Braz. j. . vol.80 número6

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

www.bjorl.org

ORIGINAL

ARTICLE

Effectiveness

of

balloon

sinuplasty

in

patients

with

chronic

rhinosinusitis

without

polyposis

夽

,

夽夽

Cassiana

Burtet

Abreu

,

Leonardo

Balsalobre

,

Gabriela

Robaskewicz

Pascoto

_,

_Moacir

_Pozzobon

_,

_Sandra

_Costa

_Fuchs

_,

_Aldo

_Cassol

_Stamm

a_{DepartmentofOtorhinolaryngology,HeadandNeck,HospitalMonteSinai,UniversityHealthNetwork,UniversidadedeToronto,}

Toronto,Canada

b_{ProgramadeEstudosPós-GraduadosemCardiologia,UniversidadeFederaldoRioGrandedoSul(UFRGS),PortoAlegre,RS,}

Brazil

c_{CentrodeOtorrinolaringologiadeSãoPaulo,ComplexoHospitalarEdmundoVasconcelos,SãoPaulo,SP,Brazil}

d_{DepartmentofOtorhinolaryngology,HeadandNeck,UniversidadeFederaldeSãoPaulo(UNIFESP),SãoPaulo,SP,Brazil}

Received15May2013;accepted22July2014 Availableonline29August2014

KEYWORDS Sinusitis; Nasalmucosa; Video-assisted surgery;

Paranasalsinuses

Abstract

Introduction:Balloonsinuplastyisaminimallyinvasiveendoscopicprocedure,developedwith theaimofrestoringpatencyoftheparanasalsinusesostiawithminimaldamagetothemucosa. Objective:Toevaluatetheeffectivenessofballoonsinuplastyinpatientswithchronic rhinosi-nusitis.

Methods:Thiswasaprospectivecohortstudycomprising18patientswithchronic rhinosinusi-tiswithoutpolyposiswho underwentballoonsinuplasty.Patientswereevaluated forclinical criteria,qualityoflife(Sino-NasalOutcomeQuestionnaireTest-20[SNOT-20]),andcomputed tomographyofthesinuses(Lund---Mackaystaging)preoperativelyandthreetosixmonthsafter theprocedure.

Results:Outof18patientsassessed,13wereincluded,withameanageof39.9±15.6years. Ostiasinuplastywasperformedin24ostia(foursphenoid,tenfrontal,andtenmaxillarysinus). Atthe follow-up,22 (92%) ostia were patentand therewas no majorcomplication. There wassymptomaticimprovement(SNOT-20),withCronbachcoefficients forconsistency ofthe questionnaireitemsof0.86(95%CI:0.73---0.94)preoperativelyandof0.88(95%CI:0.77---0.95) postoperatively,thedifferencebeingstatisticallysignificant(p<0.001).Inaddition,therewas markedreductionofthecomputedtomographysigns,anaverageof4.2pointscore(p<0.001).

夽 _{Pleasecitethisarticleas:AbreuCB,BalsalobreL,PascotoGR,PozzobonM,FuchsSC,StammAC.Effectivenessofballoonsinuplastyin}

patientswithchronicrhinosinusitiswithoutpolyposis.BrazJOtorhinolaryngol.2014;80:470---5.

夽夽

CentrodeOtorrinolaringologiaeFonoaudiologiadeSãoPaulo---ComplexoHospitalarEdmundoVasconcelos,SãoPaulo,SP,Brazil.

∗_{Correspondingauthor.}

E-mail:cassiabreu@terra.com.br(C.B.Abreu).

http://dx.doi.org/10.1016/j.bjorl.2014.08.011

Conclusion: Sinuplastyiseffective inreducing symptomsand improvingquality of lifeas a treatmentoptionforchronicrhinosinusitisinselectedpatients.

© 2014Associac¸ãoBrasileira de Otorrinolaringologiae CirurgiaCérvico-Facial. Publishedby ElsevierEditoraLtda.Allrightsreserved.

PALAVRAS-CHAVE Sinusite;

Cirurgia videoassistida; Seiosparanasais; MucosaNasal

Efetividadedasinuplastiacombalãoempacientescomrinossinusitecrônicasem polipose

Resumo

Introduc¸ão: Sinuplastiacom balão é um procedimento endoscópico minimamente invasivo, desenvolvidocomoobjetivoderestaurarapatênciadosóstiosdosseiosparanasaiscommínimo danoàmucosa.

Objetivo: Avaliara efetividade dasinuplastia com balãoem pacientescom diagnóstico de rinossinusitecrônica.

Método: Estudodecoorte,prospectivo,envolvendo18pacientescomrinossinusitecrônicasem poliposesubmetidosàsinuplastiacombalão.Foramavaliadoscritériosclínicos,qualidadede vida(SNOT-20)etomografiacomputadorizadadosseiosdaface(estadiamentodeLund-Mackay) trêsaseismesesapósoprocedimento.

Resultados: Dos18 pacientesavaliados,13foramincluídos,commédiadeidade39.9±15.6 anos. A sinuplastia foi realizada em 24 óstios (10 frontais, 10 maxilares e 4 esfenóides). Apósacompanhamento,22(92%) óstiospermaneceram patentes,semterocorridonenhuma complicac¸ãomaior.Houvemelhorasintomática(SNOT-20)comcoeficientedeCronbachpara consistência dos itensdoquestionáriode0,86(IC95%0,73-0,94) nopré-operatórioe 0,88 (IC95%0,77-0,95) nopós-operatório,respectivamente,sendoestatisticamentesignificativa adiferenc¸a(P<0,001)ereduc¸ãomarcantedossinaisàtomografia,emmédia4,2pontosdo escore(P<0,001).

Conclusão:Sinuplastiamostrou-seefetivaparareduc¸ãodesintomasemelhoradaqualidadede vidacomoopc¸ãodetratamentodarinossinusitecrônicaempacientesselecionados.

©2014Associac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial.Publicado por ElsevierEditoraLtda.Todososdireitosreservados.

Introduction

Approximately5---15%oftheWesternpopulationhaschronic rhinosinusitis,1---3 _{which imposes an economic burden and} lowers the quality of life in patients affected.4,5 Clini-cal treatment is still the primary approach, but patients who do not succeed undergo surgical treatment of the chronicrhinosinusitis,whichhasevolvedconsiderablywith thedevelopmentofendoscopicsurgery.

Over the past two decades, endoscopic sinus surgery had a marked progress toward less invasive approaches.6 Functional endoscopic surgery (FESS) is a procedure that preserves the normal tissues and the mucosa of the paranasal sinuses, while presenting fewer postoperative complications.7,8 _{Although FESS is moreconservative than} conventionalsurgery,itstillmightcausesignificant bleed-ing,orbit lesions,andcicatricial airwaystenosis. Inorder to minimize such complications, the endoscopic surgery throughdilatation by balloon catheter (balloon sinuplasty [BSP])methodwasdeveloped.5,6 _{Thisapproachappearsto} cause fewer complications in comparisonwith other pro-cedures to preserve tissues and mucosa of the paranasal sinuses.7,8 _{Some of the classic goals of FESS --- open} the sinus ostia and restore the normal physiology of

the paranasal sinuses --- also apply to BSP, in addition to the recommendation for pediatric patients with seri-ous underlying diseases or increased anesthetic risk.7,9 The safety of BSP has already been established, but its potential complications are the same as those caused by FESS, such as cerebrospinal fluid (CSF) leak and orbital injury.5,6,9

A case series with Brazilian patients has reported the technique usedin BSP,10 _{but information onits effect on} qualityoflifeinpatientswithchronicrhinosinusitisisstill scarce. Therefore,this study aimedto assess the clinical andradiographiceffectivenessofBSPonthequalityoflife ofpatientswithchronicrhinosinusitis.

Therefore, this study aimed to evaluate clinical char-acteristics, including quality of life, and radiographic signs, using the Lund---Mackay score, of the effective-nessof BSPin patientswithchronic rhinosinusitiswithout polyposis.

Methods

InstitutionalResearchEthicsCommittee,underthe proto-colnumber 019/11, and all participants provided written informedconsentforparticipation.

Patients aged 18---75 years, males and females, with chronic rhinosinusitis without polyposis and other complications refractory to clinical treatment, were consecutively enrolled from January of 2011 to March of 2012. Symptoms were evaluated through a standardized questionnaire with primary and secondary findings of chronic rhinosinusitis,1 _{and severitywas assessed through} the sino-nasal outcome questionnaire test (SNOT-20).11 Patients underwent an optimized treatment for chronic rhinosinusitis, based on four to six weeks of antibiotics, withorwithoutsystemicandtopicalsteroids,andforthose whodidnotrespondtoclinical treatment,sinuplasty was indicated.

Inadditiontophysicalexam,patientsunderwenttothe sinuses computed tomography scan (CT) and rigid nasal endoscopy(30◦_{) at thebaseline. Patientswhohad}

persis-tent symptoms of rhinosinusitis (clinical history with two main factors or a primary combined with two secondary factors and CT findings suggestive of chronic rhinosinusi-tisin frontal, sphenoid, or maxillary sinus) were eligible. Thosewhoreportedpreviouslynasosinusaltumororsurgery, nasal polyposis, or psychosocial were excluded. The pro-cedurerequired,onaverage,24hhospitalizationafterthe BSP,andpatientswerethendischarged.Thefollow-upwas conductedapproximatelysevendaysafter BSP(first post-operative visit), and a new endoscopy was performed to clean thenasal cavity. Other follow-upvisits were sched-uledat15(secondvisit),30(third),60(fourthvisit),and90 daysafter surgery (fifth visit) toperformrigid endoscopy and assess incidence of complications, such as epistaxis andadhesions.Inthelastvisit,patientswereinvestigated forclinical symptoms, qualityoflife (Sino-NasalOutcome Questionnaire Test-20 [SNOT-20]), and a new CT scan of thesinuseswasrequested.In thelastvisit,patientswere asked if they would perform the procedure again, and howmuchtimetheyspentbeforereturningtotheirusual activities.

Clinicalandqualityoflifeevaluation

The SNOT-20consists of20 questions regardingsymptoms andtheirimpactonqualityoflife,categorizedfromzero (absent)tofive(highest).Theinstrumentwasadministered individually at the baseline and at the lastpostoperative visit.

Endoscopicevaluation

Rigid nasal endoscopy, performed at 30◦_{, was used to}

observe nasal cavities regarding mucosal secretions and polyps(Lund---Kennedycriteria).1,12_{Nasalcavitywascleaned} withtopicalanesthesiaandforcepsdelicateforpatientsin need.TheendoscopicstagingofLund---Kennedy12 _wasused fordiagnosticclassificationpurposes,basedon:swellingof thenasalmucosa,presenceof secretions,andassessment ofbilateralpolyp.Edemawasscoredas0(absent),1(mild tomoderate),or2(polypoiddegeneration); secretionas0 (absent),1(hyaline),or 2(thickmucusor pus);andpolyp

as0(absent),1(onlyinthemiddlemeatus),or2 (extend-ingthenasalcavity). Theevaluation oftwonasalcavities resultedinascorerangingfrom0to12.12

Tomographyevaluation

PatientsunderwentCT scanof theparanasalsinuses, and thefilmswereindependentlyassessedbytworesearchers, usingtheLund---Mackayscore,13_{whichdeterminesan} opaci-fication ranging from 0 (none), 1 (partial), and 2 (total). Thefrontal,maxillary,anteriorethmoid,posteriorethmoid, and sphenoid sinus were individually graded, while com-plexostiomeatalreceivedadifferentassessment,scoring0 (none)to2(opacification).Theanalysisoftomographywas presentedforeachofthesinus(0---2),andanoverallscore forallsinuseswasalsocalculated,rangingfrom0to24.13

BSP

Patientsunderwent generalanesthesiaand theprocedure wasperformed underendoscopicvisualization (optical 0◦

, 30◦_,and45◦_{);thecatheterwasplacednearthesinusostium.}

Aguidewirewaspassedthroughtheguidecatheterand con-firmedbytransilluminationcatheter.Theballooncatheter (RelievaSolo®_{)wasthenpassedovertheguidewireintothe}

sinusostiumregion.Afterthecorrectlocationoftheballoon atthesinusostia,thepressureinsidetheflask was gradu-allyincreasedbysalineinfusion.Afterdilation,theballoon was deflated and the catheter was gradually withdrawn. Then, a catheterwasplaced for washing the sinus cavity withinstillationofsalinesolution.Finally,thenasalcavity andstructuresofinterestwerereviewedbeforeendingthe procedure.

Statisticalanalysis

StatisticalanalysiswasperformedusingSPSS®_,version17.0

(Chicago,IL,UnitedStates).Pairedt-testwasusedto com-paremeans±standarddeviations(SD),andnon-parametric tests (Wilcoxon signed ranks test) assessed the change in severityofsymptomsandqualityoflifebeforeandafterthe BSP.Thepercentageofpatientswhowouldrepeatthe pro-cedureandthemediantimetoreturntonormalactivities werealsoinvestigated.

ThechangeintheLund---Mackayscorebetween preoper-ativeandpostoperative,therebyeliminatingthevariation amongindividualsanddeterminingtheintra-subject varia-tion,wascalculated.Additionally,differencesamongpairs of individuals usingnonparametric analyses tested differ-encesinmedians.Differenceswereconsideredstatistically significantifp<0.05.

The intra-class correlation coefficient was determined fortheitemsoftheSNOT-20questionnaireusingthe Cron-bach’salphaforconsistency.

Results

Table1 ComparisonofSino-NasalOutcomeQuestionnaireTest-20[SNOT-20]scoresperitem(mean±DP)betweenpre-and postoperativeperiod(n=13).

Pre-operative Post-operative p-Valuea

Needtoblownose 2.8±1.5 0.9±0.8 <0.001

Sneezing 2.5± 1.5 0.7± 1.0 0.001

Runnynose 2.7±1.8 0.4±1.0 0.001

Cough 3.1±1.3 0.3±0.8 <0.001

Postnasaldischarge 4.0± 0.7 0.6± 1.0 <0.001

Thicknasaldischarge 3.2±1.7 0.2±0.4 <0.001

Earfullness 0.8± 1.2 0 0.04

Dizziness 0.3±0.8 0.2±0.6 0.3

Earpain 0.2± 0.8 0 0.3

Facialpain/pressure 3.3±1.4 0.1±0.3 <0.001

Difficultyfallingasleep 1.5± 1.7 0.6± 1.3 0.02

Wakeupatnight 1.7± 1.9 0.9± 1.4 0.2

Lackofagoodnight’ssleep 2.2±2.0 0.6±1.1 0.006

Wakeuptired 2.1± 2.0 0.6± 1.0 0.008

Fatigue 2.0±1.9 0.6±1.2 0.01

Reducedproductivity 2.2± 1.6 0.2± 0.6 <0.001

Reducedconcentration 1.1±1.8 0.3±0.8 0.1

Frustrated,restless,irritable 1.9± 1.9 0.2± 0.6 0.006

Sadness 1.5±1.8 0.1±0.3 0.01

Embarrassment 2.5±1.9 0.1±0.3 0.001

a _{Pairedt-testandWilcoxon’ssignedrankstest.}

39.9±15.6years.Fivepatientsdidnotcompletethe eval-uationandwereexcludedoftheanalysis.

Sinuplasty wasperformed in 24 sinuses of 13 patients (tenmaxillar,foursphenoid,tenfrontalsinuses).Onlyone ofthe13patientsunderwentahybridprocedureconsisting ofballoonwithintheleftfrontalsinussurgery,followedby conventionalmaxillarybilateral,atthesurgeon’sdiscretion. Itwasconsideredthattheballoonapproachforthe maxil-lary sinuses would notlead to goodresults with only the sinuplasty(uncinateprocessatelectasis).Allotherpatients underwentBSPonly.Thetechniqueforsinuscatheterization wasperformedforallpatients,andtherewasnodifficulty orimpossibility.Patientswerereassessedatapproximately 8.2±4.5monthsaftertheprocedure.

Table1demonstratesthatthereweremarkeddifferences inclinical signsatthepre-andpostoperativeassessment, verifiedthroughtheSNOT-20,particularlycough,post-nasal drip,thicknasaldischarge,painoverthesinuses,and reduc-tion of daily life activities. The Cronbach coefficient for consistencyoftheitemsoftheSNOT-20questionnairewas 0.86(95%CI:0.73---0.94)inthepreoperativeand0.88(95% CI:0.77---0.95)inthepostoperativeperiod(p<0.001).

Fig.1showsasignificant reductionintheoverall score ofclinicalsignsbetweenthepre-andpostoperativeperiod.

Table 2 shows a marked reduction in the tomographic score, onaverage 4.2±2.5 points.Besides the individual variation,thereweresignificantdifferencesinthescores, sincetheminimumandmaximumscoresrangedfrom1to10 inthepre-operativeperiod,andfrom0to3inthe postop-erative.Therewashighpatencyrateaftertheprocedure(22 outof24catheterizedsinuses).Fig.2showsatomographic improvementintreatedpatients.

In the preoperative period,onaverage 1.9 sinuses per patient were affected; in the postoperative, there was

a reduction to 0.4 per patient. The number of balloon catheterizationsperpatientrangedfromonetofour.

No patient had significant bleeding, CSF leak, orbital injury, or other complications. Surgical revision was not necessaryinanypatient.Itwasobservedthatallpatients remainedmotivatedandwerewillingtorepeatthe proce-dure,andtook,onaverage,7.0±2.8daystoreturntotheir usualactivities.

Discussion

This study confirmed the safety and high success rate in ostialdilationoftheprocedure,whichresultedinpatencyof thesinusesatthefollow-up.Therewerenosevereadverse events,suchasCSFfistula,orbital injury,or major bleed-ing.This study confirmed the reductionof symptoms and theincreaseinqualityoflifein patientswithchronic rhi-nosinusitiswhounderwentballooncatheterization.14,15

The effectiveness of sinuplasty had already been described5,10,14,15_{andthepresentresultsconfirmedthe} via-bility of this procedure in otolaryngology practice.5,14,15 The use of a standardized instrument,such as the SNOT-20questionnaire,allowedtoquantifytheimprovementon symptomsandqualityoflife14,15 _{after theprocedure,and}

Table 2 Comparison of Lund---McKay tomographic score

betweenpre-operativeandpostoperative.

Score Pre-operative Post-operative p-Value

Mean 5.2 1.2 0.001a

Standarddeviation 2.7 1.1

Snot-20

Preop

Posop

–0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0

Need to b

lo

w nose

Sneezing

Runn

y nose Cough

P

ostnasal discharge

Thic

k nasal discharge

F

acial pain/ pressure

Dificulty f

alling asleep

W

ak

e up at night*

Lac

k of a good nights’

s sleep

W

ak

e up tired F

atigue

Reduced productivity

Reduced concentr

ation

F

rustr

ated, restless

, irr

itab

le

Sadness/embarr

assment

Dizziness*

Figure1 ChangeinclinicalsignsoftheSino-NasalOutcomeQuestionnaireTest-20[SNOT-20]frompre-topost-operativeperiod. Forallclinicalsigns,thechangefrompre-topostoperativehadp-value≤ 0.01,exceptforthosemarkedwith*(≥0.2).

therewere substantialbenefits. Consideringthe patient’s perspective,theresultsjustifythetherapeuticapproachby ballooncatheterization.

However,someconsiderationsshouldbemaderegarding these patients, since they were selected in a reference center, according to the recommendations for sinuplasty (patientswithchronicrhinosinusitisandwithlocalized dis-easewithout polyposis or other complicating factors).13,15 Therefore,thepresentstudyevaluatedasubsetofpatients withchronicrhinosinusitisrefractorytoclinicaltreatment, forwhomsinuplastywaseffective.

Radiological assessment of the sinuses by the Lund---Mackay score is strength of the study, since the ballooncatheterizationcausesbonemicro-fracturesofthe paranasalostiaandaCTscancandetectthem.15

Therigidendoscopywasusedasacomplementary diag-nosticexam tothe physical exam, in the preoperative as

Preoperative 0

2 4 6 8 10 12

Lund-mac

ka

y score

Postoperative

Figure2 Lund---Mackayscoreoftomographicsignsinthe pre-andpostoperativeperiod.

Lund---Mackayscoreinpoints.

wellasthepostoperativefollow-up.Thisprocedureallowed forthedetectionofpotentialcomplications,butduetothe subjectivityintheinterpretationoftheresults,itwasnot further analyzed in the before---after comparisons; it was usedtoassesstheanatomyofthesinuses.

SpecificindicationsforuseofBSPinrhinosinusitisarenot yetconsensual,beyondthoseusedinthisstudy.They proba-blywillemergeinsubsequentstudies,designedtoestablish furtherindicationsandtheiradvantages.Statistical power wasdeterminedaposterioritoestablish thebetaerror in thedetectionofassociations.Thedifferencesbetweenthe pre- and post-operative Lund---Mackay score (5.2±2.7 vs. 1.2±1.1),inasampleof13patients,werelargeenoughto conferover90%ofpowerandp<0.05,astatistically signifi-cantassociation.Finally,abroaderanalysisofthebenefitsof theprocedureshouldtakeintoaccountacost-effectiveness analysis.Astudy comparingsinuplastyversusconventional FESSshowedsimilarcosts.8_{However,theywerenot} repre-sentativeoftheBrazilianpatientsandthepublichealthcare system.

Conclusions

In conclusion, sinuplasty with balloon catheterization is effectiveinreducingsymptomsandimprovingqualityoflife inselectedpatientswithchronicrhinosinusitis.Theresults arebeyondreportedsymptomsandconfirm thebenefitof BSP.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

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