Disclosure*

Faculty*ERUS2014*– Travel fee, registration and hotel

Proctor*Intuitive*Surgery*– Cystectomy, intracorporeal diversion – Prostatectomy ! NO STOCKS

*

Businesscase**

*

Cost*effectiveness*

*

Healthcare*systems**

*

*

What*is*Return*Of*Investment?*

For*example:*

*

250*RARP*/year*

Operational+Costs+–  Charge Off 5 years

*

Xi*system* *€*1.800.000*

Maintenance *€*****150.000*/*year*(R1)*

Other*costs *€*****100.000**

Total + +€+2.500.000++Per*year * *€*****500.000*(excl*tax)*

*

Costs*instruments*/*procedure*

Prostatectomy € 1.310 Nephrectomy € 1.090 Partial Nephrectomy € 1.310 Sacrocolpopexy € 1.310 Cystectomy € 1.550 Pyeloplasty € 1.090

Accessorykit : € 314,60 Hot Shears : € 387,20 Maryland Bipolair : € 326,70 Needle driver : € 266,20 Prograsp : € 266,20 Tip cover : € 24 Suction : € 35 Trocar 15 : € 30 Bladeless trocar 12 : € 53 Trocar 5 : € 53 Drain : € 42

Total ca.: € 2.000 /procedure

RARP!

Costs+250+RARP+/+year+*R*Operational*costs* *:********** *€****500.000*

*R*Instruments/disposables*:********** *€****500.000***

*R*extra*costs*(clips*etc) *:********** *€******40.000*

*R*staff * * *: *€****400.000*

*R*overhead*hospital *: *€****400.000 **

*****

Total*Costs * *€+1.840.000++*

Revenu*

€+8.000++x*250*RARP*

=*****

€+2.000.000+*

€ 2.000.000!€ 1.840.000!

Break Even!

LAPAROSCOPY!

Costs*Laparoscopy*(250*cases)*

***

*R*video/scoop(5*yr)** *:*€****20.000*

*R*maintenance * *:*€****20.000*

*R*disposables * **:*€**100.000*

*R*other*costs * *:*€****10.000*

*R*staff * * *:*€*400.000*

*R*overhead*hospital *:*€*400.000*

Total *** *:*€*950.000*

Costs*laparoscopy *:*€*950.000*+Revenu+

250*prostatectomy*x*€*8.000* *=*€*2.000.000*

Cost*effectiveness?*

*

Difference**

robot*–*laparoscopy**

around**

*€*1.000.000*

Savings++Hospitalisation * * *€*350*/*day*

Packed*Cells*(1) * * *€*300*

Nutrition*(iv) * * *€*250*/*day*

Intensive*Care * * *€*2.000*/*day*

Scrub*nurse * * *€*40*/*hour*

ORRtime * * * *€*11*/*minute*

*

*

*ICER*2009*(Institut*for*Clinical*and*Economic*Review);*active*surveillance*&*radical*prostatectomy*for*the*management*of*low*risk,*clinicallyRlocalized*prostate*cancer*(Estimate*on*cost*of*major*complications*for*open*prostatectomy;*based*on*CMS*national*payment*rates).*

Carlsson+et+al,+UROLOGY+75+(5),+2010++*

Major*complication*prostatectomy***

costs:*€+13+385++

Savings+/+complications+Stricture*operation* *€*5000*

*

Incontinence*

*Male*Sling * *€*2500*excl*OR*

*AMS * * *€*5000*excl*OR**

*

*

Platinum Priority – Review – Prostate CancerEditorial by Quoc-Dien Trinh, Khurshid R. Ghani and Mani Menon on pp. 16–18 of this issue

Positive Surgical Margin and Perioperative Complication Rates ofPrimary Surgical Treatments for Prostate Cancer: A SystematicReview and Meta-Analysis Comparing Retropubic, Laparoscopic,and Robotic Prostatectomy

Ashutosh Tewari a,*, Prasanna Sooriakumaran a,b, Daniel A. Bloch c, Usha Seshadri-Kreaden d,April E. Hebert d, Peter Wiklund b

a Institute of Prostate Cancer and LeFrak Center for Robotic Surgery, James Buchanan Brady Foundation Department of Urology, Weill Cornell Medical

College–New York Presbyterian Hospital, New York, NY, USA; b Department of Molecular Medicine and Surgery, Karolinska University Hospital, Solna,

Sweden; c Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA; d Department of Clinical Affairs, Intuitive

Surgical Inc., Sunnyvale, CA, USA

E U R O P E A N U R O L O G Y 6 2 ( 2 0 1 2 ) 1 – 1 5

ava i lable at www.sciencedirect .com

journal homepage: www.europeanurology.com

Article info

Article history:Accepted February 14, 2012Published online ahead ofprint on February 24, 2012

Keywords:RoboticsLaparoscopyRetropubicProstatectomyComplicationsProstate cancerMargins

Please visitwww.eu-acme.org/europeanurology to read andanswer questions on-line.The EU-ACME credits willthen be attributedautomatically.

Abstract

Context: Radical prostatectomy (RP) approaches have rarely been compared adequatelywith regard to margin and perioperative complication rates.Objective: Review the literature from 2002 to 2010 and compare margin and perioper-ative complication rates for open retropubic RP (ORP), laparoscopic RP (LRP), and robot-assisted LRP (RALP).Evidence acquisition: Summary data were abstracted from 400 original research articlesrepresenting 167 184 ORP, 57 303 LRP, and 62 389 RALP patients (total: 286 876). Articleswere found through PubMed and Scopus searches and met a priori inclusion criteria (eg,surgery after 1990, reporting margin rates and/or perioperative complications, study size>25cases).Theprimaryoutcomeswerepositivesurgicalmargin(PSM)rates,aswellastotalintra- and perioperative complication rates. Secondary outcomes included blood loss,transfusions, conversions, length of hospital stay, and rates for specific individual compli-cations. Weighted averages were compared for eachoutcome using propensity adjustment.Evidence synthesis: After propensity adjustment, the LRP group had higher positivesurgical margin rates than the RALP group but similar rates to the ORP group. LRP andRALP showed significantly lower blood loss and transfusions, and a shorter length ofhospital stay than the ORP group. Total perioperative complication rates were higher forORP and LRP than for RALP. Total intraoperative complication rates were low for allmodalities but lowest for RALP. Rates for readmission, reoperation, nerve, ureteral, andrectal injury, deep vein thrombosis, pneumonia, hematoma, lymphocele, anastomoticleak, fistula, and wound infection showed significant differences between groups,generally favoring RALP. The lack of randomized controlled trials, use of margin statusas an indicator of oncologic control, and inability to perform cost comparisons arelimitations of this study.Conclusions: This meta-analysis demonstrates that RALP is at least equivalent to ORP orLRP in terms of margin rates and suggests that RALP provides certain advantages,especially regarding decreased adverse events.# 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

* Corresponding author. Institute of Prostate Cancer and LeFrak Center for Robotic Surgery, JamesBuchanan Brady Foundation Department of Urology, Weill Cornell Medical College–New YorkPresbyterian Hospital, 525 East 68th Street, Box 94, New York, NY 10065, USA. Tel. +1 212 746 9343.E-mail address: ashtewarimd@gmail.com (A. Tewari).

0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2012.02.029

Laparoscopy and Robotics

Surgery-related Complications in1253 Robot-assisted and 485 OpenRetropubic Radical Prostatectomies atthe Karolinska University Hospital, SwedenStefan Carlsson, Andreas E. Nilsson, Martin C. Schumacher, Martin N. Jonsson,Daniela S. Volz, Gunnar Steineck, and Peter N. Wiklund

OBJECTIVES To quantify complications to surgery in patients treated with robot-assisted radical prostatectomy(RARP) and open retropubic radical prostatectomy (RRP) at our institution. Radical prostatec-tomy is associated with specific complications that can affect outcome results in patients.

METHODS Between January 2002 and August 2007, a series of 1738 consecutive patients underwent RARP(n ! 1253) or RRP (n ! 485) for clinically localized prostate cancer. Surgery-related compli-cations were assessed using a prospective hospital-based complication registry. The baselinecharacteristics of all patients were documented preoperatively.

RESULTS Overall, 170 patients required blood transfusions (9.7%), 112 patients (23%) in the RRP groupcompared with 58 patients (4.8%) in the RARP group. Infectious complications occurred in 44RRP patients (9%) compared with 18 (1%) in the RARP group. Bladder neck contracture wastreated in 22 (4.5%) patients who had undergone RRP compared with 3 (0.2%) in the RARPgroup. Clavien grade IIIb-V complications were more common in RRP patients (n ! 63; 12.9%)than in RARP patients (n ! 46; 3.7%).

CONCLUSIONS The introduction of RARP at our institution has resulted in decreased number of patients withClavien grade IIIb-V complications, such as bladder neck contractures, a decrease in the numberof patients who require blood transfusions, and decreased numbers of patients with postoperativewound infections. UROLOGY 75: 1092–1099, 2010. © 2010 Elsevier Inc.

Only some decades ago, retropubic radical prosta-tectomy (RRP) was considered a surgical proce-dure associated with significant morbidity.1 The

pioneering work by Walsh and Donker2 that led to abetter understanding of the anatomy of the prostate, andconsequently to modification of surgical technique, hasalso made possible better hemostasis, improved visualiza-tion during dissection, and preservation of neurovascularbundles supplying corpora cavernosa. Since the introduc-tion of laparoscopic and later robot-assisted radical pros-tatectomy (RARP), numerous articles have been pub-lished comparing the outcome of these new techniqueswith the RRP.3 To date, no clear differences regardingcancer control and functional results, such as continenceand potency, have been reported between the minimally

invasive techniques and RRP. Obviously, a man with anewly diagnosed prostate cancer appreciates the possibil-ity of being free from prostate cancer while also beingable to avoid being affected by urinary leakage and erec-tile dysfunction after his radical prostatectomy. However,all complications from surgery must be considered whenchoosing treatment modalities, as they can affect thepatient’s short- and long-term health as well as haveeconomic consequences. The objective of the presentstudy was to quantify complications to surgery in a con-secutive series of 1738 patients treated with open RRPand RARP for clinically localized prostate cancer. At ourhospital we have performed RRP and RARP in parallel,using the same wards and surgical theaters.

MATERIAL AND METHODSA total of 1738 men consecutively underwent a radical prosta-tectomy at Karolinska University Hospital in Solna, Stock-holm, between January 2002 and August 2007. We collectedprospectively standard preoperative assessments including age,digital rectal examination, prostate specific antigen (PSA),Gleason score, clinical stage, and prostate volume. Nine sur-geons performed 485 RRP; 6 of these surgeons (I-VI) also

The study was supported by grants provided from the Swedish Cancer Society (4598-B01-01XAC), ALF (founding of clinical research by Stockholm County Council),and the Johanna Hagstrand and Sigfrid Linnér Foundation.

From the Section of Urology, Department of Molecular Medicine and Surgery,Karolinska Institute, Stockholm, Sweden; and Division of Clinical Cancer Epidemiol-ogy, Department of Oncology, Sahlgrenska Academy, Gothenburg, Sweden

Reprint requests: Stefan Carlsson, M.D., Ph.D., Department of Urology, Karolin-ska Hospital, 171 76 Stockholm, Sweden. E-mail: stefan.karlsson@karolinska.se

Submitted: March 7, 2009, accepted (with revisions): September 2, 2009

1092 © 2010 Elsevier Inc. 0090-4295/10/$34.00All Rights Reserved doi:10.1016/j.urology.2009.09.075

Perioperative+Outcomes+(mean)+ ORP+

P*Value*ORP*vs.*RALP* LRP+

P*Value*LRP*vs.*RALP* RALP+

Estimated*blood*loss*(ml)* 745.3* <0.0001* 377.5* <0.0001* 188*

Blood*transfusions*(%)* 16.5* <0.0001* 4.7* <0.0001* 1.8*

Conversions*to*open*(%)* n/a* n/a* 0.7* 0.11* 0.3*

Length*of*stay*(US)* 3.1* <0.0001* 2.1* <0.0001* 1.4*

Length*of*Stay*(OUS)* 9.9* <0.0001* 6.3* <0.0001* 4*

Variable/Clavien+Grade+ All++(n+=1738)++

RRP+(n+=+485)++ RARP+(n+=+1253)++

Bladder*neck*contracture*(%)/IIIb** 25*(1.4)***

22*(4.5)***

3*(0.2)***

Surgery*for*urinary*incontinence*(%)/IIIb* 18*(1,0)* 11*(2.2)** 7*(0.5)*

#ERUS14+ Ashutosh Tewari et al, EUROPEAN UROLOGY 62 (2012) 1–15 Stefan Carlsson et al, UROLOGY 75 (5), 2010 !

!

complication+ other+technique+ robot+ Price+difference+Stricture* 4.5*%* 0,2*%* €*53.750*Incontinence*OR* 2,2*%* 0,5*%* €*23.475*Major*complication* 12,9*%* 3,7*%* €*307.855*LOS* 5*days* 2*days* €*337.500*Transfusion* 16,5*%* 1,8*%** €*15.000*

Total* €*724.080*

Businesscase*250*RARP*

RARC*vs*ORC*

Author Year Technique Number Complication+Rate(%)

Shabsigh 2009 Open 1142 64 Novarra 2009 Open 358 49 Swatek 2010 Open 283 54

1.  Shabsigh, A., Korets, R., Vora, K. C. et al.: Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2009; 55: 164.

2. Novara, G., De Marco, V., Aragona, M. et al.: Complications and mortality after radical cystectomy for bladder transitional cell cancer. J Urol 2009; 182: 914.

3.  Svatek, R. S., Fisher, M. B., Matin, S. F. et al.: Risk factor analysis in a contemporary cystectomy cohort using standardized reporting methodology and adverse event criteria. J Urol 2010; 183: 929.

Example:+30+RARC+/+year+*

*

*

*

ORC:*ca.*6*Major*Complications*=*€*40.000*x*6*=*€*240.000*

RARC:*ca.*3*Major*Complications*=*€*40.000*x*3*=*€*120.000*

*

Savings:++€+120.000+

Complications+ RARC+ ORC+

Overall*CR* 35%* 57%* p=*0,001*

Major*CR* 10%* 22%* p=**0,019*

complication+ other+technique+ robot+ Price+difference+

Major*complication* 22*%* 10*%* €*120.000*

LOS* 20*days* 8*days* €*162.000*

Transfusion* 35*%* 15*%** €*3.600*

ICRunit* 1R2*days* 0R1*days* €*40.000*

Total*savings*RARC*

€*325.600*

Businesscase*30*RARC*

0*

10*

20*

30*

40*

50*

60*

70*

80*

90*

100*

ORC* sRORC* RARC*

Costs+

Robot*costs*(purchase*and*maintenance)*

TPV*and*transfusions*

Extra*surgery*materials*

Hospital*costs*nonRurological*dep.*(Intensive*care*etc)*

Hospital*costs*urology*dep.*(including*readmission)**

Single*center*retrospective*

Learning+curve+++ +1Z20+ 21Z40+ 41Z56+Age+ 66* 69* 69*

ASA+ 1,8* 1,85* 2,1*

Blood+loss+(cc)+ 225* 241* 191*

ORZtime+(min)+ 371* 341* 297*

Length+of+stay+(days)+ 15* 15* 9,9*

Parental+nutrition+(days)+ 8,1* 3,9* 1,6*

Transfusionrate+ 10%* 15%* 0%*

Clavien+≥+III+ 2*(10%)+ 4*(20)%+ 0*(0)%+

Percentage+costs+ 97,8%+ 101,7%+ 77,8%+

#ERUS14+

Learning+curve+++ +1Z20+ 21Z40+ 41Z56+Age+ 66* 69* 69*

ASA+ 1,8* 1,85* 2,1*

Blood+loss+(cc)+ 225* 241* 191*

ORZtime+(min)+ 371* 341* 297*

Length+of+stay+(days)+ 15* 15* 9,9*

Parental+nutrition+(days)+ 8,1* 3,9* 1,6*

Transfusionrate+ 10%* 15%* 0%*

Clavien+≥+III+ 2*(10%)+ 4*(20)%+ 0*(0)%+

Percentage+costs+ 97,8%+ 101,7%+ 77,8%+

#ERUS14+

Total*RARC*(30)* €*325.600*Total*RARP*(250)* €*724.080*

Total+ €+1.049.680+

Total*savings*

What*is*Return*Of*Investment?*

•  250*RARP*•  30*RARC*

‘Break*even’*

#ERUS14+

Did*not*speak*about:*

• Other*indications*

•  Shorter*learning*curve*•  Ergonomics*

• Macro*economic*costs/savings*

System*support*Intuitive*

System*support*Intuitive**

S+system*•  End*manufacturing*by*end*2014*

•  End*support*end*2018R19*(spare*parts)*•  US*regulatory*states*that*there*needs*to*be*a*5*year*

support*after*the*last*manufacturing*date*

System*support*Intuitive**

Si+system*

• No*end*of*manufacturing*date*known*yet***

• will*continue*to*be*manufactured*and*supported*

Conclusions*

•  ‘BreakREven’**– 250 RARP – 30 RARC

• CostReffectiveness*studies*wanted*

Operational*costs/year *€*500.000*

Cases/year( Costs/procedure(100( €(5.000((200( €(2.500((300( €(1.667((400( €(1.250((500( €(1.000((

Other+savings**

*

*

*

RRP (n=147) RARP (n=127) age 58 (42-63) 57.8 (43-64) LOS 3 (1-9) 1 (1-13) Sick Leave 49 (0-356) 11 (0-355)