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.

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.

With 1-year follow-up, standalone balloon dilation is as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS.

Objectives/HypothesisTo provide the final results from the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long‐term follow‐up) full‐study cohorts and perform meta‐analyses of standalone balloon sinus dilation studies to explore long‐term outcomes in a large patient sample.Study DesignRandomized controlled trial and meta‐analysis.MethodsFinal outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with functional endoscopic sinus surgery (FESS) or in‐office balloon dilation, were evaluated. One hundred thirty patients had 12‐month data, 66 had 18‐month data, and 25 had 24‐month data. In addition, a meta‐analysis evaluated outcomes from six studies including 358 standalone balloon dilation patients with up to 24 months follow‐up.ResultsOutcomes out to 2 years from the REMODEL full‐study cohort are consistent with 6‐month and 12‐month outcomes. In the meta‐analysis of standalone balloon dilation studies, technical success is 97.5%, and mean 20‐item Sino‐Nasal Outcomes Test scores are significantly and clinically improved at all time points (P < .0001). There are significant reductions (P < .0001) in work/school days missed, homebound days, physician/nurse visits, acute infections, and antibiotic prescriptions. Mean recovery time is 1.4 days. Comparison of 12‐month symptom improvements and revision rates between the REMODEL FESS arm (n = 59), REMODEL balloon dilation arm (n = 71), and pooled single‐arm standalone balloon dilation studies (n = 243) demonstrated no statistical difference.ConclusionsAll outcomes are comparable between FESS and balloon dilation at all time points from 6 months to 24 months. Balloon dilation produces faster recovery, less postoperative pain, and fewer debridements than FESS. There is significant, durable benefit in a large series of 358 patients undergoing standalone balloon dilation.Level of Evidence1b. Laryngoscope, 126:44–50, 2016

Transantral balloon dilation can be performed safely in the clinic and operative settings with symptom improvement sustained through 1 year.