Reply from Authors re: Urs E. Studer, Laurence Collette. Robot-Assisted Cystectomy: Does It Meet Expectations? Eur Urol 2010;58:203–4

Reply from Authors re: Urs E. Studer, Laurence Collette. Robot-Assisted Cystectomy: Does It Meet Expectations? Eur Urol 2010;58:203–4

204 EUROPEAN UROLOGY 58 (2010) 203–206 selection criteria and/or the surgical technique be refined to obtain at least the same oncologic safety as w...

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EUROPEAN UROLOGY 58 (2010) 203–206

selection criteria and/or the surgical technique be refined to obtain at least the same oncologic safety as with open surgery. Another point of concern is that only 25% of all patients undergoing RARC received an orthotopic bladder substitute. In a selected group of patients such as this, one would expect only about half of patients to receive an ileal conduit. Furthermore, no information is given about the postoperative potency or continence rate in the patients receiving orthotopic bladder substitutes. If nerve sparing cannot be attempted on at least one side, the nocturnal continence rate would be rather poor [3,4]. Furthermore, because the urinary diversion was usually performed extracorporeally, the devascularized ureters had to be left long, and an increased stricture rate is to be expected. Such outcome data, affecting patients for the rest of their lives, are more important than the length of the scar or the time to first bowel movement. The pooled data of 495 patients who underwent RARC are extremely valuable but also put the urologic community in a very unpleasant situation. If we are no longer sure that the oncologic results and perhaps even the functional results with RARC are at least as good as those with open cystectomy, we must ask whether we are still allowed, especially from an ethical point of view, to further expose patients who undergo RARC to possibly increased risks both in terms of oncologic safety and quality of life. It is legitimate for patients to expect that results obtained with novel techniques be at least as good as those obtained with established techniques from the very beginning. In the present instance, this means that the results with RARC should match those from open radical cystectomy combined with extended pelvic

lymph node dissection and, if possible, a well-functioning continent urinary diversion. The members of the International Robotic Cystectomy Consortium must be commended for the frank reporting of their results, although some are worrisome. In doing so candidly, they remind us that new surgical techniques or technologies, such as those for cystoprostatectomy, should only be accepted (and paid for by the health care providers) as alternatives to standard treatment if efficacy has been proven by at least one prospective randomized trial that is sufficiently powered to show at least equivalence to the current standard of treatment. Conflicts of interest: The authors have nothing to disclose.

References [1] Hayn MH, Hussain A, Mansour A, et al. The learning curve of robotassisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol 2010;58:197–202. [2] Herr H, Lee C, Chang S, Lerner S. Standardization of radical cystectomy and pelvic lymph node dissection for bladder cancer: a collaborative group report. J Urol 2004;171:1823–8. [3] Burkhard FC, Kessler TM, Fleischmann A, Thalmann GN, Schumacher M, Studer UE. Nerve sparing open radical retropubic prostatectomy— does it have an impact on urinary continence? J Urol 2006;176: 189–95. [4] Ong CH, Schmitt M, Thalmann GN, Studer UE. Individualized seminal vesicle sparing cystoprostatectomy combined with ileal orthotopic bladder substitution achieves good functional results. J Urol 2010;183:1337–41. doi:10.1016/j.eururo.2010.05.039

Platinum Priority Reply from Authors re: Urs E. Studer, Laurence Collette. Robot-Assisted Cystectomy: Does It Meet Expectations? Eur Urol 2010;58:203–4 Matthew H. Hayn a, Abid Hussain a, Ahmed M. Mansour a, Paul E. Andrews b, Paul Carpentier h, Erik Castle b, Prokar Dasgupta d, Peter Rimington d, Raju Thomas c, Shamim Khan d, Adam Kibel e, Hyung Kim o, Murugesan Manoharan f, Mani Menon g, Alex Mottrie h, David Ornstein i, James Peabody g, Raj Pruthi j, Joan Palou Redorta k, Lee Richstone l, Francis Schanne m, Hans Stricker g, Peter Wiklund n, Rameela Chandrasekhar a, Greg E. Wilding a, Khurshid A. Guru a,* a

Department of Urologic Oncology, Roswell Park Cancer Institute, Buffalo, New York, USA b Mayo Clinic, Phoenix, Arizona, USA c Department of Urologic Oncology, Tulane University, New Orleans, Louisiana, USA d Department of Urologic Oncology, Guy’s Hospital, King’s College, London, England e Department of Urologic Oncology, Washington University, St. Louis, Missouri, USA f Department of Urologic Oncology, University of Miami, Miami, Florida, USA

g

Henry Ford Health System, Detroit, Michigan, USA Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium i Department of Urologic Oncology, Vanguard Urologic Institute, Houston, Texas, USA j Department of Urologic Oncology, University of North Carolina, Chapel Hill, North Carolina, USA k Fundacio Puigvert, Barcelona, Spain l Arthur Smith Institute for Urology, Long Island, New York, USA m Urologic Surgical Associates of Delaware, Wilmington, Delaware, USA n Karoliniska University, Stockholm, Sweden o Cedars-Sinai Medical Center, Los Angeles, California, USA h

We appreciate the opportunity to publish our study, which provides timely information on the learning curve associated with robot-assisted radical cystectomy (RARC) [1]. We also welcome the editorial comments from Drs. Studer and Collette [2]. Incorporating a novel surgical DOIs of original articles: 10.1016/j.eururo.2010.04.024, 10.1016/j.eururo.2010.05.039 * Corresponding author. Department of Urologic Oncology, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, USA. Tel. +1 716 845 3389; Fax: +1 716 845 3300. E-mail address: [email protected] (K.A. Guru).

EUROPEAN UROLOGY 58 (2010) 203–206

approach into a urology practice can be challenging. Accurate assessment of the challenge is difficult due to various factors including influence of baseline surgical experience, variability of surgeon ability, and differences in patient selection. The introduction of RARC represents an incremental progression from robot-assisted radical prostatectomy (RARP). Several issues raised in Studer and Collette’s editorial [2] need to be addressed. The current operative principles of open radical cystectomy (ORC) have evolved over the past century. Do we really know what the learning curve looks like for ORC? In fact, initial mortality rates with ORC approached 35% [3]. The first reported RARC was performed only 8 yr ago [4]. Learning curves exist in any operation, and there have clearly been improvements in ORC and urinary diversion over the previous half century. It is possible that even the large number of cases required to master RARC is really no different than the number required to master ORC. As stated in the editorial [2], all surgeons in the International Robotic Cystectomy Consortium (IRCC) series had some prior RARP experience, ranging from <50 to >1000 cases [1]. Although intuitively one would think that increased RARP experience would lead to improved outcomes at RARC, this was not borne out in separate analyses [5]. Surgical outcomes, such as estimated blood loss, operative time, and lymph node yields, improved for surgeons who had performed <50 prior RARPs and 50–100 RARPs, but additional prior RARP experience did not further improve RARC outcomes [5]. The IRCC agrees that ‘‘novice’’ robotic surgeons should probably not be performing RARC; however, it is not necessary to have thousands of prior robotic cases to become initially proficient at RARC. Given the multi-institutional and international scope of the IRCC, it was impossible to quantify the influence of patient selection separately from the individual institutions and surgeons. Studer and Collette raise the issue that only 36% of the patients had pT3/T4 disease, which they infer is secondary to patient selection [2]. Extravesical disease in the IRCC cohort, however, is no different than large ORC series in which the rates of pT3/T4 disease ranged from 33% to 45% [6,7]. The median age and prior comorbidities reported in our series were also similar to ORC series. Urinary diversion and functional outcomes were not addressed in this initial report from the IRCC. Even in the setting of extracorporeal diversion, dissection and preservation of well-vascularized ureters of adequate length are facilitated by the enhanced vision and magnification allowed by the robot. The ability to cut the ureter short to allow for anastomosis to an afferent isoperistaltic ileal segment, as described by Studer et al. [8], has been controversial so far. However, the incidence of stricture using the Studer technique is similar to ORC series that utilize the entire length of ureter for urinary diversion [9–11]. In addition, types and methods for robot-assisted intracorporeal urinary diversion are evolving and use minimum manipulation of the ureters [12,13]. These techniques should largely eliminate the need for extensive ureteral

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mobilization for urinary diversion. Long-term follow-up for functional outcomes and the need for secondary procedures in patients who undergo RARC are still needed to address this issue. The concerns regarding soft tissue surgical margins are valid and perhaps are the single most important aspect in invasive bladder cancer surgery. A positive margin is, in essence, a death sentence for the patient. Without dwelling on older data, a recent multicenter ORC series evaluated 4400 patients treated at 12 academic institutions from 1980 to 2008 (40% treated from 1990 to 2000 and 47% treated after 2000) [7]. The group demonstrated an overall soft tissue surgical margin rate of 6.3%, with a 12.3% positive margin rate in pT3/T4 disease. Despite their impressive numbers (approximately 368 cases per institution), the margin rates did not differ significantly from those seen by our group (7% overall and 16% in patients with pT3/T4 disease), which averaged 35 cases per institution [1]. Other IRCC operative parameters, including lymph node yield, blood loss, and operative times, are also similar to ORC series. We agree with the plea for a randomized multiinstitutional trials examining open versus robot-assisted radical cystectomy. Until such a trial is completed, however, patients should be offered all options. Is it ethical to withhold such information? Our retrospective analysis creates the framework for offering patients all available options. In conclusion, history is repeating itself! It was not long ago that laparoscopic nephrectomy, shock wave lithotripsy, and percutaneous stone extraction were considered experimental. Surgeons who perform both open and robotassisted cystectomies will agree that robot-assisted surgery can reproduce the maneuvers performed in an open fashion. The question is how difficult it is to teach a surgeon to perform these maneuvers. Our paper attempts to address this question [1]. Conflicts of interest: Kibel is affiliated with Sonofi Adventis, Spectrum, and Envisioneering. Kim is affiliated with Pfizer. Ornstein is affiliated with Correlogies. Peabody is affiliated with Intuitive Surgical. Pruthi is affiliated with GTX. Thomas is affiliated with Gulf South Lithotripsy, Olympus, and Intuitive Surgical. Guru is affiliated with Intuitive Surgical and Simulated Surgical Systems.

References [1] Hayn MH, Hussain A, Mansour AM, et al. The learning curve of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol 2010;58:197–202. [2] Studer UE, Collette L. Robot-assisted cystectomy: does it meet expectations? Eur Urol 2010;58:203–4. [3] Hinman F. The technique and late results of ureterointestinal implantation and cystectomy for cancer of the bladder. Int Soc Urol Rep 1939;7:464–524. [4] Menon M, Hemal AK, Tewari A, et al. Nerve-sparing robot-assisted radical cystoprostatectomy and urinary diversion. BJU Int 2003;92: 232–6. [5] Hayn MH, Hellenthal NJ, Hussain A, et al. Does prior robot-assisted radical prostatectomy experience affect outcomes at robot-assisted radical cystectomy? Results from the International Robotic Cystectomy Consortium. Urology. In press.

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[6] Hautmann RE, Gschwend JE, de Petriconi RC, Kron M, Volkmer BG.

[10] Hautmann RE, de Petriconi R, Gottfried HW, Kleinschmidt K,

Cystectomy for transitional cell carcinoma of the bladder: results of

Mattes R, Paiss T. The ileal neobladder: complications and functional

a surgery only series in the neobladder era. J Urol 2006;176:486–

results in 363 patients after 11 years of followup. J Urol 1999;161:

92, discussion 491–2.

422–7, discussion 427–8.

[7] Novara G, Svatek RS, Karakiewicz PI, et al. Soft tissue surgical

[11] Abol-Enein H, Ghoneim MA. Functional results of orthotopic ileal

margin status is a powerful predictor of outcomes after radical

neobladder with serous-lined extramural ureteral reimplantation:

cystectomy: a multicenter study of more than 4,400 patients. J Urol 2010;183:2165–70. [8] Studer UE, Ackermann D, Casanova GA, Zingg EJ. Three years’ experience with an ileal low pressure bladder substitute. Br J Urol 1989;63:43–52. [9] Thoeny HC, Sonnenschein MJ, Madersbacher S, Vock P, Studer UE. Is

experience with 450 patients. J Urol 2001;165:1427–32. [12] Guru K, Seixas-Mikelus SA, Hussain A, et al. Robot-assisted intracorporeal ileal conduit: marionette technique and initial experience at Roswell Park Cancer Institute. Urology. In press. [13] Pruthi RS, Nix J, McRackan D, et al. Robotic-assisted laparoscopic intracorporeal urinary diversion. Eur Urol 2010;57:1013–21.

ileal orthotopic bladder substitution with an afferent tubular segment detrimental to the upper urinary tract in the long term? J Urol 2002;168:2030–4, discussion 2034.

doi:10.1016/j.eururo.2010.06.021