Sinus Surgeries

Number: 0937

Policy

Aetna considers endoscopic sinus surgery (ESS) medically necessary for any of the following indications:

• Allergic fungal rhino-sinusitis documented by the presence of eosinophilic mucus, and objective evidence of disease by computerized tomographic (CT) imaging (see CT imaging requirements below)Footnotes*; or
• Antrochoanal polyp documented by CT imagingFootnotes*; or
• Cerebrospinal fluid (CSF) rhinorrhea or conditions in which there is a skull base defect; or
• Chronic rhino-sinusitis (longer than 12 weeks) with nasal polyps (CRSwNP) with persistent symptoms that have failed maximal medical treatment (i.e., saline irrigations, antibiotics if bacterial infection is suspected, and intra-nasal corticosteroids) and objective evidence of disease by CT imagingFootnotes*; or
• Chronic rhino-sinusitis (longer than 12 weeks) without nasal polyps (CRSsNP) with persistent symptoms that have failed maximal medical treatment (i.e., saline irrigations, antibiotics if bacterial infection is suspected, and intra-nasal corticosteroids) and objective evidence of disease by CT imagingFootnotes* (See Appendix); or
• Complications of sinusitis, including abscess (brain and sub-periosteal) and extension to adjacent structures (e.g., orbit, skull base); or
• Endonasal endoscopic hypophysectomy for pituitary adenoma; or
• Endoscopic orbital decompression for Graves ophthalmopathy, with or without optic nerve decompression; or
• Para-nasal sinus mucocele documented by CT scan (excluding benign, asymptomatic mucus retention cysts); or
• Recurrent acute rhino-sinusitis (RARS) (4 or more documented episodes within 12 continuous months), that has failed maximal medical treatment (i.e., saline irrigations, antibiotics if bacterial infection is suspected, and intra-nasal corticosteroids) and objective evidence of disease by CT imagingFootnotes* (See Appendix); or
• Sino-nasal polyposis with nasal airway obstruction or sub-optimal asthma control (forced expiratory volume in 1 second (FEV1) of less than 80 % despite maximal medical treatment (i.e., saline irrigations, antibiotics if bacterial infection is suspected, and intra-nasal corticosteroids)); or
• Unilateral para-nasal sinus opacification, symptomatic or asymptomatic, consistent with CRSsNP, CRSwNP, fungus ball, or benign neoplasm (e.g., sino-nasal inverted papilloma).

Footnotes*Abnormal CT findings include but are not limited to air fluid levels, air bubbles, greater than 3 mm of mucosal thickening, pansinusitis, or diffuse opacification.

Aetna considers ESS experimental and investigational for all other indications.

Aetna considers revision ESS medically necessary when the following selection criteria are met:

• At least 12 weeks have passed since previous ESS; and
• Chronic rhino-sinusitis has been present for at least 12 continuous weeks; and
• Failure of at least one 5 to 7 day course of antibiotics since the previous ESS; and
• Persistent objective evidence of sinus disease as documented by CT imaging.

Aetna considers revision ESS experimental and investigational for all other indications.

Aetna considers balloon sinus ostial dilation (balloon sinuplasty) of the frontal, maxillary or sphenoid sinuses medically necessary for the treatment of uncomplicated sinusitis without nasal polyposis (e.g., sinusitis confined to the paranasal sinuses without adjacent involvement of neurologic, soft tissue, or bony structures) when criteria are met (See Appendix).

Note: Balloon sinus ostial dilatation is performed either as a stand-alone procedure or as part of functional endoscopic sinus surgery (FESS).  However, when used with FESS in the same sinus cavity,  it is considered to be an integral part of the primary procedure.  Also see Appendix for “Table 1: Medical Necessity for Balloon sinuplasty - Statements That Reached Consensus Patients Criteria” and “Table 2: Medical Necessity for Balloon sinuplasty - Statements That Did Not Reach Consensus Patients Criteria” (from the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)'s "Clinical consensus statement: Balloon dilation of the sinuses", Piccirillo et al, 2018).

Aetna considers balloon ostial dilation experimental and investigational for any of the following indications (not an all-inclusive list):

• Bony dysplasia (i.e., including but not limited to fibrous dysplasia, Paget’s disease)
• Extensive fungal sinusitis
• History of failed balloon procedure in the sinus to be treated
• Isolated ethmoid sinus disease
• Mucocele causing sinusitis
• Nasal polyposis (grade 2 or greater)
• Repeat balloon procedure in any of the sinuses
• Samter’s triad (aspirin sensitivity)
• Severe sinusitis secondary to autoimmune or connective tissue disorders (i.e., including, but not limited to, sarcoidosis, granulomatosis with polyangiitis (PGA))
• Severe sinusitis secondary to ciliary dysfunction, (i.e., including but not limited to, cystic fibrosis, Kartagener’s syndrome)
• Suppurative or non-suppurative complications of sinusitis including extension to adjacent structures such as the orbit or central nervous system
• Suspected or known sino-nasal benign or malignant tumor (including but not limited to squamous cell, adenoid cystic or adenocarcinoma, inverted papilloma).

Aetna considers image-guided ESS medically necessary for the following indications:

• Benign and malignant sino-nasal neoplasms (e.g., sino-nasal inverted papilloma); or
• Cerebrospinal fluid rhinorrhea or conditions in which there is a skull base defect; or
• Disease abutting the skull base, orbit, optic nerve, or carotid artery; or
• Distorted sinus anatomy of development, post-operative, or traumatic origin (e.g., hypoplastic maxillary sinus, orbital fat and medial rectus herniation from a medial orbital blowout fracture, scarring or absence of normal surgical landmarks from prior sinus surgery; not an all-inclusive list); or
• Sino-nasal polyposis with nasal airway obstruction or sub-optimal asthma control; or
• Revision sinus surgery; or
• Sinus disease (as defined above) involving the frontal, posterior ethmoid, and sphenoid sinuses.

Aetna considers image-guided ESS experimental and investigational for all other indications.

Aetna considers up to 3 post-operative nasal endoscopies with debridement after sinus surgery medically necessary within the six weeks following sinus surgery.  Additional debridement procedures during that time, and debridement procedures performed outside of the 6 week postoperative period, are considered not medically necessary unless clinical circumstances are well-documented. Additional debridements may be allowed if records are provided documenting any of the following (not an all-inclusive list):

• persistent crusting
• recurrent polyps
• allergic mucin
• retained fungal material
• synechiae obstructing sinus ostia; or
• lateralized middle turbinate with ostial obstruction.

Aetna considers post-operative nasal endoscopy with debridement not medically necessary after nasal surgery (e.g., septoplasty, turbinectomy) and after balloon sinuplasty.

Aetna considers diagnostic endoscopy with puncture of the sphenoid and/or maxillary sinuses medically necessary when abnormal findings on CT scanning indicate the need for an invasive diagnostic procedure.

Examples include tumor/mass and multiple sinus symptoms (nasal obstruction, anterior or posterior mucopurulent (foul) drainage, facial pain, pressure, headache (when other causes have been ruled out) and/ or fullness over the affected sinus, decreased sense of smell).

Aetna considers these procedures not medically necessary when these criteria are not met.

See also CPB 0593 - Aerosolized or Irrigated Anti-Infectives for Sinusitis, CPB 0694 - Paranasal Sinus Ultrasound for the Evaluation of Sinusitis, CPB 0840 - Devices for Post-Operative Use Following Endoscopic Sinus Surgery, and CPB 0935 - Mometasone Furoate Sinus Implant (Sinuva).

Background

Endoscopic Sinus Surgery

Rhino-sinusitis refers to symptomatic inflammation of the para-nasal sinuses and nasal cavity that may or may not have an infective component and includes nasal polyposis.  Acute rhino-sinusitis (ARS) lasts up to 12 weeks and resolves completely.  Chronic rhino-sinusitis (CRS) persists over 12 weeks and may involve acute exacerbations.  Rhino-sinusitis is common, affecting approximately 15 % of the population and results in significant reduction in quality of life (QOL).  The diagnosis is based largely on symptoms with confirmation by nasal endoscopy.  Computerized tomography (CT) scans and magnetic resonance imaging (MRI) are abnormal in about 1/3 of the population, thus, they are not recommended for routine diagnosis; but should be reserved for individuals with acute complications, diagnostic uncertainty or failed medical therapy.  Underlying conditions such as immune deficiency, Wegener's granulomatosis, Churg-Strauss syndrome, aspirin hypersensitivity and allergic fungal sinusitis may present as rhino-sinusitis.  Multiple therapies are used in the management of CRS with nasal polyps (CRSwNP) or without polyps (CRSsNP), including antibiotics, saline irrigations and sprays, intra-nasal and systemic glucocorticoids, and anti-leukotriene agents.  Surgery should not be the first intervention in most cases, with the possible exception of allergic fungal rhino-sinusitis (Scadding et al, 2008; Hamilos, 2018).

Rosenfeld and colleagues (2015) provided an update of a 2007 guideline from the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Foundation .  This update furnished evidence-based recommendations to manage adult rhino-sinusitis.  Changes from the prior guideline included a consumer added to the update group, evidence from 42 new systematic reviews, enhanced information on patient education and counseling, a new algorithm to clarify action statement relationships, expanded opportunities for watchful waiting (without antibiotic therapy) as initial therapy of acute bacterial rhino-sinusitis (ABRS), and 3 new recommendations for managing CRS.  The purpose of this multi-disciplinary guideline was to identify quality improvement opportunities in managing adult rhino-sinusitis and to create explicit and actionable recommendations to implement these opportunities in clinical practice.  Specifically, the goals were to improve diagnostic accuracy for adult rhino-sinusitis, promote appropriate use of ancillary tests to confirm diagnosis and guide management, and promote judicious use of systemic and topical therapy, which includes radiography, nasal endoscopy, CT, and testing for allergy and immune function.  Emphasis was also placed on identifying multiple chronic conditions that would modify management of rhino-sinusitis, including asthma, cystic fibrosis (CF), immunocompromised state, and ciliary dyskinesia.

The update group made strong recommendations that clinicians should perform the following:

• Distinguish presumed ABRS from ARS caused by viral upper respiratory infections and non-infectious conditions
• Confirm a clinical diagnosis of CRS with objective documentation of sino-nasal inflammation, which may be accomplished using anterior rhinoscopy, nasal endoscopy, or CT.
• Either offer watchful waiting (without antibiotics) or prescribe initial antibiotic therapy for adults with uncomplicated ABRS
• Prescribe amoxicillin with or without clavulanate as 1st-line therapy for 5 to 10 days (if a decision is made to treat ABRS with an antibiotic)
• Re-assess the patient to confirm ABRS, exclude other causes of illness, and detect complications if the patient worsens or fails to improve with the initial management option by 7 days after diagnosis or worsens during the initial management
• Distinguish CRS and recurrent ARS from isolated episodes of ABRS and other causes of sino-nasal symptoms
• Evaluate the patient with CRS or recurrent ARS for multiple chronic conditions that would modify management, such as asthma, CF, immunocompromised state, and ciliary dyskinesia
• Confirm the presence or absence of nasal polyps in a patient with CRS
• Recommend saline nasal irrigation, topical intra-nasal corticosteroids, or both for symptom relief of CRS. 

The update group stated as options that clinicians may:

• Recommend analgesics, topical intra-nasal steroids, and/or nasal saline irrigation for symptomatic relief of viral rhino-sinusitis
• Recommend analgesics, topical intra-nasal steroids, and/or nasal saline irrigation) for symptomatic relief of ABRS
• Obtain testing for allergy and immune function in evaluating a patient with CRS or recurrent ARS.

The update group made recommendations that clinicians:

• Should not obtain radiographic imaging for patients who meet diagnostic criteria for ARS, unless a complication or alternative diagnosis is suspected
• Should not prescribe topical or systemic anti-fungal therapy for patients with CRS.

The American Academy of Otolaryngology-Head and Neck’s “Clinical indicators for endoscopic sinus surgery in adults” (AAO-HNs, 2015 are listed below:

• Allergic fungal rhino-sinusitis
• Chronic rhino-sinusitis without nasal polyps (CRSsNP) with persistent symptoms and objective evidence of disease by endoscopic and/or CT imaging that is refractory to optimal medical treatment
• Chronic rhino-sinusitis with nasal polyps (CRSwNP) with persistent symptoms and objective evidence of disease by endoscopic and/or CT imaging that is refractory to medical treatment
• Complications of sinusitis, including extension to adjacent structures (i.e., orbit, skull base)
• Mucocele
• Recurrent acute rhinosinusitis (RARS)
• Sino-nasal polyposis with nasal airway obstruction or suboptimal asthma control
• Unilateral para-nasal sinus opacification, symptomatic or asymptomatic, consistent with CRSsNP, CRSwNP, fungus ball, benign neoplasm (i.e., inverted papilloma)

Antro-Choanal Polyps

Yuca and co-workers (2006) stated that antro-choanal polyp (ACP) is a benign maxillary sinus polyp that originates from the mucosa of the maxillary sinus, passes through a sinus ostium, and extends into the choana.  The common presentation of ACP is unilateral nasal obstruction.  These investigators discussed radiographic findings and differential diagnosis of ACPs by comparing them with data in the literature.  This study included 19 surgically treated patients with ACPs (14 male, 5 female; median age of 24.5 years, range of  8 to 75 years) diagnosed by clinical examination, nasal endoscopy, and CT.  Nasal obstruction was found in all cases; ESS was preferred for removal of the nasal part of ACPs in 13 cases.  Only in 1 case, polypectomy combined with Caldwell-Luc operation and septoplasty was performed.  The observed complications were as follows: minor hemorrhage in 3 cases, mild cheek swelling with pain in 2 cases, and infra-orbital hypoesthesia in 1 case.  Histopathologic examination of ACPs revealed loose mucoid stroma and mucous glands, which were covered by respiratory epithelium.  The authors concluded that ESS may be indicated in patients with ACPs because the function and capacity of the maxillary antrum are preserved.  The greater portion of the antral part of polyp could be removed while leaving the healthy antral mucosa intact.

Eski and colleagues (2012) evaluated the long-term results of ESS and combined approach with Caldwell Luc procedure for the treatment of ACPs.  Between January 2002 and December 2009, a total of 41 patients (24 males, 17 females; mean age of 34.7 years; range of 14 to 78 years) were retrospectively analyzed.  Patients were divided into 2 groups according to treatment modality: group 1 included 26 patients who underwent ESS alone and group 2 included 15 patients who underwent ESS in combination with Caldwell Luc procedure.  Both groups were compared for recurrence and complication rate; 17 of 41 patients were diagnosed with right-sided lesions, while 24 patients had left-sided lesions.  Recurrence was seen in 3 patients, including 2 in group 1 and 1 in group 2.  There was no statistically significantly difference between the groups in terms of recurrence and complication rate (p > 0.05).  Mean follow-up was 50.5 months (range of 15 to 94 months).  The authors concluded that current approach for the treatment of ACPs is ESS.  However, combined approaches should be performed to avoid recurrences, unless removal of antral part of the ACP completely by endoscopic resection is possible.  Selection of the combined techniques depends on the surgeon familiarity with the procedure and whether the patient is pediatric case.  Combined approach with Caldwell Luc is a safe procedure in adults.

In a systematic review, Galluzzi and associates (2018) evaluated the recurrence rate after surgery for ACPs in children; secondly, these investigators analyzed the rate of recurrence for different types of surgery and the risk factors involved.  They performed a systematic review searching PubMed and Medline databases including English-language published studies from June 1989 to October 2017 regarding surgical treatment of ACPs in children.  These researchers included 13 studies, 8 were retrospective and 5 prospective, with 285 participants, the mean rate of recurrence after ACPs surgery was 15.0 % (95 % confidence interval [CI]: 11.0 to 20.0).  Functional ESS (FESS) was the main type of surgery used for primary cases (75.4 %) followed by the combined approach (i.e., FESS with a trans-canine sinusoscopy or mini Caldwell-Luc (14 %)), the Caldwell-Luc (CWL) (8 %) and simple polypectomy (SP) (2.8 %).  This analysis has demonstrated a significant reduction of recurrences using the combined approach 0 % (95 % CI: 0.0 to 8.0) compared with FESS 17.7 % (95 % CI: 12.8 to 23.4) or SP 50 % (95 % CI: 15.7 to 84.3) (p < 0.05); but no significant differences with CWL 9.1 % (95 % CI: 1.1 to 29.2) and others surgical approaches (p > 0.05).  The analysis of the possible risk factors involved in recurrences were inconclusive.  The authors concluded that recurrences of ACPs in children were still high; ESS was considered the 1st choice for primary treatment, while the external approach may be a valid option in case of recurrence.  These investigators noted that it appeared that the combined approach could reduce recurrence rates in selected patients that could not be completely managed with endoscopy.

Para-Nasal Sinus Mucoceles

Zukin and colleagues (2017) stated that para-nasal sinus mucoceles are benign cystic lesions originating from sinus mucosa that can impinge on adjacent orbital structures, causing ophthalmic sequelae such as decreased visual acuity (VA).  Definitive treatment requires surgery.  These investigators presented the first meta-analysis quantifying the effect of pre-operative visual function and time to surgery on post-operative VA outcomes.  Data sources included PubMed, Ovid, Embase, Web of Science, and the Cochrane Library.  Two independent authors systematically reviewed articles describing outcomes after ESS for para-nasal sinus mucoceles presenting with visual loss.  Available data from case reports and series were combined to analyze the associations among pre-operative VA, time-to-surgery, and post-operative outcomes. A total of 85 studies were included that provided data on 207 patients.  The average presenting VA was 1.57 logMAR (logarithm of the minimum angle of resolution), and the average post-operative VA was 0.21 logMAR, with visual improvement in 71.5 % of cases.  Pre-operative VA of greater than or equal to 1.52 logMAR correlated with post-operative improvement greater than 1 logMAR (R = 0.4887, p < 0.0001).  A correlation was found between a time-to-surgery of less than 6 days and post-operative improvement (R = 0.297, p < 0.0001).  Receiver operator curve analysis of these thresholds demonstrated a moderately accurate prognostic ability (area under the curve: 75.1 for pre-operative VA and 73.1 for time-to-surgery).  The authors concluded that visual loss resulting from para-nasal sinus mucoceles is potentially reversible in most cases, even those presenting with poor vision.  When possible, surgery should be performed promptly after diagnosis, but emergency surgery did not appear to be necessary for vision restoration.

Sino-Nasal Inverted Papilloma

Jiang and colleagues (2017) stated that sino-nasal inverted papilloma (SNIP) is noted for its high rate of recurrence and malignant transformation.  Although many clinical studies have demonstrated the effectiveness of the endoscopic approach for SNIP, the surgical strategy has been the subject of much debate.  These researchers examined the effectiveness of the endoscopic endo-nasal approach in SNIP.  They performed a systematic review of patients with a diagnosis of SNIP and who had surgery at the authors’ institution from June 2005 to March 2013.  All the patients who had post-operative follow-up for greater than 2 years were enrolled.  Each case was categorized into 1 of 4 stages as reported by Krouse.  Demographic and tumor date, operative approach, complications, and recurrence rates were collected.  A total of 125 patients were included in this study.  There were 17 patients in stage 1, 40 in stage 2, 57 in stage 3, and 11 in stage 4.  The overall recurrence rate was 8.0 %.  There was no significant difference in recurrence among the stages (all p > 0.05).  Recurrence after endoscopic endo-nasal approach (8.4 %) and a combined endoscopic and open exposure procedure (5.6 %) were not significantly different (p > 0.05).  The recurrence rate was significantly (p < 0.05) higher in patients with revision (15.6 %) than in patients in the primary cases (3.8 %).  A common site of tumor origin was recorded to be from the maxillary sinus (40.2 %); 20 % of recurrences were observed up to 5 years after surgery.  The authors concluded that endoscopic surgery may be preferred for treating SNIP.  The elevated recurrence rate after revision emphasized the significance of the first surgery.  These researchers encouraged a follow-up period of at least 5 years.

Attlmayr and associates (2017) noted that SNIP is the most common benign tumor affecting the nose.  There is a high rate of recurrence and a potential of malignant transformation.  These investigators identified the best available management of this disease.  They carried out a systematic review of the current English-language literature.  Only original articles with a minimum follow-up of 1 year and an average follow-up of 2 years were included.  A total of 1,385 patients from 16 case series were identified.  The total recurrence rate for all patients was 11.5 %.  Significantly lower recurrence rates were found for procedures using an attachment-oriented excision (recurrence of 6.9 %; p = 0.0001) and utilizing frozen sections (recurrence of 7.0 %; p = 0.0001).  The authors concluded that there is a general trend towards endoscopic surgery.  There may be some benefit to the use of attachment-oriented surgery and frozen sections.

Revision Endoscopic Sinus Surgery

McMains and Kountakis (2005) reported objective and subjective outcomes after revision endoscopic sinus surgery (RESS) for CRS.  These investigators performed a retrospective analysis of prospectively collected data in 125 patients requiring revision functional ESS (FESS) after failing both maximum medical therapy and prior sinus surgery for CRS.  Patients were seen and treated over a 3-year period (1999 to 2001) in a tertiary rhinology setting; CT scans were graded as per Lund-MacKay and patient symptom scores were recorded using the Sino-Nasal Outcome Test 20 (SNOT-20) instrument.  Individual rhino-sinusitis symptoms were evaluated on a visual analog scale (VAS; 0 to 10 scale) before and after surgery.  All patients had a minimum 2-year follow-up.  The mean number of prior sinus procedures was 1.9 +/- 0.1 (range of 1 to 7) and the mean pre-operative CT grade was 13.4 +/- 0.7.  Patients with asthma and polyposis had higher CT scores than those without these processes.  Pre-operative mean SNOT-20 and endoscopy scores were 30.7 +/- 1.3 and 7.3 +/- 0.4, respectively.  At the 2-year follow-up, mean SNOT-20 and endoscopy scores improved to 7.7 +/- 0.6 and 2.1 +/- 0.4, respectively (p < 2.8 x 10(-10)).  At 12-month follow-up, each individual symptom score decreased significantly.  Overall, 10 patients failed RESS and required additional surgical intervention for an overall failure rate of 8.0 %.  All patients who failed RESS had nasal polyposis.  The authors concluded that revision FESS benefited patients who failed maximum medical therapy and prior sinus surgery for CRS by objective and subjective measures.

Le and colleagues (2008) stated that many studies have examined the prognostic factors affecting the success of ESS, and a history of previous ESS is generally regarded as a factor contributing to a poor surgical outcome.  These investigators examined if previous ESS with polypectomy is associated with poor surgical outcomes after RESS by comparing the post-operative results between primary ESS (PESS) and RESS groups for CRS with nasal polyposis (CRSwNP).  These researchers performed a retrospective analysis of prospectively collected data on 2 groups with a minimum 1-year follow-up: patients who underwent PESS with polypectomy (101 patients) and those who required RESS with polypectomy (24 patients).  The extent of disease was compared using the Lund-MacKay scoring system, and the degree of polyposis was measured.  Subjective patient symptom scores were recorded using the SNOT-20 questionnaire, and objective endoscopic physical findings were scored according to the parameters pre-operatively and 6 and 12 months post-operatively.  The surgical outcomes of the PESS and RESS groups were compared using the SNOT-20 and nasal endoscopy scores.  The Lund-Mackay score and degree of pre-operative polyposis did not differ statistically between the groups.  The pre-operative mean SNOT-20 and nasal endoscopy scores were improved significantly at 6 and 12 months post-operatively, and the subjective and objective surgical outcomes of the 2 groups did not differ statistically.  The need for additional medications during the follow-up period and the proportion of patients who required additional surgical intervention due to surgical failure was similar in both groups.  The authors concluded that the findings of this study suggested that a history of ESS with polypectomy did not predict an unsuccessful surgical outcome after RESS and that ESS with polypectomy was a reliable and effective method for improving a patient's QOL regardless of primary or revision surgery.

Shen and co-workers (2011) stated that outcomes for RESS are rarely reported in relation to technique.  These investigators documented the outcome of full-house FESS (FHF) (complete spheno-ethmoidectomy with Draf IIA frontal sinusotomy) for treatment of this recalcitrant group.  A total of 21 patients with CRS having had at least 1 previous sinus surgery (mean of 2.14) underwent FHF, followed by post-operative nasal douching and oral antibiotics for 12 weeks.  After a minimum 6-months follow-up, patients were asked to complete a 5-item Patient Response Score (PRS) (graded on a 6-point scale from 1 = completely improved to 6 = much worse).  Objective measures collected included CT Lund MacKay score (L-M score, LMS), and endoscopic findings: mucosal swelling (MS) and mucopus (MP) (graded on a 4-point scale from 0 = none to 3 = severe).  Patients were divided into 3 subgroups based on months of follow-up from surgery: 6 to 12, 12 to 18, and 18 to 24 months.  There was no statistical difference in any outcome based on length of follow-up.  Mean symptom outcome was reported as much improved (PRS = 1.9 ± 0.1).  Both mucosal swelling and mucopus improved dramatically (2.48 versus 0.29, p < 0.001; 2.52 versus 0.29, p < 0.001, respectively); LMS also improved dramatically (11.52 versus 2.1, p < 0.001).  Presence of nasal polyps did not affect any subjective or objective outcome.  The authors concluded that marked improvements in symptoms and mucosal findings were consistently obtained with FHF between 6 and 24 months post-operatively.

Prasad and associates (2017) noted that RESS may be required for partially controlled or uncontrolled CRS.  Studies that reported technical success, e.g., sinus ostia patency after RESS, did not address whether the patient's symptoms and QOL improve after surgery.  However, patient-reported outcome measures (PROM) are useful to assess the impact of sinus surgery on a patient's symptoms and QOL.  These investigators carried out a systematic review to evaluate the impact of RESS on PROMs.  Medical literature databases were searched for studies in English.  References from retrieved articles and relevant reviews were examined for additional studies.  Those studies that reported QOL outcome tools in patients who underwent RESS and with a minimum follow-up of 6 months were included.  A search of the sources yielded 1,856 citations.  There were 72 articles after abstract review and exclusion, identified for full-text review, with 12 studies (which contained data from 1,308 patients) that met the inclusion criteria for this systematic review.  There were 4 "good" and 8 "fair" studies; 3 studies used the Rhinosinusitis Disability Index and Chronic Sinusitis Survey in tandem; 2 each used the SNOT-20 and the SNOT-22; the remaining studies used either the Adelaide Disease Severity Score, PRS, Rhinosinusitis Symptom Inventory, Rhinosinusitis Outcome Measure 31, or the Chinese version of the University of Pennsylvania Smell Identification Test.  All studies used validated PROMs apart from the study that used PRS.  Studies consistently reported improvement in the 5 key symptoms of nasal obstruction, rhinorrhea, post-nasal drip, facial pain, and anosmia, although improvement in halitosis, fever, dental pain, and cough were modest.  The authors concluded that several PROMs demonstrated that RESS improved patient's QOL.

Balloon Ostial Dilation (Balloon Sinuplasty)

Balloon ostial dilation (BOD), also known as balloon catheter sinusotomy, is a procedure in which the frontal, sphenoid, or maxillary sinus ostium is dilated or the ethmoid infundibula is pushed aside using a balloon catheter.  This procedure does not involve surgical removal of tissue and can be performed in the office-setting under local anesthesia.  Dilation of the maxillary sinus ostium involves insertion of the balloon catheter through an antral puncture of the maxillary sinus (Hamilos, 2018).

Stankiewicz and associates (2012) stated that multiple studies have reported results from balloon-only procedures and hybrid balloon sinus surgeries through intermediate follow-up periods of up to 1 year.  Long-term durability results beyond 2 years were limited.  In this study, revision rate, symptom improvement, and productivity improvement were prospectively evaluated after a minimum follow-up of 2 years.  A total of 59 patients (107 maxillary ostia) underwent balloon dilation of the maxillary sinus outflow tract and completed post-procedure follow-up assessment at 27.0 ± 3.6 months. Patients’ SNOT-20 score improved from 2.65 ± 0.97 at baseline to 0.79 ± 0.71 at long-term follow-up (p < 0.0001).  Improvement in work productivity and activity due to sinus-related health issues for all patients was statistically significant across all survey instrument characteristics (p range, < 0.0001 to 0.02).  An analysis of the outcomes in a subgroup of patients with maxillary and anterior ethmoid disease (20 %; 34 %) showed similar significant improvement in symptoms (SNOT-20 decrease = -2.1; p < 0.0001).  Approximately 92 % of all patients reported satisfaction with the balloon procedure; 4 (6.8 %) patients underwent revision sinus surgery at 11.1 ± 7.3 months after treatment.  The authors concluded that patients with CRS and radiographic evidence of isolated maxillary disease with or without anterior ethmoid disease have reported clinically meaningful and statistically significant improvement in symptoms, productivity, and activity through a minimum of 2 years following standalone balloon dilation.

In a prospective, multi-center, randomized, controlled trial (RCT), Cutler and co-workers (2013) tested the hypotheses that symptom improvement after balloon dilation was non-inferior to FESS; and balloon dilation was superior to FESS for post-operative debridement.  Adults with uncomplicated CRS of the maxillary sinuses with or without anterior ethmoid disease who met criteria for medically necessary FESS were randomized 1:1 to office balloon dilation or FESS and followed for 6 months.  A minimum of 36 patients per arm were required to test the hypotheses with 90 % power.  Symptom improvement using the validated SNOT-20 survey, debridement, recovery outcomes, complications, and revision surgeries were compared between groups.  A total of 92 patients (50 balloon dilation; 42 FESS) were treated.  Mean SNOT-20 improvement was 1.67 ± 1.10 and 1.60 ± 0.96 in the balloon and FESS arms, respectively.  Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement and the balloon arm was non-inferior (p < 0.001) to FESS.  The mean number of post-procedure debridement per patient was 0.1 ± 0.6 in the balloon arm versus 1.2 ± 1.0 in the FESS arm, with the balloon group showing superiority (p < 0.0001).  Occurrence of post-operative nasal bleeding (p = 0.011), duration of prescription pain medication use (p < 0.001), recovery time (p = 0.002), and short-term symptom improvement (p = 0.014) were all significantly better for balloon dilation versus FESS.  No complications occurred in either group and 1 revision surgery was reported in each arm.  The authors concluded that balloon dilation was non-inferior to FESS for symptom improvement and superior to FESS for post-operative debridement in patients with maxillary and anterior ethmoid disease.  They stated that balloon dilation was an effective treatment in patients with uncomplicated CRS who met the criteria for medically necessary FESS.

In a prospective, multi-center, randomized trial, Bikhazi and colleagues (2014) compared 1-year outcomes from the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long-term follow-up) study between office balloon dilation and FESS.  Adults with maxillary CRS, including those with anterior ethmoid disease, who failed medical management and were surgical candidates for FESS, underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed-up fora minimum of 1 year.  Sino-nasal symptom improvement was assessed using the validated SNOT-20 survey.  Standardized effect sizes were computed to further assess clinical significance.  Ostial patency rate, rhino-sinusitis episode frequency, impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey, complications, and revision rate were also compared between the 2 groups.  A total of 92 patients (50 balloon dilation; 42 FESS) were treated and 89 (96.7 %) completed 1-year follow-up.  Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement in mean overall SNOT-20 scores and in all 4 SNOT-20 subscales.  The 1-year mean change in SNOT-20 after balloon dilation (-1.64) was non-inferior to FESS (-1.65; p < 0.001).  The standardized effect size was large, showing clinically significant improvement for both interventions.  Ostial patency was 96.7 % and 98.7 % after balloon dilation and FESS, respectively, and each group reported significant reductions (p < 0.0001) in rhino-sinusitis episodes (mean decrease, 4.2 for balloon dilation and 3.5 for FESS).  Overall work productivity and daily activity impairment due to CRS were significantly improved (p < 0.001) in both groups.  There were no complications and revision surgery rate was 2 % in each arm through 1 year.  The authors concluded that with 1-year follow-up, standalone balloon dilation was as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS.

In a prospective, multi-center, open-label clinical trial, Gould and associates (2014) evaluated 1-year changes in sino-nasal symptoms and health care use after office-based multi-sinus balloon dilation.  Adults diagnosed with CRS or RARS according to the 2007 adult sinusitis guidelines were enrolled in this Institutional Review Board (IRB)-approved study.  Balloon dilation of the maxillary sinuses/ethmoid infundibula with or without frontal or sphenoid ostial dilation was performed in the physician's office under local anesthesia.  Intra-operative procedure technical success and subject procedure tolerance were recorded.  Efficacy was assessed using the patient-reported SNOT-20 and Rhinosinusitis Symptom Inventory (RSI).  Complications and revision surgeries were also recorded.  A total of 313 ostial dilations were attempted and 307 were successfully completed (98.1 %) in 81 subjects.  Mean procedure tolerance was 2.8 ± 2.2 (0 = no pain; 10 = severe pain).  Clinically meaningful and statistically significant (p < 0.0001) mean SNOT-20 symptom improvement was observed at 1 and 6 months and sustained through 1 year. The RSI treatment effect for all major rhino-sinusitis symptoms was "large" and improvement in each was significant (p < 0.0001).  Compared with the previous 1-year period, patients reported an average of 2.3 fewer acute sinus infections (p < 0.0001), 2.4 fewer antibiotic courses taken (p < 0.0001), and 3.0 fewer sinus-related physician visits (p < 0.0001) after balloon dilation.  No serious device or procedure-related AEs occurred; 1 subject (1.3 %) underwent revision surgery.  The authors concluded that in-office, multi-sinus balloon dilation was safe, effective, and well-tolerated.  Patients reported significant reductions in both sino-nasal symptoms and health care use after balloon dilation.  Efficacy observed at 1 and 6 month follow-up was sustained through 1 year with a very low rate of revision surgery.

In a prospective, multi-center study, Sikand and colleagues (2015) evaluated patient-reported outcomes 1 year after office-based balloon sinus dilation (BSD).  Adult patients with medically refractory CRS were prospectively enrolled into a single-arm study and treated with office-based BSD under local anesthesia.  Follow-up on 203 patients was conducted at 2, 8, and 24 weeks post-surgery using validated outcome measures for QOL (SNOT-20) and CT imaging (Lund-Mackay score).  After 24 weeks, patients were re-enrolled for 1-year follow-up to evaluate changes in SNOT-20 scores and revisions.  All patients who re-enrolled (n = 122) completed the study, with an average follow-up of 1.4 years.  Neither pre-operative SNOT-20 nor Lund-Mackay CT scores was predictive of re-enrollment and return for follow-up.  Compared to baseline, improvements in SNOT-20 scores remained statistically significant (p < 0.001) and clinically meaningful (mean decrease greater than or equal to 0.8).  In patients followed to 1.4 years, 9 of 122 (7.4 %) had revision surgery.  The authors concluded that following office-based BSD, significant improvements in QOL observed at 24 weeks were maintained 1 year post-surgery.  These extended results provided further evidence of office-based BSD as an effective, minimally invasive procedure for appropriately selected patients with CRS.

Chandra and co-workers (2016) provided the final results from the REMODEL study and performed meta-analyses of standalone balloon sinus dilation studies to explore long-term outcomes in a large patient sample.  Final outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with FESS or in-office BOD, were evaluated; 130 patients had 12-month data, 66 had 18-month data, and 25 had 24-month data.  In addition, a meta-analysis evaluated outcomes from 6 studies including 358 standalone BOD patients with up to 24 months follow-up.  Outcomes out to 2 years from the REMODEL full-study cohort were consistent with 6-month and 12-month outcomes.  In the meta-analysis of standalone BOD studies, technical success was 97.5 %, and mean SNOT-20 were significantly and clinically improved at all time-points (p < 0.0001).  There were significant reductions (p < 0.0001) in work/school days missed, home-bound days, physician/nurse visits, acute infections, and antibiotic prescriptions.  Mean recovery time was 1.4 days.  Comparison of 12-month symptom improvements and revision rates between the REMODEL FESS-arm (n = 59), REMODEL BOD- arm (n = 71), and pooled single-arm standalone BOD studies (n = 243) demonstrated no statistical difference.  The authors concluded that all outcomes were comparable between FESS and BOD at all time-points from 6 months to 24 months.  The authors concluded that BOD produced faster recovery, less post-operative pain, and fewer debridement than FESS; there was significant, durable benefit in a large series of 358 patients undergoing standalone BOD.

In a prospective, multi-center, single-arm study, Soler and associates (2017) examined the effectiveness of BOD in children (aged 2 to 21 years) with CRS who had failed medical management and were followed-up to 6 months post-procedure.  A total of 50 children were treated at 4 centers; 33 participants were 2 to 12 years old (mean ± standard deviation age: 6.6 ± 2.2 years) and 17 participants were older than 12 to 21 years (mean age of 15.7 ± 2.5 years).  A total of 157 BOD were attempted (98 maxillary, 30 frontal, and 29 sphenoid sinuses) and all were successful with no complications.  Significant improvement in the Sinus and Nasal Quality of Life Survey (SN-5) was seen for all children between baseline and 6 months (4.6 ± 1.2 versus 1.7 ± 0.8; p < 0.0001) and 92 % improved by a minimal clinically important difference (MCID) of 1.0 or more.  Children aged 2 to 12 years with standalone BOD also showed significant SN-5 improvements between baseline and follow-up (4.5 ± 1.0 versus 1.9 ± 0.8; p < 0.0001).  Multi-variate regression analysis showed no differences or associations of SN-5 improvement at 6 months with the presence of allergy, asthma, or concomitant procedures.  For adolescents, overall SNOT-22 mean scores were also significantly improved at 6 months (42.2 ± 19.2 versus 10.4 ± 9.7; p < 0.0001).  The authors concluded that BOD was safe and appeared effective for children with CRS aged 2 years and older.

In a meta-analysis, Xu and colleagues (2017) evaluated the post-operative clinical effects of balloon sinuplasty on CRS.  PubMed, Ovid, Embase, Cochrane Library, Proquest, Web of Science, Sinomed, Wan Fang and CNKI database (from established time to March of 2017) were searched for trials about CRS treated by balloon sinuplasty.  Relevant literatures were screened, and prospective control studies were chosen.  Lund-Mackay and SNOT-20 scores were used as the outcome indicators, and the methodological quality of the literatures were evaluated.  The extracted data were analyzed by Revman 5.3 software.  A total of 7 prospective before-after self-controlled studies were included, and the overall quality of which was relatively high.  Meta-analysis showed that the Lund-Mackay scores at 6 months post-operation, the SNOT-20 scores at 6 months and more than 1 year post-operation were significantly lower than baseline when balloon sinuplasty was used in the surgery; the SNOT-20 scores at more than 1 year post-operation was lower than baseline when a standalone balloon sinuplasty was performed.  All the results was statistically significant (p < 0.05), and all the standard mean differences (SMD) were more than 0.8.  The authors concluded that the post-operative effect of balloon sinuplasty on CRS was obvious, and the subjective symptoms in patients were relieved effectively.

The AAO-HNS’ position statement on “Dilation of sinuses, any method (e.g., balloon, etc.)” (2017) stated that sinus ostial dilation (e.g., BOD) is a therapeutic option for selected patients with CRS and RARS who have failed appropriate medical therapy.  Clinical diagnosis of CRS and RARS should be based on symptoms of sinusitis and supported by nasal endoscopy documenting sino-nasal abnormality or mucosal thickening on CT of the para-nasal sinuses.  This approach may be used alone to dilate an obstructed sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (e.g., micro-debrider, forceps).

Li and associates (2018) examined the effectiveness of balloon catheter dilation (BCD) in the treatment of CRS, analyzed the possible factors which led to BCD failure, and provided basic reference for BCD clinical usage.  A total of 46 sinuses of 32 patients with CRS underwent "balloon-only" BCD or "FESS-assisted" BCD at the authors’ institution between September 2014 and December 2016.  By recording details of the operation of all the subjects and following-up the clinical symptoms, nasal endoscopy, CT of the sinuses, and post-operative complications 6 months after operation, these investigators evaluated the difficulty, safety, effectiveness and especially, the failing reasons of BCD.  Balloon catheter dilation was approached in 46 sinuses (19 maxillary sinus, 22 frontal and 5 sphenoid), and succeeded in 13 maxillary sinuses, 19 frontal sinuses, and 4 sphenoid sinuses.  Of the 13 maxillary sinuses, 9 underwent "balloon-only" procedure, other 4 cases underwent "FESS-assisted" procedure; 3 cases of frontal sinus failed because of the frontal recess anatomical complexity and the twisted drainage.  Of the 5 sphenoid sinuses, 4 succeeded, including fungal sphenoiditis cases, in which the mold was completely cleared through the dilated ostia, and 1 case failed.  All patients were followed-up for 1, 3 and 6 months for patient's QOL, nasal endoscopy, and CT of the sinuses; SNOT-20 scores of QOL showed significant relief of symptoms; nasal mucosa status improved significantly, dilated ostium remained open; no obvious scar formation, no severe operative complications were reported.  The authors concluded that BCD in the treatment of CRS was safe and effective.  However, they noted that the indications for BCD are limited, and many factors influence the success rate of BCD.  In this regard, pre-operatively gaining the information of nasal cavity and anatomical structure around ostium according to patients' nasal endoscopy and sinus CT is critical to success of BCD.

In a prospective, multi-center randomized study, Minni and co-workers (2018) evaluated the validity and safety of BCD versus ESS in symptomatic CRS of the frontal sinus.  This trial enrolled a total of 102 adult patients (64 men and 38 women; 148 frontal sinuses) with non-polypoid CRS.  For a better evaluation of the disease, these researchers decided to analyze both radiological (Lund-McKay CT scoring modified by Zinreich) and symptomatic results (SNOT-20 questionnaire).  They divided the affected subjects in 2 groups -- one with light/mild frontal CRS and the other with moderate/severe frontal CRS, basing on radiological findings at Lund-MacKay modified by Zinreich score.  Every group was divided in 2 subgroups, in one these investigators used BCD and in the other they used traditional ESS.  The current literature does not support the suggestion that indications for BCD and ESS are identical, and additional research is needed to determine the role for BCD in specific patient populations.  The results showed a not statistically significant difference between BCD and conventional ESS of the frontal sinus in patients with light/mild CRS and in patients with moderate/severe CRS at Lund-Mackay modified by Zinreich score.  The same not statistically significant difference was observed comparing the results of SNOT-20 questionnaire in the group of light/mild frontal CRS.  However, these researchers noticed a statistically significant better outcome of SNOT-20 score in patients with moderate/severe CRS who underwent BCD of frontal sinus compared to ESS.  The authors concluded that BCD and ESS are 2 alternative weapons in the armamentarium of endoscopic surgeons because they presented similar outcomes, safety and effectiveness both in light/mild and moderate/severe CRS of the frontal sinus.  An interesting finding of this study was the statistically significant better outcome of SNOT-20 score in patients who underwent BCD of frontal sinus for a moderate/severe CRS, compared to those who underwent a traditional ESS.

Piccirillo and colleagues (2018) developed a clinical consensus statement on the use of sinus ostial dilation (SOD) of the para-nasal sinuses.  An expert panel of otolaryngologists was assembled to represent general otolaryngology and relevant subspecialty societies.  The target population was adults aged 18 years or older with CRS or recurrent rhino-sinusitis (with or without nasal polyps, with or without prior sinus surgery) for whom SOD is being recommended, defined as endoscopic use of a balloon device to enlarge or open the outflow tracts of the maxillary, frontal, or sphenoid sinuses, as a standalone procedure or with ESS.  A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus.  After 3 iterative Delphi method surveys, 13 statements met the standardized definition of consensus while 45 statements did not.  The clinical statements were grouped into 3 categories for presentation and discussion: patient criteria, peri-operative considerations, and outcomes.  Strong consensus was obtained for not performing SOD in patients without sino-nasal symptoms or positive findings on CT in patients with symptoms only of headache or sleep apnea without criteria for sinusitis.  In addition, strong consensus was met that CT scan of the sinuses was necessary before performing SOD and that surgeons need to understand and abide by regulations set forth by the Food and Drug Administration (FDA) if they choose to re-use/re-process devices.  The authors concluded that expert panel consensus may provide helpful information for the otolaryngologist considering the use of SOD for the management of patients with a diagnosis of rhino-sinusitis.  This panel reached consensus on a number of statements that defined the use of SOD as inappropriate in the management of a variety of symptoms or diseases in the absence of underlying sinusitis.  When patients meet the definition of CRS as confirmed by CT scan, SOD of the sinuses can be indicated and/or effective in certain scenarios.

Stolovitzky and associates (2018) noted that CRS is a devastating disease affecting nearly 30 million people in the U.S.  An interim analysis of data from the present study suggested that, in patients who had previously failed medical therapy, balloon sinus dilation (BSD) plus medical management (MM) provided a significant improvement in QOL at 24 weeks post-procedure compared to MM alone.  The primary objective of this final analysis was to evaluate the durability of treatment effects through the 52-week follow-up.  Adults aged 19 and older with CRS who had failed MM elected either BSD plus MM or continued MM.  Patients were evaluated at 2 (BSD arm only), 12, 24, and 52 weeks post-treatment.  Balloon dilations were performed either as an office-based procedure under local anesthesia or in the operating room per physicians' and patients' discretion.  The primary end-point was change in patient-reported QOL as measured by Chronic Sinusitis Survey (CSS) total score from baseline to the 24-week follow-up.  Secondary outcomes including changes in CSS, Rhinosinusitis Disability Index (RSDI), and SNOT total and sub-scores, sinus medication usage, missed days of work/school, number of medical care visits, and sinus infections from baseline to the 52-week follow-up were reported.  Balloon sinus dilation led to sustained greater improvements in self-reported QOL using the CSS and RSDI total scores with a trend toward improvement in the SNOT-20 total score from baseline to the 52-week follow-up compared to continued MM.  There were no changes in medication usage apart from nasal steroid usage for which the MM cohort had an increase in usage.  There were no device-related serious AEs.  The authors concluded that the current analysis high-lighted the safety, effectiveness, and durability of BSD in CRS patients aged 19 and older who had previously failed MM.

Image-Guided Endoscopic Sinus surgery

Endoscopic sinus surgery was developed to treat at-risk CRS.  Although morbidity is low in ESS, there is a risk of serious intra-operative complications due to the anatomic proximity of the brain, carotid artery, dura mater optic nerve, and sinus cavities.  To minimize potential intra-operative complications, medical imaging-assisted mapping aids have been developed to aid surgeons performing ESS.  Various computer-assisted navigation or image-guided surgery systems (IGS) have been developed in ESS in the past 20 years based on electromagnetic or infrared detection technology.   Image-guidance technology gives the surgeon the ability to navigate real-time the surgical instruments to and in the diseased sinuses, correlate their position in and around vital structures while watching the monitor.  This is especially useful when a patient has polyps or needs revision surgery in which the normal anatomy may be distorted.  It should be noted that not all sinus surgeries require image-guidance.

Ramakrishnan and Kingdom (2015) stated that IGS is progressively used in ESS.  Current literature does not show a clear reduction in surgical complications.  The routine use of IGS in ESS as a deterrent to medico-legal liability is not substantiated by recent reported data.  There are particular situations in which IGS may be helpful, but its use is likely not needed for routine ESS

Sunkaraneni and colleagues (2013) stated that the advantages and limitations of IGS for ESS are unclear.  These investigators carried out a retrospective analysis of ESS performed with IGS versus without IGS; a total of 355 cases was included.  Primary outcomes included complication rates and time to revision surgery.  Within 1.5 years of the index sinus surgical procedure, the risk of revision surgery was significantly higher for patients treated with non-assisted versus computer-assisted ESS (p = 0.001).  Meta-analysis did not indicate a reduction in complications or revision surgery procedures with the use of IGS, although the majority of included studies showed a non-significant reduction in revision surgery.  The authors concluded that the findings of this study offered some evidence that computer-assisted ESS may delay residual disease and reduce the requirement for revision surgery.  Although this finding was not borne out in the meta-analysis, the majority of identified studies demonstrated a trend towards fewer revision procedures after computer-assisted ESS.

Dalgorf et al (2013) noted that although IGS is considered a valuable tool, its impact on peri-operative morbidity for ESS remains unclear.  In a meta-analysis, these researchers reviewed the evidence from reported literature.  Medline and Embase were searched using a search strategy for publications on IGS during ESS that reported original data on peri-operative morbidity.  Primary outcome was major and total complications; secondary outcomes were specific orbital and intra-cranial injury, major hemorrhage, ability to complete the operation, and revision surgery.  The incidence of these events was defined as dichotomous variables and expressed as a risk ratio (RR) in a fixed-effects model.  A total of 2,586 articles fulfilled the search, producing 55 included studies; 14 were comparative cohorts of IGS and non-IGS sinus surgical patient populations used for meta-analysis.  Among the cohorts, major complications were more common in the non-IGS group (RR = 0.48; 95 % confidence interval [CI]: 0.28 to 0.82; p = 0.007).  Total complications were greater in the non-IGS group (RR = 0.66; 95 % CI: 0.47 to 0.94; p = 0.02).  All other outcomes did not reach significance on meta-analysis.  The authors concluded that contrary to current review articles on the topic of IGS use during ESS, there is evidence from published studies that the use of IGS for ESS, within selected populations, is associated with a lower risk of major and total complications compared with non-IGS sinus surgery.

Irugu and Stammberger (2014) stated that navigation technique plays a vital role in the resection of extensive diseases because anatomic landmarks are often destroyed in such cases.  These investigators noted that approaching sellar, para-sellar and orbital areas has become much easier and safer since navigation system was introduced.  These areas are now being explored with greater accuracy and precision.  In cases of revision surgeries where there is extensive scarring and adhesions, navigation helps in identifying the distorted landmarks and distinguishing pathological lesions from normal areas.  Tumors residues that are invisible through endoscopy can be revealed via navigation and complete resection of tumor can be performed in such cases.  Moreover, these investigators noted that the use of electromagnetic navigation system has to be avoided in patients with electronic devices implanted to the brain or the nervous system, however optical tracking navigation system can be used in such patients.  They also noted that the use of navigation system was previously contraindicated in patients with cardiac pacemakers, but recent advent in medical technology has enabled the use of navigation system in these patients.

Jiang and Liang (2014) stated that the application of IGS to sinus surgery is gaining popularity.  These investigators evaluated the efficacy of IGS in the fenestration of the sphenoid sinus in CRS patients who received revision functional ESS (FESS).  A total of 51 CRS patients who received revision FESS incorporating IGS between January 2010 and August 2011 by 2 surgeons were enrolled in this study.  A group of 30 CRS patients who underwent revision FESS by the senior surgeon without incorporating IGS was chosen for comparison.  The penetration rates for the sphenoid sinus were 91.2 % when performed by the senior surgeon with IGS and 91.3 % when done by the other surgeon with IGS.  The penetration rate for the sphenoid sinus was 68.6 % for revision FESS without IGS.  The fenestration rate for the sphenoid sinus in revision FESS without IGS was significantly lower than that in revision FESS with IGS (p = 0.004).  The authors concluded that these findings showed that IGS was beneficial for opening the sphenoid sinus in the revision cases.

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS, 2014) endorsed the use of IGS during ESS in select cases based on expert consensus opinion and literature evidence.  The recommended indications include:

• Benign and malignant sino-nasal neoplasms
• Cerebrospinal fluid (CSF) rhinorrhea or conditions in which there is a skull base defect
• Disease abutting the skull base, orbit, optic nerve, or carotid artery
• Distorted sinus anatomy of development, post-operative, or traumatic origin
• Extensive sino-nasal polyposis
• Pathology involving the frontal, posterior ethmoid, and sphenoid sinuses
• Revision sinus surgery

Ramakrishnan and Kingdom (2015) stated that IGS is progressively used in ESS, and surgeons’ comfort with the technology has increased.  Current literature does not show a clear reduction in surgical complications.  The routine use of IGS in ESS as a deterrent to medicolegal liability is not substantiated by recent reported data.  There are particular situations in which IGS may be helpful, but its use is likely not required for routine ESS and appeared best left to surgeon discretion.

Ference and associates (2018) stated that currently there are no data on the relative frequency of ESS performed for CRSwNP versus CRSsNP in the United States.  These investigators compared the rate of surgical interventions for CRSwNP and CRSsNP.  Cases identified by CPT codes were extracted from the 2009 to 2011 State Ambulatory Surgery Databases for California (CA), Florida (FL), Maryland (MD), and New York (NY).  Patient demographics, extent of surgery, mean charges, and operating room (OR) time were compared.  A total of 97,228 ESS cases were performed in the 4 states; 29.2 % of surgeries were for patients with CRSwNP, 66.0 % of patients with CRSsNP, and 4.8 % for other indications.  The proportion of ESS for CRSwNP varied across states, with CA having the highest percentage (34.6 %) and MD having the lowest (26.4 %) (p < 0.0001).  Patients with Medicaid (33.8 %) and Medicare (32.2 %) had higher rates of surgery for CRSwNP compared with patients with private insurance (29.9 %) (p < 0.001).  Surgeons who performed a higher volume of sinus surgery compared to lower volume surgeons performed a lower percentage of surgery for CRSwNP (24.4 % versus 33.5 %; p < 0.001).  ESS cases for CRSwNP were more extensive (relative risk [RR] of 4 sinus surgeries of 1.88; p < 0.0001), used IGS more frequently (RR, 1.39; p < 0.0001), and were less likely to include a balloon procedure (RR, 0.69; p < 0.0001).  Patients with CRSwNP had longer OR times (ESS that involved all 4 sinuses took 14 minutes longer) (p < 0.0001), but no difference in charges compared with patients with CRSsNP who underwent a similar extent of surgery.  The authors concluded that almost 30 % of ESS were performed for CRSwNP, and these cases were, on average, more extensive, used more OR time, and more often used IGS than surgeries for CRSsNP.  The rate of surgery performed for CRSwNP varied based on geography, payer, and surgical volume, which indicated that patient selection impacted surgical management.

Post-Operative Nasal Debridement following Functional Endoscopic Sinus Surgery

Green and colleagues (2015) evaluated the evidence relating to post-operative debridement of the nasal cavity following FESS to guide best practice.  These investigators carried out a search of the following databases: Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Control Trials, Ovid Medline, Embase, and PubMed.  The following key words were used: Postoperative, functional endoscopic sinus surgery, sinus surgery, debridement, follow-up, from 1970 to 2013.  Two independent reviewers assessed the relevant articles using the consort guidance on systematic reviews Moher et al. BMJ 2010; 340: c869.  The best evidence available was 1B, with 6 RCTs identified; 4 studies compared debridement against no debridement, and 2 looked at the frequency of the debridement.  Cumulatively, results for 337 patients were included; VAS were used in all studies.  None of the results at the long-term follow-up showed any difference in sino-nasal outcome test scores or objective endoscopic scores.; 4 of the 6 studies demonstrated some benefit in symptom scores but only 1 in the long-term; 2 papers demonstrated the debridement group suffered more pain in the post-operative period.  The authors concluded that currently, there is no clear evidence for frequent post-operative debridement.  They stated that further well-designed RCTs are needed to establish clear benefit, optimal frequency, extent and timing of debridement.

In a RCT, Varsak and associates (2016) evaluated the post-operative debridement frequency following ESS.  A total of 62 adult patients with a diagnosis of CRSwNP and CRSsNP meeting the inclusion criteria were enrolled in this prospective study.  Participants were randomized equally to frequent debridement (FD; at post-operative weeks 1, 2 and 4) or to a single debridement (SD; at post-operative week 1) after surgery.  The outcomes were assessed with VAS for 9 main symptoms concerning patient discomfort within the first 4 weeks, with the modified Lund-Kennedy endoscopic score (MLKES) at weeks 4 and 24 and with the sino-nasal outcome test-20 (SNOT-20) at week 24; 37 of the patients were male, and 25 were female.  The mean age was 36.1 ± 13.5 in FD group and 39.2 ± 14.7 in SD group.  In the SD group, the VAS scores at post-operative week 4 showed significantly less discomfort at visits (p = 0.004) and less negative effects on their work (p = 0.013).  There was no statistically significant difference between the 2 groups in the week 4 and 24 MLKES and in the week 24 SNOT-20 scores (p > 0.05).  The endoscopic findings did not show significant differences between the groups.  The authors concluded that these findings indicated that FD caused more discomfort at the required visits, more facial pain and more negative effects on patients' work; this method was not superior to post-operative single 7th day debridement in terms of the 24-week QOL and endoscopic scores.  Level of evidence = 1b.

Eloy and co-workers (2017) stated that CRS with and without nasal polyps is a common disease affecting people all over the world; and FESS has become the gold standard treatment for medically refractive disease.  Post-operative care is recommended by international leaders as an important part of the patient's management.  These investigators provided a critical review and discussion focusing on post-operative care, which is based on expert opinion, clinical studies, RCTs and meta-analysis studies.  Post-operative care including nasal rinsing, topical corticosteroids, antibiotics and avoidance of nasal packing are unanimously considered to be the cornerstone of best practice following FESS.  However, the effectiveness of in-office nasal debridement is still under debate.  The authors concluded that there is a lack of consensus regarding the necessity of performing in-office nasal debridement and the majority of clinicians perform their post-operative care according to experience and their own preference.  This is often determined by the extent of surgery performed, the severity of the post-operative inflammation, as well as being dependent on the patient's discomfort, the time constraints associated with post-operative care and the costs associated with additional appointments.  Ideally, nasal debridement should be performed by the operating surgeon under endoscopic control both gently and atraumatically.

Tzelnick and colleagues (2018) stated that ESS is often recommended for symptomatic patients with recurrent acute rhinosinusitis or CRS who have failed conservative treatment.  Post-operative care has been felt to be critical for both maintaining the surgical patency of the operated sinuses and improving patient symptoms.  Debridement of the sino-nasal cavities is one such post-operative care measure that has frequently been studied in the literature, often with conflicting conclusions.  These investigators examined the effects of post-operative sino-nasal debridement versus no debridement following ESS.  The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); PubMed; Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.  The date of the search was May 21, 2018; RCTs comparing post-operative nasal debridement versus no debridement in adult patients with recurrent acute rhinosinusitis or CRS undergoing ESS.  These researchers included studies in which the patients acted as self-controls (i.e., 1 side of the nose underwent debridement and the other side did not) only for the secondary endoscopy outcomes.  These investigators used the standard methodological procedures expected by Cochrane.  The primary outcome measures were: health-related QOL, disease severity (patient-reported symptom scores) and significant adverse effects (bleeding requiring intervention, severe pain, iatrogenic injury).  Secondary outcomes were: post-operative endoscopic appearance of the sino-nasal surgical cavities (endoscopic scores), recorded use of post-operative medical treatment and rate of revision surgery.  They used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.  These investigators included 4 studies (152 participants), with a follow-up duration ranging from 3 to 12 months.  In 2 studies patients acted as self-controls, i.e., 1 side of the nose underwent debridement and the other side did not (“split-nose” studies).  The risk of bias in all studies was high, mostly due to the inability to blind the patients to the debridement procedure.  Primary outcomes included disease-specific health-related QOL scores.  Only 1 study (58 participants) provided data for disease-specific health-related QOL.  At 6 months follow-up, lower disease-specific health-related QOL scores, measured using the Sino-Nasal Outcome Test-22 (SNOT-22, range 0 to 110), were noted in the debridement group, but the difference was not statistically significant (9.7 in the debridement group versus 10.3 in the control group, p = 0.47) (low-quality evidence).  Disease severity (patient-reported symptom score): Only 1 study (60 participants) provided data for disease severity measured by VAS score.  No significant differences in total symptom score were observed between groups post-operatively (low-quality evidence).  Significant adverse effects related to the debridement procedure were not reported in any of the included studies, however it is unclear whether data regarding adverse effects were not collected or if none was indeed observed in any of the included studies.  Secondary outcomes: All 4 studies assessed the post-operative endoscopic appearance of the sino-nasal cavities using the Lund-Kennedy score (range 0 to 10).  A pooled analysis of endoscopic scores in the 2 non “split-nose” studies revealed better endoscopic scores in the debridement group, however this was not a statistically significant difference (mean difference [MD] -0.31, 95 % CI: -1.35 to 0.72; I² = 0 %; 2 studies; 118 participants) (low-quality evidence).  A sub-analysis of the adhesion formation component of the endoscopic score was available for all 4 studies and revealed a significantly lower adhesion rate in the debridement group (risk ratio [RR] of 0.43, 95 % CI: 0.28 to 0.68; I² = 29 %; 4 studies; 152 participants).  Analysis of the number needed to treat to benefit revealed that for every 3 patients undergoing debridement, the endoscopic score would be decreased by 1 point in 1 patient.  For every 5 patients undergoing debridement adhesion formation would be prevented in 1 patient.  Use of post-operative medical treatment was reported in all studies, all of which recommended nasal douching.  Steroids (systemic or nasal) were administered in 2 studies.  However, the data were very limited and heterogeneous, thus, these researchers could not analyze the impact of concomitant post-operative medical treatment.  The rate of revision surgery was not reported in any of the included studies, however it was unclear whether these data were not recorded or if there were no revision surgeries in any of the included studies.  The authors concluded that they were uncertain about the effects of post-operative sino-nasal debridement due to high risk of bias in the included studies and the low quality of the evidence.  They stated that sino-nasal debridement may make little or no difference to disease-specific health-related QOL or disease severity.  Low-quality evidence suggested that post-operative debridement is associated with a significantly lower risk of adhesions at 3 months follow-up.  Whether this has any impact on longer-term outcomes is unknown.

Endoscopic Orbital Decompression for Graves Ophthalmopathy

Ogura and Thawley (1980) presented their clinical experience, diagnostic techniques, surgical recommendations, and the results in 252 patients who have undergone trans-antral orbital decompression for malignant exophthalmos.  Reduction of proptosis up to 12 mm. has been obtained.  In 80 % of the patients the eyes were balanced within 1 mm.  Complications have been minimal.  The authors believed that this procedure had proved its effectiveness in the treatment of malignant exophthalmos.  In most cases it made possible the preservation or improvement of vision and arrested the progressive extra-ocular muscle imbalance.  The importance of close co-operation between the otolaryngologist, endocrinologist, and ophthalmologist could not be over-emphasized in the management of this disorder.

Graham and colleagues (1999) stated that certain cases of thyroid-related orbitopathy may require surgical decompression of the orbit.  These investigators high-lighted new techniques of orbital decompression in thyroid-related orbitopathy.  They presented 2 illustrative cases selected from their recent surgical experience.  The techniques of combined-approach decompression, trans-caruncular approach to the medial orbital wall, drilling reduction of the greater wing of sphenoid and lateral wall lag-screw fixation after lateralization by greenstick fracture were presented.  The relative utility of each technique was examined.  The authors concluded that these techniques expanded the surgical repertoire for this condition and allowed individualization of treatment for a specific patient's needs.

Metson and Pletcher (2006) noted that endoscopic orbital decompression has become the surgical treatment of choice for many patients with orbital manifestations of Graves' disease, including proptosis and optic neuropathy.  The unparalleled visualization provided by endoscopic instrumentation allowed for a safe and thorough decompression, especially when operating along the orbital apex and skull base.  The authors concluded that although the benefits of and indications for decompression of the orbit are well-established, the role of optic nerve decompression remains controversial.

In a systematic review, Leong and associates (2009) compared the surgical outcomes of orbital decompression for dysthyroid orbitopathy.  Data sources used were PubMed, Embase, and Cochrane search for English-language literature from January 1990 to April 2008, combined with manual review of citations within article bibliographies.  Citations retrieved from the targeted search were filtered independently by 2 researchers.  Relevant articles were reviewed to obtain information including interventions and outcome measures.  Articles were then assigned level-of-evidence grades as defined by the Oxford Centre for Evidence-Based Medicine.  A total of 516 citations were generated from which 135 abstracts were regarded as potentially relevant.  After other relevant articles identified from the bibliography and duplicate articles excluded, 56 studies were available for analysis; 50 studies were identified as level-IV and 6 as level-III evidence.  A total of 2,315 patients were pooled, from which 4,176 orbits were decompressed; 15 different surgical techniques were broadly identified.  The most common surgical indication was cosmesis.  Decompression by combined transpalpebral-endoscopic technique resulted in the highest average reduction in post-operative proptosis.  The largest improvement in visual acuity (VA) was after coronal approach orbital decompression.  The overall complication rate was 9.3 %.  The most significant complications were vision loss and cerebro-vascular accident (CVA).  The highest complication rate was associated with combined endoscopic and transpalpebral decompression.  The authors concluded that there were myriad techniques in practice for decompressing the orbit, but no one technique has yet to achieve consistently good outcome and low complication rates.  The reporting of outcomes should conform to a minimum data-set.

Boboridis and co-workers (2015) noted that orbital decompression is the indicated procedure for addressing exophthalmos and compressive optic neuropathy in thyroid eye disease.  There are an abundance of techniques for removal of orbital bone, fat, or a combination published in the scientific literature.  The relative efficacy and complications of these interventions in relation to the specific indications remain as yet undocumented.  These researchers carried out a systematic review of the current published evidence for the effectiveness of orbital decompression, possible complications, and impact on QOL.  They searched the current data-bases for medical literature and controlled trials, oculoplastic textbooks, and conference proceedings to identify relevant data up to February 2015.  They included RCTs comparing 2 or more interventions for orbital decompression.  These investigators identified only 2 eligible RCTs for inclusion in the review.  As a result of the significant variability between studies on decompression, i.e., methodology and outcome measures, they did not perform a meta-analysis.  One study suggested that the trans-antral approach and endonasal technique had similar effects in reducing exophthalmos but the latter was safer.  The second study provided evidence that intravenous  (IV) steroids may be superior to primary surgical decompression in the management of compressive optic neuropathy requiring less secondary surgical procedures.  The authors concluded that most of the published literature on orbital decompression consisted of retrospective, uncontrolled trials.  There is evidence from those studies that removal of the medial and lateral wall (balanced) and the deep lateral wall decompression, with or without fat removal, may be the most effective surgical methods with only few complications.  There is a clear unmet need for controlled trials evaluating the different techniques for orbital decompression.  Ideally, future studies should address the effectiveness, possible complications, QOL, and cost of each intervention.

Lv and associates (2016) described a novel approach to orbital decompression for dysthyroid optic neuropathy (DON).  An augmented endoscopic trans-ethmoid medial orbital wall decompression (ETMOWD) was performed on 43 consecutive patients (72 eyes) with DON in order to access the orbital apex adequately.  Concurrently, endoscopic trans-ethmoid fat decompression (ETFD) using a novel aspiration/cutting instrument to remove orbital fat was performed for further reduction of proptosis.  All patients were followed-up periodically for at least 6 months.  Outcomes such as improvement of VA, color vision, degree of proptosis reduction as well as the incidence of surgical induced diplopia were analyzed at the final review.  A total of 69 out of 72 eyes (95.8 %) had a statistically significant improvement in VA from -0.65 ± 0.30 to -0.25 ± 0.22 post-operatively, with a mean improvement of 0.55 ± 0.17 (p < 0.001); 34 out of 45 eyes had an improvement in color vision (p < 0.001).  The range of proptosis reduction was 4 to 9 mm (mean of 6.2 ± 1.2 mm).  Post-operative symmetry was achieved to within 2 mm using an exophthalmometer in 39 of 43 patients (90.7 %); 5 patients developed diplopia in the post-operative phase, but had complete resolution within 3 months; 2 patients had further deterioration in their diplopia following surgery.  The authors concluded that this technique of a combined ETFD with ETMOWD appeared to be effective in managing patients with DON, with minimal morbidities and a low incidence of post-operative diplopia.

Rootman (2018) stated that the literature regarding orbital decompression for thyroid eye disease is vast, spanning multiple specialty areas including neurosurgery, head and neck, maxilla-facial, and ophthalmic plastic surgery.  Although techniques have advanced considerably over the more than 100 years during which this procedure has been performed, the 4 major approaches remain: trans-antral, trans-cranial, trans-nasal, and trans-orbital.  The explosion in literature related to orbital decompression has mostly involved minor technical variations on broader surgical themes.

Tooley and colleagues (2019) noted that orbital decompression surgery and medical therapy for thyroid eye disease (TED) have evolved over the past 150 years and afforded the opportunity to restore pre-disease appearance and visual function.  These researchers examined the past 150 years of surgical innovation for the treatment of TED.  The "Age of Surgical Heroism" spans from 1888 to 1979 during which the pioneers of orbital decompression developed lateral orbitotomy, trans-cranial decompression, para-nasal sinus decompression, and trans-antral decompression despite an incomplete understanding of the pathophysiology of both TED and a limited ability to non-invasively evaluate their patients.  The "Age of Surgical Refinement" dawned with the development of CT and represents the years 1979 to 2000.  During this time, the "swinging eyelid" approach for 2- and 3-wall decompressions was introduced, a combined orbital-extradural 4-wall decompression procedure was developed, fat decompression was explored, and endoscopic decompression techniques were advanced.  At the beginning of the 21st century, the understanding of the orbital pathophysiology of TED evolved significantly.  Clinicians recognized the age-related phenotype of TED based largely on the relative contribution of extra-ocular muscle enlargement versus orbital fat expansion.  The "Modern Age" of Customized Orbital Decompression features both "medical decompression" during the active phase of TED and, in the stable phase, customized surgical plans incorporating individual patients' anatomy, orbital pathology, and surgical goals that collectively maximize therapeutic benefit while minimizing therapeutic morbidity.

Furthermore, an UpToDate review on “Treatment of Graves' orbitopathy (ophthalmopathy)” (Davies and Burch, 2020) states that “For patients with moderate-to-severe orbitopathy, we suggest initial treatment with glucocorticoids (Grade 2B).  These can be given either orally or intravenously (IV) depending on the severity of the disease.  Initial IV therapy is appropriate in more severe or progressive cases.  If glucocorticoid therapy is contraindicated, cannot be tolerated, or is ineffective, options include other medical therapies, external orbital radiation, or orbital decompression surgery”.

Appendix

Selection Criteria for Balloon Sinuplasty and Recurrent Acute / Chronic Sinusitis (must meet all (I, II, III, and IV) of the following):

1. Two or more of the following symptoms:

   • Nasal obstruction;
   • Anterior or posterior mucopurulent (foul) drainage;
   • Facial pain, pressure, headache (when other causes have been ruled out) and/or fullness over the affected sinus;
   • Decreased sense of smell; and

2. Either of the following:

   • Four or more documented episodes of acute rhinosinusitis (e.g., less than 4 weeks duration) in 1 year; or
   • Chronic sinusitis (e.g., greater than 12 weeks duration); and

3. Maximal medical therapy has been tried, as indicated by all of the following:

   • Antibiotic therapy for at least 5 to7 days; and
   • Trial of nasal steroids for at least 6 weeks; and
   • Saline nasal irrigation for at least 6 weeks; and
   • Allergy testing (if symptoms are consistent with allergic rhinitis and have not responded to appropriate environmental controls and pharmacotherapy (e.g., anti-histamines or intranasal corticosteroids or leukotriene antagonists, etc.)); and

4. Abnormal findings from diagnostic work-up, as indicated by computed tomography (CT) findings suggestive of obstruction or infection (e.g., but not limited to, air fluid levels, air bubbles, greater than 3 mm of mucosal thickening, pansinusitis, or diffuse opacification).

Table 1: Medical Necessity for Balloon sinuplasty - Statements That Reached Consensus Patients Criteria

Number	Statement	Mean	Outliners
4	Balloon dilation is not appropriate for patients who are without both sinonasal symptoms and positive findings on CT.	9.00	0
7	Balloon dilation is not appropriate for management of headache in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.	8.77	0
18	Balloon dilation is not appropriate for management of sleep apnea in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.	8.77	0
17	CT scanning of the sinuses is a requirement before balloon dilation can be performed.	8.46	0
2	Balloon dilation is not appropriate for patients with sinonasal symptoms and a CT scan that does not show evidence of sinonasal disease.	8.08	1
11a	Balloon dilation can be appropriate as an adjunct procedure to FESS in patients with chronic sinusitis without nasal polyps.	7.62	0
13a	There can be a role for balloon dilation in patients with persistent sinus disease who have had previous sinus surgery.	7.62	1
6	There is a role for balloon sinus dilation in managing patients with recurrent acute sinusitis defined in the AAO-HNSF guideline based on symptoms and the CT evidence of ostial occlusion and mucosal thickening.	7	1

Statements are ordered according to mean value for the 9-point Likert scale of agreement, with the statement obtaining the highest amount of agreement listed first (Adapted from Piccirillo et al, 2018).

Table 2: Medical Necessity for Balloon sinuplasty - Statements That Did Not Reach Consensus Patients Criteria

Number	Statement	Mean	Outliners
5	There is a role for balloon sinus dilation in managing patients with recurrent acute sinusitis defined in the AAO-HNSF guideline based on symptoms alone without CT evidence of disease.	4.69	8
16	CT scanning of the sinuses is a requirement before balloon dilation can be considered.	6.69	8
3	Balloon dilation is appropriate for patients with sinonasal symptoms and a CT that shows ostial occlusion and normal mucosa.	5.77	4
9	Balloon dilation is appropriate as a standalone procedure in patients with chronic sinusitis without nasal polyps.	6.54	4
14	There is not a role for balloon dilation in patients with persistent sinus disease who have had previous sinus surgery.	3.46	4
15	The surgical threshold for balloon dilation and traditional sinus surgery is equivalent.	6.77	4
10	Balloon dilation is appropriate as an adjunct procedure to FESS in patients with chronic sinusitis with nasal polyps.	6.38	3
11	Balloon dilation is appropriate as an adjunct procedure to FESS in patients with chronic sinusitis without nasal polyps.	7.31	2
1	When surgery is indicated for patients with CRS, balloon dilation is a valid and appropriate option.	6	2
12	For patients with CRS with limited sinus disease who meet criteria for surgery, balloon dilation is an appropriate standalone procedure before considering more extensive sinus surgery.	6.62	1
13	There is a role for balloon dilation in patients with persistent sinus disease who have had previous sinus surgery.	6.69	1
8	Balloon dilation is appropriate as a standalone procedure in patients with chronic sinusitis with nasal polyps.	2.23	1

Items in the boldface text reached “near consensus”; all other items reached “no consensus”.  Statements are ordered according to the number of outliners, with the statement obtaining the highest number of outliners listed first.  When more than 1 statement had the same number of outliners, the statements were then ordered according to the mean value for the 9-point Likert scale of agreement, with the statement obtaining the highest amount of agreement listed first (Adapted from Piccirillo et al, 2018).

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+" :
Endoscopic sinus surgery (ESS) :
CPT codes covered if selection criteria are met:
31233	Nasal/sinus endoscopy, diagnostic with maxillary sinusoscopy (via inferior meatus or canine fossa puncture)
31235	Nasal/sinus endoscopy, diagnostic with sphenoid sinusoscopy (via puncture of sphenoidal face or cannulation of ostium)
31240	Nasal/sinus endoscopy, surgical; with concha bullosa resection
31253	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including frontal sinus exploration, with removal of tissue from frontal sinus, when performed
31254	Nasal/sinus endoscopy, surgical with ethmoidectomy; partial (anterior)
31255	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior)
31256	Nasal/sinus endoscopy, surgical, with maxillary antrostomy
31257	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including sphenoidotomy
31259	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including sphenoidotomy, with removal of tissue from the sphenoid sinus
31267	Nasal/sinus endoscopy, surgical, with maxillary antrostomy; with removal of tissue from maxillary sinus
31276	Nasal/sinus endoscopy, surgical, with frontal sinus exploration, including removal of tissue from frontal sinus, when performed [general Draf procedures]
31287	Nasal/sinus endoscopy, surgical, with sphenoidotomy
31288	Nasal/sinus endoscopy, surgical, with sphenoidotomy; with removal of tissue from the sphenoid sinus
Other CPT codes related to the CPB:
30130	Excision inferior turbinate, partial or complete, any method
30140	Submucous resection inferior turbinate, partial or complete, any method
30520	Septoplasty or submucous resection, with or without cartilage scoring, contouring or replacement with graft
31292	Nasal/sinus endoscopy, surgical, with orbital decompression; medial or inferior wall
31293	Nasal/sinus endoscopy, surgical, with orbital decompression; medial and inferior wall
31237	Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or debridement (separate procedure)
+61781	Stereotactic computer-assisted (navigational) procedure; cranial, intradural (List separately in addition to code for primary procedure)
+61782	Stereotactic computer-assisted (navigational) procedure; cranial, extradural (List separately in addition to code for primary procedure)
+61783	Stereotactic computer-assisted (navigational) procedure; spinal (List separately in addition to code for primary procedure)
70480 - 70481	Computed tomography, orbit, sella, or posterior fossa or outer, middle, or inner ear; without/with contrast material
70486 - 70488	Computed tomography, maxillofacial area; without/with contrast material
70490 - 70491	Computed tomography, soft tissue neck; without contrast material
76380	Computed tomography, limited or localized follow-up study
ICD-10 codes covered if selection criteria are met:
B49	Unspecified mycosis [fungus ball]
C11.0 - C12	Malignant neoplasm of nasopharynx and pyriform sinus
C30.0 - C31.9	Malignant neoplasm of nasal cavity and accessory sinuses
D10.6	Benign neoplasm of nasopharynx
D14.0	Benign neoplasm of middle ear, nasal cavity and accessory sinuses
D16.4	Benign neoplasm of bones of skull and face
E05.00 - E05.01	Thyrotoxicosis with diffuse goiter [endoscopic orbital decompression for Graves ophthalmopathy]
G96.0	Cerebrospinal fluid (CSF) rhinorrhea
H05.011 - H05.019	Cellulitis of orbit
J01.00 - J01.91	Acute sinusitis
J30.0 - J30.9	Vasomotor and allergic rhinitis
J31.0	Chronic rhinitis
J32.0 - J32.9	Chronic sinusitis
J33.0 - J33.9	Nasal polyps
J34.0	Abscess, furuncle, and carbuncle of nose
J34.1	Cyst and mucocele of nose and nasal sinus
J34.89	Other specified disorder of nose and nasal sinuses
Balloon sinus ostial dilation (balloon sinuplasty):
CPT codes covered if selection criteria are met:
31295	Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (eg, balloon dilation), transnasal or via canine fossa
31296	Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (eg, balloon dilation)
31297	Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (eg, balloon dilation)
31298	Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (eg, balloon dilation)
ICD-10 codes covered if selection criteria are met:
C11.0 - C11.9	Malignant neoplasm of nasopharynx
C30.0 - C31.9	Malignant neoplasm of nasal cavity and accessory sinuses
D14.0	Benign neoplasm of middle ear, nasal cavity and accessory sinuses
J01.00 - J01.01	Acute maxillary sinusitis
J01.10 - J01.11	Acute frontal sinusitis
J01.30 - J01.31	Acute sphenoidal sinusitis
J32.0	Chronic maxillary sinusitis
J32.1	Chronic frontal sinusitis
J32.3	Chronic sphenoidal sinusitis
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
D86.0 - D86.9	Sarcoidosis
E84.0 - E84.9	Cystic fibrosis
J01.20 - J01.21	Acute ethmoidal sinusitis
J32.2	Chronic ethmoidal sinusitis
J34.1	Cyst and mucocele of nose and nasal sinus [mucocele causing sinusitis]
J70.8	Respiratory conditions due to other specified external agents [Samter’s triad (aspirin sensitivity)]
L40.50 - L40.59	Arthropathic psoriasis
L93.0	Discoid lupus erythematosus
M06.00 - M06.09	Rheumatoid arthritis without rheumatoid factor
M30.1	Polyarteritis with lung involvement [Churg-Strauss]
M31.30	Wegener’s granulomatosis without renal involvement [granulomatosis with polyangiitis (PGA)]
M31.7	Microscopic polyangiitis
M32.0 - M32.9	Systemic lupus erythematosus (SLE)
M33.00 - M33.19	Dermatomyositis
M33.20 - M33.29	Polymyositis
M34.0 - M34.9	Systemic sclerosis [scleroderma]
M35.00 - M35.09	Sicca syndrome [Sjogren]
M35.4	Diffuse (eosinophilic) fasciitis
M85.00 - M85.09	Fibrous dysplasia (monostatic)
M88.0 - M88.9	Osteitis deformans (Paget’s disease)
M91.10 - M91.12	Juvenile osteochondrosis of head of femur [Legg-Calve-Perthes]
Q78.0	Osteogenesis imperfecta (brittle bone disease)
Q79.6	Ehlers-Danlos syndrome
Q87.40 - Q87.43	Marfan's syndrome
Q87.81	Alport syndrome
Q89.3	Situs inversus [Kartagener’s syndrome]
Image Guided Endoscopic sinus surgery:
CPT codes covered if selection criteria are met:
31235	Nasal/sinus endoscopy, diagnostic with sphenoid sinusoscopy (via puncture of sphenoidal face or cannulation of ostium)
31254	Nasal/sinus endoscopy, surgical with ethmoidectomy; partial (anterior)
31255	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior)
31276	Nasal/sinus endoscopy, surgical, with frontal sinus exploration, including removal of tissue from frontal sinus, when performed
31287	Nasal/sinus endoscopy, surgical, with sphenoidotomy
31288	Nasal/sinus endoscopy, surgical, with sphenoidotomy; with removal of tissue from the sphenoid sinus
Other CPT codes related to the CPB:
77011	Computed tomography guidance for stereotactic localization
77012	Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation
77021	Magnetic resonance guidance for needle placement (eg, for biopsy, needle aspiration, injection, or placement of localization device) radiological supervision and interpretation
ICD-10 codes covered if selection criteria are met:
B49	Unspecified mycosis [fungus ball]
C11.0 - C12	Malignant neoplasm of nasopharynx and pyriform sinus
C30.0 - C31.9	Malignant neoplasm of nasal cavity and accessory sinuses
D10.6	Benign neoplasm of nasopharynx
D14.0	Benign neoplasm of middle ear, nasal cavity and accessory sinuses
D16.4	Benign neoplasm of bones of skull and face
G96.0	Cerebrospinal fluid (CSF) rhinorrhea
H05.011 - H05.019	Cellulitis of orbit
J01.00 - J01.91	Acute sinusitis
J30.0 - J30.9	Vasomotor and allergic rhinitis
J31.0	Chronic rhinitis
J32.0 - J32.9	Chronic sinusitis
J33.0 - J33.9	Nasal polyps
J34.0	Abscess, furuncle, and carbuncle of nose
J34.1	Cyst and mucocele of nose and nasal sinus
J34.89	Other specified disorder of nose and nasal sinuses

The above policy is based on the following references: