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ABSTRACT
Background: A prospective randomized controlled study was conducted on patients with chronic rhinosinusitis (CRS) to test the hypotheses that symptom
improvement after balloon dilation was noninferior to functional endoscopic sinus surgery (FESS) and balloon dilation was superior to FESS for postoperative
debridements.
Methods: Adults with uncomplicated CRS of the maxillary sinuses with or without anterior ethmoid disease who met criteria for medically necessary FESS
were randomized 1:1 to office balloon dilation or FESS and followed for 6 months. A minimum of 36 patients per arm were required to test the hypotheses with
90% power. Symptom improvement using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey, debridements, recovery outcomes, complications, and revision surgeries were compared between groups.
Results: Ninety-two patients (50 balloon dilation; 42 FESS) were treated. Mean SNOT-20 improvement was 1.67 1.10 and 1.60 0.96 in the balloon
and FESS arms, respectively. Both groups showed clinically meaningful and statistically significant (p 0.0001) improvement and the balloon arm was
noninferior (p 0.001) to FESS. The mean number of postprocedure debridements per patient was 0.1 0.6 in the balloon arm versus 1.2 1.0 in the FESS
arm, with the balloon group showing superiority (p 0.0001). Occurrence of postoperative nasal bleeding (p 0.011), duration of prescription pain
medication use (p 0.001), recovery time (p 0.002), and short-term symptom improvement (p 0.014) were all significantly better for balloon dilation
versus FESS. No complications occurred in either group and one revision surgery was reported in each arm.
Conclusion: Balloon dilation is noninferior to FESS for symptom improvement and superior to FESS for postoperative debridements in patients with
maxillary and anterior ethmoid disease. Balloon dilation is an effective treatment in patients with uncomplicated CRS who meet the criteria for medically
necessary FESS.
(Am J Rhinol Allergy 27, 416 422, 2013; doi: 10.2500/ajra.2013.27.3970)
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the mean number of postoperative debridements defined as transnasal maneuvers performed within the nasal cavity to remove dead,
contaminated, or adherent tissue or foreign material that may promote infection and impede healing occurring throughout the study
period.
Secondary Endpoints
Secondary end points included recovery outcomes (postdischarge
nausea, nasal bleeding, duration of analgesic use, and recovery time),
short-term improvement in sinus symptoms, complication rate, and
revision rate. Postdischarge recovery time was reported by each
patient as the time to return to normal daily activities (i.e., baseline
activity level before surgery). Short-term improvement in sinus symptoms was computed using the combined 1-week and 1-month
changes in SNOT-20 scores from baseline. A complication was defined as a serious device-related or procedure-related adverse event.
Revision surgery was defined as surgery on any sinus initially treated
during the study procedure or surgery on a previously untreated
sinus. Nasal surgeries performed over the duration of the study were
also reported but not included in the calculation of revision rate.
Study Procedures
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Figure 1. Criteria for medically necessary functional endoscopic sinus surgery (FESS).
Sample size for both primary endpoints was calculated using PASS
2008.16 The minimum required sample size was driven by the longterm symptom improvement (SNOT-20) endpoint. A minimum of 36
subjects was required in each study arm to have 90% power to show
noninferiority of balloon dilation with a margin of 0.8 compared with
FESS at a one-sided -level of 0.025. The margin was established as
the clinically meaningful difference from the developer of the validated SNOT-20 instrument (Piccirillo et al.15). A minimum of 23
subjects was required in each arm to have 90% power to show
superiority of balloon dilation over FESS for postoperative debridement rate at a one-sided -level of 0.025.
One-sided Students t-test was used to compare symptom improvement between study arms and a Wilcoxon signed-rank test was used
to compare postoperative debridements per patient between study
arms. Values of p 0.025 were considered statistically significant.
Repeated measures regression modeling was used to compare shortterm symptom improvement between study arms. Two-sided Students t-tests were used to compare other continuous measures and
Fishers exact tests were used to compare other categorical measures.
For the secondary endpoint measures evaluated, a Benjamini-Hochberg17 adjustment for multiple comparisons was used to determine
statistical significance and control the overall for the family of tests
at 0.05. For other statistical tests, values of p 0.05 were deemed
statistically significant. An independent statistician calculated the
required sample sizes and performed all statistical analyses. All analyses were performed using SAS Version 9.3 (SAS Institute, Cary, NC).
Primary Endpoints
The first primary endpoint was long-term improvement in sinus
symptoms as assessed by the mean change in overall 20-item SinoNasal Outcome Test (SNOT-20) score between baseline and 6-month
follow-up. The SNOT-20 is a validated QOL outcome measure specifically for patients with rhinosinusitis. Patients rate the severity of
20 different symptoms on a scale of 0 (no problem) to 5 (problem as
bad as it can be). A decrease of 0.8 of the mean SNOT-20 score is
considered clinically meaningful.15 The second primary endpoint was
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RESULTS
Patients and Procedures
Between December 2011 and December 15, 2012 a total of 105 adults
at 10 sites were enrolled and either underwent treatment or withdrew
before the study procedure. No study center contributed 20% of
patient enrollments and results were consistent across sites. Of the 105
patients enrolled, 52 were randomly assigned to undergo balloon
dilation and 53 to undergo FESS (Fig. 2). A total of 13 patients who
underwent randomization withdrew their consent for treatment (2 in
the balloon dilation arm and 11 in the FESS arm). Eight of the 11
patients who withdrew from the FESS group were unwilling to
undergo sinus surgery. Ninety-two (50 balloon dilation and 42 FESS)
patients were treated and 91 (98.9%) completed 6-month follow-up.
There were no significant differences in any of the baseline characteristics between treatment study arms (Table 1).
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Age (yr)
Gender
Male
Female
Ethnicity
White
Hispanic
African American
Other
Smoking history
Never smoked
Former smoker
Current smoker
Allergies
None
All year
Seasonal
Asthma/bronchitis
Previous nasal surgery
Septal deviation
Lund-MacKay score
CRS diagnosis
Chronic (12-wk duration)
Recurrent acute (4 episodes in 1 yr)
Sinuses affected
Maxillary only
Maxillary and anterior ethmoid
Duration of rhinosinusitis (yr; n 50, 41)
Baseline SNOT-20 score
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47.0 14.6
16 (32.0%)
34 (68.0%)
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N
42 (84.0%)
5 (10.0%)
2 (4.0%)
1 (2.0%)
29 (58.0%)
14 (28.0%)
7 (14.0%)
p Value*
Mean SD or n (%)
47.9 14.5
19 (45.2%)
23 (54.8%)
36 (85.7%)
3 (7.1%)
3 (7.1%)
0 (0.0%)
0.763
0.205
0.813
27 (64.3%)
10 (23.8%)
5 (11.9%)
0.828
16 (32.0%)
21 (42.0%)
13 (26.0%)
13 (31.0%)
17 (40.5%)
12 (28.6%)
1.000
8 (16.0%)
7 (14.0%)
30 (60.0%)
3.2 3.2
8 (19.0%)
8 (19.0%)
25 (59.5%)
3.6 3.5
0.786
0.578
1.000
0.555
34 (68.0%)
16 (32.0%)
29 (69.0%)
13 (31.0%)
1.000
31 (62.0%)
19 (38.0%)
12.4 13.0
2.54 0.91
26 (61.9%)
16 (38.1%)
12.7 13.9
2.54 0.79
1.000
0.934
0.972
*The p value from two-sample two-sided Students t-test or Fishers exact test.
CRS chronic rhinosinusitis; FESS functional endoscopic sinus surgery; SNOT-20 20-item Sino-Nasal Outcome Test.
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arm, 81 maxillary antrostomies with uncinectomies were attempted and 80 were successfully completed (98.8%), (4 unilateral
and 38 bilateral). One FESS patient was treated under local anesthesia and the planned bilateral procedure was converted to a
unilateral procedure because of uncontrolled sneezing and patient
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Total No. of
Debridements
50
Mean SD
No. of Patients
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0.1 0.6
42
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Control (FESS)
Total No. of
Debridements
Mean SD
50
1.2 0.9
p Value*
0.0001
*Based on a one-sided two-sample Wilcoxon test for superiority. Statistical significance is determined by comparing the p value to 0.025. In conclusion, the
mean number of debridements for patients undergoing balloon dilation is superior (i.e., less debridements) to that for patients undergoing FESS.
FESS functional endoscopic sinus surgery.
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Primary Endpoints
Secondary Endpoints
Postoperative recovery outcomes by study group are provided
in Table 3. A total of 28.0% of the balloon dilation patients were
discharged with nasal bleeding compared with 54.8% of the FESS
patients (p 0.011). On average, balloon dilation patients were
able to return to normal daily activities faster (1.6 days) than FESS
patients (4.8 days; p 0.002). The balloon dilation patients took
prescription pain medications for fewer days (0.9 days) compared
with the FESS patients (2.8 days; p 0.001). The mean short-term
improvement in SNOT-20 score was better for patients in the
balloon dilation arm than for patients undergoing FESS (p 0.014;
Table 4).
No (0%) complications occurred in either the balloon dilation arm
or the FESS arm. One (2.0%) patient in the balloon dilation arm
received revision sinus surgery on postoperative day 89 and one
(2.4%) patient in the FESS arm received revision surgery on postoperative day 147. In the balloon patient, unilateral, left-sided endoscopic sinus surgery including maxillary antrostomy, uncinectomy,
ethmoidectomy, and frontal sinusotomy was completed without issue. In the FESS patient, septoplasty, resection of a concha bullosa,
bilateral maxillary antrostomy, and bilateral sphenoidotomy were
completed. Separately, two other FESS patients underwent additional
nasal surgery during the study. One patient underwent bilateral
turbinate reduction 98 days after the study procedure and the other
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Balloon Dilation
(n 50)
Control (FESS)
(n 42)
Mean SD or n (%)
Mean SD or n (%)
3 (6.0%)
14 (28.0%)
1.6 1.1
7 (16.7%)
23 (54.8%)
4.8 6.2
0.9 1.4
1.6 2.0
2.8 2.7
2.7 4.0
Postdischarge nausea
Discharged with nasal bleeding
Recovery time (days)
(return to normal daily activities)
Duration of prescription pain medications (days)
Duration of OTC pain medications (days)
p Value*
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*The p value from two-sample two-sided Students t-test or Fishers Exact test.
FESS functional endoscopic sinus surgery; OTC over-the-counter.
Table 4 Short-term change in SNOT-20 Score from baseline by study arm
Follow-Up
Interval
1 wk
1 mo
Balloon Dilation
Control (FESS)
Mean Change SD
Mean Change SD
48
49
1.49 0.87
1.70 0.98
41
40
0.96 1.12
1.62 0.95
0.177
0.011
0.002
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0.001
0.126
p Value*
0.3 (0.5,0.1)
0.014
*Based on a repeated measures regression model using the combined 1-wk and 1-mo changes in SNOT-20 from baseline. Model adjusted for baseline SNOT-20
score, study arm, and follow-up visit. In conclusion, the mean short-term improvement in SNOT-20 score for patients undergoing balloon dilation is
significantly better than that for patients undergoing FESS.
FESS functional endoscopic sinus surgery; SNOT-20 20-item Sino-Nasal Outcome Test.
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DISCUSSION
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Diseased sinuses
Maxillary only
Maxillary and anterior
ethmoid
Accessory ostium
Yes
No
Septal deviation
Yes
No
CRS diagnosis
Chronic (12 wk duration)
Recurrent acute (4 episodes
in 1 yr)
Balloon Dilation
n
Mean
Change SD
p Value*
Mean Change SD
p
Value*
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18
1.62 1.15
1.74 1.03
0.0001
0.0001
25
16
1.63 1.04
1.55 0.86
0.0001
0.0001
0.973
0.576
17
31
1.76 1.38
1.62 0.93
0.0001
0.0001
9
32
1.89 0.64
1.52 1.03
0.0001
0.0001
0.735
0.699
28
20
1.67 1.15
1.67 1.05
0.0001
0.0001
24
17
1.56 0.97
1.66 0.98
0.0001
0.0001
0.722
0.988
32
16
1.72 1.12
1.57 1.08
0.0001
0.0001
28
13
1.58 1.00
1.64 0.90
0.0001
0.0001
0.629
0.838
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*The p value from paired t-test, testing if change between baseline and 6-mo follow-up statistically different from zero.
#The p value from two-sample t-test, comparing changes from baseline between study arms.
CRS chronic rhinosinusitis; FESS functional endoscopic sinus surgery; SNOT-20 20-item Sino-Nasal Outcome Test.
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p Value#
Control (FESS)
CONCLUSION
Adult patients with maxillary and anterior ethmoid sinus disease
who fail medical management and meet surgical criteria for uncomplicated CRS experience long-term symptom improvement after balloon dilation that is noninferior to the improvement also occurring
after FESS. Balloon dilation results in fewer postoperative debridements than FESS, indicating superiority of the balloon arm. In addition, the number of patients discharged with nasal bleeding, duration
of prescription pain medication use, recovery time, and short-term
symptom improvement are all significantly better in patients who
undergo balloon dilation compared with FESS. Balloon dilation and
FESS are both safe because neither procedure produced any serious
adverse events and the durability of each has been established
through very low reported rates of revision surgery within each
treatment arm.
ACKNOWLEDGMENTS
The REMODEL Principal Study Investigators include Michael
Armstrong, M.D., Richmond ENT, Richmond, VA; Nadim Bikhazi,
M.D., Ogden Clinic, Ogden, UT; Stephen Chandler, M.D., Montgomery Otolaryngology, Montgomery, AL; Jeffrey Cutler, M.D., Associates of Otolaryngology, Denver, CO; Aliya Ferouz-Colborn, M.D., San
Diego Sleep and Sinus Clinic, San Diego, CA; James Gould, M.D.,
Synergy ENT Specialists, St. Louis, MO; Joshua Light, M.D., Ear, Nose
and Throat Associates of South Florida, Boynton Beach, FL; Jeffrey
Marvel, M.D., Marvel Clinic, Tullahoma, TN; Michael Schwartz,
M.D., Ear, Nose, and Throat Associates of South Florida, West Palm
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Beach, FL; and Theodore Truitt, M.D., St. Cloud Ear, Nose, and
Throat, St. Cloud, MN.
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