Robotic Surgery: New and Improved or New and the Same?

Robot and human hands almost touching - 3D render. A modern take on the famous Michelangelo painting in the Sistine Chapel; titled "The Creation of Adam".

By Rochelle Nataloni

Robotic surgery is either a medical marvel or healthcare hype – depending on your perspective. On one hand, studies suggest that outcomes are no better with robotic surgery than with minimally invasive laparoscopic procedures, and that the additional costs associated with robotic surgery exceed their relative value. On the other hand, hospitals continue to invest in and market these systems — and even use them as leverage to attract surgeons who view access to surgical robots as integral to providing patients with all of the available treatment options.

There are numerous robotic surgical systems in development – and even a few on the market — but the one that is essentially synonymous with “robotic surgery” today is the da Vinci System, (Intuitive Surgical, Sunnyvale, CA), which was the first robotic system cleared by the FDA, in 2000, for general laparoscopic surgery. In the following years, the FDA cleared the da Vinci System for thoracoscopic (chest) surgery, cardiac procedures performed with adjunctive incisions, as well as urologic, gynecologic, pediatric and trans-oral otolaryngology procedures. To date, the robotic system has been used in the treatment of more than two million patients worldwide.

The da Vinci Surgical System

The da Vinci Surgical System

The surgical robot market was valued at $3.2 billion last year, and is expected to reach $20 billion by 2021.1 This optimistic outlook prevails despite relentless controversy on a variety of associated topics, led most notably by consistently unfavorable cost/benefit analyses. Like the laparoscopic minimally invasive surgery (MIS) that spawned it, robotic surgery offers shorter hospital stays, faster recovery, smaller incisions, reduced risk of infection and decreased blood loss. However, unlike manual MIS, robotic surgery is dependent on capital-intensive equipment that adds thousands of dollars to each surgery. The cost of a da Vinci system ranges from $1.5 million-to-$2.2 million depending on the configuration of the robot, but the costs extend beyond just the platform, with average tangential costs running from about $1,500 to $2,000 per case. Intuitive receives recurring revenue from contracts to service the robots, and those contracts cost between $100,000 and $170,000 a year.

Superfluous or Superior?

Screen Shot 2015-07-15 at 15.43.15Like most evolutionary leaps in healthcare, robotic surgery has a legion of early adopters who are aggressively employing the technology, as well as a contingent of naysayers who argue that even if there are bona fide perks, the associated costs make the new-fangled technique superfluous — not superior. While there is a substantial body of literature showing that robot-assisted surgery is a valuable tool, careful distillation of those reports suggests that it is primarily valuable, from an outcomes standpoint, when the alternative is traditional ‘open’ surgery. This has supporters of the surgical specialty on the defensive when faced with the question: Is robotic surgery the future of healthcare or just an expensive marketing gimmick?

Case in point, the use of robotic surgery for hysterectomies has grown dramatically in recent years, even though it costs one-third more than other MIS and has little added benefit, according to a study that raises questions about whether the fast-growing surgical technology brings value to patients along with higher costs.2 In this study, researchers at Columbia University examined the records of 264,758 women who had hysterectomies for noncancerous conditions at 441 US hospitals between 2007 and 2010. Surgeons performed the procedure using one of four methods: abdominal cuts; vaginal removal; minimally invasive laparoscopic surgery performed by hand; or minimally invasive surgery using a robot. The researchers found about 25% of the women who had laparoscopic hysterectomies were hospitalized for more than two days, compared with 20% of those who had robotic surgery. Meanwhile, the average total cost to the hospital for a robotic surgery was $8,868, compared with $6,679 for the laparoscopic hysterectomy and $6,651 for the abdominal procedure. The researchers also found that the use of the robot technique grew from 0.5% of hysterectomies performed in 2007 to 9.5% of those performed in 2010. Over that same time period, laparoscopic procedures rose from 24% to 30% of hysterectomies, while abdominal surgeries decreased and vaginal surgeries remained steady. Moreover, 22% of 2010 hysterectomies at hospitals that invested in robot systems were conducted using a robotic system.

Jason D. Wright, MD

Jason D. Wright, MD, lead author of the study and an assistant clinical professor of gynecologic oncology at Columbia, said the main reason for the growth in robotic surgery for gynecological procedures is that robotic surgery has been marketed extensively to not only hospitals and physicians, but also directly to patients. According to Dr. Wright, there is minimal data in gynecology that robotic surgery is advantageous, and he stresses the importance of ensuring that patients understand there are a variety of options and that they should discuss the pros and cons of these options with their physician.

Intuitive Surgical maintains that the most appropriate way to evaluate safety and efficacy of any surgical approach is through clinical data, and notes that for hysterectomy, two representative studies show that da Vinci hysterectomy is as safe as laparoscopy and also reduces the length of hospital stays, and for prostatectomy, two of the larger studies demonstrate that da Vinci prostatectomy is safer than open surgery. 3-6 Complications, death, blood loss and length of hospital stay were all substantially better – within a statistically significant margin – for the da Vinci prostatectomy patients, according to the studies.

Safety, Efficacy and Satisfaction

robot surgeon iconSafety and efficacy are twin lynchpins of any surgical procedure, but patient satisfaction can’t be overlooked. One study that focused on patient satisfaction revealed that women who had a da Vinci robotic-assisted hysterectomy reported greater satisfaction than women whose surgeons used other approaches, including open, vaginal and laparoscopic hysterectomies. 7 The study found that women’s satisfaction with hysterectomy surgery has generally improved over time, and that women who had da Vinci hysterectomy reported the greatest overall satisfaction and willingness to recommend and choose the same type of surgery again. The study’s lead author Michael Pitter, MD, chief of minimally invasive and gynecologic robotic surgery at Newark Beth Israel Medical Center said, “Results from our survey reinforce the importance of patient satisfaction and time to return to normal activities when evaluating the cost-benefit of different surgical approaches.” The survey measured women’s satisfaction with their procedure in terms of the level of pain and discomfort they experienced, and the reported time it took respondents to return to normal activities, such as walking, driving and work. In total, 9,177 women completed the survey. The study then focused specifically on the 6,262 respondents who had a hysterectomy for a non-cancerous condition and who specified the surgical approach used. Women who had robotic-assisted surgery reported significantly higher overall satisfaction, were more likely to recommend the approach to others, and more likely to choose robotic-assisted surgery again. Those who had open hysterectomy were less likely or unlikely to recommend the same approach and less likely to choose the same approach again. Results also showed that between 2001 and 2013, rates of open surgery for hysterectomy decreased by 64 percent. During the same period, robotic-assisted surgery rates rose from zero use to more than one-third of all hysterectomies performed. To minimize potential for bias, the authors obtained data from women who had surgery at many different hospitals, performed by many different surgeons across the US. In their analysis, they controlled for differences across socio-economic groups that could affect study results.

Another study that cast some positive light on robotic surgery found that in terms of quality-adjusted life-years gained, the benefits of robotic-assisted partial nephrectomy surgery for kidney cancer patients outweighed the health care and surgical costs to patients and payers by a ratio of five to one.8 The Precision Health Economics (PHE) study set out to determine if the investment in a surgical robot could be linked to improvements in long-term patient outcomes, and found that partial nephrectomies had significantly lower rates of renal failure when compared with radical nephrectomies. The study also concluded that the costs incurred in adopting robotic-assisted surgery were offset by higher survival and lower renal impairment rates. “The preferred and healthiest option to cure a small renal cancer is to perform a partial nephrectomy,” said Sam B. Bhayani, MD, MS, professor of urology, surgery, Washington University School of Medicine and chief medical officer, vice president of medical affairs at Barnes-Jewish West County Hospital, Saint Louis, MO. “And the most effective way for a hospital and surgeon to perform partial nephrectomy,” said Dr. Bhayani, “is to have access to robotic surgery.” The study found that adoption of robot-assisted MIS led to a 52 percent increase in the rate of kidney sparing partial nephrectomy versus full radical nephrectomy. The five-year net benefit per procedure, in terms of the difference between quality-adjusted survival gains and health care costs incurred, was $406,217 for radical and $512,561 for partial nephrectomy patients, for an incremental value of $106,344 for each patient who received partial rather than radical nephrectomy. The study found no evidence that the availability of robot-assisted MIS increased the likelihood that inappropriate patients received partial nephrectomy. It did, however, find that use of robotically assisted surgery might increase access to partial nephrectomy, which is associated with improvements in one-year survival rates after surgery and large reductions in renal failure rates. Patient cost and outcome data were derived from the Surveillance, Epidemiology and End Results (SEER) Program, linked to Medicare claims.

Cost factors top the list of controversies surrounding adoption of surgical robots, but complications and the delay – or absence — in reporting them – is a concern, as well. Problems resulting from surgery using robotic equipment – including deaths – have been reported late, inaccurately or not at all to the FDA, according to one study.9

The study focused on incidents involving the da Vinci System over nearly 12 years. Researchers found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries, but they also found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all.

While the study noted that robotic surgery has promising benefits, it stressed that it’s essential that device related complications be uniformly captured, reported and evaluated so the medical community fully understands the safety of new technology.

Intuitive Surgical released a statement following publication of that study’s findings encouraging the study’s authors to conduct a comparable study assessing the reporting of both open and laparoscopic surgical events and then to compare them to those of robot-assisted surgery.

Meanwhile, in an unrelated study of MIS procedures, health economists found that half of the procedures reviewed, including robot-assisted and laparoscopic surgeries, cost insurance providers less than the same surgeries performed in the traditional manner. Four of the six minimally invasive surgeries also resulted in fewer lost days of work — sometimes several weeks fewer, essentially representing a cost savings for society as a whole.10

Dr. Karen Kerr

Relying on the literature to help navigate the medical minutiae on any given topic is efficient, but sometimes it’s illuminating to examine the trees instead of the forest. Dr. Karen Kerr says the benefits associated with robotic surgery are playing out in the operating rooms of health care systems around the world on a daily basis. Dr. Kerr is a widely knowledgeable source on the current state of surgical robotics having recently organized the Hamlyn Symposium on Medical Robotics, at The Imperial College London, where she is the Director of Operations for the Paul Hamlyn Chair of Surgery.   “Robotics delivers significant advantages for patients such as improved outcomes for robotic prostatectomy and robotic partial nephrectomy, and patients can also expect better cosmesis, and a quicker return to the activities of daily living, as well as improved oncological and quality of life outcomes,” said Dr. Kerr. “Compared with open surgery, patients can expect an improved length of hospital stay, minimal blood loss and lower blood transfusion rates,” she added.

Imperial College acquired a da Vinci System in 2001, and was the first to establish a formal urological robotic surgery program, in 2004. Robotic surgery has since become a mainstay in prostate surgery and has since developed further into renal and bladder surgery, as well, Dr. Kerr pointed out.

Robotics Promise Realized

A decade-old consensus document on robotic surgery prepared by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) noted that robotic surgery showed promise in hysterectomy for both benign and malignant disease, as well as myomectomy. “In myomectomy, the robot may provide substantial benefit by allowing minimally invasive fertility sparing options,” the document stated. Today this once-promising possibility is a reality in gynecological surgery practices around the world.

Arnold Advincula, MD, chair of women’s health & chief of gynecology at Columbia University, is a leader in minimally invasive surgical techniques and one of the world’s most experienced gynecologic robotic surgeons. He says using the da Vinci system for myomectomy, in particular, helps him provide patients not only with the benefit of a less invasive approach and shorter hospital stay, but the possibility of conceiving if they choose to become pregnant — providing there are no other infertility factors involved.

TransOral robotic surgery (TORS) is another example of a procedure where patients can benefit from the robotic approach. Head and neck cancer is most often treated through a regimen of surgery and/or radiation.  Advanced cases may also include chemotherapy. Conventional surgery for throat cancer often requires that a patient’s jaw be broken, or that a large incision be made across the throat, which can cause difficulty with speech and/or swallowing after surgery.

TORS allows surgeons to reach the tumor through the patient’s mouth. This technique has proved effective in protecting the long-term swallowing function, reducing the risk of infection and speeding recovery time. Eduardo Mendez, MD, Associate Professor Department of Otolaryngology – Head and Neck Surgery University of Washington School of Medicine, Seattle, WA (USA) points out that with TORS he’s able to offer patients an organ preserving option and a function preserving option.

Raymond Douglas, MD, PhD, an ophthalmologic surgeon at the Kellogg Eye Center, Ann Arbor, MI, believes there are a variety of procedures within his specialty that could benefit from robotic surgery, as well. “I can certainly see it being used for orbital procedures; and I believe it would also be very reasonable for retinal surgery,” he said. Among the benefits of robotic surgery that are particularly relevant to ophthalmic surgery, he said, is the level of precision it offers. Previously, robotic instrumentation was precise to within 1 mm – clearly inadequate for retinal membrane peeling — but this has improved over the last several years. 11,12

Improvements in 3D visualization of the eye may also encourage more ophthalmic surgeons to consider robotic surgery, according to Dr. Douglas. “3D visualization and viewing surgery directly through the scope is critical for ocular surgery. In the past, we were hampered by 3D technology – viewing an image on the screen was not quite the same as direct visualization, even for most experienced surgeons. However, 3D technology has gotten much better, especially in the last couple of years, so this may lead to an upsurge in use in ophthalmology,” he said.

Clearly, robotic surgery must overcome a number of hurdles in order to gain widespread acceptance; interestingly, many of the current challenges associated with robotic surgery were once the bane of laparoscopic MIS, which is now standard of care in many centers and specialties. Imperial College’s Dr. Kerr acknowledges that there are obstacles to the pervasive employment of surgical robotics, but suggests that simple solutions are not far off. Dr. Kerr says, “Low cost and frugal innovation in robotic technology is the key to making wide adoption of robotic surgeries worthwhile.”

 

References

  1. Surgical Robots: Market Shares, Strategy, and Forecasts, Worldwide, 2015 to 2021. WinterGreen Research, Inc.
  2. Wright J.D, Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease. 2013;309(7):689-698. doi:10.1001/jama.2013.186.
  3. Liu et. al., “Perioperative Outcomes for Laparoscopic and Robotic Compared with Open Prostatectomy Using the National Surgical Quality Improvement Program (NSQIP) Database”, European Urology (2013), doi:10.1016/j.eurouro.2013.03.080
  4. Kowalczyk et. al., “Temporal National Trends of Minimally Invasive and Retropubic Radical Prostatectomy Outcomes from2003 to 2007: Results from the 100% Medicare Sample”, European Urology (2011), doi:10:1016/j.eurouro.2011.12.020
  5. Lau et. al. “Outcomes and Cost Comparisons After Introducing a Robotics Program for Endometrial Cancer Surgery”, Obstetrics & Gynecology (2012), DOI: 10.1097/AOG.ob013e31824c0956
  6. Wright et. al. “Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease”, JAMA 2013;309(7):689-698.
  7. Pitter MC, Simmonds C, Seshadri-Kreaden et al. The Impact of Different Surgical Modalities for Hysterectomy on Satisfaction and Patient Reported Outcomes, Interact J Med Res 2014;3(3):e11.See comment in PubMed Commons below
  8. Chandra A, Snider JT, Wu Y, et al. Robot-assisted surgery for kidney cancer increased access to a procedure that can reduce mortality and renal failure. Health Aff . 2015 Feb;34(2):220-8. doi: 10.1377/hlthaff.2014.0986.
  9. Cooper MA, Ibrahim A, Lyu H, Makary MA.Under-reporting of Robotic Surgery Complications. J Healthc Qual. 2013 Aug 27.
  10. Epstein AJ, Groeneveld PW, Harhay MO, et al, Impact of Minimally Invasive Surgery on Medical Spending and Employee Absenteeism, JAMA Surg. 2013; 148(7):641-647. doi: 10.1001/jamasurg.2013.
  11. Fine HF, Simaan WWF. Could robots ever do retina surgery? Review of Ophthalmology. May 2010.
  12. Douglas RS. Robotic surgery in ophthalmology: fantasy or reality? Br J Ophthalmol 2007; 91:1.

Post a Comment