Health Policy Advisory Committee on Technology Technology Brief Update

Transcription

Health Policy Advisory Committee on
Technology
Technology Brief Update
Balloon Sinuplasty for Chronic Rhinosinusitis
February 2014
© State of Queensland (Queensland Department of Health) 2014
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DISCLAIMER: This Brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This Brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
The State of Queensland acting through Queensland Health (“Queensland Health”) does not
guarantee the accuracy, currency or completeness of the information in this Brief. Information may
contain or summarise the views of others, and not necessarily reflect the views of Queensland
Health.
This Brief is not intended to be used as medical advice and it is not intended to be used to diagnose,
treat, cure or prevent any disease, nor should it be used for therapeutic purposes or as a substitute
for a health professional's advice. It must not be relied upon without verification from authoritative
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incurred by use of or reliance on the information.
This Brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
Advisory Committee on Technology (HealthPACT). The production of this Brief was overseen by
HealthPACT. HealthPACT comprises representatives from health departments in all States and
Territories, the Australian and New Zealand governments and MSAC. It is a sub-committee of the
Australian Health Ministers’ Advisory Council (AHMAC), reporting to AHMAC’s Hospitals Principal
Committee (HPC). AHMAC supports HealthPACT through funding.
This brief was prepared by Jonathan Henry Jacobsen from ASERNIP-S.
TECHNOLOGY BRIEF UPDATE 2014
Technology, Company and Licensing
Register ID
WP060
Technology name
Balloon Sinuplasty
Patient indication
For patients with chronic rhinosinusitis
Stage of development in Australia
Yet to emerge
Established
Experimental
Established but changed indication
or modification of technique
Should be taken out of use
Investigational
Nearly established
Australian Therapeutic Goods Administration approval
Yes
ARTG number (s): 203853, 168057, 178372,
197043, 215963, 215961
No
Not applicable
International utilisation
Country
Level of Use
Trials underway or
completed
Limited use
Australia


Austria

Finland

Spain

Turkey


United States of America
United Kingdom
Widely diffused

2014 Evidence and Policy
It should be noted that hybrid procedures are sometimes referred to as balloon
sinuplasty; therefore, the term balloon sinus dilation has been used in the update to
avoid confusion.
Balloon sinuplasty for chronic rhinosinusitis: update February 2014
1
2014 Safety and effectiveness
One systematic review (BlueCross Blue Shield) (level I Intervention evidence) (1) and
two randomised controlled trials (RCTs) (level II Intervention evidence) (2, 3) evaluating
balloon sinus dilation for chronic rhinosinusitis were included in this update.
The systematic review summarised all available evidence up to December 2012
evaluating balloon sinus dilation for chronic rhinosinusitis. The two additional RCTs
were published after the literature review and compared the safety and efficacy of
balloon sinus dilation with functional endoscopic sinus surgery (FESS) in a total of 107
patients. The primary outcome of both RCTs was improvement in the 20-item Sinonasal
Outcome Test (SNOT-20), a quality of life measure for patients with rhinosinusitis.
However, the other reported outcomes differed between the studies. Achar et al (2)
reported the average postoperative recovery time and saccharin clearance time (SCT)
(an indication muco-ciliary clearance time). By contrast, Cutler et al (3) reported postdischarge nausea, nasal bleeding, duration of analgesic use, recovery time, short-term
improvement in sinus symptoms, complications and revision rate. A summary of the
included studies is outline in Table 1.
Table 1 Characteristics of included studies evaluating balloon sinus dilation
Study
BlueCross BlueShield. 2013
Cutler et al. 2013
Achar et al. 2012
Design (evidence
level)
Systematic review (includes II –
IV)
Randomised controlled trial (II)
Randomised controlled trial (II)
Intervention (number
of patients)
Balloon sinus dilation (15-1036)
Balloon sinus dilation (n=50)
FESS (n=42)
FESS (n=12)
Follow-up
Up to 2 years
6 months
6 months
Conflict of interest
No conflicts of interests declared
The first and third authors are
paid consultants and
stockholders of Entellus Medical,
Inc.
Not reported
FESS: functional endoscopic sinus surgery; NA: Not applicable.
BlueCross BlueShield 2013
The systematic review aimed to determine the safety and efficacy of balloon sinus
dilation compared with FESS. A systematic search of MEDLINE was conducted, with the
latest publication date set for December 2012. Additional limits included Englishlanguage articles and studies performed on humans. Studies were excluded if they did
not report clinical outcomes, were of unusual or special patients, or were case series of
fewer than 10 patients. A formal quality assessment of the included studies was not
undertaken.
The literature search identified one RCT (level II Intervention evidence), three nonrandomised controlled trials (level III Intervention evidence) and nine case series
studies (level IV Intervention evidence) evaluating balloon sinus dilation for chronic
rhinosinusitis (Table 2). Two balloon dilation technologies with differing indications
2
were included in the review: the Relieva® Balloon Sinuplasty System (Acclarent, Inc.,
Menlo Park, CA, USA), for chronic rhinosinusitis in the frontal, maxillary and sphenoid
sinuses, and FinESS (Entellus Medical, Inc., Plymouth, MN, USA) for chronic
rhinosinusitis in the maxillary, anterior and ethmoid sinuses. In several studies, patients
were treated with both balloon sinus dilation and the traditional FESS procedure.
Table 2 Details of studies included in the BlueCross BlueShield report
Author, year
Location
Plaza et al (2011) (4)
Spain
Study design (evidence level)
Interventions
RCT (II)
Ramadan & Terrell (2010) (5)
USA
Non-randomised comparative study (III-2)
Balloon sinus dilation + mandatory
anterior ethmoidectomy
n= 16
FESS + mandatory anterior
ethmoidectomy
n= 16
Balloon sinus dilation + adenoidectomy
n= 30
Adenoidectomy
n= 19
Friedman et al (2008) (6)
USA
Thottamet al (2012) (7)
USA
Levine et al (2008) (8)
27 practice sites
USA
Case series (IV)
Karanfilov et al (2012) (9)
USA
Case series (IV)
Bolger et al (2007) (10)
USA
Case series (IV)
Kuhn et al (2008)
(Same patients as Bolger et al) (11)
USA
Weiss et al (2008) (12)
(Same patients as Bolger et al)
USA
Cutler et al (2011) (13)
USA
Case series (IV)
Stankiewicz et al (2012) (14)
USA
Case series (IV)
Ramadan et al (2010) (15)
USA
Case series (IV)
Kutluhan et al (2009) (16)
Turkey
Case series (IV)
Balloon sinus dilation
n= 35
FESS + ethmoidectomy
n= 35
Balloon sinus dilation + ethmoidectomy
n= 15
FESS + ethmoidectomy
n= 16
Registry of 1,036 patients with varying
balloon sinus dilation + FESS
procedures
n= 203
n= 109/115
n= 70 of the original 115
Case series (IV)
n= 65 of the original 115
Case series (IV)
n= 71
Transantral balloon dilation
n= 59
n= 32
n= 30
FESS: functional endoscopic sinus surgery.
The authors of the systematic review could not draw conclusions regarding the
comparative efficacy of balloon sinus dilation and FESS. The single RCT was of poor
quality, with no formal comparison between the two treatment arms. In addition, it
was statistically underpowered to detect any clinically meaningful difference in
3
outcomes between the two patient groups. However, it is worth noting that both
balloon sinus dilation and FESS achieved similar reductions in disease severity as
assessed by the Lund-Mackay scoring system.
The results from the three non-randomised comparative studies were inconclusive. The
retrospective analysis in two studies introduced significant bias. In addition, the study
selection by Friedman et al (6) induced a significant imbalance between the two groups,
whereby the patients in the FESS group had more severe sinusitis. Despite this, there
was no difference in mean postoperative disease severity scores between the two
groups. Thottam et al demonstrated no improvement in symptoms after either balloon
sinus dilation or FESS (7), while Ramadan and Terrell compared balloon sinus dilation
with adenoidectomy instead of FESS (5).
The nine case series studies, three of which reported on the same patient population,
demonstrated an overall improvement in sinusitis symptoms after balloon sinus
dilation, with long-term results indicating relief for up to two years following the
intervention. However, the lack of a comparator meant that the efficacy of balloon
sinus dilation could not be conclusively determined. In addition, the findings were
further complicated by the heterogeneity of the studies with respect to patient
selection, disease severity and concurrent sinus procedures. Adverse events resulting
from balloon sinus dilation were uncommon in the case series studies.
BlueCross BlueShield concluded that the current evidence base was insufficient to
demonstrate that balloon sinus dilation improved health outcomes in the
investigational setting. Despite the lack of clinical effectiviness and robust outcomes
data, however, the technology appears to be widely diffused in the USA.
Cutler et al 2013
One hundred and five adults with either chronic or acute recurrent rhinosinusitis were
recruited into an RCT (level II Intervention evidence) across 10 centres in the USA.(3)
Patients with posterior ethmoid, sphenoid, or frontal rhinosinusitis requiring FESS,
fungal sinusitis, a deviated septum resulting in obstruction, gross sinonasal polyposis,
previous surgery within three months and anyone requiring concomitant sinonasal
surgery were excluded from the trial. A physician blinded to treatment assignment
performed scoring of the baseline computed tomography scans and debridement
details. Patients were randomly assigned on a 1:1 basis to either balloon sinus dilation
or FESS. However, 13 patients subsequently withdrew (2 from the balloon sinus dilation
group and 11 from FESS). Consequently, 92 patients (50 balloon dilation and 42 FESS)
were treated. Postoperative follow-up appointments were scheduled for one week, and
one, three and six months following the intervention. One patient in the balloon
dilation group was lost to follow-up after three months.
4
There was no difference in preoperative patient demographics between the two groups
with respect to age, sex distribution, ethnicity, smoking history, allergies, SNOT-20
score, previous nasal surgery, Lund-Mackay score, chronicity of rhinosinusitis or other
prognostic variables (p>0.05 for all variables). The balloon sinus dilation and FESS
cohorts reported a mean age of 47 (16 men and 34 women) and 48 years (19 men and
23 women), respectively.
Safety
No deaths or complications occurred in either the balloon sinus dilation or FESS study
arms.
Efficacy
Technical success was achieved in 97 of 98 balloon dilation procedures (99%) and 80 of
81 FESS procedures (99%).
The study’s primary outcomes are listed in Table 3. The mean changes in SNOT-20
scores were similar in both groups at one week and six months after treatment.
Comparison of the mean change in SNOT-20 at 6 months determined that the mean
symptom improvement for patients undergoing balloon sinus dilation was non-inferior
to patients undergoing FESS. Patients who underwent balloon sinus dilation required
significantly fewer postoperative debridement procedures compared with FESS
(p<0.0001).
Table 3 Primary outcomes assessed by Cutler et al (3)
Outcome
Balloon dilation (n=50)
FESS (n=42)
p-value
1 week
-1.5 (0.9)
-1.0 (1.1)
0.01
1 month
-1.7 (1.0)
-1.6 (1.0)
NR
6 months
-1.7 (1.1)
-1.6 (1.0)
<0.0001*
Mean (SD) number of postoperative
debridement procedures per patient
0.1 (0.6) (7 procedures)
1.2 (0.9) (50 procedures)
<0.0001
Number of patients not requiring debridement
46 (92%)
11 (26%)
<0.0001
Mean (SD) change in SNOT-20
*Statistically non-inferior to FESS
FESS: functional endoscopic sinus surgery; NR: not reported; SNOT: sinonasal outcome test; SD: standard deviation.
Secondary outcomes are listed in Table 4. Patients who received balloon dilation had
fewer nasal bleeding discharges, recovered more quickly and required fewer days on
prescription pain medication than those who underwent FESS. However, both groups
reported similar rates of post-discharge nausea and use of over-the-counter pain
medication.
5
Table 4 Secondary outcomes assessed by Cutler et al (3)
Outcome
Balloon dilation (n=50)
FESS (n=42)
p-value
Post-discharge nausea (n)
3 (6%)
7 (17%)
0.18
Discharged with nasal bleeding (n)
14 (28%)
23 (55%)
0.01
Mean (SD) recovery time (days)
1.6 (1.1)
4.8 (6.2)
0.002
Mean (SD) duration of prescription
pain medication (days)
0.9 (1.4)
2.8 (2.7)
<0.001
Mean (SD) duration of over-thecounter pain medications (days)
1.6 (2.0)
2.7 (4.0)
0.13
FESS: functional endoscopic sinus surgery; SD: standard deviation.
Achar et al 2012
Twenty-four patients with chronic rhinosinusitis who were referred for surgery after
medical treatment for their symptoms had failed, were recruited into this RCT.(2)
Patients were excluded: if they were younger than 18 years of age; were unwilling to
undergo endoscopic sinus surgery; had extensive sinonasal polyps; had undergone
previous surgery or trauma to the sinonasal complex; had an aspirin sensitivity; had
asthma, sinonasal tumours or obstructive lesions, ciliary dysfunction or cystic fibrosis;
or were pregnant. Patients were assigned to either balloon sinus dilation (n=12) or FESS
(n=12) using a block randomisation list. Follow-up appointments were conducted at 6,
12 and 24 weeks post-surgery. No patients were lost during follow up.
The preoperative patient demographics reported were limited to sex and age. The
balloon sinus dilation and FESS cohorts reported a mean age of 38.9 and 44.1 years,
respectively. Both groups reported similar numbers of men (3 of 12 undergoing balloon
sinus dilation and 2 of 12 in the FESS group).
Limitations of this RCT included a lack of blinding, small patient numbers, exclusion of
patients with severe polyposis and the performance of FESS in several patients in the
balloon sinus dilation treatment group to reduce the polyposis.
Safety
No deaths or adverse events were reported.
Efficacy
The procedural success rate was not reported.
Patients undergoing balloon sinus dilation reported shorter postoperative recovery
times, although the statistical significance of this result was not reported. The balloon
sinus dilation group experienced a greater change in mean SNOT-20 and SCT scores,
compared with FESS (p=0.03) (Table 5).
6
Table 5 Effectiveness outcomes assessed by Achar et al (2)
Outcome
FESS (n=12)
p-value
Postoperative recovery time (days)
2.2
5.0
NR
Mean (SD) change in SNOT-20 score
43.8 ± 15.2
30.0 ± 12.3
0.03
Mean (SD) change in SCT time (minutes)
7.5 ± 5.1
3.5 ± 4.3
0.03
NR: not reported; SD: standard deviation; SNOT: sinonasal outcome test; SCT: saccharine clearance time.
2014 Economic evaluation
No cost effectiveness studies of balloon sinoplasty were identified in the literature.
2014 Ongoing research
Five clinical trials were identified, from searches of the ClinicalTrials.gov website and
the Australian and New Zealand Clinical Trials Register, that are investigating balloon
sinus dilation for treatment of chronic rhinosinusitis in either adult or paediatric
patients (Table 6). Three studies are utilising technology by Acclarent, Inc., (RELIEVA
Spin® or ULTIRRA®) and two studies are using the Entellus Medical, Inc. (XprESS™)
system.
Table 6 Current clinical trials evaluating balloon sinus dilation
Trial Identifier/
Location
Trial status
N
Details
Diagnosis
Interventions
Estimated
completion
date
NCT01525849/
USA
Ongoing,
but not
recruiting
120
RCT
Chronic
sinusitis
Balloon sinus dilation (Entellus
Medical, Inc.) vs.
December
2014
Recruiting
400
NCT01714687/
USA
NCT01990820/
USA
NCT01685229/
USA
Single
centre
RCT
Single
centre
Recruiting
48
RCT
Single
centre
Recruiting
250
Nonrandomised
comparative
study
Functional endoscopic sinus
surgery
Recurrent
acute
rhinosinusitis
Balloon sinus dilation (Acclarent,
Inc.) vs.
Chronic
rhinosinusitis
in children
Inc.) + irrigation vs.
Chronic
rhinosinusitis
Inc.) vs.
October
2014
Medical management
March 2016
Adenoidectomy + maxillary sinus
irrigation
March 2014
Medical management
Single
centre
NCT01612780/
USA
Ongoing,
but not
recruiting
120
Case series
Single
centre
Not
mentioned
Balloon sinus dilation (Entellus
Medical, Inc.)
April 2014
NCT01525849: primary outcome is improvement in chronic sinusitis symptoms during
the first 12 months following treatment; secondary outcomes were not mentioned.
7
NCT01714687: primary outcome is change in quality of life 24 weeks after the
intervention; secondary outcomes include disease specific medication usage, number
of school/work days missed due to sinusitis, number of sinus infections, number of
revisions required, number of patients electing to cross over to balloon dilation and
time to return to normal activity.
NCT01990820: primary outcome is quality of life during the first 12 to 18 months
following the intervention; secondary outcomes were not mentioned.
NCT01685229: primary outcome is change in quality of life 24 weeks after the
intervention; secondary outcomes include disease-specific medication usage, number
of school/work days missed due to sinusitis, number of sinus infections, number of
revisions required, number of patients electing to cross over to balloon dilation and
time to return to normal activity.
NCT01612780: primary outcome is change in quality of life and rate of revision or
additional sinus surgery during the first 12 months following treatment; secondary
outcomes were not mentioned.
2014 Other issues
Although not apparent in the included studies, high procedural failure rates with
balloon sinus dilation have been reported in the literature (>65%) (17). This may be
attributable to the significant learning curve associated with the procedure.
2014 Summary of findings
Balloon sinus dilation is a novel therapy for chronic rhinosinusitis. The highest level of
evidence, the BlueCross BlueShield systematic review, determined there was
insufficient evidence that balloon sinus dilation improved health outcomes in the
investigational setting when compared with FESS. Furthermore, the BlueCross
BlueShield noted that the studies of higher intervention evidence (levels II and III) were
often of poor quality and contained significant biases. One RCT published after the
systematic review showed greater improvements in SNOT-20 scores in patients
undergoing balloon sinus dilation, compared with FESS. A second RCT showed equivocal
results. Both studies reported that patients undergoing balloon sinus dilation had a
quick recovery and less pain as compared to patients undergoing FESS. Both procedures
were associated with a minimal number of adverse events. However, the short-term
follow up, conflicts of interest and small patient numbers limited the conclusions of
these two studies.
Two large randomised clinical trials are anticipated to be completed within 2014.
However, only one of these compares balloon sinus dilation with FESS, the most
appropriate comparator. Therefore, balloon sinus dilation should be used utilised in the
8
context of research and clinical trials. Despite the lack of supporting evidence, balloon
sinus dilation appears to be widely diffused in the USA and, potentially, Australia.
2014 HealthPACT assessment
Based on the level of evidence and the wide diffusion of balloon sinus dilation it is
recommended that the technology be archived.
2014 Number of studies included
All evidence included for assessment in this Technology Brief has been assessed
according to the revised NHMRC levels of evidence. A document summarising these
levels may be accessed via the HealthPACT web site.
Total number of studies: 3
Total number of systematic reviews: 1 (level II to IV evidence)
Total number of Level II studies: 2
2014 References
1.
BlueCross BlueShield Association (2013). Balloon Sinus Ostial Dilation for
Treatment of Chronic Rhinosinusitis, BlueCross BlueShield Association,, Chicargo
http://www.bcbs.com/blueresources/tec/vols/27/balloon-sinus-ostialdilation.html.
2.
Achar, P., Duvvi, S.&Kumar, B. N. (2012). 'Endoscopic dilatation sinus surgery
(FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of
chronic rhinosinusitis: a pilot study'. Acta Otorhinolaryngol Ital, 32 (5), 314-9.
3.
Cutler, J., Bikhazi, N. et al (2013). 'Standalone balloon dilation versus sinus
surgery for chronic rhinosinusitis: a prospective, multicenter, randomized,
controlled trial'. Am J Rhinol Allergy, 27 (5), 416-22.
4.
Plaza, G., Eisenberg, G. et al (2011). 'Balloon dilation of the frontal recess: a
randomized clinical trial'. Ann Otol Rhinol Laryngol, 120 (8), 511-8.
5.
Ramadan, H. H.&Terrell, A. M. (2010). 'Balloon catheter sinuplasty and
adenoidectomy in children with chronic rhinosinusitis'. Ann Otol Rhinol Laryngol,
119 (9), 578-82.
6.
Friedman, M., Schalch, P. et al (2008). 'Functional endoscopic dilatation of the
sinuses: patient satisfaction, postoperative pain, and cost'. Am J Rhinol, 22 (2),
204-9.
7.
Thottam, P. J., Haupert, M. 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 (9), 1355-60.
8.
Levine, H. L., Sertich, A. P., 2nd et al (2008). 'Multicenter registry of balloon
catheter sinusotomy outcomes for 1,036 patients'. Ann Otol Rhinol Laryngol,
117 (4), 263-70.
9
9.
Karanfilov, B., Silvers, S. et al (2013). 'Office-based balloon sinus dilation: a
prospective, multicenter study of 203 patients'. Int Forum Allergy Rhinol, 3 (5),
404-11.
10.
Bolger, W. E., Brown, C. L. et al (2007). 'Safety and outcomes of balloon catheter
sinusotomy: a multicenter 24-week analysis in 115 patients'. Otolaryngol Head
Neck Surg, 137 (1), 10-20.
11.
Kuhn, F. A., Church, C. A. et al (2008). 'Balloon catheter sinusotomy: one-year
follow-up--outcomes and role in functional endoscopic sinus surgery'.
Otolaryngol Head Neck Surg, 139 (3 Suppl 3), S27-37.
12.
Weiss, R. L., Church, C. A. et al (2008). 'Long-term outcome analysis of balloon
catheter sinusotomy: two-year follow-up'. Otolaryngol Head Neck Surg, 139 (3
Suppl 3), S38-46.
13.
Cutler, J., Truitt, T. et al (2011). 'First clinic experience: patient selection and
outcomes for ostial dilation for chronic rhinosinusitis'. Int Forum Allergy Rhinol,
1 (6), 460-5.
14.
Stankiewicz, J., Truitt, T. et al (2012). 'Two-year results: transantral balloon
dilation of the ethmoid infundibulum'. Int Forum Allergy Rhinol, 2 (3), 199-206.
15.
Ramadan, H. H., McLaughlin, K. et al (2010). 'Balloon catheter sinuplasty in
young children'. Am J Rhinol Allergy, 24 (1), e54-6.
16.
Kutluhan, A., Bozdemir, K. et al (2009). 'Endoscopic balloon dilation sinuplasty
including ethmoidal air cells in chronic rhinosinusitis'. Ann Otol Rhinol Laryngol,
118 (12), 881-6.
17.
Tomazic, P. V., Stammberger, H. et al (2013). 'Feasibility of balloon sinuplasty in
patients with chronic rhinosinusitis: the Graz experience'. Rhinology, 51 (2), 1207.
10
TECHNOLOGY BRIEF 2012
REGISTER ID
NAME OF TECHNOLOGY
PURPOSE AND TARGET GROUP
WP060
BALLOON SINUPLASTY
TO DILATE OBSTRUCTED SINUS OPENINGS IN A MINIMALLY
INVASIVE MANNER IN PATIENTS WITH CHRONIC
RHINOSINUSITIS
STAGE OF DEVELOPMENT IN AUSTRALIA

Yet to emerge

Experimental





Investigational
Nearly established
Established
Established but changed indication
or modification of technique
Should be taken out of use
AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION APPROVAL

Yes

No

Not applicable
ARTG number: 168057, 178372 and
181941
INTERNATIONAL UTILISATION
COUNTRY
LEVEL OF USE
Trials underway
or completed
Limited use
Widely diffused
United States


Canada

Australia and New Zealand

Europe (Austria, Denmark,
Finland, Germany, Greece,
Ireland, Italy, Poland, Spain, UK)
‐‐
Presumed in use but rate of diffusion unknown
Central / S. America (Brazil,
Chile, Mexico, Venezuela)
‐‐
Asia (Brunei, India, Malaysia,
Singapore, Thailand, Turkey)

Middle East (Israel, Saudi
Arabia, United Arab Emirates)
‐‐

2012 IMPACT SUMMARY
Chronic rhinosinusitis (CRS) is estimated to affect about 9 per cent of the Australian
population. Several manufacturers provide balloon sinuplasty (BSP) systems (e.g. Relieva™
by Acclarent; FinESS™ by Entellus Medical Inc) for the minimally invasive treatment of CRS
16
that is unresponsive to medical management. The technology would be made available
through otolaryngology surgeons for adults and possibly children (≥ 2 years) with CRS.
The current surgical approach to unresponsive CRS is functional endoscopic sinus surgery
(FESS), a procedure that involves endoscopic removal of tissue and bone to dilate narrowed
sinus passageways. This procedure can be complex and time‐ consuming. Four relatively
small low‐quality studies assessed the safety and efficacy of BSP devices, reporting results
that are at least as favourable as those achieved with FESS.
BSP devices have been approved for marketing in many countries including Australia. It
appears that uptake of the device has been broad, particularly in the United States (USA)
where >100,000 patients have been treated; worldwide, >5600 physicians have been trained
by the manufacturers of BSP systems and training in Australia is slated for April 2012.
2012 BACKGROUND
CRS is the inflammation of the lining of one or more of the sinuses, which occurs due to
nasal mucus membrane swelling, excessive mucus production or an anatomical abnormality,
blocking the drainage of the sinuses. The obstruction can lead to bacterial infection and
further inflammation. Symptoms include pressure‐like pain on the forehead, temples,
cheeks, nose, or around the eyes; difficulty breathing through the nose; abnormal nasal
drainage; and reduced sense of smell or taste. By definition, CRS lasts for more than 2‐3
months and recurrent sinusitis involves ≥ 3 episodes a year (AIHW 2010).
In most patients diagnosed with CRS, symptoms are successfully managed with
decongestants, analgesics, antibiotics, topical steroids or nasal/sinus irrigation. However, for
those patients who do not respond to medical management, surgical treatment may be
required. FESS is currently the standard surgical treatment for CRS. This procedure aims to
open the sinus ostia in order to return mucosa to their normal state and improve aeration
and drainage; however, long‐term, surgical procedures may be ineffective, due to the
development of adhesions and scarring around the ostium of the sinus.
The BSP system was introduced in 2005 as a minimally invasive tool to treat CRS. The system
follows the principles of over‐the‐wire, catheter‐based balloon dilatation, such as that used
in interventional cardiology. The balloon is advanced under fluoroscopic guidance to a
narrowed segment in a sinus opening and then inflated under high pressure, dilating the
passageway by creating microfractures and moulding the bone (Friedman et al 2008; Levine
& Rabago 2011). Unlike the traditional surgical approach, tissue and bone are not removed.
The National Institute of Health and Clinical Excellence (NICE) in the United Kingdom (UK)
suggests that BSP may be offered as a routine treatment option for patients with chronic
sinusitis, provided that doctors are certain that (i) the patient understands what is involved
and agrees to the treatment, and (ii) the results of the procedure are monitored (NICE
2008).
17
Studies have assessed the safety and utility of BSP alone, in combination with FESS, and in
combination with adenoidectomy in children. Common outcome measures used to assess
patients suffering from CRS include:
Sino‐Nasal Outcome Test (SNOT‐20) scores: symptom severity over the previous 2
weeks in 20 categories is measured using a 1 to 6 scale (0=no problem, 6=bad as it
can be); pre‐ and post‐operative scores are compared (Weiss et al 2008).
Degree of sinus opacity on computed tomography (CT) using the Lund‐McKay score:
measures the degree of opacification of a sinus: 0=none, 1=partial, 2=total; 6 sinuses
are scored on each side for a possible maximum score of 24 (Lund & Kennedy 1995).
2012 CLINICAL NEED AND BURDEN OF DISEASE
About 1.8 million Australians (9.2%) reported having CRS in 2004/05, 1 making it one of the
most frequently reported health conditions. Prevalence was higher among females (10.9%)
than males (7.5%). The peak age in females was 70‐74 years versus peaks in males at 55‐59
and 75‐79 (Figure 1).
Figure 1
Prevalence of CRS in Australia 2004/05 by age and sex (AIHW 2010)
It is currently unclear what proportions of CRS patients in Australia would be eligible for BSP
procedures; however, the published literature suggests that approximately 20 per cent of
patients suffering from CRS are refractory to medical treatment and may require surgery
(Cummings et al 2009).
The disorder is associated with genetic susceptibility and infectious diseases as risk factors,
and smoking, air pollution, and occupational exposure are trigger factors. Associations with
asthma and hay fever are common; about 300,000 people in Australia had all three
conditions. In addition to local sinonasal symptoms, CRS also has a significant negative
1
Similar data for New Zealand were not located.
18
impact on the energy levels, mood and physical and social functioning of sufferers. However,
deaths are very rare – fewer than 10 annually (AIHW
2010).
In Australia, acute and chronic sinusitis is the primary reason for 1.3 per cent of general
practitioner (GP) consultations, accounting for 1.5 million GP visits each year (Britt et al
2010). Australian Institute of Health and Welfare (AIHW) health services data for CRS and
2
hayfever 2 in 2006/07 (AIHW 2010):
Principal diagnosis for 11,117 hospitalisations; average length of stay 1.3 days
Hospital separation rates increase with age until 60–64 years, and then fall
progressively
Related surgical cases:
o Intranasal maxillary antrostomy (7,535 cases): surgical creation of a hole between
the nasal passages and the maxillary sinuses to ease mucous drainage.
o Sinoscopy (6,003 cases): examination of the sinuses via magnifying lenses.
o Ethmoidectomy (5,558 cases): surgical enlargement of holes between ethmoid
cavities, polyp removal, and mucous drainage.
o Septoplasty (3,308 cases): straightening of the nasal septum.
2012 DIFFUSION OF TECHNOLOGY
Australia
Three BSP technologies are listed on the Australian Register of Therapeutic Goods
(ARTG, 2011):
168057: Acclarent Inc (USA); sponsored by Johnson & Johnson Medical Pty Ltd,
NSW, Australia. Effective date January 15, 2010.
178372: Karl Storz GmbH & Co KG (Germany); sponsored by Karl Storz
Endoscopy Australia Pty Ltd, NSW, Australia. Effective date December 15, 2010.
181941: Joline GmbH & Co (Germany); sponsored by Endocorp Pty Ltd, NSW,
Australia. Effective date April 7, 2011.
According to a press release from the Department of Human Services in Victoria, the first
pilot project in the world on this technology was completed in 10 patients at The Alfred
Hospital in Melbourne by Dr. Christopher Brown, and a larger trial including six USA sites
was planned (DHS 2006). 3
2
Utilisation data for hayfever and chronic sinusitis are combined (AIHW 2010).
3
The planned multicentre trial is likely Bolger et al (2007), an early publication on the safety and efficacy of
BSP with authors from nine USA sites plus Dr. Brown from Melbourne
19
It was not readily apparent how widely diffused BSP is in Australia, but the website of device
manufacturer Acclarent lists physicians trained in the use of the technology; seven are listed
in Australia covering New South Wales (1), Queensland (2), South Australia (1), and Victoria
(3), and four in New Zealand (Acclarent 2011).
The 2012 Scientific Meeting of the Australian Society of Otolaryngology Head & Neck
Surgery (ASOHNS) in late March in Adelaide will cover the topic of balloons in
otolaryngology, including a full day post‐meeting satellite workshop (April 4) titled ‘Balloon
dilatation technology and its application in ENT: sinuses, airway and oesophagus’; the
workshop includes hands‐on experience with BSP using cadavers (ASOHNS 2011).
USA
The Food & Drug Administration (FDA) approved the Relieva™ Sinus Balloon Dilation
Catheter as a Class I device on April 5, 2005. The approved indication was to ‘dilate the sinus
ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic
procedures’ (US FDA 2005). Since then, variations of this catheter have also been approved,
for example the Relieva Acella™ catheter (US FDA 2008a).
Other manufacturers produce similar technologies, for example the FinESS which is
marketed by Entellus Medical (Maple Grove, Minnesota) for treatment of the ethmoid
infundibulum and maxillary ostium (US FDA 2008b). The latter is a ‘minimally invasive option
for treating patients in an office setting [using local anaesthesia]’ (Entellus Medical 2011).
Two professional organisations in the USA have issued position statements on BSP, the
American Academy of Otolaryngologists – Head & Neck Surgeons (AAO‐HNS) and the
American Rhinologic Society (ARS):
AAO‐HNS: ‘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 (e.g. microdebrider, forceps). The final
decision regarding use of techniques or instrumentation for sinus surgery is
the responsibility of the attending surgeon.’ (AAO‐HNS 2010) (Note that there
are no references supporting this statement.)
ARS: The position statement briefly reviews three studies from 2006 (one is on
cadavers and one is very small), sets out the organisation’s position, and also
endorses the position statement of the AAO‐HNS (ARS 2011):
o Based on currently available scientific medical evidence, endoscopic
balloon dilation technology is acceptable and safe for use in the
management of sinus disease.
20
o Endoscopic balloon dilation technology is a tool, not a procedure,
available to the operating surgeon at his/her discretion for the surgical
management of sinus disease.
o Patients who are treated with this technology may require concurrent
conventional endoscopic sinus surgery especially in the ethmoid sinuses
much like any surgical instrument that may be used in some parts of the
sinus and not others or in combination with other technologies.
o In a group of selected patients, the use of balloon catheter dilation
technology alone may eliminate the need for other surgical techniques.
o Endoscopic balloon catheter dilation as a tool for dilating the opening of
the maxillary sphenoid, and frontal sinuses is not investigational or
experimental and should not be viewed as such.
Europe & beyond:
CE Mark clearance in Europe was granted in February 2006 and international sales
commenced a year later. According to marketing materials, BSP devices are marketed and
sold in more than 30 international markets (EDGAR Online 2008) and 5,600 physicians have
been trained in their use as of 2010 (Acclarent 2010). Acclarent provides training for
physicians and includes physician names on their website (Acclarent 2011). The list of 26
countries (outside the USA) with links to physician contact information covers: Europe (10
countries), Americas (5), Asia (6) and the Middle East (3), in addition to physicians in
Australia and New Zealand.
COMPARATORS
The current reference standard for the surgical treatment of CRS that is non‐responsive to
medical management is FESS, which was introduced in the USA in 1985. FESS is constantly
evolving (e.g. through‐cutting forceps, powered instrumentation, and image guidance), and
is associated with success rates of between 75 and 95 per cent (Bolger et al 2007; Levine et
al 2008; Stankiewicz et al 2008).
In the USA, FESS is the leading driver of litigation among otolaryngology procedures with a
mean settlement of about US $750,000. Incidence of major adverse events (AEs) is low but
includes death, cerebrospinal fluid leak, blindness and major bleeding in about one per cent
of cases; minor AEs such as minor bleeding, infection, periorbital swelling and bruising occur
in more than five per cent of cases (Levine et al 2008).
2012 SAFETY AND EFFECTIVENESS ISSUES
Study description
A total of four studies assessing the safety and efficacy of BSP for chronic rhinosinusitis were
included in this brief, three in adults and one in children (Table 1). Two studies involved
21
comparisons between study arms where patients were given a choice between procedures,
and blinding was not employed (Freidman et al and Ramadan et al, level III‐2 intervention
evidence). The two other studies were case series of patients receiving BSP (level IV
intervention evidence).
Table 1
Authors
(Year);
Location
Overview of included studies
Study Type & Level
of Evidence (See
Appendix)
Study Arms
Patient
Enrollment (#
Sinuses)
Outcomes Assessed
Length of
Follow-Up
One arm: Patients received
BSP using the Relieva
System
n=115 adults
(307 sinuses)
at 6 months; 65
adults (195
sinuses) at 24
months
Sinus ostium patency
assessed by endoscopy
(6 months) or CT (2
years)
SNOT-20 scores
Rate of revision surgery
6 months
(Bolger et
al 2007) &
24
months
(Weiss et
al 2008)
Retrospective
review of
prospectively
collected data; two
parallel groups;
level III-2 evidence
Two arms: Patients given the
choice of BSP Relieva
System or FESS
n=70 adults; 35
in each group
(208 sinuses)
SNOT-20 scores
Patient satisfaction
Narcotic use
Cost
Minimum
3 months
Stankiewicz
et al (2009);
USA (3 sites)
‘BREATHE I’
study
Prospective, multicentre case series;
level IV evidence
One arm: Patients received
BSP using the FinESS
System
n=30 adults (58
sinuses)
Sinus ostium patency
via CT scanning
SNOT-20 scores
6 months
Ramadan &
Terrell
(2010); USA
Prospective,
controlled, nonrandomised; two
parallel groups;
level III-2 evidence
Two arms: Patients referred
for adenoidectomy & offered
BSP ± adenoidectomy if
required, as an alternative
n= 49 children
ages 2-11
years; 30 BSP±
adenoidectomy
if required, 19
adenoidectomy
alone
SN-5 scores
Rate of revision surgery
12 ± 2
months
Bolger et al
(2007) &
Weiss et al
(2008);
multiple sites
in the USA *
Prospective, multicentre case series;
level IV evidence
Freidman et
al (2008);
USA
(Chicago)
BSP: balloon sinuplasty; CT: computed tomography; FESS: functional endoscopic sinus surgery; SNOT: Sino-Nasal Outcome Test
* An Australian site (Melbourne) appears to have been included in the first publication but not the second
For the four included studies, further (selected) study detail, including inclusion and
exclusion criteria and the medical/surgical treatment methods used are outlined in Table 2.
All studies enrolled patients with CRS who had failed medical management. Generally, more
‘complex’ patients, such as those with severe disease, a Lund‐McKay score >12, or
significant nasal polyposis, were excluded. One study excluded patients with previous sinus
surgery (Ramadan et al 2010); however, three studies included patients who were
undergoing revision surgery (Friedman et al 2008; Stankiewicz et al 2009; Weiss et al 2008).
22
Table 2
Authors
(year)
Inclusion and exclusion criteria and surgical methods used in the included studies
Study Type
Bolger et al
(2007) &
Weiss et al
(2008)
Prospective,
multi-centre
case series
Freidman et
al (2008)
Retrospectiv
e review of
prospectively
collected
data; two
parallel
groups
Stankiewicz
et al (2009);
‘BREATHE I’
study
Ramadan &
Terrell
(2010)
Prospective,
multi-centre
case series
Prospective,
controlled,
nonrandomised;
parallel
groups
Selected Inclusion & Exclusion Criteria
Included: Consecutive adults with CRS, no
response to medical Rx, slated for FESS,
April–Dec 2005
Excluded: Extensive nasal polyposis,
extensive previous sinus surgery or
osteoneogenesis, CF, tumour, facial trauma,
ciliary dysfunction, pregnancy
Included: Adults with CRS, lack of response
to medical Rx & who had BSP or FESS
between Dec 2005 & May 2006
Excluded: Severe disease, Lund-McKay
score >12, significant nasal polyposis, sinus
osteoneogenesis, systemic disease, Rx with
BSP & FESS combined
Included: Adults with a Dx of CRS in
maxillary ± anterior ethmoid sinuses &
abnormal sinus CT after medical Rx from
Sept 2007 to March 2008
Excluded: CRS posterior ethmoid, frontal or
sphenoid / evidence of fungal sinusitis
Included: Children ages 2-12 with CRS
(medical Rx 3-6 months) deemed to be
surgical candidates between Feb 2006 and
May 2008
Excluded: Positive cilia biopsy, extensive
previous sinus surgery or osteoneogenesis,
CF, tumour or other obstruction, facial
trauma
Selected Details about Medical and Surgical
Treatment of Patients
Patients were prepared for surgery and
treated post-op as for FESS
All patients booked for FESS were offered
BSP and all accepted
Relieva System Rx under local anaesthesia
alone (9%), local with sedation, (23%) or
general anaesthesia (69%) OR FESS Rx
under general anaesthesia (100%)
All surgery was performed by one surgeon
1-3 weeks of antibiotic Rx pre-surgery
FinESS Rx of sinuses under local (73%) or
general (27%) anaesthesia
All surgery was performed by one surgeon
After pre-op evaluation, patients were
offered BSP at the time of adenoidectomy:
o 17 (35%) had BSP + adenoidectomy
o 13 (26%) had only BSP (previous
adenoidectomy or little tissue present)
o 19 (39%) had only adenoidectomy
All had general anaesthesia
BSP: balloon sinuplasty; CF: cystic fibrosis; CRS: chronic rhinosinusitis; CT: computed tomography; Dx: diagnosis; FESS: functional endoscopic sinus
surgery; Rx: treatment; SNOT: Sino-Nasal Outcome Test
Safety
Three of the four included studies reported safety outcomes (Bolger et al 2007 updated in
Weiss et al 2008, Stankiewicz et al 2009 and Freidman et al 2008) (Table 3). Where the rate
of AEs following BSP and FESS were compared, no significant differences were observed.
Table 3
Adverse events reported in included studies
Authors (year)
Adverse Events reported
Bolger et al (2007)
Weiss et al (2008)
No serious AEs; Bolger et al reported that 9 patients had sinus infections in first 6 months
Freidman et al (2008)
Stankiewicz et al (2009)
Ramadan & Terrell (2010)
Turbinate lateralisation or scarring: BSP 8 versus FESS 3; p=0.19
Sinus infections (1-4) in follow-up period: BSP 6 versus FESS 9; p=0.65
Post-op bleeding: None=83%, resolved w/in 6 hours=13%, up to 48 hours=4%
Device-related AEs: Severe=0, mild=3 (tooth numbness, 2; facial numbness, 1)
Not reported
BSP: balloon sinuplasty; FESS: functional endoscopic sinus surgery; w/in: within
23
Efficacy
The key efficacy outcomes reported in the four included studies are summarised in Table 4.
Bolger et al (2007) & Weiss et al (2008): From one report to the next, study sites dropped
from nine (including Melbourne) to six and patient numbers dropped from 115 to 65.
Longer‐term (24‐month) data showed improvement in symptoms for 85 per cent of
patients (15% unchanged) and a clinically significant decrease in SNOT‐20 scores and
sinus opacity as assessed on CT. Revision surgery was required in four per cent of sinuses
in 9 per cent of patients.
Freidman et al (2008): Revision surgery was performed in 36 per cent of patients and
local anaesthesia was employed for 31 per cent of those with BSP (0% for FESS).
Changes in SNOT‐20 scores showed that patients in both groups had clinically
meaningful clinical responses. Patient satisfaction was higher and post‐operative
narcotic use lower for those in the BSP group. The one patient requiring revision
surgery was in the BSP group.
Stankiewicz et al (2009): All patients but one were able to undergo the procedure with
local anaesthetic, with (76%) or without (24%) intravenous sedation. The procedural
completion rate was 95 per cent, CT‐assessed sinus ostial patency at 3‐months was 96
per cent, and overall SNOT‐20 scores dropped significantly as assessed 1 week post‐
operatively (from 2.9 to 0.8; p<0.0001) with the favourable score sustained at 3 and 6
months. Recovery time (discharge to normal activities) was rapid (47% in 24 hours,
another 43% in 48 hours) and the mean duration of post‐operative analgesia was short
(1.4 ± 1.3 days; range, 0‐6).
Ramadan & Terrell (2010): All children had general anaesthesia. Guardians completed
SN‐5 questionnaires to assess health‐related quality of life. Results were superior for
BSP (± adenoidectomy) versus adenoidectomy alone: 80 versus 53 per cent
improvement in symptoms. Two children in the BSP group required FESS revision
surgery, whereas three children in the adenoidectomy alone group required BSP
treatment. Multivariate logistic regression showed no effect on surgical success due to
age, gender, pre‐operative CT score, prior adenoidectomy, asthma or allergies.
24
Table 4
Authors (Year)
Bolger et al
(2007) & Weiss
et al (2008) –
only Weiss 24month data are
presented here
Efficacy outcomes reported in included studies
n=# Sinuses;
F/u Period
Sinus Patency
n=195
sinuses; 24
month f/u
Of the 65
patients, 34
had BSP only;
31 had
‘hybrid’ = BSP
+ FESS
n=208
sinuses;
minimum 3
month f/u
Assessed on
CT via LundMcKay scores
Significant
improvement
over baseline in
both groups
(mean 2.7 vs
9.7; p<0.001)
--
Stankiewicz et
al (2009)
n=58 sinuses;
6 month f/u
CT patency at 3
months: 96%
Ramadan &
Terrell (2010)
n=57 sinuses;
12 month f/u
--
Freidman et al
(2008)
SNOT-20 Scores *
(SN-5 for children) **
Rate of Revision
Surgery
BSP & hybrid:
Significant
improvement over
baseline in both groups
(0.9 vs 2.1; p<0.001)
Overall required in
4% of sinuses in
9% of patients
Improvement in
symptoms: 85%
better,15% same, 0%
worse
BSP & FESS:
Significant
improvement over
baseline (p<0.0001)
Score change clinically
significant for both
groups: BSP 1.99 ±
0.66 versus FESS 1.41
± 0.98
Mean change in scores
at 6 months = 2.1 (from
2.9 ± 1.0 pre-op to 0.8
± 0.8; p<0.0001)
1 patient in the
BSP group; 0 in
the FESS group
(but short f/u
period)
Patient satisfaction:
Overall experience***:
BSP +3.71 ± 1.20 vs
FESS +2.94 ± 1.39;
p=0.016
Mean # days narcotic
use post-op: BSP 0.80 ±
0.72 vs FESS 1.34 ±
0.99; p=0.011
Recovery time
(discharge to normal
activities): 47% w/in 24
hours, 43% w/in 24-48
hours
Mean duration of post-op
analgesia: 1.4 ± 1.3
(range, 0-6) days
--
Significant change in
SN-5 scores from preto post-op (mean score
of 4.1 dropped to 2.9;
p<0.0001)
BSP: 4.2  3.0;
p<0.0001
Adenoidectomy
alone: 3.8  2.9;
p<0.01
--
BSP alone =
2/13 (15%)
Adenoidectomy
alone = 3/19
(15%)
BSP +
adenoidectomy
= 4/17 (24%)
Other
BSP: balloon sinuplasty; FESS: functional endoscopic sinus surgery; f/u: follow-up; Rx: treatment; w/in: within
* Difference between pre- and post-op scores calculated; change > 0.8 is considered clinically significant
** SN-5 score measures health-related quality of life in children with persistent sinonasal symptoms; a decrease ≥0.5 is considered clinically significant
(Ramadan & Terrell, 2010).
*** Rated from -5 (worst I could have expected) to +5 (best I could have expected).
Other evidence: registry of study data 2005‐2007
A registry report was also located (Levine et al 2008); this is presumed to include some of
the data from the four studies in the brief. Information from December 2005 to May 2007
was gathered by chart review from 27 centres in the USA employing BSP (n=1036 patients).
Data collection and analysis were funded by Acclarent Inc. Balloon catheters were used in
3,276 sinus procedures with a mean of 3.2 per patient. The revision rate was 1.3 per cent
after a mean follow‐up of 40 weeks. Sinus symptoms improved for 95 per cent of patients,
were unchanged for 4 per cent and were worse for 1 per cent. These results were consistent
across patient categories including BSP‐only and revisions. No major AEs were reported in
this registry study.
25
COST IMPACT
The economic impact of sinusitis in the USA has been evaluated (Ray et al 1999). This study
which was conducted in 1996, estimated the direct and indirect health expenditure due to
sinusitis. The total health expenditure attributed to sinusitis was $5.8 billion, of which $3.4
billion was for the primary diagnosis of acute and chronic sinusitis. These costs were
associated with 26.7 million outpatient visits, the majority of which were for the primary
diagnosis of acute or chronic sinusitis, and the 46.9 million medications ordered at these
visits. Additionally, there were 45,000 hospital discharges and 156,000 hospital days that
were attributed to sinusitis.
The cost of Relieva™ BSP devices (including the balloon catheter and various consumables)
per procedure in Australia, provided by the Sponsor (Johnson & Johnson Medical Pty Ltd), is
$2,104. However, in a field evaluation funded by the Victorian Department of Health and
conducted at the Royal Victorian Eye and Ear Hospital in Melbourne, the cost of BSP devices
per procedure was $1,250.
A US study by Friedman et al (2008) compared the cost of BSP with that of FESS. This
retrospective review examined 2005‐2006 data for patients who received BSP under local
anaesthesia (n=35) versus those who had classic FESS under general anaesthesia (n=35).
Both primary surgeries and revisions (about 20% of cases) were included.
The costs for time and equipment proved to be similar for primary procedures; however, for
revision procedures, costs were lower for BSP. In particular:
Primary: BSP = $14,022 ± $2,200 versus FESS = $13,574 ± $2,795; p=0.56.
Revision: BSP = $10,346 ± $3,324 versus FESS = $16,190 ± $1,653; p<0.0001.
Equipment charges: Higher for BSP, e.g. BSP set ($1,500), C‐arm ($500‐1,000)
versus FESS which sometimes used a microdebrider and blades ($500) and
image‐guided system ($500).
Time charges: Due to use of local anaesthesia, BSP required less operating room
time ($600 per 15 minutes) and post‐anaesthesia recovery time ($300 per 15
minutes).
ETHICAL, CULTURAL OR RELIGIOUS CONSIDERATIONS
No issues were identified from the retrieved material.
26
OTHER ISSUES
Upcoming clinical trials: 4
NCT01319305 (‘BREATHE’): This long‐term (24 month) US study is a case series
(n=70) exploring BSP technology using FinESS™ and is a follow‐up to BREATHE I
(n=30), a feasibility and 6‐month safety assessment of BSP under local
anaesthesia (Stankiewicz et al 2009). Outcomes are SNOT‐20 scores and results
of work productivity assessment questionnaires. According to clinicaltrials.gov
the study is complete but no publications were located.
NCT00939393 (‘ORIOS’): This Acclarent‐sponsored open‐label parallel US study
has a focus on costs, comparing those for use of the Relieva™ System in an office
setting with those in the operating room where the BSP system may or may not be
a component of FESS. Safety and efficacy are secondary outcomes. Estimated
enrollment was 100 adults. The study commenced in April 2008 and was to end in
September 2011.
NCT01107379 (“ORIOS2”): Also Acclarent‐sponsored, this prospective, single‐
arm, multi‐centre, 6‐month, post‐market study in aimed to enrol 100 adult
patients with CRS who were treated with the Relieva™ System under local
anaesthetic in an office setting. The US study was to cease in December 2011 with
final data collection in April 2011. Primary outcomes are changes on CT and SNOT‐
20 scores. Patient tolerability and pain scores are secondary outcomes.
NCT01455948: A 6‐month, randomised, single blind study of FESS using
specialised cannulating probes and small resection forceps versus the Relieva™
System is planned in Toronto, Canada. The study aims to recruit 200 otherwise
healthy working adults (ages 18 to 65) with CRS unresponsive to medical
treatment. Data collection is expected to stop in mid‐2013 and study completion
is scheduled for late 2013. The main outcome measures are economic, i.e. direct
and indirect costs of treatment. Secondary outcomes include health status (EQ‐5D
questionnaire) and symptom relief (SNOT‐20). Conflict of interest of study
authors:
In most of the included studies, one or more authors received compensation from BSP
device manufacturers in the form of remuneration or stock options (Ramadan et al 2010,
Stankiewicz et al 2009, Levine et al 2008, Weiss et al 2008 and Bolger et al 2007). The study
by Freidman et al (2008) was an exception, as it was funded entirely by the first author, and
reported that there were no financial relationships to disclose with the device manufacturer.
4
Information from www.clinicaltrials.gov
27
SUMMARY OF FINDINGS
Based on a few small low‐quality studies, BSP appears to be at least comparable in efficacy
to the conventional, more invasive FESS procedure, while offering several advantages, such
as the ability to deliver care under local anaesthesia, as well as high levels of patient
symptom relief and satisfaction. In addition, BSP is associated with a low rate of AEs.
However, it is a technology that appears to have diffused widely before extensive high‐
quality research has established safety and effectiveness, and it is unclear whether high‐
quality studies (e.g. randomised, blinded, comparative) are now possible. More than
100,000 patients have been treated in the USA since 2005, but it is less clear how widely the
technology has diffused in Australia and New Zealand.
HEALTHPACT ASSESSMENT:
In Australia, at least three BSP devices have received ARTG approval, physicians have been
trained in its use, and a 2012 Australian otolaryngology conference has included this
technology as a topic theme and is devoting a day to hands‐on instruction. In addition, a
number of clinical trials and field evaluations, the results of which will provide valuable
information about the utility of BSP, are currently ongoing. Therefore, due to the wide
diffusion of BSP technology in other countries, and an apparent interest in Australia,
HealthPACT wish to monitor the technology, which will be reviewed in 24 months time.
NUMBER OF STUDIES INCLUDED
All evidence included for assessment in this Technology Brief has been assessed
according to the revised NHMRC levels of evidence. A document summarising these
levels may be accessed via the following link on the HealthPACT web site.
Total number of studies
Total number of Level III‐2 studies
Total number of Level IV studies
4
2
2
REFERENCES
Acclarent (2010). Press release: New study demonstrates safety of Balloon Sinuplasty™
Technology in pediatric patients suffering from chronic sinusitis. Available from:
http://www.acclarent.com/company/newsroom/press‐releases/index.cfm?i=1472. [Accessed
December 30, 2011].
Acclarent (2011). Find a doctor. Available from: http://www.acclarent.com/international‐
physicians. [Accessed December 29, 2011].
American Academy of Otolaryngology — Head and Neck Surgery (AAO‐HNS) (2010). Dilatation
of sinuses, any method (e.g., balloon, etc.) [Internet]. Available from:
http://www.entnet.org/Practice/Balloon‐Dilation.cfm. [Accessed December 30, 2011].
American Rhinologic Society (ARS) (2011). Balloon sinuplasty [Internet]. Available from:
http://www.american‐rhinologic.org/position_balloon_sinuplasty. [Accessed December 30, 2011].
28
Australian Institute for Health & Welfare (AIHW 2010). Asthma, chronic obstructive pulmonary
disease and other respiratory diseases in Australia. Asthma series. Cat. no. ACM 20. Canberra:
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December 31, 2011]
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catheter’ [Internet]. Available from:
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on%20sinus~0~cuDevices?OpenView [Accessed December 29, 2011].
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Bolger, W. E., Brown, C. L. et al (2007). ‘Safety and outcomes of balloon catheter sinusotomy: a
multicenter 24‐week analysis in 115 patients’, Otolaryngol Head Neck Surg, 137(1), 10‐20.
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Series no 27, Australian Institute for Health & Welfare. Canberra: AIHW. Cummings, J. P., Leong, H.
et al (2009). ‘The role of balloon sinuplasty in the treatment of chronic sinusitis’, J Clin Outcomes
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of balloon catheter sinusotomy outcomes for 1,036 patients’. Ann Otol Rhinol Laryngol, 117(4),
263‐70.
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chronic rhinosinusitis’, Postgrad Med, 123(2), 112‐8.
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Group’, Ann Otol Rhinol Laryngol Suppl, 167, 17‐21.
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Ramadan, H.H. & Terrell, A.M. (2010). ‘Balloon catheter sinuplasty and adenoidectomy in
children with chronic rhinosinusitis’, Ann Otol Rhinol Laryngol, 119(9), 578‐82.
Ray, N. F., Baranuik, J. N. et al (1999). ‘Healthcare expenditure for sinusitis in 1996: Contributions
of asthma, ehinitis and other airway disorders’, J Allergy Clin Immunol, 103, 408‐414.
Stankiewicz, J., Tami, T. et al (2009). ‘Transantral, endoscopically guided balloon dilatation of
the ostiomeatal complex for chronic rhinosinusitis under local anesthesia’, Am J Rhinol Allergy
23(3), 321‐7.
United States Food & Drug Administration (US FDA) (2005). 501(k) approval letter for Relieva
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United States Food & Drug Administration (US FDA) (2008a). Acclarent Inc. 501(k) summary for the
Relieva Sinus Balloon Catheter (K043527) and Relieva Acella Sinus Balloon Catheter (K061903)
29
[Internet]. Available from:
http://google2.fda.gov/search?q=cache:oIaD3K6ItoQJ:www.accessdata.fda.gov/cdrh_docs/pdf7/
K073041.pdf+relieva&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_n
o_dtd&ie=UTF‐8&access=p&oe=ISO‐8859‐1 [Accessed December 29, 2011].
United States Food & Drug Administration (US FDA) (2008b). 501(k) approval letter for Entellus
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Weiss, R.L., Church, C.A. et al (2008). ‘Long‐term outcome analysis of balloon catheter
sinusotomy: two‐year follow‐up. Otolaryngol Head Neck Surg, 139(3 Suppl 3), S38‐46.
SEARCH CRITERIA TO BE USED
Balloon catheter OR Sinuplasty OR Sinusotomy; Chronic rhinosinusitis OR Rhinosinusitis
OR sinusitis
30

Health Policy Advisory Committee on Technology Technology Brief Update

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