balloon sinus ostial

Technology Evaluation Center

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Balloon Sinus Ostial Dilation for Treatment of Chronic Rhinosinusitis

Executive Summary

BackgroundChronic rhinosinusitis is a common condition characterized by symptoms of nasal blockage, obstruc-tion, or congestion or nasal discharge, lasting more than 12 weeks. Treatment with nasal steroids, irrigation, and antibiotics are considered first-line treatment for chronic rhinosinusitis. However, surgery is often recommended for patients in whom medical treatment does not relieve symptoms. Functional endoscopic sinus surgery (FESS) is the most frequently used surgical intervention.

Balloon sinus ostial dilation is an alternative technique to FESS for treating chronic rhinosinusitis. Rather than using cutting tools to open sinuses, inflatable balloons are threaded into the sinuses and inflated under pressure. Balloon sinus ostial dilation is applied selectively to some or all of the affected sinuses, depending on the judgment of the treating physician and the ability to successfully access and dilate the involved sinus. The procedure may be as effective as FESS in the treatment of chronic rhinosinusitis. It may be less invasive, in that there is less tissue damage, shorter operative times, shorter recovery times, and less postoperative pain and morbidity.

ObjectiveThe objective of this Assessment is to determine whether balloon sinus ostial dilation improves health outcomes when used as a treatment for chronic rhinosinusitis as compared to standard surgical treatment (FESS).

Search StrategyMEDLINE® was searched (via PubMed) using the terms “balloon” or “dilation OR dilatation” and “sinusitis.” The search was performed with no time limitation through December 2012, limited to English-language articles on human subjects. Bibliographies of identified articles supplemented the original search.

Selection CriteriaCase series, nonrandomized comparison trials and randomized clinical trials of balloon sinus ostial dilation that had a sample size of at least 10 in which clinical outcomes of patients with chronic rhinosinusitis were reported were included. Studies of special populations such as trauma patients were excluded.

Main ResultsOne randomized clinical trial, 3 nonrandomized comparative trials, and 9 case series studies met selection criteria.

Assessment ProgramVolume 27, No. 9April 2013


2 ©2013 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.

The one randomized clinical trial compared balloon ostial dilation of the frontal sinus plus ethmoidectomy (using FESS) versus FESS of the frontal sinus plus ethmoidectomy. In this small poor quality trial of 34 patients, improvements in computed tomography images, symptom scores, and olfactory threshold were noted within each group. No statistical between-group comparisons were reported, but the magnitude of improvement in these outcomes appeared similar.

One nonrandomized, retrospective, comparative trial evaluated balloon sinus ostial dilation and FESS in 70 adults. Compared to excluded patients, those enrolled had less-severe rhinosinusitis on imaging, and without systemic disease or excessive nasal polyps. Patients undergoing combined balloon sinus ostial dilation and FESS were excluded. The decrease in rhinosinusitis symptoms as measured by the SNOT-20 score was greater in the balloon sinus ostial dilation group than in the FESS group (1.99 versus 1.41, p=0.005) at 3 months. Overall patient satisfaction favored balloon sinus ostial dilation and postoperative narcotic use was less in the balloon sinus ostial dilation group.

The second nonrandomized, retrospective study compared balloon sinus ostial dilation to FESS in 31 pediatric patients. No specific rhinosinusitis symptom assessment was performed. Medical charts were reviewed for documentation of the presence and change in symptoms over time. Improvement was documented for 80% of balloon sinus ostial dilation patients and 62.5% of FESS patients (p not significant between the groups).

A third nonrandomized study compared the results of 30 pediatric patients undergoing balloon sinus ostial dilation and adenoidectomy to 19 patients undergoing adenoidectomy. Eighty percent of balloon sinus ostial dilation patients improved at least 0.5 in the SN-5 score compared to 52.6% of adenoidectomy patients. However, the lack of comparison to FESS further limits study implications.

Several case series studies of balloon sinus ostial dilation found improvements in symptom scores after surgery. In the subsets of patients in the various studies followed at least 2 years, symptom improvement appeared durable. Few adverse events were reported. Revision rates after surgery varied from 3 to 9%.

Author’s Comments and ConclusionsStudies of balloon sinus ostial dilation do not allow conclusions regarding the comparative efficacy of balloon sinus ostial dilation to FESS. The one randomized clinical trial showed roughly similar magnitude of relief of symptoms with no formal comparison between the 2 treatment arms. The study was underpowered to detect a clinically significant difference between the 2 treatment arms or to assess a clinically meaningful noninferiority margin.

The nonrandomized studies also do not allow conclusions regarding comparative efficacy. The lack of randomization may bias the study findings. In the comparative study in adults, restriction of the balloon sinus ostial dilation group to subjects who only had balloon sinus ostial dilation without FESS resulted in a group with fewer diseased sinuses than the FESS group. In the other nonrandomized comparative studies of pediatric patients, one showed no difference in improve-ment of sinusitis symptoms between groups, and the other was of limited relevance because balloon sinus ostial dilation was compared to adenoidectomy rather than FESS.

Although the case series show improvement of sinusitis symptoms after surgery, and appear to show relief up to 2 years after surgery, such studies cannot provide conclusions regarding compar-ative efficacy to FESS. Potential differences in patient selection and disease severity do not allow comparisons to published studies of FESS. In these studies, patients commonly had both balloon sinus ostial dilation and FESS procedures, further complicating the interpretation of the findings. However, surgical complications attributable to balloon sinus ostial dilation appear uncommon.



Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether balloon sinus ostial dilation as a treatment for chronic rhinosinusitis meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria.

1. The technology must have final approval from the appropriate governmental regulatory bodies.

In March 2008, the device “Relieva Sinus Balloon Catheter” (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The indications are for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. In June 2008, the device, FinESS Sinus Treatment (Entellus Medical, Inc, Maple Grove, MN) was cleared for marketing by the FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach.

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

The evidence is insufficient to determine the effect of the technology on health outcomes. One randomized clinical trial comparing balloon sinus ostial dilation to FESS was inadequately powered and did not evaluate differences in outcomes between the two treatments. While most nonrandomized comparative studies of balloon sinus ostial dilation and FESS show no difference in health outcomes between the 2 treatments, confounding factors may bias the comparison of the two treatments. Several case series show improvement in symptoms of rhinosinusitis over baseline measures, and such improvement appears durable up to 2 years. Case series do not allow conclusions regarding the comparative efficacy of balloon sinus ostial dilation to FESS.

3. The technology must improve the net health outcome; and4. The technology must be as beneficial as any established alternatives.

The current evidence does not allow conclusions regarding the comparative efficacy of balloon sinus ostial dilation to FESS.

5. The improvement must be attainable outside the investigational settings.

The evidence is insufficient to demonstrate that balloon sinus ostial dilation improves health outcomes in the investigational setting. Therefore, it cannot be demonstrated whether improve-ment is attainable outside the investigational setting.

Based on the available evidence, balloon sinus ostial dilation for the treatment for chronic rhinosinusitis does not meet TEC criteria.



Published in cooperation with Kaiser Foundation Health Plan and Southern California Permanente Medical Group.

TEC Staff Contributors

Author—David H. Mark, M.D., M.P.H.; TEC Executive Director—Naomi Aronson, Ph.D.; TEC Director, Technology Assessments—Mark D. Grant, M.D., M.P.H.; Director, Clinical Science Services—Kathleen M. Ziegler, Pharm.D.; Research/Editorial Staff—Claudia J. Bonnell, B.S.N., M.L.S.; Kimberly L. Hines, M.S.

Blue Cross and Blue Shield Association Medical Advisory Panel

Allan M. Korn, M.D., F.A.C.P.—Chairman, Senior Vice President, Clinical Affairs/Medical Director, Blue Cross and Blue Shield Association; Steven N. Goodman, M.D., M.H.S., Ph.D.—Scientific Advisor, Dean for Clinical and Translational Research, Stanford University School of Medicine, Professor, Departments of Medicine, Health Research and Policy; Mark A. Hlatky, M.D.—Scientific Advisor, Professor of Health Research and Policy and of Medicine (Cardiovascular Medicine), Stanford University School of Medicine. Panel Members Peter C. Albertsen, M.D., Professor, Chief of Urology, and Residency Program Director, University of Connecticut Health Center; Sarah T. Corley, M.D., F.A.C.P., Chief Medical Officer, NexGen Healthcare Information Systems, Inc.—American College of Physicians Appointee; Helen Darling, M.A., President, National Business Group on Health; Josef E. Fischer, M.D., F.A.C.S., William V. McDermott Professor of Surgery, Harvard Medical School—American College of Surgeons Appointee; I. Craig Henderson, M.D., Adjunct Professor of Medicine, University of California, San Francisco; Jo Carol Hiatt, M.D., M.B.A., F.A.C.S., Chair, Inter-Regional New Technology Committee, Kaiser Permanente; Saira A. Jan, M.S., Pharm.D., Associate Clinical Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Residency Director and Director of Clinical Programs Pharmacy Management, Horizon Blue Cross and Blue Shield of New Jersey; Thomas Kowalski, R.Ph., Clinical Pharmacy Director, Blue Cross Blue Shield of Massachusetts; Bernard Lo, M.D., Professor of Medicine and Director, Program in Medical Ethics, University of California, San Francisco; Randall E. Marcus, M.D., Charles H. Herndon Professor and Chairman, Department of Orthopaedic Surgery, Case Western Reserve University School of Medicine; Barbara J. McNeil, M.D., Ph.D., Ridley Watts Professor and Head of Health Care Policy, Harvard Medical School, Professor of Radiology, Brigham and Women’s Hospital; William R. Phillips, M.D., M.P.H., Clinical Professor of Family Medicine, University of Washington—American Academy of Family Physicians’ Appointee; Richard Rainey, M.D., Medical Director, Regence BlueShield of Idaho; Rita F. Redberg, M.D., M.Sc., F.A.C.C., Professor of Medicine and Director, Women’s Cardiovascular Services, University of California San Francisco; Alan B. Rosenberg, M.D., Vice President, Medical Policy, Technology Assessment and Credentialing Programs, WellPoint, Inc.; Maren T. Scheuner, M.D., M.P.H., F.A.C.M.G., Clinical Genetics and Principal Investigator, Health Services Genomics Program, VA Greater Los Angeles Healthcare System; Health Sciences Associate Clinical Professor, Department of Medicine, David Geffen School of Medicine at UCLA; Natural Scientist, RAND Corporation; J. Sanford Schwartz, M.D., F.A.C.P., Leon Hess Professor of Medicine and Health Management & Economics, School of Medicine and The Wharton School, University of Pennsylvania; Earl P. Steinberg, M.D., M.P.P., Executive Vice President, Innovation and Dissemination & Chief, Geisinger Healthcare Solutions Enterprise.

CONFIDENTIAL: This document contains proprietary information that is intended solely for Blue Cross and Blue Shield Plans and other subscribers to the TEC Program. The contents of this document are not to be provided in any manner to any other parties without the express written consent of the Blue Cross and Blue Shield Association.

Review of Evidence 8

Summary of Application of the 18 Technology Evaluation Criteria

References 20

Contents

Assessment Objective 5

Background 5

Methods 7

Formulation of the Assessment 8



and effective for patients not responding to medical therapy (Fokkens et al. 2012).

The standard surgical treatment for chronic sinusitis is called functional endoscopic sinus surgery (FESS). FESS is a set of minimally invasive techniques in which sinus air cells and ostia are opened under direct visualization. The goal of FESS is to restore sinus ventilation. Over the past 2 decades, FESS has become a stan-dard of care for patients needing surgery over other procedures such as antral lavage, exter-nal, intranasal and transantral ethmoidectomy, external frontal sinus surgery and the Caldwell-Luc procedure (Khalil and Nunez 2006).

However, the evidence base supporting the efficacy of FESS does not have a large number of clinical trials. A Cochrane review of func-tional endoscopic surgery identified only 3 randomized controlled trials involving 212 par-ticipants (Khalil and Nunez 2006). One of the trials compared 2 surgical approaches, a con-ventional surgery versus endoscopic surgery, and found no difference in symptom scores at follow-up. Another compared FESS with medical treatment against medical treatment alone. At 12 months, both groups improved, but there was no statistically significant differ-ence between groups. The third trial compared patients treated with FESS to patients undergo-ing medical treatment. There was no difference in the total symptom scores at the end of 12 months.

The Cochrane authors concluded that the avail-able evidence does not demonstrate that FESS, as performed in the included trials, is superior to medical treatment with or without sinus irrigation in patients with chronic rhinosinus-itis. The results of these clinical trials indicate that there is variability in the natural history of chronic sinusitis, and that some patients may improve without surgical treatment. Lack of randomized, controlled trial evidence supporting FESS is recognized in both the Canadian clinical practice guidelines for acute and chronic rhinosinusitis and the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) (Desrosiers et al. 2011; Fokkens et al. 2012).

Other reviews of FESS have evaluated large numbers of case series studies and concluded that FESS provides benefit in patients with chronic rhinosinusitis who have failed medical

Assessment Objective

The objective of this Assessment is to deter-mine whether balloon sinus ostial dilation improves health outcomes when used as a treatment for chronic rhinosinusitis compared with standard surgical treatment.

Background

Chronic RhinosinusitisSinusitis is defined as an inflammation of the nasal sinuses that may be caused by infection, allergy, or autoimmune diseases. Sinusitis is chronic when lasting more than 12 weeks. According to guidelines included in the European Position Paper on Rhinosinusitis (Fokkens et al. 2012), the definition requires at least 2 symptoms, of which, one must be symptoms of nasal blockage/obstruction/ congestion or nasal discharge, and at least one more symptom that may include facial pain/pressure or reduction/loss of smell.

Rhinosinusitis is common. It is estimated to affect more than 30 million Americans of all ages (Khalil and Nunez 2006). The pathogen-esis of chronic rhinosinusitis is thought to be that environmental factors such as bacteria, viruses, or allergens cause local inflammation of the lining of the sinuses. Although in most cases the inflammation will resolve, in chronic sinusitis, the inflammation persists, causing sinus blockage, bacterial growth, and further inflammation. This chronic inflammation causes dysfunction of the lining of the sinuses, perpetuating the situation. In addition, the continuous inflammation can cause the devel-opment of nasal polyps, which are grape-like structures in the upper nasal cavity consisting of loose connective tissue, inflammatory cells, glands, and capillaries.

Treatment of Chronic RhinosinusitisThe initial evaluation of patients with symptoms consistent with chronic rhinosinusitis includes confirmation of the diagnosis with endoscopy or computed tomographic imaging. Patients can be classified as to whether they have nasal polyps or not. The initial medical treatment of chronic rhinosinusitis consists of topical steroids and nasal irrigation (Fokkens et al. 2012). Antibiotics are considered if there is clinical suspicion of infection based on endoscopy or imaging. Surgery has been endorsed as safe



light-emitting source at the guidewire tip, allowing correct positioning without radiation exposure.

Two balloon dilation systems are currently marketed for use. The Relieva sinus balloon catheter is designed to be inserted through the nose to dilate the frontal, maxillary, and sphenoid sinuses. If rhinosinusitis of the ethmoid sinuses requires treatment, it must be performed with concurrent FESS. The FinESS balloon catheter is designed to dilate the max-illary sinus through a puncture made in the upper jaw into the maxillary sinus, called the transantral approach. Dilation of the maxillary sinus by this method also provides sinus drain-age of the anterior ethmoid sinus; thus, this system is indicated for disease of the maxillary and anterior ethmoid sinuses only.

Outcome Assessment in RhinosinusitisSeveral assessment instruments for measuring rhinosinusitis severity have been developed. Some of the more common instruments will be mentioned here. The SNOT-20 is a disease-specific health-related quality of life measure for rhinosinusitis. It contains 20 items mea-sured on a 6-point scale assessing the severity of rhinosinusitis symptoms, effects on function, and emotional effects. A study of the test char-acteristics of the SNOT-20 showed it to have high test-retest correlation and good sensitivity to patients’ perception of change in disease state (Piccirillo et al. 2002). It was estimated in this study that a decrease of 0.80 or greater is clinically meaningful.

The Lund-Mackay score is an assessment of the severity of rhinosinusitis based strictly on CT imaging. Each side is divided into 6 regions, corresponding to the location of specific sinuses. Ethmoid sinuses are divided into 2 regions, anterior and posterior, and the ostiomeatal complex is evaluated separately. Each region is scored as 0, 1, or 2, based on the severity of mucosal inflammation or fluid accumulation. Thus the score can range from 0, complete lucency of all 12 regions, to 24, complete opacity of all regions. The score can be also be used to assess each sinus.

The SN-5 is a disease-specific quality of life scale for sinusitis evaluation in children. It con-sists of 5 questions inquiring about the severity of sinus infection symptoms, nasal obstruc-tion symptoms, allergy symptoms, emotional distress, and activity limitations. Answers on

treatment. A systematic review by Smith et al. (2005) included 45 studies, of which 42 were classified as level 4 evidence (case series). There appears to have been no formal process for evaluating the results of these studies, but they conclude that the articles generally sup-ported the finding that FESS improves symp-toms and/or quality of life in adult patients with chronic rhinosinusitis.

A more formal quantitative systematic review by Chester et al. (2009) performed a meta-analysis of case series studies, where changes in symptom severity scores from preoperative status to postoperative status across studies were summarized. They identified 21 studies that included 2,070 patients meeting their inclusion criteria. The postoperative assess-ment was performed at a mean of 13.9 months after FESS. All differences in various symptoms were statistically significantly improved. With efficacy measured as the standardized effect size (ES), nasal obstruction (ES=1.73), head-ache (ES=0.98), hyposmia (ES=0.97), facial pain (ES=1.13), and postnasal discharge (ES=1.19) were all improved. The ES for a combined symptom score was 1.19. Studies reporting 1 year or longer outcomes found similar effect sizes as those reporting outcomes over shorter intervals. Effect sizes of the magnitude shown in this meta-analysis are consistent with clini-cal benefit. However, the uncertain natural history of chronic sinusitis or medically treated chronic sinusitis makes it uncertain if the improvement noted in these studies can be wholly attributed to FESS.

Balloon Sinus Ostial DilationThe concept of dilating a conduit with a high-pressure balloon was developed and is used in the fields of cardiology, vascular surgery, and urology. Similar to these other uses, in sinus surgery, a catheter is advanced and posi-tioned over a guidewire that has been placed in the area of interest. The delivery catheter, which is specifically designed for each sinus, is positioned at the entrance of the relevant ostium. The balloon is then advanced over the guidewire into the ostium, where it is then inflated at a high pressure. Compared with FESS, where the tissue and bone is removed, the balloon compresses the mucosa and causes microfracture of the underlying bone (Ahmed et al. 2011). The original device required fluo-roscopic confirmation of correct placement in the sinus, requiring fluoroscopic radiation exposure. Newer devices have a fiber optic



organization in the U.K., concluded that current evidence on the short-term efficacy of balloon sinus ostial dilation was adequate and raised no major safety concerns (National Institute for Health and Clinical Excellence 2011).

FDA Status. In March 2008, the device “Relieva Sinus Balloon Catheter” (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

In June 2008, the device, FinESS Sinus Treatment (Entellus Medical, Inc, Maple Grove, MN) was cleared for marketing by the FDA through the 510(k) process. The stated indica-tion is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a trans-antral approach. The bony sinus outflow tracts are remodeled by balloon displacement of adja-cent bone and paranasal sinus structures.

Methods

Search StrategyMEDLINE® was searched (via PubMed) using the terms “balloon” or “dilatation” and “sinus-itis. The search was performed with no time limitation through December 2012, limited to English-language articles on human subjects. Review articles provided background informa-tion. The bibliographies of retrieved articles were reviewed to identify references that may have been overlooked by the electronic search. The “related articles” function was used in conjunction with key articles to identify other papers that may have been missed by the search process. Manufacturers and other vendor websites were consulted for information on commercial products.

Study SelectionStudy selection was limited to studies examin-ing clinical outcomes of subjects undergo-ing balloon dilation of paranasal sinuses for chronic sinusitis. We allowed randomized trials, nonrandomized comparison trials, and case series. We excluded studies not reporting clini-cal outcomes, such as studies only reporting imaging, physiologic, or anatomic findings. We excluded studies of unusual or special patients,

a 1- to 7-point scale are averaged to obtain an overall score. The SN-5 scale has been demon-strated to have good test-retest reliability and to correlate with changes in clinical status (Kay and Rosenfeld 2003).

Practice GuidelinesVarious groups have assessed FESS and balloon sinus ostial dilation in position statements or practice guidelines. The American Rhinologic Society endorses the use of endoscopic balloon dilation technology as acceptable and safe for use in the management of sinus disease (American Rhinologic Society 2007). The state-ment asserts that endoscopic balloon dilation technology is a tool, not a procedure, and may be used alone or in combination with other surgical techniques.

The American Academy of Otolaryngology-Head and Neck Surgery considers balloon sinus dilation an appropriate therapeutic option for selected patients either by itself or in con-junction with other instruments (American Academy of Otolaryngology-Head and Neck Surgery 2010).

Canadian clinical practice guidelines published in 2011 on management of acute and chronic rhinosinusitis mention FESS, but not balloon sinus ostial dilation (Desrosiers et al. 2011). The guidelines give a “moderate” recommen-dation supporting the use of surgery in patients who fail medical treatment, but classify the supporting evidence for the recommendation as weak. The authors note that compelling clinical trial evidence for the efficacy of FESS remains scant. They emphasize that FESS is indicated for those who have failed maximal medical therapy, although standards for maximal medical therapy do not yet exist.

EPOS guidelines published in 2012 are sup-portive of FESS, despite recognition that randomized clinical trial evidence is limited (Fokkens et al. 2012). Regarding balloon sinus ostial dilation, they suggest that the procedure appears to be safe based on case series studies, but the studies have unclear inclusion criteria, making the results difficult to generalize. They conclude, “Overall, the place of these systems in the sinus surgeon’s armamentarium remains unclear (Evidence level IV).”

The National Institute for Health and Clinical Excellence (NICE), the technology assessment



Health OutcomesBenefits. The benefits of balloon sinus ostial dilation and FESS include relief of symptoms of chronic rhinosinusitis assessed by degree of relief and duration. Benefits of balloon sinus ostial dilation may also include lower postop-erative morbidity in terms of postoperative pain and complications. Balloon sinus ostial dilation may be more likely to be performed without general anesthesia, which may be preferable for some patients.

Harms. Potential harms of balloon sinus ostial dilation include postoperative complications. Revision rates may differ from traditional FESS.

Specific Assessment QuestionDoes balloon sinus ostial dilation, or treatment approaches using balloon sinus ostial dilation, improve health outcomes as measured by relief of symptoms of chronic sinusitis, treatment-related morbidity, duration of relief, or need for revision surgery, as compared with FESS?

Review of Evidence

We identified one randomized clinical trial, 3 nonrandomized comparison studies, and 7 case-series reports of the Relieva balloon sinus ostial dilation system that met selection crite-ria. Three of the 7 case-series reports include the same set of patients reported at 3 different follow-up intervals. There are 4 published case series reports of the FinESS balloon sinus ostial dilation system; however, these studies include the same patients and we only included only 2 reports that include the same subjects’ initial surgical outcomes and the latest follow-up.

Randomized TrialThe randomized clinical trial (Plaza et al. 2011) enrolled only patients with frontal sinus disease. Patients in both groups received man-datory anterior ethmoidectomy, and posterior ethmoidectomy and sphenoidotomy if required using FESS techniques. Thus the trial repre-sents a study of balloon sinus ostial dilation “plus” FESS, compared to FESS alone.

Many outcome measures were assessed, but incompletely described. Apparently, visual analog scale scores of rhinosinusitis symptoms were obtained, but it is not clear whether or how these were combined to produce the one symptom score presented in the results. The olfactory threshold test, a butanol test, was not

such as trauma patients. We excluded single case-report studies and studies with sample size less than 10.

Medical Advisory Panel ReviewThis Assessment was reviewed by the Blue Cross and Blue Shield Association’s Medical Advisory Panel (MAP) on December 12, 2012. To maintain the timeliness of the scientific information in this Assessment, literature search updates were performed subsequent to the Panel’s review (see “Search Methods”). If the search updates identified any additional studies that met the criteria for detailed review, the results of these studies were included in the text where appropriate.

Formulation of the Assessment

Patient IndicationsPatients indicated for balloon sinus ostial dilation have chronic sinusitis. Patients failing maximal medical treatment have disease con-sidered treatable with FESS.

Patients being treated with the Relieva system have disease in the frontal, maxillary, and sphenoid sinuses. Disease in the ethmoid sinuses is not considered accessible with the Relieva system, and such patients will usually have a concurrent ethmoidectomy performed using FESS.

Patients treated with the FinESS system have disease in the maxillary sinuses with pos-sible additional disease only in the anterior ethmoid sinuses. The FinESS system dilates the maxillary sinus opening through a transantral approach achieved by puncturing the upper jaw, thus, only treating the maxillary sinus and the anterior ethmoid sinus.

Technologies to be ComparedBalloon sinus ostial dilation is compared to standard FESS. Complicating this comparison, however, is that in individual patients, balloon sinus ostial dilation and standard FESS tech-niques are often combined. Some sinuses may be treated with balloon sinus ostial dilation, and others with FESS. There is also a procedural failure rate of balloon sinus ostial dilation, which will result in crossing over to FESS.



imbalance between the 2 arms of the study. The FESS group had more sinuses treated than the balloon sinus ostial dilation group, indicating potentially more severe disease. Both groups had a decrease in SNOT-20 scores at 3 months. The decrease in SNOT-20 score was greater in the balloon sinus ostial dilation group than the FESS group (1.99 versus 1.41, p=0.005). An overall rating of patient satisfaction assessed at 3-months’ follow-up favored balloon sinus ostial dilation (3.71 versus 2.94 on a -5 to +5 scale, p=0.016). Postoperative narcotic use was less in the balloon sinus ostial dilation group (0.80 days versus 1.34 days, p=0.011). Only one type of adverse event was mentioned; turbinate lateralization or scarring occurred in 8 balloon sinus ostial dilation patients and in 3 FESS patients.

The two other nonrandomized studies enrolled children. Of note, FDA-labeled indications for the Relieva balloon system only include the maxillary sinus in children. In these studies, some children had frontal sinuses treated and were thus treated outside the FDA-cleared indi-cations for balloon sinus ostial dilation.

The study by Thottam et al. (2012) was a non-randomized retrospective study comparing balloon sinus ostial dilation with FESS in 31 patients. All patients in both treatment arms had ethmoidectomy performed using FESS. The data collection in this study were completely retrospective; charts were examined for reports of various symptoms, and a symptom score for preoperative status and follow-up was con-structed based on the medical record. Using this approach for assessing outcomes, the per-centage of patients who had total improvement (absence of all prior symptoms) or improve-ment (absence of at least one prior symptom) was 80% in the balloon sinus ostial dilation group and 62.5% in the FESS group (p not sig-nificant). Adverse events were not mentioned.

The study by Ramadan and Terrell (2010), also in children, compared the results of 30 patients undergoing balloon sinus ostial dila-tion and adenoidectomy with 19 patients who underwent adenoidectomy. There was almost a 3-year mean age difference between groups (balloon sinus ostial dilation 7.7 years, adenoid-ectomy 4.8 years). Outcomes were assessed using the SN-5 score. An improvement of at least 0.5 in the SN-5 score at 1-year follow-up was achieved in 80% of children having balloon sinus ostial dilation and 52.6% of children who had adenoidectomy (p=0.04). A multivariable

described or referenced, but presumably was related to others in use (Stevens et al. 1998).

At 12 months, 32/34 patients were retained in the trial for assessment of outcome. (Table 1) Improvements in total Lund-Mackay score, frontal sinus Lund-Mackay score, olfactory threshold, and symptom score were all statisti-cally significant within each group compared to the preoperative score. The study did not report any between-group differences for these outcomes. Resolution of frontal sinus disease on CT imaging was similar and not statistically different between groups.

No major complications were reported for either group. One patient in the balloon sinus ostial dilation group needed further surgery, and 3 patients in the FESS group needed further surgery. The quality of the study was poor. No statement of statistical power was provided, and it appears that the study was inadequately powered to detect other than a very large difference in treatment effectiveness, or to determine equivalency with a meaningful noninferiority margin. The principal outcome measure of the study is not stated. The com-posite symptom score is not adequately docu-mented. Appropriate between-group statistical tests were not performed. Other than stating that no major complications were observed in the trial, there is no description of a specific protocol for defining and recording adverse events. No substantive conclusions regarding the comparative efficacy of balloon sinus ostial dilation and FESS in these patients is possible beyond the observation that the improvements in symptoms and other outcomes appeared to be similar.

Nonrandomized Comparison StudiesThree nonrandomized comparison studies meeting selection criteria were identified (Table 2). The study by Friedman et al. (2008) was a retrospective study comparing patients who had undergone balloon sinus ostial dila-tion compared with a concurrent group of patients who had undergone FESS. Patients were selected to have Lund-Mackay scores 12 or less, persistent abnormal computed tomog-raphy scans, but not severe disease, systemic disease, or excessive nasal polyps. Of note, patients who had combined FESS and balloon sinus ostial dilation were excluded. Because the ethmoid sinuses cannot be dilated with the balloon sinus ostial dilation device used in this study, this selection criterion potentially creates

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Table 1. Summary of Randomized Controlled Trial of Balloon Sinus Ostial Dilation versus FESS (Plaza et al. 2011)

Description of Patient Population Description of Procedures Outcomes

Patients with opacified frontal sinuses, nasal polyps, failed medical therapy (steroids, antibiotics, nasal irrigation). Exclusions: revisions, symptomatic asthma, severe systemic disease, smoking >20 cig/day

Balloon—balloon sinus ostial dilation plus mandatory anterior ethmoidectomy, posterior ethmoidectomy and sphenoidotomy as requiredn=16

Control—Draf I procedure or Draf IIa procedure if required, mandatory anterior ethmoidectomy, posterior ethmoidectomy and sphenoidotomy as requiredn=16

Lund-Mackay score* Baseline 12 monthsBalloon 19.2 3.6Cont 18.6 4.2

Frontal sinus Lund-Mackay*Balloon 1.9 0.5Cont 2.0 0.4

Resolution of frontal disease on CT scanBalloon 21/26 (80.8%) sinusesCont 18/24 (75%) sinuses

Olfactory threshold*Balloon 1 4Cont 1 5

“symptom score”*Balloon 8 3Cont 7 4

Subsequent revision surgeryBalloon 1 (6%)Cont 3 (19%)

*all pre-post single group comparisons statistically significant, no between-group tests performed

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Table 2. Nonrandomized Comparison Studies of Balloon Sinus Ostial Dilation

Author Patient Description Procedures Outcomes Notes

Thottam et al. 2012 Retrospective cohort of pediatric patients; complex patients, polyps, unilateral disease all excluded

15 patients, balloon sinus ostial dilation + ethmoidectomy16 patients, traditional FESS + ethmoidectomy

10 patients in each group with maxillary disease, 5 patients in balloon group with maxillary and frontal disease, 6 patients in FESS group with maxillary and frontal disease.

Number of patients noting a symptom at that time Pre-surgery Post-surgeryFacial pain Balloon 7 2Cont 7 1 Sinus congestion Balloon 11 3Cont 8 5Post-nasal drip Balloon 9 1Cont 9 4RhinorrheaBalloon 13 6Cont 10 3HeadachesBalloon 7 4Cont 10 2Low-grade feverBalloon 0 0Cont 2 0

Symptom total improvement (reduction of 1 point in symptoms reported as present 6 hours a day and affecting daily life)

Balloon 12/15 (80%)Cont 10/16 (62.5%)

Symptom scores constructed retrospectively from medical charts, not systematically recorded pre- or post-surgery.

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Table 2. Nonrandomized Comparison Studies of Balloon Sinus Ostial Dilation (cont’d)


Friedman et al. 2008 Retrospective cohort of patients with Lund-Mackay scores ≤12, persistently abnormal CT scan, ≥3 recurrences per year. Exclusions: significant polyposis, systemic disease, sinus osteoneogenesis.

35 patients balloon sinus ostial dilation (without ethmoidectomy)35 patients traditional FESS + ethmoidectomy

12–13 in each group were revision procedures. Baseline Lund-Mackay scores similar (p=0.796), baseline SNOT-20 similar (2.8 vs. 2.7)

Pre-surgery 3 monthsSNOT-20 scoreBalloon 2.8 0.78Cont 2.7 1.29Overall experienceBalloon 3.7Cont 2.9% would undergo procedure againBalloon 90%Cont 47%Average days using narcotic pain medBalloon 0.8 daysCont 1.34 days

Ramadan and Terrell 2010 Prospective enrollment pediatric patients with rhinosinusitis, failing prior medical therapy

30 patients balloon sinus ostial dilation + adenoidectomy (in 17)

19 patients adenoidectomy alone

12-month outcomes SN-5 changeSuccess (>0.5 improvement, no revisions)Balloon 80%Adenoidectomy 52.6%p=0.038 multivariable adjusted

Change in SN-5 score Pre-surgery 1 yearBalloon 4.2 3.0Adenoidectomy 3.8 2.9



to 2.4, depending on the type of procedure (balloon sinus ostial dilation alone or combined FESS/balloon sinus ostial dilation). Outcomes assessed at various time points showed improvement in SNOT-20 scores to slightly above or below one depending on the group or follow-up time. Overall revision rates in the 65 patients followed out to 2 years were 6/65 (9.2%).

Kutlahan et al. (2009) reported a case series of 30 patients who underwent balloon sinus ostial dilation with or without FESS. In this series, some patients underwent ethmoidectomy using the balloon technique, the only study report-ing use of the balloon for treatment of ethmoid sinuses. Other sinuses were operated on using either balloon sinus ostial dilation or FESS. At one-year follow-up, the mean SNOT-20 score decreased from 25.7 to 6.5 (p<0.01). Lund-Mackay scores also decreased significantly. Two patients required revision after 6 months due to symptom recurrence.

Karanfilov et al. (2012) reported a case series of 203 patients undergoing balloon sinus ostial dilation in the office setting under local anes-thesia. Combined procedures with FESS were not included in the study. However, patients with ethmoid disease were included, but the ethmoid sinuses were left untreated. In the 203 patients, dilation was attempted in 592 sinuses, and 552 (93.2%) were considered successful during the surgery. There were no device-related adverse events. Follow-up was assessed at 24 weeks in 113 patients. Mean SNOT-20 scores decreased from 2.1 at baseline to 0.9 at 24 weeks. Six patients out of 203 (3.0%) required revision procedures at 24 weeks. Of 31 patients with radiographic evidence of ethmoid disease, 64.5% showed resolution of rhino-sinusitis at 24 weeks. One procedure-related adverse event was reported, a case of perior-bital ecchymosis that resolved within 24 hours.

Levine et al. (2008) reported the results of a registry reporting on 1,036 patients across 27 practices. Patients were followed for an average of 40.2 weeks from surgery (range: 8 to 88 weeks). Patients had a mix of different types of procedures. Sixty-three percent of the cases had concurrent ethmoidectomy performed using FESS. Other sinuses were also treated with FESS as deemed necessary by the treat-ing physician. Thirty-two percent of the 1,036 patients were treated solely with balloon sinus ostial dilation. There is very limited informa-tion on patient symptom outcomes in this study.

analysis adjusting for age, computed tomogra-phy score, and other confounders still found a significant effect of surgery. Two patients (6%) receiving balloon sinus ostial dilation were considered failures and required FESS. The authors state that no complications or adverse events occurred in the study.

The nonrandomized studies of balloon sinus ostial dilation also have deficiencies. There is a single study of adults. Nonrandomized treat-ment assignment of all studies produces poten-tial imbalances in disease severity between treatment groups. In the study by Friedman et al. (2008), there were more treated sinuses in the FESS group than the balloon sinus ostial dilation group. The study also evaluated out-comes only through 3 months. In Ramadan and Terrell (2010), there was a substantial and meaningful age difference between the 2 treat-ment groups and the study did not compare balloon sinus ostial dilation to FESS, but to adenoidectomy. It is difficult to assess the quality of reporting adverse events. Only the study by Friedman et al. mentions the occur-rence of one type of adverse event. However, none of the studies define any procedure or protocol for the determination of adverse events.

Case Series StudiesWe present results from 9 published reports of case series studies that met selection criteria (Table 3 and Table 4). Several of the studies report the same series of patients. Three of the studies report on the same series of patients reported at different follow up intervals (Bolger et al. 2007; Kuhn et al. 2008; Weiss et al. 2008). Of the studies of the FinESS balloon dila-tion system, the study by Cutler et al. (2011) reports initial results and adverse events of a case series, and the study by Stankiewicz et al. (2012) reports long-term outcomes of the same series of patients.

The publications of Bolger et al. (2007), Kuhn et al. (2008), and Weiss et al. (2008) report on a case series of 115 patients scheduled to undergo balloon sinus ostial dilation. About half were to undergo balloon sinus ostial dila-tion with concurrent FESS. Due to losses to follow up and intraoperative conversions to FESS with no balloon sinus ostial dilation, 84 patients were assessed at 24 weeks, 65 patients at 1 year, and 61 patients at 2 years. Results as shown in Table 3 show that at all three time points outcomes were roughly similar. Preoperative SNOT-20 scores ranged from 2.1

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Table 3. Case Series Studies of Transnasal Balloon Sinus Ostial Dilation

Author Patients, Procedures Outcomes

Bolger et al. 2007 Patients: Chronic sinusitis unresponsive to medical therapy. Exclusions: extensive polyps, previous surgery, osteoneogenesis, prior trauma. Procedures: Balloon used in 109/115 patients. Balloon attempted in 358 sinuses. Successful cannulation 347/358. Dilation considered successful in 342/347, supplemented with FESS in 5/347. 52/109 patients with balloon procedures only, 57/109 balloon on some sinuses, FESS on others.

Pre-surgery 24 weeksMean SNOT-20 scoresAll patients (n=84) 2.3 1.13Balloon/FESS (n=48) 2.42 1.02Balloon only (n=36) 2.14 1.27

% patients reporting significantly improved or improved at 24 weeksAll patients (n=95) 84%Balloon/FESS (n=51) 88%Balloon only (n=44) 80%

Patency rates of sinus ostia post dilation at 24 weeksMaxillary sinus (n=124 original n=143) 91%Sphenoid sinus (n=66, original n=75) 61%Frontal sinus (n=114, original n=124) 82%

Kuhn et al. 2008 (Same patients as Bolger et al.)

Same patients as Bolger et al, 70 of original 115 (86 eligible for study) 70/86 (81%) follow-up rate. 23 balloon only, 30 with balloon on some sinuses, FESS on others.

Pre-surgery 52 weeksMean SNOT-20 scoresAll patients (n=65) 2.14 0.91Balloon/FESS (n=34) 2.26 0.87Balloon only (n=31) 2.01 0.95

Lund-Mackay scores of balloon-treated sinusesFrontal sinus (n=64) 1.03 0.22Maxillary sinus (n=76) 1.05 0.34Sphenoid sinus (n=32) 0.97 0.19

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Table 3. Case Series Studies of Transnasal Balloon Sinus Ostial Dilation (cont’d)


Weiss et al. 2008 (Same patients as Bolger et al.)

Same patients as Bolger et al. and Kuhn et al., 65 of original 115 patients

Pre-surgery 2 yearsMean SNOT-20 scoresAll patients (n=61) 2.17 0.87Balloon/FESS (n=32) 2.26 0.64Balloon only (n=32) 2.09 1.09

% of patients reporting improved symptoms at 2 yearsAll patients (n=60) 85%Balloon/FESS (n=29) 93%Balloon only (n=31) 77%

Levine et al. 2008 Registry of 1,036 patients, 27 practice sites, no exclusion criteria for registry, varying combinations of balloon and FESS procedures on various sinuses. No formal follow-up mechanism, median follow-up 39 weeks (range 8 to 88 weeks)

Adverse events“no major events attributable to balloon catheters”2 CSF leaks in cases with concomitant ethmoidectomy6 case minor bleeding in cases with concomitant FESS

25/1036 (2.4%) revision rate

Symptom improvement reported by physician 95.5%

Ramadan et al. 2010 Case series of 32 children mean age 6.5 with medical treated rhinosinusitis for 3-6 months. 15 with concurrent adenoidectomy, 6 with concurrent ethmoidectomy. Procedural success declared in 56/63 (89%) sinuses.

Followup at 52 weeks available on 24/32 (75%) Pre-surgery 52 weeksSN-5 4.9 2.95Categories of SN-5 change>1.5 improvement 50%1–1.4 improvement 29%0.9–0.5 improvement 8%0–0.4 improvement 4%Worsening 8%

No complications reported

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Table 3. Case Series Studies of Transnasal Balloon Sinus Ostial Dilation (cont’d)


Kutluhan et al. 2009 Case series of 30 patients with chronic rhinosinusitis, medically treated failures. Mixed procedures, 63% of sinuses treated with balloon, 7.5% of sinuses treated with FESS, 30% of sinuses untreated. Ethmoid sinus treated with balloon.

Pre-surgery 9–12 monthsMean SNOT-20 score 25.7 6.5Lund-Mackay score 0.95 0.52

No major complications2/30 patients needed revision

Karanfilov et al. 2012 Case series of 203 patients with chronic rhinosinusitis, severe polyposis and planned FESS excluded.

Follow up at 24 weeks available on 113/203 Pre-surgery 24 weeksSNOT-20 2.1 0.9

No procedure-related complications reported6/203 (3.0%) revision rate at 24 weeks

Table 4. Case Series of Transantral Balloon Sinus Ostial Dilation


Cutler et al. 2011Stankiewicz et al. 2012

Only maxillary and anterior chronic sinusitis, failing prior medical therapy, appropriate anatomy

71 patients in original study59 patients followed to 2 yearsTransantral balloon dilation only

97.7% procedural success rateSNOT-20 scorePresurg 1 year 2 years2.62 0.79 0.79

4/59 (6.8%) needed revision



(2008) revealed that only 32% of patients are treated solely with balloon sinus ostial dilation. In such combined procedures, it would be dif-ficult to assess which procedure contributed to clinical success or failure. However, these case series uniformly report symptom improvement in chronic rhinosinusitis. The improvement in symptoms appears to be durable in the subset of patients followed up to 2 years. Acute adverse event rates appeared low. Although none of the studies specify a protocol or pro-cedure for identifying and recording adverse events, it might be presumed that the known adverse events of FESS, such as CSF leakage or excessive bleeding, would be reasonably reported, and revision rates ranged between 3 and 9 percent, but the follow-up time varied across studies.

Author’s Comments and ConclusionsThe lack of rigorous trials of balloon sinus ostial dilation hinders a full understanding of its risks and benefits compared to FESS. Despite this, balloon sinus ostial dilation appears to have diffused widely, at least in the U.S., and thus conducting clinical trials of this technology may be difficult. However, there may be classes of patients in which equipoise still exists in the judgment of treating physicians, and it may be reasonable to propose that randomized clinical trials in specific patient groups can be carried out. Trials could be carried in patient groups in which balloon sinus ostial dilation alone is compared to FESS in which only disease which is accessible to the balloon is included in the trial. Or, given that a large proportion of patients in current practice undergo both FESS and balloon sinus ostial dilation, a trial could be designed that compares balloon sinus ostial dilation plus FESS versus FESS alone, allow-ing some latitude in physician judgment as to which procedure to use in which sinus.

As noted in the background section, FESS became the standard treatment for chronic sinusitis without rigorous clinical trials showing its efficacy. Thus there is a lack of information comparing surgical techniques to optimum medical therapy. Patient selection may have a strong influence on whether a particular treat-ment will be effective.

Outcome assessment for chronic sinusitis appears to be at a mature stage, and studies should use one of the established sinusitis qual-ity-of-life scales. Although outcomes of balloon sinus ostial dilation at relatively short follow-up

According to the perspective of the operating physicians, 95.5% reported that sinus symptoms had improved. The overall revision rate was 2.4% (patient-level analysis). Patients receiving only balloon sinus ostial dilation had a revision rate of 3.1%. Patients receiving mixed pro-cedures had a revision rate of 2.1%. In terms of adverse events, 2 CSF leaks were reported in cases in which concomitant FESS was per-formed. Six cases, also with concomitant FESS, were reported in which bleeding required packing or cautery.

Ramadan et al. (2010) reported the results of 32 children (mean age 6.5 years) undergoing balloon sinus ostial dilation. Six patients had concurrent ethmoidectomy performed with FESS. Balloon dilation was performed on max-illary sinuses, sphenoid sinuses and frontal sinuses. Follow-up data at 1 year were available on 24 children. Eighty-seven percent of chil-dren had an improvement in SN-5 score greater than 0.5 and were considered successful. No serious adverse events occurred. The need for revision surgery was not mentioned.

Stankiewicz et al. (2012) reported the 2-year results of patients undergoing balloon sinus ostial dilation using the FinESS dilation system. (Table 4) This system dilates only the maxil-lary sinus outflow tract using a transantral approach, and thus is indicated only for max-illary and anterior ethmoid disease. Out of an original 71 patients in the initial study, 62 patients were eligible for long-term follow-up, and 59 patients completed 2-year follow-up. Symptom improvement as assessed by SNOT-20 score improved from 2.65 at baseline to 0.79 at the latest follow-up. A total of 4 patients (6.8%) required eventual revision surgery. Three serious adverse events were reported, 2 of which were distant in time from surgery. One patient had subcutaneous emphysema when being treated with continuous positive airway pressure the day after surgery.

Conclusions of efficacy of balloon sinus ostial dilation compared to FESS are difficult to make based on evaluation of case series data. Success rates, adverse event rates, and revision rates may be due to confounding influences of disease severity. An additional complicating factor in the evaluation of this technology is that, depending on the patient and judgment of the treating physician, FESS and balloon sinus ostial dilation may be combined during one operation. The registry study by Levine et al.



the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. In June 2008, the device, FinESS Sinus Treatment (Entellus Medical, Inc, Maple Grove, MN) was cleared for marketing by the FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach.

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

The evidence is insufficient to determine the effect of the technology on health outcomes. One randomized clinical trial comparing balloon sinus ostial dilation to FESS was inadequately powered and did not evaluate differences in outcomes between the two treat-ments. While most nonrandomized comparative studies of balloon sinus ostial dilation and FESS show no difference in health outcomes between the two treatments, confounding factors may bias the comparison of the two treatments. Several case series show improvement in symp-toms of rhinosinusitis over baseline measures, and such improvement appears durable up to 2 years. Case series do not allow conclusions regarding the comparative efficacy of balloon sinus ostial dilation to FESS.

3. The technology must improve the net health outcome; and

4. The technology must be as beneficial as any established alternatives.

The current evidence does not allow conclu-sions regarding the comparative efficacy of balloon sinus ostial dilation to FESS.

5. The improvement must be attainable outside the investigational settings.

The evidence is insufficient to demonstrate that balloon sinus ostial dilation improves health outcomes in the investigational setting. Therefore, it cannot be demonstrated whether improvement is attainable outside the investi-gational setting.

Based on the available evidence, balloon sinus ostial dilation for the treatment for chronic rhi-nosinusitis does not meet TEC criteria.

times such as 3 months appear to be durable out to at least 2 years, studies should follow up patients long enough to accumulate enough revision events for comparison. The current case series studies of balloon sinus ostial dilation suffer from lack of complete follow up of patients. Further studies that have high follow-up rates out to 2 years are needed.

Balloon sinus ostial dilation has been charac-terized as less invasive in terms of less distor-tion of the original anatomy (Ahmed et al. 2011). Some studies have proposed that it can be more successfully performed in non-opera-tive settings or with less extensive anesthesia than FESS (Karanfilov et al. 2012; Stankiewicz et al. 2012). Very few studies have documented the extent to which secondary outcomes such as postoperative morbidity and pain compare between balloon sinus ostial dilation and FESS. If such a difference can be demonstrated, it would support a rationale for noninferiority studies, in which sinus ostial dilation does not necessarily need to demonstrate superiority to FESS for relief of chronic rhinosinusitis symptoms but can be considered a viable alternative based on noninferior performance compared to FESS. Better and more thorough documentation of these secondary benefits would strengthen the case for the efficacy of balloon sinus ostial dilation.

Summary of Application of the Technology Evaluation Criteria

Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether balloon sinus ostial dilation as a treatment for chronic rhinosinusitis meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria.

1. The technology must have final approval from the appropriate governmental regulatory bodies.

In March 2008, the device “Relieva Sinus Balloon Catheter” (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The indications are for use in dilating



NOTICE OF PURPOSE: TEC Assessments are scientific opinions, provided solely for informational purposes. TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated.

CONFIDENTIAL: This document contains proprietary information that is intended solely for Blue Cross and Blue Shield Plans and other subscribers to the TEC Program. The contents of this document are not to be provided in any manner to any other parties without the express written consent of the Blue Cross and Blue Shield Association.



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Kutluhan A, Bozdemir K, Cetin H et al. (2009). Endoscopic balloon dilation sinuplasty including ethmoidal air cells in chronic rhinosinusitis. Ann Otol Rhinol Laryngol, 118:881-6.

Levine HL, Sertich AP 2nd, Hoisington DR et al. (2008). Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol, 117:263-70.

National Institute for Health and Clinical Excellence. (2011). Balloon catheter dilation of paranasal sinusostia for chronic sinusitis. Accessed November 2012 at: http://www.nice.org.uk/nicemedia/live/11899/42156/42156.pdf

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Karanfilov B, Silvers S, Pasha R et al. (2012). Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol, Nov 7. doi: 10.1002/alr.21112.

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Thottam PJ, Haupert M, Saraiya S et al. (2012). Functional endoscopic sinus surgery (FESS) alone versus balloon catheter sinuplasty (BCS) and ethmoidectomy: a comparative outcome analysis in pediatric chronic rhinosinusitis. Int J Pediatr Otorhinolaryngol, 76:1355-60.

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