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25 Post-Tympanostomy Tube Otorrhea andOther Complications
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Fig. 25.2 Schematic drawing
of the optimal placement of
the ventilation tube [8]
225
Fig. 25.3 Paparella’s
ventilation tubes
Short-Term Ventilation Tubes
Indications
Short-term ventilation tubes are indicated to the majority of
OME cases (Fig.25.4). The preference for short-term tubes
is based on clinical data showing that only 15–30% of
patients who underwent tympanostomy tube surgery needed
an additional surgery over time [16]. There is no consensus
on which type of tube should be used in each case, as studies
dedicated to compare the results of these tubes failed to demonstrate signicant differences in outcomes [17]. The tubes
usually stay in place from 6 to 18months and then extrude
spontaneously. Although there is no consensus regarding
which cases would not benet from a short-term tube, it
seems that cases with atelectatic tympanic membrane, failure
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Fig. 25.4 Endoscopic image of a Shepard ventilation tube placed in
the tympanic membrane in a left ear
of a previous short-term tube, and the need to maintain adequate ventilation for long periods in cases such as craniofacial syndromes or malformations that imply prolonged tubal
dysfunction should be treated with a long-term tube.
Short-Term Tube Complications
Otorrhea (PTTO)
PTTO is the most frequent postsurgical complication of tympanostomy tubes. Several risk factors have been cited for
PTTO, and these could be intrinsic or extrinsic. Extrinsic
risk factors are the type of ventilation tube (short- versus
long-term), location of the tympanotomy, perioperative antibiotic therapy, and environmental exposure to predisposing
factors to upper respiratory infections (i.e., children who
attend daycare centers). Intrinsic factors include age of the
patient, bacteriology of middle ear effusion, previous diseases of nose, adenoids and paranasal sinuses, prior treatment for acute otitis media, and nasopharyngeal and
gastroesophageal reux [18]. However, it seems that the
most important factor resulting in PTTO is the presence of
intractable tissue pathology in the middle ear, including
granulation tissue, hyperplasia and metaplasia of the mucosal lining, and cholesteatoma.
In younger children (<2years old), the otorrhea is commonly caused by Streptococcus pneumoniae, Moraxella
catarrhalis, and Haemophilus inuenza. In younger children
with persistent otorrhea and older children, the most preva-
H. F. Pauna et al.
lent agents are Pseudomonas aeruginosa and Staphylococcus
aureus [19].
The treatment of uncomplicated acute PTTO is topical
uoroquinolone with or without steroids. There is a strong
recommendation against the use of topical aminoglycosides
and oral antibiotic therapy, as aminoglycosides are potentially ototoxic and oral antibiotics are largely ineffective for
treating PTTO [20]. Complicated acute otorrhea should be
treated with systemic antibiotic therapy with amoxicillin
(75–100mg/kg/day) two times a day for ten days or amoxicillin with clavulanate. In refractory cases, the antibiotic
therapy would preferentially be guided by culture and antibiogram [20]. A randomized, controlled trial compared
effectiveness of antibiotic-glucocorticoid eardrops versus
oral antibiotics versus watchful waiting in treating mild
PTTO: it was demonstrated that eardrops were more effective as compared with the other two treatment options [13].
The use of routine postoperative topical antibiotic therapy
to prevent PTTO is controversial, as several studies failed to
demonstrate a benecial effect. However, the meta-analysis
study published by Hochman et al. [12] showed a 48%
decrease in the risks of PTTO by using prophylactic topical
antibiotic therapy. Most studies that recommend topical prophylaxis indicate uoroquinolones (ooxacin or ciprooxacin) as the safest alternative. The dosage depends on the
presence of active infection at the time of the procedure (i.e.,
at the time of the tympanotomy). If signs of active infection
are observed, it was suggested that a therapeutic dose of four
drops should be used twice daily for ve to seven days. In the
absence of active infection, a prophylactic dose of three
drops should be used twice daily for three days [20].
Considering the potential ototoxic effects of topical antibiotics in patients with ventilation tubes, two randomized,
controlled studies revealed that ciprooxacin did not associate with signicant risks of hearing loss [21]. Other alternatives for the prevention of otorrhea with proven efcacy by
randomized clinical studies and meta-analyses are intraoperative washing of the middle ear with saline solution after
the tympanostomy [19, 21, 22].
Tympanostomy Tube Blockage
Mucus, blood, earwax, and granulation tissue can obstruct
the lumen of the ventilation tubes. The tube blockage may
occur immediately after surgery or after varying periods of
time [14]. Eardrops can be used to clear the clogging, but
none of the otic drops available for commercial use are currently approved by the FDA for this purpose.
One study compared the outcomes of children with tube
blockage treated with 5% sodium bicarbonate otological
solution, 3% hydrogen peroxide, or watchful waiting.
Clearance of the tube block was observed in 56 and 71% of
the patients treated with hydrogen peroxide and sodium
25 Post-Tympanostomy Tube Otorrhea andOther Complications
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227
bicarbonate, respectively, compared to 0% on the observation group [23]. An alternative therapeutic option proposed
by some authors is to insert a 3-French metal suction catheter
into the lumen of the tube to clear the obstruction. However,
the risks of inserting a suctioning device into the tube should
be carefully weighed against the potential benets, as it may
lead to pain, bleeding, dizziness, and tube medialization or
extrusion.
Chronic Tympanic Membrane Perforation
The prevalence of chronic tympanic membrane perforation
following short-term tubes is low (0%–2.2%), being lower
than in long-term tubes [14, 24].
The factors contributing to a chronic tympanic membrane
perforation are size of the myringotomy and the presence of
tympanosclerosis [24]. The presence of a perforation may be
seen in cases of early extrusion– in these cases, most heal
spontaneously and no not demand additional treatment.
However, persistent, chronic perforations may require
myringoplasty [14].
Granulation Tissue
The formation of granulation tissue in the external auditory
canal and tympanostomy site is uncommon in both shortand long-term tubes, with an estimated prevalence of 5%
[14] (Fig.25.5). The development of granulation tissue over
the tube seems to associate with the presence of chronic
inammation and otorrhea. It can be treated with the use of
eardrops containing antibiotics and corticosteroids, associ-
ated with oral antibiotic therapy and local cauterization with
silver nitrate solution. In cases where the granulation tissue
does not heal by clinical treatment, surgical removal may be
necessary [19].
Tympanosclerosis
It occurs due to the accumulation of collagen bers in the
lamina propria, associated with hyaline degeneration and
calcication. Most frequently, it is caused by inammatory
tissue changes secondary to otitis media. However, authors
have hypothesized that it might occur because of foreign
body reaction, brous hyperplasia, local hemorrhage, and
free hemoglobin release after the myringotomy. It is a common consequence of the tympanostomy tubes (34.6%), and
it usually locates in the lower quadrants. Hearing loss associated with tympanosclerosis secondary to ventilation tubes is
rare [25]. The diagnosis is made through otoscopy, showing
whitish plaques on the tympanic membrane. Pneumatic otoscopy can demonstrate reduced or absent tympanic membrane
mobility [20].
Focal Atrophy oftheTympanic Membrane
The presence of a focal atrophy of the tympanic membrane is
frequent after tympanostomy tube insertions, especially in
cases where a large tympanostomy is performed. The atrophy can occur from several mechanisms, including middle
ear dysventilation caused by otitis media, and as direct consequence of the lack of regeneration of the medial brous
layer of the tympanic membrane, as only the epithelial and
mucous layers regenerate. It affects approximately 25% of
the ears that underwent tympanostomy tube insertions [20],
and it can lead to areas of tympanic membrane fragility, with
greater susceptibility to retraction and perforation over time.
Fig. 25.5 Granulation tissue obstructing the lumen of a Shepard tympanostomy tube in the right ear
Other Complications
Early extrusion (4%) and medial tube displacement (0.5%)
[20].
Long-Term Ventilation Tubes
Indications
Long-term ventilation tubes (Fig.25.6) are mostly indicated
for patients with chronic eustachian tube dysfunction who
have low perspective of improvements in the short term [9].
Although the exact indications of long-term tubes are controversial, it has been proposed that long-term tubes should preferred in the following situations: (1) anatomical obstructions
such as malignant tumors (nasopharyngeal carcinoma, lymphoma, and chondrosarcoma), brosis, and adhesions caused
by adenoidectomy or other surgical procedures [26]; (2)
patulous eustachian tube [26]; (3) cranial malformations
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Fig. 25.6 A Paparella type 2 ventilation tube placed in posterior–inferior quadrant of the right ear tympanic membrane
associated or not with genetic syndromes (such as Treacher
Collins syndrome, Robin sequence, Crouzon syndrome, and
DiGeorge syndrome) [27]; (4) genetic disorders leading to
poor clearance of mucus, such as Kartagener’s, CHARGE,
Young, mucopolysaccharidosis, primary ciliary dyskinesia
[28]; (5) immunodeciencies (acquired immunodeciency
syndrome, selective IgA immunodeciency, and common
variable immunodeciency agammaglobulinemia) [29–31];
(6) hereditary factors and a family history of chronic ear
disease [32]; (7) chronic inammation of the nasal mucosa
resulting in tubal obstruction (e.g., allergies and laryngopharyngeal reux) [27]; (8) failure to treat OME using eustachian tube dilation [33]; (9) muscular problems causing
dilatory dynamic dysfunction [26]; (10) adhesive otitis stage
III or IV with or without conductive hearing loss [34]; and
(11) deep retractions pockets and/or atrophic scars with tympanograms type C, Cs, or B [34].
The cost versus benet should be weighed in the decisionmaking process for indicating long-term tubes. Eliachar
etal. [34] described that the long-term tubes can prevent the
development and formation of retraction pockets, reduce the
frequency of middle ear infections, improve hearing, and
provide a well-ventilated middle ear cavity. On the other
hand, as compared with short-term tubes, they associate with
an increased relative risk of chronic tympanic membrane
perforations and cholesteatoma, and also with an increased
cost of treatment, as patients will have longer follow-ups and
might require additional procedures for removing the tube or
treating a residual perforation [35].
H. F. Pauna et al.
Complications
Otorrhea (PTTO)
PTTO is the most frequent complication of ventilation tubes.
The prevalence of PTTO following long-term tympanostomy tube surgery varies greatly among studies, ranging
from 0.8% to 50%. There is a great debate on whether a
long-term tube leads to increased risks of developing a PTTO
as compared with short-term ones, with most studies showing that the incidence is higher in long-term tubes [35]. Kay
et al. [14] hypothesized that long-term tubes are generally
indicated for patients who have a chronic eustachian tube
dysfunction or a more advanced underlying middle ear disease, and it seems that the increased risk of PTTO may correlate with the severity of the middle ear disease rather than
being a direct consequence of the ventilation tube.
As in short-term tubes, there are many intrinsic and
extrinsic factors that increase the risks of developing
PTTO.The extrinsic factors include type of tympanostomy
tube placed, environmental exposure to upper respiratory
infections, tube type, ear canal sterilization, pacier use, and
perioperative antibiotic use. The intrinsic factors are the
presence of eustachian tube dysfunction, nasopharyngeal
reux, status of the middle ear effusion at the time of the
tympanostomy tube placement, swelling of the peritubal
mucosa caused by allergic rhinitis or chronic rhinosinusitis,
direct eustachian tube blockage by an enlarged adenoid, age
of patient, and colonization of the middle ear by pathogenic
bacteria [12].
Simon etal. [35] showed insufcient evidence to support
that the PTTO could be prevented by precautions over water
exposure. It seems that most PTTOs develop either from an
upper respiratory tract infection or through penetration of
bacteria from the external auditory canal to the middle ear.
Most frequently, the otorrhea following eustachian tube
insertion is caused by a bacterial infection—in younger children, the most common pathogens identied are
Streptococcus pneumoniae, Haemophilus inuenzae, and
Moraxella catarrhalis. In older children, the otorrhea is fre-
quently caused by pathogens arising from the external auditory canal, which include Pseudomonas aeruginosa and
Staphylococcus aureus.
There is consensus that PTTO should be treated with topical antibiotic solutions, either with or without topical steroids [35]. As most PTTOs are caused by Pseudomonas
aeruginosa, quinolone eardrops are sufcient to treat the
otorrhea in most cases. There is a strong recommendation
against treating PTTOs with oral antibiotics for several reasons [3]: rst, the most common pathogen (Pseudomonas
aeruginosa) is resistant to most oral antibiotics prescribed to
children. Second, the use of antibiotics to treat otitis media is
considered as one of the most critical vectors leading to bac-
25 Post-Tympanostomy Tube Otorrhea andOther Complications
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terial resistance. Moreover, quinolone eardrops, which are
safe and effective, can achieve local drug levels up to 1000
times higher than oral antibiotics [18]. Steele etal. [36] also
demonstrated that treatment of PTTO with topical quinolones is more efcient than watchful waiting. Regarding the
recommendation for removing the tube in cases of PTTO,
there is no high-grade evidence in the literature supporting
that it should be routinely performed, as (1) chronic PTTO
could associate with the presence of a chronic suppurative
otitis media, which—in turn—require specic treatment;
and (2) removing the tube may lead back to OME.Thus, it is
paramount that the pros and cons of keeping or removing the
tubes are carefully discussed with the parents.
Chronic Tympanic Membrane Perforation
Some patients who receive tympanostomy tubes develop a
chronic eardrum perforation. The prevalence of chronic perforation of the tympanic membrane following spontaneous
extrusion of the tube is higher in patients who receive a
long- term tympanostomy tube (16%) as compared with
patients receiving short-term tubes (2%) [14]. In patients
who have their grommets removed surgically, the prevalence seems to be much higher, ranging from 10% to 47%
among studies [37].
There higher prevalence of persistent tympanic membrane perforation seen in patients with long-term tubes is
most likely multifactorial. The larger mass and diameter of
the long-term tubes, the need for a larger tympanostomy
incision, and the longer permanence of the tube in the eardrum seem to play a pivotal role in the development of such
complication. Patients who are predisposed to have recurrent
or chronic ear infections (such as Down syndrome or with
craniofacial malformations) also seem to have an increasing
risk of developing a chronic perforation following tube
extrusion. A persistent tympanic membrane perforation may
result in a number of detrimental outcomes, including conductive hearing loss, increased risks of otorrhea and middle
ear infections, and higher risks of developing a cholesteatoma over time. Furthermore, patients may need to undergo
further surgical procedures to close the perforation (Brown
and Behar 2019).
Cholesteatoma
Several studies showed that tympanostomy tubes could
result in cholesteatoma formation (Fig.25.7). The incidence
of such complication is very low, being estimated at 0.03–
1.1%, and it seems that there is a higher incidence in longterm than short-term tubes [38]. Kay etal. [14] showed that
T-tubes (in relation to short-term tubes) associate with a 2.6
increase in the risk of developing cholesteatoma.
Many pathophysiological mechanisms were proposed.
The cholesteatoma could be the result of (1) the accumulation of debri in cases where a tube is placed in a retraction
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Fig. 25.7 Otoendoscopic image of the right tympanic membrane of a
28-year-old woman with adhesive otitis media who had underwent
placement of a Sheppard ventilation tube 2 years before. The image
shows global retraction of the tympanic membrane, and keratin debri
located at the site where the tube had been previously placed.
Exploratory tympanotomy later revealed the presence of mesotympanum cholesteatoma, located in the area adjacent to the residual perforation left after extrusion of the tympanostomy tube
pocket or an atrophic, accid area; (2) shedding and implantation of epithelial cells into the middle ear in cases of an
improper tympanostomy; (3) ingrowth of epithelial cells
through the margins of the perforation to the middle ear
mucosa, a process that could be further facilitated by the
anges of the tube; and (4) progression of the tissue abnormalities that are inherent to chronic otitis media. It is possible that several of these pathological processes occur in
association, and the tympanostomy tube is a facilitator.
Although the hypothesis that the tympanostomy tube could
create a pathway for the epithelium to migrate to the middle
ear is compelling and corroborated by clinical evidence [38],
this theory is still considered controversial. Kokko and Palva
[39], Padgham etal. [40] and Kinsella [41] did not nd a
signicant increase in the incidence of cholesteatoma in their
patients despite a considerable increase in the number of
ventilation tubes performed by their groups.
Golz etal. [38] investigated a total of 2829 children who
underwent a total of 6701 tympanostomy tube placements
and observed that the incidence of cholesteatoma directly
attributable to the tubes (behind an intact drum or next to a
perforation at or near the site of the tube insertion, in the
mesotympanum or hypotympanum) was 1.1%. The authors
found that the most critical risk factors associated with this
complication were (1) younger children (<5years old); (2)
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H. F. Pauna et al.
use of Goode T-tubes; (3) repeated tube insertions; (4) the
tube exceeds 12months placed in the tympanic membrane;
and (5) patients with recurrent or intractable PTTO.
In conclusion, although cholesteatoma formation following tympanostomy tubes is a rare complication, it is important that the risks are discussed with the patients or parents,
and that periodic examinations are performed to detect this
complication as early as possible [38].
Indications forTube Removal
There is no consensus as to when long-term tubes should be
removed, or even whether they should be removed at all. As
these tubes are indicated for patients with a worse prognosis
of having adequate middle ear ventilation, authors may have
proposed that the tubes should not be removed if there is no
evidence of associated complications. Other authors proposed some potential indications for the removal of the tympanostomy tubes [42], which include (a) chronic otorrhea; b)
granulation tissue that do not resolve with clinical treatment;
(c) long-standing tube in patients who would be expected to
have a functional eustachian tube; and (d) tubes that remain
placed for over 2years [42, 43].
Conclusion
It is established that the insertion of ventilation tube improves
hearing and consequently the social and language development and reduces the risk of progression to chronic otitis
media and its consequences. The indication of tube type
must be individualized for each patient weighing the risk and
benets of the procedure.
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Vaccination Policies inOtitis Media
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AnnHermansson
26
Prevention of infectious diseases with vaccination is an
effective way to avoid both the risk of serious disease, complications, and the drawbacks of antibiotic treatment in children. Vaccinations have been very effective in preventing, for
instance, serious pediatric infections such as meningitis and
epiglottitis caused by Hemophilus inuenzae type b [1].
Conjugate H. inuenzae type b (Hib) vaccine was introduced
in the beginning of the 1990s and is since then administered
as part of a routine childhood vaccination program in most
countries.
Acute otitis media (AOM) is one of the main causes of
antibiotic prescriptions to children worldwide, and a reduced
number of infections should be important in the global ght
against antibiotic resistance. It has therefore been a priority
to try to nd vaccination against otitis media. The obvious
problem is, however, that “otitis media” is not one disease
caused by one microbe but a multifaceted problem caused by
a multitude of bacteria and viruses. In most studies,
Streptococcus pneumonia, Hemophilus inuenzae (Hi),
Moraxella catarrhalis (Mc), and Streptococcus pyogenes are
the four most important bacteria causing acute otitis media.
The role for viruses in AOM has been debated, but it is
agreed that viruses cause AOM and that they also play an
important role in facilitating bacterial infections [2, 3].
Current Vaccines
The introduction of the conjugated Hib vaccine did not affect
the number of AOM episodes signicantly which probably is
since the vaccine only confers protection against Hib and not
to other types of capsulated H.in. or non-typeable Hi
(NTHi). It has been shown in several studies that H. inuen-
zae AOM in most cases is caused by NTHi and that the relative number of H. inuenzae–positive AOM probably have
A. Hermansson (*)
Department of ENT, Lund University Hospital, Lund, Sweden
e-mail: ann.hermansson@med.lu.se
increased after the introduction of pneumococcal vaccines
[4]. There has been a marked reduction in Hib meningitis
though, and it might be argued that this could be related to a
decrease in Hib AOM.
Polysaccharide vaccine against Streptococcus pneu-
moniae has been available for many years (23-valent vaccine
was introduced in 1983) and confers a good protection in
adults and older children against the included types. After
the successful introduction of conjugated Hib vaccination in
children, a conjugate 7-valent vaccine against pneumococci
was introduced with the same protein as in the Hib vaccine,
CRM
rier. These seven serotypes were responsible for eighty percent of invasive disease caused by S. pneumoniae in young
children prior to the introduction of pneumococcal vaccination in the United States. It provided a good protection
against invasive disease in the parts of the world where these
strains were dominating. The reduction in AOM episodes
was more moderate. The two large early studies of the
7-valent vaccine [5, 6] both showed only a modest reduction,
around six percent, in the total number of AOM episodes in
vaccinated children. This has also been shown in later studies
[7]. However, there was a greater reduction of episodes
caused by the included pneumococcal strains (57%), and a
better protection was also later shown in otitis prone children
if vaccinated early [8].
Hi has also been introduced. This vaccine is designed to confer not only protection against pneumococcal disease but
also to infections caused by NTHi [9]. Most of the antigens
of this vaccine are carried by protein D a surface protein isolated from NTHi [10]. Thus, there are two slightly different
pneumococcal vaccines on the market today: pneumococcal
protein D-conjugate vaccine and CRM
vaccines.
have been found in conjunction with episodes of AOM and
SOM. In many instances, bacterial and viral co-infections
are seen in AOM and it seems as though the presence of
derived from Corynebacterium diphteriae, as a car-
197
A 10-valent vaccine conjugated to a surface protein from
-conjugated
197
Many viruses (e.g. inuenza, rhinovirus, and coronavirus)
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
M. V. Goycoolea et al. (eds.), Textbook of Otitis Media, https://doi.org/10.1007/978-3-031-40949-3_26
233
234
https://t.me/medicina_free
A. Hermansson
viruses are associated with prolonged clinical illness [3, 11–
13]. The effect of viral vaccines on AOM has been studied in
several settings with very different results depending on the
settings. In Finland, inuenzae A vaccination during season
gave a better protection than pneumococcal vaccination [12,
13], but looking at long term the results are less impressive.
Eect
The impact of pneumococcal vaccines on OM is not easy to
determine. The immediate reduction in episodes of AOM
after vaccination has been modest in all controlled clinical
trial settings, while most observational studies have shown a
greater impact [14]. There are several confounding factors
that could contribute to this discrepancy. The main problem
in interpreting the observational studies is the introduction of
“watchful waiting” policies in most countries during the
same period as the introduction of pneumococcal vaccination [15]. In Sweden for instance where a reduction of over
30% in antibiotic prescriptions in children was seen between
1987 and 2004 after the introduction of a “watchful waiting”
regime for AOM, it is hard to decide the effect of vaccination
per se [16]. The same tendencies with a sharp decline in the
numbers of uncomplicated episodes of AOM seen in primary
care have been observed in other countries after the introduction of “watchful waiting” policies.
In the United States, a downward trend in OM visits was
seen from 2004 to 2011, coinciding with both the introduction of pneumococcal vaccines and guidelines advocating
watchful waiting in 2004.The incidence of tympanic mem-
brane perforations and otorrhea cases remained unchanged
throughout the study period, indicating that the reduction in
visits mostly was in uncomplicated cases [17]. To study the
reduction in more complicated AOM, several evaluations of
the impact on mastoiditis have been made without consistent
results. In most studies, there is no change in the number of
serious complications. There is generally a reduction in mastoiditis caused by serotypes included in the vaccines, but the
total number of complications seems not to have been
affected, with other serotypes of pneumococci or other bacteria seen more frequently [18–20].
The effect of vaccination on secretory otitis media and
chronic otitis media has been less studied. Potentially, an effect
could be seen, and some studies have shown an effect while
others have failed to prove a measurable impact [21–23].
Future
In some areas, a signicant shift has taken place in AOM
bacteriology after routine pneumococcal vaccinations.
Strains not included in the vaccines have been taking over,
and a need for more serotypes included is obvious. Vaccines
containing more serotypes are currently introduced, but there
are also attempts to develop a vaccine that will retain its efcacy for most pneumococcal serotypes [24, 25]. It has also
been shown that other bacteria might be more frequently isolated in AOM after pneumococcal vaccination why vaccines
with an effect also against H.in and viruses are of interest.
Conclusion
Vaccines against Hib and pneumococci have reduced the
burden of invasive diseases in children, but the effect on
AOM has been modest in controlled clinical studies. The
effect in observational studies has been much better, but
these results might be affected by the introduction of regimes
of “watchful waiting.” These regimes as well as a known
protection against serious disease could reduce the numbers
of uncomplicated AOM being seen in primary care.
Vaccination thus have denitively helped in reducing the
need for antibiotic treatment for AOM, and further development of both bacterial and viral vaccines is of great
importance.
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