Rimell, Frank L.

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.

Background Balloon catheter sinuplasty (BCS) for chronic rhinosinusitis (CRS) was found to be successful in adults. The safety and feasibility of BCS in children has been recently established. The purpose of this study was to study the outcome of this technology in CRS in children. Methods A prospective, multicenter, nonrandomized evaluation was performed on patients with CRS. Thirty-two children between the ages of 2 and 11 years were enrolled. Safety was assessed by rate of adverse events. Effectiveness was assessed using the Sino-Nasal (SN)-5 quality-of-life questionnaire for children with CRS at 52 weeks follow-up. Results Thirty-two children were enrolled of which 24 completed their 52 weeks follow-up. No adverse events were reported because of the procedure. SN-5 score improved from a mean of 4.9 at baseline to a mean of 2.95 at 52 weeks (p < 0.0001). Twelve (50%) children had a significant improvement of their SN-5 (> – 1.5), 7 (29%) had moderate improvement (> –1.0 and < –1.5), 2 (8%) had mild improvement (> –0.5 and < –1.0), 1 (4%) remained the same, and 2 (8%) had worsening scores. Conclusions Balloon catheter dilation of the sinus ostia in children was safe and a significant number showed improvement of their SN-5 at 1 year follow-up. Additional studies comparing balloon sinuplasty to other modalities of treatment in children are needed to determine its efficacy in the treatment of CRS in children.

Insertion of tympanostomy tubes is a common elective pediatric surgical procedure and is typically performed under general anesthesia. The potential to reduce general anesthetic requirements for young children has led to increased interest in alternatives for tympanostomy tube placement. A tympanostomy tube system, developed to enable tympanostomy tube placement in a single pass on conscious patients under moderate sedation, was evaluated. A prospective study on 128 children and 253 tympanostomy tube placements conducted at 4 centers in the United States demonstrated an 88.3% success rate in performing the procedure under moderate sedation with adverse events within normal rates reported in the literature. The feasibility of completing tympanostomy tube placement under moderate sedation enables avoidance of general anesthesia and provides additional choices to physicians and parents.