Tuesday, August 18, 2015

Diffusion of Robotics in Urology: Responsible Introduction of Surgical Innovation

The use of robotic surgery in urology began in 2001 with the advent of robot assisted radical prostatectomy (RARP). Since then, it has diffused throughout the field, providing an alternative to the open approach in numerous urologic procedures. However, the evidence for the utility and added benefits of the robotic approach is limited and varies among procedures. Given the fact that robotic-assisted procedures cost the patient an additional $1000 and the hospital nearly $100,000 annually, it is necessary to investigate the benefits of this technology and to determine for which procedures and which patients it is worth this increased cost. Furthermore, it is critical to assess whether the early introduction of this technology is safe for patients. Not only is the data supporting the use of robotics unclear, but also, in retrospect, the introduction of robotics may have led to unfavorable patient outcomes in certain settings. This blog will serve as overview of some of the early data regarding the use of robotics in the surgical management of three index cancers and will end with a brief discussion of safety during the initial diffusion of robotic prostatectomy.
    

RADICAL PROSTATECTOMY

Most of the initial data regarding RARP came from small, retrospective, single-center studies, most of which reported less blood loss, lower rates of transfusion, shorter length of stay and fewer short term complications. A recent prospective, multi-center, controlled trial from Sweden showed that RARP was associated with 500cc less blood loss, shorter length of stay by one day, and lower rates of reoperation during the initial hospital stay [1]. Therefore, at least in the short term, there seems to be good evidence for RARP improving perioperative outcomes.

Figure 1. RARP is associated with better short-term outcomes including less blood loss, shorter length of stay, and less rates of reoperation.  From Wallerstedt, et al. [1].

Data regarding long-term outcomes are more controversial. Based on numerous studies, it is difficult to interpret whether there is any benefit or drawback to achieving the "trifecta" of oncologic control, continence, and potency with robotic assistance. A recent prospective, non-randomized study from Sweden suggests that there may be some benefit to RARP with regard to potency, but no difference for oncologic control or continence [2]. Of note, the only randomized trial that sought to investigate this was terminated due to slow patient enrollment. Therefore, some evidence points to the benefits of RARP, some to its detriment, but most suggest equivalence between open and robotic.

 

PARTIAL NEPHRECTOMY

The use of robotics in partial nephrectomy (PN) is a different story. PN is the preferred surgical management of small renal masses (when technically feasible) because of its ability to preserve kidney function (i.e. nephron-sparing) with equivalent oncologic control. Minimally invasive PN has been shown to be associated with less blood loss, shorter length of stay, faster recovery, and less post-operative pain compared to the open flank incision [3]. Within the category of minimally invasive surgery, Pierorazio et al. showed that robotic assisted partial nephrectomy (RAPN) is associated with shorter operative time, less blood loss, and shorter warm ischemia time (WIT) [4]. Regarding complications, Mullins et al. found no difference in complication rates, but when stratified by Clavien grade, the RAPN cohort was more likely to have lower grade complications [5]. A meta-analysis comparing robotic vs. laparoscopic PN found no differences in operative times, blood loss, conversion rates, complications, or length of stay. However, RAPN was associated with shorter WIT, the key to renal preservation, which ultimately is the primary goal of PN [6].

Figure 2. RAPN is associated with shorter WIT.  From Aboumarzouk, et al. [6].

Robotic technology has led to an increased use of PN, due in part to the superior range of motion that aids in tumor excision and reconstruction under ischemic time constraints. This has been shown to be a real phenomenon, with a demonstrable increase in PN compared to radical nephrectomy in the years of robotic diffusion. [7] In addition, robotics has allowed urologists to tackle more complex renal tumors, such as tumors invading the large veins of the kidney and retroperitoneum (i.e. IVC thrombectomies), intrarenal, and posterior tumors, with comparable functional outcomes and less risk of conversion to radical nephrectomy [8-10].

 

RPLND

Retroperitoneal lymph node dissection (RPLND) is a treatment option for men with stage I and select stage II nonseminomatous germ cell tumors and is particularly useful for men who want to avoid long term surveillance or chemotherapy. Laparoscopic RPLND has been shown to have comparable oncologic outcomes with superior perioperative outcomes compared to open [11, 12]. The data regarding robotic RPLND is scant due to its nascency in the field, however a recent study shows that early on, robotic RPLND is comparable to laparoscopic in terms of perioperative outcomes [13]. Given the increased cost and risk of serious complications due to the intimacy with the great vessels during this procedure, the role of robotics in RPLND remains largely unknown at this point.

 

DIFFUSION AND PATIENT SAFETY

Given the variable and unclear data, particularly regarding RARP, how did robotics diffuse so rapidly and widely among urologists? First, it is important to note that in order to introduce new technology, one only needs a 510(k) clearance from the FDA. In the case of RARP, da Vinci received FDA clearance in 2000, the first RARP was in 2001, and the first population-based outcomes study was published in 2009. So many were performing RARP blindly without any population based data on efficacy or safety. Parsons et al. sought to retrospectively investigate if there was an effect on patient safety during this diffusion period using patient safety indicators (PSI). They found that in the year before the "tipping point," a set point indicating when RARP diffused from centers of excellence to more general urologists, there was a two-fold increase in PSI [14].

Figure 3. RARP during diffusion era is associated with a two-fold increase in PSI.  From Parsons, et al. [14].

These results highlight the importance of responsibility with regards to the introduction of new technology. Is a compromise to patient safety in the initial years of dissemination necessary? Does new technology always come with risk? How do we know when to stop pursuing a given technique? When is a reasonable time to assess whether it is inferior and causing more harm than good? Was RARP even worth this increased risk given its limited utility and increased cost? Finally, is the culprit here technology, or does innovation by nature have barriers at first?

 

SUMMARY

The role of robotics in urology today raises many questions regarding comparative efficacy, cost justification, and patient safety with innovation. Radical prostatectomy and partial nephrectomy illustrate a juxtaposition of results – RAPN seems to have succeeded while RARP has yet to show a demonstrable benefit other than less blood loss. It has also raised questions about patient safety during the dissemination of new technology and bears the question, how does an innovator responsibly report results while marketing and patient demand accelerate the innovation's diffusion? Moving forward, standardized training and credentialing programs as well as systematic reporting to non-industry groups could be instituted in order to diffuse innovation while keeping the patient first.





This blog was written by Kelly Harris, a medical student at Johns Hopkins Medical School.  Kelly recently finished a four-week sub-internship at the Brady Urological Institute and gave a presentation to the department on "The Diffusion of Robotic Surgery in Urology" from which this blog is inspired. Kelly is looking forward to a career in urology.






1. Wallerstedt A, Tyritzis SI, Thorsteinsdottir T, et al. Short-term Results after Robot-assisted Laparoscopic Radical Prostatectomy Compared to Open Radical Prostatectomy. Eur Urol 2015: 67:660-70
2. Haglind E, Carlsson S, Stranne J, et al. Urinary Incontinence and Erectile Dysfunction After Robotic Versus Open Radical Prostatectomy: A Prospective, Controlled, Nonrandomised Trial. Eur Urol 2015
3. Hung AJ, Cai J, Simmons MN, Gill IS. "Trifecta" in partial nephrectomy. J Urol 2013: 189:36-42
4. Pierorazio PM, Mullins JK, Eifler JB, et al. Contemporaneous comparison of open vs minimally-invasive radical prostatectomy for high-risk prostate cancer. BJU Int 2013: 112:751-7
5. Mullins JK, Feng T, Pierorazio PM, Patel HD, Hyams ES, Allaf ME. Comparative analysis of minimally invasive partial nephrectomy techniques in the treatment of localized renal tumors. Urology 2012: 80:316-21
6. Aboumarzouk OM, Stein RJ, Eyraud R, et al. Robotic versus laparoscopic partial nephrectomy: a systematic review and meta-analysis. Eur Urol 2012: 62:1023-33
7. Patel HD, Mullins JK, Pierorazio PM, et al. Trends in renal surgery: robotic technology is associated with increased use of partial nephrectomy. J Urol 2013: 189:1229-35
8. Ball MW, Gorin MA, Jayram G, Pierorazio PM, Allaf ME. Robot-assisted radical nephrectomy with inferior vena cava tumor thrombectomy: technique and initial outcomes. Can J Urol 2015: 22:7666-70
9. Harris KT, Ball MW, Gorin MA, Curtiss KM, Pierorazio PM, Allaf ME. Transperitoneal Robot-Assisted Partial Nephrectomy: A Comparison of Posterior and Anterior Renal Masses. J Endourol 2014: 28:655-9
10. Curtiss KM, Ball MW, Gorin MA, Harris KT, Pierorazio PM, Allaf ME. Perioperative outcomes of robotic partial nephrectomy for intrarenal tumors. J Endourol 2015: 29:293-6
11. Bhayani SB, Ong A, Oh WK, Kantoff PW, Kavoussi LR. Laparoscopic retroperitoneal lymph node dissection for clinical stage I nonseminomatous germ cell testicular cancer: a long-term update. Urology 2003: 62:324-7
12. Steiner H, Peschel R, Janetschek G, et al. Long-term results of laparoscopic retroperitoneal lymph node dissection: a single-center 10-year experience. Urology 2004: 63:550-5
13. Harris KT, Gorin MA, Ball MW, Pierorazio PM, Allaf ME. A Comparative Analysis of Robotic versus Laparoscopic Retroperitoneal Lymph Node Dissection for Testicular Cancer. BJU Int 2015
14. Parsons JK, Messer K, Palazzi K, Stroup SP, Chang D. Diffusion of surgical innovations, patient safety, and minimally invasive radical prostatectomy. JAMA Surg 2014: 149:845-51

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    the delivery fee. two days later I receive the cure from the courier
    service so I used it as the herbal man instructed me to, before the week
    complete my sister cancer was healed and it was like a dream to me not
    knowing that it was physical I and my family were very happy about the
    miracle of Doctor so my dad wanted to pay him 5 million us dollars the
    herbal man did not accept the offer from my dad, but I don't know why he
    didn't accept the offer, he only say that I should tell the world about him
    and his miracle he perform so am now here to tell the world about him if
    you or your relative is having any kind of disease that you can't get from
    the hospital please contact dr.sakuraspellalter@gmail.com or whats app him
    +2348110114739  you can follow him up on Instagram @herbalist_sakura for the cure, he will help you out with the
    problem. And if you need more information about the doctor you can mail me
    davidclara223@gmail.com 

    ReplyDelete
  24. A GREAT SPELL CASTER (DR. EMU) THAT HELP ME BRING BACK MY EX GIRLFRIEND.
    Am so happy to testify about a great spell caster that helped me when all hope was lost for me to unite with my ex-girlfriend that I love so much. I had a girlfriend that love me so much but something terrible happen to our relationship one afternoon when her friend that was always trying to get to me was trying to force me to make love to her just because she was been jealous of her friend that i was dating and on the scene my girlfriend just walk in and she thought we had something special doing together, i tried to explain things to her that her friend always do this whenever she is not with me and i always refuse her but i never told her because i did not want the both of them to be enemies to each other but she never believed me. She broke up with me and I tried times without numbers to make her believe me but she never believed me until one day i heard about the DR. EMU and I emailed him and he replied to me so kindly and helped me get back my lovely relationship that was already gone for two months.
    Email him at: Emutemple@gmail.com  
    Call or Whats-app him: +2347012841542

    ReplyDelete
  25. I'm very excited to inform everyone that I'm completely cured from my HSV 1&2 recently. I have used Oregano oil, Coconut oil, Acyclovir, Val acyclovir, Famciclovir , and some other products and it's really help during my outbreaks but I totally got cured from my HSV 2 with a strong and active herbal medicine ordered from a powerful herbalist and it completely fought the virus from my nervous system and I was tested negative after three weeks of usage. I'm here to let y'all know that HSV 1& 2 has a complete cure, I got rid of mine with the help of Dr Moses Buba and his herbal exploit, AFTER I engage with other wrong doctors. Contact him via email: buba.herbalmiraclemedicine@gmail.com or Call/WhatsApp him at +2349060529305
    thank you..

    ReplyDelete
  26. I'm very excited to inform everyone that I'm completely cured from my HSV 1&2 recently. I have used Oregano oil, Coconut oil, Acyclovir, Val acyclovir, Famciclovir , and some other products and it's really help during my outbreaks but I totally got cured from my HSV 2 with a strong and active herbal medicine ordered from a powerful herbalist and it completely fought the virus from my nervous system and I was tested negative after three weeks of usage. I'm here to let y'all know that HSV 1& 2 has a complete cure, I got rid of mine with the help of Dr Moses Buba and his herbal exploit, AFTER I engage with other wrong doctors. Contact him via email: buba.herbalmiraclemedicine@gmail.com or Call/WhatsApp him at +2349060529305
    thank you..

    ReplyDelete
  27. I was diagnosed as HEPATITIS B carrier in 2013 with fibrosis of the
    liver already present. I started on antiviral medications which
    reduced the viral load initially. After a couple of years the virus
    became resistant. I started on HEPATITIS B Herbal treatment from
    ULTIMATE LIFE CLINIC (www.ultimatelifeclinic.com) in March, 2020. Their
    treatment totally reversed the virus. I did another blood test after
    the 6 months long treatment and tested negative to the virus. Amazing
    treatment! This treatment is a breakthrough for all HBV carriers.

    ReplyDelete