shivank bhatia m.d. · 2016 197men prostate size 30 to 80 cc were randomized 2:1 between thermal...
TRANSCRIPT
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PROSTATEARTERYEMBOLIZATION:ISTHEREAPATHTOTREATMENTOFCHOICE?
SHIVANKBHATIAM.D.CHAIRMAN
DEPARTMENTOFINTERVENTIONALRADIOLOGYASSOCIATEPROFESSOR,INTERVENTIONALRADIOLOGYANDUROLOGY
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FacultyDisclosuresShivank Bhatia:Consultant– Embolx,Mentice,MeritMedical;Speakers’Bureau– Mentice,MeritMedical,Siemens,Terumo
Brandnamesareincludedinthispresentationforparticipantclarificationpurposesonly.Noproductpromotionshouldbeinferred.
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PATHWAYTOTREATMENTOFCHOICE–AUAGUIDELINES
• LEVELIEVIDENCE– RCTSHAM/TURPOP/HOLeP
• SAFETY/DURABILITY- REGISTRY
• UROLOGIST– COLLABORATION
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IPSSSCORE/QOL
QMAX/PVR
PROSTATEVOLUME
RETREATMENTRATES
SEXUALFUNCTION
PSA
LUTSOUTCOMEMEASURES
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IPSSSCORE
ReductionofIPSSscorebynumberofpoints–Mean/median
PercentageReductionInIPSSScores
StatisticallySignificantChange
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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
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AUAGUIDELINES2010/2014
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COMMONPROCEDURESFORPROSTATE<80GM
TURP/ bipolar TURP PVP- “greenlight” TUVP- button electrode
Common issue- high rate of retrograde ejaculation !
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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
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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
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Proceduresforlargeprostate>80g
SimpleProstatectomy
• Modalities• Open• Laparoscopic/Robotic
Endoscopicenucleation• Holmiumlaser- HoLEP• Thuliumlaser- ThuLEP
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AUAGUIDELINES2018
UROLIFT,REZUM,AQUABLATION
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EJACULATIONPRESERVINGMIS
Prerequisite- prostate < 80 gm
Water vapor thermal therapy: REZUM Prostatic urethral lift : Urolift
Prerequisite- prostate < 80 gm & absence of median lobe
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UROLIFT– PATHWAYTOGUIDELINES5YEAROUTCOMES
UROLIFTVSSHAM– 201PTS– 2:1RANDOMIZATIONIPSS improvement afterPULwas88%greaterthanthatofSHAM at3months.
ImprovementinIPSS,QOLandQmax weredurablethrough5yearswithimprovementsof36%,50%and44%respectively.
Surgicalretreatmentwas13.6%over5years.
Sexualfunctionwasstableover5yearswithnodenovo,sustainederectileorejaculatorydysfunction.
142016
80PTS
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2016
197menProstatesize30to80ccwererandomized2:1betweenthermaltherapywiththeRezūm®Systemandcontrol.
ThermaltherapyandcontrolIPSSwasreducedby11.2± 7.6and4.3± 6.9respectively(p
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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
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MIST:MICROWAVE,UROLIFT,REZUM,AQUABLATION
Inofficeprocedure
Qmax– 50percent
InferioroutcomestoTURP(40-50%IPSSreduction– 8-12POINTS)(EXCEPTAQUABLATION)
EbbingJ.Curr Opin Uro 2014;24:1
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J- UROLOGYEDITORIALSONMIST• Datasometimesappeartobebetterthanwhatweexperienceinreal-lifepractice.
• Real-lifeexperiencewiththesetechniquesintheurologicalcommunityhasnotbeenaswellreceived.
• WhileMITsprocedureshavelessmorbidity,formanypatientsefficacyisnotasgoodaswithTURP andforsome,itisatbestmarginal.However,formanypatientsagoodresultisgoodenough.
• ThereshouldbeahealthydoseofskepticismaboutallMITs. ThebottomlineisthatduringthenextfewyearswewillbeinundatedwithavarietyofnewMITs,mostwillhaveintermediateresults,anddurabilitywillbequestionedandbelargelydrivenbyreimbursement.
• Let’snotbecomecapturedbytechnologiesthatarelookingforindications!
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PAECOMPARATIVESTUDIES
•GaoRCT- China- 2014– TURP– Radiology•Carnevale etal- Brazil– 2015– TURP- CVIR•Abt RCT- Switzerland- 2018– TURP– BMJ•UKROPE– 2018– TURP- BJU
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GAOETAL:RADIOLOGY2014
N=104
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22
CARNEVALEETAL:CVIR2016
N=30
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ABTETALBMJ 2018
UnderestimatedthedifficultyofbilateralPAEresultinginunderpoweredstudy
12weeksmaybeearlyforprimaryendpoint
Ejaculatorydisorder(56%)percentageissomewhatunique
Despitedesignflaws,IPSSreductionwascomparabletoTURPwithlesscomplications(althoughdidnotprovenon-inferiority)
N=99
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12months:
189PAE
65TURP
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PAECOMPARATIVESTUDIES
•GaoRCT– ChineseStudy•Carnevale – notadequatelypowered•Abt RCT– didnotprovenoninferiority•UKROPE– didnotprovenoninferiority
APRIL2018PAEINCLUDEDINNICEGUIDELINES
PAEAPPROVEDBYNHSASSOC
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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
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Thepanelincludedinterventionalradiologists,urologists,SIRFoundationleadership,and
industryrepresentatives
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PAECOMPARATIVESTUDIES
•GaoRCT– ChineseStudy•Carnevale – notadequatelypowered•Abt RCT– didnotprovenoninferiority•UKROPE– didnotprovenoninferiority• SHAMRCT– excellentstudybutrecent
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PATHWAYTORXOFCHOICE?
LEVELIEVIDENCE– RCT– SHAM /TURP/OP/
HOLeP
DURABILITY–LARGESCALEREGISTRY
UROLOGIST/COLLABORATION /
SIR-AUAACCESSTOPATIENTS
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PAE
2022
PAE
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The new paradigm for Surgical Therapy for BPH World?
Tolerability
Effective
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THANKYOU