RESUMEN
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.
RESUMEN
OBJECTIVE: To evaluate the effectiveness of OtoScan CO2 laser-assisted myringotomy (OtoLAM ESC/Sharplan) for acute otitis media and chronic otitis media with effusion (COME) in children. STUDY DESIGN: Retrospective review of 47 children with refractory acute otitis media (RAOM) or COME more than 3 months in duration in a pediatric otolaryngology practice. METHODS: Laser-assisted myringotomy was performed on 47 patients (79 ears) using the OtoLAM device. There were 28 children (ages 0.50-3 years) with RAOM and 19 children (ages 0.58-15 years) with COME. RESULTS: A total of 57.4% of procedures were considered treatment failures. Failures occurred in 53.6% of patients with RAOM on average +/-SD 3.89 +/- 2.16 weeks after the procedure and in 63.2% of patients with COME on average +/-SD 7.25 +/- 5.57 weeks after the procedure. Age, sex, microorganism isolated, myringotomy size, wattage, and laterality did not predict outcome. Ventilation tube insertion was performed in 27 (57.4%) patients. Two patients have persistent tympanic membrane perforations at 2 years. CONCLUSIONS: Laser-assisted myringotomy in children with RAOM and COME was associated with a high incidence of recurrence or persistence of disease and with perforation of the tympanic membrane. Recommendations for use of the OtoLAM should include discussion of high failure rates and the strong likelihood of subsequent ventilation tube insertion. The OtoLAM remains an option for office-based ventilation of the middle ear for families and patients where general anesthesia is a concern.
