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ORIGINAL ARTICLE
Urethral pressure controlled balloon refilling or balloon change for artificial sphincter secondary procedure?
Repressurisation par remplissage du ballon sous contrôle de la pression
urétrale ou changement de ballon du sphincter artificiel, dans la gestion de la perte secondaire d’efficacité de la prothèse sphinctérienne AMS800 ®
B. Maximilien
a,∗, A. Aublea
a, A. Gillibert
b, C. Delcourt
a, P. Grise
a, J.-N. Cornu
a,1aDépartementd’urologie,CHUdeCharles-Nicolle,1,ruedeGermont,76000Rouen,France
bDépartementdestatistique,CHUdeCharles-Nicolle,1,ruedeGermont,76000Rouen, France
Received23April2017;accepted8November2017 Availableonline6December2017
KEYWORDS
Urinaryincontinence;
Artificialurinary sphincter;
AMS800®; Revision;
Explantation
Summary
Objectives.—Toreportourexperienceofinflatingorchangingpressureballoontotreatrecur- renturinaryincontinenceafterAMS800®implantationinsteadofchangingallthedevices.
Patientsandmethods.—Aretrospectivestudywasconducted inatertiary referencecenter between2005and2015.Allpatients,treatedbyAMS800®implantationforpost-prostatectomy urinaryincontinenceandwhomballoonwassubsequentlychangedorinflated,wereincluded.
Mainclinicalendpointwastheneedforanothersurgery.Secondaryendpointswereurethral erosion,infection,andefficacyonpadtestandpaduse.
Results.—Thirty-onepatientswereincluded.Allhadhada61—70cmH20balloonimplanted, withasinglecuff(13withtranscorporealplacement).Twenty-onepatientshadtheirballoon changedfor a71—80cmH20type,while10patientshadtheir balloonrefilled(median3mL [range2—7]).Medianfollow-upwas23months(range1—129).Overallrateofanothersubse- quentsurgerywas48.3%(n=15).Erosionandatrophyoccurredmorefrequentlyafterballoon repressurizingthanafterballoonreplacement(80%vs33%,P=0.024).Atlastfollow-up,median padusewashigherinrepressurizinggroup(2vs1,P=0.033).
∗Correspondingauthor.
E-mailaddress:maximilienbaron@hotmail.com(B.Maximilien).
1 Allauthorscontributedtothisarticlebydraftingandrevisingthearticlecriticallyforimportantintellectualcontent.PrCornuJean- Nicolasdidfinalapprovaloftheversiontobepublished.
https://doi.org/10.1016/j.purol.2017.11.002
1166-7087/©2017ElsevierMassonSAS.Allrightsreserved.
Conclusion.—Balloonrepressurizingisassociatedwithahighererosionandreoperationrate thanchangingpressureballoon.ContinenceresultsseembetterwhenPRBischanged.Itcould beanalternativeinsteadofchangingalldevicesinpatientswithfrailurethra.
Levelofevidence.—4.
©2017ElsevierMassonSAS.Allrightsreserved.
MOTSCLÉS Incontinence urinaire; Spincterurinaire artificiel; AMS800® ; Révision; Explantation
Résumé
Introduction.—Lebutdecetteétudeétaitd’évaluerlesrésultatsduchangementoudurem- plissageduballonréservoirdepressionlorsd’unepertesecondaired’efficacitéd’unsphincter AMS800® chezl’homme.
Méthodes.—Uneétuderétrospectivedel’ensembledespatientsayanteuunchangementde ballonouunregonflagedeballondesphincterartificielAMS800®,entre2005et2016,dansun centreuniversitairederéférenceaétémenée.Lecritèredejugementprincipalétaitletaux deré-opérationaprèsrepressurisation.Lescritèressecondairesétaientlasurvenued’érosion urétrale,d’infection,l’efficacitédutraitementévaluéeparlepad-testdes24hetleportde garnitures.
Résultats.—Trenteetunpatientsontétéinclus.Touslespatientsontétéimplantésavecun dispositifAMS800® avecballonnet61—70cmH20,avecplacementinitial dela manchetteen péri-uréthral(n=18)ouintracaverneux(n=13).Unesimplerepressurisation(regonflagede2à 5mLsouscontrôledepressionuréthralerétrograde)aétéeffectuéedans10casetunchange- mentdeballon(71—80cmH20)dans21cas.Lamédianedesuiviétaitde23mois(1—129).Au total,48,3%(n=15)despatientsontnécessitéunereprisechirurgicale.Larepressurisationdu ballonétaitassociéeàunrisqueaccrud’érosionetd’atrophieurétrale(80%vs33%,p=0,024).
Letauxsubjectifdecontinenceétaitégalementplusfaible(nombredeprotectionsparjour, 2vs1,p=0,033).
Conclusion.—Lechangementduballonderégulationdepression(71—80cmH2Oàlaplacede 61—70cmH2O) entraînemoinsderéintervention,demorbiditéetunemeilleurecontinence quelarepressurisationseule.
Niveaudepreuve.— 4.
©2017ElsevierMassonSAS.Tousdroitsr´eserv´es.
Introduction
Theartificialurinarysphincter(AUS)hasbecomethe‘‘gold standard’’ in the treatment of moderate to severe male urinaryincontinence (UI) after radical prostatectomy [1].
HydraulicallycontrolledAMS800® device(BostonScientific, Boston, MA, USA) is one of the most frequent sphincter implanted all over the world, with excellent long-term results [2,3]. AMS800® failure is defined by persistent or recurrent incontinence after device implantation. It is caused by mechanical or non-mechanical failure that can,sometimes,overlap[4].Severaltechniqueshavebeen reported to treat AMS800® failure due to urethral atro- phyandmechanicalornon-mechanicalfailurewithoutany consensusaboutwhethertochangeallthedevice[5]oronly onecomponent ofthe devicesuch asdownsizingthecuff [6,7],addingasecondcuff,implantingtranscorporalcuff[8]
orrepositioningthecufftoamoreproximalordistalloca- tion[9].However,changingthecuffimpliesanotherurethral surgerywithanincreasedriskofurethralinjuryanderosion [10].Itisalsopossibletoincreasepressurearoundtheure- thrabyinflatingorchangingthepressureregulatingballoon
(PRB)withahigherrating(61—70cmH20to71—80cmH20) without touching thecuff which couldtheoretically avoid urethral injury.In this study,we report thelargest series in the literature that compare inflation of PRB with PRB upsizingtotreatAMS800® failure.
Materials and methods
We retrospectively reviewed all patients implanted with AMS800®, who had their 61—70cm H20 PRB changed or inflated for persistent or recurrent incontinence, in our academic center,between 2005and2016. Clinicalfactors such as incontinence cause, radiation history, prior ure- thralsurgery,incontinencesurgery,numberofpaduseand pad test volume, and surgical details such as cuff size, PRBpressureandplacementtechniquewerecomputerized and analyzed. All devices were initially placed through a perinealincision.WhenAMS800® failureoccurred,patients were evaluatedwithurinaryanalysis, fibroscopy toelimi- nateurethralerosionandtoobjectivecoaptationfailureof thecuffandurodynamicstudytoanalyzeRCOP.PlainX-ray
wasalsoperformedtolookforalossoffluidfromthebal- loonorcuff.Patientshadtheir61—70cmH20PRBreplaced with71—80cmH20PRBortheirPRBrefilledwith2or3mL ofiso-osmoticcontrastsolution(Telebrix12oromnipaque 350, 53%, sterile water 47%).Surgery wasmade in dorsal position,under general anesthesia. The device wasdeac- tivatedandaninguinalincisionwasperformed.Torefilled PRB,aYconnectorwasinsertedbetweentheballoontube andthepump tube afterpreviousclamping. A12Fr-foley catheterwasintroducedintheurethraandconnectedtoa dripinfusionverticalcolumntomeasuretheretrogradecuff occlusionurethralpressure(RCOP)aspreviouslydescribed [11].Therefillingwasconductedstepbystep,startingwith 2mL injected in the balloon, then reconnectionfollowed withapumpmanoeuver.Thevolumeofballoonfillingwas controlledafter tubing reconnectionin order toreachan 80cm H20 RCOP above the urethra level. If necessary, a refillingwith1mLwasperformedfollowingthesameproce- dure.BalloonfillingwasstoppedwhenRCOPreached80cm H20.Nourinarydrainagewasused.Allthepatientsweredis- chargedatday0to1withtheirsphincteractivated.Patients wereeligibleforeitheroneofthesetechniquesifurethral atrophyoccurred withoutmechanical dysfunction.AllAUS
deviceimplantationandrevisionweremadebyasinglesur- geonexpertinthetechnique.PRBrefillingwasusedforthe firstcases but,after ten cases,it wasdecidedto change thePRBin all cases.Mainclinical end point wastherate of reoperationafter repressurizing. Secondary end points weretheoccurrenceofurethralerosion,infectiondeviceor persistentorrecurrentincontinence.Subjectivecontinence wasobtainedifpatientworenopadoruseonlyonesecurity padperday.Follow-uptimereferstomediantimebetween thefirstrevisionandlast medicalconsultation. Statistical analysisweremadeusingFisherexacttest.Allpatientsgave writteninformedconsenttoparticipateinthestudy.Given theretrospective nature of thestudy and the absenceof experimentalarm,thework wasconductedinaccordance withtheprovisionsofthe1964DeclarationofHelsinkiand itslateramendments.
Results
The study population included 31 inflatingballoon proce- dures, respectively 21 balloon upsizing (group 1) and 10 refilling(group2).Demographicscharacteristics arelisted
Table1 Patients’characteristics(n=31).
Age(years),Mean 71(43—90)
Incontinenceetiology
BPHsurgery 4(13)
Radicalprostatectomy 27(87)
Background
Priorradiation 12(38)
PRBchanged 9(42)
PRBrefilled 3(30)
Internalurethrotomy 9(29)
PRBchanged 7(33)
PRBrefilled 2(20)
UrinaryincontinencetreatmentpriorAMS800® implantationdevice
None 23(74)
Macroplasticinjection 3(9.6)
Pro-ACTTMdevice 1(3.2)
TOMSTMsling 5(16)
Cufflocation
Peri-bulbar 18(58)
Transcorporal 13(42)
Mediancuffsize 5(4—5.5)
MedianinitialfillingofPRB 24(20—25)
Mediantimefromdeviceimplantationtorepressurizing(months) 41(6—157)
Medianfollow-upafterrepressurizing(months) 23(1—129)
Medianpreoperativeretrogradecuffocclusionpressure(RCOP)cmH20,median
PRBchanged 53(30—85)
PRBrefilled 25(7—50)
MedianpostoperativeRCOP
PRBchanged NA
PRBrefilled 72.5(25—80)
Medianpre-repressurizingpaduseperday 1.5(1—4)
Medianpre-repressurizingpadtest(g) 50(30—210)
BPH:benignprostatichyperplasia;PRB:pressureregulatingballoon;RCOP:retrogradecuffocclusionurethralpressure.
inTable1.MedianpreoperativeRCOPwaslowerinrefilling groupthanPRBupsizinggroup(25cmH20[range7—50]vs 53cmH20[range30—85];P=0.002).
Peroperative
StudyflowchartisshowninFig.1.MedianPRBrefillingwas 3mL(2—7). Inpatients whohadtheir PRBupsized, 5had lowervolume in their PRB than when implanted (median 14mL [1—19]). However, one (who had only 1mL still in thedeviceatthetimeofsurgery)hadhiscuffchangedtwo monthslaterbecauseofcuffleak.Inrefilledgroup,median peroperativeRCOP wassignificantlyhigherthanpreopera- tive(72.5cmH20[25—80]vs25cmH20[7—50];P=0.002).
Postoperative
At last follow-up, overall reoperation rate was 48.3%
(n=15),respectively33%group1and80%group2(Table2).
ThreepatientswhohadtheirPRBrefilledhadpersistent UI.OnepatientineachgrouphadrecurrentUI.RecurrentUI occurredwithinamediantimeof20months.Urethralero- sionoccurred4monthsaftersurgeryfor1outof21patient inthefirstgroup.Erosionoccurredfor4outof10inthesec- ondgroupwithamedianerosiontimeof42months(2—116).
Allpatients witherosionhadpast history of surgeryprior toAUSimplantation(3internalurethrotomy,includingone afterrepressurizing, inone patient,1 macroplasticinjec- tion,1erosionpriorrepressurizing,1TOMSTM).Twoeroded patients had also past history of radiation, threehad no other comorbiditieswhile onewasdiabetic andan active smokerandanotherwasanactivesmokerwitharteriopathy.
Bothinfectionsoccurred, in onepatientwithpast history ofTOMSandinonepatientimmunosuppressedbecauseof malignanthemopathy.
Erosionandatrophyoccurredmorefrequentlyafterbal- loon repressurizing than after balloon upsizing (8 vs 2, P=0.03).
At the end of follow-up, overall subjective conti- nencewassignificantlyimprovedfrompreoperativeperiod
Figure1. Studyflowchart.PRB:pressureregulatingballoon.
(P=0.012). Subjective continence was achieved for 3 patients (30%) after refilling and 8 patients (38%) after PRBreplacement.Medianpaduseperdaywassignificantly decreasedinthePRBreplacementgroupcomparedtoPRB refillinggroup (1vs2,P=0.033).Therewasnodifference in objective continence (50g [30—210] vs 50g [0—300], P=0.47).
Discussion
BesttreatmentoptionwhenAMS800® failureoccurredisnot known. We report the second largest series of PRB infla- tion or change for treatment of persistent or recurrent urinaryincontinenceafterdeviceimplantation.Inourstudy, reoperationratewassignificantlylowerwhenballoonwas changedthanwhenballoonwasrefilled,33%(n=7)vs80%
(n=8)(P=0.024).WhenPRBwasupsized,wefoundaninfec- tion/erosionrateof14.2%.ThisiscomparabletoEswarawho founda5.3%to21.4%infection/erosionratewhencompar- ingfourtypesofrevisionafterAUSfailure(cuffdownsizing, cuff relocation, tandem cuff placement and higher PRB replacement) [10]. There were no evidence of increased riskfor urethralerosionwithinalltechniques. Wangetal.
compared29PRBreplacementorupsizingaloneto15revi- sionofthe existingcuffalone[12].Indicationfor revision procedure was recurrent incontinence. Sixteen out of 29 patients(55.2%)underwenttertiarysurgeryafterreservoir revisionversus8outof15(53.3%)aftercuffrevision.Ero- sionratewas27.8%(8/29),mechanicaldysfunctionoccurred in 3 cases(10.3%) andrecurrent incontinencein 13.7% of cases (4/29) after reservoir revision. Reservoir procedure was associated with higher erosion rates and less recur- rent incontinence compared to cuff revision. Our results were alsocomparabletothe11.1% infection/erosionrate reportedbyLinderinpatientswhounderwententiredevice replacement[13].Althoughwedidnotobserveanyinfection intherefillinggroup,erosionratewashigh(40%).
RefillingtheballoonisatechniqueinitiallyusedbyMail- letetal.insevenAUSrevisionprocedures[11].Theydidnot observeanyurethralerosion.However,threepatientswere reoperatedonwithin30monthsforrecurrentincontinence.
Theoretically,balloonrepressurizingwasjustifiedbythe hypo-osmotic fluid leakage through the silicone that has becomeporousthroughtime[11].Itwasalsojustifiedbythe coatingfibrosisthathasdevelopedaroundtheballoonand thecuff,whichaltertheircomplianceandleadtoincrease thepressuretransmittedtotheurethra[11].Itwasassumed tobetter control the pressuretransmitted tothe urethra comparetoPRBupsizing.However,inourstudy,theremight havebeenartefactintheRCOPmeasureleadingtoanover- fillingofthePRB,andhigherriskoferosionandatrophy,as pressuretransmissionfromtheballoontothecuffisdelayed bythepumpresistance.Thishigherosionrateledustoaban- donthistechnique.WeusedPRBchangetoahigherpressure rate (61—70cm H20 to71—80 cm H20)in order tobetter controlthepressuredeliveredtothecuff.
Changing only one component expose the patient to mechanicalfailureofanothercomponent.Linderetal.[13]
compared outcomes of single component revision versus entiredevicereplacementandconcludedthatrateofter- tiary surgery was not different between two groups (24%
Table2 Complicationsleadingtosurgeryafterinitialrepressurizing.
Complications PRBupsizingto 71—80cmH20 n=21(%)
PRBfilledwith sterilewater n=10(%)
P Treatment
Reoperation 7(33) 8(80) 0.024
Urethralerosion 1(4.7) 4(40) 0.03 Deviceexplantation
Infection 2(9.5) 0 0.34 Deviceexplantation
1
Balloonexplantation 1
Urethralatrophy 1(4.7) 4(40) 0.0155 Transcorporalcuff
Balloonmigration 1(4.7) 0 1 Balloonrepositioned
Leakontheballoon 1(4.7) 0 1 Balloonchanged
Leakonthecuff 1(4.7) 0 1 Cuffchanged
PRB:pressureregulatingballoon.
vs13%,P=0.17).Moreover,three-yeardevicesurvivalwith- outrevisionwasnotsignificantlydifferentbetweenentire devicereplacementandsinglecomponentrevision(76%vs 60%,P=0.11)[13].Ithasbeensuggestedthatatermof 3 or 5yearssinceinitial implantationcouldbeused[14,15]
asacutofftochoosebetweentwotechniques(changingall deviceorjustacomponent).However,Linderetal.[13],in 2016,failedtodetermineasignificantinteractionbetween time from device implantation to mechanical failure and typeofrevisionperformedinacohortof125AMS800® revi- sion. Interestingly, in our study,in both groups, only one patient(3%)hadmechanicalfailureofanothercomponent (cuffleak)withinfollow-up.HehadhisAUSimplantedfor 2.2years.
UrethralatrophyisoneofthemaincauseoflateAMS800® failure.Itis responsible for43.9% ofall reoperationafter primary AUS device implantation [16]. The urethral wall atrophy is difficult to appreciateand quantify withimag- ing,evenwithMRItechnique,whoappreciatesbettercuff location and filling. Therefore, urethral dissection might be better toevaluate urethral atrophy and toadapt sur- gicaltechnique(cuffdownsizing...)ratherthanarbitrarily increaseurethralpressurewithhigherPRB.However,when considering recurrent incontinence, we should not mis- diagnose mechanical failure that can occur in 29.3% of reoperationindications[16].When lowvolumein thePRB wasobserved we should have seek for leak in other con- stituentswhentherewasnoleakobservedintheballoon.
However,wewouldnotadvocateforchangingallthedevice whenPRBhaslowervolumeas, inourstudy,fourpatients hadlossoffluidinthedevicewithoutanyleak,whichisan argumenttoPRBmalfunctionandprobableporosityofthe system although we used iso-osmotic mixture. New tech- niques suchas the ohmmeter [17] couldbe useful in the futuretopreciselyassessthesiteof theleakandprevent entiredevicereplacement.
We observed only 38% of subjective continence in patientswhohadtheirPRBreplaced.Ourresultsareinferior tothoseofDiMarcoandElliott[18],whichfoundanoverall 56%(10/18)rateofsuccesswithtandemcuffimplantation.
ForEswaraetal.[10]tandemcuffsweresuperiortoallother revisiontechniquesconcerningrecurrentUI.However,itis
difficulttocomparesubjectivecontinenceresults,aspost- operativepadusewasnotavailablefor33.3%ofpatients.
Weareawareofthelimitationsofourstudy.Itisaretro- spectivestudywithmissingpadusedata,urodynamicsand RCUP measurements data. Patients’ heterogeneity might have influencedclinical results. We didnot use validated questionnairetoevaluateUIorpatientsatisfaction.
However,ourstudyis interestingbecause,where other studiesfocusedonurethra,wetriedtodeterminewhether touchingonlythe PRBwould beefficientand safe.As we knowthatchangingonecomponentexposestoothercom- ponentfailure and a tertiarysurgery, we wouldadvocate forchangingallthedevicesinyoungpopulation.However, changingonlyPRBcouldbeanalternativewithacceptable morbidity and reserved to fragile population in order to avoidanotherurethraldissection.
Conclusion
WhenAMS800®failureoccurs,PRBupsizingismoreefficient, lessmorbidandleadtolessreoperationthanPRBrefilling.
However,riskforfailureofothercomponentswouldadvo- cate considering this technique for a selected population whenminimalsurgeryisbestindicated.
Disclosure of interest
Theauthorsdeclarethattheyhavenocompetinginterest.
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