Prospective ultrasonographic follow-up of synthetic mesh in cohort of patients after vaginal repair of cystocele 夽

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ORIGINAL ARTICLE

Prospective ultrasonographic follow-up of synthetic mesh in cohort of patients after vaginal repair of cystocele ^夽

Suivi échographique prospectif des prothèses synthétiques dans une cohorte de patientes opérées d’une cure de cystocèle par voie vaginale

E. Mousty

^a^,∗

, S. Huberlant

^a

, O. Pouget

^a

, P. Mares

^a

, R. de Tayrac

^a

, V. Letouzey

^a^,^b

aServicedegynécologie-obstétrique,CHUdeMontpellier1,placeProfesseur-Robert-Debré, 30000Nîmes,France

bServicematernité,GHUCaremeau,placeProfesseur-Robert-Debré,30029Nîmes,France

Received12January2013;accepted24March2013

KEYWORDS Cystocele;

Pelvicorgan prolapse;

Shrinkage;

Ultrasound;

Vaginalmesh

Summary

Objective.—We sought to validate asequence of ultrasonographic meshmeasurements to determinetherelevanttimepointsinthepostoperativemonitoringofmeshsize.

Methods.—Meshwasmeasuredpreoperativelyexvivo,priortoinsertion,in25patientssched- uledtoundergovaginalrepairofcystoceleinvolvinginsertionofaUgytex^TM transobturating polypropylenemesh.A2D/3Dperinealultrasoundscanwasperformedattheendofthesurgi- calprocedure(D0),thenonthirddayaftersurgery(D3)and6weeks(W6)aftertheoperation.

Medio-sagittalviewwasusedtomeasuremeshtotallengthandthesagittalarc(lengthbetween themostdistantpointsofthemesh).

Results.—Time-coursechangesinsagittalarcweremarkedbya8%increaseonD3(withrespect toD0)anda20% decreaseatW6 (withrespecttoD3).Meshtotal lengthatW6 onaverage correspondedto74%(±20)ofmeshtotallengthmeasuredonD3.

Conclusion.—Thisstudyshowedthechangesinthemeshultrasonographicmeasurementsfol- lowingvaginalplacementbyvaginalroute.TheD3ultrasoundscanshouldappeartobesuitable asareferenceforsubsequentultrasonographicmonitoring.

夽 Levelofevidence:4.

∗Correspondingauthor.

E-mailaddress:emousty.go@gmail.com(E.Mousty).

http://dx.doi.org/10.1016/j.purol.2013.03.018

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Vaginalmeshultrasound 531

MOTSCLÉS Cystocèle; Prolapsus; Échographie; Prothèsesvaginales

Résumé

Objectif.—Nousavonsvouluvalideruneséquencedemesureséchographiquesdesprothèses aﬁndedéterminerlespointspertinentsdeleurévolutionenpostopératoire.

Méthodes.—Chez25patientesayantunecuredecystocèleavecmiseenplaced’uneprothèse enpolypropylènetrans-obturatricedetypeUgytex^TM,laprothèseestmesuréeenpréopératoire exvivoavantlapose.Puis,uneéchographiepérinéale2D/3Destréaliséeenﬁnd’intervention chirurgicale(D0),autroisièmejourpostopératoire(D3)etàsixsemainespostopératoire(W6).

Surunecoupemédio-sagittale,lalongueurtotaledelaprothèseetsonarc(distanceentreles deuxpointslesplusdistants)étaientmesurés.

Résultats.—L’évolutiondel’arcsagittalestmarquéeparuneaugmentationde8%àD3(par rapportàD0),etunediminutionde20%àW6(parrapportàD3).Lalongueurtotalesagittale àW6correspondaitenmoyenneà74%(±20)delalongueurtotalemesuréeàD3.

Conclusion.—Cetteétudeaobservél’évolutiondesmesureséchographiquesd’uneprothèse implantée parvoievaginale.L’échographie D3 pourraitêtrel’examende référencepour la surveillanceéchographiqueultérieuredesprothèsesimplantéesparvoievaginale.

Introduction

Surgeryforgenitalprolapseisoneofthemostfrequentpro- ceduresconductedinpost-menopausalwomen.Prevalence of genital prolapse in women aged more than 70years is about 70% [1]. Prolapse is generallyaccompanied by urinary,bowelandsexualsymptoms[2]thatimpactonpatient qualityoflife[3].

The conventional management of cystocele by vaginal surgery consisted in performing an anteriorcolporrhaphy.

Butpostoperativecystocelerecurrencewasfrequentabout 41% 3years after surgery given the natural weakness of the tissues [4]. Polypropylene vaginal meshes have been developed over the last 10years to improve the results achievedwithcystocelerepair.Thesetechniquesmostoften use tension-freemeshes where the armsof the mesh are placedacrosstheobturatorforamen,andtheyreducedthe riskofshort-termanatomicalrecurrence[5].However,cystocele recurrencecontinued tobe seen in 4.7 to8.8% of casesfollowing insertionof an anteriormesh [5,6].These newtechniques arealso associated witha risk of vaginal meshexposure(prevalencebetween5%and10%)[7].

Mesh integration into native tissue appeared to be accompaniedbymeshsizevariation[8]andthiscouldcause postoperativepainanddyspareunia[9].Anotherpointwas thatthemagnitudeoftheshrinkagemayappeartobepre- dictiveoftheriskoffuturerecurrence[10].

Pelvicultrasonographyhasprovedtobeanexcellenttool for mesh visualization [11]and wasﬁrstused tovisualize tension-freevaginaltape(TVT)andestablishacorrelation betweentapepositionandclinicalsymptoms[12].Thepol- ypropylenevaginal meshes usedin cystocele repair could bevisualizedintheformofahyperechogenicline,andthis madepossibletheirstudyby2Dor3Dpelvicultrasonography [10,13,14].

Few prospective studies were done to prospectively assessthesyntheticmeshsizeevolution.‘‘Meshshrinkage’’

wassodifﬁculttoanalyzewithclinicalexamination.Itcould betie todyspareunia or chronicpain. Prospectivefollow- upof synthetic meshin a cohortof femalepatients after

vaginalrepairofcystocelecouldbedonebyultrasonogra- phy.Wesought tovalidateasequence ofultrasonographic meshmeasurementstodeterminetherelevanttimepoints inthepostoperativefollow-upofmeshsize.

Materials and methods

Thiswasaprospective,observationalstudyconductedatthe UniversityHospitalCenterandreceivedafavorableopinion fromamedicalethicscommittee(CEROG-2009-007).

Patientspresenting withsymptomatic cystocele(POPQ [15]≥stage 2) and undergoingsurgery in our department with insertion of a Ugytex^TM synthetic mesh (Sofradim- Covidien,Trévoux,France)wereincludedinthestudy.Based onliteraturedata,ouraimwastoinclude25patients[13].

Ugytex^TMisacollagen-coated,monoﬁlamentpolypropyl- enemeshwithweightof38g/m² and89%ofporosity with poresizeexceeding1.5mm.

Allthepatientswereoperatedonusingthesamesurgi- caltechnique.Thepatientwasplacedinthegynecological positionunderstrictlyasepticconditions.Averticalcolpo- tomywasmade.Dissectionthencontinuedlaterallytothe sciaticspine.Themesh,preparedunderasepticconditions, wasmeasured beforeinsertionand a real-sizedrawingof themeshwasalsomade(Fig.1).

Themeshwasthenpositionedusingancillaryprocedures with the four arms placed across the obturator foramen [16,17].Theanteriorcolpotomywasthenclosedbymeans ofanabsorbable3/0continuoussuture.

AFoleyurinarycatheterwasinstalledatthestartofthe procedureandwaskeptinplacefor48hthereafter.Intrav- aginalpack wasinserted at the end of the procedure for 24h.

No colpectomy was performed conjointly with mesh insertion.Alsononeofthepatientsunderwentbladderpli- cationincombinationwithmeshinsertion.

Differentprocedures, depending onpatientsymptoms, were performed in association with cystocele repair, for instanceuseofTVTforstressurinaryincontinence.

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Figure1. Meshmeasurementspriortoinsertionandduringultrasonographicfollow-up.

Patient functional disability and impact on quality of lifewereassessedpreoperativelyandatthepostoperative consultation after 6weeks. The ICS POP Q [15] prolapse quantiﬁcationsystem wasused for a classiﬁcation at the same time points, i.e. preoperatively and 6weeks after surgery(Fig.2).

Transvaginal and transperineal ultrasoundscans (in 2D and3D)wereobtainedbytwotrainedoperatorsonaVolus- sonE^TMorVoluson730^TMultrasoundsystem(GEHealthcare, Milwaukee,WI,USA)usinga5to9MHzvaginalprobe.This ultrasonographywasperformed in accordancewithlitera- ture data [18].Medio-sagittal and transversal views were obtainedofthevagina.Themeshwasvisualizedintheform ofa hyperechogenic line andthemedio-sagittal viewwas usedtomeasuremeshtotallength(B)andthesagittalarc (C)(Fig.1).Thisarcwasdeﬁnedasthelengthbetweenthe most distantpoints onthe mesh. Inthe transversal view, the width of the mesh and the corresponding arcs were measured at the two ends of the mesh. Proximal width at the bladder neck was deﬁned as vulva width (E) and

distalwidthbelowuterinecervixwasdefinedasfundalwidth (D)(Fig.1).Inordertoidentifyfolds,afoldingcoefficient wasdefined,correspondingtothe ratioof sagittalarc(C) tomesh totallength(B).The thicknessofthemesh(mesh hyperechogenicity in the middle of mesh onmediosagital view),anditspositionwithrespecttothebladderneck(A), werealsorecorded(Fig.1).

An initial ultrasound scan(day 0=D0) was obtained in the operatingroom at theend of the surgical procedure.

The patientwas placed in the gynecological position and theD0ultrasoundscanobtainedunderstrictlyasepticcon- ditionsaftersuturingthecolpotomy,butbeforethevaginal pack wasinserted. Two furtherfollow-up scans werealso obtained:oneonthethirdday(D3)aftersurgery,beforethe patientleftthehospital,afterremovalofthevaginalgauze andurinarycatheter,andanother6weekspostoperatively (W6)duringthepostoperativeconsultation(Fig.2).

Patient and mesh characteristics were expressed by meansandstandarddeviations(SD)forcontinuousvariables andbynumberandpercentageforqualitativevariables.

Figure2. Clinicalfollow-upofpatientsand mesh.*:ultrasonographyonD0attheendofthesurgical procedure,aftersuturingthe colpotomy,butbeforevaginalpackwasinserted.Op:operative;D0:operativeday;D3:thirddayaftersurgery;W6:6weeksaftersurgery;

US:ultrasound.

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Table1 Intraobserverandinterobserverreliability.Tochecktheconsistencyofmeasurements,aninter-andintraob- server reliabilitywerecalculated previouslyonseriesfor each value performed by twooperators(VLand EM)on10 ultrasoundscansfromsavedvolumes.Thetypicalmeasurementerrorwas7.8%fortheD3meshtotalvaginallength.

ICC CI Pvalue

Intraobserver:D3meshtotalvaginallength 0.87 0.77—0.92 <0.0001

Interobserver:D3meshtotalvaginallength 0.76 0.59—0.86 <0.0001

ICC:intraclasscorrelation;CI:conﬁdenceinterval;D3:thirddayaftersurgery.

Table2A MeshmeasurementspreoperativelyandbyultrasonographyonD0(operativeday),D3(thirddayaftersurgery) andatW6(6weeksaftersurgery).MeanandSDforpreoperativeandsagittal,fundalandvulvaarcvalues.

Preoperativeexvivo

mm(±SD) Measurements D0

mm(±SD) D3

mm(±SD) W6

mm(±SD)

65(±4) Sagittalarc(C) 37(±5) 40(±8) 32(±8)

73(±7) Fundalarc 42.5(±6) 47.5(±7) 38(±6)

49(±4) Vulvaarc 40(±9) 39(±9) 31(±8)

n=25forpreoperativemeasurementsandultrasoundonD0andD3;n=24forultrasoundatW6.SD:standarddeviation;D0:operative day;D3:thirddayaftersurgery;W6:6weeksaftersurgery.

Interobserver reproducibility (Table 1) for ultrasonographic measurements was previously assessed by calcu- lating the intraclass correlation coefﬁcient and using the Bland-Altmanmethod[19]foragreement,which consisted instudying differencesbetweenaseriesofmeasurements andtheirmean.

MeshsizeassessedonD0,D3andafter6weekswerecom- paredbetweenthesethreegroups.Themeshsizereduction wascomparedonD3andafter6weeksbyStudent’sttestor Wilcoxon’stest.Thecorrelationbetweenthemeshsizeand foldingcoefficientwasquantifiedusingSpearman’scorrela- tioncoefficient witha95% confidenceinterval.Statistical significancewassetat5%.

ThestatisticalanalysiswasperformedusingSASversion 9.1(SASInstitute,Cary,NorthCarolina).

Results

Inall,25patientswereincludedoveraregularperiodwith recruitmentdepending primarilyonsonographeravailabil- ityand thatof theultrasonograph inthe operatingroom.

Meanpatientagewas68years(±9years).Patientparitywas a mean of 2.75 (±1.7) for a mean birth weightof 3534g (±415g).

Six patients had undergone previous surgery for prolapse(foursub-vesicalplications,tworectocelerepairsby plication)andfourhadundergonesurgeryforurinaryincon- tinence(twoBurch,oneTVT,oneBologna).

Elevenpatientshadduringsurgeryaconcomitantproce- dureforurinaryincontinence(TOT).

No immediate postoperative complications were observed.OneexplantationwasrequiredonD20following aperiprosthetichematomawithscardehiscence.Noother

complications,particularlymesh infection,wereobserved duringthefollow-upperiod.

The mesh was visible at each ultrasound examination (Fig.3)andwasvisualizedintheformofahyperechogenic line under the bladder. The arms of the mesh were also visible but couldnot be studied along their entire length becauseofboneinterposition.

Meshdimensionspriortoinsertionandultrasonographic measurementsmadeonD0,D3and6weekspostoperatively are reported in Tables 2A and 2B. Mesh total length (B) remained stable between the preoperative measurement [65mm(±4)]andtheultrasonographicmeasurementsonD0 andD3.Onlyarclengthchangedoverthisperiod(Table2A).

D0sagittalarc(C)correspondedto57%ofpreoperativemesh length.Meshtotallength(B)6weeksaftersurgery[40mm (±9)]correspondedtoonly61%ofinitialpreoperativemesh length(Table2B).TheW6sagittalarc(C)[32mm(±8)]corresponded to only 49% of the preoperative initial length (Table2A).

Whenwecomparedevolutionofmeshsizebetweenthe differentultrasoundscans(D0,D3,andW6),wenotedthat the sagittalarc (C) and the fundal arc increasedby 8 to

Table2B MeanandSDformeasurementsoftotallength andfundalandvulvawidthbyultrasonographyatW6.

Measurements W6

mm(±SD)

Totallength(B) 40(±9)

FundalWidth(D) 47(±9)

VulvaWidth(E) 38(±12)

SD:standarddeviation;W6:6weeksaftersurgery.

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Figure3. Perinealultrasonographyofpolypropylenemeshes.Themeshwasvisualizedintheformofahyperechogenicline.A.Measure- mentofthesagittalarc(C)onthesagittalviewofthemesh.B.Visualizationbythesagittalviewofahematomaincontactwiththemesh.

C.Measurementoffundalwidth(D)(onthetransversalview).D.Presenceofmajormeshfoldingonthetransversalview.

11%betweentheultrasonographicmeasurementsonD0and D3. These arcs then decreased by about 20% in 6weeks (W6−D3/D3) (Table 3A). Mesh total length (B) at W6 on average corresponded to 74% (±20) of mesh total length measuredonD3(Table3B).

Time-coursechangesinmeshtotallength(B)andsagittal arc(C)areshownonFig.4.

These successive ultrasoundscans alsoserved tostudy meshlocationwithregardtothebladderneck(A).Sixweeks aftersurgery,theloweredgeofthemeshwasseentohave risentowardthevaginalfundusbyabout6mmwithrespect tothebladderneck.Asnoneofthepatientshadcystocele recurrenceafter6weeksitwasimpossibletoestablishany correlation between this elevation and a risk of prolapse recurrence.

Mesh thickness measured by ultrasonography on D3 and at W6 did not vary signiﬁcantly (1.8mm±0.7 vs.

Table3A Time-coursechangesinmeshvaluesbetween the different ultrasoundscans. Ratio between arc val- ues on D0 and measurement of the corresponding arc on D3 (in %); and ratiobetween arcvalues on D3 and measurementofthecorrespondingarcatW6(in%).

Ratio D3−D0/D0

%

W6−D3/D3

%

Sagittalarc(C) ±8 −20

Fundalarc ±11 −20

Vulvaarc −2 −20

SD:standarddeviation;D0:operativeday;D3:thirddayafter surgery;W6:6weeksaftersurgery.

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Table3B MeanandSDoftheratiobetweentotalmesh length(B)orfundalandvulvawidthonD3andthecor- respondingmeasurementsatW6(in%).

Ratio W6/D3

%(±SD)

Totallength(B) 74(±20)

Fundalwidth(D) 81(±22)

Vulvalwidth(E) 79(±11)

SD:standarddeviation;D3:thirddayaftersurgery;W6:6weeks aftersurgery.

1.7mm±0.7, P>0.05). As no vaginalmesh exposure was notedinourcohortitwasimpossibletoestablishanycorre- lationbetweenmeshthicknessandtheonsetoferosion.

The ultrasonography on D3 showed the presence of a hematomaaroundthemeshinsevenpatients(30%)(Fig.3B).

Suture rupture in one of these seven patients on D20 requiredmeshexplantation.

TheultrasoundscansobtainedpostoperativelyonD0and D3showedmarkedfoldingorwavingofthemesh(Fig.3D).

These foldswere notedin 23patients (92%) bythe ultra- sonographyonD3.

In order to better identify these folds we devised a folding coefficient that corresponds to the ratio of sagittal arc (C) to mesh total length (B). The folding coefficients on D3 (0.76±0.11) and at W6 (0.80±0.11) showed a statistically significant correlation, with a correlation coefficient of 0.49. This indicates that folding on D3 corresponded to that noted by ultrasonography at W6.

Figure4. Graphicrepresentation ofchanges inmean of total length(B)andsagittalarc(C)overtime[preoperativeandultra- soundscanatD0(operativeday);D3(thirddayaftersurgery);W6 (6weeksaftersurgery)].Meanwereexpressinmillimeter.Preop:

preoperative;D0:operativeday;D3:thirddayaftersurgery;W6:

6weeksaftersurgery.

Discussion

Weusedsuccessivepelvicandperinealultrasoundexamina- tionsfortheprospectivefollow-upofsyntheticmeshesina cohortoffemalepatientsaftervaginalrepairofcystocele.

Inallcasesthepolypropylenemeshwasvisiblebypelvic ultrasonography in the form of a hyperechogenic line.

Whetherthemeshwassmoothlyspreadorshowedfoldswas easilyevaluableinalltheultrasoundscans,consistentwith literaturedata[14].

Our ultrasonographicmeasurements consisted of mesh totallength(B),whichthereforeincludedmeshfolds,and thatofwhatwecalled the‘‘arc’’.Thiscorresponded toa directmeasurementofthedistancebetweentheendsofthe meshinthesagittalortransversalview.Weconsideredthis measurementasparticularlyusefulasitshouldcorrespond totheeffectivesizeofthemeshsupportingthebladder[13].

Oursuccessive ultrasonographic measurementsshowed that arc distance decreased substantially between the preoperative measurement and that taken on D0. The surgical procedure itself and mesh insertion may in part explain this change. Also, the change in mesh measurement technique certainly played a role in this decrease giventhatpreoperativemeasurementsweremadedirectly on the mesh whereas the others were obtained by ultrasonography.

The sagittal (C) and fundal arc measurements then increasedby 8to 11%between the D0 andD3 ultrasound examinations.The insertionof vaginalpackat theend of thesurgicalprocedure,butaftertheD0ultrasoundmeasure- ment,mayexplainthisincreasegiventhatthecompression exertedbythevaginalpackfor 24h wouldhelp themesh spread and started to integrate native tissues. As folding coefﬁcient (sagittal arc/mesh total length) at the D3 ultrasound examination was closely correlated with that observedatW6,itmaybeassumedthatthefoldingwhich tookplacebyD3waspermanent.

The D3 ultrasound scan would therefore appear tobe suitableas a reference for future ultrasonographic monitoring.Subsequentscansmaythereforebecomparedwith theD3scan,notthepreoperativemeasurement.

Mesh total length (B) 6weeks after surgery corre- spondedtoonly61% ofpreoperative mesh lengthandthe sagittal arc (C) corresponded to only 49% of this length (Tables 2A and 2B). Mesh size had therefore decreased byabout 40%.The length supporting thebladder, i.e.the sagittalarc,thereforecorrespondedtoonlyabouthalfthe length of the mesh when inserted. This decrease in size couldcorrespond to shrinking of the mesh. These results wereconsistent withthoseof Tunnetal. whonotedthat meshproximal-distaldistanceafter6weekscorrespondedto 43.2%ofinitiallength[13].ButacomparisonbetweentheD3 andW6ultrasonographicresultsappearedtocloserreﬂect realitythanacomparisonwiththepreoperativevaluesince theD3ultrasoundscantookaccountof theimpactofthe surgicalprocedureandanyfoldsinthemesh.Inthiscase, weobserved thatmesh totallength (B) decreasedby 26%

betweenD3andW6,andthesagittalarc(C)decreasedby 20%(Tables3Aand3B).

Velemiretal.demonstratedarelationshipbetweenmesh shrinkage and an increase in its thickness, as visualized by ultrasonography [10]. In our study, the D3 ultrasound

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scan showed evidence of periprosthetic hematomas and marked mesh folding, both causing major inﬂammation whichmayexplainmoremarkedshrinkageorpostoperative complications.TheD3ultrasoundscanshowedevidenceof ahematomain apatientwhorequired meshexplantation onD20duetoruptureofthesuture.

Pelvicultrasonographycouldalsobeusedtostudymesh positionandvisualizethelocationofanyrecurrentprolapse withrespecttothe mesh[10,14].Two recurrencemecha- nisms have been described using this technique. Prolapse recurrencemayoccur due tothe mesh incompletely cov- ering thelower partof the vagina[10]. Ourdatashowed thatthemeshgraduallyroseover6weekstowardthevagi- nalfundus. The wayusedtoﬁxthe mesh couldinﬂuence theclinicalrecurrencethroughthedecreaseofvaginaarea coveredbythemesh[20].Otherrecurrencesmayoccurdue todefectiveanchoringofthemesharms,leadingtoafun- dalrecurrence.In thesecases3Dultrasonographyshowed that the mesh changed orientation during the Valsalva manoeuvre[14].

The postoperative follow-up period in our study that stopped at 6weeks, was insufﬁcient for us to establish anycorrelationbetweenultrasonographicdataandclinical recurrencerate.Neitherwerewe abletoestablish acor- relationbetweenthepresenceofhematomas,meshfolds, locationwithrespecttobladderneck,andtheriskofmesh exposureorprolapserecurrence.

Such correlations could only be detected by more long-term patient follow-up conducted to note prolapse recurrencesanddetermineetiology(poorcoverofthelower partof the vagina)[10] and problems withtheanchoring ofmeshposteriorarms[14].Finally,outfindingsshouldbe confirmedbystudiesinvolvingothertypesofmeshkits(dif- ferentmaterials and type of fixation), thus assessing the impactofsurgicaltechnique.

Conclusion

Pelvic ultrasonography was a useful tool for the in vivo study of polypropylene meshes employed for the vaginal repairofprolapseasthetechniquecanbeusedtomonitor the mesh. This study showed changes in the mesh measurements made by ultrasound. The D3 ultrasound scan should appear to be suitable as a reference for subse- quentultrasonographic monitoring. Performedafter mesh spreading,it may took accountof the impactof the sur- gicalprocedure.Ultrasonographyshouldthereforeprovide initialmeshmeasurementspost-implantation,inparticular thatof thesagittalarc.It alsoserved tolocatethemesh withrespecttothebladderneckandvisualizehematomas and mesh folds. Results at longer-term follow-up will be necessary tocorrelate ultrasonographic data withclinical results.Moreover,theimpactofthemeshﬁxationshouldbe assessed.

Disclosure of interest

Theauthorsdeclarethattheyhavenoconﬂictsofinterest concerningthisarticle.

Appendix A. Supplementary data

Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.purol.

2013.03.018.

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