| Surgery Section - Balloon Catheter Dilation
for Treatment of Chronic Sinusitis
| Topic: Balloon
Catheter Dilation for Treatment of Chronic Sinusitis |
Date of Origin: 08/08/2006 |
| Section: Surgery |
Policy No: 153 |
| Approved Date: 02/09/2010 |
Effective Date: 03/01/2010 |
| Next Review Date: 03/2011 |
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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
- BlueCross and BlueShield Association Medical Policy
Reference Manual, Policy 7.01.105
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Lanza DC, Kennedy DW. Balloon sinuplasty: not ready
for prime time. Ann Otol Rhinol Laryngol.
2006;115(10):789-90
- American
Rhinologic Society Position Statement (Revised
May, 2007) (Verified 12/01/09)
- 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)
- 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
| CODES |
NUMBER |
DESCRIPTION |
| There is no CPT code that specifically
describes the use of the sinus balloon dilatation
device. In June 2007, the AMA-CPT Editorial Panel
addressed the reporting issues surrounding Balloon
Sinuplasty. The recommendation was that the unlisted
procedure code 31299 is the only CPT code that
should be used for reporting this balloon technique. Based
upon this, Regence considers it to be inappropriate
to report this procedure using the nasal/sinus
endoscopy codes 31231 through 31294. |
| CPT |
None |
|
| HCPCS |
S2344 |
Nasal/sinus endoscopy, surgical; with enlargement
of sinus ostium opening using inflatable device
(i.e., balloon sinuplasty) |
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