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Complications in a Series of 4400 Paediatric Cochlear Implantation
Article in International Journal of Pediatric Otorhinolaryngology · May 2015
DOI: 10.1016/j.ijporl.2015.05.024
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Complications in a series of 4400 paediatric cochlear implantation
Ahmad Daneshi
a, Mohammad Ajalloueyan
b,*, Mohammad Mahdi Ghasemi
c,
Basir Seyed Hashemi
d, Hesam Emamjome
a, Mohammad Farhadi
a, Zahra Ajalloueyan
eaIranUniversityofMedicalSciences,Rassol(PBUH)Hospital,Tehran,Iran
bBaqiyatallahUniversityofMedicalSciences,BaqiyatallahHospital(PBUH),Tehran,Iran
cMashhadUniversityofMedicalSciences,Ghaem(PBUH)Hospital,Mashhad,Iran
dShirazUniversityofMedicalSciences,KhaliliHospital,Tehran,Iran
eTehranUniversityofMedicalSciences,Tehran,Iran
1. Introduction
Congenitalsevere-to-profoundhearinglosshasbeenshownto limit children’s ability to develop effective auditory and oral linguistic capabilities and communication skills [1]. Cochlear implants provide people with severe-to-profound hearing loss greater access to sound and improvement in their auditory abilities, speech understanding, and linguisticdevelopment [2].
Cochlearimplantsurgeryinchildrenmaypresentadditionalrisks thatarenotpresentinadultpatients[3].Preoperativeevaluation ina childalsohaschallenges.Beforeconsiderationforcochlear implantationthedegreeofhearinglossneedstobeestablished.
Current objective testing with sedated auditory brainstem responses, auditory-evoked potentials, auditory steady-state
responses and play audiometry has enabled more accurate evaluation of hearing. Post-operative device programming can alsobedifficultinthepaediatricpatient.
Itisimportantthatthethresholdsareaccurateandthedeviceis set at comfortable levels to enable optimalfunctioning of the cochlear implant[4].Theprocedure continuestobeperformed with increasingfrequency, although cochlearimplantation (CI), like any other surgical procedure, has some minor or major complications [5]. Since the introduction of newborn hearing screeninginIranin2001,morethan85%ofnewbornsarescreened forhearinglosswithinthefirstfewdaysoflife.Consequently,more patientsarebeingdetectedwithhearinglossearlyinlife,andmore paediatricpatientsaregettingcochlearimplantsinthecourseof theirhearing rehabilitation.On average,childrenachievehigher linguistic,academic,andsocialskillswhenmanagementofhearing lossisimplementedearlier[6].Thepurposeofthisstudywasto evaluatemajorcomplicationsandsafetyofcochlearimplantation inchildrenthroughamulti-centricstudyinIran.Althoughsurgical techniqueshaveimprovedsincethefirstCIprocedure,thereare InternationalJournalofPediatricOtorhinolaryngology79(2015)1401–1403
ARTICLE INFO
Articlehistory:
Received6February2015
Receivedinrevisedform22May2015 Accepted24May2015
Availableonline19June2015
Keywords:
Cochlearimplantation Iran
Complication
ABSTRACT
Objectives:Thepurposeofthisstudyistoretrospectivelyreviewthecomplicationsofpaediatricpatients undergoingcochlearimplantationatfourmajorIraniancochlearimplantcentres.
Methods:A retrospectiveanalysis was performedofallpatientswhounderwentprimarycochlear implantationfrom January1991to December 2013.Thepatients werereviewedfordemographic information,andcomplicationsincludingcerebrospinalfluidleak,meningitis,facialpalsy,andwound infection.
Results:4400recordswerereviewed.Fifty-fourpatientswerelosttofollow-up;therefore,4346records wereanalysed.Themostcommonaetiologyofhearinglosswasnon-syndromicgeneticsensori-neural hearingloss(69%).OtherlesscommonaetiologiesofhearinglossincludedTORCH(Toxoplasmosis,Other infections,Rubella,Cytomegalovirus,Herpes)(11%),syndromichearingloss(7%),ototoxicity(5%),and autoimmuneinner-eardisease(4%).ThemostcommonmajorcomplicationswereCSFleak(0.4%),skin necrosis(0.2%),meningitis(0.1%),facialparalysis(0.07%)andmassivehaemorrhage(0.05).
Conclusion:Cochlearimplantationcontinuestobereliableandsafeinexperiencedhands,withavery lowpercentageofseverecomplications.
ß2015ElsevierIrelandLtd.Allrightsreserved.
* Correspondingauthorat:No.9,KadooeeSt.,ShariatiSt.,Tehran,Iran.
Tel.:+982122002393;fax:+982122002392.
E-mailaddress:[email protected](M.Ajalloueyan).
ContentslistsavailableatScienceDirect
International Journal of Pediatric Otorhinolaryngology
j ou rna l h ome pa ge : w ww . e l se v i e r. co m/ l oc a te / i j porl
http://dx.doi.org/10.1016/j.ijporl.2015.05.035
0165-5876/ß2015ElsevierIrelandLtd.Allrightsreserved.
stillsomecomplications, both majorand minor.Majorsurgical complications necessitate hospital admission and intervention, whileminorcomplicationscanbemanagedconventionally[7].
2. Methods
The national review board’s permission was obtained. We performedaretrospectiveanalysisofallpatientswhounderwent cochlearimplantation fromJanuary1991 toDecember 2013at fourmajoracademiccentrestofindouttheleadingaetiologiesfor paediatriccochlearimplantationandalsomajorcomplicationsof this procedure. The patients were reviewed for demographic information, cochlear implant device,and major complications includingmeningitis,woundinfection,cerebrospinalfluidleakand facialpalsy.Minor surgicalcomplications suchasmagnet sore, stitch abscess, local pain and facial numbness were locally managedandwerenotincludedinthisanalysis.Fifty-fourpatients werelostduetoinsufficientfollow-upordeathunrelatedtoCI.
Selectioncriteriaforthechildpopulationinthisstudywereage betweenfivemonthsand 12years,bilateralsevere-to-profound hearinglosswithpuretoneaverageof90dBSPLormore,minimal benefitfromhearingaids(definedasdetectionoflessthan20–30%
onsingle-syllablewordtest)orforyoungerchildren,a bilateral profound sensori-neural hearing loss over a time period of 3 months or more, no medical contra-indications, and realistic expectationsonthepartoftheparents.Surgicalcontraindications were central auditory lesions, cochlear aplasia and persistent chronicearinfectionwithotorrhoea.Pre-operativetemporal-bone CTscanswereanalysedandanomalieswerenoted.
3. Results
4400recordswerereviewed.Fifty-fourpatientswerelostdue toemigrationordeath unrelatedtoCI;therefore,4346 records wereanalysed.Allpatientswerefollowedforatleastoneyearafter implantation.Thepredominantaetiologyofhearinglosswasnon- syndromic,genetichearingloss(69%).Table1demonstratesthe aetiologiesofhearinglossinthisseries.Maletofemaleratiois1.
Intra-operative complications, such as CSF leak, massive haemorrhageduetoruptureofunderdiagnosedveryhighjugular bulb,andseverefacialnervetrauma,werefew,andmanagedinthe samesession.AsummaryofthecomplicationsisgiveninTable2.
Themostcommonpost-operativecomplicationwasflapnecrosis (0.2%). The first patients had the traditional C-shaped post- auricularincision,andalloftheflapfailuresbelongedtothisgroup.
Otherpatients hadsmallstraight orhockey-stickpost-auricular incisionswithoutflapfailures.
Flapandwounddisordersweremanagedwithlocalcareand,in case of complete failure, rotational musculo-cutaneous or free forearmflapwereused (eightcases)(Fig. 1). Skinnecrosisand wounddehiscenceoccurred withinsixmonthsof implantation.
Magnetsoresweremanagedwithweakermagnetsandlocalcare in170patients(4%).
The rateofpost-operativemeningitisin ourserieswas0.1%
and the causative organism was proven to be pneumococcus onlyinoneoftheearliestcases.Wehaveroutinelyusedpre-and
intra-operative antibiotics, and until recently pre-operative pneumococcalvaccinationwasnotmandatory.
Inner-earanomaliescanplayaroleasapredisposingfactor.The overall rateof inner-ear anomalies which were diagnosed pre- operatively in CT scans was 3.9% (rate of meningitis=0.1%).
Structuralanomalies wereasfollows: largevestibularaqueduct (n=75,1.7%); Mondinidysplasia (n=36, 0.8%);common cavity (n=25,0.6%);cochlearhypoplasiaandabnormalcommunication between lAC to cochlea or vestibule (n=21, 0.5%); cochlear ossification(n=l3,0.3%).Pneumococcalmeningitiswasthemost common aetiology of cochlear ossification. Overall, in 4345 CI patients,themajorcomplicationratewas0.8%(n=34).
4. Discussion
Cochlear implantation has been done successfully in the paediatric population forseveral years. Surgeons have toknow several areasofpotentialrisk.Asreportedin theliterature,the mostcommonaetiologyforreoperationisdevicefailure[8],our resultsis2.3%andarecomparabletothereportsofChungetal.[9]
andDonatelliandTresa[8].Recently,Trotteretal.[10]reported thattherateofdevicefailurehasbeenreduced;thismightbethe resultofimprovementsinthemanufacturingprocess.Wenoticed thatthebulkofourreimplantationsbelongedtotheoldgeneration of MED-EL combi40 devices; very few device failures were diagnosed with new released devices, so we can confirm this finding.
Veryyoungchildrenhaveathinskullandscalp.Althoughithas been claimed that thin scalp may increase the risk of wound breakdown[11],flapfailureshavenotbeenseeninveryyoung kids.Post-operatively,parentsorbabycarersneedtodailyobserve themagnetstrengthandscalpappearanceoverthereceiver,and earlyskin-colourchangeorflapproblemscanthenbemanaged withlocalwoundcare;reductionofmagnetstrengthcouldprevent breakdown.AccordingtoBritoetal.[12],complicationsrelatedto flapproblemsseemtobedecreasinginincidencecomparedwith
Table1
Aetiologiesofpaediatrichearingloss.
Aetiology %
Non-syndromicgenetic 69
TORCHS 11
Syndromic 7
Ototoxicity 5
Autoimmuneinnereardisease 4
Others 4
Table2
Majorintraandpostoperativecomplications.
Aetiology No. %
IntraoperativeCSFleakage 17 0.4
Flap(skin)necrosis 8 0.2
Postoperativemeningitis 4 0.1
Severefacialnervedamage 3 0.07
Massivehaemorrhage 2 0.05
Total 34 0.8
Fig.1.Deviceextrusionfromnecrosedskin.
A.Daneshietal./InternationalJournalofPediatricOtorhinolaryngology79(2015)1401–1403 1402
olderreporteddata.Thedecreaseincomplicationsisrelatedto improvement in technology, anatomy-based flap design, and learningcurveofmedicalstaff.Thesedays,asthedeviceshave becomethinnerandsmaller,lesssoft-tissuedamageisincurred [13].EarlierlargeC-shapedflapshavebeenreplacedwithsmall, straightanatomical-basedflapstosavebloodsupplyandvenous drainagetotheflaps,soskinnecrosisandflapfailureshavebeen dramaticallydecreased,asreportedbyAjalloueyanetal.[14].In ourseriesall of theflapfailureswere amongtheold large C- shape designs; we believe improvelearning curve resulted in decreasein flapnecrosis. Wefoundnoflap failurewith small straightincisions;thisiscomparabletotheresultsofBajajetal.
[15].
Intra-operativeCSFleakagemostlyoccursaftercochleostomy incaseswithinner-earanomalies[16],butmayoccurincaseswith intact labyrinth in pre-operative CT scan too. In our series it occurredin0.4%ofcases,mostlywithinner-earanomalies,and was managed during surgery without long-term complication;
Daneshietal. [17]reported thesamemanagementand results.
Thisleakage,whichusuallystopsafterawhilewithhyperventila- tion,sometimescontinues as CSF rhinorrhoea for two tothree days.Aconservative approachsolvedthis probleminall ofour caseswithoutanyneedforsecondintervention.Thismeansintra- operative CSF leakage from cochleostomy sites is not a major concern.
Wehadtwocasesof trauma tomajor vesselsandmassive bleeding wascontrolledin the same session,though Gastman and Hirsch [18] reported potential risk of carotid damage inCI.
Inadvertentburrtraumatofacialnerveinfacialrecessoccurred inthreecaseswithtrainingsurgeonsandwasmanagedonsiteby cable graft. Long-term results are not satisfactory and some synkinesisanddisfigurationhasoccurred.Thisawfulcomplication shouldbepreventedinanysurgicalsettingbycloseobservation and care by expert surgeons. Transient facial palsy (paresis) occurredinabout7%ofthecases,withspontaneousorsteroid- supportedcompleterecovery.Thismaybeduetothermaldamage tothenerveduringdrillingormayberelatedtoviralorstress- inducedBell’spalsy.Thisproblemcontinuestobeoccurringafter introduction of continues irrigation technique when drilling aroundfacialrecessand usingcuttingburrs. We mayconclude that this is somesort of Bell’s palsy and shouldbe medically managed.FayadandWanna[19]reportedtheriskoffacialnerve damageduringCIandmadesomeusefulcommentstopreventthis complication.
Risk of meningitis as a horrible complication in Western countries was reduced after the introduction of pneumococcal vaccines.Itwasreportedtobeasmuchas4%inthepre-vaccineera buthasbeenreducedtonearzeroinrecentyears,asreportedby Mooreetal. [20].In ourexperience, totalrisk ofpneumococcal meningitishasbeenlessthan0.1%withthesamedistributionin thepre-andpost-vaccineeras.Although,accordingtothelatest IraniannationalhealthguidelineforCI,pneumococcalvaccination ismandatorybefore CI,wecannotconcludethatpneumococcal vaccinationhasreducedriskofmeningitisinourseries.Afsharpai- manetal.[21]reportedthesameresults.
Acknowledgments
TheauthorswouldliketothankdirectorsoffourmajorIranian cochlearimplantcentresofMashhad,Shiraz,Rasool(PBUH)and Baqiyatallah(PBUH)fortheirkindcooperation.
AppendixA. Supplementarydata
Supplementarydataassociatedwiththisarticlecanbefound,in theonlineversion,athttp://dx.doi.org/10.1016/j.ijporl.2015.05.035.
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