Policy Statement-Cochlear Implants in Children: Surgical Site Infections and Prevention and Treatment of Acute Otitis Media and Meningitis ...
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FROM THE AMERICAN ACADEMY OF PEDIATRICS
Policy Statement—Cochlear Implants in Children:
Surgical Site Infections and Prevention and
Treatment of Acute Otitis Media and Meningitis
Lorry G. Rubin, MD, Blake Papsin, MD and the COMMITTEE
ON INFECTIOUS DISEASES AND SECTION ON abstract
OTOLARYNGOLOGY–HEAD AND NECK SURGERY
The use of cochlear implants is increasingly common, particularly
KEY WORDS in children younger than 3 years. Bacterial meningitis, often with
cochlear implant, deafness, meningitis, acute otitis media,
vaccination
associated acute otitis media, is more common in children with
cochlear implants than in groups of control children. Children
ABBREVIATIONS with profound deafness who are candidates for cochlear implants
FDA—Food and Drug Administration
should receive all age-appropriate doses of pneumococcal conju-
CSF— cerebrospinal fluid
CI— confidence interval
gate and Haemophilus influenzae type b conjugate vaccines and
PCV7— heptavalent pneumococcal conjugate vaccine appropriate annual immunization against influenza. In addition,
PPSV23—23-valent pneumococcal polysaccharide vaccine starting at 24 months of age, a single dose of 23-valent pneumococ-
PCV13—13-valent pneumococcal conjugate vaccine cal polysaccharide vaccine should be administered. Before implant
Hib—Haemophilus influenzae type b conjugate vaccine surgery, primary care providers and cochlear implant teams
This document is copyrighted and is property of the American should ensure that immunizations are up-to-date, preferably with
Academy of Pediatrics and its Board of Directors. All authors completion of indicated vaccines at least 2 weeks before implant
have filed conflict of interest statements with the American surgery. Imaging of the temporal bone/inner ear should be per-
Academy of Pediatrics. Any conflicts have been resolved through formed before cochlear implantation in all children with congenital
a process approved by the Board of Directors. The American deafness and all patients with profound hearing impairment and a
Academy of Pediatrics has neither solicited nor accepted any history of bacterial meningitis to identify those with inner-ear mal-
commercial involvement in the development of the content of formations/cerebrospinal fluid fistulas or ossification of the co-
this publication.
chlea. During the initial months after cochlear implantation, the
risk of complications of acute otitis media may be higher than dur-
ing subsequent time periods. Therefore, it is recommended that
acute otitis media diagnosed during the first 2 months after implan-
tation be initially treated with a parenteral antibiotic (eg, ceftriax-
one or cefotaxime). Episodes occurring 2 months or longer after
implantation can be treated with a trial of an oral antimicrobial
agent (eg, amoxicillin or amoxicillin/clavulanate at a dose of ap-
proximately 90 mg/kg per day of amoxicillin component), provided
the child does not appear toxic and the implant does not have a
spacer/positioner, a wedge that rests in the cochlea next to the
www.pediatrics.org/cgi/doi/10.1542/peds.2010-1427 electrodes present in certain implant models available between
1999 and 2002. “Watchful waiting” without antimicrobial therapy is
doi:10.1542/peds.2010-1427
inappropriate for children with implants with acute otitis media. If
All policy statements from the American Academy of Pediatrics feasible, tympanocentesis should be performed for acute otitis me-
automatically expire 5 years after publication unless reaffirmed, dia, and the material should be sent for culture, but performance of
revised, or retired at or before that time. this procedure should not result in an undue delay in initiating
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). antimicrobial therapy. For patients with suspected meningitis, ce-
Copyright © 2010 by the American Academy of Pediatrics rebrospinal fluid as well as middle-ear fluid, if present, should be
sent for culture. Empiric antimicrobial therapy for meningitis oc-
curring within 2 months of implantation should include an agent
with broad activity against Gram-negative bacilli (eg, meropenem)
plus vancomycin. For meningitis occurring 2 months or longer after
implantation, standard empiric antimicrobial therapy for meningi-
tis (eg, ceftriaxone plus vancomycin) is indicated. For patients with
meningitis, urgent evaluation by an otolaryngologist is indicated for
consideration of imaging and surgical exploration. Pediatrics 2010;
126:381–391
PEDIATRICS Volume 126, Number 2, August 2010 381
Downloaded from www.aappublications.org/news by guest on February 15, 2020FIGURE 1
Diagram of the implanted cochlear device. External devices pick up, process, and transmit the sound across the skin to a receiver-stimulator implanted in
bone. The receiver sends the code down a bundle of wires that passes through the middle ear and continues as the electrode array that is threaded into
the cochlea. (Reprinted with permission from Papsin BC, Gordon KA. N Engl J Med. 2007;357[23]:2380 –2387. Copyright © 2007 Massachusetts Medical
Society. All rights reserved.)
BACKGROUND By the end of 2005, nearly 15 000 chil- although implants have been placed
A cochlear implant is an implanted dren and 22 000 adults in the United successfully in infants younger than 1
electronic hearing device designed to States and nearly 100 000 people year with profound hearing loss.3–5 It is
produce useful hearing sensations to worldwide had received cochlear im- increasingly likely that a primary care
a person who is profoundly deaf or se- plants for treatment of hearing loss.2 pediatrician will have 1 or more chil-
verely hard of hearing by electrically In another important trend, some dren with a cochlear implant in his
stimulating nerves inside the inner adults and children are now receiving or her practice. Potential infectious
ear. The implant consists of an exter- bilateral cochlear implants.1 Approxi- complications of cochlear implants
nal portion that sits behind the ear and mately 1 million people in the United include postoperative wound and
internal components that are surgi- States are potential candidates for co- device-related infections and bacte-
cally placed under the skin and in- chlear implants. The current minimum rial meningitis. In children with cochlear
serted in the cochlea (Fig 1).1,2 Co- age for placement of cochlear im- implants, an episode of acute otitis me-
chlear implants are increasingly being plants approved by the US Food and dia may lead to inner-ear infection, de-
used as a treatment for hearing loss. Drug Administration (FDA) is 1 year, vice infection, device extrusion, device
382 FROM THE AMERICAN ACADEMY OF PEDIATRICS
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TABLE 1 Acute Otitis Media in Children With Cochlear Implants
Reference (Year) Study No. of No. of Patients With ⱖ1 Age at Length of Time Interval From Management No. of
Design Patients Episode of Acute Otitis Implantation Follow-up Time Implantation to Episodes of
Evaluated Media in Implanted Ear (Mean Age at After Implantation Acute Otitis Media, Meningitis
(Total No. of Episodes That Implantation), (Mean), y Range (Mean), mo
Occurred in Either or y
Both Ears)
Luntz et al9 (2004) Prospective 60 17 (22) (3.4) 0.25–2.5(1.7) ⬍1, 6 cases Myringotomy and tube placed 0
⬎1, 11 cases All received oral antimicrobial
agents; 46% also received
parenteral antimicrobial
agents
House et al10 Retrospective 43 NR (4) 2.7–17.5 (8.3) Up to 23⁄4 NR Oral antimicrobial therapy 0
(1983)
House et al11 Retrospective 20 8 (13) 2.9–8.7 1–4 (1.3) 1–17 (6.4) Oral antimicrobial therapy NR
(1985)
Kempf et al12 Retrospective 366 11 (20) 1–14 ⱕ8 NR Route or choice of 0
(2000) antimicrobial agent not
specified; myringotomy
performed in 7 of 20
episodes
Migirov et al13 Retrospective 234 47 0.9–16 (4.8) ⱖ2 NR Intravenous ceftriaxone for NR
(2006) 3–5 d; no myringotomy
NR indicates not reported.
failure, and/or meningitis. Thus, there is ative period, but it is possible that symptoms including hearing loss at-
a need for guidelines for prevention, rec- the use of prophylactic antimicrobial tributable to damage to auditory pri-
ognition, and management of cochlear agents may also reduce the rate of oc- mary afferent neurons, vestibular dys-
implant–related infections, acute otitis currence of postoperative wound in- function, and meningitis. In addition,
media, and bacterial meningitis in chil- fection, acute otitis media, and implant inner-ear infection can result in loss of
dren with cochlear implants. infection. Patients with suspected the implant because of implant con-
postoperative wound infections should tamination or implant malfunction re-
Postoperative Wound Infections be referred urgently to the surgeon who lated to ossification of the cochlea.
Postoperative surgical site infection performed the implant. Published data concerning the inci-
has been reported in 1% to 12% of pa-
Acute Otitis Media in Cochlear dence and prognosis of acute otitis
tients who have undergone cochlear
Implant Recipients media in children with implants are
implantation.6,7 Major infections may
limited (Table 1).9–13 Theoretically, in
have serious consequences, including With an increasing number of children
the initial months after placement of a
loss of the implant, and may occur younger than 3 years receiving co-
cochlear implant, the risk of complica-
more frequently in pediatric patients.6 chlear implants, primary care provid-
tions associated with an episode of
In 1 case series, 8 of 9 patients with ers are likely to be confronted with
acute otitis media may be higher if the
device exposure (ie, an opening in the children with cochlear implants who
cochleostomy, the communication be-
skin overlying the device as a result of present with acute otitis media. Rates
tween the middle and inner ear cre-
wound infection and resultant wound of morbidity associated with acute oti-
ated during implantation, has not
dehiscence) ultimately required de- tis media may be higher in children
healed. An animal model has demon-
vice removal, compared with 3 of 17 with cochlear implants than in other
patients with a wound infection with- children, because the surgically strated that acute otitis media induced
out device exposure.7 Although the use placed electrode traverses the middle within 2 weeks after cochlear implan-
of prophylactic perioperative antimi- ear to the inner ear through the co- tation may result in severe cochlear
crobial agents has varied among cen- chlear wall (cochleostomy) or the damage.14 However, postmortem study
ters and surgeons, the FDA recom- round window membrane (Fig 1). Al- of the temporal bone of implant recip-
mended in 2003 that “[h]ealth care though the opening created between ients 2 to 10 years after implantation
providers should consider prophylac- the middle and inner ear is generally demonstrated that the opening in the
tic antibiotic treatment periopera- sealed with fascia or other material, it round window around the electrode
tively in children receiving cochlear remains a potential route for acute oti- was sealed with fibrous tissue.15
implants.”8 This recommendation was tis media– causing bacteria in the mid- In the only prospective study of acute
made to reduce the risk of meningitis dle ear to spread to the inner ear. otitis media in implant recipients,
that occurs in the immediate postoper- Inner-ear infection can result in severe Luntz et al9,16 studied 60 children whom
PEDIATRICS Volume 126, Number 2, August 2010 383
Downloaded from www.aappublications.org/news by guest on February 15, 2020they categorized as otitis media prone 1).10,11,13 In contrast, the fourth study12 plantation, surgeons may place tympa-
(on the basis of previous history of fre- revealed that patients with implants nostomy tubes before or at the time of
quent otitis media; n ⫽ 34; mean age at were more likely to require intrave- implantation in children with a history
cochlear implant: 48 months) and nous antimicrobial therapy and a myr- of recurrent acute otitis media or per-
non– otitis media prone (n ⫽ 26; mean ingotomy.12 Furthermore, of the 11 ep- sistent middle-ear effusion.16,19 A con-
age at cochlear implant: 35 months). isodes of acute otitis media reported sensus report prepared by 8 cochlear
Preoperatively, the otitis media–prone in this study, 7 patients underwent sur- implant surgeons recommended, on
group underwent ventilation-tube gical treatment for mastoiditis. No the basis of theoretical considerations
placement with or without adenoidec- child in any of the 4 series was re- and a series of otitis media–related
tomy and, in some cases, additional ported to have developed bacterial meningitis episodes in adults,20 avoid-
measures. Patients were required to meningitis. Although these reports ance of implantation if middle-ear fluid
have a normal tympanic membrane provide useful insight, they contain is present.21 The surgeons stated that
and no drainage via the ventilation significant limitations, including the if middle-ear fluid is encountered at
tube for at least 2 weeks before im- retrospective design, possibly leading the time of implantation, they recom-
plantation. With a mean follow-up pe- to identification and inclusion of only mended high-volume irrigation of the
riod of 20 months after implantation, the more severe acute otitis media ep- middle ear, administration of topical
at least 1 episode of acute otitis media isodes. Another limitation is the lack of antimicrobial agents into the middle-
had occurred in 15 (44%) of the 34 oti- report of pathogens causing acute oti- ear space, and systemic therapy with
tis media–prone children and 2 (8%) of tis media episodes. ceftriaxone.21
the non– otitis media–prone children. That no cases of bacterial meningitis Bacterial Meningitis in Cochlear
Six (10%) children with implants, 5 of were reported in these case series of Implant Recipients
whom were in the otitis media–prone children with acute otitis media is not
group, had an episode of acute otitis Factors independent of cochlear im-
surprising, given the small number of
media within 1 month of implantation, plantation may place children with
cases in these series and a reported
a finding that supports the assertion hearing loss at increased risk of bac-
incidence of Streptococcus pneu- terial meningitis.17 Some children have
that children are at highest risk of moniae meningitis in children with co- an inner-ear malformation (eg, com-
acute otitis media during the immedi- chlear implants of 138 cases per mon cavity malformation) that predis-
ate postoperative period. All these ep- 100 000 person-years.17 However, in a poses them to bacterial meningitis as
isodes of acute otitis media were study of bacterial meningitis in chil- a complication of middle- and inner-
treated successfully with oral antimi- dren with implants, for the subgroup ear infection. For example, a 6-year-old
crobial agents, typically amoxicillin/ of children with bacterial meningitis child with Mondini-type malformation
clavulanate. Thirteen patients devel- that occurred at least 30 days after im- and a cochlear implant in the left ear
oped acute otitis media later than 1 plant surgery (and for whom clinical placed 2 years earlier developed rap-
month after implantation; all of them information was available concerning idly fatal meningitis.22 Examination of
had installation of a new ventilation the presence of acute otitis media), the temporal bones at autopsy showed
tube to establish middle-ear drainage, acute otitis media was present in 13 that acute meningitis was related to
unless the patient had a preexisting (50%) of 26 patients at the time of pre- right middle-ear infection and suppu-
ventilation tube, and were treated ini- sentation with meningitis (although rative labyrinthitis. The left middle ear
tially with oral antimicrobial therapy. whether acute otitis media was in the on the side of the implant was unin-
Six children required hospitalization same ear as the implant was not re- fected. Thus, in this case and in a sec-
and administration of intravenous an- ported).17,18 These findings indicate ond case,23 just having an inner-ear
timicrobial therapy because of failure that, at least in some cases, there may malformation, rather than a cochlear
of oral antimicrobial agents and, in 2 of be a causal relationship between implant, was the risk factor for acute
these 6 children, acute mastoiditis. acute otitis media and bacterial men- otitis media–related meningitis. Bacte-
Four retrospective studies of acute oti- ingitis. Signs of acute otitis media rial meningitis in infants is an impor-
tis media in children with implants were not reported in any of 9 episodes tant cause of acquired deafness, which
have been reported. In 3 studies, the of bacterial meningitis that presented may lead to cochlear implantation, and
severity or outcome of acute otitis me- within 30 days of implantation of a co- preimplant meningitis has been identi-
dia was found to be satisfactory when chlear device. To prevent episodes of fied as a risk factor for postimplant
using standard treatments (Table acute otitis media after cochlear im- meningitis.24
384 FROM THE AMERICAN ACADEMY OF PEDIATRICS
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In most cases of meningitis in patients meningitis was 189 cases per 100 000 a fatal outcome. Of 198 cases of
with an implant, the initial event in the person-years, a more than 30-fold in- postimplant bacterial meningitis in
pathogenesis of meningitis is acute creased risk compared with that in the children and adults reported to the
otitis media that occurs in the ipsilat- overall population.17 In a study in Den- FDA, the mortality rate in the 184
eral ear, especially when meningitis mark, the rate of bacterial meningitis cases for which the outcome of infec-
occurs more than 30 days after sur- was 43 cases per 100 000 person-years tion was known was 16% (Eric Mann,
gery. After acute otitis media develops, in young children with hearing loss FDA, personal communication, Feb-
bacteria can enter the inner ear (10.4% of the cohort had cochlear im- ruary 7, 2008). Of 38 children who ex-
through an incompletely sealed co- plants).26 In the same study, young chil- perienced 41 episodes of meningitis
chleostomy. Pathways of bacterial ac- dren with hearing loss and without a reported by Reefhuis et al17 and Bier-
cess to the cerebrospinal fluid (CSF) cochlear implant were at a 4.1-fold in- nath et al,18 3 children died.
from the inner ear include entry into creased relative risk (95% confidence
Streptococcus pneumoniae is the
the labyrinth, infiltration of the co- interval [CI]: 1.5–11.0) for development
most common pathogen that causes
chlear turns along the electrode enter- of bacterial meningitis compared with
meningitis in children with cochlear
ing the Schuknecht bony channels, and a group of children without hearing
implants17,18 and in patients with an
following perineural and/or perivascu- loss. Within the group of children with
inner-ear malformation that predis-
lar pathways into the internal auditory implants in the US study, the risk of
posed them to bacterial meningitis.28
canal to the meninges.21 In patients meningitis was significantly higher for
Pathogens associated with bacterial
with a malformed cochlea in which patients with a particular implant
there is a connection to the subarach- model (AB-5100H or AB-5100H-11 [Ad- meningitis that occurred within 30
noid space, meningitis also can occur vanced Bionics, Sylmar, CA]) that in- days of implant surgery were S pneu-
via the cochlear aqueduct. In the ab- cluded a positioner (or a so-called moniae in 4 of 9 cases and Acineto-
sence of a surgical procedure to re- spacer, a wedge that rests in the co- bacter baumannii (2 cases), Esche-
duce such risks, these children remain chlea next to the electrodes).17 During richia coli, Haemophilus influenzae
at increased risk of meningitis after the period from 1997 to 2004, only 19% type b, and Enterococcus spp in the re-
cochlear implantation. In addition, as of the cohort of children had a model mainder.17 Of 25 cases that occurred
postulated by Arnold et al21 and stud- with a positioner, yet these children more than 30 days after implant sur-
ied experimentally by Wei et al,25 cases accounted for 71% of the children with gery with an identified pathogen, the
of bacterial meningitis in implant re- meningitis. The models with position- etiology was S pneumoniae in 80%;
cipients may originate via pneumococ- ers were available beginning in 1999 nontypeable H influenzae in 12%; H
cal bacteremia with hematogenous and were voluntarily recalled in the influenzae type b in 4%; and Strepto-
seeding of the cochlea, such as at a United States in July 2002. In a multi- coccus pyogenes in 4%.17,18 Neisseria
site of tissue necrosis related to the variate analysis of a case-control meningitidis (meningococcus) has
electrode or positioner (locus minoris study, the odds ratio for meningitis in not been reported as an etiology of
resistentiae) with contiguous spread patients with an implant with a posi- meningitis in children with cochlear
to the CSF and meninges. tioner was 4.5 (95% CI: 1.3–17.9). Al- implants (although meningococcal
In addition, cochlear implants them- though the increased risk of meningi- meningitis has been reported in 2
selves increase the risk of bacterial tis in patients with an implant with a children with congenital malforma-
meningitis, especially during the first 2 positioner continues beyond 24 tion of the middle ear26), and avail-
months after implantation. In a nested months after implantation,18 to date, able data do not support cochlear
case-control investigation of US chil- elective removal of these implants or implants as a risk factor for menin-
dren younger than 6 years with co- their positioners is not recommend- gitis attributable to N meningitidis.
chlear implants and meningitis be- ed,18,27 and these implants remain in As noted earlier, acute otitis media
tween 1997 and 2002, 26 children with place in many patients. In the same was not noted to be present at the
bacterial meningitis were identified analysis, an additional risk factor for time of diagnosis in any of the cases
among 4264 children with cochlear im- development of meningitis was inner- that occurred during the first 30
plants.17 During an additional 2 years ear malformation with a CSF leak days after implantation but was
of follow-up of this cohort, 12 addi- (odds ratio: 9.3 [95% CI: 1.2–94.5]). noted in 52% of cases that oc-
tional episodes of bacterial meningitis Episodes of meningitis in patients curred more than 30 days after
were identified.18 The rate of bacterial with a cochlear implant may have implantation.
PEDIATRICS Volume 126, Number 2, August 2010 385
Downloaded from www.aappublications.org/news by guest on February 15, 2020Use of Pneumococcal and H fold and 7.8-fold increases in anticap- H influenzae meningitis in implant
influenzae Type b Vaccines for sular antibody concentration to the 7 recipients.17
Prevention of Acute Otitis Media serotypes in the vaccine in children 14
and Meningitis months to 2 years of age and children 2 RECOMMENDATIONS
Immunization of the general popula- through 5 years of age, respectively.37 US Preventive Services Task Force Rat-
Among children 2 through 5 years of ings criteria42 were used to assess the
tion of infants with the primary series
age, a single dose of PCV7 was more strength of evidence for recommenda-
of heptavalent pneumococcal conju-
immunogenic than a single dose of tions. All of the recommendations were
gate vaccine (PCV7) has resulted in a
PPSV23 for the 7 serotypes in PCV7. classified as “I” indicating insufficient ev-
marked decrease in invasive pneumo-
PPSV23 was immunogenic in children idence except where a different rating
coccal disease, including meningi-
older than 5 years, adolescents, and (ie, ratings A, B, C, or D) is noted after the
tis.29,30 In addition, immunization of in-
young adults; there was a mean 4.2- statement (see Appendix).
fants has resulted in an approximately
7% reduction in episodes of acute oti- fold increase in anticapsular antibody
1. Evaluations and Management
tis media from all etiologies and a 34% concentration to the 7 PCV7 sero-
Before or During Insertion of
reduction in pneumococcal otitis me- types.37 The distribution of serotypes of
Cochlear Implant
dia.31,32 However, 2 randomized double- S pneumoniae causing meningitis in
● Imaging of the temporal bone/inner
blind studies of prevention of acute oti- implant recipients is unknown but is
assumed to be the same as in children ear should be performed before co-
tis media in children 1 to 6 years of age chlear implantation in all children
identified as otitis prone in which the without cochlear implants. On Febru-
with congenital deafness and all pa-
treatment group received 1 or 2 doses ary 24, 2010, a 13-valent pneumococcal
tients with profound hearing impair-
of PCV7 followed 6 months later by a conjugate vaccine (PCV13) was li-
ment and a history of bacterial men-
dose of 23-valent pneumococcal poly- censed by the FDA on the basis of
ingitis (if not known to have normal
saccharide vaccine (PPSV23) revealed safety and immunogenicity. This vac-
hearing before meningitis) to identify
no effect on the rate or severity of epi- cine contains polysaccharides of the 7
those with inner-ear malformations/
sodes of acute otitis media.33,34 Al- serotypes in PCV7 and polysaccha-
CSF fistulas or ossification of the co-
though PCV7 results in a reduction in rides from 6 additional serotypes. It
chlea. In patients with inner-ear mal-
nasopharyngeal colonization with vac- has not been studied in children with
formations that are associated with a
cine serotypes, overall carriage of cochlear implants or in children older
higher likelihood of CSF fistulas after
pneumococci is unchanged as a result than 71 months. This vaccine replaces
cochlear implantation (eg, wide ves-
of colonization with nonvaccine sero- PCV7 for all scheduled doses of PCV7 in
tibular aqueduct syndrome or Mon-
types.35 PPSV23, licensed for children 2 infants.38 In addition, a supplemental dini malformation), particular atten-
years of age and older, reduces the in- dose of PCV13 is recommended for tion must be paid to sealing the
cidence of invasive pneumococcal dis- children 14 months through 18 years cochleostomy during the cochlear im-
ease but does not prevent pneumococ- of age with a cochlear implant.38 plant surgery to further lower the risk
cal colonization or acute otitis media.36 H influenzae type b conjugate vaccine of developing bacterial meningitis.
Therefore, it is uncertain, theoretically, (Hib) is highly effective for prevention ● For otitis-prone children or children
whether PPSV23 in children with im- of invasive disease and colonization with persistent middle-ear effusion,
plants would prevent meningitis at- with this pathogen39,40 and, presum- tympanostomy tube placement
tributable to pneumococcal infections ably, is effective for prevention of should be considered before co-
that originate in the middle ear acute otitis media attributable to H in- chlear implantation.9,16,43
and cause meningitis by contiguous fluenzae type b. Cochlear implant re-
spread of bacteria. There are no data cipients have anticapsular antibody 2. Primary and Secondary
on the efficacy of PCV7 or PPSV23 in concentrations to H influenzae type b Prevention of Meningitis and Acute
prevention of pneumococcal meningi- after immunization that are likely to be Otitis Media
tis in children with cochlear implants, protective.37,41 Hib vaccine does not ● All children, including those with se-
but there are immunogenicity data. A prevent colonization or infection with vere hearing impairment or infants
single dose of PCV7 in children 14 non–serotype b strains; most H influ- with profound deafness, should re-
months through 5 years of age with enzae strains that cause acute otitis ceive all doses of PCV13 (or PCV7 if
cochlear implants induced a substan- media are nontypeable strains, as PCV13 is not yet available) and Hib,
tial immune response with mean 12- were the isolates from most cases of according to the routine recom-
386 FROM THE AMERICAN ACADEMY OF PEDIATRICS
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mended schedule (ie, a dose of each vaccine given at 12 months of age or 3. Management of Postoperative
at 2, 4, 6, and 12–15 months of age, older was PCV13. Wound Infection or Suspected
except that a dose of Hib is not ● A single dose or supplemental dose of Cochlear Implant Infection
needed at 6 months of age if PCV13 may be administered to pediat- ● Patients with suspected postopera-
PRP-OMP [PedvaxHIB or ComVax, ric patients 6 through 18 years of age tive wound infection or suspected im-
Merck, Whitehouse Station, NJ] who have a cochlear implant or are plant infection should be referred
was given for the first 2 doses)44 scheduled to receive a cochlear im- urgently to the surgeon who per-
(recommendation A). plant regardless of previous doses of formed the implant procedure.
● Starting at 2 years of age and at least PCV7 and PPSV23. Broad-spectrum antimicrobial ther-
2 months after the last dose of PCV13 ● When assessing a history of previ- apy that includes an agent or agents
(or PCV7 if PCV13 is unavailable), a ous immunization with pneumococ- with activity against methicillin-
dose of PPSV23 should be adminis- cal vaccines, care should be exer- susceptible and methicillin-resistant
tered to (1) children scheduled for co- cised to avoid confusing past Staphylococcus aureus should be
chlear implantation (or after cochlear immunization with other vaccines initiated.
implantation if not previously admin- that could be considered “meningi-
istered) and (2) children with an 4. Early Diagnosis of Acute Otitis
tis vaccines” (ie, Hib and quadriva-
inner-ear malformation with a CSF Media and Meningitis
lent meningococcal polysaccharide
communication45,46 (recommenda- or conjugate vaccines) with doses ● Patients and parents should be edu-
tion B). For maximal benefit, adminis- of PCV7 and PPSV23. cated as to symptoms of acute otitis
tration of the doses of PCV13 and media and meningitis and to seek im-
● Meningococcal conjugate vaccine
PPSV23 should be completed at least mediate medical evaluation for acute
should be administered in accor-
2 weeks before implant surgery. Chil- illness with symptoms possibly
dance with routine recommenda-
dren 24 through 71 months of age attributable to either acute otitis
tions,48–50 but given current data, co-
who have received 2 or fewer previ- media (eg, fever or earache) or
ous doses of PCV13 (or PCV7) before chlear implant recipients should
meningitis (eg, fever, headache,
24 months of age should receive 2 not be considered a group at high vomiting, stiff neck, or change in
doses of PCV13 at least 2 months risk of invasive meningococcal dis- level of consciousness).
apart, and those who have received 3 ease. Therefore, children younger
● Clinicians should consider bacterial
previous doses of PCV13 (or PCV7) than 11 years should not be immu-
meningitis in the differential diagno-
should receive 1 dose of PCV13.47 nized routinely.
sis of all patients with cochlear im-
PPSV23 should be administered 2 ● In most studies, administration of in- plants who present with fever with or
months after completion of the PCV13 fluenza vaccine to healthy children re- without acute otitis media on physical
(PCV7) series. For children older than duced the incidence of episodes of examination, particularly during the
71 months who have not received acute otitis media during influenza first 2 years after implantation in pa-
PCV13, administration of 1 dose of season.51–54 To reduce the number of tients with cochlear implants without
PCV13 should be considered. All such episodes of acute otitis media, annual positioners and indefinitely in pa-
children should receive PPSV23 (2 administration of influenza vaccine tients with cochlear implants placed
months after PCV13 if PCV13 is admin- with trivalent inactivated vaccine or between 1999 and August 2002 with
istered) if not previously adminis- live attenuated nasal vaccine (if the positioners (Advanced Bionics model
tered (recommendation B). Admin- child has no condition that constitutes AB-5100H or AB-5100H-11).
istration of more than 1 dose of a medical contraindication) to pa-
PPSV23 to children with cochlear im- tients with a cochlear implant is rec- 5. Management of Acute Otitis
plants is not recommended. ommended, and influenza immuniza- Media in Children With Cochlear
● A single supplemental dose of tion of their household contacts Implants
PCV13 should be administered to should be strongly considered (rec- ● Patients with cochlear implants who
children 14 months through 71 ommendation B). are diagnosed with acute otitis media
months of age who have been fully ● Tympanostomy tube placement also should be started urgently on sys-
immunized with PCV7. A supplemen- should be considered if recurrent temic antimicrobial therapy; watchful
tal dose is unnecessary if the fourth episodes of acute otitis media occur waiting is inappropriate for these
dose of pneumococcal conjugate after cochlear implantation. children.55 Initial empiric treatment
PEDIATRICS Volume 126, Number 2, August 2010 387
Downloaded from www.aappublications.org/news by guest on February 15, 2020with an oral antimicrobial agent (eg, omy with or without ventilation place- Mary Anne Jackson, MD
amoxicillin or amoxicillin/clavulanate, ment should be performed to drain Harry L. Keyserling, MD
David W. Kimberlin, MD
at a dose of 80 –90 mg/kg per day) is the middle ear. Walter A. Orenstein, MD
reasonable if all of the following crite- Gordon E. Schutze, MD
6. Management of Bacterial Rodney E. Willoughby Jr, MD
ria are fulfilled: (1) the episode occurs
Meningitis in Patients With a LIAISONS
2 or more months after cochlear im-
Cochlear Implant Beth P. Bell, MD – Centers for Disease Control
plantation; (2) the patient does not and Prevention
have an uncorrected Mondini or sim- ● CSF should be submitted for culture.
Robert Bortolussi, MD – Canadian Paediatric
ilar inner-ear malformation or CSF/ If present, middle-ear fluid should Society
middle-ear fistula; (3) the patient does be obtained and sent for culture. Richard D. Clover, MD – American Academy of
The choice of empiric antimicrobial Family Physicians
not appear severely ill and there is no Marc A. Fischer, MD – Centers for Disease
clinical evidence of mastoiditis or therapy for meningitis (eg, ceftriax- Control and Prevention
meningitis; and (4) the cochlear im- one or cefotaxime plus vancomycin) Richard L. Gorman, MD – National Institutes of
is similar to that for children with- Health
plant does not have a spacer/posi- Lucia Lee, MD – Food and Drug Administration
tioner (Advanced Bionics model AB- out implants. An exception is for R. Douglas Pratt, MD – Food and Drug
5100H or AB-5100H-11). Patients with children with the onset of meningi- Administration
tis during the first 2 weeks after co- Jennifer S. Read, MD, MS, MPH, DTM&H –
acute otitis media who fulfill these cri- Eunice Kennedy Shriver National Institute of
chlear implantation; in such cir-
teria are likely to be at a lower risk of Child Health and Human Development,
cumstances, causal bacteria may National Institutes of Health
developing inner-ear infection or
include a broader range of patho- Bruce G. Gellin, MD, MPH – National Vaccine
meningitis complicating acute otitis Program Office
gens, including Gram-negative
media. If feasible, middle-ear fluid Jeffrey R. Starke, MD – American Thoracic
bacilli such as A baumannii and Society
should be obtained through the tym-
Gram-positive bacteria such as En- Jack T. Swanson, MD – AAP Committee on
panostomy tube or a tympanocente- Practice and Ambulatory Medicine
terococcus spp. Selection of a com-
sis or myringotomy for culture just CONSULTANTS
bination of agents that provide
before initiation of antimicrobial ther- H. Cody Meissner, MD
broader-spectrum activity against
apy, but this should not be allowed to Lorry G. Rubin, MD
Gram-negative bacilli (eg, mero-
cause an undue delay in initiation of EX OFFICIO
penem and vancomycin) should be Larry K. Pickering, MD – Red Book Editor
antimicrobial therapy. For patients
considered. Patients with a cochlear Carol J. Baker, MD – Red Book Associate Editor
with a cochlear implant who do not
implant and bacterial meningitis Sarah S. Long, MD – Red Book Associate Editor
meet these criteria (including pa-
should be evaluated urgently by an STAFF
tients with implants of an unknown otolaryngologist for consideration of Jennifer Frantz, MPH
type implanted between 1999 and Au- imaging and surgical exploration. SECTION ON OTOLARYNGOLOGY–HEAD
gust 2002), initial therapy with a par- AND NECK SURGERY EXECUTIVE
enteral antimicrobial agent for treat- LEAD AUTHORS COMMITTEE, 2009 –2010
Lorry G. Rubin, MD Scott R. Schoem, MD, Chairperson
ment of acute otitis media (eg,
Blake Papsin, MD Charles Bower, MD
ceftriaxone or cefotaxime) is recom- Joshua A. Gottschall, MD
mended. Patients with a cochlear im- COMMITTEE ON INFECTIOUS DISEASES, Diego Preciado, MD, PhD
2009 –2010 Kristina W. Rosbe, MD
plant and acute otitis media should be
Joseph A. Bocchini Jr, MD, Chairperson Sally Richard Shott, MD
evaluated by an otolaryngologist if John S. Bradley, MD Mark S. Volk, MD, DMD
their condition worsens despite 24 Michael T. Brady, MD CONTRIBUTING MEMBER
hours of antimicrobial therapy. A Henry H. Bernstein, DO
Blake Papsin, MD
Carrie L. Byington, MD
sample of middle-ear fluid should be Margaret C. Fisher, MD STAFF
obtained for culture, and a myringot- Mary P. Glode, MD Aleksandra Stolic, MPH
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tices. Pneumococcal vaccination for co- Notice to readers: recommendation from mittee on Management of Acute Otitis Me-
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Committee on Infectious Practices. MMWR ningococcal conjugate vaccine (MCV4) in 1451–1465
390 FROM THE AMERICAN ACADEMY OF PEDIATRICS
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APPENDIX Grading of Recommendations
Grade Definition
A Recommended: there is high certainty that the net benefit is substantial.
B Recommended: there is high certainty that the net benefit is moderate
or there is moderate certainty that the net benefit is moderate to
substantial.
C Recommendation against routinely providing: there may be
considerations that support providing the service in an individual
patient, and there is at least moderate certainty that the net benefit is
small.
D Recommends against the service: there is moderate or high certainty
that the service has no net benefit or that the harms outweigh the
benefits.
I The current evidence is insufficient to assess the balance of benefits
and harms of the recommendation. Evidence is lacking, of poor
quality, or conflicting, and the balance of benefits and harms cannot
be determined.
Modified from the US Preventive Services Task Force recommendations categories (available at: www.ahrq.gov/clinic/
uspstf/grades.htm).
PEDIATRICS Volume 126, Number 2, August 2010 391
Downloaded from www.aappublications.org/news by guest on February 15, 2020Policy Statement−−Cochlear Implants in Children: Surgical Site Infections and
Prevention and Treatment of Acute Otitis Media and Meningitis
Lorry G. Rubin, Blake Papsin and the COMMITTEE ON INFECTIOUS DISEASES
AND SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY
Pediatrics originally published online July 26, 2010;
Updated Information & including high resolution figures, can be found at:
Services http://pediatrics.aappublications.org/content/early/2010/07/26/peds.2
010-1427
Permissions & Licensing Information about reproducing this article in parts (figures, tables) or
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Downloaded from www.aappublications.org/news by guest on February 15, 2020Policy Statement−−Cochlear Implants in Children: Surgical Site Infections and
Prevention and Treatment of Acute Otitis Media and Meningitis
Lorry G. Rubin, Blake Papsin and the COMMITTEE ON INFECTIOUS DISEASES
AND SECTION ON OTOLARYNGOLOGY-HEAD AND NECK SURGERY
Pediatrics originally published online July 26, 2010;
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/early/2010/07/26/peds.2010-1427
Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
has been published continuously since 1948. Pediatrics is owned, published, and trademarked by
the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,
60007. Copyright © 2010 by the American Academy of Pediatrics. All rights reserved. Print ISSN:
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