Chronic rhinosinusitis (CRS) is a highly prevalent inflammatory disorder of the paranasal sinuses and the mucosa of the nasal passages that affects 3% to 7% of adults.^1, In adults, CRS is characterized by symptoms related to nasal and sinus obstruction and inflammation, including mucopurulent nasal drainage, nasal congestion, facial pain or pressure, and anosmia or hyposmia, that persist for at least 12 weeks.

Three CRS subtypes exist and may have somewhat different treatment strategies: CRS without nasal polyposis; CRS with nasal polyposis; and allergic fungal sinusitis. The latter is a less common subtype thought to result from chronic allergic inflammation to colonizing nasal fungi. This policy focuses on the more common subtypes: CRS with and without nasal polyposis. Both subtypes present with similar symptoms. However, CRS with nasal polyposis is, by definition, associated with nasal polyps that are visible on rhinoscopy or nasal endoscopy. Further, CRS with nasal polyposis is more likely to be associated with asthma and aspirin intolerance; this triad is referred to as Samter syndrome or aspirin-exacerbated respiratory disease.

CRS is associated with impaired quality of life for affected patients, and with high direct and indirect costs for medical treatments and lost productivity. Most often, the negative health effects of CRS are related to the unpleasant symptoms associated with CRS, including nasal congestion, nasal drainage, and facial pain or pressure. In rare cases, CRS can be associated with serious complications, including orbital cellulitis, osteomyelitis, or intracranial extension of infection.

While acute sinusitis is considered a more traditional infectious process, CRS is a chronic inflammatory disease of the upper airways, with multiple underlying causes. Risk factors for CRS with or without nasal polyps include anatomic variations and gastroesophageal reflux. There are conflicting reports about the association between allergy and CRS without nasal polyps, although weak evidence has suggested that allergy may be associated with CRS with nasal polyps. In addition, aspirin sensitivity may be associated with CRS with nasal polyps. The role of bacterial, viral, and fungal microorganisms in CRS has been actively investigated. There is some evidence that CRS is associated with a predominance of anaerobic bacteria.^2,3, On the other hand, a study that used bacterial ribosomal RNA sequencing to evaluate the sinus microbiome in patients with and without CRS found a quantitative increase in bacterial and fungal RNA expression in patients with CRS, but no major differences in the types of microorganisms detected.^4, Bacterial biofilms have been identified in cases of CRS.^5,

Medical Therapy

Medical therapy for CRS, with or without polyps, is often multimodal, including nasal irrigation, topical and/or systemic corticosteroids, and/or antibiotic therapy. ^6, Guidelines from the American Academy of Otolaryngology-Head and Neck Surgery (2015) have recommended the use of saline nasal irrigation, topical intranasal corticosteroids, or both, for symptom relief of CRS, on the basis of systematic reviews of randomized controlled trials (RCTs).^7,8, There is a specific recommendation against the use of topical and systematic antifungal therapies. The guidelines do not include a statement specifically addressing the use of systemic antibiotics for CRS; however, in the list of future research needs, the authors included: “Perform additional RCTs to clarify the impact of antibiotic therapy on CRS outcomes.”

A systematic review by Rudmik and Soler (2015) evaluated the evidence for various medical therapies for chronic sinusitis, excluding allergic fungal sinusitis.^1, Reviewers included 29 studies, with 12 meta-analyses (with a total of >60 RCTs), 13 systematic reviews, and 4 individual RCTs not included in any meta-analyses. Topical corticosteroids were associated, in multiple studies, with improved symptom scores, reduced polyp size, and decreased polyp recurrence after surgery. Saline nasal irrigation was associated, in multiple studies, with significant improvements in symptoms scores. There was some evidence that two systemic therapies (oral corticosteroids, doxycycline), both for three weeks, improved polyp scores in patients with CRS with nasal polyps. Long-term (>3 months) macrolide therapy was associated in an RCT with improved symptoms and quality of life in individuals with CRS without nasal polyps, although other studies did not find a benefit with chronic macrolide use.

In 2014, an evidence-based review summarized a series of earlier evidence-based reviews with recommendations related to CRS.^9, This review concluded that both saline irrigation and topical corticosteroids are well-supported by the available published literature for treatment of CRS, with and without nasal polyps. For CRS with polyps, the evidence demonstrated short-term improvement in symptoms after short-term oral corticosteroid treatment. For CRS with or without nasal polyps, a small number of RCTs have shown improvement in nasal endoscopy scores and some symptoms with oral macrolide therapy. However, for CRS with or without nasal polyps, there was very limited evidence on the use of nonmacrolide oral antibiotics.

A 2011 Cochrane review of studies comparing systemic antibiotics with placebo for CRS in adults identified a study (n=64 patients) judged to be at high-risk of bias.^10, Reviewers concluded: “Further good quality trials, with large sample sizes, are needed to evaluate the use of antibiotics in chronic rhinosinusitis.”

Surgery

The goals of surgery for CRS include removing polyps and debris that may be sources of inflammatory mediators and prevent the effective delivery of local medical therapies. In addition, to varying degrees, surgical techniques involve the creation of open sinus cavities, usually via dilation of the sinus ostia, to permit better drainage from the sinus cavities and more effective delivery of local therapies.

Techniques for functional endoscopic sinus surgery (FESS), in which an endoscope is used to access the sinus cavities and varying degrees of tissue are removed and the sinus ostia are opened, have evolved since the development of the nasal endoscope in the 1960s. FESS has largely replaced various open techniques for CRS (eg, Caldwell-Luc procedure), although open procedures may have a role in complicated sinus pathologies (eg, endonasal tumors).

FESS encompasses a variety of degrees of sinus access and tissue removal and is described based on the sinuses accessed. The Draf classification is used to describe degrees of endoscopic frontal sinusotomy (see Table 1).

Table 1. Draf Classification for Endoscopic Frontal Sinusotomy

Type	Description
Draf I	Anterior ethmoidectomy without altering frontal sinus ostium
Draf IIA	Removal of ethmoid cells that extend into frontal sinus
Draf IIB	Removal of frontal sinus floor between the middle turbinate and the lamina papyracea
Draf IIIa	Removal of frontal sinus floor from orbit to orbit with contiguous portions of the superior nasal septum

^a Modified Lothrop procedure.

FESS can also be used to access the ethmoid sinuses, which may involve creation drainage into the maxillary sinuses (maxillary antrostomy).

Regulatory Status

FESS is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

Related Policies

• Balloon Ostial Dilation as an Alternative to Endoscopic Sinus Surgery for Treatment of Chronic Rhinosinusitis (Policy #077 in the Surgery Section)

1. The member has 2 or more of the following signs and symptoms of chronic rhinosinusitis which are present for at least 12 continuous weeks:
a. Mucopurulent nasal drainage;
b. Nasal congestion;
c. Facial pain-pressure-fullness;
d. Anosmia or hyposmia.

AND

2. Appropriate medical therapy has been attempted, including all of the following:

a. Topical nasal steroids for at least 4 consecutive weeks;
b. Nasal lavage for at least 8 consecutive weeks;
c. Consideration for allergic and/or immune evaluation if the member has symptoms consistent with allergic rhinitis and/or immunodeficiency.

AND


3. There is objective evidence of mucosal inflammation as demonstrated by one of the following:

a. Sinus computed tomography or magnetic resonance imaging showing significant mucosal thickening or opacification of the paranasal sinuses; OR
b. Nasal endoscopy with purulent mucus or edema in the middle meatus or anterior ethmoid region OR polyps in the nasal cavity or middle meatus.

AND


4. There are no serious urgent complications of acute sinusitis that would suggest orbital cellulitis or abscess, intracranial extension of infection, or other complication that would require urgent or emergent surgery such that “appropriate medical therapy” for 8 weeks would not be appropriate.

[RATIONALE: This policy was created in 2017 with a search of the PubMed database. The most recent literature update was performed through January 7, 2020.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice. The following is a summary of the key literature to date.

This review focuses on the use of surgical therapies for uncomplicated chronic rhinosinusitis (CRS) with or without nasal polyposis. It focuses on functional endoscopic sinus surgery (FESS).

The primary outcome measures relevant to the treatment of CRS are patient-reported symptoms and quality of life. Studies should predefine responder criteria for outcome measures used and assess between-group differences in the proportion of patients considered responders. Examiner evaluation of the nasal and sinus appearance and polyp size may provide some information about treatment outcomes, but these evaluations are limited by the lack of universally accepted standards.

Functional Endoscopic Sinus Surgery for Uncomplicated Chronic Rhinosinusitis Eligible for Medical Therapy
Clinical Context and Test Purpose

The purpose of FESS is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medical management, in patients with CRS with or without nasal polyposis.

The question addressed in this policy is: does FESS improve the net health outcome for patients with CRS?

The following PICO was used to select literature to inform this policy.

Patients

The relevant population of interest is individuals with CRS with or without nasal polyposis.

Interventions

The therapy being considered is FESS.

Comparators

Comparators of interest include medical management. Medical management for CRS includes saline nasal irrigation, corticosteroids, antibiotics, and immunotherapy.

Outcomes

To quantify the severity of CRS, various measures can be used, including patient-reported quality of life measures, radiologic scores, and endoscopic grading. The Lund-McKay scoring system uses radiologist-rated information derived from computed tomography scans regarding opacification of the sinus cavities, generating a score ranging from 0 to 12.^11,12, Several disease-specific patient-reported quality of life scores have been used. Commonly used is the Sino-Nasal Outcome Test-20 (SNOT-20), a validated questionnaire, in which patients complete 20 symptom questions on a categorical scale (0 [no bother] to 5 [worst symptoms can be]). Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains. The SNOT-22 is a variation of the SNOT-20 that includes 2 additional questions (“nasal obstruction” and “loss of smell and taste”). The minimal clinically important difference for the SNOT-22 has been estimated to be 8.9 points.^13,14, Additionally, quality of life may be reported based on overall health-related quality of life scores, such as the 36-Item Short-Form Health Survey. The Survey consists of 8 scales on various health domains, which are transformed into a scale ranging from 0 to 100 (100 corresponding to best health).

The existing literature evaluating FESS as a treatment for CRS with or without nasal polyposis has varying lengths of follow-up, ranging from 3- to 12-months. While studies described below all reported at least one outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 12-months of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Despite the widespread use of FESS, only a small number of RCTs have directly compared FESS with medical management. To the extent possible, CRS with and without nasal polyposis have been evaluated separately. If studies did not specify that the patient populations included only those with CRS with nasal polyposis, or if studies included both groups, the study was grouped with those addressing CRS with and without nasal polyps

Chronic Rhinosinusitis With or Without Polyposis
Review of Evidence
Randomized Controlled Trials

One RCT from 1997 compared FESS plus sinus irrigation to sinus irrigation alone in patients with CRS, not limited to patients with polyposis.^15, Patients were randomized to sinus irrigation, with a second irrigation a week after the first if needed, or to FESS within three days of enrollment. Randomization techniques were not described. The trial enrolled 89 patients (45 in each group), with 77 patients included in data analysis. A major limitation of this trial is that a single sinus irrigation is not the current standard of medical therapy.

Symptom scores and mucosal appearance on nasal endoscopy (scored on a 1-4 scale) were evaluated at baseline and 2, 6, 12, and 52 weeks after enrollment. Sinus radiographs were reevaluated at 12 weeks. For patient-reported symptoms, the prevalence of purulent rhinitis decreased from 91% to 40% after sinus irrigation alone and from 86% to 16% after sinus irrigation plus FESS (p=0.027), while the prevalence of loss of smell decreased from 49% to 18% after sinus irrigation and from 51% to 11% after sinus irrigation plus FESS (p=0.026). Changes in other patient-reported outcomes, including snoring, nasal obstruction, headache, and dry mouth on waking, did not differ significantly between groups. Nasoendoscopy-based scores of mucosal swelling and the prevalence of middle turbinate purulence did not differ significantly between groups at any follow-up time point. The proportion of patients in each group with specific findings on sinus radiographs (complete opacity, fluid level, mucosal swelling of at least 50% of the mediolateral diameter of the maxillary sinus) or with normal sinus radiographs at 12-week follow-up did not differ significantly between groups.

Systematic Reviews

A 2006 Cochrane review summarized the evidence on FESS for CRS.^16, This review was updated in 2010, with a literature search through November 2008, with no change to reviewers’ conclusions. Reviewers included RCTs comparing FESS alone or FESS plus other therapies with medical treatment and/or other types of sinus surgery. Three RCTs (total n=212 patients) met reviewers’ inclusion criteria, one of which was unpublished: one compared FESS plus sinus irrigation and medical treatment (antibiotics) with medical treatment alone; another compared endoscopic middle meatal antrostomy with conventional inferior meatal antrostomy; and a third compared FESS plus medical treatment (antibiotics, combination steroid and decongestant nasal spray, and nasal irrigation, followed by steroid nasal spray and saline nasal irrigation) with medical treatment alone. For the risk of bias assessment, reviewers reported: “It was unclear whether allocation concealment was carried out in any of the trials. There was no blinding applied in any of the included studies. Intention-to-treat analysis was applied in two of the studies.” Two trials reported no between-group differences in symptom scores at follow-up, and the third reported no between-group differences in overall cure rates. No major complications were reported across the three studies.

Vlastarakos et al (2013) reported on results of a systematic review and meta-analysis of FESS for CRS with or without nasal polyps in children, which included any interventional studies.^17, Reviewers selected 4 prospective, 5 retrospective comparative, and 6 retrospective studies (total n=1301 treated patients); no RCTs were identified. Although reviewers concluded that FESS was associated with improvements in patients’ quality of life, the conclusions that can be drawn from retrospective studies are limited.

Chronic Rhinosinusitis With Polyposis

Surgical approaches may include a simple polypectomy (defined as the removal of polyps without intentionally entering the sinuses or enlarging the natural ostia), polypectomy with FESS (removing polyps and other causes of obstruction from the ethmoid sinuses and lateral or nasal wall), or more radical nasalization of the ethmoid sinuses. We focus on studies comparing FESS with medical therapy for the management of CRS with nasal polyps.

Review of Evidence
Randomized Controlled Trials

Alobid et al (2005) reported on an RCT comparing FESS with oral steroids for individuals who had nasal polyposis, with a focus on nasal symptoms, polyp size, and quality of life.^18, Eligible patients had nasal polyposis, defined by the presence of both of the following: visualization of polyps under endoscopic examination and bilateral opacification of paranasal sinuses on computed tomography scan. Patients were randomized to 14 days of oral prednisone (n=52) or to FESS (n=56). All patients received 1 year of intranasal budesonide for 12 months. Symptoms were patient-reported on a 0-to-3 scale, while nasal polyp score was endoscopically assessed on a scale ranging from 0 to 3. At the 6- and 12-month follow-ups, patients in both groups reported improvements in nasal symptoms. At six months, the FESS group had greater improvements than the medical therapy group in nasal symptom scores (1.6 for FESS vs 1.2 for medical therapy, p<0.05), loss of smell scores (0.9 for FESS vs 0.5 for medical therapy, p<0.05), and polyp size score (2.3 for FESS vs 0.8 for medical therapy, p<0.05).

Systematic Reviews

A Cochrane review by Rimmer et al (2014), compared surgical interventions with medical interventions for CRS with nasal polyps.^19, Reviewers identified 4 studies (total n=231 randomized participants), none of which was considered at low-risk of bias. In all trials, topical steroids were used in both arms, but the trials otherwise varied by comparison groups; 1 study (n=109 enrolled, 95 analyzed) compared FESS with systemic steroids, 2 studies (combined n=87) compared polypectomy with systemic steroids, and 1 study (n=35) compared FESS plus a topical steroid (usual dose) with antibiotics plus high-dose topical steroid. Across trials, there were no important differences between treatment groups in terms of patient-reported disease severity scores, disease-specific quality of life scores (eg, SNOT-22), or overall health-related quality of life scores. Two trials reported on endoscopic sinus mucosal appearance, although there is no single accepted endoscopic grading system. In the RCT (n=95 analyzed) comparing FESS with systemic steroids, polyp size scores (graded on a 0-3, point scale) were significantly better in the FESS group (mean difference, -1.5; 95% confidence interval, -1.8 to 0 -1.2; corresponds to large effect size). In the RCT (n=34) comparing FESS plus topical steroid to antibiotics plus topical steroids, the percentage improvement in polyp size did not differ significantly between groups , but the estimate was limited due to the small sample size. Overall, reviewers concluded: “Evidence relating to the effectiveness of different types of surgery vs medical treatment for adults with CRS with nasal polyps is of very low quality. The evidence does not show that one treatment is better than another in terms of patient-reported symptom scores and quality of life measurements.”

Section Summary: Functional Endoscopic Sinus Surgery for Uncomplicated Chronic or Acute Recurrent Rhinosinusitis Eligible for Medical Therapy

The evidence from RCTs comparing FESS with medical management in individuals who had CRS with or without nasal polyposis is limited. Multiple observational studies and single-arm trials, with methodologic limitations, generally have not reported clinically significant differences in symptom improvements with FESS compared with medical therapy. Controlled trials with low-risk of bias are important to determine the efficacy of FESS compared with maximal medical therapy.

Functional Endoscopic Sinus Surgery for Uncomplicated Chronic Rhinosinusitis Refractory to Medical Therapy
Clinical Context and Test Purpose

The purpose of FESS is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medical management, in patients with uncomplicated CRS refractory to medical therapy.

The question addressed in this policy is: does FESS improve the net health outcome for patients with CRS?

The following PICO was used to select literature to inform this policy.

Patients

The relevant population of interest is individuals with CRS with or without nasal polyposis refractory to maximal medical therapy.

Interventions

The therapy being considered is FESS.

Comparators

Comparators of interest include continued medical management. Medical management for CRS may include saline nasal irrigation, corticosteroids, and antibiotics.

Outcomes

The general outcomes of interest are symptoms, change in disease status, quality of life, treatment-related morbidity. Subjective scales are the SNOT-20 or SNOT-22, SF-36, and VAS.

The existing literature evaluating FESS as a treatment for CRS with or without nasal polyposis has varying lengths of follow-up, ranging from 3- to 12-months. While studies described below all reported at least one outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 12-months of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Review of Evidence
Randomized Controlled Trials

Ragab et al (2004) reported on the results of an RCT comparing medical management to FESS in 90 patients who had CRS, with or without nasal polyposis,who had failed initial medical management (6-week regimen of a corticosteroid spray and an alkaline nasal douche).^20, Eligible patients had 1 of the following: 8 or more weeks of persistent signs and symptoms and signs at least 2 major or 1 major and 2 minor symptoms (major: nasal congestion obstruction, nasal discharge, facial pain or pressure, headache, olfactory disturbance; minor: fever, halitosis [97% of patients]) or 4 episodes per year of recurrent acute rhinosinusitis each lasting at least 10 days in association with persistent changes on computed tomography. Patients who had persistent symptoms and changes in computed tomography scan following initial medical therapy were randomized to an FESS group, which received FESS performed by 1 of 2 surgeons, or to a medical therapy group, which received a 12-week course of oral erythromycin, alkaline nasal douche, and topical nasal corticosteroids.

Both patient-reported (SNOT-20, SF-36 and VAS) and objective (nasal examination with scoring, acoustic rhinometry, saccharine clearance time, total nasal nitric oxide levels) outcomes were used, without blinding of outcome assessment. At 6- and 12-month follow-up visits, both groups demonstrated significant improvements in subjective outcomes, with no significant between-group differences. For example, the percent change in visual analog scale score at 6 months was 49.7% in the FESS group compared with 45.3% in the medical therapy group (p>0.05). There were no significant differences between the 2 groups in the change in SNOT-20 or SF-36 scores or in any objective measurements at 6- or 12-month follow-up visits, with the exception of total nasal volume at 6 months in patients without polyposis (mean percent change from baseline, 21.8% in the FESS group vs 3.2% in the medical therapy group; p<0.01).

A second report (Ragab et al [2006]) assessed asthma-related outcomes in the subgroup of 45 patients with asthma,^21, and a third (Ragab et al [2010]) detailed the quality of life measurement outcomes in this study.^22,

Systematic Reviews

Patel et al (2017) conducted a systematic review of cohort and crossover studies to compare appropriate medical therapy with endoscopic sinus surgery in adults with CRS who had undergone at least 3 weeks of antibiotics, with or without corticosteroids (Table 2).^23, Six observational or crossover studies were selected; no RCTs were available for analysis. Included in the meta-analysis were studies by Smith et al (2011, n=130), Smith et al (2014, n=31), and Luk et al (2015, n=212). In Smith et al (2011) patients self-selected continued medical therapy (n=55) or surgical therapy (n=75). Smith et al (2014) was a crossover study of patients who failed medical therapy. Luk et al (2015) included 40 patients in their medical cohort and 152 patients in their surgical cohort.

For the pooled analysis of disease-specific quality of life measures, the 2 studies by Smith et al (2011, 2014; n=180 patients) were included. The studies used different outcome measures, the Rhinosinusitis Disability Index and SNOT-22, and were therefore pooled using the standardized mean difference. There was significant heterogeneity (p<0.001, I²=97%) but both studies favored surgery. For the pooled analysis of endoscopic grading scores, 2 studies by Smith et al and Luk et al (n=241 patients) were combined, again with significant heterogeneity (p=0.004, I²=88%). Mean scores in both studies favored surgery. For missed days of work, there was no significant difference between the medical therapy and surgical groups (the same 3 studies). Other studies assessed olfaction, health utility quality of life, and economic impact. No studies evaluated adverse events. A limitation of the cohort studies included in this systematic review is the lack of comparable groups; patients who selected surgery had lower disease-specific quality of life at baseline.

Table 2. Systematic Review and Meta-analyses Characteristics

Study	Dates	Trials	Participants	N (Range)	Design	Duration
Patel et al (2017)23,	2005-2016	6	Patients with CRS who had undergone > 3 weeks of antibiotics, with or without corticosteroids, and received continued medical therapy or surgery	N (31 to 280)	Analysis of prospective cohorts and crossover studies that compared surgery to continued medical therapy. Meta-analysis was conducted on 3 studies.	6 to 12 month follow-up

CRS: Chronic rhinosinusitis.

Other systematic reviews with meta-analyses have summarized pre- and post data from cohort studies, finding improvements in sleep quality^24,, fatigue^25,, and SNOT-22 outcomes^14, following FESS. However, these systematic reviews did not describe whether patients included in the primary studies had failed maximal medical therapy, limiting their interpretation. Criteria for “maximal medical therapy” used before endoscopic sinus surgery is attempted have been reported in a minority (21%) of published studies of FESS.^6, The criteria used vary across studies, but studies that have reported specific criteria most often report using topical steroids (91.4%; mean duration, 8.4 weeks) and oral antibiotics (87.7%; mean duration, 23 days) systemic corticosteroids (61% mean duration 18 days), saline irrigations (39%), oral antihistamines (11%), oral mucolytics (10%), and topical/oral decongestants (10%)

Section Summary: Functional Endoscopic Sinus Surgery for Uncomplicated Chronic or Acute Recurrent Rhinosinusitis Refractory to Medical Therapy

One RCT was identified in patients who have failed therapy with nasal irrigation and corticosteroids. This RCT found that FESS was not superior to maximal medical therapy that includes antibiotics along with nasal irrigation and topical or systemic corticosteroids. No RCTs have been identified that evaluated FESS in patients with CRS who failed this regimen. One systematic review of patients who had failed a treatment regiment that included antibiotic therapy identified non-randomized comparative cohorts and pre-post studies. These studies indicate that in patients who have failed maximal medical therapy (nasal irrigation, corticosteroids, and antibiotics), FESS can improve symptoms compared to continued medical therapy. Patients most likely to select and benefit from FESS are those with lower disease-specific quality of life.

Summary of Evidence

For individuals with uncomplicated CRS with or without nasal polyposis who receive FESS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, change in disease status, quality of life, and treatment-related morbidity. A small number of trials, with methodologic limitations, generally have not reported clinically significant differences in symptom improvement with FESS compared with medical therapy. Cochrane reviews evaluating FESS for CRS with and without nasal polyposis have reported that FESS can be accomplished safely, but clinical trials have not demonstrated significant improvements with FESS compared with standard medical therapy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with uncomplicated CRS refractory to medical therapy who receive FESS, the evidence includes an RCT and a systematic review of non-randomized comparative studies. Relevant outcomes are symptoms, functional outcomes, change in disease status, quality of life, and treatment-related morbidity. One RCT was identified in patients who have failed therapy with nasal irrigation and corticosteroids. This RCT found that FESS was not superior to maximal medical therapy that includes antibiotics along with nasal irrigation and topical or systemic corticosteroids. Although no RCTs have been identified that evaluated FESS in patients with CRS who failed a regimen that included antibiotic therapy, a systematic review of non-randomized comparative cohorts and pre-post studies is available. This meta-analysis suggests that in patients who have failed maximal medical therapy (nasal irrigation, corticosteroids, and antibiotics), FESS can improve symptoms compared to continued medical management. Patients most likely to select and benefit from FESS are those with lower disease-specific quality of life. Surgical treatment of CRS with FESS may thus be appropriate for individuals who meet diagnostic criteria for CRS and have failed maximal medical management. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome..

SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements

Guidelines on the diagnosis and management of CRS are described in Tables 3 and 4.

Table 3. Chronic Rhinosinusitis Diagnostic Criteria

Organization	Chronic Rhinosinusitis Definition
International ConsensusStatement on Allergy and Rhinology: Rhinosinusitis (2016)26,	“Sinonasal inflammation persisting for more than 12 weeks. Symptoms must include at least 2 of the following: Nasal blockage/obstruction/congestion Nasal discharge (anterior/posterior) Facial pain/pressure Reduction/loss of smell” “Additionally, the diagnosis must be confirmed by: Evidence of inflammation on paranasal sinus examination or computed tomography (CT) Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.” “CRS is divided into CRSwNP or CRSsNP based on the presence or absence of nasal polyps”
American Academy of Allergy, Asthma, and Immunology et al (2005)27,	“Symptoms for 8 weeks or longer of varying severity consisting of the same symptoms as seen in acute sinusitis. In chronic sinusitis there should be abnormal findings on CT or MRI. Some patients with chronic sinusitis might present with vague or insidious symptoms.”
American Academy of Otolaryngology – Head and Neck Surgery Foundation (2015)7,8,	“Twelve weeks or longer of two or more of the following signs and symptoms: Mucopurulent drainage (anterior, posterior, or both), Nasal obstruction (congestion) Facial pain-pressure-fullness, or Decreased sense of smell. AND inflammation is documented by one or more of the following findings: purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region, polyps in nasal cavity or the middle meatus, and/or radiographic imaging showing inflammation of the paranasal sinuses.”

CRS: chronic rhinosinusitis; CRSsNP: chronic rhinosinusitis without nasal polyps; CRSwNP: chronic rhinosinusitis with nasal polyps; CT: computed tomography; MRI: magnetic resonance imaging.
Evaluation of patients for allergic disorders, immunodeficiencies, or both, may be indicated depending on the presence of associated symptoms.

Table 4. American Academy of Otolaryngology-Head and Neck Surgery Guidelines on Management of CRS in Adults*

Guideline	Type of Recommendation	Aggregate Evidence Quality	Confidence in Evidence
“The clinician should confirm a clinical diagnosis of CRS with objective documentation of sinonasal inflammation, which may be accomplished using anterior rhinoscopy, nasal endoscopy, or computed tomography.”	Strong recommendation	B (cross-sectional studies)	Medium
“Clinicians should assess the patient with chronic rhinosinusitis or recurrent acute rhinosinusitis for multiple chronic conditions that would modify management such as asthma, cystic fibrosis, immunocompromised state, and ciliary dyskinesia.”	Recommendation	B (1 systematic review, multiple observational studies)	Medium
“The clinician may obtain testing for allergy and immune function in evaluating a patient with chronic rhinosinusitis or recurrent acute rhinosinusitis.”	Option	C (systematic review of observational studies)	Medium
“The clinician should confirm the presence or absence of nasal polyps in a patient with CRS.”	Recommendation	A (systematic review of RCTs)	Medium
“Clinicians should recommend saline nasal irrigation, topical intranasal corticosteroids, or both for symptom relief of CRS.”	Recommendation	A (systematic reviews of RCTs)	High
“Clinicians should not prescribe topical or systemic antifungal therapy for patients with CRS.”	Recommendation (against therapy)	A (systematic reviews of RCTs)	High

Adapted from Rosenfeld et al (2015)^8,
CRS: chronic rhinosinusitis; RCT: randomized controlled trial.
U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2020 did not identify any ongoing or unpublished trials that would likely influence this review.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis
FESS
Chronic Rhinosinusitis, Functional Endoscopic Sinus Surgery for
Rhinosinusitis, Chronic, Functional Endoscopic Sinus Surgery for
Sinus Surgery, Functional Endoscopic, Chronic Rhinosinusitis

References:
1. Rudmik L, Soler ZM. Medical Therapies for Adult Chronic Sinusitis: A Systematic Review. JAMA. Sep 01 2015; 314(9): 926-39. PMID 26325561

2. Finegold SM, Flynn MJ, Rose FV, et al. Bacteriologic findings associated with chronic bacterial maxillary sinusitis in adults. Clin Infect Dis. Aug 15 2002; 35(4): 428-33. PMID 12145727

3. Brook I. Bacteriology of chronic maxillary sinusitis in adults. Ann Otol Rhinol Laryngol. Jun 1989; 98(6): 426-8. PMID 2729825

4. Aurora R, Chatterjee D, Hentzleman J, et al. Contrasting the microbiomes from healthy volunteers and patients with chronic rhinosinusitis. JAMA Otolaryngol Head Neck Surg. Dec 2013; 139(12): 1328-38. PMID 24177790

5. Singhal D, Psaltis AJ, Foreman A, et al. The impact of biofilms on outcomes after endoscopic sinus surgery. Am J Rhinol Allergy. May-Jun 2010; 24(3): 169-74. PMID 20537281

6. Dautremont JF, Rudmik L. When are we operating for chronic rhinosinusitis? A systematic review of maximal medical therapy protocols prior to endoscopic sinus surgery. Int Forum Allergy Rhinol. Dec 2015; 5(12): 1095-103. PMID 26201538

7. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): Adult Sinusitis Executive Summary. Otolaryngol Head Neck Surg. Apr 2015; 152(4): 598-609. PMID 25833927

8. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. Apr 2015; 152(2 Suppl): S1-S39. PMID 25832968

9. Orlandi RR, Smith TL, Marple BF, et al. Update on evidence-based reviews with recommendations in adult chronic rhinosinusitis. Int Forum Allergy Rhinol. Jul 2014; 4 Suppl 1: S1-S15. PMID 24889751

10. Piromchai P, Thanaviratananich S, Laopaiboon M. Systemic antibiotics for chronic rhinosinusitis without nasal polyps in adults. Cochrane Database Syst Rev. May 11 2011; (5): CD008233. PMID 21563166

11. Hopkins C, Browne JP, Slack R, et al. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict?. Otolaryngol Head Neck Surg. Oct 2007; 137(4): 555-61. PMID 17903570

12. Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg. Sep 1997; 117(3 Pt 2): S35-40. PMID 9334786

13. Hopkins C, Gillett S, Slack R, et al. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. Oct 2009; 34(5): 447-54. PMID 19793277

14. Soler ZM, Jones R, Le P, et al. Sino-Nasal outcome test-22 outcomes after sinus surgery: A systematic review and meta-analysis. Laryngoscope. Mar 2018; 128(3): 581-592. PMID 29164622

15. Hartog B, van Benthem PP, Prins LC, et al. Efficacy of sinus irrigation versus sinus irrigation followed by functional endoscopic sinus surgery. Ann Otol Rhinol Laryngol. Sep 1997; 106(9): 759-66. PMID 9302908

16. Khalil HS, Nunez DA. Functional endoscopic sinus surgery for chronic rhinosinusitis. Cochrane Database Syst Rev. Jul 19 2006; (3): CD004458. PMID 16856048

17. Vlastarakos PV, Fetta M, Segas JV, et al. Functional endoscopic sinus surgery improves sinus-related symptoms and quality of life in children with chronic rhinosinusitis: a systematic analysis and meta-analysis of published interventional studies. Clin Pediatr (Phila). Dec 2013; 52(12): 1091-7. PMID 24146231

18. Alobid I, Benitez P, Bernal-Sprekelsen M, et al. Nasal polyposis and its impact on quality of life: comparison between the effects of medical and surgical treatments. Allergy. Apr 2005; 60(4): 452-8. PMID 15727575

19. Rimmer J, Fokkens W, Chong LY, et al. Surgical versus medical interventions for chronic rhinosinusitis with nasal polyps. Cochrane Database Syst Rev. 2014; (12): CD006991. PMID 25437000

20. Ragab SM, Lund VJ, Scadding G. Evaluation of the medical and surgical treatment of chronic rhinosinusitis: a prospective, randomised, controlled trial. Laryngoscope. May 2004; 114(5): 923-30. PMID 15126758

21. Ragab S, Scadding GK, Lund VJ, et al. Treatment of chronic rhinosinusitis and its effects on asthma. Eur Respir J. Jul 2006; 28(1): 68-74. PMID 16510462

22. Ragab SM, Lund VJ, Scadding G, et al. Impact of chronic rhinosinusitis therapy on quality of life: a prospective randomized controlled trial. Rhinology. Sep 01 2010; 48(3): 305-11. PMID 21038021

23. Patel ZM, Thamboo A, Rudmik L, et al. Surgical therapy vs continued medical therapy for medically refractory chronic rhinosinusitis: a systematic review and meta-analysis. Int Forum Allergy Rhinol. Feb 2017; 7(2): 119-127. PMID 27863163

24. Sukato DC, Abramowitz JM, Boruk M, et al. Endoscopic Sinus Surgery Improves Sleep Quality in Chronic Rhinosinusitis: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. Feb 2018; 158(2): 249-256. PMID 29065273

25. Chester AC, Sindwani R, Smith TL, et al. Fatigue improvement following endoscopic sinus surgery: a systematic review and meta-analysis. Laryngoscope. Apr 2008; 118(4): 730-9. PMID 18216743

26. Orlandi RR, Kingdom TT, Hwang PH. International Consensus Statement on Allergy and Rhinology: Rhinosinusitis Executive Summary. Int Forum Allergy Rhinol. Feb 2016; 6 Suppl 1: S3-21. PMID 26878819

27. Slavin RG, Spector SL, Bernstein IL, et al. The diagnosis and management of sinusitis: a practice parameter update. J Allergy Clin Immunol. Dec 2005; 116(6 Suppl): S13-47. PMID 16416688

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