www.bjorl.org
Brazilian
Journal
of
OTORHINOLARYNGOLOGY
ORIGINAL
ARTICLE
Retrospective
analysis
of
skin
complications
related
to
bone-anchored
hearing
aid
implant:
association
with
surgical
technique,
quality
of
life,
and
audiological
benefit
夽
Daniel
Pe˜
naranda
a,
Juan
Manuel
Garcia
b,c,
Maria
Leonor
Aparicio
b,
Felipe
Montes
d,
Clemencia
Barón
b,
Roberto
C.
Jiménez
d,
Augusto
Pe˜
naranda
a,b,∗ aUniversidaddelosAndes,FacultaddeMedicina,Bogotá,ColombiabFundaciónSantaFedeBogotá,GrupodeImplanteCoclear,Bogotá,Colombia
cFundaciónUniversitariadeCienciasdelaSalud,DivisióndeOtologíayNeurotología,Bogotá,Colombia dUniversidaddelosAndes,DepartamentodeIngenieríaIndustrial,Bogotá,Colombia
Received22November2016;accepted27March2017 Availableonline25April2017
KEYWORDS Skincomplications; Qualityoflife; Bone-anchored hearingaid; BAHA; Surgicaltechnique Abstract
Introduction:Thebone-anchoredhearingaid isaneffectiveformofauditory rehabilitation. Duetothenatureoftheimplant,themostcommoncomplicationsareskinrelated.Anumber ofalternativesurgicalimplantationtechniqueshavebeenusedtoreducethefrequencyand severityofskincomplications,includingtheU-shapedgraftandthelinearincision.
Objective:Toassessskincomplicationsandtheirassociationwithsurgicaltechnique,quality oflife,andaudiologicalbenefitinpatientswithbone-anchoredhearingaids.
Methods:This was aretrospectivestudy conducted inatertiary referral centerinBogotá, Colombia.Patientswhohadbeenfittedwithabone-anchoredhearingaidimplant(unilaterally orbilaterally)foratleast6monthswereincludedinthestudy.TheHolgersclassificationwas usedtoclassifyskincomplications(Grade0=none;Grade1=erythema;Grade2=erythemaand discharge;Grade3=granulationtissue;andGrade4=inflammation/infectionresultinginthe removaloftheabutment).TheGlasgowBenefitInventoryquestionnairewasusedtodetermine qualityoflife,andtheAbbreviatedProfileofHearingAidBenefit questionnairewasusedto determinethesubjectiveaudiologicalbenefit.
夽 Pleasecitethisarticleas:Pe˜narandaD,GarciaJM,AparicioML,MontesF,BarónC,JiménezRC,etal.Retrospectiveanalysisofskin
complicationsrelatedtobone-anchoredhearingaidimplant:associationwithsurgicaltechnique,qualityoflife,andaudiologicalbenefit.
BrazJOtorhinolaryngol.2018;84:324---31.
∗Correspondingauthor.
E-mail:augpenar@gmail.com(A.Pe˜naranda).
PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial. https://doi.org/10.1016/j.bjorl.2017.03.012
1808-8694/©2017Associac¸˜aoBrasileiradeOtorrinolaringologiaeCirurgiaC´ervico-Facial.PublishedbyElsevierEditoraLtda.Thisisanopen accessarticleundertheCCBYlicense(http://creativecommons.org/licenses/by/4.0/).
Results:A totalof37patientswereincludedinthestudy(30withunilateralimplantsand7 with bilateralimplant).Of the44implantsevaluated,31(70.3%)were associatedwithskin complications(7[15.9%]Grade1;4[9.1%]Grade2;15[34.1%]Grade3,5[11.4%]Grade4).The U-shapedgraftwasstatisticallyassociatedwithmajorcomplications(Grades3and4)compared withthelinearincisiontechnique(p=0.045).Nostatisticallysignificantdifferenceswerefound betweenAbbreviatedProfileofHearingAidBenefitscoresandseverityofcomplications. Simi-larly,nodifferenceswerefoundbetweenGlasgowBenefitInventoryphysicalhealthquestions andskincomplications.
Conclusion: Despitethehighfrequency,skincomplicationsdidnotseemtoaffectqualityof lifeorsubjectiveaudiologicalbenefitsofpatientswithbone-anchoredhearingaids.
© 2017 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Published by Elsevier Editora Ltda. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/). PALAVRASCHAVE Complicac¸ões cutâneas; Qualidadedevida; Próteseauditiva óssea; BAHA; Técnicacirúrgica
Análiseretrospectivadecomplicac¸õescutâneasrelacionadasaoimplantedeprótese auditivaóssea:associac¸ãocomtécnicacirúrgica,qualidadedevidaebenefício audiológico
Resumo
Introduc¸ão: Apróteseauditivaóssea(BAHA,doinglêsBone-AnchoredHearingAid)éumaforma eficazdereabilitac¸ãoauditiva.Devidoànaturezadoimplante,ascomplicac¸õesmaiscomunssão relacionadasàpele.Váriastécnicasalternativasdeimplantac¸ãocirúrgicatêmsidoutilizadas para reduzirafrequênciaeagravidadedascomplicac¸õescutâneas,incluindooenxertoem formadeUeaincisãolinear.
Objetivo: Avaliarascomplicac¸õescutâneasesuaassociac¸ãocomatécnicacirúrgica,qualidade devidaebenefícioaudiológicoempacientescomBAHAs.
Método: Esseéumestudoretrospectivorealizadoem umcentroterciáriodereferênciaem Bogotá,Colômbia.OspacientesquereceberamumimplantedeBAHA(unilateralou bilateral-mente)durantepelomenos6mesesforamincluídosnoestudo.Aclassificac¸ãodeHolgersfoi uti-lizadaparaclassificarascomplicac¸õescutâneas(Grau0=nenhuma,Grau1=eritema,Grau2= eritemaesecrec¸ão,Grau3=tecidodegranulac¸ãoeGrau4=inflamac¸ão/infecc¸ãoresultando naremoc¸ão daestruturadeapoio). OquestionárioGlasgow BenefitInventory (GBI)foi uti-lizadoparadeterminaraqualidadedevida,eoquestionárioAbbreviatedProfileofHearing AidBenefit(APHAB)foiutilizadoparadeterminarobenefícioaudiológicosubjetivo.
Resultados: Umtotal de37 pacientes foi incluídono estudo (30com implantesunilaterais e 7 comimplantes bilaterais).Dos 44 implantes avaliados, 31 (70,3%) foramassociados às complicac¸õescutâneas(7[15,9%]Grau1;4[9,1%]Grau2;15[34,1%]Grau3,e5[11,4%]Grau4). OenxertoemformadeUfoiestatisticamenteassociadoacomplicac¸õesmaiores(Graus3e4) emcomparac¸ãocomatécnicadeincisãolinear(p=0,045).Nãoforamencontradasdiferenc¸as estatisticamentesignificativasentreosescoresAPHABegravidadedascomplicac¸ões.Domesmo modo,nãoforamencontradasdiferenc¸asentreasquestõesdesaúdefísicapeloquestionário GBIecomplicac¸õescutâneas.
Conclusão:Apesardaaltafrequência,ascomplicac¸õescutâneasnãoparecemafetara quali-dadedevidaouosbenefíciosaudiológicossubjetivosdepacientescomBAHAs.
© 2017 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Publicado por Elsevier Editora Ltda. Este ´e um artigo Open Access sob uma licenc¸a CC BY (http:// creativecommons.org/licenses/by/4.0/).
Introduction
The bone-anchored hearing aid (BAHA) has proved to be effective in auditory rehabilitation. The device was introducedbyTjellströmandCarlssonin1977,1andwas
ini-tiallyapprovedforconductiveandmixedhearingloss.More recently,theimplantshavebeenacceptedforbilateraland sensorineuralhearingloss.2---4Severalstudieshavereported
improvements in quality of life aswell assubjective and objectiveaudiological benefits in patients fitted withthe implant(s).4---6Evenpatientswithcongenitalabnormalities,
suchas aural atresia, arereported to benefitfrom BAHA implants.7
TheBAHAisanacousticamplificationsystemconsisting ofthreeelements:atitaniumfixtureimplantedinthe mas-toidprocessofthetemporalbone,askinabutment,anda
soundprocessoranchoredtotheabutment.Duetothe inher-entcontactoftheimplantwiththeskin,themostcommon complicationsare skin related,such aserythema, inflam-mationandinfection.Severecomplicationsmayrequirethe removaloftheskinabutment.8
Severalsurgicalmodificationstotheimplantation tech-niquehavebeenusedinanattempttoreducethenumberof skincomplications.TheseincludetheU-shapedgraftandthe linearincisiontechniques.9,10Ourcenter,atertiaryreferral
center,hasspecificallyusedthesetwosurgicaltechniquesin previousyears,andwehaveobserveddifferencesbetween thetwotechniquesintermsofnumberandseverityofskin complications.
To date, no statistical associations have been made between the type of skin complications and the quality of life or the subjective audiological benefits in patients withBAHAimplantsusingvalidatedquestionnaires.Arecent meta-analysisof complications associatedwith osseointe-gratedhearingaidssuggestedthatlackofacousticbenefit andsocialconsiderationsplayanimportantroleindeciding tobecomeanon-user.8Thus,itispossiblethatpatientswho
haveexperiencedahigherdegreeofskincomplicationsmay indicateaworsesubjectiveaudiological benefitoralower qualityoflife.
The aims of the current study were to evaluate the frequency and severity of skin complications following BAHAimplantation,andtoinvestigatepossibleassociations betweenskincomplicationsandthesurgicaltechniqueused, patientqualityoflife,andsubjectiveaudiologicalbenefit.
Methods
Studydesignandpatients
This was a retrospective study conducted in an otologic referralcenter (Otolaryngology Department,Hospital Uni-versitario Fundacion Santafe, Universidad de Los Andes, Bogotá, Colombia). The study included patients who had been fitted with a BAHA device (either unilaterally or bilaterally)between 2003 and2011. In ordertominimize ‘‘enthusiasmbias’’,onlypatientswhohadhadthedevice foratleastsixmonthswereincluded.Therewereno exclu-sioncriteriaforparticipationinthisstudy.Allofthepatients wereoperated onby twootologists(A.P.or J.M.G)ofthe OtologyCenterintheUniversityHospitalFundacionSantafe, Bogotá, Colombia. The study wasapproved by the ethics committeeofFundacionSantafedeBogotá.Patientconsent wasnotneededduetotheretrospectivenatureofthestudy. Twodifferentsurgicaltechniqueswereemployedinthe study.TheU-shapedgrafttechniquewithBAHAdermatome9
was used in 20 patients, 6 of whom received bilateral implants.Askintransplantwasharvestedandcompletesoft tissueremovaltotheperiosteumwasperformedunderthe skintransplantarea.Afterthedrillingandinsertionofthe implantwereperformed,aholewaspunchedforthe abut-mentandthesplitskintransplantwassuturedtightlytothe periosteum.11
Thelinearincisiontechnique10 wasusedin15patients,
allofwhomreceivedunilateralimplants.Inthistechnique, an incisionapproximately2.5cmin length was madeand softtissue was mobilizedand raised over the periosteum
attheimplantsite,butallhairfollicleswereleftintact.A holewaspunched forthe abutment at0.5---1cmfromthe incisionalline,leavingan intactperiosteumexceptat the sitewherethefixtureisinserted.Theincisionwassutured onlyatskinlevel,withnosuturestotheperiosteum.11
Allpatients were fitted withthe 5mm abutment. The tioblastimplantsurfacewasnotusedinanyoftheimplants. Perioperativeandpostoperativeantisepticswerenotused. Thebandageconsistedofgauzedressingbetweentheskin andahealingcapimpregnatedwithanantisepticointment (Bactigras, Smith andNephew, Canada),which were kept in place for 48h. Patientswere fitted with the processor betweenthethirdandfourthweekafterthesurgery.
Information on the surgical technique for two of the patients(onepatientwithbilateralBAHA)wasnotavailable astheyunderwentsurgeryatdifferenthospitals.Therefore, weanalyzed26implantswiththedermatometechnique,15 implantswithlinearincisiontechnique,and3implantswere thetechniqueinformationwasunavailable,foratotalof44 implantsin37patients.
Evaluationofskincomplications
The Holgers classification was used to evaluate skin complications12: Grade 0=no adverse reaction; Grade
1=skin with erythema; Grade 2=skin with erythema and discharge; Grade 3=granulation tissue; and Grade 4=inflammation/infection resultingin the removal of the abutment. Skin complications were divided into minor (Grades1and2)andmajor(Grades3and4)complications basedontheseverityandtheneedforrevisionsurgery.
All patients operated between 2003 and 2011, were invited to a follow-up consultation during which a pho-tographic record of the implant was made in order to objectively assess the grade of the complication. Sub-sequently, patients were asked to indicate which skin complications they had ever experienced by using pho-tographs of complication grades according tothe Holgers classification.Werevisedthemedicalhistorynotesofeach patient in order to ensure that all complications were recorded.Thesemedicalhistoriesalsoprovidedarecordof patientadherencetofollow-upvisitsandtreatment.
Apatientquestionnaire,developedbytheauthorsofthis study, was used to determine subjective advantages and disadvantagesofthedevice,aswellastheneedfor treat-mentforthedifferentskincomplications(refertoColumn
1)(Table2).
Evaluationofqualityoflife
Qualityoflifeaftersurgerywasdeterminedusingthe Glas-gow Benefit InventoryQuestionnaire (GBI).13 The GBI is a
retrospective generic quality-of-life questionnaire devel-oped by Robinson et al. to measure outcomes after otorhinolaryngologic procedures.This study hasbeen pre-viouslyvalidated.5Itissensitivetochangesinhealthstatus
thatresultfromanintervention,anditenablescomparisons betweendifferentinterventions.
In this questionnaire, 18 items cover three domains; 12 items arerelated togeneral improvement, 3to social improvement,and3tophysicalimprovement.Responsesare givenusinga5point Likertscale.The totalscore calcula-tions vary from −100 (maximum lack of benefit) to +100
(maximum benefit), with a score of 0 meaning no bene-fit.Forthecurrentstudy,we usedtheSpanishtranslation providedbytheInstituteofHearingresearchwebsite.14
Onlythequestionsthatfocusedonthehealth statusof thepatientsandtheuseoftreatmentormedicationswere analyzedin thecurrentstudy.Thequestionnairewas self-administered,butsupervisedbyanaudiologistandmedical student during a scheduled post-surgery consultation to provideanyclarificationifrequired.Wedecidedtousethese specificquestionsforanalysisinordertoexaminewhether highergradesofcomplicationswereassociatedspecifically withtheuseoftreatmentorattendanceatfollow-up consul-tations.
Evaluationofsubjectiveaudiologicalbenefit
Toinvestigatewhethersubjectiveaudiologicalbenefitswere associatedwithskincomplications,weusedtheAbbreviated ProfileofHearingAidBenefit(APHAB),6,15whichisahearing
disabilityquestionnaireconsistingof24questionscovering foursubscales.TheAPHABoutcomesarescoredforunaided andaidedconditions,andbenefitiscalculatedby compar-ingthepatient’sreporteddifficultyintheunaidedcondition withtheirdifficultywithamplification.
Three of the subscales address speech understanding in variouseverydayenvironments: ease ofcommunication (EC,underrelativelyfavorableconditions),listeningunder reverberant conditions(RV, communicationin reverberant rooms), andlistening inbackground noise (BN,in settings withhighbackgroundnoiselevels).TheAversiveness(AV)of soundssubscalemeasuresthenegativereactionsto environ-mentalsounds.
The APHABhasascoringscalefrom1to99;thehigher thescore,thegreaterthehearingdisability.Anoverall dif-ference in theunaided andaided scores of more than 10 pointsforagivensubscale(EC,RV,BN,andAV)was consid-eredtobestatisticallysignificant.12 Forthecurrentstudy,
weusedtheSpanishversionoftheAPHABprovidedbythe UniversityofMemphiswebsite.16
Statisticalanalysis
Individual patient data were coded and analyzed anony-mously. The skin complications were explored using the Holgersclassificationsystem usinga descriptiveapproach. Thepatientquestionnaireresultswereanalyzed using fre-quencytables.
Documented parameters in the patient questionnaire included: daily use of BAHA system, self-report of skin complications, attendance at medical consultations for skin complications, treatment and improvement of complications,replacementofabutmentandprocessor,and self-perceivedbenefitsanddisadvantagesoftheBAHA sys-tem.
Comparisons of the skin complications by type of sur-gical technique were assessed using Fisher’s exact test. Non-parametric analysis, using the Mann---Whitney U and Wilcoxontests,wereusedforthecomparisonofAPHABand GBIresultswithskincomplications.Alevelofsignificanceof ˛=0.05wasimplemented,andthesoftwareusedwasStata 10.0andMathematica9.
Table1 Baselinecharacteristicsofpatients.
Variable Category n(%)
Ageofactivation Median(range) 32(9---63)
Gender Male 21(57%)
Female 16(43%)
Amplification Unilateral 30(81%)
Bilateral 7(19%)
Etiology Bilateralmicrotia 11(29%) Unilateralmicrotia 10(26%) Bilateralmastoidectomy 5(13%) Sensorineuralhearingloss 4(10%) Chronicotitismedia 2(5%) TeacherCollinssyndrome 2(5%) Pfiffersyndrome 2(5%) Unilateralmastoidectomy 2(5%) Hearinglossintheear
withthedevice
Mixed 18(49%) Conductive 15(41%) Sensorineural 4(10%) Unilateral patients-hearingin contralateralear Mixed 14(48%) Normal 6(21%) Sensorineural 4(17%) Conductive 4(14%) Processor Bp100 22(61%) Divino 12(33%) Ponto 2(6%)
Results
Atotal of 37 patients (44 implants)were included in the study.Themale:femaleratiowas21:16,andthepatients’ agesatinitiationofthestudyrangedfrom9to63years.
Priortosurgery,18patients(48.6%)experiencedmixed hearinglossintheimplantedear,15(40.5%)presentedwith conductivehearingloss,and4(10.8%)presentedwith sen-sorineuralhearingloss.
Inpatientswithaunilateralimplant(n=30),thehearing levelinthecontralateralearwasmixedhearinglossin14 (48.3%),normalhearingin6(20.7%),sensorineuralhearing lossin5(17.2%),andconductivehearinglossin4(13.8%).
The etiologiesof thehearing lossin theimplanted ear aresummarized inTable1.Ofnote,onepatienthadboth chronicotitismediaandamastoidectomy,and21patients hadexternalauditorycanalagenesia.
Skincomplications
Resultsfromthepatientquestionnaire
Results from the patient questionnaire showed that 33 patients(89.2%)reportedusingtheBAHAformorethan4h aday,3patients(8.1%)usedthedevicebetween2and3ha day,and1patient(2.7%)reportedusingthedevicebetween
1and2haday(Table2).Thequestionnaireresultsshowed
that 28 patients (75.7%) used the BAHA system 7 days a week,2patients(5.4%)usedit6daysaweek,and7patients (18.9%)usedthedevicebetween2and5daysaweek.Atotal of29patients(78.4%)subjectivelyreportedexperiencinga skincomplication;allofthesepatientsreceivedtreatment withtopicalsteroidcreams,whichimprovedtheskin symp-toms.Feedbacknoiseandesthetics,whichwerereportedin
Table2 Patientquestionnaire.
Question Response n(%)
HowmanyhoursadaydoyouusetheBAHA? 1---2haday 1(2.7%)
2---3haday 3(8.1%)
>4haday 33(89.2%)
HowmanydaysaweekdoyouusetheBAHA? 2---5daysaweek 7(18.9%)
6daysaweek 2(5.4%)
7daysaweek 28(75.7%)
Haveyouexperiencedanyskincomplications? Yes 29(78.4%)
No 8(21.6%)
Ifyes,haveyougonetomedicalconsultationforthis skincomplication?
Yes 29(100%)
No 0
Didtreatmentimprovetheskincomplication? Yes 28(96.5%)
No 1(3.5%)
Howmanytimeshaveyouchangedyourabutment? Never 5(13.5%)
Once 32(86.4%)
Howmanytimeshaveyouchangedyourprocessor?a Never 12(33.3%)
Once 12(33.3%) Twice 7(19.4%) Threetimes 1(2.8%) Fourtimes 2(5.5%) Fivetimes 1(2.8%) Sixtimes 1(2.8%)
WhatdoyoumostdislikeabouttheBAHA?b Feedbacknoise 19(40.4%)
Estheticallyunpleasant 7(14.8%)
Skincomplications 4(8.5%)
Stabilityoftheprocessorc 14(29.8%)
Nothing 3(6.3%)
aOnly36patientsweretakenintoaccountinthisquestion. b Patientscouldselectmultipleanswersinthisquestion.
c Stabilityreferstoeasilyfallingoffand/orthedurationofbatteries.
40.4%and14.8%ofpatients,respectively,wereconsidered tobethemostunpleasantfactorsassociatedwiththeBAHA.
Severityofskincomplications
Inouranalysisofthe44implants(37patients),13implants (29.6%) did not experience any skin complication (Grade 0), 7 implants (15.9%) had experienced Grade 1 skin complications, 4 implants (9.1%) Grade 2, 15 implants (34.1%) Grade 3 and 5 implants (11.4%) Grade 4 skin complications(Fig.1).Overall,45.5%oftheimplantswere associatedwithmajorskincomplicationsandrequired revi-sionsurgery.
Associationofskincomplicationswithsurgical technique
Statistically significant differences in the severity of skin complicationswerefoundbetweenthesurgicaltechniques usedforBAHAimplantation,accordingtotheFisher’sexact test (Fig. 2). In fact, the U-shaped graft technique with BAHA dermatome was statistically associated with major complicationscomparedwiththelinearincisiontechnique (p=0.045). 29.6 15.9 9.1 34.1 11.4 0 5 10 15 20 25 30 35 40 4 3 2 1 0 F re q u ency (% pati en ts)
Grade of skin complication
Figure1 Severityofskincomplications.
Associationofskincomplicationswithsubjective audiologicalbenefit
No statistically significant differences were found between APHAB global score or subscales and severity of complications The p-values of the Mann---Whitney U
statistical differencetest were >0.05for the global score and each of the subscales (EV score p=0.0769, BN score
15 10 p=0.045 5 F requency 0 U-shaped
Minor complications Major complications
Linear incision
Figure 2 Frequency of minor and major complications by interventiontechnique.
p=0.646, RF score p=0.087, AV score p=0.190, Global scorep=0.270).
Associationofskincomplicationswithqualityof life
Nostatisticallysignificantdifferenceswerefoundbetween anyofthefourGBIphysicalhealthquestionsresults (ques-tions8,12,13,and16)andtheseverityofskincomplications (Fig. 3). For each of the questions, the p-values of the Wilcoxon test were >0.05 (p=0.113, 0.848, 0.806, and 0.988,respectively).
Discussion
The aims of this study were to assess the severity of skin complicationsrelatedtoBAHAimplantsandto inves-tigate whether there was an association between skin complications andtypeof surgery,subjective audiological benefit,andqualityoflife.
In terms of severity of skin complications, 45.5% of patientsreportedhavingGrade3orGrade4complications. This is a high rate of major complication compared with those quoted in the literature (9.4---84%).17 This
differ-encemaybeexplainedby selectionbias,aspatientswith morecomplicationsmaybemorelikelytoattendfollow-up consultations. Almostall ofthe patientswho experienced skincomplicationsshowedanimprovementinskinsymptoms withtheuse ofmedicaltreatment. Itisworthmentioning thatskincomplicationswerenotviewedasamajor unpleas-antfactoroftheBAHAsysteminthecurrentstudy;feedback noiseandthelookofthedevicewereconsideredtobethe mostunpleasantfactorsoftheBAHA.
The linear incision technique was statistically signifi-cantly associated with fewer major complications, which correlateswithotherreports.VandeBergetal.18compared
foursurgicaltechniques(retroauricularskingraft,skinflap, dermatome,andverticalincision)inatotalof143patients, andfoundthatthelinearincisiontechniquewassignificantly associatedwithfewermajorcomplications(p=0.0021),and withashortertimeuntiluseofBAHA(2months)compared
with the other techniques. Wilkinson et al.10 reported a
complicationsrateof16.9% in71patientsfor thevertical incision.DeWolfetal.19 reportedskinreactionsinatotal
of1038observationsfrom150patients(16.6%ofthe obser-vations),withthemajority(10.1%)beingHolgersGrade1. Faberetal.20observedskinreactionsin130patients(52.4%
ofthetotalsample), and18.6%hada majorcomplication (Holgers Grades 2---4). In their recent systematic review, Mohamadetal.21 concludedthattheuseoflinearincision
appeared to beassociated with fewer complications, but highlightedtheneedforuniformreportingstandards.
Newer techniques have been introduced in order to reduce the frequency of complications, such as the BAHAimplantationwithout tissuereductionintroducedby HultcrantzandLanis.22 Thistechniquehasexhibitedbetter
outcomesincomparisonwiththedermatometechnique22;
however,outcomecomparisonsbetweenthelinearincision withandwithouttissuereductionremaintobeelucidated. Our study also sought to correlate skin complications withsubjectiveaudiologicalbenefitsandqualityoflifeafter surgery.Indeed,wehypothesizedthatapersonwithmajor complications and requiring revision surgery would have alterationsintheirqualityoflifeandsubjectiveaudiological benefits,asreportedbytheGBIandAPHABquestionnaires. However,wedidnotfindstatisticallysignificantassociations between GBI and APHAB results, and skin complications. Again,althoughBAHAskin complicationsarethemost fre-quentcomplications, these do not seem to influence the patient’ssubjectiveaudiological benefitsor thequalityof lifeafterthesurgery.Strengthsofthisstudyincludetheuse ofvalidatedquality-of-lifeandauditoryquestionnairesand theevidenceofthemost positiveandnegativeBAHA fac-torsbasedonthepatient’sperspective.Limitationsinclude theretrospectivestudydesign,thefactthatitwasasingle centerstudyandthesubjectivenatureofthemeasures.In lightofthis,morestudieswithalargernumberofpatients areneededtoclarifytheseassociations.
Conclusion
Despitethehighfrequencyofskincomplicationsassociated withBAHAs in our cohort, patients appeared tobe satis-fiedwiththe device and skin complications didnot seem toaffectqualityoflifeorthesubjectiveaudiological bene-fits.Basedonourcohortofpatients,werecommendtheuse ofthelinearincisionsinceitwasassociatedwithfewerskin complicationsincomparisonwiththeU-dermatome.Further analysiswillincludelargersampleswithlongerfollow-ups, andcomparisonswiththenewtranscutaneousimplants.
Conflicts
of
interest
Theauthorsdeclarenoconflictsofinterest.
Acknowledgments
Wethankallthepatientsofthestudyandtheethics com-mitteeofFundacion SantafedeBogotá. Theanonymityof thepatientswaspreserved.Theauthorswouldliketothank
0 1 12 4 3 1 2 7 2 4 0 2 4 6 8 10 12 14 Much less often Less often No change Frequency 0 1 2 3 4 5 6 7 8 9 10 Frequency 1 0 Much more often Much more often 2 0
More often More often
7 9 No change 7 8 Less often 0 3 Much less often 0 0 11 6 3 0 1 9 2 4 0 2 4 6 8 10 12 Much less Less No Change More Much more Frequency 0 1 6 6 7 0 2 3 5 6 0 1 2 3 4 5 6 7 8 Much less Less No Change More Much more Frequency
Minor complications Major complications
a
b
c
d
Figure3 FrequencyofeachoptionansweredbypatientspresentingminorandmajorskincomplicationsfortheGlasgow Ben-efitInventoryquestionsrelatedtohealthstatusandtheuseoftreatmentormedications:(a)Question8:Haveyoubeentoyour familydoctor,for anyreason,more orlessoften,since youroperation/intervention;(b) Question12:Sinceyouhadthe oper-ation/intervention, doyou catch coldsor infections moreor less often?;(c)Question 13: Haveyou hadto take moreor less medicineforanyreason,sinceyouroperation/intervention?;(d)Question16:Sinceyouroperation/intervention,areyoumoreor lessinconveniencedbyyourhealthproblem?
MedSense Ltd., HighWycombe, UK for providing editorial assistance.
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