Skovlund, Sandra M.

Myringotomy with ventilation tube placement is a common surgical procedure performed in children and adults to remove fluid buildup behind the tympanic membrane. However, retention of tubes beyond achievement of therapeutic response increases risk for complications and additional intervention. This small feasibility study was conducted to demonstrate proof of concept of a novel bioabsorbable ventilation tube that provides the necessary duration of ventilation with absorption shortly thereafter. Tubes were placed in 15 ears of 14 patients meeting indications for short or intermediate duration of middle ear ventilation. Two independent examiners documented tube patency and tube absorption status at 3, 6, and 12 weeks or until absorption was complete. Results indicate that average ventilation time was 12 weeks (range, 3 weeks to 18 months). There was no observation of blockage. These findings support the feasibility of a novel bioabsorbable ventilation tube.

Abstract 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.