Analysis of Paparella Type 1 tympanostomy tubes in pediatric patients: A single-center retrospective review

Executive Summary of Clinical Practice Guideline on Tympanostomy Tubes in Children (Update).

Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. Despite the frequency of tympanostomy tube insertion, there are currently no clinical practice guidelines in the United States that address specific indications for surgery. This guideline is intended for any clinician involved in managing children, aged 6 months to 12 years, with tympanostomy tubes or being considered for tympanostomy tubes in any care setting, as an intervention for otitis media of any type. The primary purpose of this clinical practice guideline is to provide clinicians with evidence-based recommendations on patient selection and surgical indications for and management of tympanostomy tubes in children. The development group broadly discussed indications for tube placement, perioperative management, care of children with indwelling tubes, and outcomes of tympanostomy tube surgery. Given the lack of current published guidance on surgical indications, the group focused on situations in which tube insertion would be optional, recommended, or not recommended. Additional emphasis was placed on opportunities for quality improvement, particularly regarding shared decision making and care of children with existing tubes. ACTION STATEMENTS: The development group made a strong recommendation that clinicians should prescribe topical antibiotic eardrops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea. The panel made recommendations that (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months' duration; (2) clinicians should obtain an age-appropriate hearing test if OME persists for 3 months or longer (chronic OME) or prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer (chronic OME) and documented hearing difficulties; (4) clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who did not receive tympanostomy tubes until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (5) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (6) clinicians should offer bilateral tympanostomy tube insertion to children with recurrent AOM who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (7) clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors; (8) in the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications; (9) clinicians should not encourage routine, prophylactic water precautions (use of earplugs, headbands; avoidance of swimming or water sports) for children with tympanostomy tubes. The development group provided the following options: (1) clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) and symptoms that are likely attributable to OME including, but not limited to, vestibular problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life and (2) clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is unlikely to resolve quickly as reflected by a type B (flat) tympanogram or persistence of effusion for 3 months or longer (chronic OME).

Microbiology of chronic and recurrent otitis media with effusion in young infants

Introduction Otitis media (OM) is the most common reason children receive general anesthesia, with bilateral tympanostomy tube (TT) insertion the second most common surgery in children. Prior research suggests overuse of TT. As part of a project designed to improve appropriateness of OM referrals, we evaluated appropriateness of TT insertion in a patient cohort. Methods Patients younger than 9 years with initial otolaryngology (ORL) visits in academic and private office settings for OM from January 1, 2012, to August 31, 2013, were identified through claims database. A detailed retrospective chart review of patients undergoing TT insertion was performed to determine appropriateness of TT insertion per the 2013 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) guidelines. Results A total of 120 patients undergoing TT insertion were randomly chosen for detailed chart review; 32 patients were excluded. Sixty-six (75%) of 88 patients available for analysis met AAO-HNSF guidelines for TT. Recurrent acute OM with middle ear effusion was the most common indication (56%). Other indications included chronic OME and TT in at-risk patients with speech, learning, or behavioral delays. Of the 22 patients undergoing TT insertion not meeting AAO-HNSF guidelines, 11(50%) had abnormal exams, but were 1 to 2 infections short of meeting guidelines; 7 (33%) had normal exams but met criteria for number of infections. Discussion Contrary to prior publications, 75% of patients undergoing TT insertion had an appropriate indication per AAO-HNSF guidelines. In only 5% was TT insertion a substantial departure from guidelines. Implications for Practice The study outcomes suggest appropriate clinical decision making, improved guideline adherence, and better guideline applicability from the previously published 1994 and 2004 guidelines.

Bilateral myringotomy and tympanostomy tube placement (BMT) is the most common pediatric surgery in the United States. Intraoperative middle ear effusion (MEE) is a risk factor for future BMTs in children with recurrent acute otitis media (RAOM). However, the impact of the type of MEE is unknown. Here, we assess otologic outcomes based on intraoperative MEE type and indication for surgery. Case series chart review. After institutional review board approval, we performed a review of children undergoing BMTs between 2008 and 2009. Included patients had their first BMT, preoperative visit, and an operative report. Patients with cleft palate or Down syndrome were excluded. Indications for surgery included RAOM and chronic otitis media with effusion (COME). Other variables evaluated were future BMT, acquired cholesteatoma, and otorrhea. Logistic regression was used for statistical analysis. Out of 1,045 patients reviewed, 680 were included and underwent their first BMT. There were 619 patients who had RAOM. Serous effusions were present in 22.2%, mucoid in 31.3%, purulent in 12.9%, undocumented or bloody in 2.3% of patients, and 31.2% of patients had dry middle ears. Moreover, 22.7% of patients underwent future BMTs. In RAOM patients, serous effusions decreased odds of perforation (odds ratio [OR]: 0.195, 95% confidence interval [CI]: 0.0438-0.867, P = .032), and purulent effusions increased the odds of in-office otorrhea suctioning (OR: 2.13, 95% CI: 1.20-3.77, P = .010) compared to dry. Mucoid effusions had no significant effect on outcomes in COME or RAOM patients. Intraoperative MEEs were noted in 68.7% of cases; purulent effusions increase the odds of in-office suctioning in RAOM patients. 4 Laryngoscope, 131:E993-E997, 2021.

ConclusionsAlthough exposure to infectious agents and parental smoking are known to influence the overall risk of otitis media, these risk factors do not appear to be linked with the tendency to develop chronic otitis media with effusion (COME) instead of recurrent acute otitis media (RAOM). The genetic inflammatory response type of the child appears to influence the risk of persistent middle ear effusion in COME.ObjectiveTwo different clinical presentations of childhood otitis media are encountered: RAOM; and COME, which is associated with persistent effusion in the middle ear. The objective of this study was to assess putative factors that may regulate the development of persistent middle ear effusion in COME.Material and methodsIn total, 159 children with RAOM and their parents (n=304), and 55 children with COME and their parents (n=110) were evaluated. All the children with COME or RAOM were aged <4 years.ResultsThere was no difference in the frequency of attendance at day care outside the home, number of siblings or parental smoking between children with RAOM and those with COME. The frequency of parental allergy and asthma was lower among children with COME than those with RAOM.

Comparison of tympanostomy tube insertion with and without radiofrequency ablation eustachian tuboplasty for treating chronic otitis media with effusion.

A variety of cytokines, such as interleukin 1 and tumor necrosis factor (TNF), appear to play a key role in the initiation and maintenance of the inflammatory response in a variety of diseases, including chronic otitis media with effusion (COME). Recently, cytokine inhibitors have been isolated and are presumed to regulate the proinflammatory effects of these cytokines. This has lead us to hypothesize that the chronic inflammation seen in COME is the result of an imbalance in the ratio of proinflammatory cytokines and inhibitors that favors the proinflammatory cytokines. Middle ear effusions were evaluated for the cytokine TNF-alpha and the inhibitor TNF soluble receptor (TNFsolR) using a combination of enzyme-linked immunosorbent assays and radioactive immunoassays. We determined the presence and quantified the amounts of TNF-alpha and TNFsolR and correlated this result with clinical parameters in patients with COME. University hospital. To test this hypothesis, 35 middle ear effusions were obtained from 29 children aged 2 to 102 months (mean, 39.6 months) undergoing tympanostomy tube insertion for COME. Children were followed up for at least 12 months postoperatively and the number of subsequent episodes of otitis media correlated with cytokine levels. The TNF-alpha and TNFsolR were present in 83% and 91% of effusions, respectively. The TNF-alpha mean (+/-SEM) cytokine values were 110.6 +/- 32.1 pg/mg of total protein, and 12886 +/- 3108 pg/mg total protein for TNFsolR. Analysis of correlations in a univariate model revealed a statistically significant relationship for TNF-alpha correlated with TNFsolR (R2 = 0.463; P < .001). The TNF-alpha levels were significantly lower for children with multiple tube insertions (P = .02). Higher levels of TNF-alpha were noted in those children who subsequently developed episodes of otitis media after tube placement (P = .02). The ratio of TNF-alpha to TNFsolR, the mean (+/-SEM) inhibitor index was 430 +/- 220 U. Our data support the hypothesis that cytokines and their inhibitors are present in a large number of middle ear effusions and in part are likely important in the regulation of inflammatory processes in COME.

Objective: This study evaluated the effects of radiofrequency ablation (RFA) eustachian tuboplasty on the treatment of chronic otitis media with effusion (COME), and associated complications, in patients with premature extrusion of the tympanostomy tube (TT). Materials and Methods: Tuboplasty and T-tube reinsertion were performed in 23 ears with COME, a history of premature TT extrusion, and thickened mucus. Tube retention, perforation closure, hearing improvement, and complications were evaluated. Results: All 23 patients with COME and previous premature TT extrusion had remarkable mucosal hypertrophic disease or mucosal polypoid changes in the posterior cushion or posterior wall in the nasopharyngeal eustachian tube (ET) orifice. All surgeries were completed within 20 minutes after general anesthesia and were performed in the operating room. Pre-and post-air-bone gap gain was 18.3 ± 2.5 dB. The TT was retained for at least 12 months in 19 patients, whereas intentional premature removal at postoperative 8 to 9 months was required in 2 patients and premature extrusion occurred in 2 patients. Thus, the tube retention success rate was 91.3% (21/23). Of the 21 ears with intentional removal, the perforation closure rate was 81.0% (17/21). None of the patients reported RFA-related serious adverse events or a patulous ET. However, a scar synechia of the anterior-posterior wall was seen in 1 ET orifice, and stenosis of the ET orifice in 4 patients. Conclusions: RFA eustachian tuboplasty combined with TT insertion is a simple and minimally invasive technique for the treatment of intractable COME in patients with a thickened mucosa of the nasopharyngeal ET orifice. This technique may prevent premature TT extrusion.

Children with recurrent acute otitis media (RAOM) presenting without middle ear effusion (MEE) do not meet indications for surgical intervention as outlined by Clinical Practice Guidelines (CPGs). The objective of this study was to determine which patients presenting with RAOM without MEE ultimately received tympanostomy tubes. Case series. Single academic pediatric otolaryngology clinic. Children (0-12 years) presenting with RAOM and no MEE were identified from October 2017 to December 2019. As per CPGs, no surgery was offered initially. Patients were given a semiurgent return appointment should they experience another suspected otitis media episode. If MEE was observed, tympanostomy tube insertion was offered. Patients were followed for 1-year following enrollment. One-hundred and twenty-four patients were included. The median age was 3.15 years old (interquartile range: 4.10). Seventy-five (60%) patients did not require additional follow-up and thus did not require tympanostomy tubes. Forty-nine (40%) patients were seen again; of these, 11 patients received tympanostomy tubes. Therefore, of patients presenting with no MEE, 91% did not require tympanostomy tubes. Patients who had surgery were younger on initial assessment than those who did not (mean difference 2.68 years, 95% confidence interval: 2.14-3.23). This study demonstrates the practical effect of adhering to CPGs for RAOM and suggests that many children may not require tympanostomy tube placement within the 1st year after the consultation if they did not initially present with MEE.

ObjectivesThe role of pro-inflammatory cytokines in the course of chronic otitis media with effusion (COME) has been documented. However, there are fewer studies on the action of anti-inflammatory cytokines in the middle ear. We sought determine whether there is an association between COME and anti-inflammatory cytokines and whether there are any differences in the cytokine profile in COME children with and without atopy.MethodsEighty-four children were divided into 3 groups: 32 nonatopic children with COME (group NA), 31 atopic children with COME (group A), and 21 children without COME and without atopy (control group C). Specimens from the middle ear were collected and evaluated by enzyme-linked immunosorbent assay for the cytokines interleukin-1 receptor antagonist (IL-1Ra) and immunoregulatory IL-10.ResultsSignificantly higher IL-10 concentrations were found in both nonatopic and atopic children with COME compared to controls. No significant differences in IL-1Ra levels were found between atopic and nonatopic children with COME and the control group.ConclusionWe found no differences in the levels of IL-1Ra in atopic and nonatopic children with COME compared to controls. However, we found elevated IL-10 levels in the middle ear effusions from children with COME, with or without atopy. These elevated immunoregulatory cytokine levels suggest a role for new immunomodulatory treatments to prevent disease progression in COME, regardless of atopy.

Adenoidectomy for otitis media with effusion in 2–3-year-old children

Otitis media with effusion (OME) is a highly prevalent disease in children, but the exact pathogenesis and role of bacteria are still not well understood. This study aimed to investigate the presence of otopathogenic bacteria in the middle ear effusion (MEE) and adenoid of children with chronic OME (COME), and to investigate in vivo whether these bacteria, especially Haemophilus influenzae, are organized as a biofilm in the middle ear fluid. MEE and adenoid samples were collected from 21 patients with COME. Extensive bacterial culturing and genotyping was performed on all middle ear and adenoid samples. Fluorescence in situ hybridization (FISH) and confocal laser scanning microscopy (CLSM) was used to visualize possible biofilm structures for a selection of middle ear effusion samples. 34 MEE samples were collected from 21 patients of which 64.7% were culture positive for bacteria and 47.0% were culture positive for Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus and/or Streptococcus pneumoniae. All 21 adenoid samples were culture positive for one or more of these four otopathogens. H. influenzae (35.3%) and S. pneumoniae (76.2%) were the most frequently cultured bacteria in the MEE and adenoid samples, respectively. The same bacterial species was found in MEE and adenoid for 84.6% of the patients and in 81.2% of the cases where the same species was found in more than one site it involved the same bacterial genotype. FISH and CLSM demonstrated the presence of H. influenzae specific biofilm structures in five of the eight culture positive MEEs that were tested, but in none of the two culture negative MEEs. The findings in this study indicate that the adenoid acts as a reservoir for bacteria in MEE and confirms that biofilms, in at least half of the cases consisting of H. influenzae, are indeed present in the MEE of children with COME. Biofilms may thus play a crucial role in the pathogenesis of COME, which is important in the understanding of this disease and the development of potential future treatment options.

A prospective clinical cohort study was established to investigate the humoral immune response in middle ear fluids (MEF) and serum against bacterial surface proteins in children suffering from recurrent acute otitis media (rAOM) and chronic otitis media with effusion (COME), using Luminex xMAP technology. The association between the humoral immune response and the presence of Moraxella catarrhalis and Streptococcus pneumoniae in the nasopharynx and middle ear was also studied. The levels of antigen-specific IgG, IgA, and IgM showed extensive interindividual variation. No significant differences in anti-M. catarrhalis and anti-S. pneumoniae serum and MEF median fluorescence intensity (MFI) values (anti-M. catarrhalis and antipneumococcal IgG levels) were observed between the rAOM or COME groups for all antigens tested. No significant differences were observed for M. catarrhalis and S. pneumoniae colonization and serum IgG levels against the Moraxella and pneumococcal antigens. Similar to the antibody response in serum, no significant differences in IgG, IgA, and IgM levels in MEF were observed for all M. catarrhalis and S. pneumoniae antigens between OM M. catarrhalis- or S. pneumoniae-positive and OM M. catarrhalis- or S. pneumonia-negative children suffering from either rAOM or COME. Finally, results indicated a strong correlation between antigen-specific serum and MEF IgG levels. We observed no significant in vivo expressed anti-M. catarrhalis or anti-S. pneumoniae humoral immune responses using a range of putative vaccine candidate proteins. Other factors, such as Eustachian tube dysfunction, viral load, and genetic and environmental factors, may play a more important role in the pathogenesis of OM and in particular in the development of rAOM or COME.

The role of vascular endothelial growth factor in pediatric otitis media with effusion