Medical Policy

Policy Num.      07.001.155
Policy Name:    Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis
Policy ID            [07.001.155]  [Ac / B / M+ / P+]  [7.01.155]

Last Review:   March 19, 2025
Next Review:   March 20, 2026
 

Related Policies:

07.001.051 - Balloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis
07.001.134 - Steroid-Eluting Sinus Stents
07.001.128 - Balloon Dilation of the Eustachian Tube

Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis

Summary

Description

Chronic rhinosinusitis (CRS) is a common chronic condition associated with significant morbidity. Functional endoscopic sinus surgery (FESS) involves the removal of varying amounts of tissue and the opening of sinus ostia to treat CRS.

Summary of Evidence

For individuals with uncomplicated CRS with or without nasal polyposis who receive FESS, the evidence includes randomized controlled trials (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 that the technology results in an improvement in the net health outcome.

For individuals with uncomplicated CRS refractory to medical therapy who receive FESS, the evidence includes a 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.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine whether functional endoscopic sinus surgery in patients with uncomplicated chronic rhinosinusitis improves the net health outcome.

Policy Statements

The use of functional endoscopic sinus surgery is considered medically necessary for individuals with chronic rhinosinusitis when the following criteria are present:

Chronic rhinosinusitis that negatively impacts quality of life, characterized by at least 2 of the following, at least 1 of which is (a) or (b), present for at least 12 continuous weeks:

1. Mucopurulent nasal drainage (anterior, posterior, or both);

2. Nasal obstruction (congestion);

3. Facial pain-pressure-fullness;

4. Decreased sense of smell.

AND

Optimal medical therapy has been attempted and failed, as indicated by all of the following:

• Allergy evaluation, education, and optimal treatment when indicated;

• Two 10 day courses of antibiotics or 1 prolonged course of oral antibiotic for at least 21 days;

• Decongestants when indicated;

• Topical and/or systemic corticosteroids for at least 8 weeks;

• Saline nasal irrigations for at least 8 consecutive weeks;

• Treatment of rhinitis medicamentosa (rebound nasal congestion due to extended use of topical decongestants), when present;

• Education on environmental irritants including tobacco smoke.

AND

Clinical and radiographic documentation of persistent inflammation following optimal medical therapy (see Policy Guidelines).

AND

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.

The use of functional endoscopic sinus surgery is considered investigational for the treatment of chronic rhinosinusitis when the above criteria are not met.

Policy Guidelines

Inflammation may be documented by all of the following:

• Nasal endoscopy showing purulent (not clear) mucus or edema in the middle meatus, anterior ethmoid, or sphenoethmoid region.

AND

• Abnormal CT scan of the paranasal sinuses.

According to the 2015 American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) guideline on adult sinusitis, abnormal findings on CT imaging may include moderate-to-severe mucosal thickening, opacification, or air-fluid levels. A subsequent consensus statement on balloon dilation of the sinuses published by the AAO-HNS in 2018 states: "The requirement of objective evidence of inflammation in addition to sinonasal symptoms suggestive of rhinosinusitis is consistent with AAO-HNSF diagnostic criteria for rhinosinusitis. However, evidence of inflammation or other findings on a CT scan was not deemed sufficient alone to make a patient a candidate for balloon dilation. The consensus that both symptoms and objective evidence of sinonasal disease are needed to deem a patient appropriate for a SOD [sinus ostial dilation] procedure is also reflected in many of the randomized clinical trials involving balloon dilation. The inclusion criteria for many of these trials require that the patient be deemed appropriate for conventional sinus surgery, which includes a trial of medical therapy and the presence of sinonasal symptoms in addition to objective evidence of sinus mucosal inflammation. On the surface, this statement may seem incompatible with the guidelines that mandate the presence of objective findings but do not specify which objective findings those are (ie, polyps, purulence, or CT findings) for the diagnosis of CRS. However, the panel felt that the transition from diagnosis to management requires additional information. In that vein, a CT scan is necessary before proceeding with surgical management, and the findings of that CT scan would direct which sinuses were to be addressed. It was also agreed that an improved taxonomy for the classification of sinusitis would be helpful to improve the quality of clinical research."

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Chronic Rhinosinusitis

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 evidence review 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.

Chronic rhinosinusitis 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, monoclonal antibodies, and/or antibiotic therapy.^6, Guidelines from the American Academy of Otolaryngology-Head and Neck Surgery (2015; affirmed in 2020 by the American Academy of Family Physicians) 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 systemic 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 symptom scores. There was some evidence that 2 systemic therapies (oral corticosteroids, doxycycline), both for 3 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 non-macrolide oral antibiotics.

A 2016 Cochrane review of studies evaluating systemic and topical antibiotics for CRS included 5 RCTs (N=293), all of which compared systemic antibiotics with placebo or another pharmacological intervention.^10, Reviewers found "very little evidence that systemic antibiotics are effective in patients with chronic rhinosinusitis" and that "more research in this area, particularly evaluating longer-term outcomes and adverse effects, is required."

In 2019, the U.S. Food and Drug Administration (FDA) approved the first treatment for CRS with nasal polyps - dupilumab (Dupixent^®). Results from clinical trials revealed that patients who received dupilumab "had statistically significant reductions in their nasal polyp size and nasal congestion compared to the placebo group" and also "reported an increased ability to smell and required less nasal polyp surgery and oral steroids."^11, This was followed by the approval of omalizumab (Xolair^®) in 2020 as add-on maintenance treatment for adults with nasal polyps with an inadequate response to nasal corticosteroids.^12, In 2021, mepolizumab (Nucala®) was also approved as an add-on maintenance treatment in adults with CRS with nasal polyps.^13,

Surgery

The goals of surgery for CRS include removing polyps and debris that may be sources of inflammatory mediators and preventing 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. Functional endoscopic sinus surgery 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).

Functional endoscopic sinus surgery 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 (Table 1).

Table 1. Draf Classification for Endoscopic Frontal Sinusotomy

   a Modified Lothrop procedure.

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

Regulatory Status

Functional endoscopic sinus surgery is a surgical procedure and, as such, is not subject to regulation by the FDA.

Rationale

This review was created in October 2016 with a search of the PubMed database. The most recent literature update was performed through January 7, 2025.

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, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 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. Randomized controlled trials 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.

Population Reference No. 1

Functional Endoscopic Sinus Surgery for Uncomplicated Chronic Rhinosinusitis Eligible for Medical Therapy

Clinical Context and Test Purpose

The purpose of functional endoscopic sinus surgery (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 chronic rhinosinusitis (CRS) with or without nasal polyposis.

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

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

Populations

The relevant population of interest is individuals with uncomplicated CRS with or without nasal polyposis eligible for medical therapy.

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.^14,15, 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.^16,17, The Questionnaire of Olfactory Dysfunction (QOD) is a validated, olfactory-specific survey that summarizes Likert scale responses from 0 (“Disagree”) to 3 (“Agree”), where higher total scores (range: 0 to 51) represent higher global impacts of olfactory impairment. 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 1 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.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

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

Systematic Reviews

A 2006 Cochrane review summarized the evidence on FESS for CRS.^18, 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 (N=212) met reviewers’ inclusion criteria, 1 of which was unpublished: 1 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 2 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 3 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.^19, Reviewers selected 4 prospective, 5 retrospective comparative, and 6 retrospective studies (N=1301); 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.

Randomized Controlled Trial

One RCT from 1997 compared FESS plus sinus irrigation to sinus irrigation alone in patients with CRS, not limited to patients with polyposis.^20, Patients were randomized to sinus irrigation, with a second irrigation a week after the first if needed, or to FESS within 3 days of enrollment. Randomization techniques were not described. The trial enrolled 89 patients (45 in each group), with 77 patients included in the 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 to 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=.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=.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.

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.

Systematic Review

A Cochrane review by Rimmer et al (2014), compared surgical interventions with medical interventions for CRS with nasal polyps.^21, Reviewers identified 4 studies (N=231), 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, n=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 to 3 point scale) were significantly better in the FESS group (mean difference, -1.5; 95% confidence interval [CI], -1.8 to -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 versus medical treatment for adults with CRS with nasal polyps is of very low quality. The evidence does not show that 1 treatment is better than another in terms of patient-reported symptom scores and quality of life measurements.”

Randomized Controlled Trial

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.^22, 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 6 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<.05), loss of smell scores (0.9 for FESS vs. 0.5 for medical therapy, p<.05), and polyp size score (2.3 for FESS vs. 0.8 for medical therapy, p<.05).

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.

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 that the technology results in an improvement in the net health outcome.

Population Reference No. 2

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 evidence review is: does FESS improve the net health outcome for patients with CRS?

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

Populations

The relevant population of interest is individuals with uncomplicated CRS 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, and treatment-related morbidity. Subjective scales are the SNOT-20 or SNOT-22, SF-36, QOD, visual analog scale (VAS), and "sniffin' stick pens", that evaluate odorant threshold, discrimination, and identification (TDI).

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 1 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.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

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<.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=.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 a lower disease-specific quality of life at baseline.

Table 2. Systematic Review and Meta-analyses Characteristics

   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^17, 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%)

Randomized Controlled Trial

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).^26, 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 a 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 VAS score at 6 months was 49.7% in the FESS group compared with 45.3% in the medical therapy group (p>.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<.01).

A second report (Ragab et al [2006]) assessed asthma-related outcomes in the subgroup of 45 patients with asthma,^27, and a third (Ragab et al [2010]) detailed the quality of life measurement outcomes in this study.^28,

Non-Randomized Comparative Study

A National Institutes of Health-funded multicenter study by Mattos et al (2021) evaluated improvements in olfactory function in patients undergoing FESS after failed medical therapy.^29, Pre- and postoperative scores of 113 patients from "sniffin' stick pens" were compared with 164 non-affected volunteers of similar age and gender. Secondary outcomes included the QOD and olfactory cleft endoscopy scores. TDI scores pre-operatively were 6.8 (95% CI, 4.9 to 8.7) points lower than controls. There was an improvement of 3.7 (95% CI, 2.2 to 5.2) points postoperatively, with post-operative TDI scores of 25.7 (8.6 standard deviation) compared to 28.8 (7.0 standard deviation) in controls. Secondary outcomes showed similar improvements, and about half of patients had post-operative scores that were at least as good as the controls. Multivariate regression found decreased odds of improvement in patients with nasal polyposis and previous FESS, while septoplasty increased the odds of improvement.

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 regimen 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 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.

Suplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

Guidelines on the diagnosis and management of CRS are described in Tables 3 through 5.

Table 3. Chronic Rhinosinusitis Diagnostic Criteria

   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*

   * Adapted from Rosenfeld et al (2015)8, CRS: chronic rhinosinusitis; RCT: randomized controlled trial.

Table 5. Joint Task Force on Practice Parameters Guidelines for the Medical Management of CRS with Nasal Polyposis*

   *Adapted from Rank et al (2023)35, AERD: aspirin (or nonsteroidal anti-inflammatory drug)-exacerbated respiratory disease; ATAD: aspirin therapy after desensitization; CRSwNP: chronic rhinosinusitis with nasal polyposis; INCS: intranasal corticosteroids.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

A currently unpublished trial that might influence this review is listed in Table 6.

Table 6. Summary of Key Trials

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