Policy Statement-Cochlear Implants in Children: Surgical Site Infections and Prevention and Treatment of Acute Otitis Media and Meningitis ...

 
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Policy Statement-Cochlear Implants in Children: Surgical Site Infections and Prevention and Treatment of Acute Otitis Media and Meningitis ...
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
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FIGURE 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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FROM THE AMERICAN ACADEMY OF PEDIATRICS

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
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they 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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FROM THE AMERICAN ACADEMY OF PEDIATRICS

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
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Use 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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FROM THE AMERICAN ACADEMY OF PEDIATRICS

   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, 2020
with 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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390      FROM THE AMERICAN ACADEMY OF PEDIATRICS
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FROM THE AMERICAN ACADEMY OF PEDIATRICS

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
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Policy 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
                              in its entirety can be found online at:
                              http://www.aappublications.org/site/misc/Permissions.xhtml
Reprints                      Information about ordering reprints can be found online:
                              http://www.aappublications.org/site/misc/reprints.xhtml

               Downloaded from www.aappublications.org/news by guest on February 15, 2020
Policy 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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