La chirurgia robotica della prostata e del rene. Moderatore: C. Terrone Pianist: A. Cestari, B. Rocco Shooter: L. Da Pozzo, M.

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1 La chirurgia robotica della prostata e del rene Moderatore: C. Terrone Pianist: A. Cestari, B. Rocco Shooter: L. Da Pozzo, M. Maffezzini Milano, 30 Novembre 2012

2 La chirurgia robotica del rene Pianist A. Cestari Milano, 30 Novembre 2012

3 ROBOTIC IN ONCOLOGIC RENAL SURGERY THE PIANIST Andrea Cestari San Raffaele Turro Hospital Vita-Salute San Raffaele University Milano

4 BUT..

5 NEPHRON-SPARING SURGERY: WHY? IMPERATIVE ELECTIVE

6 Gold standard Largest series worldwide Long-term oncological outcomes Standardized techniques To date: the shortest ischaemia time (???) Different tumor size T1a ( 4 cm )1 T1b (4-7 cm) 2 T2 and T3 (still under investigation ) 3 Complex cases Central/Hylar tumors Solitary kidneys 4 OPEN PARTIAL NEPHRECTOMY 1 Elective nephron-sparing surgery should become standard treatment for small unilateral renal cell carcinoma: long-term survivaldata of 216 patients Becker F et al Eur Urol 2006 Feb; 49 (2); Long.term outcomes after nephron sparing surgery for renal cell carcinoma larger than 4 cm Peycelon N et al J Urol 2009 Jan; 181 (1); Oncological efficacy and safety of nephron-sparing surgery for selected patients with locally advanced renal cell carcinoma Margulis V et al BJU Int 2007; 100 (6); Open partial nephrectomy for tumor in a solitary kidney: experience with 400 cases. Fergany AF et al J Urol 2006 May; 175 (5);

7 OPEN PARTIAL NEPHRECTOMY Morbidities Blood loss Postoperative pain Long hospital stay Long convalescence Surgical scar Minimally invasive surgery Minimally invasive surgery Laparoscopic partial nephrectomy Robot-assisted partial nephrectomy

8 Robot-assisted Laparoscopic partial nephrectomy (RALPN) 1 RALPN by Gettman in 2004: more than 8 year WWW experience!!! Gill et al. J Urol. (2000 )164: Gettman et al. Urology (2004) 64:

9 ROBOT-ASSISTED PARTIAL NEPHRECTOMY:

10 ROBOTIC PARTIAL NEPHRECTOMY: NOT ONLY FOR SMALL RENAL MASSES

11 ROBOTIC PARTIAL NEPHRECTOMY: NOT ONLY FOR SMALL RENAL MASSES

12 What s in & What s new in Nephrometry 2 Warm Ischaemia time 3 Well done parameters (MIC/Trifecta) 4 Intraoperative facilities: Ultrasound/Fluorescence 5 Robotic technology is associated with increased utilization of partial nephrectomy (Patel HD J Urol in press)

13 THANK YOU FOR THE KIND ATTENTION

14 La chirurgia robotica del rene Shooter L. Da Pozzo Milano, 30 Novembre 2012

15 La chirurgia Robotica del Rene Luigi F. Da Pozzo USC Urologia Ospedali Riuniti di Bergamo

16 Yu H, J Urol 2012

17 Hua-yin, J Urol 2012

18 - Robotic radical nephrectomy is a safe, feasible and effective for performing radical nephrectomy - No outstanding benefits of RRN observed over Laparoscopic radical nephrectomy Hemal A J Urol 2009

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20 46,396 patients Patel J Urol 2012

21 TRENDS IN RENAL SURGERY: ROBOTIC TECHNOLOGY IS ASSOCIATED WITH INCREASED UTILIZATION OF PARTIAL NEPHRECTOMY Patel H, J Urol 2012

22 Patel H J Urol 2012

23 Hung A., J Urol 2013

24 Current status of robot-assisted Partial Nephrectomy 2,57 cm Cha E., BJUint 2011

25 - Radical Nephrectomy: a non robotic procedure! - Is robotic partial nephrectomy to be reserved in hyperspecialized centres and for selected cases? - LPN could be considered a cheaper, minimally invasive alternative to RAPN in high-volume centers with skills in laparoscopy and in which the da Vinci robot is not yet available - Is robotic partial nephrectomy economically sustainable?

26 - LPN could be considered a cheaper, minimally invasive alternative to RAPN in high-volume centers with skills in laparoscopy and in which the da Vinci robot is not yet available - Until more definitive prospective evidence is available decision making regarding the optimal approach will be determined by individual patient and surgeon preference

27 La chirurgia robotica della prostata Pianist B. Rocco Milano, 30 Novembre 2012

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29 Procedure robotiche In Italia, nel 2011 si sono effettuati circa 7000 interventi Incremento del 47% rispetto al % 3% 20% 15% 58% Urologia Ginecologia Chirurgia generale Otorinolaringoiatria Cardio/toracica

30 Total RARP RRP Lowrance WT et al, J Urol, 2012

31 Is robotic surgery growth only marketing driven?

32 RARP vs. RRP Perioperative Outcomes Oncological outcomes Functional outcomes

33 RARP vs. RRP Perioperative Outcomes

34 Blood Transfusion Rates Novara et al, Eur Urol, 2012

35 Trinh et al, Eur Urol, 2012

36 RARP vs. RRP Oncological outcomes

37 Overall PSM rates Novara et al, Eur Urol, 2012

38 Resultados Oncológicos - BCR RALP vs. RRP Surgical approach was not a significant predictor of biochemical recurrence in the multivariate model Barocas et al, J Urol, 2010

39 RARP vs. RRP Functional Outcomes

40 Continence- RARP vs. RRP Ficarra et al, Eur Urol, 2012

41 Potency RARP vs. PRR Cumulative analyses of 12-mo potency rates Ficarra et al, Eur Urol, 2012

42 Poor accrual, which leads to underpowered studies Refusal of randomization by patients - they may already have chosen their surgeon or have a preference for a given approach Blinding of surgeons, patients and the party assessing the measured outcome usually impractical The difficulty of controlling for the disparities in skill and experience between surgeons and centers. The generalizability of these trial s findings is limited: studies comparing outcomes of surgical techniques are merely a comparison of different surgeons performances Toujier K, Eur Urol, 2012

43 The robot will not transform a bad surgeon into a good one...but it helps high-volume surgeons to further improve their outcomes and ultimately shorten the learning curve for surgeons in training. Cooperberg QC et al, JCO, 2012

44 Costs Most of the existing studies have failed to mention additional costs associated with treatment of perioperative complications, hospital readmission and long term complications (ED, incont) If robotic surgery were to yield better quality of life, this can have an impact on cost per quality of life; this may be of little importance to direct hospital costs, it is highly relevant to society as a whole. A patient who returns to work sooner adds to the cost effectiveness of his mode of surgery Ahmed et al, BJU Int, 2012

45 Health Technology Assessment RALP were superior to open procedures across a range of outcomes evaluated. There is a decreased risk of positive surgical margins for pathological stage pt2 tumours superior functional outcomes (urinary continence and sexual function) reduction in peri-operative transfusion requirements. Overall lengths of stay are reduced. The robot-assisted procedure is, however, associated with a longer operating time.

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47 Robotic lymphadenectomy

48 Besides being a staging procedure, pelvic LND/eLND can be curative, or at least beneficial, in a subset of patients with limited lymph node metastases Pelvic elnd remains a surgical procedure that increases morbidity in the treatment of Pca Complications consist of lymphocoeles, lymphoedema, deep venous thrombosis, and pulmonary embolism

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50 Comparison with other approaches Truesdale 2010 et al. J Endourol. 2010;24(7):

51 Comparison with other approaches Truesdale 2010 et al. J Endourol. 2010;24(7):

52 The cistectomy experience Davis JW et al. Curr Urol Rep Nov 9.

53 The cistectomy experience Davis JW et al. Curr Urol Rep Nov 9.

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55 Hu et al, JAMA, 2009

56 Limitations MIRP- combined two very different procedures in the MIRP category (LRP and RARP) Only patients older than 65 years Nerve-sparing procedure not reported Results based only on coding of incontinence or erectile dysfunction, the definitions of these outcomes were not standardized. No difference in the rates of procedures MIRP higher expectations, higher social status. Report complications more frequently? Learning curve for RARP included in the analysis ( excluded from assessment) Observational study - Unable to adjust unknown factors

57 Our study is akin to comparing mean scores of professionally instructed golfers and/or those with >20 years of experience using vintage clubs (RRP) versus mostly self-taught beginners using high-tech clubs (MIRP). Jim C. Hu

58 Medicare data set is limited to patients 65 years of age or older, which represent a mere 35% of patients undergoing RP Medicare patients are significantly more likely to be treated by a lowvolume surgeon/hospital The majority of RARPs, which are performed in younger individuals with private insurance in high-volume centers Questions related to functional outcomes were phrased to reflect urinary and sexual bother since the time of surgery; fails to validly assess the transient nature of bother for some patients Medicare-based findings are less generalizable and only applicable to similar individuals. Thrin QC et al, JCO, 2012

59 Schroeck et al, Eur Urol, 2010

60 Patients who choose the innovative may expectations for their postoperative HRQoL have higher Duke surgeons were far more experienced with prostatectomy (learning curve for RARP included) open Urinary domain tends to improve with longer follow-up. Follow-up was 70% longer for the open cases Dissatisfaction with treatment is related to complex socioeconomic factors. (Education, affect, psychosocial functioning, and use of emotion regulation strategies) These patients may have personality types or socioeconomic characteristics that render them prone to regretting their decisions Menon et al, Eur Urol, 2010

61 Diffusione capillare o centri di riferimento? IRCCS: Modello adeguato per le nuove tecnologie? Su cosa basare una strategia di allocazione razionale? - geografica? - economica? - H index? - Volumi chirurgici?

62 Urologia e robotica Lombardia (26%), Toscana (15%), Lazio (11%), Veneto (9%) sono le regioni con la maggiore concentrazione di sistemi robotici, seguite da Puglia (6%) e Piemonte (6%)

63 Urologia e robotica Tra le regioni più attive, Lombardia, Veneto, Toscana e Lazio si distinguono per l elevata casistica di interventi urologi eseguiti con sistema robotico davinci 40% 35% 30% 25% 20% 15% 10% 5% 0% Emilia Romagna Lazio Liguria Lombardia Piemonte Puglia Toscana Valle d'aosta Veneto

64 La mobilità ospedaliera La mobilità ospedaliera fra regioni è un fenomeno che resta rilevante: nel 2008, le regioni sono state interessate da circa 650 mila ricoveri ospedalieri di pazienti non residenti (immigrazione ospedaliera) e da oltre 570 mila ricoveri effettuati dai pazienti in una regione diversa da quella di residenza (emigrazione ospedaliera) ISTAT 2011 le regioni con un flusso di emigrazione piuttosto consistente rispetto ai ricoveri effettuati dai propri residenti sono state la Calabria (16,1) e l Abruzzo (14,2).

65 Urologia e robotica Lombardia (26%), Toscana Lombardia (26%), Toscana (15%), Lazio (11%), Veneto (15%), Lazio (11%), Veneto (9%) sono le regioni con la (9%) sono le regioni con la maggiore concentrazione di maggiore concentrazione di sistemi robotici, seguite da sistemi robotici, seguite da Puglia (6%) e Piemonte (6%) Puglia (6%) e Piemonte (6%)

66 La chirurgia robotica della prostata Shooter M. Maffezzini Milano, 30 Novembre 2012

67 HOT TOPICS IN PROSTATE CANCER ACTIVE SURVEILLANCE FOR LOW RISK PROSTATE CANCER RADICALE PROSTATECTOMY FOR HIGH RISK PROSTATE CANCER ROBOT ASSITED RADICAL PROSTATECTOMY

68 CANCER SPECIFIC MORTALITY Low Intermediate High Prostate Cancer Risk Cooperberg et al. Cancer 2010

69 GS 8 GS 8 GS = 7 GS = 7 GS = 6 GS = 6 Vickers et al. Eur Urol 2012

70 DISTRIBUZIONE DELLE METASTASI LINFONODALI NEL CARCINOMA PROSTATICO 9-15% 16-40% % 49-58% >70% Burkhard F, Studer UE World J Urol 26:231-36,2008 Heidenreich A et al J Urol, 167: , 2002

71 PREVALENZA DI METASTASI LINFONODALI IN RAPPORTO ALL ESTENSIONE DELLA LINFOADENECTOMIA E ALLA CLASSE DI RISCHIO Estensione PLND Media di linfonodi rimossi Gruppoa basso rischio (ct1c, PSA<10, Gleason 6) Gruppoa rischio intermedio (Gleason 7 o PSA 10-20, ct2) Gruppoad alto rischio (ct3 o Gleason 8-10 or PSA>20) Bhatta-Dar et al, 2004 Limitata NA 0.5% - - Makarov et al, 2006 Limitata % - - Kawakami et al, 2006 Limitata % 2% 7% Yossepowich et al Limitata NA 4% 3% 12% Heidenreich et al, 2008 Estesa % 20% 55% Studer U et al, 2008 Estesa 20 3% - - Briganti A et al, 2009 Estesa % 8.2% 33.7% Weckermann et al,2006 Estesa NA 7% - - Heidenreich et al, 2010 Estesa % - -

72 IMPORTANZA DELL ESTENSIONE DELL INVASIONE LINFONODALE NEI PAZIENTI N+ TRATTATI CON TERAPIE ADIUVANTI Roehl et al, J Urol172 : , 2004

73 703 pts. Briganti A, Karnes JR, Da Pozzo LF et al Eur Urol, 55: , 2009

74 von Bodman et al. J Urol 2010, 184:

75 Media di linfonodi rimossi: prima del 1989, 5.3 dal 2001 al 2005 PAZIENTI AD ALTO RISCHIO: 6.7 Abdollah et al, Eur Urol, 2010

76 Feifer et al, Cancer 2011

77 ROBOT-ASSISTED RADICAL PROSTATECTOMY LOW RISK PROSTATE CANCER: GOLD STANDARD OR ALTERNATIVE TO ACTIVE SURVEILLANCE? HIGH (INTERMEDIATE) RISK PROSTATE CANCER: GOLD STANDARD OR ALTERNATIVE TO OPEN RP WITH EXTENDED LYMPHADENECTOMY?