Robotic surgery ‘here to stay’ despite concerns about cost, lack of data

Since Intuitive Surgical’s da Vinci Surgical System received FDA approval for general laparoscopic surgery in 2000, robotic surgery for oncologic and non-oncologic indications has skyrocketed.

Nearly 2,600 da Vinci systems — the only robotic laparoscopic surgery system approved by the FDA — had been installed in hospitals worldwide by the end of 2012. The approximately 450,000 minimally invasive, robotically performed procedures in 2012 represented a 25% increase from the previous year.

“Depending on how it’s measured, robotic surgery has been successful in terms of the patient demand as well as short-term outcomes,” William Lowrance, MD, MPH, assistant professor in the division of urology at the University of Utah School of Medicine and a researcher at the university’s Huntsman Cancer Institute, told 
HemOnc Today. “Urologists were the initial adopters of this technology for the treatment of prostate cancer, but now gynecologists, cardiac surgeons, otolaryngologists — you name the specialty — they’re looking to somehow adopt robotics into their surgical practices.”

Those advantageous short-term outcomes — suggested by comparative studies — include shorter hospital stays, lower risk for bleeding and less postoperative discomfort.

However, the cost of robotic surgery, which can range from $1 million to $2.3 million per robot, and the lack of data about long-term outcomes have contributed to skepticism.

“The robot is just a surgical tool,” Lowrance said. “It’s not magic. Complications are still seen with robotic procedures, similar to those seen with open or purely laparoscopic procedures.”

HemOnc Today spoke with several surgeons who perform robotic procedures about the technique’s role in the treatment of prostate, gynecologic, and head and neck cancers, its cost-effectiveness, the extensive training required to master the technique, and the advantages and disadvantages of its rapid rise in popularity.

A transformation in prostate cancer

Open surgery had long been the primary surgical treatment for prostate cancer.

That changed in 2001 when the FDA approved the da Vinci system for robotic prostatectomy. NCI data suggest four of five radical prostatectomies are now performed robotically.

“Robotic surgery has transformed the surgical management of prostate cancer,” Lowrance said. “It’s by far the dominant surgical modality used today in the treatment of prostate cancer.”

Compared with open radical prostatectomy, there are short-term benefits of robotic procedures.

Lowrance and colleagues performed a literature review to compare outcomes of robotic surgery with open surgery. Results were published in 2010 in The Scientific World Journal.

One study included in the review showed a 2-day median length of stay with minimally invasive procedures, including robotic-assisted and standard laparoscopic prostatectomy, compared with 3 days for open procedures (P<.001). Another study showed estimated blood loss (100 mL vs. 450 mL; P<.001) and rates of required transfusion (0.8% vs. 3.4%; P=.002) favored men who underwent robotic procedures.

These types of benefits have allowed a greater percentage of men to undergo prostatectomy, said David B. Samadi, MD, chairman of urology and chief of robotic surgery at Lenox Hill Hospital in New York.

“Our patients haven’t required a transfusion in years,” Samadi told HemOnc Today. “For patients who are Jehovah’s Witnesses or who do not want a risk for contracting hepatitis, HIV, etc, robotic surgery has taken care of their limitations.”

Samadi was a member of the surgical team that first performed robotic prostatectomies in 2001 in France. He since developed the Samadi Modified Advanced Robotic Technique (SMART).

With SMART, Samadi and colleagues have performed robotic prostatectomy in challenging cases, including patients who have undergone transurethral resection of the prostate, patients with abdominal gunshot wounds and those who are obese. Lenox Hill was the first to perform robotic surgery on a patient with hemophilia.

During SMART, which combines aspects of open, standard laparoscopic and robotic procedures, surgeons remove the prostate from the surrounding nerves and tissues instead of mobilizing the surrounding nerves and tissue.

With this technique, patients have a 97% chance of continence and 85% are sexually active after the procedure, Samadi said.

The literature review conducted by Lowrance and colleagues demonstrated differing results from Samadi and colleagues. Lowrance found that rates for continence among patients who underwent robotic surgery were similar to those who underwent open surgery. The mean time to continence recovery was significantly shorter with robotic vs. open prostatectomy (25 days vs. 75 days; P<.001). Potency rates also were higher at 1 year, although the difference was not statistically significant (70% vs. 63%; P=.08).

Despite these advantages, survival outcomes cannot be accurately compared due to a lack of long-term data, Lowrance said.

“Typically you don’t see overall and disease-specific survival events in men who undergo prostatectomy until many years down the road,” he said. “When you consider that robotic prostatectomy didn’t become mainstream until 2004 to 2006, that’s just not enough follow-up time to allow for meaningful comparisons between open and robotic procedures.”

Instead, Lowrance and colleagues assessed surgical margins and biochemical recurrence as markers of oncologic outcomes. Yet, these data are inconsistent.

In one study Lowrance and colleagues reviewed, positive surgical margins were lower in patients treated robotically than those who underwent open procedures (15% vs. 35%; P<.001). Other data indicate comparable surgical margins (16% for robotic vs. 17% for open; P=.61). They found no significant differences in short-term biochemical (PSA) recurrence.

One study in which Samadi was involved examined health-related quality of life. Results showed 88% of patients who underwent robotic prostatectomy did not regret their decision to undergo the robotic procedure.

“The debate whether we should be performing prostatectomy with the robot vs. open has already been put to rest,” Samadi said. “There’s absolutely no reason to cut the abdomen and put the patient through 4 hours of open surgery, with which there is a 20% chance of transfusion, when you can have a beautiful [robotic] surgery that’s like art. With all of the complications that are involved with open surgery, it just doesn’t make sense to do it anymore.”

Robotic hysterectomy

Robotic surgery also has become common in other specialties, including gynecology.

The FDA approved the Da Vinci system for robotic hysterectomy in 2005.

Before that time, few gynecologic surgeons were performing laparoscopic procedures, Colleen Feltmate, MD, director of minimally invasive surgery in gynecologic oncology at Brigham and Women’s Hospital and assistant professor of obstetrics at Harvard Medical School, told HemOnc Today.

“With the robot came the ability to make a jump from an open approach to a minimally invasive approach, especially for a lot of gynecologic oncologists who were already in practice and who didn’t have much laparoscopic experience in their training,” Feltmate said.

Many of the advantages associated with robotic surgery are from the surgeon’s standpoint, she said.

Instead of rigid instrumentation and mirroring gestures of standard laparoscopy, robotic surgery offers “seven degrees of freedom,” mimicking each gesture of the surgeon and making it an easier procedure to learn. Robotic instrumentation also dampens hand tremors, unlike laparoscopic instrumentation.

The robotic system also provides depth perception and magnification, bringing the surgeon much closer to the working field, Feltmate said.

Still, little data exist to illustrate robotic hysterectomy is clearly the preferred approach over conventional laparoscopy, according to Jason D. Wright, MD, assistant clinical professor of gynecologic oncology at Columbia University.

“The greatest benefit we’re seeing with the introduction of robotic surgery is that there are more women who are now having minimally invasive hysterectomy,” Wright said. “However, the problem with robotic surgery is that there aren’t many studies that show a decreased complication rate when you compare robotics to laparoscopy. In addition, we don’t know if there is any long-term survival difference between robotic and either laparoscopic or open hysterectomy.”

Wright and colleagues evaluated data from 1,027 women who underwent laparoscopic hysterectomy and 1,437 women who underwent robotic hysterectomy for the treatment of endometrial cancer between 2008 and 2010.

The results, published in 2012 in the Journal of Clinical Oncology, showed comparable complication rates for the two procedures — 9.8% for laparoscopic vs. 8.1% for robotic (P=.13).

After researchers accounted for patient, surgeon and hospital characteristics, results showed no significant differences in intraoperative complications (OR=0.68; 95% CI, 0.42-1.08), surgical site complications (OR=1.49; 95% CI, 0.81-2.73), medical complications (OR=0.64; 95% CI, 0.4-1.01) or prolonged hospitalization (OR=0.85; 95% CI, 0.64-1.14).

Cantrell and colleagues conducted a retrospective analysis to evaluate survival outcomes of women who underwent robotic radical hysterectomy for cervical cancer. At 3 years, researchers reported 94% PFS and 94% OS. The investigators reported no statistically significant differences in PFS (P=.27) or OS (P=.47) between robotic surgery and traditional laparotomy.

The biggest difference between the two procedures is cost, Wright said.

“It appears that robotic surgery is much more expensive than laparoscopy,” Wright said. “From a public health standpoint, that’s certainly a limitation.”

Besides the initial cost of the robot, hospitals pay a $100,000 to $170,000 annual service agreement fee to Intuitive Surgical. Disposable instrumentation costs $1,300 to $2,200 per procedure, according to the company.

In their analysis, Wright and colleagues found the mean cost for robotic hysterectomy was $10,618 per procedure vs. $8,996 for laparoscopic hysterectomy (P<.001).

“We can’t compare levels of efficiency and cost because there’s nothing to compare it to. There’s only one robot, so the cost is dictated by one company,” Feltmate said. “Once someone else comes on the market, the cost will drop significantly. Despite cost, robotic hysterectomy still provides a considerable advantage to both the patient and the hospital in terms of length of stay and time to recovery. Anytime we can do less on our patients, that has to be an advantage.”

Paradigm shift for head, neck cancers

Transoral robotic surgery (TORS) developed from a hypothesis that the da Vinci system could treat head and neck cancers more effectively than conventional radical surgery and chemoradiation, according to Bert W. O’Malley Jr., MD, who developed TORS with colleague Gregory S. Weinstein, MD.

TORS, approved by the FDA in 2009, is now the preferred surgical approach for the treatment of oral cavity, oropharynx, supraglottic and laryngeal cancers, said O’Malley, co-director of the Head and Neck Cancer Center of the University of Pennsylvania.

The shift toward TORS has reduced “in and out” operating time from 8 to 10 hours to 2.5 hours, O’Malley said. It eliminated the need for mandibular splits and tracheotomies, and it also reduced the use of chemoradiation, associated with proven late toxic effects.

“Typically with more advanced stage cancers, which is how oropharyngeal tumors tend to appear, the majority of patients will need high-dose radiation in combination with chemotherapy even after radical surgery. These treatments are very destructive,” O’Malley said. “With minimally invasive TORS, we significantly decrease the side effects of chemoradiation and of more radical surgery. That’s why the development of TORS is such a paradigm shift.”

A substantial learning curve exists for surgeons to master the use of the robot, J. Scott Magnuson, MD, director of the robotic head and neck cancer surgery program at the Nicholson Center for Surgical Advancement at Florida Hospital, said in an interview.

Magnuson and colleagues performed a prospective case study to evaluate the learning curve in surgeons who performed TORS on 168 patients between 2007 and 2011.

The results appeared earlier this year in JAMA Otolaryngology – Head & Neck Surgery.

As TORS experience increased during the 4-year period, operative time decreased by 47%, total mean length of intubation decreased by 87%, and mean length of hospital stay decreased from 3 days to 1.4 days.

Operative time tended to decrease by half after surgeons performed 40 procedures. The data leveled off after surgeons performed 100 procedures.

“The learning curve is influenced not just by the number of cases, but by the surgeon’s own technical ability and the frequency of cases,” Magnuson said. “It’s not just getting to 100 cases, but how quickly do you get those 100 cases? If all of your patients have early-stage cancers, you’re going to learn faster than if you have patients with difficult cases.”

In addition, da Vinci instrumentation — designed for abdominal procedures — is not ideal for use in head and neck cancers, Magnuson said.

“We have to take three out of the four robotic arms and put them through the mouth without any collisions,” Magnuson said. “The instruments are fairly large for the small space we’re working in.”

With this instrumentation, it also is difficult to access areas in the vocal cords, lower throat, nasal pharynx and skull base, O’Malley said.

“In the future, miniaturization of technology will be important in allowing the robot to gain broader access in the head and neck region,” O’Malley said. “But the robot is here to stay.”

Reporting guidelines needed

Cooper and colleagues conducted a study to evaluate robotic surgery complications reported to the FDA from 2000 to Aug. 1, 2012. The researchers cross-referenced the FDA database with cases identified through LexisNexis and Public Access to Court Electronic Records (PACER) to identify cases in which FDA reports contained inaccuracies, were filed late or were never filed.

The results, published earlier this year in the Journal for Healthcare Quality, showed 245 adverse events related to the da Vinci system were reported during the nearly 12-year study period. They included 71 deaths and 174 nonfatal injuries.

Cooper and colleagues identified eight cases in which FDA reports were improperly filed. In five cases, no report was filed within a mean follow-up period of 4.1 years (range, 2.3-5.8). In three other cases, reports were filed but a mean 611 days (range, 292-930) elapsed between the event and the report filing.

Of the eight cases in which reports were improperly filed, two were prostatectomies, one was a hysterectomy, one was a left salpingo-oophorectomy, one was a minimal valve repair and one was an unspecified urologic procedure. The nature of the other two surgeries was not reported.

“As part of ongoing quality improvement efforts, it is essential that device-related complications be uniformly captured, reported and evaluated,” Cooper and colleagues wrote. “Improved reporting would allow the medical community to better understand the safety of this new technology.”

In response to the report, Intuitive Surgical issued a statement: “We agree with the assertion … regarding the need for a more robust and standardized system for reporting adverse events. We strongly encourage the authors of the article to conduct a comparable study that assesses the under-reporting of both open and laparoscopic surgical events and would welcome a comparison with robotic-assisted surgery.”

Still, many of the surgeons who spoke with HemOnc Today also emphasized the need for improved reporting with regard to robotic surgery.

“Guidelines for reporting should be standardized.” Magnuson said. “Death following a surgical procedure should be differentiated between a result of the procedure or due to disease. This is especially important for patients with cancer.”

Feltmate said more transparency is necessary.

“What’s important is being clear about what needs to be reported so we can learn from it,” she said. “It’s not about being punitive. It’s about making sure we’re safe.”

The technology may be in the limelight because it is a novel surgical option, Wright said.

“With any type of surgery, there is a risk for adverse outcomes,” he said. “This has received a lot of attention because this is a new procedure, but certainly, we need longer follow-up.”

Importance of experience

The increased popularity of robotic surgery may be partially to blame for adverse events, Samadi said.

“We see a lot of negative news about robotic surgeons who use the technology as a gimmick,” he said. “Patients need to do their diligence and make sure the doctor is committed to their surgery and their care.”

This type of commitment comes from experience performing robotic surgery, Samadi said. Some institutions may try to profit off of the robot by having one surgeon perform multiple operations, going from one operating room to another rather than overseeing one procedure from start to finish.

“Robotic surgery is an excellent technology in the hands of someone who knows how to drive it, who has the skills, the volume and is part of a dedicated program that actively follows outcomes, and who is honest with themselves and their patients,” Samadi said. “The same technology in the hands of someone who doesn’t have any of those elements is devastating and causes high rates of complications.”

Feltmate said there is another concern: Surgeons who do not have backgrounds in oncology are increasingly performing robotic surgeries on patients with cancer.

“Robotic surgery has transitioned from the early innovators to a more mainstream process, which has its pros and cons,” Feltmate said. “We’re all going to have to think about what makes sense in terms of who should be performing these types of surgeries.”

The mainstream nature of robotic surgery is due to hospital and Intuitive Surgical marketing, Lowrance said.

He and colleagues conducted a study that found that many hospital websites promoted their da Vinci systems with weakly supported evidence, and 42% failed to mention risks associated with the procedure.

“From a business standpoint, Intuitive Surgical was a master at how it marketed the da Vinci robot,” Lowrance said. “They went directly to the consumers and physicians. A ‘buzz’ was created that this was the best way to treat prostate cancer, when in fact, we didn’t have the outcome data that we as researchers wanted to have before the robotic surgery explosion took off.”

However, marketing cannot explain the positive results physicians and patients have seen with robotic surgeries, O’Malley said.

“In the long run, the outcomes and the benefits to the patients will be the tests of time,” he said. “From our standpoint, we didn’t approach TORS as a marketing effort. We approached it as a scientific study. We’ve been scientifically looking at this prospectively, and so far — as we move on and as we publish — the data continue to support the use of this technology.” — by Alexandra Todak

References:

Cantrell LA. Gynecol Oncol. 2010;117:260-265.

Cooper MA. J Healthc Qual. 2013;doi:10.111/jhq.12036.

Intuitive Surgical. da Vinci Surgical System investor presentation: Quarter 3, 2013. Available at: phx.corporate-ir.net/phoenix.zhtml?c=122359&p=irol-IRHome. Accessed on Nov. 20, 2013.

Intuitive Surgical. Intuitive surgical statement on Journal for Healthcare Quality article. Available at: www.intuitivesurgical.com/company/media/statements. Accessed on Nov. 20, 2013.

Lavery HJ. J Urol. 2012;188:2213-2218.

Lowrance WT. ScientificWorldJournal. 2010;10:2228-2237.

Mirkin JN. Health Aff (Millwood). 2012;31:760-769.

National Cancer Institute. NCI Cancer Bulletin. Tracking the rise of robotic surgery for prostate cancer. 2011;8(16). Available at: www.cancer.gov/ncicancerbulletin/080911/page4. Accessed on Nov. 20, 2013.

White HN. JAMA Otolaryngol Head Neck Surg. 2013;139:564-567.

Wright JD. J Clin Oncol. 2012;30:783-791.

For more information:

Colleen Feltmate, MD, can be reached at Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115; email: cfeltmate@partners.org.

William Lowrance, MD, MPH, can be reached at Huntsman Cancer Institute, 1950 Circle of Hope, Salt Lake City, UT 84112; email: will.lowrance@hci.utah.edu.

J. Scott Magnuson, MD, can be reached at Florida Hospital, 410 Celebration Place, Suite 305, Celebration, FL 34747; email: scott.magnuson@flhosp.org.

Bert W. O’Malley Jr., MD, can be reached at the Hospital of University of Pennsylvania, 5 Silverstein, 3400 Spruce St., Philadelphia, PA 19104; email: bert.omalley@uphs.upenn.edu.

David B. Samadi, MD, can be reached at Lenox Hill Hospital, 100 E. 77th St., New York, NY 10075; email: robotmd@aol.com.

Jason D. Wright, MD, can be reached at Columbia University Medical Center, Herbert Irving Pavilion, 161 Fort Washington Ave., New York, NY 10032; email: jw2459@columbia.edu.

Disclosure: Feltmate, Lowrance, Magnuson, O’Malley, Samadi and Wright report no relevant financial disclosures.

Is robotic surgery cost-effective for gynecologic cancers?

Robotic surgery is cost-effective with clear indications.

Overall, robotic surgery is more expensive than laparoscopy on an individual, patient-by-patient basis. However, when you consider the total hospital and societal costs, robotics is cheaper than laparotomy and is allowing a minimally invasive approach in patients who otherwise would have undergone a more invasive surgical route.

In particular, when the case is complex or difficult, robotic surgery is cost-effective because it allows patients to be surgically treated by a minimally invasive approach.

When we look specifically at gynecologic cancer, robotic surgery appears cost-effective because patients stay in the hospital for less time. If you include the societal benefits of patients returning to work earlier, robotic appears even more advantageous. With laparotomy, patients will be out of work for 6 weeks, but with robotic surgery, they’ll go back to work sooner.

At our institution, specifically evaluating the operating cost of robotic-assisted surgery for gynecologic cancer, it appears about 8% more costly compared with laparoscopy, without considering hospital and societal factors. Robotic surgery becomes cost-effective when you consider the fact that patients are avoiding a laparotomy. If you have an operation you cannot do laparoscopically but you can do robotically instead of with laparotomy — even if you pay 8% more for the operation itself — it becomes cost-effective. For simple, short operations, which can be equally performed by laparoscopy, it is a more costly surgical technology.

When advanced laparoscopic procedures started, critics initially claimed it was more expensive than open surgery, and it took longer in the operating room. Now, laparoscopy is standard treatment for many conditions. Everyone has accepted that patient outcomes, less blood loss, shorter hospital stay and faster recovery are benefits of laparoscopy compared with open surgery. Robotics is an improved laparoscopic technology. It not only allows you to do the same operations as laparoscopy, but it also allows you to perform others that could not be performed laparoscopically by many gynecologists.

Robotics enables hysterectomy in patients who otherwise would have undergone laparotomy. That’s a major societal benefit. If you can reduce the number of open surgeries, you’re obviously saving money, too. It would be ideal to have all patients undergoing minimally invasive hysterectomy.

Societal benefits, discomfort and the risks for adverse events all appear improved with robotic vs. open surgery. An incision in the abdomen has a 10% risk of having a hernia, whereas the risk is only 1% for incisions of laparoscopy and robotics. Laparoscopy made surgery gentler for the patient but not the surgeon. Robotics made surgery gentler for the patient and the surgeon.

In the future, it’s likely that the cost disparity will drop once there is competition in the market. Once there were multiple companies providing instruments and clear indications for laparoscopy, laparoscopy became more cost-effective compared with open surgery. I imagine with time, the cost-effectiveness of robotics vs. laparoscopy will follow a similar pattern.

Javier F. Magrina, MD, is a gynecologic oncologist at Mayo Clinic in Phoenix. He can be reached at Mayo Clinic, 5779 E. Mayo Blvd., Phoenix, AZ 85054; email: jmagrina@mayo.edu. Disclosure: Magrina reports no relevant financial disclosures.

More studies are needed to determine its cost-effectiveness.

Conventional laparoscopy and robotic surgery share similar advantages over laparotomy, including decreased morbidity, rapid recovery and improved aesthetics of incisions. However, both are associated with complications, such as trocar injuries, insufflation-related problems, and an increased risk of bladder and ureteral injury.

Unique complications that may occur with robotic surgery include mechanical breakdown of the robotic equipment, use of excessive pressure due to lack of tactile feedback, or errant movement or positioning of a robotic arm.

For benign gynecologic disease, there is no high-quality evidence that robot-assisted laparoscopy is superior to laparotomy or conventional laparoscopy. The American Association of Gynecologic Laparoscopists states that robot-assisted laparoscopy should not replace conventional laparoscopic or vaginal procedures for benign gynecologic disease (AAGL Advancing Minimally Invasive Gynecology Worldwide. J Minim Invasive Gynecol. 2013;20:2-9). A systematic review of two small randomized trials found no evidence of improvement in effectiveness or safety with robotic surgery (Liu H. Cochrane Database Syst Rev. 2012;2:CD008978).

Another meta-analysis compared robotic surgery with other approaches and found that robotic surgery compared with open surgery was associated with significant decreases in blood loss and length of hospital stay (Reza M. Br J Surg. 2010;97:1772-1783). Compared with conventional laparoscopy, the only significant difference for robotic surgery was a decrease in blood loss and fewer conversions to open surgery for endometrial cancer staging.

There is general consensus among gynecologic oncologists that robotic surgery has become the standard of care for patients with endometrial cancers that require surgical staging with lymphadenectomy.

Robotic technology has allowed the majority of patients with endometrial cancer to undergo a minimally invasive procedure. Although hospital stay and surgical morbidity is decreased with robotic surgery, it is difficult to conclude that robotic surgery is cost-effective because the surgical device, maintenance and instruments are very expensive.

Future studies designed to evaluate outcomes of endometrial cancer patients who undergo robotic surgery are needed to determine the cost-effectiveness of this approach.

J. Michael Straughn Jr., MD, is a professor in the University of Alabama at Birmingham (UAB) Division of Gynecologic Oncology and also a senior scientist in the experimental therapeutics program at the UAB Comprehensive Cancer Center. He can be reached at UAB Women & Infants Center, 1700 Sixth Ave. South, Birmingham, AL 35233; email: jstraughn@uabmc.edu. Disclosure: Straughn reports no relevant financial disclosures.