Use of Topical Phenol in Awake Young Children for Tympanostomy Tube Placement.

Importance: Phenol kits cleared by the Food and Drug Administration (FDA) are indicated as a topical anesthetic for the tympanic membrane (TM) in adults. However, there is no existing literature that reports outcomes to support the safety and use of phenol on the TM of awake children. Objective: Determine if topical phenol is safe and at low risk for complications and therefore be used effectively in awake children to facilitate office otologic procedures as in adults. Design, Setting, and Participants: Children under 21 years of age whose parents agreed to participate in an awake office setting for tympanostomy tube (TT) placement. All children had TT placement after phenol placement on the TM prior to insertion. Main Outcomes and Measures: TM perforation or other signs of TM complications through a minimum of 6-month clinical follow-up, along with assessment of the tolerability of the procedure by the child. Results: A total of 228 children with an age range of 6 months to 15.9 years and 435 TMs completed TT placement using phenol as a local anesthetic while awake in the office. There were no complications reported in the 204 children at the first follow-up visit post TM placement within 3 to 10 weeks. Of the 93 children followed up at least 6 months, there were no TM complications reported. Conclusions: This is the first study to report the outcomes on the use of phenol in an office setting in children. In this large experience, phenol appears to be tolerable and safe for use in young children in the office and is a potential safe choice of topical anesthesia for surgeons if they choose to perform office procedures such as myringotomies or TT placement on children.

In-office insertion tympanostomy tubes in children using single-pass device.

OBJECTIVES: Insertion of tympanostomy tubes (TT) is generally accomplished in children in the operating room under general anesthesia. We report on 229 children treated in-office with a novel device. METHODS: Investigators participated in an IRB-approved, prospective, single arm, multisite investigation of in-office TT placement in awake children. Topical anesthetic was applied, and protective restraint was used. TT placement was performed with a single-pass TT insertion device. Safety was assessed by monitoring procedural events. RESULTS: Four hundred and forty-four ears were treated in 229 children at 10 sites. Children were in age groups 6-24 months (n = 211, mean = 13 months) and 5-12 years (n = 18, mean = 8.3 years). Two hundred and fifteen children received bilateral TT placement, and 14 received unilateral placement. Overall, 226/229 (98.7%) children had successful TT placement in the office (209/211 in 6-24 months and 17/18 in 5-12 years). Three children were rescheduled for the operating room due to anatomical challenges or patient movement. Median procedure time for bilateral cases in both age groups was 4:53. Two minor adverse events (AEs) were reported in one patient. Per independent assessment of 30 procedure videos by clinicians, TT placement was tolerated acceptably by all children. CONCLUSION: In-office TT placement in awake young children using topical anesthetic, enabled by a single pass delivery device, was safe, successful and well tolerated. The American Academy of Otolaryngology (AAO) recently released a Position Statement supporting in-office TT placement in appropriate children. These results affirm an in-office alternative for clinicians and parents who have concerns with the risk, inconvenience and cost of surgery in an operating room under general anesthesia.Level of Evidence: 2c.Clinical Trials Registration Number: NCT03544138.

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up.

BACKGROUND: The objective of this prospective, multicenter, randomized trial was to evaluate and compare 1-year outcomes from the REMODEL study between office balloon dilation and functional endoscopic sinus surgery (FESS). METHODS: Adults with maxillary chronic rhinosinusitis (CRS), including those with anterior ethmoid disease, who failed medical management and were surgical candidates for FESS, underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed through a minimum of 1 year. Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey. Standardized effect sizes were computed to further assess clinical significance. Ostial patency rate, rhinosinusitis episode frequency, impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey, complications, and revision rate were also compared between the two groups. RESULTS: Ninety-two patients (50 balloon dilation; 42 FESS) were treated and 89 (96.7%) completed 1-year follow-up. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales. The 1-year mean change in SNOT-20 after balloon dilation (-1.64) was noninferior to FESS (-1.65; p < 0.001). The standardized effect size was large, showing clinically significant improvement for both interventions. Ostial patency was 96.7 and 98.7% after balloon dilation and FESS, respectively, and each group reported significant reductions (p < 0.0001) in rhinosinusitis episodes (mean decrease, 4.2 for balloon dilation and 3.5 for FESS). Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved (p < 0.001) in both groups. There were no complications and revision surgery rate was 2% in each arm through 1 year. CONCLUSION: 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.

In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up.

OBJECTIVES: This study evaluated in-office balloon dilation of maxillary sinus ostia and ethmoid infundibula to treat chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS). METHODS: Seventy-four patients with disease in the maxillary and anterior ethmoid sinuses on computed tomography were prospectively enrolled across 12 study centers. All procedures were performed in the office. The primary outcomes were clinical effectiveness and health-care utilization at 1 year, measured by the validated surveys Sino-Nasal Outcome Test (SNOT-20) and Rhinosinusitis Symptom Inventory (RSI). RESULTS: Dilation was successful in 69 patients (93.2%), and the average periprocedural pain level was 3.2 (scale of 0 to 10). The mean improvement on the SNOT-20 at 1 year was clinically and statistically significant (p < 0.0001), with no significant difference between the CRS and RARS patient outcomes. The treatment effect was the same in the CRS and RARS subgroups and was either "moderate" or "large" for 10 of 12 symptoms. The mean numbers of antibiotic courses (p < or = 0.001), sinus-related physician visits (p < 0.0001), and number of acute sinus infections (p < 0.001) decreased significantly in both subgroups. There were no serious device-related adverse events, and the rate of revision surgery was 5.8%. CONCLUSIONS: Stand-alone balloon dilation of the maxillary sinus ostia and ethmoid infundibula performed in the office is well tolerated and effectively treats both CRS and RARS.

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial.

BACKGROUND: A prospective randomized controlled study was conducted on patients with chronic rhinosinusitis (CRS) to test the hypotheses that symptom improvement after balloon dilation was noninferior to functional endoscopic sinus surgery (FESS) and balloon dilation was superior to FESS for postoperative debridements. METHODS: Adults with uncomplicated CRS of the maxillary sinuses with or without anterior ethmoid disease who met criteria for medically necessary FESS were randomized 1:1 to office balloon dilation or FESS and followed for 6 months. A minimum of 36 patients per arm were required to test the hypotheses with 90% power. Symptom improvement using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey, debridements, recovery outcomes, complications, and revision surgeries were compared between groups. RESULTS: Ninety-two patients (50 balloon dilation; 42 FESS) were treated. Mean SNOT-20 improvement was 1.67 ± 1.10 and 1.60 ± 0.96 in the balloon and FESS arms, respectively. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement and the balloon arm was noninferior (p < 0.001) to FESS. The mean number of postprocedure debridements per patient was 0.1 ± 0.6 in the balloon arm versus 1.2 ± 1.0 in the FESS arm, with the balloon group showing superiority (p < 0.0001). Occurrence of postoperative nasal bleeding (p = 0.011), duration of prescription pain medication use (p < 0.001), recovery time (p = 0.002), and short-term symptom improvement (p = 0.014) were all significantly better for balloon dilation versus FESS. No complications occurred in either group and one revision surgery was reported in each arm. CONCLUSION: 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.

Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool.

BACKGROUND: A multicenter prospective study was conducted to assess the safety and sustained effectiveness of a new instrument possessing multifunctionality as an ostium seeker, suction-irrigator, and malleable balloon-dilator indicated for treating multiple sinuses. METHODS: Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit. RESULTS: A total of 497 balloon dilations (279 frontal, 138 sphenoid, and 80 maxillary) were attempted in 175 patients. Over 96% (479/497) of the attempted sinus dilations were successfully completed, while 18 dilations were converted to traditional dissection due to an inability to access or dilate the targeted anatomy. Two (1.1%) nonserious adverse events were reported following hybrid-balloon dilation and both were unrelated to the device or the procedure. Forty-four of 50 patients in the extended follow-up cohort completed the 1-year follow-up. Sinus symptom improvement in this group improved significantly from an average severity of 1.9 ± 1.1 to 0.8 ± 0.7 (p < 0.0001) and 1-year ostial patency was 91.6% (76/83). One revision surgery (2.3%) was performed. CONCLUSION: These results indicate that a multifunctional, malleable, balloon-dilating device can be safely and successfully used to treat multiple sinuses with sustained ostial patency and symptom improvement for at least 1 year.

Two-year results: transantral balloon dilation of the ethmoid infundibulum.

BACKGROUND: Multiple prospective and retrospective studies have reported results from balloon-only procedures and hybrid balloon sinus surgeries through intermediate follow-up periods of up to 1 year. Long-term durability results beyond 2 years are limited. METHODS: One-year results from the original study of standalone transantral balloon dilation in patients with computed tomography (CT) evidence of chronic inflammation in the maxillary sinuses alone or maxillary and anterior ethmoid sinuses combined were previously reported. Revision rate, symptom improvement, and productivity improvement were prospectively evaluated after a minimum follow-up of 2 years. RESULTS: Fifty-nine patients (107 maxillary ostia) underwent balloon dilation of the maxillary sinus outflow tract and completed postprocedure follow-up assessment at 27.0 ± 3.6 months. Patient 20-item Sino-Nasal Outcome Test (SNOT-20) score improved from 2.65 ± 0.97 at baseline to 0.79 ± 0.71 at long-term follow-up (p < 0.0001). Improvement in work productivity and activity due to sinus-related health issues for all patients was statistically significant across all survey instrument characteristics (p range, <0.0001 to 0.02). An analysis of the outcomes in a subgroup of patients with maxillary and anterior ethmoid disease (20; 34%) showed similar significant improvement in symptoms (SNOT-20 decrease = -2.1; p < 0.0001). Approximately 92% of all patients reported satisfaction with the balloon procedure. Four (6.8%) patients underwent revision sinus surgery at 11.1 ± 7.3 months after treatment. CONCLUSION: Patients with chronic rhinosinusitis and radiographic evidence of isolated maxillary disease with or without anterior ethmoid disease have reported clinically meaningful and statistically significant improvement in symptoms, productivity, and activity through a minimum of 2 years following standalone balloon dilation.

First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis.

BACKGROUND: To report outcomes for subjects undergoing balloon dilation in either the operating room (OR) or the clinic and define criteria to identify suitable candidates for local anesthesia procedures. METHODS: Subjects with medically refractory chronic rhinosinusitis (CRS) underwent de novo surgery via transantral balloon dilation of the maxillary sinus ostium and ethmoid infundibulum. Concomitant nasal or endoscopic sinus surgeries were contraindicated. Technical success, surgical parameters, and long-term outcomes were evaluated through 12-month follow-up. RESULTS: Seventy-one subjects underwent balloon dilation and 94% completed follow-up through 12 months. A total of 132 maxillary ostia were targeted for treatment and 129 were successfully dilated (98%). Almost one-half (33) of the procedures were performed in the OR under local anesthesia with intravenous sedation. Average balloon procedure times for unilateral and bilateral treatment were 28.3 ± 21.1 and 40.2 ± 17.7 minutes, respectively. Thirty-three ostial dilations in 19 subjects were attempted in the clinic. Each ostium was successfully accessed and ballooned under local anesthesia. Patient tolerance was very good with an average self-reported pain level of 2.7 (2 = hurts a little bit) out of 10. Each subject was discharged within 2 hours of the procedure and there was no postoperative bleeding. Symptomatic improvement of the clinic subgroup at 3, 6, and 12 months postprocedure was statistically significant (p ≤ 0.0012) and clinically meaningful and similar in magnitude to improvement seen across all subjects regardless of site of service. CONCLUSION: Transantral balloon dilation can be performed safely in the clinic and operative settings with symptom improvement sustained through 1 year.

Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum.

BACKGROUND: Although multiple clinical trials have demonstrated that balloon dilation of sinus ostia in patients diagnosed with chronic rhinosinusitis (CRS) results in sustained symptomatic improvement, less data are available to measure the effects of sinusitis on worker productivity. The objective of our research was to analyze work and activity impairment before and after transantral, endoscopically-guided balloon dilation of the maxillary sinus ostia and ethmoid infundibulum. METHODS: Subjects diagnosed with CRS and computed tomography (CT) evidence of disease in the maxillary sinuses alone, or maxillary and anterior ethmoid sinuses, completed the Work Productivity and Activity Impairment (WPAI) questionnaire and the Work Limitation Questionnaire (WLQ) before treatment and at 3, 6, and 12 months postprocedure. RESULTS: A total of 56 subjects were enrolled and 53 completed the 1-year follow-up. The lost productivity composite score computed from the WLQ improved by 73% (9.0 to 2.4; p < 0.0001) at 1-year follow-up whereas lost productivity at work as measured by the WPAI improved by approximately 76% (38.3 to 9.2; p < 0.0001) 12 months after treatment. CONCLUSION: These results indicate that sinus-related health problems impose a substantial burden on work productivity and physical/mental activity levels. Treatment of CRS by dilating the maxillary sinus ostium and ethmoid infundibulum can significantly improve quality of life (QOL) and work productivity.

One-year results: Transantral balloon dilation of the ethmoid infundibulum.

A prospective, multicenter research study is under way to demonstrate long-term improvement in chronic rhinosinusitis symptoms after transantral balloon dilation of the ethmoid infundibulum. Trial results from an interim analysis of symptomatic status using the Sino-Nasal Outcome Test 20 survey demonstrate significant and sustained improvement through post-procedure 1-year follow-up. Additionally, these data provide evidence that the symptomatic improvements following balloon expansion within the ostiomeatal unit to treat medically refractory inflammation of the maxillary sinuses, either alone or with concomitant anterior ethmoid disease, are similar.

Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia.

BACKGROUND: A multicenter study (BREATHE I - Entellus Medical, Inc.) was performed to assess the safety and outcomes of a new, less invasive system that uses direct endoscopic visualization to facilitate balloon dilation of the maxillary sinus ostia and ethmoid infundibulum. General anesthesia was avoided in most subjects to assess feasibility of performing transantral ostial dilatation in an office setting. METHODS: Subjects with chronic rhinosinusitis of the maxillary sinuses alone or maxillary and anterior ethmoid sinuses underwent baseline evaluation including CT imaging and symptom assessment using the Sino-Nasal Outcome Test (SNOT 20). Subjects underwent transantral balloon dilation and follow-up evaluation at 1 week, 3 months, and 6 months post-procedure. RESULTS: Thirty subjects were treated at three centers. Fifty-five of 58 maxillary ostia were successfully treated for a procedural completion rate of 94.8%. Ninety-seven percent of the procedures were completed under local anesthesia with or without minimal intravenous sedation. There were no device-related serious adverse events or unanticipated adverse device effects. The mean overall SNOT 20 score at baseline was 2.9 +/- 1.0. Mean overall SNOT 20 scores at 1-week, 3-month, and 6-month follow-up were 0.8 +/- 0.8, 0.7 +/- 0.8, and 0.8 +/- 0.9 respectively. Patency at 3-months as confirmed by CT imaging was 95.8%. CONCLUSION: These results indicate that transantral balloon dilation of the ostiomeatal complex under local anesthesia appears to be a safe technique for managing isolated maxillary or maxillary and anterior ethmoid sinusitis and can potentially be performed safely in an office setting.