Timing of First Set of Pressure Equalization Tubes in Pediatric Patients With Cleft Deformities.

OBJECTIVES: Children with cleft palates often have comorbid eustachian tube dysfunction requiring pressure equalization tubes (PETs). PETs can relieve middle ear effusions that impede hearing. Ideal PET placement timing in this population is controversial. In this study, the audiologic exam passing rates of patients with cleft palate prior to and following PET insertion were assessed. Rates for patients receiving PETs at different ages were compared. It was hypothesized that earlier PET placement may benefit patients with additional months of improved hearing. METHODS: A retrospective chart review was performed of patients with cleft palate between November 22, 2016 and November 22, 2021 at a tertiary center. Statistical analysis compared passing/normal audiologic exams in patients receiving PETs at different ages. RESULTS: A total of 348 patients had cleft palate diagnoses, received PETs, and had adequate hearing data for inclusion. Those with PETs inserted at 3 months of age or less had an increase in percent of patients passing audiologic exams following versus prior to PET insertion of 13% (1.3 times improvement). Those receiving PETs between 7- and 12-months had the largest rate of improvement (42%) (2.4 times improvement); other groups had changes in passing rates between 31% and 40%. The rate of passing audiologic exams following PET insertion was high across all groups, ranging from 66% to 81%. CONCLUSION: This is one of the first studies exploring the timing of PET placement in this population and showed that patients receiving PETs at 3 months of age or younger passed subsequent audiologic exams at similar rates relative to those receiving PETs later in life. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:3391-3394, 2024.

Office Insertion of Tympanostomy Tubes and the Role of Automated Insertion Devices.

OBJECTIVE: Insertion of tubes in an office setting and automated tube insertion devices were identified as high-priority quality improvement opportunities during the update process for the 2013 clinical practice guideline on tympanostomy tubes from the American Academy of Otolaryngology-Head and Neck Surgery. The guideline update group, however, decided to avoid any recommendations on these topics, based on limited research evidence, and instead selected a subset of group members to author this state of the art review, with the goal of facilitating informed decisions in clinical practice. DATA SOURCES: PubMed through September 2021, Google search of device manufacturer websites, and SmartTots research website for articles on anesthesia neurotoxicity. REVIEW METHODS: A state of the art review format emphasizing evidence from the past 5 years, with manual cross-checks of reference lists of identified articles for additional relevant studies. CONCLUSIONS: The existing literature is too sparse to make recommendations about procedure setting and optimal technique or assess long-term outcomes. The role of automated devices is uncertain, given the increased equipment cost and limited information on characteristics of the proprietary preloaded tubes, including intubation duration and rates of otorrhea, obstruction, medialization, granulation tissue, and persistent perforation. IMPLICATIONS FOR PRACTICE: Whether to undertake in-office tube insertion in awake children should be based on clinician experience, clinician ability to interact with and reassure caregivers, shared decisions with caregivers, and judgment regarding the level of cooperation (or lack thereof) to be expected from a given child. Clinicians should remain alert to new research and expect increasing queries from patients and families.

Risk Factors for Multiple Tympanostomy Tube Placements in Children: Systematic Review and Meta-Analysis.

OBJECTIVES/HYPOTHESIS: To determine the rate and predictors of receiving multiple tympanostomy tube (TT) placements in children. STUDY DESIGN: Systematic review and meta-analysis. METHODS: PubMed, EMBASE, and Cochrane Library databases were searched for studies reporting the risk factors for receiving repeat TT (r-TT) placements in children with chronic otitis media with effusion or recurrent acute otitis media. These articles were systematically reviewed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) recommendations. Data were pooled using a random-effects model. RESULTS: Twenty-one studies involving a total of 290,897 children were included. Among all patients, 24.1% (95% confidence interval (CI), 18.2%-29.9%) underwent ≥2 TT placements and 7.5% (95% CI, 5.7%-9.4%) underwent ≥3 TT placements. Craniofacial disease (odds ratio (OR) 5.13, 95% CI, 1.57-16.74) was the strongest predictor of r-TT. Younger age at initial TT placement and shorter TT retention time were also significantly associated with r-TT. Receipt of primary adenoidectomy with initial TT placement was associated with decreased odds of r-TT (OR, 0.46; 95% CI, 0.39-0.55). Long-term tubes also significantly reduced the odds of r-TT (OR, 0.27; 95% CI, 0.17-0.44). CONCLUSIONS: About 1 in 4 children receiving TT will receive at least one repeat set of TT and about 1 in 14 will receive multiple repeat sets. Concurrent adenoidectomy and long-term tubes reduced the incidence of r-TT. Younger patients and those with earlier extrusion of the initial set are at increased risk for repeat surgery. The identification of these risk factors may improve parental counseling and identify patients who might benefit from closer follow-up. LEVEL OF EVIDENCE: NA Laryngoscope, 131:E2363-E2370, 2021.

Biofilm distribution on tympanostomy tubes: An ex vivo descriptive study.

BACKGROUND: Tympanostomy tube (TT) insertion is a common procedure in children with otitis media with effusion. Post-TT otorrhea (PTTO) is a frequent post-operative complication. Biofilms are involved in chronic PTTO cases. OBJECTIVE: To describe and qualitatively analyze the geometry and sites prone to biofilms on removed TTs, relatively to their position in the ear, past medical/surgical history and PTTO presence. METHODS: Biofilms presence and topographic distribution on TTs were ex vivo evaluated by using scanning electron microscope, confocal microscope and stereo-microscope. RESULTS: Forty-eight TTs from 30 children were analyzed. Indications for removal were: 71% due to retained TTs (average time from insertion: 24.4 ± 15.1 months), 23% due to chronic PTTO, and 6% due to TT obstruction/dysfunction. Different types of bacterial biofilms were detected on all TTs, regardless the time from their insertion nor their types. Biofilms were observed more on the perpendicular junction and on the internal lumen, and more biofilm colonies were detected on the medial part, facing the middle ear mucosa. TTs removed from children with PTTO exhibited more biofilm colonies when compared to their peers. Of the 16 children who underwent adenoidectomy concomitantly with TT insertion, 10 (62%) children were sent for TT removal due to retained TTs, and 6 (38%) children due to chronic PTTO (p = 0.03). CONCLUSION: Descriptive analysis of biofilm topographic distribution demonstrated adhesions on specific TT areas: perpendicular junctions and the internal lumen. Such "prone zones" may be the future target areas for changes in TT geometry or can be specifically coated with anti-biofilm materials.

The relationship between the tympanostomy tube extrusion time and viscosity.

OBJECTIVE: The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid. METHODS: Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded. RESULTS: The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant. CONCLUSION: The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time. TRIAL REGISTRATION NUMBER: NCT03848026.

Tympanostomy Tube Innovation: Advances in Device Material, Design, and Office-Based Technology.

OBJECTIVES: With tympanostomy tube insertion remaining the most common procedure performed in children to date, growing interests in minimizing both procedural costs and anesthetic exposure in the pediatric population have inspired innovation with respect to tympanostomy tubes. As such, we aim to discuss the current state of tympanostomy tube innovation including insertion devices, tube material, and design. METHODS: Computerized literature review. RESULTS: (1) Numerous single-use devices consisting of a myringotomy knife and preloaded tympanostomy tube offer potential advantages of decreasing or eliminating operating room time and may be performed under moderate instead of a general anesthetic. (2) Innovation with respect to tympanostomy tube material and design may offer enhanced ototopical drug delivery, decreased rates of tube occlusion, and/or the ability to dissolve "on-command" with application of a novel ototopical material. (3) These technologies currently remain in various phases of preclinical and clinical testing. CONCLUSIONS: While clinical testing for a number of new technologies is preliminary and ongoing, tympanostomy tube-related innovations hold exciting promise to supplement or potentially replace the present-day armamentarium of tympanostomy tube design and insertion moving forward.

The History of Myringotomy and Grommets.

The first recorded myringotomy was in 1649. Astley Cooper presented 2 papers to the Royal Society in 1801, based on his observations that myringotomy could improve hearing. Widespread inappropriate use of the procedure followed, with no benefit to patients; this led to it falling from favor for many decades. Hermann Schwartze reintroduced myringotomy later in the 19th century. It had been realized earlier that the tympanic membrane heals spontaneously, and much experimentation took place in attempting to keep the perforation open. The first described grommet was made of gold foil. Other materials were tried, including Politzer's attempts with rubber. Armstrong's vinyl tube effectively reintroduced grommets into current practice last century. There have been many eponymous variants, but the underlying principle of creating a perforation and maintaining it with a ventilation tube has remained unchanged. Recent studies have cast doubt over the long-term benefits of grommet insertion; is this the end of the third era?

Subannular ventilation tubes in the pediatric population: Clinical outcomes of over 1000 insertions.

OBJECTIVES: Long-term transtympanic tube insertions for chronic middle ear disease are associated with high rates of complications. The objective of this study was to examine the clinical outcomes achieved with an alternate technique, the subannular tube insertion, by determining mean tube lifespan, cumulative incidence of post-operative events and complications, audiometric changes and risk factors associated with earlier tube extrusion in the pediatric population. METHODS: A retrospective chart review of all patients operated for subannular tube insertion between January 2007 and 2013 was conducted in a single pediatric tertiary care center. Exploratory Cox regression analysis was performed to identify potential risk factors. RESULTS: A total of 1014 tubes from 459 patients were included in the study. Mean subannular tube lifespan was 41.3 months with median time of 35.0 months. Cumulative incidence of post-operative events in decreasing frequency were otorrhea (21.7%), tube blockage (16.0%), tympanic membrane retraction (12.5%), otitis media with effusion (10.0%), acute otitis media (6.4%), perforation (4.6%) and cholesteatoma formation (1.1%). For patients with available pre- and post-operative audiograms, mean air-bone gap improved from 19.5 dB to 7.0 dB after subannular tube insertion (p < 0.01). Increasing age and previous subannular tube insertion carried hazard ratios of 1.029 (p < 0.01) and 1.749 (p < 0.01) for tube extrusion respectively, while craniofacial anomalies and concomitant tympanoplasty at the time of tube insertion had hazard ratios of 0.795 (p < 0.01) and 0.680 (p = 0.03). CONCLUSIONS: Subannular tube insertion appears to be a safe and effective alternate technique for middle ear ventilation in cases of intractable disease.

A retrospective review of Paparella Type 1 tympanostomy tubes.

OBJECTIVE: This study aims to provide data on ear tube extrusion and complication rates for patients who have Paparella Type 1 tympanostomy tube (TT) placement. METHODS: Retrospective chart review of patients 6 months to 12 years old who underwent insertion of Paparella Type 1 TT by a single surgeon. RESULTS: Of 197 tubes evaluated, 3% were plugged between 1 and 3 months after surgery. Of the 144 tubes evaluated long-term, all tubes extruded within 4 years. There were no tympanic membrane perforations. CONCLUSIONS: This chart review showed expected rate of initial ear tube plugging. The rate of tympanic membrane perforation was lower than expected.

Factors affecting persistent tympanic membrane perforation after tympanostomy tube removal in children.

OBJECTIVES: Evaluate and compare the rates of persistent tympanic membrane (TM) perforations between short-term vs long-term tympanostomy tubes. In addition, to determine which demographic, anatomical, and physical factors affect ear drum healing after tympanostomy tube (TT) removal and simultaneous paper patch myringoplasty (PPM) in children. STUDY DESIGN: Retrospective chart review. METHODS: Charts were reviewed from the Women and Children's of Buffalo hospital and our pediatric otolaryngology practice electronic medical record. Data was retrieved from patients less than 18 years old who underwent surgical removal of a TT and concomitant PPM between January 2005 and January 2017. RESULTS: 343 ear drums were studied that underwent tympanostomy tube removal and paper patch myringoplasty. 45/343 (13%) of ears had a persistent perforation after PPM. The rate of persistent perforation with short-term tubes and long-term tubes was significantly different (6.6% and 20% respectively). Patient characteristics significantly associated with persistent perforations were: age at time of tube removal and number of tubes that patient received. Ear drum characteristics that significantly impacted persistent perforation included: size of ear drum perforation, and presence of tympanosclerosis. Length of intubation, ear drum atrophy, retraction, granulation tissue, middle ear effusion and thickened ear drum were not found to be significant factors. CONCLUSION: Overall, we found an 87% perforation closure rate after surgical removal of the TT and PPM. Persistent perforations occurred significantly more often in patients with long-term tubes than short term tubes. Our data also suggests that several patient and ear drum characteristics may be important factors that contribute to persistent perforation after tympanostomy tube placement and removal.

What's New with Tubes, Tonsils, and Adenoids?

Evidence-based recommendations are constantly being updated for various pediatric surgical procedures, including the role for tympanostomy tubes, as well as indications for adenoidectomy and tonsillectomy. With a growing body of research available on some of the most prevalent pediatric conditions, an update on the current concepts surrounding management is warranted.

Pneumocephalus and orbital emphysema associated with the use of an autoinflation device: a unique case report and review of the literature.

BACKGROUND: Autoinflation devices are commonly used for otitis media with effusion and Eustachian tube dysfunction. Generally, these are very safe devices, with few or no complications.Case reportThis paper presents a case study of pneumocephalus and orbital emphysema, associated with the use of an autoinflation device, in a 73-year-old woman with Eustachian tube dysfunction and otitis media with effusion, and a history of extensive endoscopic sinus surgery 13 years previously. CONCLUSION: A literature review showed autoinflation-related pneumocephalus in patients with skull base defects relating to cranial surgery or tumours; however, this has not been described previously with the Otovent system or its use in relation to functional endoscopic sinus surgery. Given the theoretical risk of undetected bony abnormalities in post-operative functional endoscopic sinus surgery patients, it is suggested that autoinflation devices are used cautiously in patients with a history of sinus surgery.

Association of Tympanostomy Tubes With Future Risk of Advanced Ear Surgery-A Population Study.

OBJECTIVE: To investigate future surgery for chronic ear disease in children who underwent tympanostomy tube (TT) placement, compared with non-surgically treated patients and healthy controls. STUDY DESIGN: Retrospective population-based cohort study. SETTING: All hospitals in the Canadian province of Ontario. PATIENTS/INTERVENTION: Of children aged 18 years and younger, three cohorts were constructed: 1) TT: patients who had undergone at least one TT procedure (n = 193,880), 2) No-TT: patients with recurrent physician visits for middle ear concerns who did not undergo TT (n = 203,283), and 3) Control: an age-sex matched control group who had not had TT or physician visits for recurrent middle ear concerns (n = 961,168). MAIN OUTCOME MEASURES: Risk, and odds ratios (ORs) of surgery for chronic ear disease. RESULTS: The TT cohort had a higher risk of tympanoplasty (OR 9.50 versus No-TT, p < 0.001; OR 207.90 versus Control, p < 0.001), ossiculoplasty (OR 3.22 versus No-TT, p < 0.001; OR 84.13 versus Control, p < 0.001), atticotomy (OR 4.41 versus No-TT, p < 0.001; OR 44.78 versus Control, p < 0.001), and mastoidectomy (OR 3.22 versus No-TT, p < 0.001; OR 89.12 versus control, p < 0.001). CONCLUSION: This study describes the population risk of subsequent ear surgeries in TT patients. These TT patients have a significantly higher risk of surgery for chronic ear disease versus those patients with recurrent middle ear disease that did not undergo TT, and age-sex matched controls.

Contribution of the Use of a Pen-Type Endoscope to Evaluate and Treat Ears Simultaneously During Cleft Palate Surgery in Late Presented Cases.

BACKGROUND: The prevalence of secretory otitis media is very high among the nonoperated cleft palate patients. METHODS: Ninety-one cleft palate operations were performed on late presented cases in Sudan, Africa. The surgeries were performed according to the Veau-Wardill-Kilner push-back technique. A laptop connected pen-type endoscopic camera was used to evaluate the tympanic membrane and address middle ear disease in all patients simultaneously. The procedure was performed after removing wax from the external auditory canal. A small incision was made with a myringotomy knife through the layers of the tympanic membrane if any sign of fluid collection was observed, after which the middle ear effusion was evacuated and the ventilation tube was inserted. RESULTS: This procedure was undertaken in 182 ears; 41 ears (22.5%) were healthy, 19 ears (10.5%) had chronic perforations, 122 ears (67%) underwent myringotomy procedures, and 54 (44.2%) were treated by inserting a ventilation tube. Despite the challenging work environment, standard monitoring facilities were available and all operations were completed with no early complications. CONCLUSION: The pen-type camera instead of an operating microscope was a tremendous contribution, as it was easy to handle and contributed to the good outcomes. The use of this technique is strongly recommended in surgical camps. LEVEL OF EVIDENCE: III.

Analysis of factors associated with multiple ventilation tube insertions in children with otitis media with effusion.

OBJECTIVE: To determine the factors related to multiple ventilation tube insertions in children with otitis media with effusion. METHODS: A retrospective review was performed of 126 ears of 81 children aged less than 12 years who had undergone insertion of a Paparella type 1 ventilation tube for the first time between August 2012 and March 2018. RESULTS: Mean age at the first operation was 4.0 ± 2.2 years, and the mean duration of otitis media with effusion before the first ventilation tube insertion was 5.4 ± 4.5 months. Among 126 ears, 80 (63.5 per cent) had a single ventilation tube insertion and 46 (36.5 per cent) had multiple insertions. On multivariate logistic regression, tympanic membrane retraction, serous middle-ear discharge, and early recurrence of otitis media with effusion were independent predictive factors of multiple ventilation tube insertions. CONCLUSION: Tympanic membrane retraction, serous middle-ear discharge, and early recurrence of otitis media with effusion after the first tube extrusion are associated with multiple ventilation tube insertions.

'Smart' grommets.

OBJECTIVE: A novel, smartphone-based technique for endoscopic grommet insertion is presented.Results and conclusionThis method is both cost-effective and time-saving, offering a valuable alternative to the traditional microscope-based method in a resource-constrained setting.

Comparison of extrusion and patency of silicon versus thermoplastic elastomer tympanostomy tubes.

OBJECTIVES: This study aimed to assess the differences in the extrusion rate, patency and incidence of otorrhea according to the material properties of tubes in tympanostomy tube (TT) procedures. SUBJECTS AND METHODS: A total of 75 children with bilateral chronic otitis media with effusion were randomized in this prospective trial to receive 1.02-mm-sized TTs (thermoplastic elastomer) in one ear and 1.14-mm-sized TTs (silicone) in the other ear. Data were obtained on ventilation tube type, time to extrusion, comorbidities, tube plugging, incidence of TT otorrhea during following up, and age of the patient. Postoperatively, follow-up by an otologist continued every two months to assess the incidence of otorrhea, plugging, and TT extrusion until all tubes were extruded. RESULTS: Out of the 75 children, 7 patients were excluded during surgery and 4 were lost during follow-up. The mean extrusion time of 1.02-mm-sized TTs (thermoplastic elastomer) was 10.28 months, whereas that of 1.14-mm-sized TTs (silicone) was 7.36 months, which showed a significant difference. However, thermoplastic elastomer TTs had more plugging events than silicone TTs. CONCLUSIONS: There was a significant increase in the time to extrusion in ears with the 1.02-mm-sized thermoplastic elastomer TT, although, generally, the larger inner diameter of the tube last longer in the eardrum. This contrasting result is thought to be due to the different material properties of both TTs. This information may be helpful for TT selection in clinical practice depending on the patient's condition.

A newly designed tympanostomy stent with TiO2 coating to reduce Pseudomonas aeruginosa biofilm formation.

Biofilm formation has been implicated as a cause of post-tympanostomy tube otorrhea in patients suffering from otitis media with effusion, and biofilms have been found to adhere to all available types of tympanostomy tubes (TT) made from silicone. In this study, we present a novel stent designed with a reduced surface area and a titanium dioxide (TiO2) coating to prevent biofilm formation. Using a radio frequency power supply, tympanostomy stents (TS) made from Nitinol (Nikel-titanium) were coated with TiO2 to form an oxide layer on the metallic target. We successfully reproduced biofilms with carbenicillin-resistant Pseudomonas aeruginosa strain, PAO1-GFP (green fluorescent protein) on the tubes in vitro. We then compared the levels of biofilm formation by this strain on the two types of implants using several methods, including bacterial quantification, electron microscopy, and confocal laser fluorescent microscopy. Our results provide definitive evidence that the combination of the TiO2 coating and minimized surface area of the Nitinol stent inhibited the P. aeruginosa biofilm formation. The ability of the TS to prevent viable bacteria colonization (over 10 folds, compared to silicone TT) was verified by anti-biofilm test. Future studies will reveal more useful in reducing otorrhea and plugging complications as a novel tympanostomy tube.