PROSTATEARTERYEMBOLIZATION:ISTHEREAPATHTOTREATMENTOFCHOICE?

SHIVANKBHATIAM.D.CHAIRMAN

DEPARTMENTOFINTERVENTIONALRADIOLOGYASSOCIATEPROFESSOR,INTERVENTIONALRADIOLOGYANDUROLOGY

FacultyDisclosuresShivank Bhatia:Consultant– Embolx,Mentice,MeritMedical;Speakers’Bureau– Mentice,MeritMedical,Siemens,Terumo

Brandnamesareincludedinthispresentationforparticipantclarificationpurposesonly.Noproductpromotionshouldbeinferred.

PATHWAYTOTREATMENTOFCHOICE–AUAGUIDELINES

• LEVELIEVIDENCE– RCTSHAM/TURPOP/HOLeP

• SAFETY/DURABILITY- REGISTRY

• UROLOGIST– COLLABORATION

IPSSSCORE/QOL

QMAX/PVR

PROSTATEVOLUME

RETREATMENTRATES

SEXUALFUNCTION

PSA

LUTSOUTCOMEMEASURES

IPSSSCORE

ReductionofIPSSscorebynumberofpoints–Mean/median

PercentageReductionInIPSSScores

StatisticallySignificantChange

WHATCONSTITUTESSIGNIFICANTSYMPTOMIMPROVEMENT?

1772 BENIGN PROSTATIC HYPERPLASIA SPECIFIC HEALTH STATUS MEASURES

TABLE 3. Resmnsiveness statistics for the 2 indexes (1.145 wtientsl ~ ~ ~~

Standard Guyatt's Responsiveness Effect Size* Statistict

AUA symptom index -0.74 BPH imoact index -0.33

-0.82 -0.41

Mean raw change divided by the atandard deviation of the baseline mre. f Mean raw change of all subjeds divided by the standard deviation of the

change scores of subjects rating the condition unimproved.

TABLE 4. Mean AUA scores (and 95% confidence intervals) for patients with different responses on a global question about the

bother of the urinary condition at baseline Overall, How Bothersome has 95% any Trouble With Urination No' %f Confidence

Not at all 264 12.4 11.8-13.0 A little 565 14.4 14.0-14.9 Some 343 19.2 18.6-19.7 A lot 57 23.6 22.2-25.1

Been in the Last Wk.? h. score Interval

TABLE 5. Mean absolute and percent changes in subject AUA symptom index (mnge 0 to 35) and BPH impact index (range 0 to

13) scores depending on subject 13-week global assessments of degree of change

Mean Change Scores * SEM (%) F't. Assessment No. Of Impmvement Pts. AUA Symptom Index BPH Impact Index

Marked 223 -8.8 2 0.34 (-57 ? 2) -2.2 -t 0.15 (-68 f 4) Moderate 298 -5.1 2 0.29 (-32 5 2) -1.1 5 0.12 (-23 f 7) Slight 347 -3.0 f 0.27(-16 ? 2) -0.5 2 0.12 (+7 ? 8) None 253 -0.7 f 0.31 (-2 f 2) -0.1 2 0.13 (+25 It 7) Worse 24 +2.7 f 0.93 (+19 ? 6) +1.9 2 0.43 (+66 2 21)

with changes in AUA symptom index and BPH impact index scores, although investigators appeared to require a some- what greater AUA symptom index or BPH impact index score decrease to award a higher rating of improvement.

What threshold improvements in scores for these 2 indexes would be reliably perceptible to patients and might be con- sidered clinically significant for outcomes research studies? Any such thresholds are arbitrary and would be accompanied by misclassifications. To explore this issue, we constructed receiver operating characteristic curves and examined the ability of the change scores of each index to predict whether patients showed improvement (slight, moderate or marked) or not (unchanged or worse). Areas under the receiver oper- ating characteristic curves for the AUA symptom index and BPH impact index were 0.74 and 0.67, respectively. The area under the receiver operating characteristic curve, which rep- resents the probability that a randomly selected improved patient would have a greater score decrease than a randomly selected unimproved patient, was significantly greater for the AUA symptom index than for the BPH impact index score (p

AUAGUIDELINES2010/2014

COMMONPROCEDURESFORPROSTATE<80GM

TURP/ bipolar TURP PVP- “greenlight” TUVP- button electrode

Common issue- high rate of retrograde ejaculation !

Transurethral Resection of the Prostate (TURP):

Perioperative:• Bloodloss• Anesthesiarequirements• TUR-syndrome• Inpatientobservation• NeedforurethralcatheterIntermediate:• Urinaryretention,urethralbleeding,dysuria• Ejaculatorydysfunction• Erectiledysfunction• Incontinence(urge/stress)

Gold Standard

Slidecourtesy:Dr.BruceKava

LONG-TERMTURPOUTCOMESInitialimprovementsustainedat5years

• SymptomScoredecreasedby70%- 15-17points• QOLimprovedby69%-3.3points• Qmax improved125%- 10.7points• PVRreducedby77%

RetreatmentafterTURP• 6%at1year• 12%at5years

• 15%at10years

Madersbacher S.BrJUrol 1999;83:227Madersbacher S.Eur Urol 2005;47:499

Proceduresforlargeprostate>80g

SimpleProstatectomy

• Modalities• Open• Laparoscopic/Robotic

Endoscopicenucleation• Holmiumlaser- HoLEP• Thuliumlaser- ThuLEP

AUAGUIDELINES2018

UROLIFT,REZUM,AQUABLATION

EJACULATIONPRESERVINGMIS

Prerequisite- prostate < 80 gm

Water vapor thermal therapy: REZUM Prostatic urethral lift : Urolift

Prerequisite- prostate < 80 gm & absence of median lobe

UROLIFT– PATHWAYTOGUIDELINES5YEAROUTCOMES

UROLIFTVSSHAM– 201PTS– 2:1RANDOMIZATIONIPSS improvement afterPULwas88%greaterthanthatofSHAM at3months.

ImprovementinIPSS,QOLandQmax weredurablethrough5yearswithimprovementsof36%,50%and44%respectively.

Surgicalretreatmentwas13.6%over5years.

Sexualfunctionwasstableover5yearswithnodenovo,sustainederectileorejaculatorydysfunction.

142016

80PTS

2016

197menProstatesize30to80ccwererandomized2:1betweenthermaltherapywiththeRezūm®Systemandcontrol.

ThermaltherapyandcontrolIPSSwasreducedby11.2± 7.6and4.3± 6.9respectively(p

Aqua-ablation

Eligibility- prostate > 30 gm and < 80 gm

Uses high-pressure saline to remove parenchymal tissue through a heat-free

mechanism of hydro-dissection

MIST:MICROWAVE,UROLIFT,REZUM,AQUABLATION

Inofficeprocedure

Qmax– 50percent

InferioroutcomestoTURP(40-50%IPSSreduction– 8-12POINTS)(EXCEPTAQUABLATION)

EbbingJ.Curr Opin Uro 2014;24:1

J- UROLOGYEDITORIALSONMIST• Datasometimesappeartobebetterthanwhatweexperienceinreal-lifepractice.

• Real-lifeexperiencewiththesetechniquesintheurologicalcommunityhasnotbeenaswellreceived.

• WhileMITsprocedureshavelessmorbidity,formanypatientsefficacyisnotasgoodaswithTURP andforsome,itisatbestmarginal.However,formanypatientsagoodresultisgoodenough.

• ThereshouldbeahealthydoseofskepticismaboutallMITs. ThebottomlineisthatduringthenextfewyearswewillbeinundatedwithavarietyofnewMITs,mostwillhaveintermediateresults,anddurabilitywillbequestionedandbelargelydrivenbyreimbursement.

• Let’snotbecomecapturedbytechnologiesthatarelookingforindications!

PAECOMPARATIVESTUDIES

•GaoRCT- China- 2014– TURP– Radiology•Carnevale etal- Brazil– 2015– TURP- CVIR•Abt RCT- Switzerland- 2018– TURP– BMJ•UKROPE– 2018– TURP- BJU

GAOETAL:RADIOLOGY2014

N=104

22

CARNEVALEETAL:CVIR2016

N=30

ABTETALBMJ 2018

UnderestimatedthedifficultyofbilateralPAEresultinginunderpoweredstudy

12weeksmaybeearlyforprimaryendpoint

Ejaculatorydisorder(56%)percentageissomewhatunique

Despitedesignflaws,IPSSreductionwascomparabletoTURPwithlesscomplications(althoughdidnotprovenon-inferiority)

N=99

12months:

189PAE

65TURP

PAECOMPARATIVESTUDIES

•GaoRCT– ChineseStudy•Carnevale – notadequatelypowered•Abt RCT– didnotprovenoninferiority•UKROPE– didnotprovenoninferiority

APRIL2018PAEINCLUDEDINNICEGUIDELINES

PAEAPPROVEDBYNHSASSOC

AUAGUIDELINES– SEPT19

PAEisnotrecommendedforthetreatmentofLUTS/BPHoutside thecontextofa

clinical trial (ExpertOpinion).Given the heterogeneity in the literature—and concerns regarding radiation exposure, post-embolization syndrome, vascular access, technical feasibility, and quality control at lower volume centers—it is the opinion of the Panel that PAE should only be performed in the context of a clinical trial until sufficient evidence from rigorously performed studies is available to indicate definitive clinical benefit. The Panel recommends trials involve multi-disciplinary teams of urologists and radiologists; and that, as with other MIST therapies, RCTs comparing PAE to sham be considered to account for significant placebo effects.

https://www.auajournals.org/doi/full/10.1097/JU.0000000000000319

Thepanelincludedinterventionalradiologists,urologists,SIRFoundationleadership,and

industryrepresentatives

PAECOMPARATIVESTUDIES

•GaoRCT– ChineseStudy•Carnevale – notadequatelypowered•Abt RCT– didnotprovenoninferiority•UKROPE– didnotprovenoninferiority• SHAMRCT– excellentstudybutrecent

PATHWAYTORXOFCHOICE?

LEVELIEVIDENCE– RCT– SHAM /TURP/OP/

HOLeP

DURABILITY–LARGESCALEREGISTRY

UROLOGIST/COLLABORATION /

SIR-AUAACCESSTOPATIENTS

PAE

2022

PAE

The new paradigm for Surgical Therapy for BPH World?

Tolerability

Effective

THANKYOU