Surgery Section - Balloon Catheter Dilation for Treatment of Chronic Sinusitis

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Balloon catheter dilation for the treatment of chronic sinusitis involves placement and inflation of a balloon catheter within an obstructed frontal, sphenoid, or maxillary sinus ostium. The balloon catheter is placed using transnasal endoscopy. A transantral approach may be used for direct access to the maxillary sinus. Inflation of the balloon is intended to enlarge the sinus ostium by compressing mucosa and displacing local bony structures. This technique has been used as an alternative or adjunct to conventional endoscopic sinus surgery which involves surgical excision of the mucosa and bone.

POLICY/CRITERIA

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

SCIENTIFIC BACKGROUND

There are no randomized, controlled clinical trials comparing balloon catheter dilation with conventional endoscopic surgery for the treatment of sinusitis. Clinical trial data, some of which are summarized below, are limited to unreliable feasibility studies (2-4), case series (5-8), and retrospective reviews (9-11). In addition, long term treatment results and patients health outcomes of balloon dilation have not been reported. While these studies contribute to the body of knowledge by providing direction for future research, evidence from these studies is unreliable due to inherent design flaws, such as non-random allocation of treatment and a lack of appropriate comparison groups.

Brown and colleagues reported on a non-randomized study of ten patients who had failed medical management and were considered candidates for endoscopic sinus surgery. (2) The patients were offered  balloon catheter dilation as an alternative to conventional 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. In a commentary on this study, Lanza and Kennedy made the following points (12):

• Balloon dilation is not to be used in chronic sinusitis when polypoid disease is present; this situation represents the majority of cases where endoscopic sinus surgery is indicated.
• Crushing of bone during balloon dilation “could lead to delayed mucocele formation and to late complications”.
• Data supports the importance of tissue removal, and balloon dilation does not result in tissue removal.
• It remains to be seen whether the tissue left behind when dilation is used in lieu of excision will lead to inferior patient outcomes.

Three articles reported the 24-week, one year and two year outcomes of the CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR NCT00231062) Study sponsored by Acclarent, the makers of the Balloon Sinuplasty® system. (5-7) This study was a nonrandomized uncontrolled, non-blinded, multicenter trial in which 115 patients for whom endoscopic sinus surgery was recommended underwent balloon dilation. 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 dilation in at least one sinus, 52% of patients also had conventional endoscopic surgery in other sinuses.

In reporting the 24-week followup results, the authors based their percentage calculations only on the  307 sinuses in which dilation took place and endoscopic evaluation was available at 24-weeks follow-up. (5)  This resulted in an inflated estimation of the percentage of sinuses that were confirmed by endoscopy to remain patent. An appropriate intent to treat analysis would include all sinuses on which cannulation was attempted, including the eleven in which equipment failure prevented dilation. Of the 358 sinuses on which balloon dilation was attempted, 247 ostia were determined to be patent, 69% rather than the 80% reported by the authors. The remaining sinuses would be considered treatment failures for the following reasons: Eleven sinuses (3%) failed dilation attempts due to equipment failure during surgery; 40 sinuses (11%) were lost to followup; five sinuses (1%) were determined to be nonpatent; and 55 (16%) 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 dilation.

One- and two-year results were reported for only a subset of the subjects in the original CLEAR study. This longer term data does not permit conclusions due to a number of errors in study design and calculations such as the large loss to followup and lack of intent-to-treat analysis. 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. (6) 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%).

Wittkopf and colleagues reported on five critically ill patients who received balloon sinuplasty for acute sinusitis. (9) Due to the small number of patients, no statistical analyses could be performed and no conclusions can be drawn about the effectiveness of this procedure in critically ill patients. Another article reported on the feasibility of balloon dilation on 30 children who received balloon sinuplasty under general anesthesia performed by a single the study author. (3) The children had all failed at least six months of medical management. Balloon sinuplasty was feasible in 51 out of 56 sinuses scheduled for surgery and not feasible in four hypoplastic sinuses and one frontal sinus. Thirteen children had both balloon sinuplasty and adenoidectomy. The mean time of fluoroscopy exposure was 18 seconds per sinus (range 6 to 60 seconds). The estimated amount of radiation received was 0.18 mGy (range of 0.06 to 0.6 mGy). No complications or side effects were noted. The author did not report on change in sinusitis symptoms after surgery.

A retrospective chart review that compared results in 35 consecutive patients who received balloon sinuplasty alone and 35 consecutive patients who received functional endoscopic surgery alone. (11) There were no consistent eligibility criteria; patients generally had a history of recurrent rhinosinusitis despite medical management and either a persistently abnormal CT scan after at least four weeks of antibiotic treatment, or an abnormal CT scan during treatment with a normal scan post-treatment but at least three recurrences per year. Three months after the operation, SNOT 20, narcotic use, and satisfaction scores significantly favored the balloon dilation group. As with the studies discussed above, this study did not permit conclusions due to nonrandomized treatment assignment, the small number of patients, short-term follow-up period.  In addition, patients selected their interventions and, as the authors pointed out, they may have had more positive expectations about a novel minimally invasive procedure that received extensive media coverage.  

Clinical Practice Guidelines and Position Statements

In May 2007, the American Rhinologic Society (ARS) published an updated position statement. (13) 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. (2) 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 distinct 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.” (14) The statement also noted 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. (15) 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. 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. An updated search of the MEDLINE database through October 2009 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. 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. Ramadan HH. Safety and feasibility of balloon sinuplasty for the treatment of chronic rhinosinusitis in children. Ann Otolog Rhinolog Laryngol 2009: 118(3):161-5
4. Stankiewicz J, Tami T, Truitt T, et al. Transantral, endoscopically guided balloon dilatation of the local ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol. 2009;23(3):321-7
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. Catalano PJ, Payne SC. Balloon Dilation of the Frontal Recess in Patients With Chronic Frontal Sinusitis and Advanced Sinus Disease: An Initial Report. Ann Otol. Rhinol  Laryngol 2009;118(2):107-112
9. Wittkopf ML, Becker SS, Duncavage JA et al. Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis. Otolaryngol Head Neck Surg 2009;140(4):596-8
10. Luong A, Batra PS, Fakhri S, et al. Balloon catheter dilatation for frontal sinus ostium stenosis in the office setting.  Am J Rhinol. 2008;22(6):621-4
11. Friedman M, Schalch P, Lin HC et al. Functional endoscopic dilation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol 2008; 22(2):204-9
12. Lanza DC, Kennedy DW. Balloon sinuplasty: not ready for prime time. Ann Otol Rhinol Laryngol. 2006;115(10):789-90
13. American Rhinologic Society Position Statement  (Revised May, 2007)  (Verified 12/01/09)
14. 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 12/01/09)
15. 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

CROSS REFERENCES

None

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