members screened all abstracts and titles for candidate studies. Two reviewers, working independently, screened the full text publications for eligibility. Inter-reviewer agreement was adequate (κ = 0.7); disagreements were resolved by consensus and, if needed, adjudication by a third party.

Data Collection

Two reviewers, working independently and using a standardized, web-based form, extracted data from all eligible studies, which included:

• Descriptive data—sample size, mean patient age, % male gender, mean body mass index (BMI), length of follow-up
• Methodologic data—method of polysomnographic monitoring (in-lab, unattended) and sleep scoring (i.e., Rechtschaffen and Kales); elements of bias protection, such as allocation concealment, blinding, proportions of patients lost to follow-up
• Outcome data—the specific surgical procedure, change in the apnea-hypopnea index (AHI), assessment of or change in validated secondary outcomes such as daytime sleepiness (Epworth Sleepiness Scale) or quality of life, major complications, or death.

The data tables are available online at www.aasmnet.org .

79 studies were included.

Criteria for Assigning Grade of Evidence*

Type of Evidence

• Randomized trial: High
• Observational study: Low
• Any other evidence: Very low

Decrease Grade if:

• Serious (-1) or very serious (-2) limitation to study quality
• Important inconsistency (-1)
• Some (-1) or major (-2) uncertainty about directness
• Imprecise or sparse data (-1)
• High probability of reporting bias (-1)

Increase Grade if:

• Strong evidence of association - significant relative risk >2 (<0.5) based on consistent evidence from two or more observational studies, with no plausible confounders (+1)
• Very strong evidence of association - significant relative risk of >5 (<0.2) based on direct evidence with no major threats to validity (+2)
• Evidence of a dose response gradient (+1)
• All plausible confounders would have reduced the effect (+1)

*From Atkins D, Best D, Briss PA, et al. Grading and quality of evidence and strength of recommendations. BMJ 2004;328:1490-4.

Final Assessments of Evidence of Grade

High (Level 4): Further research is very unlikely to change confidence in the estimate of effect

Moderate (Level 3): Further research is likely to have an important impact on the confidence in the estimate of effect and may change the estimate

Low (Level 2): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate

Very Low (Level 1): Any estimate of effect is very uncertain

Statistical Analysis: Meta-analysis

To describe the effect of surgery on apnea-hypopnea index (AHI), we used a relative measure of effect, the ratio of means (ROM), which describes the extent to which the mean postoperative AHI has changed compared to the mean AHI before surgery. ROM from each study were pooled across studies—rendering a pooled ROM and its associated 95% confidence interval (CI)—using the inverse variance method for random effects meta-analysis as implemented in RevMan 5.0 (Cochrane Collaboration, 2009), as described by Friedrich and colleagues. To interpret this measure, readers can subtract the ratio of mean from 1 and multiply the result times 100 to obtain the percentage change in AHI with surgery, a procedure akin to the estimation of relative risk reduction from measures of relative risk. We used the I² statistic, which estimates the percentage of total variation across studies that is due to heterogeneity rather than chance to describe the consistency of estimates of effect across studies. This statistic reflects the proportion of the observed variability that may be due to true differences in these studies, including differences in subject characteristics, their selection by the surgeon, the surgical technique, and sleep study methodology, quality, and scoring.

The authors felt that pooling of data was most appropriate for outcomes of a specific type of surgical intervention. In general, this was most feasible with studies of solitary procedures, some of which involve a standardized surgical approach, that address a specific anatomic target. On the other hand, the authors do recognize the growing interest in the performance of multiple interventions which may target various points of airway collapse, either simultaneously or in phased surgeries. However, because the literature on such procedures describes highly varied and heterogeneous surgical approaches, the authors chose not to pool such data. The authors would refer the reader to two systematic review papers on multi-level surgeries by Kezirian et al. and Lin et al. that reported on some outcomes in aggregate.

Because so few papers independently analyzed the influence of subgroups of variables (such as age, gender, body mass index [BMI], and severity of sleep apnea at baseline) on surgical outcomes, these data were not available to the authors to conduct pooled subgroup analyses or to detect prognostic variables that would affect the outcomes of the different surgical procedures.

Because of the small number of studies in each subgroup, and the substantial heterogeneity in outcomes between studies of each surgical procedure, the authors considered a funnel plot unreliable to aid in the determination of the presence or absence of publication bias.

A Task Force of content experts was assembled by the American Academy of Sleep Medicine (AASM) in July 2007 to review evidence in the scientific literature regarding surgical therapies for obstructive sleep apnea (OSA). In most cases recommendations are based on that systemic review of evidence from studies published in the peer-reviewed literature. Some recommendations, when appropriate, have been carried forward from the previous practice parameter document with little or no change.

A formal cost analysis was not performed and published cost analyses were not reviewed.

The clinical guidelines were reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine. They were submitted and accepted for publication in May 2010.

The grade of evidence (High, Moderate, Low, Very Low) and the levels of recommendations (Standard, Guideline, Option) are defined at the end of the "Major Recommendations" field.

Diagnosis

1. The presence and severity of obstructive sleep apnea (OSA) must be determined before initiating surgical therapy (Standard).
2. The patient should be advised about potential surgical success rates and complications, the availability of alternative treatment options such as nasal positive airway pressure and oral appliances, and the levels of effectiveness and success rates of these alternative treatments (Standard).

Treatment Objective

1. The desired outcomes of treatment include resolution of the clinical signs and symptoms of obstructive sleep apnea and the normalization of sleep quality, the apnea-hypopnea index (AHI), and oxyhemoglobin saturation levels (Standard).

Surgical Procedures

1. Tracheostomy: Tracheostomy has been shown to be an effective single intervention to treat obstructive sleep apnea. This operation should be considered only when other options do not exist, have failed, are refused, or when this operation is deemed necessary by clinical urgency (Option).
2. Maxillo-Mandibular Advancement (MMA): MMA is indicated for surgical treatment of severe OSA in patients who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances, which are more often appropriate in mild and moderate OSA patients, have been considered and found ineffective or undesirable (Option).
3. Uvulopalatopharyngoplasty (UPPP) as a single surgical procedure: UPPP as a sole procedure, with or without a tonsillectomy, does not reliably normalize the apnea-hypopnea index (AHI) when treating moderate to severe obstructive sleep apnea syndrome. Therefore, patients with severe OSA should initially be offered positive airway pressure therapy, while those with moderate OSA should initially be offered either positive airway pressure (PAP) therapy or oral appliances (Option).
4. Multi-Level of Stepwise Surgery (MLS): Use of MLS, as a combined procedure or as stepwise multiple operations, is acceptable in patients with narrowing of multiple sites in the upper airway, particularly if they have failed uvulopalatopharyngoplasty as a sole treatment (Option).
5. Laser Assisted Uvulopalatoplasty (LAUP): LAUP is not routinely recommended as a treatment for obstructive sleep apnea syndrome (Standard).
6. Radiofrequency Ablation (RFA): RFA can be considered as a treatment in patients with mild to moderate obstructive sleep apnea who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances have been considered and found ineffective or undesirable (Option).
7. Palatal Implants: Palatal implants may be effective in some patients with mild obstructive sleep apnea who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances have been considered and found ineffective or undesirable (Option).

Follow-up

Postoperatively, after an appropriate period of healing, patients should undergo follow-up evaluation including an objective measure of the presence and severity of sleep-disordered breathing and oxygen saturation, as well as clinical assessment for residual symptoms. Additionally, patients should be followed over time to detect the recurrence of disease (Standard).

Definitions:

Criteria for Assigning Grade of Evidence*

Type of Evidence

• Randomized trial: High
• Observational study: Low
• Any other evidence: Very low

Decrease Grade if:

• Serious (-1) or very serious (-2) limitation to study quality
• Important inconsistency (-1)
• Some (-1) or major (-2) uncertainty about directness
• Imprecise or sparse data (-1)
• High probability of reporting bias (-1)

Increase Grade if:

• Strong evidence of association - significant relative risk >2 (<0.5) based on consistent evidence from two or more observational studies, with no plausible confounders (+1)
• Very strong evidence of association - significant relative risk of >5 (<0.2) based on direct evidence with no major threats to validity (+2)
• Evidence of a dose response gradient (+1)
• All plausible confounders would have reduced the effect (+1)

*From Atkins D, Best D, Briss PA, et al. Grading and quality of evidence and strength of recommendations. BMJ 2004;328:1490-4.

Final Assessments of Evidence of Grade

High (Level 4): Further research is very unlikely to change confidence in the estimate of effect

Moderate (Level 3): Further research is likely to have an important impact on the confidence in the estimate of effect and may change the estimate

Low (Level 2): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate

Very Low (Level 1): Any estimate of effect is very uncertain

None provided

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

The desired outcomes of treatment include resolution of the clinical signs and symptoms of obstructive sleep apnea and the normalization of sleep quality, the apnea-hypopnea index, and oxyhemoglobin saturation levels.

These practice parameters define principles of practice that should meet the needs of most patients in most situations. These guidelines should not, however, be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding propriety of any specific care must be made by the physician, in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources.

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

American Academy of Sleep Medicine

Standards of Practice Committee

Committee Members: R. Nisha Aurora, MD; Kenneth R. Casey, MD; David Kristo, MD; Sanford Auerbach, MD; Sabin R. Bista, MD; Susmita Chowdhuri, MD; Anoop Karippot, MD; Carin Lamm, MD; Kannan Ramar, MD; Rochelle Zak, MD; Timothy I. Morgenthaler, MD

All members of the American Academy of Sleep Medicine Standards of Practice Committee (AASM SPC) and Board of Directors completed detailed conflict-of-interest statements and were found to have no conflicts of interest with regard to this subject.

This was not an industry supported study. Dr. Morgenthaler has received research support from ResMed. Dr. Auerbach has participated in research supported by Sepracor and participated in a speaking engagement for Forest Pharmaceuticals. Dr. Karippot has received research support from Wyeth and is Medical Director of Akane Sleep Solutions, Inc., a sleep disorders clinic and laboratory. The other authors have indicated no financial conflicts of interest.

This is the current release of this guideline.

This guideline updates a previous version: American Sleep Disorders Association. Practice parameters for the treatment of obstructive sleep apnea in adults: the efficacy of surgical modifications of the upper airway. Sleep - Europe. 1996 Feb;19(2):152-5.

Electronic copies: Available in Portable Document Format (PDF) from the American Academy of Sleep Medicine (AASM) Web site .

Print copies: Available from the Standards of Practice Committee, American Academy of Sleep Medicine, 2510 North Frontage Road, Darien, IL 60561. Web site: www.aasmnet.org .

The following is available:

• Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep 2010 May;33(10):1408-1413. Electronic copies: Available from the American Academy of Sleep Medicine Web site .

Print copies: Available from the Standards of Practice Committee, American Academy of Sleep Medicine, 2510 North Frontage Road, Darien, IL 60561. Web site: www.aasmnet.org .

None available

This summary was completed by ECRI on April 25, 1999. The information was verified by the guideline developer on May 24, 1999. This NGC summary was updated by ECRI Institute on January 6, 2011. The updated information was verified by the guideline developer on February 7, 2011.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please contact the American Academy of Sleep Medicine (AASM) for information regarding reproduction of AASM guidelines.