Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction.

OBJECTIVE: To gather long-term follow-up data on the efficacy of balloon dilation for treating patients with persistent Eustachian tube dysfunction (ETD). STUDY DESIGN: Extended follow-up study of the treatment arm of a prospective, multicenter, randomized controlled trial. SETTING: Tertiary care academic center and private practice. PATIENTS: Patients diagnosed with medically refractory persistent ETD. INTERVENTIONS: Balloon dilation of the Eustachian tube. MAIN OUTCOME MEASURES: The endpoints were the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score, revision dilation rate, changes in assessments of middle ear function, and patient satisfaction. RESULTS: A total of 47 participants enrolled in the extended follow-up study. Mean follow-up was 29.4 months (range, 18-42 mo). There was a statistically significant mean (SD) change from baseline in the overall ETDQ-7 score (-2.5 ±â€Š1.2; p < 0.0001). A reduction of one or more in their overall ETDQ-7 score was observed by 93.6% (44/47) participants. The revision dilation rate was 2.1% (1/47). Among participants with abnormal baseline middle ear assessments, 76.0% had normalized tympanic membrane position (p < 0.0001), 62.5% had normalization of tympanogram type (p < 0.001), and 66.7% had positive Valsalva maneuvers (p < 0.0001). Participant satisfaction was 83.0% at long-term follow-up. CONCLUSIONS: Balloon dilation results in durable improvements in symptoms and middle ear assessments for patients with persistent Eustachian tube dysfunction at mean follow-up of longer than 2 years.

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.

REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.

OBJECTIVES/HYPOTHESIS: To 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 DESIGN: Randomized controlled trial and meta-analysis. METHODS: Final 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. RESULTS: Outcomes 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. CONCLUSIONS: All 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.

Balloon dilatation of the paranasal sinuses: a tool in sinus surgery.

Chronic sinusitis affects millions of patients. Balloon technology is a tool that has enhanced the surgeon's ability to treat patients suffering from chronic sinusitis. Three companies have developed products to dilate sinus ostia. An extensive literature review reveals that balloon catheters have an impressive safety profile and seem to be an effective tool for ostial dilatation. These tools are particularly effective in frontal recess dilatation and have great potential for office use under local anesthesia.

Otitis media and antihistamines.

Otitis media with effusion (OME) and acute otitis media (AOM) continue to be a significant source of morbidity in the United States, as they account for more than 3.5 billion dollars in annual costs, and OME is the sixth most common reason for an emergency department visit. The efficacy of antihistamines in the treatment of OME/AOM has been thoroughly refuted in the literature during the past three decades. However, most studies to date have used first-generation antihistamines with or without decongestants. We propose that second-generation antihistamines may have increased efficacy in the treatment of OME/AOM because of their greater selectivity for histamine receptors and lack of anticholinergic activity. Further clinical trials may be warranted, as medical treatment with second-generation antihistamines, if proven more efficacious, may reduce the need for antibiotic treatment and surgical intervention.

Effects of ototopical antihistamine on otitis media in an allergic rat.

OBJECTIVES/HYPOTHESIS: A reliable model of allergy has been created in the Brown Norway rat. In this model, allergen presentation to the middle ear causes functional disruption of the eustachian tube, predisposing to the development of otitis media with effusion. The purpose of this study was to study the effects of ototopical antihistamine on lipopolysaccharide (LPS)-induced otitis media in the allergic rat model. STUDY DESIGN: Prospective animal-based research study. METHODS: Fifteen (n = 15) rats were made allergic via sensitization to ovalbumin (OVA) by subcutaneous injection and randomized into three groups: saline (SAL) + LPS, olopatadine (OLO) + LPS, and azelastine (AZE) + LPS. Allergic rats were transtympanically injected with OVA 24 hours prior to challenge, creating a subclinical inflammatory response in which there is no visible middle ear effusion. Thirty-five microliters of test substance (SAL + LPS, OLO + LPS, or AZE + LPS) were injected into the middle ear at 0, 2, and 4 hours. Effusion was collected at 2, 4, and 6 hours. Statistical analysis was performed on effusion volume and albumin concentration. RESULTS: Significant increase in effusion volume with respect to time was noted for the SAL + LPS group, whereas the AZE + LPS group demonstrated a decrease. Intergroup comparison revealed a significant decrease in effusion volume at hour 6, with both AZE and OLO less than LPS alone. A significant decrease in albumin concentration over time was noted in the AZE group. Intergroup comparison revealed a significant difference inalbumin concentration at hour 6, with OLO significantly lower than LPS. CONCLUSIONS: Ototopical antihistamines are effective in reducing effusion volume and albumin concentration in LPS-induced otitis media in an allergic rat model. This finding supports the hypothesis that ototopic antihistamines may prove effective in treating patients with allergy-induced eustachian tube dysfunction.

Effects of ototopic steroid and NSAIDS in clearing middle ear effusion in an animal model.

OBJECTIVE: A model of otitis media with effusion (OME) has been developed in the Sprague-Dawley (SD) rat. This model was used to study the effects of an ototopic steroid and nonsteroidal anti-inflammatory drug (NSAID) on lipopolysaccharide (LPS)-induced OME. STUDY DESIGN: Twenty-six rats were randomized into 4 groups: saline solution, LPS, NSAID + LPS, and steroids + LPS. Test substance was injected into the middle ear at 0, 2, and 4 hours. The effusion was collected at 2, 4, and 6 hours. Statistical analysis of effusion volume and albumin concentration was performed. RESULTS: The LPS group demonstrated statistically significant increase in both effusion volume and albumin concentration compared with saline solution. Intergroup comparison revealed significantly less effusion volume in the steroid group and less albumin concentration in the NSAID group when compared with the LPS group. CONCLUSIONS: Transtympanic steroid reduced LPS induced middle ear effusion while NSAID reduced albumin concentration in the rat model. SIGNIFICANCE: Our results lend support to the current use of anti-inflammatory ototopicals in the treatment of inflammatory middle ear disease.

Fluorescent retrograde axonal tracing of the facial nerve.

OBJECTIVE: The objective of this study was to investigate retrograde fluorescent axonal labeling of motor nerves as an aid to surgical dissection in otolaryngology-head and neck surgery. METHODS: Cholera toxin B subunit conjugated to a fluorescent dye was injected into the facial musculature of New Zealand white rabbits. At variable time points after injection, the facial nerves were harvested and analyzed for fluorescence in the peripheral axon. RESULTS: All injected animals demonstrated axonal fluorescence. No animal demonstrated facial weakness. Fluorescence was detected a maximum of 20 mm from the distal end of the nerve. Time periods greater than 48 hours did not substantially increase transport distance. CONCLUSIONS: Cholera toxin B subunit fluorescent conjugates, when administered intramuscularly, reliably label the distal portion of the facial nerve. In vivo labeling of a motor nerve may have significant potential for identifying a nerve in surgery. This work represents a preliminary investigation into the adaptation of in vivo fluorescence techniques as an aid to surgical dissection. Further research to refine this technique should be supported.

Results of Caldwell-Luc after failed endoscopic middle meatus antrostomy in patients with chronic sinusitis.

OBJECTIVES/HYPOTHESIS: The Caldwell-Luc operation for treatment of medically refractory chronic maxillary sinusitis has largely been replaced by functional endoscopic sinus surgery. Despite this change, the Caldwell-Luc procedure still has well documented indications including treatment of both failed endoscopic middle meatus antrostomy and irreversible mucosal changes. The purpose of the study was to review the authors' experience and results of Caldwell-Luc procedure after failed endoscopic middle meatus antrostomy in patients clinically deemed to have irreversible mucosal changes. STUDY DESIGN: Retrospective review of preoperative and postoperative results of patients who underwent Caldwell-Luc procedure for refractory chronic maxillary sinusitis after failed endoscopic middle meatus antrostomy. METHODS: The preoperative and postoperative clinical course of patients treated with Caldwell-Luc procedure performed by a single surgeon between 1996 and 2001 were reviewed. Only patients with a history of chronic sinusitis after failed maximal medical therapy, no prior Caldwell-Luc procedure, prior endoscopic middle meatus antrostomy, and at least 6 months of follow-up were included. Outcome measurements including documented endoscopic examinations and the need for repeat surgery, and postoperative computed tomography scan results were evaluated to assess treatment success. RESULTS: The study involved 11 men and 26 women who underwent 50 Caldwell-Luc procedures. Caldwell-Luc procedure was performed bilaterally in 13 patients. The average number of prior endoscopic middle meatus antrostomies before Caldwell-Luc procedure was 2. Of all patients, 92% responded to surgical treatment as demonstrated by an endoscopic examination or computed tomography scan revealing a disease-free maxillary sinus. Repeat Caldwell-Luc procedure was required in 8.0% (n = 3) because of continued sinusitis. Two of the three cases with repeat Caldwell-Luc procedures demonstrated clinical improvement during follow-up. Average follow-up was 23.5 months. CONCLUSION: Caldwell-Luc procedure seems to be highly effective in the management of medically refractory chronic sinusitis after failed endoscopic middle meatus antrostomy. Caldwell-Luc procedure should remain in the otolaryngologist's surgical repertoire for these selected cases.