1. Spotlight Robotic Surgery: Risks vs. Rewards

2. Source and Credits This presentation is based on the February 2016 AHRQ WebM&M Spotlight Case –See the full article at https://psnet.ahrq.gov/webmm –CME credit is available Commentary by: Tara Kirkpatrick, MD, and Chad LaGrange, MD, University of Nebraska Medical Center –Editor, AHRQ WebM&M: Robert Wachter, MD –Spotlight Editor: Bradley A. Sharpe, MD –Managing Editor: Erin Hartman, MS 2

3. Objectives At the conclusion of this educational activity, participants should be able to: Discuss the background and current trends in robotic surgery Identify the benefits of robotic surgery as well as potential disadvantages Discuss the potential complications directly related to robotic malfunction and the current system for reporting these errors Examine potential solutions to improve the safety of robotic-assisted surgery in the future 3

4. Case: Robotic Surgery A 66-year-old man was seen by a urologist for difficulty urinating and diagnosed by biopsy with localized prostate cancer. The urologist recommended a radical prostatectomy (removal of the prostate). The urologist stated that the best and safest way to remove the prostate was with a minimally invasive robotic surgery. The robotic surgery, he explained, would involve a few small incisions, performed by a surgeon seated at a computer console in the operating room. The procedure would be carried out using robotic arms and surgical instruments. 4

5. Case: Robotic Surgery (2) The urologist explained that the robotic technology would allow for smaller incisions, better control of the instruments, lower risk of complications, and faster return of erectile function. During the procedure, mechanical problems caused the robotic arms to not respond as expected. The urologist persisted in using the robotic technology and ultimately was able to complete the procedure. The operation took twice as long as expected, but the urologist felt it had been successful. 5

6. Case: Robotic Surgery (3) Postoperatively, the patient developed serious bleeding requiring multiple blood transfusions. He was taken back to the operating room where it was noted the inferior epigastric artery (a key artery in the pelvis) had been damaged during the original procedure. The injury was repaired, but this second operation was prolonged and complicated due to the degree of bleeding. The patient ultimately required several additional surgeries and a prolonged hospital stay. 6

7. Background: Robotic Surgery Initially approved in 2000 Use of robotic surgery has expanded rapidly –More than 570,000 procedures performed worldwide in 2014 Robotic-assisted surgery (RAS) is now approved in urology, gynecology, cardiothoracic surgery, general surgery, and otolaryngology –Most commonly used in urology and gynecology 7

8. Background: Robotic Surgery (2) Developed to overcome limitations of standard laparoscopy RAS uses small incisions and insufflation of the anatomic space The robotic camera and instruments are placed through ports into the body In RAS, surgeon is not at the bedside but seated at a computer console in the operating room The surgeon uses robotic assistance to utilize the tools 8

9. Components of the System There are three major components of the robotic surgery system 1.Console: where surgeon sits; binocular lenses create a three-dimensional image; a motion filtration system minimizes hand tremor 2.Robot: a mobile tower with four "arms" 3.Bedside cart: camera and light source, transmits images to the console 9

10. System Components: Console, Robot, Bedside Cart 10

11. Benefits of Robotic-assisted Surgery Combines benefits of laparoscopic surgery with added benefit of three-dimensional magnified imaging Reported benefits include : –Smaller incisions –Less blood loss –Shorter hospital stay and faster return to work –Improved cosmesis –Low incidence of some surgical complications Yet most of these benefits are short-term There is limited evidence demonstrating robotic surgery has any long-term benefits over open techniques 11

12. Robotic-assisted Laparoscopic Prostatectomy Robotic-assisted laparoscopic prostatectomy (RALP) is one of the most common robotic surgeries More than 85% of all prostatectomies are now robot assisted in the United States RALP has many benefits compared with open approaches: –Less blood loss –Fewer transfusions –Shorter hospital stay 12

13. Other Benefits to RALP RALP may also be associated with fewer complications including: –DVTs –Wound infections –Anastomotic leaks –Ureteral injuries 13

14. RALP vs. Standard Laparoscopic Surgery RALP appears to have similar advantages over standard laparoscopic prostatectomy but the difference is less pronounced Compared to the standard laparoscopic approach, RALP is associated with –Decreased blood loss –Lower rates of transfusion –Slightly shorter hospital stays 14

15. Long-term Outcomes of RALP Proponents of RALP boast improved urinary incontinence and sexual function after surgery However, a large Medicare database showed that those who had RALP had higher rates of incontinence and erectile dysfunction compared to men who had an open procedure 15

16. Risks of Robotic Surgery In general, RAS shares the same risks as open and traditional laparoscopic surgery –Including potential for infection, bleeding, and the risks of anesthesia Additional risks are unique to robotic surgery –Potential for human error in operating the robotic technology –Risk for mechanical failure given multiple components in the system 16

17. Risks of Robotic Surgery (2) Notably, the energy source can cause burn injuries from the cautery device There is a small risk of nerve palsies from the extreme body position needed to have the robot in the correct position near the pelvis Direct nerve compression from the robotic arms can also lead to nerve palsies Lastly, robotic surgery can take longer than nonrobotic procedures and it is more expensive 17

18. Estimating Risks of RAS Overall, literature describing rates of complications of RAS likely suffers from underreporting Studies have attempted to report on specific risks –RALP has a complication rate (including minor and life- threatening) of around 10% –Robotic malfunction is rare: likely 0.1%–0.5% of cases However, when robotic errors occur, rates of permanent injury range from 4.8%–46.6% –In a web-based survey among urologists performing RALP, almost 57% of respondents had experienced an irrecoverable intraoperative malfunction of the robot 18

19. Preventing Complications of RAS Currently there are no universal standard guidelines on appropriate training or credentialing for robotic surgery Some organizations have made progress in this area –The American Urologic Association has made recommendations for training and credentialing –Various authors have developed different curricula and simulation models 19

20. Role of Institutions in Preventing Complications Until well-validated credentialing and training programs are developed, hospitals can take a number of steps –Require a basic robotic safety course (like the one provided by the AUA) –Require case logs of robotic surgery –Require case proctoring prior to granting robot privileges 20

21. Stricter Reporting Guidelines A more uniform system of error reporting with tougher penalties for noncompliance may help capture a more accurate estimate of adverse event rates This could allow for identification of key risk factors for errors and complications Then, institutions could focus on the modifiable risk factors Individual institutions should also submit local reports to the FDA 21

22. Appropriate Risk Disclosure to Patients One study showed that men undergoing robotic prostatectomy were more likely to express "dissatisfaction" and "regret" compared to men who got open surgery –Difference was attributed to unrealistic patient expectations –Less than 70% were appropriately counseled on the specific risks of robotic surgery Institutions should ensure appropriate patient counseling and informed consent is happening consistently with RAS 22

23. Summary RAS has many potential benefits for patients and providers However, the technology itself may place patients at risk National organizations and institutions should ensure appropriate training and credentialing, as well as accurate and timely error reporting 23

24. Take-Home Points Robotic surgery is a rapidly expanding technology in multiple different surgical specialties worldwide Although robotic-assisted surgery shows some short-term benefits surrounding the direct perioperative period, it has fairly equivalent long- term outcomes when compared to open surgery Robotic surgery is generally safe with low overall complication rates, but adding the robot to the surgical equation inserts another potential entry point for error into an already complex and risk- fraught arena 24

25. Take-Home Points (2) In general, surgical outcomes are ultimately a direct manifestation of the skill and experience of the surgeon, not the technology or approach used Potential areas for improvement and reduction of error in robotic surgery include more standardized training and credentialing practices, improved reporting system for robotic-associated adverse events, and enhanced patient education 25