PRACTICE PARAMETERS FOR SURGERY FOR OSA IN ADULTS Practice .

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PRACTICE PARAMETERS FOR SURGERY FOR OSA IN ADULTSPractice Parameters for the Surgical Modifications of the Upper Airway forObstructive Sleep Apnea in AdultsR. Nisha Aurora, MD1; Kenneth R. Casey, MD2; David Kristo, MD3; Sanford Auerbach, MD4; Sabin R. Bista, MD5; Susmita Chowdhuri, MD6;Anoop Karippot, MD7; Carin Lamm, MD8; Kannan Ramar, MD9; Rochelle Zak, MD10; Timothy I. Morgenthaler, MD9Mount Sinai School of Medicine, New York, NY; 2Cincinnati Veterans Affairs Medical Center, Cincinnati, OH; 3University of Pittsburgh, Pittsburgh, PA;Boston University School of Medicine, Boston, MA; 5University of Nebraska Medical Center, Omaha, NE; 6Sleep Medicine Section, John D. Dingell VAMedical Center, Detroit, MI; 7Penn State University Hershey Medical Center, Hershey, PA and University of Louisville School of Medicine, Louisville,KY; 8Children’s Hospital of NY – Presbyterian, Columbia University Medical Center, New York, NY; 9Mayo Clinic, Rochester, MN; 10Sleep DisordersCenter, University of California, San Francisco, San Francisco, CA14Background: Practice parameters for the treatment of obstructive sleep apnea syndrome (OSAS) in adults by surgical modification of the upper airwaywere first published in 1996 by the American Academy of Sleep Medicine (formerly ASDA). The following practice parameters update the previouspractice parameters. These recommendations were reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine.Methods: A systematic review of the literature was performed, and the GRADE system was used to assess the quality of evidence. The findingsfrom this evaluation are provided in the accompanying review paper, and the subsequent recommendations have been developed from this review.The following procedures have been included: tracheostomy, maxillo-mandibular advancement (MMA), laser assisted uvulopalatoplasty (LAUP),uvulopalatopharyngoplasty (UPPP), radiofrequency ablation (RFA), and palatal implants.Recommendations: The presence and severity of obstructive sleep apnea must be determined before initiating surgical therapy (Standard). Thepatient should be advised about potential surgical success rates and complications, the availability of alternative treatment options such as nasalpositive airway pressure and oral appliances, and the levels of effectiveness and success rates of these alternative treatments (Standard). Thedesired outcomes of treatment include resolution of the clinical signs and symptoms of obstructive sleep apnea and the normalization of sleepquality, the apnea-hypopnea index, and oxyhemoglobin saturation levels (Standard). Tracheostomy has been shown to be an effective singleintervention 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). MMA is indicated for surgical treatment of severe OSA in patients whocannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances, which are more often appropriatein mild and moderate OSA patients, have been considered and found ineffective or undesirable (Option). UPPP as a sole procedure, with or without tonsillectomy, does not reliably normalize the AHI when treating moderate to severe obstructive sleep apnea syndrome. Therefore, patientswith severe OSA should initially be offered positive airway pressure therapy, while those with moderate OSA should initially be offered either PAPtherapy or oral appliances (Option). Use of multi-level or stepwise surgery (MLS), as a combined procedure or as stepwise multiple operations, isacceptable in patients with narrowing of multiple sites in the upper airway, particularly if they have failed UPPP as a sole treatment (Option). LAUPis not routinely recommended as a treatment for obstructive sleep apnea syndrome (Standard). RFA can be considered as a treatment in patientswith mild to moderate obstructive sleep apnea who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whomoral appliances have been considered and found ineffective or undesirable (Option). Palatal implants may be effective in some patients with mildobstructive sleep apnea who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances havebeen considered and found ineffective or undesirable (Option). Postoperatively, after an appropriate period of healing, patients should undergofollow-up evaluation including an objective measure of the presence and severity of sleep-disordered breathing and oxygen saturation, as wellas clinical assessment for residual symptoms. Additionally, patients should be followed over time to detect the recurrence of disease (Standard).Conclusions: While there has been significant progress made in surgical techniques for the treatment of OSA, there is a lack of rigorous data evaluatingsurgical modifications of the upper airway. Systematic and methodical investigations are needed to improve the quality of evidence, assess additionaloutcome measures, determine which populations are most likely to benefit from a particular procedure or procedures, and optimize perioperative care.Keywords: Obstructive sleep apnea, surgical modifications, maxillo-mandibular advancement, uvulopalatopharyngoplasty, multi-level surgeryCitation: Aurora RN; Casey KR; Kristo D; Auerbach S; Bista SR; Chowdhuri S; Karippot A; Lamm C; Ramar K; Zak R; Morgenthaler TI. Practiceparameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. SLEEP 2010;33(10):1408-1413.to lifestyle modifications such as weight loss, avoidance of alcohol or other agents that can decrease upper airway patency,and implementation of positional therapy, the main therapeutic options include positive airway pressure therapy (PAP),oral appliances, and surgical procedures.5 For most individuals, PAP therapy remains the preferable first-line treatment forOSA. However, a significant proportion of patients are unableto tolerate PAP therapy and seek alternate treatment.6 Practiceparameters for the treatment of OSA in adults by surgical modification of the upper airway were first published in 1996 bythe AASM (formerly ASDA).7 The 1996 practice parameterswere based on a systematic review that accompanied the publication.8 Recently a series of clinical guidelines for the compre-1.0 INTRODUCTIONObstructive sleep apnea (OSA) is a syndrome characterizedby repetitive upper airway collapse or narrowing. Sequelae include adverse cardiovascular and metabolic outcomes, declinein quality of life, and neurocognitive impairment.1-4 In additionSubmitted for publication May, 2010Accepted for publication May, 2010Address correspondence to: Sharon L. Tracy, PhD, American Academy ofSleep Medicine, 2510 North Frontage Road, Darien, IL 60561-1511; Tel:(630) 737-9700; Fax: (630) 737-9790; E-mail: stracy@aasmnet.orgSLEEP, Vol. 33, No. 10, 20101408Practice Parameters—Aurora et al

Box 1—Criteria for assigning grade of evidence11Final standardsof practicerecommendationsType of evidence Randomized trial Observational study Any other evidenceAssessment of benefit/harm/burdenTable 1—AASM levels of recommendationsOverall quality of evidenceHighModerateLowVery LowBenefits clearlyoutweigh harm/burdenStandardStandardGuidelineBenefits closelybalanced withharm/burdenORuncertainty inthe estimates rdStandardStandardOptionDecrease 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 observationalstudies, 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)hensive management of sleep apnea in adults were developedat the request of the AASM Board of Directors. These guidelines included surgical modification of the upper airway butwere based largely on expert consensus and were not intendedto reflect a systematic evidence-based analysis. The Standardsof Practice Committee of the AASM appointed a task force in2007 to assist in an update of these practice parameters, theresult of which is the accompanying review paper.9Box 2—Final assessments of evidence of gradeHigh (Level 4): Further research is very unlikely to change confidencein the estimate of effectModerate (Level 3): Further research is likely to have an importantimpact on the confidence in the estimate of effect and may change theestimateLow (Level 2): Further research is very likely to have an importantimpact on our confidence in the estimate of effect and is likely tochange the estimateVery low (Level 1): Any estimate of effect is very uncertain2.0 METHODSThe Standards of Practice Committee (SPC) of the AASM, inconjunction with specialists and other interested parties, developed these practice parameters based on the accompanying review paper. A Task Force of content experts was assembled by theAASM in July 2007 to review evidence in the scientific literatureregarding surgical therapies for OSA. In most cases recommendations are based on that systematic review of evidence from studiespublished in the peer-reviewed literature. Some recommendations, when appropriate, have been carried forward from the previous practice parameters document with little or no change.The Board of Directors of the AASM approved these recommendations. All members of the AASM SPC and Board of Directors completed detailed conflict-of-interest statements and werefound to have no conflicts of interest with regard to this subject.These practice parameters define principles of practice thatshould meet the needs of most patients in most situations. Theseguidelines should not, however, be considered inclusive of allproper methods of care or exclusive of other methods of carereasonably directed to obtaining the same results. The ultimatejudgment regarding propriety of any specific care must bemade by the physician, in light of the individual circumstancespresented by the patient, available diagnostic tools, accessibletreatment options, and resources.The AASM expects these guidelines to have an impact on professional behavior, patient outcomes, and, possibly, health carecosts. These practice parameters reflect the state of knowledgeat the time of publication and will be reviewed, updated, andrevised as new information becomes available. This parameterpaper is referenced, where appropriate, using square-bracketednumbers to the relevant sections and tables in the accompanying review paper, or with additional references at the end ofSLEEP, Vol. 33, No. 10, 2010HighLowVery Lowthis paper. This practice parameter represents the first AASMdocument based on a systematic review which used the GRADEmethod of evaluating evidence quality.10 The classification ofevidence using the GRADE process is listed in Boxes 1 and 2.11Definitions of levels of recommendations used by the AASMappear in Table 1. Sections titled “Values and Trade-offs” appear under each individual practice parameter. The Valuesand Trade-offs discussion elucidates the rationale leading toeach recommendation. These sections are an integral part ofthe GRADE system and offer transparency to the process.103.0 BACKGROUNDClassic upper airway surgical techniques such as nasal-septalreconstruction, cauterization, and tonsillectomy frequently failto correct OSA.8 Consequently, specialized surgical techniquesfor treating OSA have been developed which modify either orboth the retropalatal and retrolingual areas. Historically, patterns of airway narrowing or collapse have been classified inthe following manner: Type I collapse involves narrowing ofthe retropalatal region; Type II includes narrowing or collapseof both the retropalatal and retrolingual areas; and Type III collapse occurs only in the retrolingual area.12 However, it is oftendifficult to definitively identify the area of collapse and multiplesites may be involved.1409Practice Parameters—Aurora et al

4.0 RECOMMENDATIONSThe classification of evidence was made using GRADE(Boxes 1 and 2).11 Recommendations are given as Standards,Guidelines, and Options, as defined in Table 1.Tracheostomy can be described as an upper airway bypassprocedure. Soft tissue ablation procedures intended to enhancepatency of the retropharyngeal area include uvulopalatopharyngoplasty (UPPP) and laser-assisted uvulopalatoplasty (LAUP).Retrolingual tissue ablation procedures include laser midlineglossectomy/lingualplasty (LMG), radiofrequency tongue baseablation (RFTBA), and tongue base reduction with hyoepiglottoplasty (TBRHE). Uvulopalatopharyngoglossoplasty (UPPGP) performs tissue ablation to enhance both the retropalataland retrolingual spaces. Procedures to reposition soft tissue toimprove retrolingual patency include mandibular advancement(MA), genioglossal advancement (GA), hyoid myotomy andsuspension of hyoid from mandible (HM-1), and hyoid myotomy and attachment of hyoid to thyroid cartilage (HM-2). Finally, maxillomandibular advancement (MMA) is intended toimprove patency of both retropalatal and retrolingual spaces.12The literature related to this wide array of procedures islargely descriptive in nature and is not amenable to a systematic,evidence-based review of efficacy and/or safety. Therefore, thecurrent practice parameters are limited to a subset of proceduresthat are performed more frequently and for which some evaluable literature is available. Seventy-nine papers were includedin the accompanying review9 of which 4 were RCT (3 singleprocedures and 1 multi-level procedure) and 75 were case series.Of the case series, 44 were single procedures and 31 multi-level.Therefore, there were 47 papers that looked at single procedures.The following procedures will be reviewed here:3.1 Tracheostomy: This procedure consists of creating anopening in the trachea for placement of a long termindwelling tube or stoma for ventilation, thereby bypassing upper airway obstruction causing OSA.3.2 Maxillomandibular advancement (MMA): this operation involves simultaneous advancement of the maxilla and mandible through sagittal split osteotomies. Itprovides enlargement of the retrolingual airway andsome advancement of the retropalatal airway.3.3 Uvulopalatopharyngoplasty (UPPP): This procedure enlarges the retropalatal airway through trimming and reorienting of the posterior and anterior tonsillar pillars andexcision of the uvula and posterior portion of the palate.3.4 Laser assisted uvulopalatoplasty (LAUP): This procedure consists of placing bilateral vertical incisionsor trenches directly along both sides of the uvula followed by laser ablation of the uvula.3.5 Radiofrequency ablation (RFA): Radiofrequency ablation consists of placement of a temperature controlledradiofrequency probe typically in the tongue and/orsoft palate in an effort at palatal stiffening.3.6 Soft palatal implants: this procedure consists of implanting malleable plastic rods into the soft palate under local anesthesia.3.7 Multi-level or stepwise surgery (MLS): This categoryincludes a wide array of combined procedures to address narrowing of multiple sites in the upper airway.MLS frequently consists of phase I utilizing UPPP,and or genioglossus advancement and hyoid myotomy(GAHM). Phase II surgeries consist of utilizing maxillary and mandibular advancement osteotomy (MMO),offered to those failing phase I surgeries.SLEEP, Vol. 33, No. 10, 20104.1 Diagnosis4.1.1 The presence and severity of obstructive sleep apnea must bedetermined before initiating surgical therapy (Standard).Detailed diagnostic criteria for obstructive sleep apnea areavailable and include signs, symptoms, and the findings ofpolysomnography.13Values and Trade-offs: This recommendation has notchanged from the previous practice parameter paper. A properdiagnosis of OSA ought to be determined prior to surgery forsleep apnea; to do otherwise exposes patients to needless risk.Thus, even though there is not “evidence” in the sense of studies evaluating the performance of surgery for sleep apnea inpatients with and without OSA, this recommendation deservesthe “Standard” level.4.1.2 The patient should be advised about potential surgicalsuccess rates and complications, the availability of alternativetreatment options such as nasal positive airway pressure and oralappliances, and the levels of effectiveness and success rates ofthese alternative treatments (Standard).Values and Trade-offs: This recommendation is not changedfrom the prior practice parameter paper. The committee valuesthe ethical principles of patient autonomy and safety, and thusfeels that it is imperative that all reasonable treatment alternatives for OSA be discussed in a manner that allows the patientto make an informed decision.4.2 Treatment ObjectiveThe desired outcomes of treatment include resolution of theclinical signs and symptoms of obstructive sleep apnea and thenormalization of sleep quality, the apnea-hypopnea index, andoxyhemoglobin saturation levels (Standard).Values and Trade-offs. This recommendation is unchangedfrom the previous practice parameter. OSA is a multisystemdisorder affecting neurocognitive, metabolic, and cardiovascular function as well as quality of life. The AHI does not encompass all dimensions of OSA. However, an abnormal AHIis currently necessary for disease classification, and normalization is logically an important treatment objective. Normalization of AHI does not necessarily reverse all components ofOSA. Up to 22% have residual hypersomnia after normalization of the AHI with PAP therapy,14 and some studies indicatethere are permanent neuroanatomic effects of OSA in someindividuals.15 Nonetheless, even modest elevations of the AHIcorrelate with elevated risk of cardiovascular sequelae, symptoms, and neurocognitive effects.16 Most studies demonstratingbenefit in cardiovascular risk, mortality, symptoms, and neurocognitive effects show substantial improvement in AHI.17,18Other endpoints such as subjective and objective symptommelioration and improved quality of life are also important dimensions of health, and their correlation with mortality has notbeen well studied. For all these reasons, we have placed a high1410Practice Parameters—Aurora et al

4.3.3 Uvulopalatopharyngoplasty (UPPP) as a single surgicalprocedure: UPPP as a sole procedure, with or withouttonsillectomy, does not reliably normalize the AHI when treatingmoderate to severe obstructive sleep apnea syndrome. Therefore,patients with severe OSA should initially be offered positive airwaypressure therapy, while those with moderate OSA should initiallybe offered either PAP therapy or oral appliances. [Review Section3.2.1; 3.2.2; Figure 4, 5; Table 2] (Option).value on normalization of the AHI in rating efficacy of treatments for OSA.4.3 Surgical Procedures4.3.1 Tracheostomy: Tracheostomy has been shown to be aneffective single intervention to treat obstructive sleep apnea. Thisoperation should be considered only when other options do notexist, have failed, are refused, or when this operation is deemednecessary by clinical urgency (Option).This is a change from the previous practice parameter whichrecommended UPPP for patients with narrowing or collapse ofthe retropalatal area. We now recommend that more reliabletreatment modalities be preferred in patients with moderate tosevere OSA. It is important to note that this recommendationapplies to t

1Mount Sinai School of Medicine, New York, NY; 2Cincinnati Veterans Affairs Medical Center, Cincinnati, OH; 3University of Pittsburgh, Pittsburgh, PA; 4 Boston University School of Medicine, Boston, MA; 5 University of Nebraska Medical Center, Omaha, NE; 6 Sleep Medicine Section, John D. Dingell VA

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