The management of chronic otitis media with effusion (COME) in children is a subject of much discussion and controversy and will remain so until a better understanding of its etiology has been achieved. With appropriate antimicrobial therapy, most children with OME significantly improve. However, despite many weeks of antimicrobial therapy, in some children, the middle ear effusion (MEE) persists, and surgical management is indicated.
By convention, an MEE that persists for more than 3 months is called chronic, and thus, the correct term for this condition is COME. Equivalent terms used to describe this process include persistent OME, chronic secretory OM, and glue ear.
Otitis media with effusion is an inflammatory middle ear process sufficient to produce effusion and may be divided into two broad categories - acute and chronic. It is not possible to predict accurately the etiology of an effusion merely on the basis of its physical characteristics (ie, mucoid, purulent, or serous); thus, OME is a useful generic term. A continuum exists between AOME on the one hand and COME on the other. Acute otitis media with effusion is generally accompanied by symptoms of inflammation such as otalgia, fever, irritability, and physical signs of redness and bulging of the tympanic membrane (TM). This is particularly true in the infant and younger child. In the older child, there may be no fever and only minimal otalgia, and the process may go unrecognized for a long period of time.
PATTERNS OF DISEASE
In formulating a surgical management plan for the child with COME who has failed medical therapy, it is useful to understand three patterns of disease (Figure 1 ). First, some children present with recurrent bouts of AOME that resolve completely with medical therapy (recurrent AOME). The TM appears normal and hearing is also normal between the episodes. Second, some children have persistent fluid in the middle ear space for many months without superimposed episodes of AOM (COME). Apart from hearing loss, this may be completely asymptomatic. This is typically seen in the 5- to 10-year-old child who presents with a behavioral problem at home or an educational problem at school, or who foils a screening hearing test. In infancy, although recurrent AOM with complete clearing is the most common variant, COME with minimal symptoms also can occur. The third pattern of disease is that of recurrent AOM superimposed on COME - the middle ear does not return to normal between the recurrent acute episodes, and the child has persistent hearing loss. Unless the child is examined both otologically and audiologicalíy between the acute episodes, the persistent presence of fluid and the development of COME is easily missed by the treating physician.
Figure 1. Patterns of ear disease.
The above classifications provide a rationale for considering medical versus surgical management of OME. Patients who fall into the first category, namely the otitis-prone child who has recurrent AOME with complete return of the middle ear to normal between acute episodes, are generally satisfactorily treated with antimicrobial therapy. Depending on the frequency of the attacks, particularly if they occur on a monthly basis, chemoprophylaxis is a useful medical strategy; surgical therapy in this group is reserved for the child who has "breakthrough" episodes of AOME despite adequate and proper chemoprophylaxis, or a very symptomatic child. For patients who fall into the second and third classifications, surgical treatment is indicated after the chronicity of MEE has been established and after medical therapy has failed. The demonstration of chronicity prior to surgical management is important because the duration of a given episode of AOME is variable. Teele et al1 noted persistent MEE in 40% of children 1 month after the first episode of AOM, in 20% at 2 months, and in 10% at 3 or more months. Based on these data, medical therapy should be attempted for at least 3 months before surgical treatment is considered.
Figure 2. Retraction pocket formation superiorly in tympanic membrane (A). Left untreated, the superior retraction pocket enlarges, and squamous cholesteatomatous debris accumulates (B). Osteolytic enzymes cause bony erosion.
Two reasons exist for treating COME. The first is to alleviate symptoms and the second is to reduce the occurrence of complications and sequelae. In many children, the symptoms of OME are very obvious, and in others, the symptoms are notable by their absence. Hearing impairment often tends to go unnoticed and manifestations of hearing impairment, such as discomfort, disturbed behavior, and unresponsiveness, are often attributed by parents to other causes. The complications and sequelae of COME fall into three main groups: structural changes, inner ear damage, and impaired speech, language, and development.
In the first group, various structural changes such as retraction pocket and cholesteatoma formation2 (Figure 2), tympanosclerosis, TM scarring, and adhesive otitis and ossicular necrosis (Figure 3) may accompany COME. The second group of sequelae consists of possible inner ear damage resulting in sensorineural hearing loss.3,4 The third group of sequelae includes the various impairments of speech, language, and development that are attributable to longstanding conductive hearing loss. Klein et al5 provided considerable insight into this problem when they demonstrated more retardation of educational achievement in children with frequent otitis media in families of middle versus lower socioeconomic class. Hubbard et al6 demonstrated substantial decrements in auditory and articulatory performance in children with cleft palates not treated routinely with tympanostomy tubes. Teele et al7 prospectively studied the intellectual and linguistic sequelae of middle ear disease in a randomly selected cohort of children. They concluded that after controlling for confounding variables, the estimated time spent with MEE during the first 3 years of life was significantly associated with lower scores on tests of cognitive ability, speech and language, and school performance at the age of 7.
Figure 3. Prolonged negative pressure in the middle ear may lead to the erosion of the long process of the incus and the head of the stapes. The TM adheres to the medial wall of middle ear, leading to adhesive otitis media.
The goal of treating COME is to reaerate the middle eat; thus restoring hearing and preventing retraction pocket formation, cholesteatoma development, and atelectasis. Before embarking on the treatment of COME, whether nonsurgical or surgical, a thorough search for an underlying etiology is important. This includes assessment of coexisting infective conditions such as paranasal sinusitis, immunologie problems, such as upper respiratory allergy, or anatomic problems, such as submucous cleft palate.
In OME, myringotomy was once the mainstay of therapy, but this has been largely discarded because of the usually prompt response of symptoms to antimicrobial therapy. Myringotomy should still be considered for the conditions listed in Table 1 . Myringotomy should be performed in the anterosuperior quadrant of the TM or at the point of maximum bulging, thus minimizing the risk of damage to the ossicles located in the posterior superior quadrant or to a dehiscent jugular bulb in the hypotympanum.
Recently, Kaleida et al8 failed to demonstrate that myringotomy conferred any benefit in a prospective study of patients treated with amoxicillin versus amoxicillin with myringotomy. They concluded that the data provide no support for the routine use of myringotomy either alone or adjunctively.
Indications for Myringotomy
Myringotomy and Ventilation Tube Placement Myringotomy with placement of a ventilation tube is an appealingly direct approach to the problem of COME. The myringotomy permits evacuation of the fluid from the middle ear cavity with instantaneous improvement in hearing, and the addition of a ventilation tube offers the promise of sustained middle ear ventilation for as long as the tube remains in place.
The beneficial effects of a ventilation tube on the course of AOME have been noted by several authors. Samuel et al9 observed improvement in 82% of 30 patients with recurrent AOME. Gebhart10 prospectively studied 95 children under the age of 3 with a history of recurrent AOME. Patients were randomly placed in either a ventilation tube group or a control group receiving medical management; less frequent bouts of AOME were reported in the surgically treated group.
Gonzalez et al11 also reported favorable results using a ventilation tube for the prevention of recurrent AOM. Children in this study were randomly placed in placebo, sulfisoxazole prophylaxis, or ventilation tube groups. Results were stratified for the presence of OME in association with recurrent AOM. Children with recurrent AOM and OME had significantly less infections when treated with a ventilation tube. Although sulfisoxazole prophylaxis seemed to control recurrent infection, persistent OME did not resolve on the low-dose antibiotic regimen. Patients without associated COME also did well with a ventilation tube. Sulfisoxazole out-performed the placebo-treated group, but the difference was not statistically significant.
Gates et al12 compared the outcome of myringotomy alone versus myringotomy with VT in children 4 to 8 years of age with COME. Of all measures used to assess the outcome, children treated by ventilation tube insertion fared substantially and significantly better than those who were not.
The rationale for the use of a ventilation tube is threefold: 1) to equalize middle ear pressure with atmospheric pressure, 2) to provide prolonged ventilation, and 3) to promote drainage and clearance of the middle ear. Following removal of the effusion, the presence of the tube corrects the conductive hearing loss associated with COME so long as the tube remains patent and in position. Pressure symptoms and unsteadiness also are relieved in those who are affected by these problems. In addition, the retracted TM assumes a more normal position, and retraction pockets that may have developed become smaller. Ventilation and drainage of middle ear secretions via the eustachian tube by ciliary transport are facilitated by ventilation tube placement because a vacuum is prevented from building up behind the material being cleared.
Indications for Ventilation Tubes
Special Populations for Early Consideration of Ventilation Tubes
The indications for placement of ventilation tubes are listed in Table 2. Trie presence of fluid per se in the middle ear cleft without demonstrable hearing loss is not necessarily an indication for a ventilation tube. However, such a patient should be monitored carefully for the development of hearing loss secondary to further fluid accumulation. Persistent fluid with a hearing loss of 15 dB or greater is an indication for ventilation tube placement. The measurement of 15 dB refers to that degree of conductive hearing loss measured in a sound-proof booth. This compares to approximately a 40-dB to 45-dB loss with a screening audiogram performed in a primary care physician's office.
In some children, it may be unrealistic to wait a full 3 months before resorting to surgical therapy. Such special populations are listed in Table 3. In a child who previously has demonstrated failure of COME to respond to medical therapy, it may not be necessary to wait a full 3-month period. Other factors affect this decision. For example, if it is early summer and the child is not in school, waiting until the end of the summer may be appropriate. However, if the process occurs in early fall during the school year, then rapid restoration of hearing is advised. Similarly, in a child with known sensorineural hearing loss who is relying on hearing aids for auditory reception, the addition of a 20-dB to 30-dB conductive hearing loss in addition to a 70-dB sensorineural hearing loss will preclude the use of a hearing aid for that child. In such cases, it may be appropriate to recommend tube insertion before waiting a full 12 weeks.
Certain children with known craniofacial problems, including cleft palate, who have demonstrated poor eustachian tube function should receive early ventilation tube placement in view of the failure of medical therapy in this group. Native American and Alaskan American children have a very high incidence of COME and similarly need more aggressive surgical therapy.
Approximately 75% of children with Down syndrome have COME, which is often relatively asymptomatic. Hie effusion is peculiarly resistant to medical therapy and is associated with a bony abnormality of the eustachian tube. A combination of small external canals and accumulation of cerumenous debris in the ear canals leads to underdiagnosis of COME in Down syndrome children. It is recommended that Down syndrome children receive a full otological (including microscopic) evaluation of the ear together with an audiologic evaluation by 18 months of age. The demonstration of COME together with a conductive hearing loss should lead to ventilation tube placement in this group of patients.
Choice of Ventilation Tubes
In general, the incision for myringotomy is a radial incision in the anterior half of the TM. This can be placed at an anterosuperior or anteroinferior position. The anterosuperior position just anterior to the malleus is recommended; in this position, tubes are retained longer because of the natural pattern of epithelial migration. This begins in the anterosuperior quadrant of the TM, and there is less epithelium to build up underneath the tubes to cause extrusion. When the tubes are placed in the anteroinferior quadrant, which is technically easier, epithelial migration promotes earlier extrusion.
Choosing the type of tube from the large variety available is, to some degree, a matter of preference (Figure 4). Ventilation tubes can be grouped into three types: the relatively short-acting, which last less than a year; the slightly larger, which generally remain functional for 1 to 2 years; and the long-acting or so-called permanent tube. In general, the smaller the tube, the less chance there is of a complication such as persistent perforation upon extrusion. A short-acting tube is indicated the first time the procedure is performed. If a second tube is necessary, then a medium-acting type should be used. With rare exceptions, the large T-tubes should not be used because of the relatively high rate of persistent perforation associated with their use.13 Exceptions might include children with anatomical abnormalities of the base of the skull leading to prolonged eustachian tube dysfunction and the necessity for permanent ventilation. In such cases, a permanent perforation that might be induced by a long-acting tube may in iact be desirable. When such long-acting tubes are used, the complication of persistent perforation must be discussed with the parents.
Figure 4. The wide variety of ventilation tubes that are available.
Complications of Ventilation Tubes
Complications of Ventilation Tubes
Offsetting the considerable benefits afforded by ventilation tubes are a number of untoward outcomes (Table 4). Secondary infection with otorrhea through the tube occurs relatively frequently and is associated either with a concomitant upper respiratory tract infection or after the entrance of water into the middle ear via the external auditory canal. The otorrhea should be treated with an antimicrobial that is effective against the usual organisms that cause acute otitis media, aspiration of the discharge from the external canal, and a short course of cleansing and/or anti-inflammatory ototopical medication. There is concern over the possible ototoxicity of ototopical agents used in the presence of a patent tube, but there are no documented cases of ototoxicity secondary to ototopical agents used for a short course in acute inflammation of the middle ear.
Occasionally, tiny sclerotic plaques in the TM can be seen at the site of previous tube insertion. However; these changes are minor in nature and their significance is debatable. Hearing is usually normal when the plaques are first discovered, and they do not predispose patients to the development of more serious middle ear disease or deterioration of hearing.
The incidence of persistent perforation following tube extrusion varies with the type of tube selected. Short-acting tubes have an incidence of persistent less than 0.1%, whereas longer-acting T-tubes have a rate of 13.6%.13 Surgical repair at a later date is highly successful.
If the lumen of the tube becomes obstructed, instillation of cleansing otic drops and suction may remove the plug of mucoid material in the lumen. Extrusion into the middle ear rarely occurs. When this happens, the tube can usually be left in the middle ear without risk. Indication for removal would be recurrent AOM. Small granulomas may occur around the tube and should be treated with instillation of steroid-containing otic or ophthalmic preparations. Ophthalmic solutions are generally less painful when placed in an ear with a patent tube because of the higher pH of the otic preparations.
Rarely, significant middle ear tympanosclerosis occurs both in recurrent OM treated medically and in recurrent otitis treated with ventilation tubes. The occurrence does not differ in the two groups, and the development of middle ear tympanosclerosis is related more to the underlying biological process than to the introduction of ventilation tubes. There is a small incidence of cholesteatoma following VT insertion. However, this is extremely rare, and it is difficult to differentiate cholesteatoma associated with ventilation tube insertion from coincidental congenital cholesteatoma behind an intact TM, which is more common.
Cost Effectiveness of Ventilation Tubes
The cost of ventilation tube insertion is not trivial. At Children's Hospital Medical Center in Cincinnati, Ohio, the total cost of bilateral ventilation tube insertion is $1140.64, including surgical, anesthetic, and hospital charges. However, the cost of medical therapy of recurrent AOM is not trivial, either. Table 5 shows the estimated cost of six bouts of AOM and compares this with 6 months of chemoprophylaxis. The physician visits were calculated at 12 visits at $20 apiece (two visits per episode of otitis - one diagnostic visit and one follow-up visit), and the antibiotic cost was based on a 10-day course of Augmentin suspension (arnoxicìllìn-clavulanate, Beecham Laboratones, Philadelphia, Pennsylvania) per episode, which costs $44-29. (Amoxicillin/clavulanate chewable tablets 250 mg would be slightly higher at $45.79.) Nine 10-day courses are calculated on the assumption that in 50% of the patients, the effusion will not be cleared after a single 10-day course. Knowing that the incidence of recurrent AOM is considerably higher in the day-care nursery than in the homc'care situation, loss of work for a working parent also must be figured into this equation. Each visit has been calculated to cause the loss of 4 hours of work at $10.00 per hour, totaling $480. Miscellaneous charges, including parking and travel, are estimated at $100. This adds up to a total of $1218.61. Using chemoprophylactic doses of amoxicillin/clavulanate 250 mg of the suspension daily) for 182 days costs $806.07. Assuming prophylaxis to require one half the physician visits needed for six bouts of AOM, the total cost of prophylaxis is $1216.07. In view of these figures, the cost for ventilation tube insertion does not seem inappropriate, particularly in view of the long symptom-free period that generally follows the procedure.
Cost of Medical Therapy for Recurrent Acute Otitis Media With Effusion
The role of adenoidectomy in the management of COME also remains controversial. For years, it has been believed that enlarged adenoids at the opening of the eustachian tube obstruct the eustachian tube, resulting in faulty aeration of the middle ear. It has been felt that hearing loss affecting children with COME can be cured or markedly reduced by adenoidectomy. It also has been believed that upper respiratory tract infections involving the adenoids would affect the middle ear by extension. Over the past 20 years, doubts have emerged concerning the role of adenoidectomy in the management of COME. Many children suffering from recurrent AOME or COME showed no improvement after adenoidectomy. Furthermore, adults with COME do not have enlarged adenoids, as the adenoid tissue generally atrophies during adolescence. Recently, the pendulum has begun to swing back again with several new studies advocating adenoidectomy in patients with recurrent AOME and COME.14-16
In a comprehensive review of the available literature, Sade and Luntz17 conclude that the available studies indicate that most patients with recurrent AOME or COME recover without having their adenoids removed and that even in chronic and refractory cases, the operation usually does not benefit the patient. When the entire population of such patients is reviewed, however, adenoidectomy does seem to reduce AOME and COME relapse rates by about a factor of 2, which probably depends on the type of population studied. It is still not known which patients are likely to benefit from adenoidectomy. For children who have had recurrent AOME or COME and who have had one or more ventilation tube operations in the past, adenoidectomy in conjunction with repeat ventilation tubes is still considered a reasonable option. However, the presence of upper airway obstruction and recurrent acute or chronic adenoiditis would be more compelling reasons to consider adenoidectomy for children who have COME.
Complications of Adenoidectomy
Following adenoidectomy, the incidence of secondary bleeding is very low. Of all secondary hemorrhages following adenotonsillectomy, only 3% are associated with postadenoidectomy bleeding. The two most important complications are stenosis of the nasopharynx and palatal dysfunction leading to velopharyngeal incompetence. Nasopharyngeal stenosis is extremely rare and can probably be avoided by careful attention to surgical technique. Nasopharyngeal incompetence generally occurs when adenoidectomy is done in the presence of a submucous cleft palate or an occult submucous cleft palate. When these diagnoses are entertained, a superior half adenoidectomy by electrocautery is preferable to complete adenoidectomy. The retention of the lower half of the adenoid tissue protects against the development of velopharyngeal incompetence, while removal of the upper half relieves eustachian tube obstruction.
There is little in the literature to support the view that tonsillectomy benefits recurrent AOME or COME. These diseases are not regarded as an indication for tonsillectomy. There is, however, a subgroup of patients who develop recurrent AOME with every bout of tonsillitis. In these patients in whom a tonsillectomy is performed because they meet the criteria for tonsillectomy, resolution of the recurrent AOME may be expected.
In resistant cases of COME, it is important for the clinician to consider the possible coexistence of persistent sinusitis. This is best documented by an axial CT scan of the paranasal sinuses after 6 weeks of antibiotic therapy effective against organisms associated with sinusitis in children. Such antibiotics would include amoxicillin/clavulanate (Augmentin), erythromycin/sulfisoxazole (Pediazole, Ross Laboratories, Columbus, Ohio), or cefuroxime axetil (Ceftin, Alien St Hanburys, Research Triangle Park, North Carolina). The presence of persistent disease in the paranasal sinuses and the demonstration of obstruction of the osteomeatal complex on CT scan would make the patient a probable candidate for antral lavage and/or functional endoscopie sinus surgery together with ventilation placement.
1. Teele DW, Klein JO, Rosner BA. Epidemiology of acute otitis media in children. Ann Ocol Rhinol Laeryngol. 1980;89(suppl 68):5-6.
2. Tos M, Melchiors H, Thomsen J, Plate S. Changes of the drum in untreated sit re tory otitis and chronic tubai dysfunction. Acta Otoícayngpl (SiocWi). 1982;(suppl 386):149151.
3. Ripartila MM, Oda M, HiraideF, Btady D. Pathology of sensorineura! hearing loss in otitis media. Aim Otol Rhinol Laryngol. 1972,81;632-647.
4. Ripartila MM, Coycoolea MV, MeywhoffWL. Inn« ear pathology and othis media. A review Ann Old Uanol Laryngol. 1980q89(aippl 68):249-253.
5. Klein JO, Teele DW. Manne« R, Mcnyuk P. Rosner BA. Otitis media with effusion during the first 3 yean of life and development ot speech and language. In: Lim DJ. Bluestone CD. Klein JO, et al, et- Rarem Adumces m Otras Malia Wirt Effusion. Philadelphia. Pa: BC Decker Ine; 1984:332-335.
6. Hubbaid TW, Paradise JL, McWilliaros BJ, Elster BA, Taylor FH. Conséquences of unremitting middle-ear disease in early life: otologie, audiotogic, and developmental findings in children with cleft pala«. N En¿ ) Med. 1985;3I2:1529-1534.
7. Tecle DW. Klein JO. Chase C, Menyuk P. Rosner BA, Greaiei Boston Otitis Media Study Group. Otitis media in infancy and intellectual ability, school achievement, speech, and language at age 7 icari- } Infect Du. 1990,162:685-694.
8. Kaleida PH, Casselbratit MD, Rackette HE, et al. Amoxídllín or myringocomy OE both for acute otitis media: results of a randomized clinical trial, ffediomci. 1991;87:466-474.
9. Samuel J, Rosen G, Vered Y. Use of middle ear ventilation tubes in recurrent acute otitis media. J laryngi Old. 1979;93:979-98l.
10. Gebhart DE.Tympaostromytubes in the otitis prone child. Laryngoscope. 1981;91:849666.
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14. Gates GA, Avery CA, Prihoda TJ, Cooper JC Effectiveness of adenoidectomy and tympanostomy tubes in the treatment of chmnic otitis media with effusion. N En¿ ] Med. 1987;317:1444-t451.
15. Paradise JF, Bluestone CD; Rogéis K.D, et al. Efficacy of adenoidcciomy for recurrent otitis media: results from parallel random and nonrandom trials Pediaf Ses. 1987;21:286A. Abstract.
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17. Sade J, Lunn M. Adenoideciomy in otitis media. Ann Otol RhitoI Loryngoi. 1991;100:226-231.
Indications for Myringotomy
Indications for Ventilation Tubes
Special Populations for Early Consideration of Ventilation Tubes
Complications of Ventilation Tubes
Cost of Medical Therapy for Recurrent Acute Otitis Media With Effusion