Bookmark and ShareBrowse

Pediatric

Prospective, Multicenter Evaluation of Balloon Sinus Dilation for Treatment of Pediatric Chronic Rhinosinusitis

Table of Contents


Study Background

Overview

Balloon sinus dilation is a treatment option for adults with chronic rhinosinusitis (CRS) but there are few studies of balloon sinus dilation performed in pediatric patients. The objectives of this study were to evaluate the procedural success, safety, and effectiveness of balloon sinus dilation in pediatric patients with CRS. This study was a prospective, multicenter, single-arm investigation.

Patient population

  • Aged 2 through 21 years.
  • Patients satisfied diagnostic criteria for CRS as defined by EPOS12.
  • Each patient had failed initial medical management. Failure was defined as ongoing sinonasal symptoms despite previous medical therapy.
  • Patients did not have previous sinus surgery, head or neck surgery within the previous 3 months, fungal sinus disease, cystic fibrosis, severe asthma, known immunodeficiency, anatomic conditions that prevented transnasal access, hypoplastic/atelectatic maxillary sinus or craniofacial deformity.

Procedure

  • All study participants underwent transnasal balloon sinus dilation with the XprESS™ Multi-Sinus Dilation System (Entellus Medical, Plymouth, MN).
  • The PathAssist™ LED Light Fiber™ Sinus Confirmation Tool (Entellus Medical, Plymouth, MN) was used to illuminate and confirm placement in all maxillary and frontal sinuses.
  • Fluoroscopy was not used for device placement confirmation.
  • Selection of anesthesia and the location of the procedure were at the discretion of the treating surgeon.
  • After completion of balloon sinus dilation, concomitant procedures (such as adenoidectomy, inferior turbinate reduction, and ethmoidectomy) were allowed based on individual participant needs.
  • Recovery time was documented.
  • Participants were evaluated through 6 months post procedure.

Primary and Secondary Outcome Measures

  • Primary outcomes were technical success and procedure complication rate.
    • Technical success rate was the percent of successful dilations out of all attempted dilations. A successful dilation was defined as the balloon was delivered to the target location, inflated, deflated, and withdrawn from the treated sinus.
    • Complications were defined as serious adverse events that were related to the balloon device or procedure during the initial 3 months after the procedure.
  • Secondary outcomes were the surgical revision rate and changes in disease-specific quality of life (QOL).
    • Revision surgery was defined as surgery on any sinus initially treated during the study procedure or surgery on a previously untreated sinus.
    • QOL assessments included the Sinus and Nasal Quality of Life Survey (SN-5), 22-item Sino-Nasal Outcome Test (SNOT-22) and Rhinosinusitis Symptom Inventory (RSI).

Results

Primary Endpoints

  • 157 sinus dilations were attempted.
    • 98 maxillary, 30 frontal, 29 sphenoid sinuses.
    • All were successful with no complications.
    • There were no serious adverse events reported through the 6-month follow-up period for all participants.

Procedural Characteristics

  • 50 children were treated at 4 centers.
    • 33 participants were 2 to 12 years old (mean ± standard deviation age: 6.6 ± 2.2 years).
    • 17 participants were >12 to 21 years (mean age: 15.7 ± 2.5 years).
  • 92% (144/157) of the sinus dilations included bilateral treatment of the affected sinuses.
  • 84% were conducted in surgical centers under general anesthesia.
    • 8 of the 17 adolescent participants (47.1%) were successfully treated in the office under local anesthesia only.

Table 1 shows:

  • 20 participants (40%) underwent balloon sinus dilation with no concomitant procedures.
  • 21 (42%) underwent concurrent adenoidectomy.
  • 6 (12%) had concurrent ethmoidectomy.
  • 13 (26%) underwent concurrent inferior turbinate reduction.
  • 7 (14%) had tonsillectomies

 

Table 1. Procedural characteristics

 

Characteristic Child (2–12 years) n=33 Adolescent (>12 to 21 years) n=17 All participants n=50
Procedure location
Surgical center 33 (100.00) 9 (52.9) 42 (84.0)
Office 0 (0.0) 8 (47.1) 8 (16.0)
Anesthesia type
General 33 (100.0) 9 (52.9) 42 (84.0)
Local 0 (0.0) 8 (47.1) 8 (16)
Pain assessment (n=8) NA 1.5±1.2 NA
Concomitant procedures
None 11 (33.3) 9 (52.9) 20 (40.0)
Adenoidectomy 19 (57.6) 2 (11.8) 21 (42.0)
Inferior turbinate reduction 6 (18.2) 7 (41.2) 13 (26.0)
Tonsillectomy 5 (15.2) 2 (11.8) 7 (14.0)
Ethmoidectomy 4 (12.1) 2 (11.8) 6 (12.0)
Myringotomy with ear tube placement 5 (15.2) 0 (0.0) 5 (10.0)
Concha bullosa resection 0 (0.0) 3 (17.6) 3 (6.0)
Uncinectomy 0 (0.0) 1 (5.9) 1 (2.0)
Other proceduresa 4 (12.1) 2 (11.8) 6 (12.0)
Method to control postoperative bleeding
None 31 (93.3) 16 (94.1) 47 (94.0)
Packing, removed
before discharge
2 (6.1) 0 (0.0) 2 (4.0)
Gel film 0 (0.0) 1 (5.9) 1 (2.0)

*Data are displayed as mean ± SD or n (%), as shown.

aOther concomitant procedures include: cauterization of nasal vessels (2), outfracture of inferior turbinate (2), resection of agger nasi cell (1), and septoplasty (1).

NA = not applicable; SD = standard deviation.

Secondary outcome results

  • No revision surgeries were performed during the 6-month follow-up period.
  • Significant improvement in the mean SN-5 was seen between baseline and 6 months (4.6 ± 1.2 vs. 1.7 ± 0.8; p < 0.0001) (Figure 1).
    • 92% improved by a minimal clinically important difference (MCID) of 1.0 or more.
  • Those children aged 2 to 12 years showed significant SN-5 improvements between baseline and follow-up (4.5 ± 1.0 vs. 1.9 ± 0.8; p < 0.0001) (Table 2).
  • Multivariate regression analysis showed no differences or associations of SN-5 improvement at 6 months with the presence of allergy, asthma or concomitant procedures.
  • For adolescents, overall SNOT-22 mean scores were also significantly improved at 6 months (42.2 ± 19.2 vs. 10.4 ± 9.7; p < 0.0001).
  • The RSI was used to evaluate mean change in sinus symptoms between baseline and 6 months. There were statistically significant improvements in all the major and minor symptom measures as well as the 4 domain measures.

​​

 

Table 2. SN-5 outcomes for ages 2 to 12 years

 

Quality of life item n Baseline 6-Months Change from baseline Percent improvement p
SN-5 overall score 33 4.8 ± 1.2 1.7 ± 0.8 −3.1 ± 1.4 62.4 ± 18.3 <0.0001
SN-5 sinus infection 33 5.6 ± 1.3 1.7 ± 1.1 −3.8 ± 1.7 65.9 ± 24.4 <0.0001
SN-5 nasal obstruction 33 5.5 ± 1.4 1.9 ± 1.2 −3.6 ± 1.9 57.5 ± 51.5 <0.0001
SN-5 allergy symptoms 33 4.5 ± 1.9 2.2 ± 1.6 −2.4 ± 2.0 46.1 ± 35.8 <0.0001
SN-5 emotional distress 33 4.6 ± 1.9 1.5 ± 1.1 −3.1 ± 2.1 59.2 ± 32.1 <0.0001
SN-5 activity limitations 33 3.8 ± 1.7 1.2 ± 0.6 −2.5 ± 1.7 58.0 ± 27.5 <0.0001
Overall quality of life 33 4.3 ± 1.5 8.8 ± 1.5 4.5 ± 2.0 139.5 ± 113.7 <0.0001

*Data are displayed as mean ± SD. SN-5 survey responses for each item can range from 1 (none of the time) to 7 (all of the time). The overall quality of life assessment ranges from 0 (worse possible) to 10 (best possible).

SD = Standard Deviation; SN-5 = Sinus and Nasal Quality of Life Survey.

Conclusions

  • Balloon sinus dilation has high procedural success rates and is safe for children with CRS aged 2 years and older.
  • Significant improvements in QOL were seen up to 6 months after surgery on both parent-reported and patient-reported outcome measures.
  • Future studies should evaluate outcomes beyond 6 months and further refine the role of balloon dilation within the treatment algorithm for pediatric CRS.

Featured Publication:

Soler ZM, Rosenbloom JS, Skarada D, Gutman M, Hoy MJ, Nguyen SA. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017; 7:221-229.