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Chronic Otitis Media with Effusion Sequelae
in Children Treated with Tubes

Dimitar Marev

Department of Ear, Nose, Throat Diseases, Varna University of Medicine, Varna, Bulgaria

ABSTRACT

Objective: The aim of this study is to determine the incidence and prevalence of middle ear sequelae and abnormal tympanometry results among children with chronic otitis media with effusion (OME) who received standard treatment with tympanostomy tubes.
Design: Prospective cohort study.
Setting: Community clinic and academic medical center.
Patients: A total of 140 children followed up for 8 years after tube treatment.
Main Outcome Measures: Tympanic membrane perforation, atrophy, retraction, hearing loss, myringosclerosis, low static admittance (SA) and broad-peaked tympanogram, high SA and narrow-peaked tympanogram, and negative tympanometric peak pressure.
Results: Annual incidence of sequelae was typically greater during 3 to 5 years than 6 to 8 years of followup. Greatest increases in incidence during the 5-year follow-up were for atrophy (67%), high SA and narrow- peaked tympanogram (70%), and retraction pocket (47%). Prevalence of these sequelae also increased over time, whereas low SA and broad-peaked tympanogram and negative tympanometric peak pressure decreased during follow-up. Sequelae tended to become bilateral over time, and concordance of different sequelae in the same ear was low (K, 0.05-0.42).
Conclusions: Annual incidence of sequelae decreased during follow-up. This finding parallels decreasing incidence of OME and tube placement as children mature and demonstrates that sequelae are more likely to develop during active acute and chronic OME. The cumulative effect of incidence resulted in few ears free of sequelae by 8 years of follow-up. Based on this cohort of healthy children with OME, although the risk of sequelae decreased over time, functional and morphologic sequelae were prevalent and may put children at risk for continuing middle ear problems as they grow into adolescence and adulthood.
Key words: Otitis media with effusion, Tubes, Sequelae.
Pro Otology 1:5456, 2004


INTRODUCTION

Tympanic membrane (TM) and middle ear sequelae have been reported in children who experience chronic otitis media with effusion (OME). This condition is often treated with tympanostomy tubes, making it difficult to separate effects of disease from effects of treatment. However, well-designed randomized studies have demonstrated that among children with chronic OME, some sequelae (e.g., myringosclerosis) are more common after tube treatment, whereas others occur at the same rate in tubed and untubed ears (1-4). The proportion of children or ears with a sequela at a given point in time (prevalence) can be estimated in a cross-sectional study, providing information about its current impact on the population.

However, measuring development of new sequelae over time (incidence) requires a prospective study with regular follow-up. In contrast to prevalence, incidence data provide estimates of the risk of developing the sequelae during a specified period in those who are free of it at the outset. There are only a few prospective studies with long-term follow-up and regular examination that are useful for determining the timing and concurrence of sequelae development (2,5). Sequelae incidence and prevalence rates among children with chronic OME treated with tympanostomy tubes who participated in the Long-term Sequelae of Otitis Media Study are presented herein (6).

MATERIALS AND METHODS

Between February 2000 and January 2003, 6-month-old to 8-year-old children from a suburban multispecialty clinic were enrolled in the study at the time of tympanostomy tube treatment for chronic OM. Children were excluded if they had preexisting OM complications, sequelae, anatomic conditions predisposing to OM sensorineural hearing loss of greater than 15 dB.

These included myringosclerosis, a white plaque with distinct margins on the TM surface; perforation, presence of a visible hole with absent TM mobility in an ear without a tube; and retraction pocket, atrophic area that moved principally to negative canal pressure. The combined measure of retraction included pars tensa, pars flaccida, and/or retraction pocket. Since less than 3% of ears developed generalized atrophy between 3 and 8 years of follow-up, segmental and generalized atrophy were combined for the analyses. Collection of pars tensa and pars flaccida retraction data was initiated after the third year of follow-up. Therefore, the prevalence of these 2 types of retraction and combined retraction were reported beginning with the sixth year. Hearing loss was defined as an average hearing level (500-4000 Hz) of 20 dB or higher or any of the thresholds at 30 dB or higher.

RESULTS

Mean age at the 3-year follow-up was 5.5 years (SD, 1.8 years; range, 3.5 - 11.1 years), and 61% of participants were male. By the third year of follow-up, 44% of ears had undergone 1 tube surgical procedure, 32% had undergone 2 tube surgical procedures, and 24% had undergone more than 2 tube surgical procedures; 84% of additional tubes were placed during the first 3 years of the study. Two hundred seventy-five ears of 138 children were examined and/or tested at 3 years, and 167 ears of 84 children were examined and/or tested at 8 years.

In general, annual incidence was greater in the 4- to 5-year follow-up than in the 6- to 8-year follow-up, with the range of annual incidence between 0% and 18%.

Incidence of specific sequelae varied substantially. Sixty-seven percent of ears developed atrophy, 40% developed myringosclerosis, and 3% developed perforation between 3 and 8 years of follow-up. One child had a cholesteatoma diagnosed 7 years after enrollment. At surgery, the cholesteatoma was found in a 3-mm-deep retraction pocket in the right ear that extended to the medial wall of the middle ear cleft. This child had been treated with only one set of tympanostomy tubes before cholesteatoma diagnosis.

Unlike incidence data that provide information about the risk of new sequelae in a 1-year period among ears without the sequela at the beginning of the period, prevalence describes the proportion of all ears with a given sequelae at a specific point in time.

Perforation of the TM was the least prevalent at both times, affecting only 2% of ears. At year 8, the most prevalent sequelae were atrophy and pars tensa/flaccida retraction, each present in 55% of ears.

DISCUSSION

This study demonstrates that annual risk of new OM sequelae (incidence) declined considerably throughout 3 to 8 years of follow-up for most sequelae studied. Declining incidence of OM. With fewer episodes of acute and persistent OME during the later period, a decrease in both tympanostomy tube treatment and the inflammatory processes that result in permanent changes to the TM and middle ear (e.g., myringosclerosis, perforation) were also less likely to occur, leading to a decreasing incidence of sequelae over time. In contrast, annual incidence rates for 3 sequelae (atrophy, high SA and narrow-peaked tympanogram, and retraction pocket) showed a lower rate of decrease throughout the entire follow-up period and remained at 9% to 15% at 8 years of follow-up. These sequelae are related in that they are either indicators of an overly compliant TM (high SA) or they are the consequence of TM thinning and damage (atrophy and retraction pocket).

Repeated OM episodes (as evidenced by the 8% or greater prevalence of flat tympanograms throughout follow-up) initiate production and release of an inflammatory mediator cascade. One of these mediators (collagenase) breaks down collagen fibers, e.g. thereby thinning and weakening the TM, which becomes prone to hypermobility, generalized atrophy, and retraction and may not be able to return to its normal state.

Hearing loss, an OM sequela of interest to both clinicians and researchers, was less common during follow-up than many other sequelae. Researchers have shown that conductive hearing loss associated with OM is typically in the mild-to-moderate range, with approximately 50% of children with OME having hearing levels greater than 20 dB (14,15). In an earlier report (6) on this cohort, 5- to 6-dB poorer hearing levels were associated with TM retraction occurring between 4 and 6 years of follow-up. Maw and Bawden (2) reported a similar finding of 3- to 4-dB poorer hearing associated with attic retraction at 7 and 10 years after tube treatment.

Retraction rates of 26% to 37% have been reported at 4 to 8 years of follow-up 2,18 compared with pars tensa and pars flaccida retraction rates of 38% at 6 years in this study.

The prevalence of specific sequelae (myringosclerosis, retraction pocket, TPP, hearing loss) increased with the number of tube treatments by 8 years of follow-up. However, since all children with chronic OME in this study were treated with tubes, it cannot be specifically determined whether sequelae are the consequence of disease persistence and severity or the result of number of tube treatments for refractory disease. Four studies that assigned ears to unilateral tympanostomy tube placement have reported TM sequelae 2 to 10 years later. Reported rates of tympanosclerosis (myringosclerosis) in the tubed ear have ranged widely: 20% at 10 years, 42% at 5 years, 3 48% at 1 to 3 years, 4 and 57% at 2 years.

In each study, the rate in the tubed ear was significantly higher than the rate in the nontubed or unoperated ear. The wide range of myringosclerosis rates associated with tubes could be due to tube type, co-treatment with adenoidectomy, age, OME severity, or other factors. Associations of retraction and atrophy with tympanostomy tubes are less strongly supported. In one study, atrophy or retraction occurred in 25% of tubed ears compared with 6% of ears not treated with tubes (1). However, 3 other studies reported no relationship between tubes and retraction.

Unspecified region of retraction was reported in 15% of tubed ears vs 11% of ears without tubes, 2 pars tensa retraction occurred in 18% of tubed ears and 16% of ears without tubes, 3 and attic retraction was present in 35% of tubed and 34% of untubed ears, whereas rates of pars tensa retraction were the same for both ears (13%) (4). Localized pars tensa atrophy was reported in 6% of tubed ears and 4% of ears not treated with tubes, whereas moderate-to-severe atrophy was present in 7% of tubed ears and 9% of untubed ears.4 At 10 years of follow-up, Maw and Bawden (2) found that 22% of tubed ears and 5% of nontubed ears had localized pars tensa atrophy.

Sequelae tended to be bilateral rather than unilateral at 8 years of follow-up. Previous studies (20,21) have shown that bilateral acute OM and OME predict later chronic or recurrent OME. This suggests that bilaterality may represent a more serious disease process that in turn results in bilateral sequelae. Presence of different sequelae in the same ear probably results from the ongoing effects of chronic OME complicated by episodes of acute OM. Examinations were performed quarterly for the first 3 years, twice a year for the fourth and fifth years, and annually thereafter. Families who moved out of the area often continued to participate in the study, but children did drop out over time. Differential withdrawal of those who had fewer middle ear problems during follow-up could skew the results, resulting in higher incidence and prevalence rates than one would obtain if the whole cohort was available. However, it is unlikely that study withdrawals biased these results. Prevalence of sequelae studied at 3 years did not differ significantly for withdrawals and those who participated through 8 years of follow-up. A weakness of the study is that all children in the cohort had chronic OME and were treated with tympanostomy tubes, making it difficult to separate effects of disease from effects of treatment. However, only myringosclerosis has been linked to tympanostomy tubes in all studies in which ears were randomized to unilateral tube treatment (1-4). Another study weakness is that participants were not a representative sample of children with chronic OME and tubes but were typically middle class, urban, and white.

In conclusion, based on the experience of this cohort of healthy children treated with tubes for chronic OME, sequelae typically developed earlier rather than later in disease and treatment. However, several morphologic and tympanometric sequelae (atrophy, retraction pocket, pars tensa and flaccida retraction, high SA and narrow-peaked tympanogram) were present in more than 50% of ears by 8 years of follow-up. Sequelae also tended to become bilateral over time, but concordance of similar morphologic sequelae in the same ear was only fair. Although the risk of OM decreases with age, sequelae that result from disease and/or tube treatment remain prevalent. These conditions may put children at risk for continuing middle ear problems as they grow into adolescence and adulthood examinations.

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