Pediatric
Prospective, multicenter evaluation of balloon sinus dilation
for treatment of pediatric chronic rhinosinusitis.
Study
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.
Outcomes and
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.
- 92% (144/157) of the sinus dilations included bilateral treatment of the affected sinuses.
- 84% were conducted in surgical centers under general anesthesia.
- 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.
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).
- 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.
Figure 1
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 Mar; 7(3):221-229.
Sinusitis
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