Robotic-Assisted Surgery: A Question of Value

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Evidence-Based Oncology, August 2014, Volume 20, Issue SP11

The arrival of robotics in surgery has been a roller coaster ride, offering another lesson in how technology in healthcare, unlike most industries, faces challenges to show it’s better than the status quo.

The use of surgical robotics, especially the well-publicized da Vinci Surgical System, has flourished in the past several years. The name da Vinci is nearly synonymous with the term “robotic-assisted surgery,” as it is the overwhelming market leader. As of 2012, more than 2000 of the 1000-pound devices have been sold around the world. Estimates are that da Vinci systems are used in at least 200,000 surgical procedures each year (mostly prostatectomies and hysterectomies).1

According to Intuitive Surgical, da Vinci’s manufacturer, the number of surgeries may have topped 367,000 in 2012.2 However, this roller coaster car may be headed for a long, bone-rattling dip. Today, Intuitive Surgical reports that sales are down, with revenues falling 59% for the first quarter of 2014 compared with that same period in 2013. This drop may be attributable to several things: technical issues and outcomes questions, not to mention high capital (approximately $1.5 million) and maintenance costs (about 10% of the capital costs). This may be a signal of a new wariness among payers and providers regarding the value of robotic-assisted surgery.3

Claimed Benefits: Real or Imaginary?

Robotic surgery’s promise is straightforward: small incisions and scaled-down surgical movements should mean less damage to surrounding tissue, with improved recovery the result. Yet, evidence to support surgical robotic assistance is tenuous at best.

A recent study from Finland found that when robotic surgery was used in cancer patients who needed hysterectomies, time in the operating room was greater, with patients faring no better than those who had conventional procedures. Furthermore, the cost in Finland was calculated to be at least 50% higher for these patients. These researchers found that when used with patients with benign conditions, the cost of surgical robotic assistance was closer to triple the cost of conventional conditions.4

A 2013 investigation by Columbia University researchers found that the use of robot-assisted hysterectomy for benign disorders, among 264,758 women in 441 centers, led to no outcomes benefit, and instead cost $2000 more per procedure compared with conventional laparoscopic hysterectomies.5 However, the use of this modality jumped 19-fold, from 0.5% to 9.5%, in a span of 4 years. At hospitals with the equipment, robotic-assisted procedures accounted for more than 20% of all hysterectomies performed.

Still, it is thought that robot-assisted laparoscopy has real benefit, particularly in pediatric surgeries and nerve-sparing procedures, where precise suturing, better visualization (3-dimensional view of the area of the affected tissue), and finer movements are high priorities.6,7 In patients with prostate cancer, a large (>22,000 patients), nonrandomized study found that patients undergoing surgically assisted radical prostatectomies had less frequent positive surgical margins (13.8%) compared with laparoscopic procedures (16.3%) and open surgery (22.8%).8

Positive surgical margins in prostate cancer are a wellrecognized correlate with biochemical reoccurrence. A study published this year in the Journal of Clinical Oncology reviewed records for more than 5900 patients who underwent either open radical prostatectomy (41%) or robot-assisted radical prostatectomy (59%).9 Data points compared were postoperative complications, blood transfusions, prolonged length of stay, readmissions, additional cancer therapies, and costs of care within the first year. Analyses showed that the 2 groups were similar for odds of overall complications, readmission, and additional cancer therapies. The group undergoing robot-assisted surgery had a higher probability of experiencing genitourinary and miscellaneous medical complications at 30 and 90 days postsurgery (P <.02), but they had a lower risk for requiring a blood transfusion and having a prolonged length of stay (P <.001). Even with these benefits, the expenses at 1 year were greater in this group ($13,394 vs $11,940; P <.001).9

A review of literature between 2000 and 2013 indicated that there are benefits associated with robotic prostatectomy, including decreased blood loss, fewer blood transfusions, decreased length of hospital stay and preservation of urinary and sexual function, and other quality-of-life measures that appear to be dependent upon the surgeon’s technique.10 However, costs were significantly less for procedures not employing a robotic surgical system.These results somewhat conflict with other studies for safety and length of stay. A study by Hu and colleagues11

found more complications in the group undergoing robot-assisted surgery. Pierorazio and associates12 showed a longer length of stay in those undergoing robot-assisted procedures. A review of a sampling of Medicare claims files between August 1, 2008, and December 31, 2008, concluded that similar frequencies of problems with continence and sexual function are experienced

by patients undergoing open surgery or robot-assisted prostatectomy surgery.13

Adverse Event Reports Cause Concern

The number of adverse events (AEs) associated with the da Vinci Surgical System caused the FDA to take notice. In 2013, the FDA sent a warning letter to Intuitive for underreporting AEs and issued an “urgent medical device recall” for 1300 da Vinci robot arms. A lawsuit was filed in March 2014 by Intuitive’s shareholders, claiming that the company underreported AEs and concealed recalls from the FDA.14

The number and seriousness of adverse events filed in its Manufacturer and User Facility Experience (MAUDE) database increased by one-third from 2011 to 2012, as the number of robotic procedures jumped 26%, according to Intuitive, da Vinci’s manufacturer, in a Securities and Exchange Commission quarterly filing. Reports in the MAUDE database may be filed by the manufacturer, hospitals, clinicians, and patients. Filings can be related to equipment malfunctions that cause no harm to patients, as well as injuries and deaths that may be related to the device or the surgeons operating the device. Unfortunately, data are not available to determine whether there is a correlation among the procedure, facility, patient demographics, disease/morbidity, and/or surgeon.

A 2013 study published in the Journal for Healthcare Quality evaluated AEs associated with the use of the da Vinci system over a 12-year period. Cooper and co-workers15 found a total of 245 AEs that were reported to the FDA, including 71 deaths and 174 events that caused injuries but were not fatal. Researchers from Johns Hopkins were concerned that AEs were underreported, and they termed the process for event reporting “haphazard,” calling for improvements in the reporting of these events. The study did not compare AE reporting for robot-assisted surgery with open surgeries of the same type.

Even assuming that AEs associated with robot-assisted surgery are significantly underreported, the frequency would likely amount to a tiny fraction of the total surgeries performed. Robot-assisted prostatectomy is now more common than the open surgical approach in the United States,16 although this certainly varies by geographic region and access to the devices.

The popularity of the procedure means higher billings for providers who are willing to risk the capital outlay (approximately $1.8 million) and perhaps gain a marketing edge over competing hospitals in a given region.

Where Is the Value of Surgical Robotics?

Payment and reimbursement can be a powerful incentive or disincentive to the growth of robot-assisted procedures. At present, payers do not generally reimburse differently for open surgery, laparoscopic procedures, or robot-assisted surgery. According to the medical director of a regional health plan who participated in a recent survey, “There are no CPT codes for robot-assisted

laparoscopic surgeries. This is just another form of laparoscopy. Accordingly, there is no payment differential to the providers for the use of the robot,” according to this payer, who asked not to be identified. “Those providers who try to bill with modifier 22 and claim to have a more complicated surgery with the robot are usually denied additional reimbursement. Some of the contracted facilities do have contract rates for robot-assisted surgery; however, as these contracts come up for renewal, the additional enhancement for robot surgery is being eliminated.”

Furthermore, many payers are concerned about the expanded use of this technology to “marginally indicated” procedures, based on pressure from the C suite to recoup the costs invested in devices like da Vinci. Payers are also concerned that any surgeon who does not come out of a training fellowship program where they had “hands-on” experience in using da Vinci would be subject to an unacceptable “learning curve” in actual practice.

Are surgeons and their hospitals focused on getting the latest and greatest technology? Based on the lack of proven improved outcomes, this may be the case, according to the medical director of a national plan who participated in the survey. “I’m the payer representative on our health system’s robotics committee. At a recent committee meeting, what struck me was the tone of the surgeons, which I felt was very gizmo-ish, if that is a word, in that they were clammering for more access for less-complicated procedures. The general surgeons in our area want to do them for appendectomies and gallbladder removals, and this is being pushed by the manufacturer.”

This executive added, “There was a 20-minute debate regarding one hospital that just got a new robot-assisted surgery device, who was being sold on converting (to) newest version for only $150,000 more!” The amount of training needed on the devices to safely perform the surgeries is also critical. “We’ve been told about the importance of proctoring and mentoring surgeons on the machines: physicians unfamiliar with the machines will turn a 2-hour prostatectomy into a 6- to 8-hour procedure unless properly trained. And we were told that it probably takes 200 procedures for them to become proficient in robotic prostatectomies.”

Thus, it seems the healthcare system is paying more, regardless of whether health plans know it. “The cost of operating room and anesthesia for a 6-hour prostatectomy is not noted—it is just paid,” said this payer. A 2012 technology assessment review by the Center for Evidence-Based Policy at the Oregon Health & Science University for the Washington State Health Authority summarized, “Generally there is low to moderate strength of evidence that robotic-assisted procedures are associated with improved outcomes, such as shorter hospital stays, and reduced blood loss and transfusion for several procedures (eg, prostatectomy, hysterectomy, nephrectomy, and cystectomy).

Where it has been examined, operative times using robotic assistance are generally longer than for conventional surgeries. There is a general lack of study for patient-centered outcomes (eg, quality of life, longer survival). Many studies are limited by small sample sizes, retrospective nature of data collection and analysis, dissimilar control groups, and inadequate control of potential confounders.”

The report continued, “Where it was studied, there were data indicating that there is a ‘learning curve’ for use of robotic equipment and that some outcomes were improved with increasing levels of experience (eg, operative time, length of stay, and complication rates for robotic prostatectomy).”17

A Nagging Technological Question

In other industries in the United States, particularly manufacturing, improved technology often results in improved efficiency, better quality, and lower costs. In the healthcare industry, however, it is rare to cite instances where new medical technologies had positive effects on efficiency, quality, and costs. Robotic surgery seems a prime example of the failure of technology in the healthcare industry to improve efficiency and outcomes, at least in prostate surgery. This may not be the case in other types of surgical procedures that requires precise movements. The problem is that evidence is still lacking.

As Debasish Sundi and Misop Han wrote in an editorial18 accompanying the JCO article, “Do the results of this study prove superiority or safety of one technique over another? The simple answer is no.”

Time in the Operating Room

Most robotic-assisted surgeries, particularly done in centers without a great deal of volume, tend to take significantly more time than conventional procedures. With robotic-assisted surgeries, much of this time is taken in the set-up—preparing the patient, the machinery, and properly positioning the device next to the patient (“docking”). This set-up time also includes camera placement, trochar positioning, and draping the patient.

In a center in Ireland, practitioners recorded the procedure set-up time for hysterectomies, from the first few operations performed to having completed more than 500 consecutive hysterectomies. Setting up the system can take anywhere from 20 to 90 minutes in total, depending again on the user’s experience. Furthermore, actual procedures take longer with robotic assistance (of course, depending on the complexity of the surgery), and this is also characterized by a learning curve.

Source: http://www.robotsurgery.ie/clinicaldata-

from-cork.References

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