Surgery Section - Balloon Catheter Dilation for Treatment of Chronic Sinusitis

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Chronic sinusitis is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months.  Symptoms of congestion often accompany the nasal discharge.  There also may be mild pain and/or headache.

In some cases of chronic sinusitis, surgical drainage may be necessary.  Endoscopic sinus surgery has become an important aspect for surgical management of chronic sinusitis.  For this procedure a fiberoptic nasal endoscope is used to visualize the sinus ostia and any obstruction found is corrected.  This restores patency and allows mucous transport through the natural ostium.  The procedure may be used when patients fail to respond to aggressive medical management.  About 350,000 procedures are done each year in the United States (U.S.) for chronic sinusitis.  Estimates are that about 30 million individuals in the U.S. suffer from chronic sinusitis.

A new procedure, balloon sinuplasty, is being discussed as an alternative to endoscopic sinus surgery for those with chronic sinusitis.  The procedure involves placing a balloon in the sinus ostium and then stretching the opening by inflating the balloon.  General anesthesia may be needed for this procedure to minimize patient movement.  This technique is said to allow improved sinus drainage.

Of note, surgical interventions are generally not necessary in patients with acute sinusitis.

The Relieva Sinus Balloon Inflation Device manufactured by Acclarent has received FDA 510(k) marketing clearance (2) by being considered equivalent to an existing device. In March 2008, 510(k) clearance was given for use of the device to dilate sinus ostia and spaces associated with the maxillary sinus in children aged 17 and under.  This device requires special training.

Policy/Criteria

Use of a catheter-based inflatable device (balloon sinuplasty) in the treatment of sinusitis is considered investigational.

Scientific Background

The published scientific literature for this device/procedure is very limited.  The device received FDA 510(k) marketing clearance (2) by being considered equivalent to existing devices.  No clinical outcome data were found in reviewing the FDA clearance summary.

One preliminary study of the procedure has been published. (3) This was a non-randomized study of ten patients who had failed medical management and were considered candidates for endoscopic sinus surgery.  The patients were offered sinuplasty as an alternative to endoscopic surgery.  A total of 18 sinus ostial regions were successfully dilated using the balloon technique including 10 maxillary, 5 sphenoid, and 3 frontal recesses.  Eight of the ten patients had other sinus regions treated concurrently by standard endoscopic sinus surgery.  No adverse events were noted in the immediate post-procedures period.  Mucosal trauma and bleeding were reported to be less than with conventional endoscopic techniques.  However, long term treatment results and patients health outcomes of balloon sinuplasty have not been reported. In a commentary on this study, Lanza and Kennedy indicated that balloon sinuplasty is not to be used in chronic sinusitis when polypoid disease is present and note that this situation represents the majority of cases where endoscopic sinus surgery is indicated. (4) They also noted that crushing of bone during balloon dilation “could lead to delayed mucocele formation and to late complications”. In addition, they noted that data supports the importance of tissue removal, and that balloon dilation does not result in tissue removal. Thus, it remains to be seen whether the tissue left behind when dilation is used in lieu of excision will lead to inferior patient outcomes.

Bolger and colleagues reported the outcomes of the CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR NCT00231062) Study sponsored by Acclarent. (5) This study was a nonrandomized uncontrolled, non-blinded, multicenter trial in which 115 patients for whom endoscopic sinus surgery was recommended underwent balloon sinuplasty. Successful cannulation and sinusotomy was achieved in 347 of 358 sinuses. In the remaining eleven sinuses the balloon ruptured in seven cases and the catheter tip malfunctioned in four cases.  In addition to balloon sinuplasty in at least one sinus, 52% of patients also had conventional endoscopic surgery in other sinuses.  In 307 sinuses available for endoscopic evaluation at 24-weeks follow-up, 247 ostia (80%) were determined to be patent, five (2%) were nonpatent and 55 (18%) were indeterminate due to inability to visualize the ostium with rigid endoscopy or inability of the patient to tolerate a compete endoscopic examination. Symptoms measured by the Sino-Nasal Outcome Test (SNOT 20) were also reported to have improved. Due to the short follow-up, scientific conclusions cannot be reached concerning the long-term patency rates and reoperation rates following balloon sinuplasty.

One- and two-year results were reported for a subset of the subjects in the original CLEAR study. (7) In the report of one-year follow-up, two investigators were unable to participate;  one investigator moved and the other could not reapply to his IRB for the one-year follow-up study. This left a cohort of 86 patients, 16 (19%) of whom were lost to follow-up.  Fifty-six of the remaining 70 patients had follow-up CT scans, but three were not included due to revision procedures, leaving 53 subjects in the report. Twenty-three of these patients had “balloon-only” while 30 had “hybrid” procedure which included both balloon and traditional endoscopic procedures.  Of the 66 patients who had follow-up nasal endoscopy, 85% of sinus ostia were patent.  When CT scans showing improvement were added, 92% were judged to have functional patency. The report on clinical symptoms with two-year follow-up involved a similar subset of patients (n=65). (7) In this longer-term study, where 34 patients had only “balloon” treatment, 85% of patients had improved symptoms. Revision treatment was required in 3.6% of sinuses involving six of 65 patients (9%).

Chandra discussed questions about potential radiation damage to the lens (lenticular opacity) from the fluoroscopic guidance used to position the guide wire. (8) By extrapolating information from other procedures, the authors suggested that the threshold for lenticular opacity would be attained in the left eye after approximately 29 minutes of fluoroscopy. In a recent review, Vaughan comments that in bilateral cases less than five minutes of fluoroscopy is generally used. (10) In that review, Vaughan also comments on the question whether sinuplasty represents an exciting and minimally invasive set of devices or if it represents a premature attempt to transfer dilation into otolaryngology.

Position Statements

In May 2007, the American Rhinologic Society (ARS) published an updated position statement. (11) The Society’s previous position that the data was insufficient to recommend the procedure was changed to the following:

• Endoscopic balloon dilation technology, alone or in combination with conventional endoscopic techniques, is acceptable and safe for use in the management of sinus disease.
• Endoscopic balloon dilation technology is a tool, not a procedure.
• As a tool, balloon catheter technology should not be viewed as investigational or experimental.

Three references were provided to support this change in the ARS position. One study was a preclinical cadaver study. One was the preliminary study by Brown and colleagues which is summarized above and included only ten patients. (3) The third was the six-month data from the CLEAR study, also summarized above. (5) The position that the procedure is “acceptable and safe” appears to be based primarily on the ARS’ position that this is a not a procedure.

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) stated that “Evidence regarding indications for use, efficacy, and long-term results remain pending.” (11) The statement also notes that, while this technique “may be indicated” for rhinosinusitis without polyposis in the frontal, sphenoid or maxillary sinuses, the most commonly involved of paranasal sinus disease is the ethmoid sinuses which still requires conventional surgical techniques. The AAO-HNS stated that, “Based upon current available evidence, sinus balloon catheterization may hold a potential role as an adjunct to currently accepted treatments”.

Registry Data

Levine reported on results from a registry study of 1036 patients who received this procedure at 27 sites from December 2005 to May 2007. (12) This registry was developed through retrospective chart review of consecutive cases at these institutions. All but two patients in this study had treatments under general anesthesia. An average of 3.2 sinuses was treated per patient. Symptom improvement was reported at 95%. With average follow-up of 40 weeks, the revision rate was 1.3%.

Summary

The role of this procedure, if any, in patients with sinus disease awaits further study. While more data are becoming available the role of this technique in patients with chronic sinus disease remains uncertain. The published literature consists of non-comparative results on only a small number of patients. Prospective comparative studies with larger patient populations that include relevant outcomes are needed to determine the outcomes for this treatment compared with both surgical and medical alternatives. Relevant outcomes data include symptom improvement as well as the durability of the procedure and the need for subsequent revision. In addition, more information is needed to determine which patients (which sinuses) might be treated with the balloon technique and which require the more standard approaches. It is also noted that the limited data for this procedure is just for patients who are considered candidates for sinus surgery and who do not have significant nasal polyps. Given the limitations of the available data, the uncertain impact on clinical outcomes and questions about which patients might be candidates for this procedure, this approach is considered investigational. As noted by Christmas and colleagues, long-term studies are needed to better understand indications, potential complications and long-term patency. (13) An updated search of the MEDLINE database through August 2008 failed to return any new clinical trial data that alter this conclusion.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy  7.01.105
2. www.fda.gov/cdrh/pdf5/K052198.pdf  (Verified  9/12/08)
3. 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
4. Lanza DC, Kennedy DW. Balloon sinuplasty: not ready for prime time. Ann Otol Rhinol Laryngol. 2006;115(10):789-90
5. 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
6. 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 (Suppl): 5-15  
7. Weiss RL, Church DA, Kuhn FA et al. Long-term outcomes analysis of balloon catheter sinusotomy” Two-year follow-up. Otolaryngol Head Neck Surg 2008; 139 (Suppl):16-24
8. Chandra RK. Estimate of radiation dose to the lens in balloon sinuplasty. Otolaryngol Head Neck Surg 2007;137:953-5
9. Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008;16:2-9
10. American Rhinologic Society Position Statement  (Revised May, 2007)  (Verified 09/12/2008)
11. The American Academy of Otolaryngology-Head and Neck Surgery. Sinus Balloon Catheterization Position Statement. Available online at:  http://www.entnet.org/Practice/policySinusBalloonCatheterization.cfm (Verified 9/12/08)
12. Levine HL, Sertich AP, Hoisington DR et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008;117(4):263-70
13. 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

Cross References

None

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