Tympanostomy tubes for children with acute otitis media

Recurrent AOM

Recurrent AOM is defined as the occurrence of 3 or more episodes of AOM in a 6-month period or the occurrence of 4 or more episodes of AOM in a 12-month period that includes at least 1 episode in the preceding 6 months.¹ These episodes should be well documented as separate acute infections.¹ Risk factors for recurrent AOM include craniofacial malformations, early onset of AOM (before 6 months of age), family history of recurrent AOM, daycare attendance, low socioeconomic status, and passive smoking.³ Breastfeeding is protective.³ Children with recurrent AOM are at higher risk of developing OME, as well as hearing loss–related developmental outcomes,⁵ and they have poor quality of life owing to frequent episodes of ear pain, general illness, sleepless nights, and time lost from day care or school.⁶

A population-based birth cohort with more than 50,000 children born in southwestern British Columbia in 1999 to 2000 reported almost half (48.6%) of children had 1 or more episodes of AOM by age 3 years, and 7.8% met the definition for recurrent AOM.⁷ The 7-valent pneumococcal conjugate vaccine (PCV7) became available in 2001 and has been associated with a 6% to 7% reduction in overall incidence of AOM.³ The 13-valent PCV13, available since 2011, has been associated with further reductions in AOM.³

Management options for children with recurrent AOM include observation with episodic antimicrobial therapy, antibiotic prophylaxis, and myringotomy with tympanostomy tube (TT) insertion.⁸

Myringotomy with TT insertion

Myringotomy with TT insertion is the most frequently performed ambulatory pediatric surgery in North America and is indicated for recurrent AOM with MEE as well as for chronic OME and for patients with structural TM anomalies.⁹ Tympanostomy tubes allow drainage of middle ear fluid, thus reducing the potential for infection by viruses and bacteria.³ In the United States, almost 700,000 such procedures are performed every year, and 6.8% of the population had TTs placed before the age of 3.¹⁰ The most common short-term complication of TT insertion is otorrhea, for which topical antibiotic ear drops should be prescribed.¹¹ Longer-term complications of TTs include persisting perforation of the TM, which can lead to conductive hearing loss and increased risks of infection, as well as myringosclerosis (calcification of the TM), which may cause mild hearing loss.¹²

Recommendations¹² and clinical practice guidelines, such as those from the American Academy of Otolaryngology–Head and Neck Surgery, suggest TT surgery should be avoided in children with recurrent AOM if they do not have MEE in either ear at the time of assessment.¹¹ The Canadian Society of Otolaryngology–Head and Neck Surgery recommends TT surgery for patients with 6 or more episodes of AOM in a year or 4 or more episodes in 6 months.¹³

Tympanostomy tube surgery or not?

The decision to perform TT surgery for patients with recurrent AOM is a controversial one. Benefits include the commonplace observation of increased AOM-free periods after surgery and avoidance of systemic antimicrobial treatment, while drawbacks include the cost of the surgery, complications associated with anesthesia in young children, refractory tube otorrhea, and structural TM sequelae.¹¹

Since the introduction of PCV7 and PCV13 there have been 3 main studies comparing the efficacy of TT insertion versus observation with episodic antimicrobial therapy among children with recurrent AOM.^14-16 A retrospective matched cohort study among more than 13,000 children younger than 5 years of age with recurrent AOM reported that the TT group had a lower 1-year incidence of episodes of AOM (1.96 vs 2.18, respectively; P<.001) and fewer oral antibiotic prescriptions (1.52 vs 1.67; P<.001).¹⁴ However, at the 2-year follow-up, the difference between the TT group and the medically managed group was no longer significant for episodes of AOM (1.69 vs 1.66; P=.384) or number of oral antibiotic prescriptions (0.91 vs 0.87; P=.09).¹⁴

A Finnish randomized controlled trial among 300 children 10 to 24 months of age with recurrent AOM showed intervention failure (defined as 2 or more episodes of AOM in 2 months, 3 or more episodes in 6 months, or persistent effusion for 2 months) was lower in the TT group than in the observation group (21% vs 34%, respectively; 95% CI -25% to -1%; P=.04).¹⁵ The TT group also had a lower 1-year incidence rate of AOM (1.15 vs 1.70; difference of -0.55, 95% CI -0.93 to -0.17).

A more recent US randomized controlled trial among 250 children 6 to 35 months of age with recurrent AOM found no significant difference in the rate of episodes of AOM during a 2-year period in the intention-to-treat analysis (mean of 1.5 episodes, risk ratio 0.97; 95% CI 0.84 to 1.12; P=.66).¹⁶ The time to first occurrence of AOM was longer in the TT group than in the observation group (4.34 months vs 2.33 months; hazard ratio=0.68, 95% CI 0.52 to 0.90). Children in the TT group had higher mean (SD) days per year with tube otorrhea (7.96 [1.10] vs 2.83 [0.78] days) but had fewer mean (SD) days per year with other otitis-related symptoms (2.00 [0.29] vs 8.33 [0.59] days). The TT group also received shorter mean (SD) oral antibiotic treatment (8.76 [0.94] vs 12.92 [0.90] days); however, there was no evidence of increased antimicrobial resistance among the isolates obtained from children in the observation group. The results of these 3 studies are generally consistent in that benefit of TT surgery is seen in the first year after surgery, but this benefit disappeared by the end of the second year.

There is a substantial role for shared decision making with caregivers regarding whether to proceed with or to decline TT insertion.¹⁷ In a Canadian prospective cohort study of 51 parents of children younger than 6 years of age with recurrent AOM who underwent consultation for TT placement versus watchful waiting, parental decisional conflict and decisional regret scores were higher for the watchful waiting group than for the surgical group.¹⁷ The authors postulated that parents may have felt more insecure about an unclear course of watchful waiting versus a more certain course of surgery, which led to these results.¹⁷ Parents who perceived themselves to be more involved in the decision-making process also had lower levels of decisional conflict.¹⁷ Recent interest in office-based TT placement without general anesthesia has been welcomed by caregivers but currently lacks the support of most otolaryngologists.¹⁸