A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up.

OBJECTIVE: Compare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD). STUDY DESIGN: Prospective, multicenter, randomized controlled trial. SETTING: Tertiary care academic center and private practice. PATIENTS: Diagnosed with medically refractory persistent ETD. INTERVENTIONS: 1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted. MAIN OUTCOME MEASURES: Primary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety endpoint was complication rate. RESULTS: Sixty participants were randomized (31 balloon dilation, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was -2.9 (1.4) for balloon dilation compared with -0.6 (1.0) for control: balloon dilation was superior to control (p < 0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for balloon dilation than control. Technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation. CONCLUSIONS: Balloon dilation is a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, balloon dilation is superior to continued medical management for persistent ETD. Symptom improvement is durable through a minimum of 12 months. Procedures are well tolerated in the office setting under local anesthesia.

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

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.

Randomized controlled trial of hyaluronic acid/carboxymethylcellulose dressing after endoscopic sinus surgery.

OBJECTIVE: To determine if a hyaluronic acid/carboxymethylcellulose (HA/CMC) sinus dressing reduces the rate of postoperative scarring. METHODS: In a randomized, matched-controlled, single-blinded study, following the completion of surgery, an HA/CMC dressing was randomly assigned to one side with the opposite unpacked side serving as a control. RESULTS: Fifty-three patients underwent surgery for chronic rhinosinusitis (CRS; 39 patients) or CRS with nasal polyposis (14 patients). At the 8-week follow-up, there was no difference in synechiae on the HA/CMC side compared to the control (p = 0.09). HA/CMC-treated sinuses, however, demonstrated fewer synechiae in the first 2 weeks postoperatively compared to the control (p = 0.01), and were associated with significantly less nasal congestion at the 4-week (p = 0.02) and 8-week follow-up visits (0.03). CONCLUSION: There was no long-term difference in the rate of synechiae in the HA/CMC-treated sinus compared to the control. However, less severe nasal congestion and synechiae in the initial postoperative period may reduce the need for aggressive sinus debridement.