This document addresses the use of balloon sinus ostial dilation for surgery of the sinuses, including for the treatment of sinusitis.  This procedure involves insertion of a balloon catheter device into a nasal sinus cavity to open blocked sinus ostia.

Investigational and Not Medically Necessary:

The use of balloon sinus ostial dilation for the treatment of any sinus condition, including, but not limited to sinusitis, is considered investigational and not medically necessary.

The U.S Food and Drug Administration has cleared several devices intended for the catheterization and balloon dilatation of the paranasal sinus ostia, a procedure known as balloon sinus ostial dilation, for the treatment of chronic sinusitis.

The Acclarent Relieva™ Sinus Balloon Catheter approaches the target sinus endoscopically.  The manufacturer refers to the procedure that uses their device as Balloon Sinuplasty™.  The available data addressing balloon sinus ostial dilation using this device is currently limited to a few short-term non-randomized clinical studies.  The first study included only 10 subjects who underwent 18 procedures with this device.  The authors reported successful catheterizations in all cases with no complications.  There is no data provided in the study regarding either short or long term clinical outcomes related to sinusitis (Brown, 2006). 

A second study by Bolger (2007) describes the results of a prospective multicenter study.  This study, named the CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study, included 109 subjects with sinusitis who were followed for six months post-operatively.  In over half of these subjects (52.3%), Balloon Sinuplasty was conducted in at least one sinus while traditional endoscopic procedures (FESS) were used to treat other sinuses.  The authors reported a low revision rate and no serious complications.  Self-reported data measured by the SNOT-20 evaluation tool indicated significantly improved sinusitis symptoms, although only 77% (84/109) of subjects provided a complete set of data.  Data presented evaluating the balloon-only group (n=49) vs. the combined approach group (n=57) found no significant differences between groups for symptom relief measures.  While the authors conclude that Balloon Sinuplasty produces favorable results, significant methodological flaws, including small sample size, lack of a prospectively selected control group, no blinding, use of self-reported data, short follow-up period (24 weeks), and significant loss to follow-up (23%), all negatively impact the usefulness of this data.  Additionally, the post-hoc nature of group selection and inability to separate out the impact of Balloon Sinuplasty from traditional FESS undermine the ability to draw firm conclusions. 

Two studies published in 2008 (Kuhn; Weiss) offer longer-term data of the same population previously reported on by Bolger in 2007 in the CLEAR study.  The Kuhn article describes the one year follow-up data from 66 of the original 109 subjects (40% drop out rate).  At one year endoscopy demonstrated that 85% of sinuses treated with Balloon Sinuplasty were still patent, 1% were not patent and 14% were indeterminate.  Fourteen of the 26 subjects (53%) with indeterminate patency were found to have patent ostia on CT scans, for a clinical patency rate of 91.6%.  SNOT-20 scores were statistically improved over pre-operative scores, and demonstrate continuation of the improvement reported by Bolger.  Weiss and colleagues continue to provide data on CLEAR participants at 2 years post-operation with only 65 of the original 109 subjects (60%).  The SNOT-20 scores reported do not continue to improve as was reported by Kuhn et al. at one year, but maintain the gains previously reported.  This indicates some durability of the benefits of the balloon procedure.  These are important findings, but since both the Kuhn and Weiss studies are continuations of the CLEAR study population, the methodological flaws discussed with the Bolger study carry through to these reports as well.  The small sample size, lack of a prospectively selected control group, no blinding, use of self-reported data, and significant loss to follow-up all negatively impact the usefulness of this data.  Overall, the findings available from the CLEAR study, while interesting, have limited usefulness due to the flaws inherent in the studies from which they come.

Friedman and colleagues (2008) describe the results of a nonrandomized controlled clinical trial of Balloon Sinuplasty (n=35) and standard FESS (n=35).  Individuals with medically refractory chronic sinusitis self-selected which procedure they received, and those with severe disease were excluded.  The results found that SNOT-20 scores were significantly better for the FESS group than the balloon group at the 3 month post-operative follow-up visit.  There also may have been a statistically significant difference in postoperative pain (measured by total narcotic use), with the balloon group experiencing less pain than the FESS group; the authors cautioned, however, that "lack of records regarding amount of narcotics used each day may have prevented accurate measurement."  The only significantly higher complication reported was turbinate lateralization in the Balloon Sinuplasty group.  However, the authors also cautioned that 1 subject undergoing Balloon Sinuplasty required a second surgical procedure within 3 months due to persistent infection, and that longer term studies would be required to determine if this was indeed an incrementally more significant problem following this type of surgery as compared with standard FESS.  Finally, the authors state that this study was not designed to demonstrate the efficacy of Balloon Sinuplasty.  In their Discussion section they state, "Because efficacy cannot be assessed with 3-month follow-up, this study specifically avoided drawing conclusions about efficacy.  Nevertheless, ongoing studies are essential to determine if balloon dilatation technology is worthy of continued clinical use."  They conclude by stating "valid comparisons could not be made between the two [balloon sinuplasty and FESS] groups…this study provides data to justify ongoing study of this new tool…"

Levine and others (2008) report on a retrospective case series study that included 1036 subjects who received either Balloon Sinuplasty alone or some form of hybrid procedure combining balloon and FESS.  The mean follow-up was 40 weeks with a range of 8-88 weeks.  Median time for follow-up was 39 weeks.  The authors report no complications related to the balloon procedure.  Data reported for sinus symptoms both before and post-operatively are self-reported.  The authors state that there were differences between groups with regard to blood loss, operation time, debridements, and endoscopies, with outcomes favoring the balloon only group.  However no statistical data or analysis is provided to demonstrate or support this finding.  It should also be noted that no data are presented for sinus patency.  Finally, the revision rate for individuals receiving Balloon Sinuplasty only (n=328) vs. "hybrid" surgery of Balloon Sinuplasty plus FESS (n=708) was approximately 50% higher - 3.1% vs. 2.1% by subject, and 2.2% vs. 1.2% by sinus; this is significantly higher for those receiving Balloon Sinuplasty alone, but the authors could not provide an explanation.  The authors caution that this retrospective registry review was not a prospective, controlled study and did not provide a comparative outcome analysis.

Another balloon sinus ostial dilation device, the Entellus FinESS™ device, received FDA clearance in June of 2008 for the treatment of the sinus and its outflow tract via a trans-antral approach in adults.  The available peer reviewed literature describing outcomes after the use of the Entellus FinESS device is limited to two small studies addressing this device.  Stankiewicz and colleagues reported on the use of the FinESS system in two separate case series studies in subjects with chronic sinusitis of the maxillary sinuses.  The first involved 30 consecutive subjects and had a follow-up time of 6 months.  The authors reported that there were no serious adverse events or unexpected device effects.  SNOT-20 scores were significantly improved and 95.8% of sinuses dilated continued to be patent at 3 months.  No patency data was provided for the 6 month follow-up visit.  The findings of this study are promising, but the limited follow-up time, small study population, and case series methodology do not permit wider conclusions to be drawn.  Stankiewicz and others also published an interim report of an ongoing study.  This paper discussed the findings of the first 29 subjects to complete the 12 month trial period.  Of this small sub population of the 100 subjects planned, all were successfully treated with the FinESS device alone. Data for the full study has not yet been published.  The authors reported significant improvements in SNOT-20 measures of rhinologic symptoms, ear and facial symptoms, sleep function and psychological issues.  As with the previous study by this group, this was a small case series study with no comparison group, no patency data are provided and while the follow-up time of this study is double that of the initial report by this group, 12 months is still insufficient to assess the long-term outcomes of this technology.

On June 28, 2010 the American Academy of Otolaryngology- Head and Neck Surgery (AAO-HNS) released a policy statement addressing the use of balloon dilatation.  The statement says, "Sinus ostial dilation (e.g. balloon ostial dilation) is an appropriate therapeutic option for selected patients with sinusitis. This approach may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other  instruments (eg, microdebrider, forceps).The final decision regarding  use of techniques or instrumentation for sinus surgery is the  responsibility of the attending surgeon."  While this position statement reflects the official position of AAO-HNS, careful review of the published literature does not support the conclusions of AAO-HNS.  At this time, the data addressing the use of balloon sinus ostial dilation systems, using either the intranasal and transantral approaches, is insufficient to allow a full understanding of this technology's long-term efficacy.  The currently available evidence is mostly limited to small studies of one year or less duration. Additionally, current studies have significant methodological flaws such as high drop-out rates, and lack of randomization and blinding.  Furthermore, the available data does not sufficiently describe long-term health-related outcomes. Most available studies have reported on short-term SNOT-20 measures.  This data is helpful in understanding the impact of balloon sinus dilation on symptomatology immediately following the procedure, but there is inadequate information regarding long-term sinus patency and recurrent symptoms.  The longevity and impact on health outcomes of balloon sinus ostial dilation compared to standard FESS procedures have not been sufficiently evaluated.  Additional appropriately structured comparative studies which evaluate the overall clinical impact and improvement of this procedure as compared to the standard FESS procedure would be very helpful in any future review of this procedure.

Chronic sinusitis is defined as a prolonged or recurrent infection and inflammation of the nasal sinuses.  Nasal sinuses are open spaces in the head connected by small passageways to the nasal passageways leading from the nose.  Under normal conditions, air passes in and out of the sinuses and mucus and fluid drain from the sinuses into the nose.

Sinusitis occurs when there is infection or inflammation in one or more of the sinuses.  Temporary (acute) sinusitis is often associated with upper respiratory infections or irritation due to allergic reactions which cause temporary blockage of the passages leading from the sinuses.  Blocked sinuses accumulate nasal secretions and bacteria, leading to infection.

Chronic, long term sinusitis may develop in people with chronic allergies, deviated nasal septum or other obstruction of the nose.  Additionally, dental infections such as tooth abscesses may also spread into the sinus and infect it directly.

When sinusitis recurs frequently, or lasts for a prolonged period of time, it is classified as chronic.  While acute sinusitis is usually caused by infection with a single type of bacteria or virus, chronic sinusitis is usually caused either by allergies or by infection with a mixture of different types of bacteria.

Chronic sinusitis may have less severe symptoms than acute sinusitis but can cause damage and destruction to the tissues of the sinuses.  It may flare up spontaneously or may follow respiratory infections such as colds.

Treatment of chronic sinusitis usually involves the use of antibiotics if the infection is bacterial.  Oral sinus decongestants are sometimes used as well.  In more serious cases related to allergies, topical steroids in the form of nasal sprays may be helpful in controlling inflammation.  Surgery to clean and drain the sinuses may be necessary to clear serious chronic infections.  Finally, surgical repair of a deviated nasal septum or other nasal obstruction may prevent recurrence of chronic sinusitis.

Sinus surgery is commonly done with the use of thin fiberoptic tools that are passed through the nostrils.  This method, referred to as endoscopic sinus surgery, allows visualization and manipulation of the surgical site without the need for surgical incisions in the mouth or face.  Once the endoscopic tools are in place in the surgical site, small tools are used to obliterate the sinus tissue and bone to open the sinus passages.

A technique referred to as balloon sinus ostial dilation has been proposed as an alterative or in addition to standard endoscopic surgery.  This procedure proposes the use of a small balloon-like device instead of the other devices usually used.  There are two different devices available on the market that dilate the sinuses.  With the first type of device, the balloon is placed in the blocked sinus passage under endoscopic guidance through the nostril.  The second is placed in the sinus through an incision made in the gums and maxillary bone under the front lip of the individual.  In both cases, once the balloon is in place in the ostia of the targeted sinus, the balloon is inflated to push the sinus tissue and bone out of the way, creating a larger airway passage and allowing drainage of nasal secretions.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007; 137(1):10-20.
2. Brown CL, Bolger WE.  Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006; 115(4):293-299.
3. Christmas DA, Mirante JP, Yanagisawa E.  Endoscopic view of balloon catheter dilation of sinus ostia (balloon sinuplasty). Ear Nose Throat J. 2006; 85(11): 698, 700. 
4. Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilatation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol. 2008; 22(2):204-209. 
5. Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up--outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2008; 139(3 Suppl 3):S27-37. 
6. Lanza DC, Kennedy DW.   Balloon sinuplasty: not ready for prime time. Ann Otol Rhinol Laryngol. 2006; 115(10):789-790. 
7. Levine HL, Sertich AP 2nd, Hoisington DR, et al.; PatiENT Registry Study Group. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008; 117(4):263-270.
8. Ramadan HH, McLaughlin K, Josephson G, et al. Balloon catheter sinuplasty in young children. Am J Rhinol Allergy. 2010; 24(1):e54-56.
9. Stankiewicz J, Tami Y, Truitt T. et al. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy. 2009; 23(3):321-327.
10. Stankiewicz J, Truitt T, Atkins J Jr. One-year results: Transantral balloon dilation of the ethmoid infundibulum. Ear Nose Throat J. 2010; 89(2):72-77.
11. Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. 2008; 139(3 Suppl 3):S38-46.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Otolaryngology - Head and Neck Surgery. Position statement on balloon dilatation. Available at: http://www.entnet.org/Practice/Balloon-Dilation.cfm. Accessed on May 12, 2011.
2. American Rhinologic Society Position Statement on Balloon Dilation Technology (Balloon Sinuplasty). May 2007. Available at: http://www.american-rhinologic.org/patientadvocacy.balloon.phtml. Accessed on May 12, 2011.

1. American Academy of Family Physicians. Functional Endoscopic Surgery. Available at: http://www.aafp.org/afp/980901ap/slack.html. Accessed on May 12, 2011.
2. National Library of Medicine. Medical Encyclopedia. Sinusitis. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000647.htm. Accessed on May 12, 2011.

Balloon dilatation
Balloon Sinuplasty™
Entellus FinESS™
FinESS™
Relieva™ Sinus Balloon Catheter
Relieva™ Sinus Exchange Catheter
Relieva™ Sinus Guide Catheter
Relieva™ Sinus Guidewire
Relieva™ Sinus Inflation Device
Relieva™ Sinus Lavage Catheter
Sinusitis 

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.