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Medical Policy

Surgery Section - Surgeries for Snoring, Obstructive Sleep Apnea Syndrome and Upper Airway Resistance Syndrome In Adults

Topic:  Surgeries for Snoring, Obstructive Sleep Apnea Syndrome and Upper Airway Resistance Syndrome In Adults Date of Origin:  03/31/2009
Section: Surgery Policy No:  166
Approved Date:  06/09/2009 Effective Date:  07/01/2009
Next Review Date:  07/2010  
 


IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

DESCRIPTION

Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea syndrome may be present when a person repeatedly stops breathing (apnea) for at least 10 seconds or longer during sleep. These apneic episodes are followed by lack of adequate oxygen intake with brief awakenings and usually occur many times during the night. Hypopnea, or reduced airflow, may also occur with OSA.  Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in airflow and a fall in oxygen saturation of a least 3%-4%.  OSA is caused by a blockage of the airway, usually when the soft tissue at the back of the throat collapses during relaxed sleep, closing off the airway. The hallmark clinical symptom of OSA is excessive snoring, although it is important to note that snoring can occur in the absence of OSA.

A polysomnogram performed in a sleep laboratory is considered the gold standard test used to diagnose OSA. The apnea index consists of the total number of apneic events per hour of sleep.  Apneic and hypopneic events are combined into the apnea-hypopnea index (AHI) which may also be referred to as the respiratory disturbance index (RDI). When sleep onset and offset are unknown, the RDI may be calculated based on the total recording time. The final diagnosis of OSA rests on a combination of objective and subjective criteria (e.g. AHI and excessive daytime sleepiness) that seek to identify those levels of obstruction which are clinically significant.  The following AHI levels are used for the diagnosis of OSA:

  • AHI between 5 and 15 is considered mild sleep apnea.
  • An AHI of greater than or equal to 15 is typically considered moderate OSA
  • AHI of greater than 50 is considered severe OSA

An increase in mortality is associated with an AHI greater than 15. More difficult to evaluate is the clinical significance of patients with mild sleep apnea.  Mortality has not been shown to be increased in these patients, and frequently the most significant manifestations reported by the patient are snoring, excessive daytime sleepiness, or hypertension. Isolated snoring in the absence of medical complications, while troubling to the patient’s bed partner, is not considered a medical problem requiring surgical intervention.

Upper airway resistance syndrome (UARS)

Upper airway resistance syndrome (UARS) is a variant of OSA which is characterized by a partial collapse of the airway resulting in increased resistance to airflow. Snoring may not be a feature of UARS. The resistance to airflow does not result in stopped breathing. The increased respiratory effort required to move air into the lungs results in fragmented sleep.

Diagnosis of UARS is more subtle than OSA. This sleep disturbance can be measured by electroencephalogram (EEG) and a drop in airway pressure in the chest as measured by a variety of tests including use of an esophageal manometer as part of a polysomnogram. Diagnosis of UARS rests on documentation of >10 EEG arousals per hour of sleep along with documented episodes of reduced intrathoracic pressure associated with the EEG arousals. The presence of abnormally negative intrathoracic pressures (i.e., more negative than -10 cm) in conjunction with the EEG arousals supports the UARS diagnosis. Since not all sleep labs have access to esophageal manometry, esophageal manometry is not required to confirm UARS.

See Appendix 1 for additional information on diagnostic tests for OSA and UARS.

Surgical Treatments for OSA and UARS

Medical therapy is considered the first-line treatment for OSA and UARS. These therapies include weight loss, various continuous positive airway pressure (CPAP) devices, or orthodontic repositioning devices. See Appendix 2 for a description of medical devices used in the treatment of OSA and UARS.  Most guidelines consider surgical intervention only after all medical treatments for OSA or UARS have failed.

Uvulopalatopharyngoplasty (UPPP)

Conventional surgeries for OSA include uvulopalatopharyngoplasty (UPPP) and a variety of maxillofacial surgeries such as mandibular-maxillary advancement (MMA).  UPPP involves surgical resection of the mucosa and submucosa of the soft palate, tonsillar fossa, and the lateral aspect of the uvula.  The UPPP procedure enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Thus patients who fail UPPP may be candidates for additional procedures such as mandibular and maxillary advancement surgery.

Mandibular and maxillary advancement surgery (MMA)

Mandibular and maxillary advancement surgeries are more extensive and proposed for patients who do not have an adequate response to UPPP.  These surgeries may be used to correct obstruction of the hypopharynx, the area at the very back of the throat.

Laser assisted uvuloplasty (LAUP)

LAUP is an outpatient alternative that has been proposed as a treatment of snoring with or without associated OSA. In this procedure, the tissues of the soft palate (palatal tissues) are reshaped using a laser. The extent of the surgery is typically different than standard UPPP, since only part of the uvula and associated soft-palate tissues are reshaped. The procedure, as initially described, does not remove or alter tonsils or lateral pharyngeal wall tissues. The patient undergoes from 3 to 7 sessions at 3- to 4-week intervals LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser simply representing a surgical tool that the physician may opt to use. LAUP is considered a unique procedure, raising unique issues of safety and effectiveness.

Radiofrequency ablation of the soft palate/volumetric reduction of the tongue base (RFTBR)

Radiofrequency ablation of the soft palate and tongue is similar in concept to LAUP, although a different energy source is used.  Radiofrequency energy is used to produce thermal lesions within the tissues, rather than using a laser to ablate the tissue surface, which may be painful. These procedures may also be referred to as a somnoplasty after the Somnoplastysm System device (Somnus Medical Technologies, Sunnyvale, CA) which was FDA approved through the 510(k) process.

Cautery assisted palatal stiffening procedure (CAPSO)

This palatal stiffening procedure uses cautery (electrically heated probes) to induce a midline palatal scar designed to stiffen the soft palate to eliminate excessive snoring.

Pillar palatal implant procedure

The Pillar™ Palatal Implant System (Restore Medical, St. Paul, MN) is an implantable cylindrical-shaped device that is permanently implanted in the soft palate (the soft area at the back of the upper mouth). The device was cleared for marketing by the FDA through the 510(k) process with the  labeled indication  as follows:

“The Pillar™ Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (obstructive sleep apnea).”

Suspension of the tongue base

The Repose™ device involves the use of a titanium screw which is inserted into the posterior aspect of the lower jaw at the floor of the mouth.  A loop of suture is passed through the tongue base and attached to the mandibular bone screw. The Repose™ procedure achieves a suspension or hammock of the tongue base making it less likely for the base of the tongue to drop backward during sleep.

Uvulectomy

This procedure surgically removes the uvula, the small tissue hanging from the soft palate at the back of the throat above the tongue.  The uvula, which helps stiffen and shape the back of the throat and prevents food from going down the airway, is believed to be associated with excessive snoring.

Partial Glossectomy

This procedure surgically removes of a portion of the tongue or oral cavity in an effort to widen the hypopharynx.

POLICY/CRITERIA

  1. Surgical Treatment of Snoring Alone

    Surgical intervention for the treatment of snoring in the absence of documented obstructive sleep apnea is considered not medically necessary.

  2. Surgical Treatment of Obstructive Sleep Apnea (OSA) and Upper Airway Resistance Syndrome (UARS)

    1. Procedures

      1. The following procedures may be considered medically necessary for the treatment of OSA and UARS when the criteria in either II.B and II.C or  II.B and II.D below are met:

        1. Hyoid suspension
        2. Mandibular-maxillary advancement (MMA) when there is objective documentation of hypopharyngeal obstruction
        3. Uvulopalatopharyngoplasty (UPPP) with or without inferior sagittal osteotomy with hyoid suspension

      2. All other procedures are considered investigational as treatments of OSA or UARS, including but not limited to:

        1. Uvulectomy
        2. Partial glossectomy
        3. Radiofrequency volumetric tissue reduction of the tongue base or palatal tissues
        4. Tongue base suspension procedures, including but not limited to the Repose™
        5. Laser-assisted palatoplasty (LAUP) or volumetric tissue reduction
        6. Palatal stiffening procedures such as cautery-assisted palatal stiffening operation (CAPSO)
        7. Implantation of palatal implants (also known as the pillar procedure).

    2. Failed Medical Therapy

      All of the following medical therapies have failed:

      1. Nasal CPAP – An adequate CPAP trial must be documented.  An adequate CPAP trial is defined as a minimum of four hours per night for three weeks of CPAP usage and documentation of reasonable attempts to address any problems associated with CPAP.  (Problems may include lack of improvement in apnea/hypopnea or persistent excessive daytime sleepiness, severe adverse nasal or sinus reaction to CPAP not controlled with medication and humidification, or severe psychological aversion to CPAP not responsive to a desensitization program).
      2. Maximal medical treatment of any underlying disease
      3. Adjustment in sleep position
      4. Avoidance of alcohol and sedative drugs

    3. Obstructive Sleep Apnea

      The patient has clinically significant OSA as defined below

      1. An AHI equal to or greater than 15; OR
      2. An AHI between 5 and 14 with any of the following associated symptoms:

        1. Excessive daytime sleepiness that is not better explained by other factors
        2. Documented hypertension
        3. Ischemic heart disease or congestive heart failure
        4. History of stroke
        5. Obesity
        6. Diabetes and glucose intolerance
        7. Two or more of the following that are not better explained by other factors:

          1. Choking or gasping during sleep
          2. Recurrent awakenings during sleep
          3. Unrefreshing sleep with daytime fatigue
          4. Impaired concentration or cognition
          5. Insomnia

    4. Upper Airway Resistance Syndrome

      The patient has clinically significant UARS defined as greater than 10 alpha EEG arousals per hour.

Note:  Some member contracts have specific benefit limitations for orthognathic surgery.

POSITION SUMMARY

  • Snoring in the absence of clinically significant OSA is not considered a medical condition. Therefore, any surgical intervention such as UPPP, LAUP, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, for snoring alone is considered not medically necessary.
  • Conventional uvulopalatalpharyngoplasty (UPPP) and maxillofacial surgeries such as mandibular-maxillary advancement (MMA) may improve health outcomes for some patients with OSA.  These surgical treatments are considered only after failed medical therapy and failed CPAP trials.
  • Evidence is uncertain for use of any other surgical interventions in the treatment of OSA including but not limited to uvulectomy, partial glossectomy, tongue base reduction and minimally invasive surgical procedures such as laser-assisted uvuloplasty (LAUP), radiofrequency tongue base or tissue volume reduction, pillar stiffening procedures and pillar implants.

Effectiveness

The evidence suggests conventional uvulopalatalpharyngoplasty (UPPP) and maxillofacial surgeries such as mandibular-maxillary advancement (MMA) may improve health outcomes for some patients with OSA who have failed medical therapies for OSA.

  • The available evidence does not currently support the widespread use of surgical interventions in the management of unselected patients with obstructive sleep apnea. Given the proven efficacy of CPAP in patients with moderate and severe symptoms and significant sleep disordered breathing, surgery cannot be recommended as a front line therapy, ahead of positive airways pressure systems. (4,5,6)
  • While studies on UPPP and hyoid suspension procedures were not randomized, data from ten studies which included more than 750 patients consistently reported improved outcomes for patients with OSA as measured by postoperative polysomnographic assessment of sleep disturbance and compared with concurrent groups being treated with CPAP. (7)
  • UPPP and MMA procedures are widely practiced among surgeons in the United States. These procedures have been considered a standard of care in the medical community. (7)
  • American Academy of Sleep Medicine (AASM) Practice Parameters suggest UPPP is treatment of choice for those not responding to medical therapy. (8)

Evidence is uncertain for use of any other surgical interventions in the treatment of OSA, including but not limited to uvulectomy, partial glossectomy, tongue base reduction and minimally invasive surgical procedures such as laser-assisted uvuloplasty (LAUP), radiofrequency tongue base reduction (RFTBR), pillar stiffening procedures and pillar implants.

  • A recently updated Cochrane review on surgery for OSA reports there are a limited number of trials assessing diverse surgical techniques. Inconsistent effects were reported across all trials. The report concludes evidence from these small studies does not currently support the widespread use of surgery in people with mild to moderate daytime symptoms associated with sleep apnea. (5)
  • Most trials are limited to unreliable case series and retrospective reviews that do not permit conclusions on the effectiveness or safety of these procedures for the treatment of OSA and UARS. Lack of comparison groups, randomization, and failure to define study endpoints or treatment success prior to commencement may introduce bias in favor of the new technology. In addition, retrospective study designs do not allow for control of co-treatments or confounding factors that may influence results. (5,7-9,10-36)
  • Results reported in published randomized studies do not show a consistent benefit across all trials. In addition, conclusions cannot be reached on safety and effectiveness from these trials due poor study design including small sample size, lack of blinding, unclear allocation of concealment, incomplete data outcomes reported, or enrollment of subjects with low AHI scores indicating a patient population that may not be considered  for surgery. (5, 8, 35-51)
  • The current AASM 2001 Practice Parameters for use of laser-assisted uvulopalatoplasty do not recommend LAUP for the treatment of sleep related breathing disorders including OSA.  These guidelines state LAUP is not recommended as a substitute for UPPP.(8)

Safety

Long-term safety and effectiveness of minimally invasive surgical procedures have not been established.

Potential surgical complications include nasal regurgitation, bleeding, dysphagia, infection, airway obstruction leading to tracheostomy, and extrusion of implants.

Risk of lingual nerve injury resulting in numbness to the teeth, tongue, lips or slurred speech has been reported with some tongue-base reduction and partial glossectomy procedures.

Appendix 1: Procedures for the Diagnosis of Sleep Disordered Breathing

Polysomnography (PSG)

Full night PSG consists of five to eight hours of monitoring, supervised by a sleep technician, while the patient sleeps. It is performed in a sleep lab and involves the following monitoring modalities: electroencephalogram (EEG) (to stage sleep and detect arousals), electro-oculogram (EOG) (to detect arousal and REM sleep) submental electromyogram, (EMG), electrocardiogram (EKG), two-leg EMG, respiratory airflow and effort (to detect apnea), snoring, oxygen saturation, time and position.  In addition, a full night PSG may include additional monitoring modalities as indicated, such as esophageal pressure monitoring, blood pressure monitoring, carbon dioxide trends, and pulse transit time.

The first three elements listed above (EEG, submental electromyogram, and electro-oculogram) are required for sleep staging. By definition, a polysomnogram always includes sleep staging, while a “sleep study” does not include sleep staging. The actual components of the study will be dictated by the clinical situation. Typically, the evaluation of obstructive sleep apnea would include respiratory airflow and effort, electro-oculogram, and oxygen desaturation. An EEG may not be considered necessary to evaluate OSA, although it is required to evaluate UARS, REM sleep behavior disorder (RBD), narcolepsy or other sleep disturbances.

Split Night Polysomnography

A split night study utilizes the first two or three hours for evaluating the presence of sleep apnea and the second half to titrate and adjust CPAP. The same monitoring modalities used in full night PSG are used in split night study. In patients with severe obstructive sleep apnea, a reliable assessment of the respiratory disturbance index is possible with a partial night study. Half night study for CPAP titration is reliable in selected cases of obstructive sleep apnea.

Split night studies are appropriate in patients with severe sleep apnea syndrome. The decision to conduct a split night study depends on the technical skill and experience of the staff, the initial sleep latency period, the severity and frequency of respiratory events and patient compliance. Careful patient selection and education is required to conduct a successful split night study.

Ambulatory or Portable Home Monitoring Device (PM)

A variety of portable polysomnography monitors are available for use in the home setting. Available devices evaluate different parameters including oximetry, respiratory and cardiac monitoring, and sleep/wake activity, but the majority of portable monitors do not record EEG.  While evidence indicates that portable monitoring can be a safe and effective method to evaluate OSA, there is a lack of standardization among devices and additional study is needed to determine the most reliable types of devices and combinations of home monitoring.

The following information may be useful in determining whether to use a portable home monitoring device (3):

  • Portable monitoring should only be conducted in patients with a high pretest probability of OSA and absence of comorbid conditions as determined by clinical evaluation.
  • A positive portable study with at least 3 channels of recording (e.g., arterial oxygen saturation, airflow, respiratory effort, or heart rate) has a high positive predictive value for OSA and can be used as the basis for a CPAP trial to determine efficacy of treatment.
  • A negative study can not be used to rule out OSA. Patients who have a negative result from portable monitoring or who do not respond to CPAP should undergo further evaluation.
  • Due to the probability of artifacts or loss of data, raw data from the portable monitoring device should be reviewed by a sleep specialist.
  • Follow-up and review of the APAP trial is also needed.

SNAP™ Testing

The SNAP testing system is a reflective acoustic device marketed as a screening and analysis system to locate the source of snoring and detect sleep apnea conditions.

Multiple Sleep Latency Tests (MSLT)

The MSLT measures the speed of falling asleep under conditions that favor sleep, in a series of 20-minute trials during the patient’s habitual periods of wakefulness. MSLT is the preferred method of establishing the presence of true physiological sleepiness but is accurate only if following strict protocols. MSLT is used in patients with complaints of irresistible daytime sleepiness suggestive of narcolepsy.

Maintenance of Wakefulness Test (MWT)

The patient is monitored during the usual periods of wakefulness but the patient is instructed not to fall asleep as a test of the patient’s ability to stay awake.  It may be used to evaluate the safety of drivers and their ability to stay alert.

Radiologic Studies

Radiologic images of the head and neck for anatomic abnormalities include MRI, CT scan, and cephalometry. Such studies are intended to assess for hypopharyngeal obstruction or other suspected pathology that might explain the symptoms associated with sleep disordered breathing.

Endoscopic Studies

Nasopharyngeal and laryngeal endoscopic measurements of structure and function of the upper airway are used in selected patients with suspected abnormal anatomy as an aid in the diagnosis of OSA or in the management of complications of treatment.

Epworth Sleepiness Scale

Excessive daytime sleepiness is predominantly a subjective symptom.  The Epworth sleepiness scale is a self-administered questionnaire, performed as part of the clinical evaluation, that asks patients their likelihood of falling asleep in eight situations ranked from 0 (would never fall asleep) to 3 (high chance of dozing).  The numbers are then added together to give a global score between 0 and 24.  A value of 10 or below is considered normal.  

Apnea-Hypopnea Index (AHI); Respiratory Disturbance Index (RDI)

Apnea is defined as the cessation of respiration for at least 10 seconds. Hypopnea is a reduction but not cessation of air exchange. Apneic and hypopneic events are combined into the apnea-hypopnea index (AHI). In turn the AHI is often referred to as the respiratory disturbance index (RDI), although more recently the RDI has been redefined by some physicians to include EEG arousals in addition to apneic and hypopneic events.  An AHI of greater than or equal to 20 is typically considered moderate OSA, and AHI of greater than 50 is considered severe OSA. An increase in mortality is associated with an AHI of greater than 15.

 

Appendix 2: Nonsurgical Devices for Treatment of OSA or UARS

CPAP

Nasal or oral continuous positive airway pressure (CPAP) or auto-titrating continuous positive airway pressure (APAP) is continuous positive airway pressure applied through the nose or via oral appliance. It is delivered by a flow generator through a mask to supply a pressure level sufficient to keep the upper airway patent. The pressure used is determined individually with a range of three to 15 centimeters of water.

BiPAP®

Bi-level respiratory assist device delivers alternating levels of positive airway pressure instead of the continuous pressure applied by CPAP.

A bi-level positive airway pressure device with back-up rate feature is a ventilation support system. These devices are in the FDA category of non-continuous ventilator, and as such, are primarily intended to augment patient ventilation.  

The term BiPAP® is a registered trademark of Respironics Inc., but is widely used to describe any bi-level positive airway pressure device as described above.

APAP

Auto-adjusting CPAP (APAP) is a more recent technology which alternates airway pressure between exhalation and inhalation on a breath-by-breath basis. With the C-Flex™ (Respironics, Inc) airway pressure is reduced during early exhalation in proportion to the patient’s expiratory flow rate.  Pressure is then increased again toward the end of exhalation when airway collapse is most likely.  Unlike BiPAP which delivers a static lower expiratory pressure, the C-Flex varies the pressure within the expiratory phase.

Oral Appliances (OA)

OA for the treatment of sleep disordered breathing are devices worn in the mouth during sleep to maintain a patent airway by raising the uvula, depressing the tongue, and/or advancing the mandible. Commercially available devices are usually custom-molded or custom-fitted for the individual patient by a qualified dental health professional trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures.  According to the American Academy of Sleep Medicine, dental management of patients with oral appliances should be overseen by practitioners who trained in sleep medicine and sleep related breathing disorders. (52, 53 )  Oral appliances can range from simple retaining devices, to adjustable, hinged, or two-piece designs. Some designs can be used in conjunction with a CPAP device (e.g., OPAP®).

 

References

  1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.51 Surgical Management of Obstructive Sleep Apnea Syndrome/Upper Airway Resistance Syndrome
  2. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.101, Minimally Invasive Surgery for Snoring, Obstructive Sleep Apnea Syndrome/Upper Airway Resistance Syndrome
  3. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.18, Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome
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Cross References

Orthognathic Surgery, Regence Medical Policy Manual, Surgery, Policy No. 137

Codes Number Description
Note: There is no specific CPT code for the tongue base reduction procedure.  The most appropriate code to use is 41599 (unlisted procedure).  41120 (partial glossectomy) describes a surgical resection and is not the appropriate code to use for submitting claims for tongue base reduction.
CPT

0088T

Sub mucosal radiofrequency tissue volume reduction of tongue base, one or more sites, per session (i.e., for treatment of obstructive sleep apnea syndrome) (Deleted 01/01/09)

 

21121

Genioplasty; sliding osteotomy, single piece

 

21122

Genioplasty; sliding osteotomies, two or more osteotomies (eg, wedge excision or bone wedge reversal for asymmetrical chin)

 

21141

Reconstruction midface, LeFort 1;single piece, segment movement in any direction (eg, for Long Face Syndrome), without bone graft  

 

21142

Reconstruction midface, LeFort 1; 2 pieces, segment movement in any direction, without bone graft

 

21143

Reconstruction midface, LeFort 1; 3 or more pieces, segment movement in any direction, without bone graft

 

21145

Reconstruction midface, LeFort 1; single piece, segment movement in any direction, requiring bone grafts (includes obtaining autografts)

 

21146

Reconstruction midface, LeFort 1; 2 pieces, segment movement in any direction (includes obtaining autografts) (eg, ungrafted unilateral alveolar cleft or multiple osteotomies),

 

21147

Reconstruction midface, LeFort 1; 3 or more pieces, segment movement in any direction, requiring bone grafts (includes obtaining autografts) (eg, ungrafted bilateral alveolar cleft or multiple osteotomies)

 

21196

Reconstruction of mandibular rami and /or body, sagittal split; with internal rigid fixation  

 

21198

Osteotomy, mandible, segmental

 

21199

Osteotomy, mandible, segmental; with genioglossus advancement

 

21685

Hyoid myotomy and suspension

 

41120

Glossectomy; less than one-half tongue

 

41500

Fixation of tongue, mechanical, other than suture (e.g., K-wire) 

 

41512

Tongue base suspension, permanent suture technique

 

41530

Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session

 

42140

Uvulectomy, excision of uvula

 

42145

Palatopharyngoplasty (e.g., Uvulopalatopharyngoplasty, Uvulopharyngoplasty)

 

42160

Destruction of lesion, palate or uvula (thermal, cryo, or chemical)

HCPCS

S2080

Laser-assisted uvulopalatoplasty (LAUP)

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