Article

American Journal of Rhinology & Allergy

0(0) 1–9
Medical Therapy Versus Balloon Sinus ! The Author(s) 2018
Reprints and permissions:
Dilation in Adults With Chronic sagepub.com/journalsPermissions.nav
DOI: 10.1177/1945892418773623
Rhinosinusitis (MERLOT): 12-Month journals.sagepub.com/home/ajr

Follow-up

J. Pablo Stolovitzky, MD1, Neelesh Mehendale, MD2,

Keith E. Matheny, MD3, William J. Brown, MD4,
Anthony A. Rieder, MD5, Douglas R. Liepert, MD6,
Ewen Tseng, MD3, and Andrew Gould, MD7

Abstract
Background: Chronic rhinosinusitis (CRS) is a devastating disease affecting nearly 30 million people in the United States.
An interim analysis of data from the present study suggested that, in patients who had previously failed medical therapy,
balloon sinus dilation (BSD) plus medical management (MM) provides a significant improvement in the quality of life (QOL) at
24 weeks postprocedure compared to MM alone.
Objective: The primary objective of this final analysis was to evaluate the durability of treatment effects through the
52-week follow-up.
Methods: Adults aged 19 and older with CRS who had failed MM elected either BSD plus MM or continued MM. Patients
were evaluated at 2 (BSD arm only), 12, 24, and 52 weeks posttreatment. Balloon dilations were performed either as an
office-based procedure under local anesthesia or in the operating room per physicians’ and patients’ discretion. The primary
end point was change in patient-reported QOL as measured by Chronic Sinusitis Survey (CSS) total score from baseline to
the 24-week follow-up. Secondary outcomes including changes in CSS, Rhinosinusitis Disability Index (RSDI), and Sino-Nasal
Outcome Test (SNOT) total and subscores, sinus medication usage, missed days of work/school, number of medical care
visits, and sinus infections from baseline to the 52-week follow-up are reported here within.
Results: BSD led to sustained greater improvements in self-reported QOL using the CSS and RSDI total scores with a trend
toward improvement in the SNOT-20 total score from baseline to the 52-week follow-up compared to continued MM.
There were no changes in medication usage apart from nasal steroid usage for which the MM cohort had an increase in
usage. There were no device-related serious adverse events.
Conclusion: The current analysis highlights the safety, effectiveness, and durability of BSD in CRS patients aged 19 and older
who had previously failed MM.

Keywords
rhinosinusitis, local anesthesia, office-based procedures, quality of life, balloon dilation, sinuplasty, medical management,
Chronic Sinusitis Survey
1
Department of Otolaryngology, Emory University School of Medicine,
Atlanta, Georgia
2
ENT Associates of TX, McKinney, Texas
3
Collin County ENT, Frisco, Texas
4
South FL ENT Associates, Miami, Florida
5
Introduction Alliance ENT and Hearing Center, Wauwatosa, Wisconsin
6
Allied Physicians of Michiana—Otolaryngology Associates, South
Chronic rhinosinusitis (CRS) is a disease affecting more Bend, Indiana
7
than 29 million people in the United States.1 Two pri- Advanced ENT and Allergy, Louisville, Kentucky
mary treatment options for CRS are medical therapy Corresponding Author:
Pablo Stolovitzky, Department of Otolaryngology, Emory University School
and surgical treatment. Medical management (MM)
of Medicine, 5673 Peachtree Dunwoody Road, Suite 150, Atlanta, GA
has proven to be a largely ineffective treatment option 30342, USA.
for a subset of patients with CRS2; yet, only 1.7% Email: stol@entofga.com
2 American Journal of Rhinology & Allergy 0(0)
undergo sinus surgery.3 While many studies have shown
symptom and quality of life (QOL) improvement fol-
lowing balloon sinus dilation (BSD), there is a scarcity
of data available evaluating the comparative effective-
ness of endoscopic sinus surgery (ESS) using BSD
versus continued MM. The current postmarket, pro-
spective, multicenter, nonrandomized, observational,
comparative study compares the health outcomes for
CRS patients aged 19 and older between ESS using
BSD versus continued MM. The results from this
study are intended to aid patient and physician evalu-
ation of treatment options for CRS patients who have
failed MM.4,5 A planned interim analysis, conducted
after 125 patients had completed the 24-week follow-
up demonstrated that patients who selected BSD expe-
rienced a significantly greater improvement in Chronic
Sinusitis Survey (CSS) score from baseline as com-
pared to those patients who elected continued MM
(P < .001).6 The primary objective of this final analysis
was to evaluate the durability of treatment effects
through the 52-week follow-up.
Methods
The details of the current study (NCT01685229) includ-
ing inclusion/exclusion criteria, treatment arms, baseline
assessments, outcomes, sample size calculations, and sta-
tistical analysis have been previously reported.6 Briefly,
adults aged 19 and older with CRS who had failed MM
and who had elected ESS using BSD or continued med-
ical therapy were enrolled in this study. In addition to
the CRS diagnosis as per American Academy of
Otolaryngology-Head and Neck Surgery (AAO-HNS)
guidelines and medical therapy failure criteria, all
patients were required to have a baseline mean 20-item
Sino-Nasal Outcome Test (SNOT-20) score of greater
than 0.6. This cutoff was based on data from Piccirillo
et al. that reported a population of 10 subjects without
sinusitis symptoms had a mean SNOT-20 score of 0.6.
Therefore, this protocol required a minimum score of
>0.6 for inclusion in the study in order to minimize
potential enrollment of subjects with minimal or no
symptoms.7 The Piccirillo study also described a mean
SNOT-20 change of
0.8 for those subjects who
reported an improvement in symptoms at 6 months
after treatment. Therefore, subjects with scores 0.6
are also unlikely to have an opportunity to experience
a clinically significant improvement. Treatment arm
assignment was by patient choice. The investigator
treated the subject for any surgically indicated nasal or
sinus procedures outside of the BSD procedure.
Other treatments may include but are not limited
to septoplasty, ethmoidectomy, turbinectomy or turbi-
nate reduction, uncinectomy, resection of concha
bullosa, polypectomy, or sinus irrigation. Procedures
involving the throat and known to have profound
impact on patient comfort and recovery such as uvulo-
palatopharyngoplasty were not included. BSD was con-
ducted in the operating room (OR) or office setting (IO)
per physicians’ and patients’ discretion. Patients were
evaluated at 2 (BSD arm only), 12, 24, and 52 weeks
posttreatment. MM patients could cross over to receive
a BSD procedure after the 12-week follow-up visit. After
a crossover procedure, follow-up occurred at 2, 12, and
24 weeks postprocedure. The primary end point, change
in patient-reported QOL as measured by total CSS
score8 from baseline to 24 weeks, has been previously
reported.6 This particular end point was selected as
CSS has been shown to be highly sensitive to change
following sinus surgery with a high test/retest reliabili-
ty.8,9 Here, we report secondary outcomes including
changes in CSS, Rhinosinusitis Disability Index
(RSDI),10 and SNOT-20 total and subscores,7 sinus
medication usage, missed days of work/school, number
of unscheduled medical care visits, and sinus infections
from baseline to the 52-week follow-up. Safety was
tracked by the collection of all reported medication-,
procedure-, or device-related adverse events. Informed
consent was obtained from patients prior to study
enrollment in compliance with the principles of the
International Conference on Harmonization and Good
Clinical Practice per the Declaration of Helsinki. The
study was reviewed and approved by all applicable insti-
tutional review boards (IRB) with Aspire IRB serving as
the central IRB.
Results
Baseline Demographics and Characteristics
A total of 198 patients were enrolled in the study of
whom 146 elected ESS with BSD (n ¼ 41 OR; n ¼ 105
IO) and 52 elected continued MM (see Figure 1 for par-
ticipant flow). While baseline medical history, QOL, and
medication usage are similar to those previously
reported at the 24-week interim analysis,6 an updated
summary is provided in Tables 1 and 2, respectively.
Baseline characteristics were similar between groups
with the following exceptions: (1) RSDI total baseline
score was higher in the BSD group (47.9  25.3 vs
39.5  19.9; P ¼ .032), (2) oral antibiotic usage was
higher in the BSD group (28.1  15.4 vs 22.8  6.1 days
in the prior 90 days; P ¼ .018), (3) allergic rhinitis was
more common in the MM group (90.4% vs 68.5%;
P ¼ .003), and (4) the BSD group had more sinus-
related medical visits (2.0  2.1 vs 1.2  1.6; P ¼ .013).
These differences in the baseline population have been
reasonably controlled for in the analyses using
Stolovitzky et al. 3

4 SNOT-20
2 Not BSD candidate
5 Medical therapy or CT
223 Signed Inclusion/ 2 insurance didn’t cover
Screen Fail
Informed Consent Exclusion Criteria 1 withdrew consent
2 Other

Treatment Arm 1 Screen Failure

Not Done
Selection

52 Medical Management
154 BSD Selected
Selected

Enrolled
4 withdrew consent
8 Screen Failure Not 146 BSD 52 Medical 6 LTFU
Done Procedure Management 5 crossed-over

Enrolled

2 withdrew consent 146 completed

4 LTFU 2-week visit
2 missed visit

6 missed visit

2 withdrew consent
4 LTFU 2 LTFU
134 completed 35 completed
1 death 2 crossed-over
12-week visit 12-week visit

4 missed visit 1 missed visit

1 CSS missing 1 Q

4 withdrew consent 1 LTFU

129 completed 32 completed
7 LTFU 5 crossed-over
24-week visit 24-week visit

1 CSS missing 1 Q 3 missing CSS

122 completed 27 completed

52-week visit 52-week visit

1 missing CSS

Figure 1. Patient flow. Five patients in the MM crossed over to the BSD group prior to their 12-week follow-up visit. BSD, balloon sinus
dilation; CSS, Chronic Sinusitis Survey; CT, computed tomography; SNOT-20, 20-item Sino-Nasal Outcome Test; LTFU, Lost to Follow-Up.
4 American Journal of Rhinology & Allergy 0(0)

Table 1. Baseline Medical History.

Total N ¼ 198 MM N ¼ 52 BSD N ¼ 146 P Value MM

Patients Patients Patients Versus BSD

Age (years)
Mean (SD) [n] 49.4 (14.5) [198] 46.4 (13.3) [52] 50.5 (14.8) [146] .077
Sex
Female 53.5% (106/198) 59.6% (31/52) 51.4% (75/146) .334
Medical history
Prior sinus surgery 27.3% (54/198) 23.1% (12/52) 28.8% (42/146) .473
Current polyposis 15.2% (30/198) 11.5% (6/52) 16.4% (24/146) .502
Septal deviation 65.7% (130/198) 69.2% (36/52) 64.4% (94/146) .611
Asthma 26.3% (52/198) 23.1% (12/52) 27.4% (40/146) .587
ASA sensitivity 3.0% (6/198) 3.8% (2/52) 2.7% (4/146) >.999
Allergic rhinitis 74.2% (147/198) 90.4% (47/52) 68.5% (100/146) .003
Depression 12.6% (25/198) 9.6% (5/52) 13.7% (20/146) .483
Oral steroid dependency 3.5% (7/198) 7.7% (4/52) 2.1% (3/146) .079
Current smoker 7.1% (14/196) 7.7% (4/52) 6.9% (10/144) >.999
Lund–Mackay CT score
Mean (SD) [n] 8.5 (5.1) [195] 8.7 (5.2) [50] 8.4 (5.1) [145] .715
Lund–Kennedy endoscopy score
Mean (SD) [n] 5.2 (3.2) [185] 5.5 (2.9) [42] 5.1 (3.3) [143] .381
Abbreviations: ASA, acetylsalicylic acid; BSD, balloon sinus dilation; CT, computed tomography; MM, medical management; SD, standard deviation.
Minor discrepancies from previously published data are due to changes to the final versus interim analysis dictated by the protocol.

Table 2. Baseline Quality of Life and Medication Usage.

MM N ¼ 52 BSD N ¼ 146 P Value MM

Patients Patients Versus BSD

CSS total
Mean (SD) [n] 34.3 (18.4) [52] 28.5 (17.9) [146] .058
RSDI total
Mean (SD) [n] 39.5 (19.9) [52] 47.9 (25.3) [146] .032
SNOT-20
Mean (SD) [n] 2.6 (0.9) [52] 2.6 (1.0) [146] .636
Missed work/school
Mean (SD) [n] 1.4 (2.4) [52] 3.0 (9.2) [146] .257
Oral antibiotic
Mean (SD) [n] 22.8 (6.1) [52] 28.1 (15.4) [146] .018
Oral steroids
Mean (SD) [n] 8.4 (10.0) [52] 7.9 (8.4) [146] .788
Nasal spray
Mean (SD) [n] 47.2 (28.1) [52] 53.0 (29.6) [146] .220
Abbreviations: BSD, balloon sinus dilation; CSS, Chronic Sinusitis Survey (score range 0–100); MM, medical management; RSDI, Rhinosinusitis
Disability Index (score range 0–120); SD, standard deviation; SNOT-20, 20-item Sino-Nasal Outcome Test (mean score range 0–5).
Average number of days (of the past 90 days). Minor discrepancies from previously published data are due to changes to the final versus
interim analysis dictated by the protocol. The previous P value was computed using a 2-sample t test. The current P value uses and analysis of
variance (ANOVA) model adjusting for prior sinus surgery which was found to be a significant covariate influencing the outcome of the
surgery. Postoperative P values are compared with a similar ANOVA model controlling for prior sinus surgery and baseline quality of
life score.

regression modeling. Of the 198 enrolled patients, 82.9% Safety Data

(n ¼ 121/146) patients in the BSD arm and 51.9%
Nine serious adverse events (SAEs) occurred in 6 BSD
(n ¼ 27/52) in the MM arm completed the 52-week
patients, none of which were related to the device
follow-up visit. Primary reason for discontinuation was
(see Table 3). There was 1 possible procedure-related
lost to follow-up (13.1% of patients across groups).
SAE, a transient ischemic attack in a 92-year-old patient
Stolovitzky et al. 5

Table 3. Serious Adverse Event by Relation to Device, Procedure, and Sinus Medications.

Total N ¼ 198 Patients BSD N ¼ 146 Patients MM N ¼ 52 Patients

% (n/N)/Events % (n/N)/Events % (n/N)/Events

Total 3.0% (6/198)/9 4.1% (6/146)/9 –

Possibly surgery related 0.5% (1/198)/1 0.7% (1/146)/1 –
Transient ischemic attack 0.5% (1/198)/1 0.7% (1/146)/1 –
Not related to device or surgery 2.5% (5/198)/8 3.4% (5/146)/8 –
Bell’s palsy 0.5% (1/198)/1 0.7% (1/146)/1 –
Cancer 0.5% (1/198)/1 0.7% (1/146)/1 –
Dyspnea 0.5% (1/198)/1 0.7% (1/146)/1 –
Fever 0.5% (1/198)/1 0.7% (1/146)/1 –
Gastrointestinal bleeding 0.5% (1/198)/1 0.7% (1/146)/1 –
Glioblastoma 0.5% (1/198)/1 0.7% (1/146)/1 –
Neutropenic shock 0.5% (1/198)/1 0.7% (1/146)/1 –
Pancreatitis 0.5% (1/198)/1 0.7% (1/146)/1 –
Abbreviations: BSD, balloon sinus dilation; MM, medical management.

(a) 60 (b) 0
50 * * * -0.2

Change in SNOT-20 Score

40
-0.4
30
Change in Score

-0.6
20
10 -0.8
0 -1
-10 -1.2
-20 * *
-1.4
-30
-40 -1.6
-50 * -1.8 * *
CSS CSS RSDI RSDI RSDI SNOT-20 Social-
CSS Total RSDI Total SNOT-20 Total SNOT-20 Symptom
Symptom Medicaon Physical Funconal Emoonal Emoonal
MM 29.9 36.4 23.5 -19.9 -7.9 -5.7 -6.3 MM -1.2 -1.2 -1.3
BSD 43.6 51.6 35.6 -36.5 -14.3 -11.5 -10.7 BSD -1.7 -1.7 -1.6

Figure 2. Change from baseline at the 52-week follow-up for (A) CSS and RSDI total scores and (B) SNOT total score. *P < .05. An
increase in CSS score indicates improvement, whereas a decrease in RSDI and SNOT-20 scores indicates improvement. BSD, balloon sinus
dilation; CSS, Chronic Sinusitis Survey; MM, medical management; RSDI, Rhinosinusitis Disability Index; SNOT-20, 20-item Sino-Nasal
Outcome Test.

which was mild in severity and fully resolved within emotional subscore (Figure 2(A)), SNOT-20 symptom
1 day. Four SAEs not related to the device or surgery, subscore, and SNOT-20 social–emotional subscore
neutropenic shock, gastrointestinal bleeding, dyspnea, (Figure 2(B)) in the BSD group compared to the MM
and fever, occurred in 1 patient approximately group. Table 4 also summarizes changes in medication
6 months after the BSD procedure who subsequently usage and missed days of work or school. Apart from
died. The remaining nondevice or surgery-related SAEs nasal steroid spray usage, the change in medication
occurred in 4 BSD patients. There were no nonserious usage from baseline to the 52-week follow-up was com-
device-related adverse events. parable between groups. The MM group showed an
increase in nasal steroid usage of 10.0  52.1 days in
Efficacy Outcomes the prior 90 days at the 52-week follow-up, whereas
At 52-week follow-up, patients who elected ESS with the BSD group demonstrated a decrease of 17.5  46.0
BSD showed significantly greater improvement from days in the prior 90 days at the 52-week follow-up
baseline in CSS scores compared to the MM group (P ¼ .008). When comparing BSD and MM patients,
(P ¼ .001; Figure 2(A)). For a complete summary of there were no differences in posttreatment sinus-related
change in scores from baseline to the 52-week follow- medical care visits (0.2  0.5 vs 0.1  0.6, respectively) or
up for all secondary outcomes, see Table 4. Briefly, posttreatment sinus infection (0.5  0.8 vs 0.6  0.8) at
there were greater improvements in CSS total score, the 52-week follow-up. Patients originally in the MM
CSS symptom subscore, CSS medication subscore, group who crossed over to the treatment group had sim-
RSDI total score, RSDI functional subscore, RSDI ilar results to patients initially electing BSD after
6 American Journal of Rhinology & Allergy 0(0)

Table 4. Change in Quality of Life From Baseline to 52-Week self-reported QOL, absent from changes in medication
Follow-Up. usage except for nasal steroid usage. Compared to base-
Change From Baseline P Value line, at 52 weeks, the MM cohort showed an increase in
nasal steroid usage, while the BSD cohort showed a
MM BSD MM decrease in nasal steroid usage, which may be due to
Mean (SD) Mean (SD) Versus BSD several factors including the higher incidence of allergic
CSS total 29.9 (20.9) 43.6 (21.7) .001
rhinitis observed in the MM cohort at baseline and/or
CSS symptom 36.4 (29.7) 51.6 (29.4) .002 improvement in symptomatic relief of the BSD patients
CSS medication 23.5 (26.1) 35.6 (24.6) .024 compared to MM.
RSDI total
19.9 (19.6)
36.5 (24.9) .003 A recent systematic review and meta-analysis assess-
RSDI physical
7.9 (8.1)
14.3 (9.9) .068 ing the effectiveness of surgical versus MM in patients
RSDI functional
5.7 (6.7)
11.5 (8.1) .005 refractory to medical treatment found that ESS results in
RSDI emotional
6.3 (7.0)
10.7 (9.5) <.001 significantly better outcomes including improved
SNOT-20 total
1.2 (0.9)
1.7 (1.2) .095 patient-reported QOL and nasal endoscopy score; how-
SNOT-20 symptom
1.2 (1.0)
1.7 (1.2) .023 ever, studies included in this meta-analysis were not spe-
SNOT-20 social–
1.3 (1.0)
1.6 (1.4) .007 cific to ESS with BSD.11 As previously reported, the
emotional
primary effectiveness end point in the current study
Oral antibiotic usage
22.4 (8.5)
25.8 (15.5) .270
Oral steroid usage
6.4 (14.4)
4.5 (17.0) .590
was met, improvement in patient-reported CSS scores
Nasal steroid 10.0 (52.1)
17.5 (46.0) .008 from baseline to 24-week follow-up was significantly
spray usage greater in patients electing BSD compared to those elect-
Missed days
1.2 (2.2)
1.5 (3.9) .736 ing continued MM.6 Importantly, those patients who
work/school initially elected continued MM and chose to cross over
and had a BSD procedure (n ¼ 12/52) experienced simi-
Abbreviations: BSD, balloon sinus dilation; CSS, Chronic Sinusitis Survey;
MM, medical management; RSDI, Rhinosinusitis Disability Index; SD, stan-
lar improvements to patients who initially elected BSD,
dard deviation; SNOT-20, 20-item Sino-Nasal Outcome Test. suggesting that this procedure is beneficial even after
MM failure or dissatisfaction. Of great significance, the
results presented here demonstrate the durability of
undergoing ESS using BSD (Figures 3(A) and (B)). treatment of ESS with BSD for CRS patients aged 19
There were no new revision procedures reported through and older through 52-week follow-up.
52 weeks. The prevalence remained at 2/146 revised It is important to point out that all measures of QOL
(1.4%). Importantly, when comparing those patients demonstrated a significant improvement from baseline to
who underwent a BSD procedure only and those that week 52 (CSS total score, CSS symptom subscore, CSS
underwent BSD and an adjunctive procedure(s), there medication subscore, RSDI total score, RSDI functional
were no differences in change from baseline to week 52 subscore, RSDI emotional subscore, SNOT-20 symptom
subscore, and SNOT-20 social–emotional subscore) or a
in CSS total score (44.7  22.2 vs 41.9  21.0; P ¼ .865),
trend toward improvement from baseline to week 52
RSDI total score (
36.9  25.3 vs
36.0  24.6;
(RSDI physical subscore and SNOT-20 total score).
P ¼ .530), or SNOT-20 total score (
1.6  1.2 vs
1.8
While the exact reason for the lack of statistical signifi-
 1.2; P ¼ .630), respectively. Similarly, when comparing
cance in change from baseline to week 52 in SNOT-20
those patients who had the procedure performed in the total score between the treatment and control group is
OR and those who had the procedure performed IO, not known, CSS is a more condensed, 6-item question-
there were no differences in change from baseline to naire focused on medications usage and symptoms,
week 52 in CSS total score (41.8  21.4 vs 44.3  21.9; whereas the SNOT-20 is a 20-item questionnaire assess-
P ¼ .610), RSDI total score (
39.5  24.4 vs
35.4 ing only commonly occurring symptoms (that can be
 25.1; P ¼ .309), and SNOT-20 total score (
1.9  1.0 classified under 1 of the 5 subgroups: nasal, paranasal,
vs
1.6  1.2; P ¼ .193), respectively. sleep-related, social, and emotional impairment).12
Given that CRS is a complex inflammatory disease
Discussion with a multifactorial etiology, oftentimes, multiple
approaches and alternative therapies are required to suc-
This is one of the first studies to evaluate the compara- cessfully treat patients with varying endotypes. In one
tive effectiveness of ESS using BSD versus continued retrospective study, after 3 months of medical therapy,
MM in adult patients for whom MM had previously 52.5% of patients were considered to have failed MM
failed, showing superiority of BSD compared to MM, and were offered surgery, 37.5% did not require surgery
and that the clinical benefit is sustainable up to 52 weeks (ie, were considered a success), and 10% were excluded
posttreatment. BSD led to greater improvements in from the analysis due to missing data,2 suggesting that
Stolovitzky et al. 7

(a) 70
65
60
55
50
45
40
Score

35
30
25
20
15
10
5
0
CSS Total Score RSDI Total Score
Baseline Week 12 12-Week Post-Crossover 24-Week Post-Crossover
(b) 3

2.5

2
SNOT-20 Score

1.5

0.5

0
Baseline Week 12 12-Week Post- 24-Week Post-
Crossover Crossover

Figure 3. Crossover patients (A) CSS and RSDI total scores and (B) SNOT total score. CSS, Chronic Sinusitis Survey; RSDI,
Rhinosinusitis Disability Index; SNOT-20, 20-item Sino-Nasal Outcome Test.

although MM appears to be an effective treatment for
select CRS patients, others, such as those included in the
present study, do not respond to MM. Not surprisingly,
many of these patients who previously failed MM elect
ESS,13 yet according to The State Ambulatory Surgery
Database of California, Florida, Maryland, and New
York, BSD accounted for only 8.0% of ESS procedures
in 2011.14 A recent retrospective study revealed that
treatment with traditional ESS (n ¼ 39), compared to
BSD (n ¼ 36), resulted in significantly longer sick leave
(14 vs 4 days; P < .001) and greater number of patients
with adhesions (21.1% vs 0%; P ¼ .006) with similar
procedural efficiency and no intra- or postoperative
complications in either group.15 Furthermore, compared
to 0% of ESS procedures, 33% of BSD procedures were
done IO. Local anesthesia was utilized in 74% of the
ESS procedures compared to 86% BSD procedures.
The avoidance of general anesthesia by having the pro-
cedure performed IO can lead to a myriad of patient
benefits including lower health-care cost, quicker recov-
ery, and overall convenience.16 The findings of the cur-
rent study further validate the utility of BSD as a
treatment option both IO and OR for CRS when initial
medical therapy is unsuccessful. It is also important to
point out that BSD is not commonly used in pediatric
populations.17
This study had several limitations. First, the study
was not randomized as treatment was self-selected by
study patients; and therefore, the study was unblinded.
While the authors understand the study design may be
considered a limitation, it was anticipated that patients
and physicians would be reluctant to accept
8 American Journal of Rhinology & Allergy 0(0)
randomization to previously failed MM, since it had
been demonstrated that ESS results in clinically signifi-
cant improvement for this patient population.18
Nonetheless, this represents real-world physician/patient
preference. Similarly, because treatment arm was select-
ed by the patient, it was not possible to ensure that base-
line characteristics were comparable (ie, RSDI total
score at baseline, and oral antibiotic usage was higher
in the BSD vs MM group); however, the differences in
baseline population have been reasonably controlled for
in the analysis. The study was not powered to compare
the results for the crossover patients to those of the pri-
mary treatment groups; therefore, while we present these
results, no statistical analysis is done to compare this
group to either of the primary treatment groups. While
33 subjects were reported with nasal polyps at baseline,
when assessed with polypectomies and in light of limi-
tations of data collection for this disease, the small
number limits the ability to do meaningful comparisons.
Further studies with the appropriate sample size need to
be conducted to understand the effect, if any, the pres-
ence of nasal polyps has on BSD. Medication regimen
post-enrollment and adjunctive procedure were not con-
sistent among all patients and were as the discretion of
treating physicians to enable a real-world scenario.
However, subanalysis showed that there were no signif-
icant differences in the change from baseline to week 52
in CSS, RSDI, and SNOT-20 total scores between the 2
groups, suggesting that BSD alone was, in part, respon-
sible for the improved clinical outcome demonstrated in
this study; however, the study was not powered to detect
differences between hybrid procedures as compared with
BSD alone.
Overall, the current analysis highlights the safety,
effectiveness, and durability of ESS with BSD in CRS
patients aged 19 and older and that the procedure is safe
and feasible for both IO and OR settings.
Authors’ Note
Interim results from this study were presented at the 60th
Annual Meeting of the American Rhinologic Society,
September 2014 and were published in The American Journal
of Rhinology & Allergy.
Acknowledgments
This study was sponsored by Acclarent, Inc. Writing support
was provided by Acclarent, Inc. The authors would like to
thank John Leopold of Depuy Synthes, JNJ Medical
Devices, for providing data analysis support. Study
Investigators: Spencer Payne, MD, University of VA,
Charlottesville, VA; Pablo Stolovitzky, MD, Emory
University School of Medicine, Atlanta, GA; Neelesh
Mehendale, MD, ENT Associates of TX, McKinney, TX;
Keith Matheny, MD, Collin County ENT, Frisco, TX;
William Brown, MD, South FL ENT Associates, Miami, FL;
Douglas Liepert, MD, Allied Physicians of Michiana -
Otolaryngology Associates, South Bend, IN; Ewen Tseng,
MD, Collin County ENT, Frisco, TX; Anthony Rieder, MD,
Alliance ENT and Hearing Center, Wauwatosa, WI; Andrew
Gould, MD, Advanced ENT and Allergy, Louisville, KY;
Boris Karanfilov, MD, Ohio Sinus Institute, Dublin, OH;
Christopher Melroy, MD, Georgia Nasal and Sinus Institute,
Savannah, GA; Scott Powell, MD, Tampa Bay ENT Cosmetic
Surgery, Tampa Bay, FL; Daniel VanHimbergen, MD,
Virginia Ear, Nose and Throat, Henrico, VA; A. Danny
Yaish, DO, Ear, Nose, Throat and Plastic Surgery
Specialists, Beaver Dam, WI; Mary Mitskavich, MD, Coastal
Ear, Nose and Throat, Neptune, NJ; Dale Ehmer, MD, ENT
Associates of Texas, McKinney, TX; Jay Dutton, MD,
Midwest Sinus Center, University Head/Neck, Oak Brook,
IL; Joseph Han, MD, Eastern Virginia Medical School,
Norfolk, VA; Fazlur Zahurullah, MD, Rockford Health
Physicians Office, Rockford, IL; R. Wayne Williams, MD,
Vidalia ENT Associates, Vidalia, GA; Rakesh Chandra, MD
and David Conley, MD, Northwestern University, Chicago,
IL; and Nicholas Peiffer, MD, ENT Associates of Texas,
McKinney, TX. The following surveys were used with permis-
sion: CSS, Chronic Sinusitis Survey ! Copyright Outcome
Sciences, Inc., a Quintiles company. All rights reserved.
RSDI, Copyright ! Dr. Michael Benninger, Cleveland
Clinic, Cleveland, OH 44195. SNOT-20, All rights reserved.
Copyright 1995. Washington University in St. Louis, MO.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of
interest with respect to the research, authorship, and/or publi-
cation of this article: Pablo Stolovitzky and Andrew Gould,
consultant for Acclarent, Inc.; Pablo Stolovitzky, Keith
Matheny, and Andrew Gould, speaker for Acclarent, Inc.;
William Brown and Ewen Tseng, former speaker/consultant
for Acclarent, Inc.
Ethical Approval
IRB approval was received for all sites.
Funding
The author(s) disclosed receipt of the following financial sup-
port for the research, authorship, and/or publication of this
article: Financial and logistical support for the study was pro-
vided by Acclarent, Inc.
References
1. Centers for Disease Control and Prevention. Summary
Health Statistics: National Health Interview Survey.
Atlanta, GA: Centers for Disease Control and
Prevention; 2015.
2. Young LC, Stow NW, Zhou L, Douglas RG. Efficacy of
medical therapy in treatment of chronic rhinosinusitis.
Allergy Rhinol. 2012;3(1):e8–e12.
3. Sillers MJ, Melroy CT. In-office functional endoscopic
sinus surgery for chronic rhinosinusitis utilizing balloon
Stolovitzky et al.
catheter dilation technology. Curr Opin Otolaryngol Head
Neck Surg. 2013;21(1):17–22.
4. Weiss RL, Church CA, Kuhn FA, Levine HL, Sillers MJ,
Vaughan WC. Long-term outcome analysis of balloon
catheter sinusotomy: two-year follow-up. Otolaryngol
Head Neck Surg. 2008;139(3)(suppl 3):S38–S46.
5. Plaza G, Eisenberg G, Montojo J, Onrubia T, Urbasos M,
O’Connor C. Balloon dilation of the frontal recess: a ran-
domized clinical trial. Ann Otol Rhinol Laryngol.
2011;120(8):511–518.
6. Payne SC, Stolovitzky P, Mehendale N, et al. Medical
therapy versus sinus surgery by using balloon sinus dila-
tion technology: a prospective multicenter study. Am J
Rhinol Allergy. 2016;30(4):279–286.
7. Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric
and clinimetric validity of the 20-Item Sino-Nasal
Outcome Test (SNOT-20). Otolaryngol Head Neck Surg.
2002;126(1):41–47.
8. Gliklich RE, Hilinski JM. Longitudinal sensitivity of
generic and specific health measures in chronic sinusitis.
Qual Life Res. 1995;4(1):27–32.
9. Gliklich RE, Metson R. Techniques for outcomes research
in chronic sinusitis. Laryngoscope. 1995;105(4)
(Pt 1):387–390.
10. Benninger MS, Senior BA. The development of the
Rhinosinusitis Disability Index. Arch Otolaryngol Head
Neck Surg. 1997;123(11):1175–1179.
11. Patel ZM, Thamboo A, Rudmik L, Nayak JV, Smith TL,
Hwang PH. Surgical therapy vs continued medical therapy
9
for medically refractory chronic rhinosinusitis: a systemat-
ic review and meta-analysis. Int Forum Allergy Rhinol.
2017;7(2):119–127.
12. Baumann I. Subjective outcomes assessment in chronic
rhinosinusitis. Open Otorhinolaryngol J. 2010;4:28–33.
13. Smith TL, Batra PS, Seiden AM, Hannley M. Evidence
supporting endoscopic sinus surgery in the management
of adult chronic rhinosinusitis: a systematic review. Am J
Rhinol. 2005;19(6):537–543.
14. Ference EH, Graber M, Conley D, et al. Operative utili-
zation of balloon versus traditional endoscopic sinus sur-
gery. Laryngoscope. 2015;125(1):49–56.
15. Koskinen A, Mattila P, Myller J, et al. Comparison of
intra-operative characteristics and early post-operative
outcomes between endoscopic sinus surgery and balloon
sinuplasty. Acta Otolaryngol. 2017;137(2):202–206.
16. Albritton FDt, Casiano RR, Sillers MJ. Feasibility of in-
office endoscopic sinus surgery with balloon sinus dilation.
Am J Rhinol Allergy. 2012;26(3):243–248.
17. Beswick DM, Ramadan H, Baroody FM, Hwang PH.
Practice patterns in pediatric chronic rhinosinusitis: a
survey of the American Rhinologic Society. Am J Rhinol
Allergy. 2016;30(6):418–423.
18. Smith TL, Kern RC, Palmer JN, et al. Medical therapy vs
surgery for chronic rhinosinusitis: a prospective, multi-
institutional study. Int Forum Allergy Rhinol.
2011;1(4):235–241.