A bicentric comparative and prospective study between classic photovaporization and anatomical GreenLight laser

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ORIGINAL ARTICLE

A bicentric comparative and prospective study between classic photovaporization and anatomical GreenLight laser

vaporization for large-volume prostatic adenomas

Étude bicentrique, comparative prospective entre photovaporisation classique et vaporisation anatomique par laser GreenLight pour les adénomes

prostatiques de gros volume

G. Hibon

^a^,∗

, G. Léonard

^a

, A. Franceschi

^b

, V. Misrai

^c

, F. Bruyère

^a^,^d

aDepartmentofurology,CHRUdeTours,LoireValley,2,boulevardTonnelle,37000Tours, France

bDepartmentofpublichealthuniversityofTours,hospitalofTours,37000Tours,France

cDepartmentofurology,clinicPasteur,31300Toulouse,France

dPREScentreVal-de-Loire,universitéFrancois-Rabelais,37000Tours,France

Received7November2016;accepted18April2017 Availableonline31May2017

KEYWORDS Prostate;

Benignprostatic hyperplasia;

Lazer;

GreenLight;

Urinarystress incontinence

Summary

Objective.—Long-term outcome after prostate photovaporization (PVP) remains largely unknown,especiallywhenperformedonenlargedprostates.However,newvaporisationtech- niques(e.g.,laserenucleation)areincreasinglyused.Ouraimwastocomparepostoperative resultsafterstandardPVPtothoseofananatomicaltechnique.

Materialsandmethods.—Thisbicentricprospectivestudyincludedmalestreatedforenlarged prostatecausedbybenignprostatichyperplasiausingaGreenLightlaser.Patientswerepre- operativelyassessedaccordingtoprostatevolume,post-voidresidualvolume(PVR),maximum urinary-ﬂowrate(Qmax),prostaticspeciﬁcantigens,andInternationalprostatesymptomscore (IPSS).Peroperativedataincludedvaporizationtime,energydelivered,andoperativelength.

∗Correspondingauthor.

E-mailaddresses:guillaume.r.hibon@gmail.com(G.Hibon),gregoireleonard@hotmail.com(G.Léonard),arnaudfranceschi@gmail.com (A.Franceschi),vmisrai@clinique-pasteur.com(V.Misrai),F.BRUYERE@chu-tours.fr(F.Bruyère).

http://dx.doi.org/10.1016/j.purol.2017.04.006

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Postoperativedataat1,3,6and12monthswerecomparedwithinitialdata;allcomplications wererecorded.Comparisonsweremadebetweentheconventionalvaporizationtechniquever- susanatomicalvaporization,whichinitiallydifferentiatedtheperipheralzoneoftheprostate usinganenucleationtechniquebutnomorcellation.

Results.—Recordsfrom106surgicalpatientsbetweenDecember2012andDecember2013were analyzed.Operativelength,vaporisationtime,andenergyusedweregreaterintheanatomical PVPgroup.Theaveragelengthofhospitalstay(2.0vs.2.5days),timewithacatheter(1.3 vs.1.9days),IPSS(5.0vs.6.4),PVR(15.5vs.11.7mL),andQmax(19.9vs.19.7mL/s)were comparablebetween thetwogroups.However, morecomplicationsoccurred (27%vs.37%), includingstressurinaryincontinence(0%vs.8%)whenusinganatomicvaporization.

Conclusion.—Despitecomparablegroupsandsimilarfunctionalresults,anatomicalPVPcaused morestressincontinence.However,thelearningcurvebetweenthetwotechniquesmayexplain thisdifference.

Levelofevidence.— 4.

MOTSCLÉS Prostate;

Hyperplasiebénigne deprostate; Laser; GreenLight;

Incontinenceurinaire d’effort

Résumé

Objectif.—Les résultats à long terme après la photovaporisation de la prostate (PVP) demeurentlargementinconnus,enparticulierlorsqu’ilssonteffectuéssurlesgrossesprostates.

Cependant,denouvellestechniquesdevaporisation(parexemple,l’énucléationlaser)sontde plusenplusutilisés.NotreobjectifétaitdecomparerlesrésultatspostopératoiresaprèsPVP standardparrapportàunetechniqueanatomique.

Matérieletméthodes.—Cetteétudeprospectiveàdeuxcentresinclusleshommestraitéspour unehyperplasie bénigne dela prostate degros volume àl’aided’un laser GreenLight. Les patientsontétéévaluésenpréopératoireenfonctionduvolumedelaprostate,résidupost- mictionnel (RPM), ledébiturinairemaximal (Qmax),des antigènesspéciﬁques prostatiques (PSA)etl’International prostatesymptom score(IPSS).Les donnéesperopératoirescompre- naient le temps de vaporisation, l’énergie délivrée et les temps opératoires. Les données postopératoires à 1, 3, 6 et 12 mois ont été comparés aux données initiales ; toutes les complicationsontétéenregistrées.Descomparaisonsontétéfaitesentreunetechniquede vaporisationconventionnelleparrapportàunevaporisationanatomiquequidistingued’abord la zone périphérique dela prostateen utilisantune techniqued’énucléation, maispas de morcellation.

Résultats.—Lesdossiersde106patientsopérésentredécembre2012etdécembre2013ont étéanalysés.Laduréeopératoire,lestempsdevaporisationetl’énergieutilisésétaientplus élevéesdanslegroupedePVPanatomique.Laduréemoyennedeséjour àl’hôpital(2,0vs 2,5jours),laduréedesondage(1,3vs1,9jours),l’IPSS(5,0contre6,4),leRPM(15,5vs11,7mL) etleQmax(19,9vs19,7mL/s)ontétécomparablesentrelesdeuxgroupes.Cependant,moins decomplicationssesontproduites(27%contre37%),ycomprisl’incontinenceurinaired’effort (0%contre8%)lorsdel’utilisationdelaPVPstandard.

Conclusion.—Malgrédes groupes comparables et des résultatsfonctionnels similaires,PVP anatomiqueacauséplusd’incontinenceurinaired’effort.Cependant,la différencedansles courbesd’apprentissageentrelesdeuxtechniquespeuventexpliquercettedifférence.

Niveaudepreuve.— 4.

Introduction

Benign prostatichyperplasia(BPH) isa commoncondition that causes increased volume in the prostate transition zone.

Prostate photovaporization (PVP) using a GreenLight laser is an alternative therapy; endoscopic surgery is recommended to treat urinary-tract symptoms caused by

BPH[1].However,thelong-term results areunknown[2], but suggest that PVP when used on large prostates may causeworsefunctionaloutcomesthanconductinganopen prostatectomy. Thus, enucleation was developed for the Greenlight laser, with or without morcellation of tissue removal,bystartingthevaporizationbydifferentiatingthe peripheralzoneoftheprostateusingtheHoLEPtechnique (anatomical vaporization), a technique that has already

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beendescribed[3].Asisroutinelysuggested,morcellation needsfurthermaterialandhasasigniﬁcantimpactonoper- ative times [4]. Furthermore, morcellation can increase complication rates. Consequently, enucleation techniques thatdonotrequiremorcellationneedtobedeveloped.The purposeofthisstudywastocomparetheinitialresultsafter conventionalvaporizationversusanatomicalvaporization.

Materials and methods Study population

Weconductedacomparativestudythatincludedprospec- tive data from two French centers that specialized in GreenLight laser vaporization. The inclusion period of patients was from 1st December 2012 until 1st Decem- ber2013. PatientsundergoingPVPtotreat large prostate enlargementwasperformed by anexpert surgeonin both centers. The surgeons had performed>150 PVP procedures,but had littleexperiencein HoLEP. Patientswhose prostatemesuredmorethan80cm³byultrasonographywere selected.Patientswithanon-sterilepresurgicalurinebac- terialculturewereexcluded.

Photovaporization was performed using a MoXy^® ﬁber thatdelivered180WusingaGreenLightXPS^®lasergenerator (AMSBoston[5]).

Patientsweredividedintotwogroupsdependingonhow vaporizationwasperformed. The choiceoftechnique was madebythesurgeons.Patientsingroup1underwentsurgery using a standard photovaporization technique. Group 2 malesunderwentanatomicalvaporizationthatbeganbydif- ferentiatingtheperipheralzone.

Equipment

AMoXyfiberwasusedatapowersettingof180Wforvapor- ization and 40W for coagulation. A 26-F continuous flow resectoscope (Karl Storz, Germany), with a special laser bridgefor thelaser fiber, wasused;a 30^◦ down lens was preferred.Salinesolutionwasusedforirrigationthroughout theprocedure.

Procedure

Anatomicalvaporizationwasperformed through acentral cavityintheprostateusingstandardvaporization.Thenext stepwastolocalizethecapsuleattheapexoftheadenoma bymakingabilateralincisionlateraltotheverumontanum, andthenusingthe tipof thebeakof theresectoscopeto laterallypush,ﬁnd,anddevelopaninterfacebetweenthe capsule; adenomahemostasisof the bleedingvessels was carriedoutduringtheprocedure. A6-o’clockincisionwas madebyﬁringthelaserupwardsfrombelowtheadenoma to vaporize the adenomatous tissue. This allowed visual- izationof thecapsule fromtheveru montanumuptothe bladderneckandserved asan anatomicreferenceforthe capsuleduringtherestoftheprocedure.Vaporizationwas thencarriedoutlaterallyonbothsidesandanteriorly.

Forstandard PVP, a 23-Fcontinuous ﬂow resectoscope (KarlStorz,Germany)wasused.

Preoperative antibiotic prophylaxis was given using cefuroxime 1.5g [6]. Data were collected from the com- puterizedmedicalrecordsofallpatients.

Covariate

Thefollowingpreoperativeparameterswereassessed:maximum urinary ﬂow (Qmax), an abdominal ultrasound to measurepost-voidresidualvolume(PVR),prostaticspeciﬁc antigens (PSA), ultrasound measurement of prostate volume,andresponsestotheInternationalProstateSymptom Score (IPSS). If PSA or clinic examination of the prostate wereabnormal,biopsieswereperformed.Patientswithcan- cerwereexcluded.Thefollowingperoperativeparameters wererecorded:vaporizationtime,operativetime,andthe amount ofjoules administered.Onlypatients fromone of thetwocentersreceivedintraoperativetransrectalprostate ultrasonography.

Outcomes

Thefollowingimmediatepostoperativeoutcomeswereeval- uated: hospital stay length, time with a catheter, PVR, Qmax,andcomplicationrateusingtheClavien—Dindoclas- siﬁcation[7].Themajoradverseoutcomewasstressurinary incontinence, whichwasdeﬁnedasinvoluntaryleakage of urineduringeffort,andwasassessedduringclinicalpostop- erativeevaluations.

Patientswerefollowed-up at1, 3,6and12 monthsby assessingPSA,Qmax,PVR,andIPSS.

Statistical analysis

Dataarepresented asmeans±standard deviation(SD)for quantitative variables, frequencies and percentages for qualitativevariables.Student’st-testwasusedtocompare quantitativevariables.Qualitativevariableswerecompared usingtheChi²andFisher’sexacttests.Statistical analyses were performed usingExcel and JMP software(SAS Insti- tute Inc.).A value of P<0.05 wasconsidered statistically signiﬁcant.

Results

Patients’ demographics

Onehundredandsixpatientswereincludedintheﬁnalanal- ysis. Fifty-ﬁve(52%)and51 (48%)patientsunderwentPVP andanatomicalvaporization,respectively.Patients’charac- teristicsaresummarizedinTable1.Groupswerecomparable regardingASAscore,anticoagulant/antiplatelettreatment, Prostatevolume,andIPSS. However,thePVPgroup hada greaterQmax(9mL/svs7,1mL/s;P<10⁻³).

Perioperative outcomes and functional outcomes

Theaveragelengthofvaporizationwas11minlongerinthe anatomical vaporization group, and an average of >50kJ

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Table1 Preoperativecharacteristicsofpatients.

Variable Group1:PVP

n=55

Group2:anatomical vaporization n=51

P-value

Age(years)^a 71.5±9.8 69.6±9.1 0.304

ASAscore:n(%)

1 12(22) 9(18) 0.081

2 29(52) 31(60) 0.403

3 13(24) 9(18) 0.447

4 0(0) 1(2) 0.481

dm 1(2) 1(2) 1

PSA(ng/mL)^a 5.8±5.1 6.9±5.3 0.279

Prostatevolume(mL)^a 83.0±33.8 93.5±38.2 0.136

Mid-lobe 19(35) 15(30) 0.572

Foleycatheterization 13(24) 16(31) 0.372

Qmax(mL/s)^a 9.0±5.7 7.1±2.6 <10⁻³

PVR(mL)^a 133±195 116±120 0.593

IPSS^a 17.4±5.3 17.2±6.0 0.856

Urinaryqualityoflifescore:n(%)

≤4 0(0) 26(51) <10⁻³

4< 55(100) 25(49) <10⁻³

MedicaltreatmentofBPH:n(%)

Anticholinergic 1(2) 0(0) 1

Phytotherapy 11(20) 11(22) 0.842

Finasteride 21(3) 19(37) 0.922

Alphablockers 52(95) 43(84) 0.084

Antiagregantoranticoagulanttreatment

Acetylsalicylicacid 19(35) 13(25) 0.310

Clopidogrel 4(7) 2(4) 0.680

AVK 5(9) 5(10) 1

Rivaroxaban 0(0) 1(2) 0.481

PreviousTURP:n(%) 4(7) 1(2) 0.365

PSA:prostaticspeciﬁcantigen;Qmax:maximumurinaryﬂowrate;PVR:post-voidresidue;IPSS:Internationalprostatesymptomscore;

ASA:Americanscoreofanesthesiology;TURP:trans-urethralresectionoftheprostate;BPH:benignprostatichyperplasia;5ARI:5alpha reductaseinhibitor;AVK:anti-vitaminK.

a Allquantitativedataarepresentedastheiraverage±standarddeviation.

wasdelivered.Therewere10conversionsintotransurethral resectionsoftheprostate:allwereperformed ingroup1.

IntraoperativedataaredescribedinTable2.

The mean follow-up was longer for group 1 (9.3 vs.

3.8monthsforgroup2;p<1×10⁻³).Themeanofthemax- imumurinaryﬂowratewassimilarinbothgroups;average

post-voidresidualvolumewasslightlygreateringroup1(15 vs.11mL,respectively;NS).

The postoperative complication rates were 27% and 37% (group 1 and group 2 respectively). Complications that occurred were the following: 8% of cases of urinary incontinence in group 2 vs. 0% in group 1; three cases

Table2 Intraoperativedata.

Variable Group1:PVP

n=55

P-value

Numberofjoules(kJ)^a 413±162 463±178 0.133

Vaporizationtime(min)^a 45.8±18.9 56.6±20.8 0.006

Operativetime(min)^a 74.5±32.1 88.2±33.6 0.034

No.ofJ/gofprostate^a 5.2±1.5 5.3±2.3 0.790

a Allquantitativedataarepresentedastheaverage±standarddeviation.

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Table3 Postoperativedata.

Variable Group1:PVP

n=55

P-value

Lengthofstay(days)^a 2.0±1.6 2.5±1.6 0.111

Catheterizationtime(dayspostoperative)^a 1.3±0.9 1.9±2.0 0.046

IPSS^a 5.0±3.6 6.4±3.8 0.054

QualityofLifescore:n(%)

≤4 45(82) 41(80) 0.851

<4 1(2) 1(2) 1

MD 9(16) 9(18) 0.860

PVR(mL)^a 15.5±26.1 11.7±28.9 0.478

PSA(ng/mL)^a 2.8±2.3 2.9±3.9 0.871

Qmax(mL/s)^a 19.9±8.6 19.7±6.7 0.895

Follow-up(months)^a 9.3±8.9 3.8±2.6 <1×10⁻³

Clavien—Dindocomplications

Total 15(27) 19(37) 0.271

Minor(I/II):n(%) 13(23) 16(31) 0.372

Major(III/IV):n(%) 2(4) 3(6) 0.670

Residualprostatevolume(mL) 33.4±21 29.7±17.2 0.326

Stressurinaryincontinence:n(%) 0(0) 4(8) 0.034

IPSS:Internationalprostatesymptomscore;PVR:post-voidresidualvolume;PSA:prostaticspeciﬁcantigen;Qmax:maximumurinary ﬂowrate;MD:missingdata.

aAllquantitativedataarepresentedastheiraverage±standarddeviation.

of bladder-neck sclerosis and four cases of retromeatal stenosis that required a urethrotomy (2 in each group).

Minor complications (Clavien I/II): were 11 urinary infec- tions(gradeII),9patientshadirritativesymptoms(gradeI), 1patientneededatransfusion(gradeII) and10hadacute urinaryretention that required catheterization(grade II), with no difference between the two groups. Five major complication(ClavienII/IV)neededsurgeryforclotremoval andhemostasis(gradeIIIb)(2ingroup1and3ingroup2).

ThepostoperativedataarelistedinTable3.

Discussion

Ourstudysuggeststhaturinaryincontinenceismorecom- monafterananatomicalphotovaporizationcomparedtoa conventional vaporization technique. However, our study had short follow-up periods of 9.3 and 3.8 months for groups1and2,respectively.

Anotherhypothesismayexplainthisdifference:anatomical photovaporization requires a longer learning curve.

Cystoscope movement seems to be more prevalent when anatomicvaporizationisconducted,andthiscouldexplain thedifferencein continence. Theother possibilityis that thelaserenergyontheprostaticapexcouldhavesiderthe externalsphincter. Operators oflasers areendeavoringto reduce movementsof the cystoscope asmuchaspossible andreducethepowerdeliveredtotheapex.

Functional outcomes

Inourseries,theresultsforIPSS,Qmax,PVR,andtheperiod of catheterization were comparable between the two

techniques and when compared to various recently published results using lasers [7]. At least for the initial postoperative period, we found that the anatomical techniquegavegoodfunctionalresults.

It would have been interesting to compare both techniques with open prostatectomy, which remains the gold standard[8].

Theaverageoperative timeduringanatomicalPVPwas 88min,whichiscomparabletotheoperativetimeforopen surgeryreportedbyKuntzetal.[9]andPorpigliaetal.[10]

(90and95min,respectively).

In published open prostatectomy studies, the average hospital stay ranges from 5 to 10 days.One main advan- tage of usingalaser is theclearlyshorter average length ofhospitalization(2daysinourstudy),andthus,thelower overall cost tosociety; however, thereis the large initial costoftheMoXyﬁber.Regardingourshortfollow-upperiod, thefunctionalresultswerecomparabletothosereportedby Briantetal.[11]relativetoMillinprostatectomy.

The advantages of anatomical vaporization aresimilar tothoseforopen prostatectomy,butitalsodecreasesthe numberofcomplications.

Postoperative complications

The postoperative complication rate of 27% found in our studyislessthanthatreportedbyPeyronnetetal.,of39.7%

[8]. However, our patients were younger and had lower American society of Anesthesiology scores. Complications thatoccurredafterconventionalPVPweremostlyminorand transient,suchasmacroscopichematuriaortheneedfora urinarycatheter.

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Bryant etal.[11] andLong etal.[12],whousedopen prostatectomy, found that early rates of complications ranged from 36—49% and 28%, respectively, which were muchhigher thanfound withPVP, and theseresults were independently of the technique performed. Suer et al.

[13] also observed complication rates of retropubic and transvesicalprostatectomy of31%, with0.7% casesofuri- naryincontinence.Inallthesestudiesthatfocusedonopen prostatectomy, the complication rates were greater than found in ourstudy (27%), except for stress urinaryincon- tinence.Inthisregard,reducingthepowerdeliveredtothe apexcoulddecreasetherateofstressurinaryincontinence.

Urinary stress incontinence

Inthepublishedliterature,therateofurinaryincontinence at1-yearpost-PVPwhenusingaGreenLightXPS180Wlaser iscloseto1%[8].Similarly,anatomicaltechniquesareasso- ciatedwithstress urinary incontinencerateof 1% after a 1-yearfollow-up[14].However,ourresultsareforshorter follow-upperiods.

Wecouldarguethaturinaryincontinencecausedbythe anatomical technique was a signiﬁcant complication but remainedexceptionalwhenusingthisroutinetechnique.

Ourpilotstudycomparedarecentlydevelopedtechnique withanestablishedtechnique.Unfortunately,thelearning curveforthenewtechniquemayhavecontributedtothesig- niﬁcantdifference,wefoundbetweenthetwotechniques.

A longerfollow-up is needed toobtain consistent results.

However,bothtechniqueswereconductedsimilarlyandthe experienceof thesurgeons washomogenous between the twomedicalcenters,withthiscontributingtothestrength ofourresults.

Regarding the learning curves for these techniques, a totalof30—50proceduresperoperatorseemtobeneces- sarytodefinean‘‘expert’’[15,16].ArecentstudybyMisrai et al.[17] defined the learning curve toreach an expert levelrequired120procedurestoachieveoptimallengthof surgeryandvaporizedprostatevolume.Accordingtothiscri- terion,ourtwosurgeonscanbedefinedasexperts,except whenusingtheanatomicaltechnique,wheretheyhadless experience.

Theusualvaporizationpowerusedis5kJ/cm³ofprostate measured preoperatively. However, using less power may reducethelong-termfunctionalresults.

Strengths and limitations

Oneofthemajorbiasesofthisstudyisrelatedtothelarge number of missing data. This is inherent when collecting datafrompatients’computerizedrecords.

Ourresultsreportona3-monthpostoperativeperiod;we mayhavefoundmoredifferencesoveranextendedfollow- up period. For example, a recent study by Misrai et al.

[18]reportedthat urinaryincontinenceat 2monthspost- operativelyusinganatomicalPVPwas25%versus3.4%when usingconventionalPVP.However,at6monthsaftersurgery, thisdifferencewasreducedto3.4%versus 0% whenusing theGreenLightEnucliationtechnique(GreenLEP;whichuses morcellationattheendoftheprocedure)orstandardPVP, respectively.However,GreenLEPandanatomicalvaporiza- tionaredifferenttechniques.

Another limitation of our study is its small population size,which mayexplain the lack of signiﬁcance between some of our results. Nevertheless, our results may guide urologist whoarenew tothis techniqueand suggest that incontinencerateinthepostoperativeperiodmaybehigher thanafterconventionalvaporization.

Conclusion

Despite similar functional outcome, anatomical PVP is responsiblefor slightly more postoperativecomplications, includingurinaryincontinenceinour study.Aless aggres- sivetechniquethatdecreasesthepowerusedattheapex, butlimitscystoscopemobility,coulddecreasestressurinary incontinence.Anatomical vaporizationisa newtechnique andthusrequiresalearningcurvetoachieveoptimalfunc- tionalresultsandtolimittheriskofcomplications.

Disclosure of interest

F.BruyèreandV.MisraiareproctorsforBoston-AMS.

G.Hibon,G.Léonard,andA.Franceschideclarethatthey havenocompetinginterest.

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