Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis

Zachary M Soler, Jeffrey S Rosenbloom, Douglas Skarada, Michael Gutman, Mark J Hoy, Shaun A Nguyen, Zachary M Soler, Jeffrey S Rosenbloom, Douglas Skarada, Michael Gutman, Mark J Hoy, Shaun A Nguyen

Abstract

Background: Although balloon sinus dilation is a treatment option for adults with chronic rhinosinusitis (CRS), there have been few studies performed in pediatric patients.

Methods: This study was designed as a prospective, multicenter, single-arm investigation. Children (2 to 21 years old) with CRS who had failed medical management were treated with balloon sinus dilation and followed to 6 months postprocedure.

Results: Fifty children were treated at 4 centers; 33 participants were 2 to 12 years old (mean ± standard deviation age: 6.6 ± 2.2 years) and 17 participants were >12 to 21 years (mean age: 15.7 ± 2.5 years). A total of 157 sinus dilations were attempted (98 maxillary, 30 frontal, and 29 sphenoid sinuses) and all were successful with no complications. Significant improvement in the Sinus and Nasal Quality of Life Survey (SN-5) was seen for all children between baseline and 6 months (4.6 ± 1.2 vs 1.7 ± 0.8; p < 0.0001) and 92% improved by a minimal clinically important difference (MCID) of 1.0 or more. Those children aged 2 to 12 years with standalone balloon dilation also 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 22-item Sino-Nasal Outcome Test (SNOT-22) mean scores were also significantly improved at 6 months (42.2 ± 19.2 vs 10.4 ± 9.7; p < 0.0001).

Conclusion: Balloon sinus dilation is safe and appears effective for children with CRS aged 2 years and older.

Trial registration: ClinicalTrials.gov NCT02278484.

Keywords: adolescent; balloon; child; chronic, rhinosinusitis; outcome; quality of life; sinuplasty; sinusitis; surgery; therapy.

© 2016 The Authors International Forum of Allergy & Rhinology, published by ARSAAOA, LLC.

Figures

Figure 1
Figure 1
Mean change from baseline in overall and subscale SN‐5 scores over time. SN‐5 = Sinus and Nasal Quality of Life Survey.

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Source: PubMed

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