Robotic Surgery: Too Much, Too Soon?

An Increase in Robotic Surgery AERs, Hence the FDA Survey

Robotic technology has gained popularity in various surgical specialties, including urology, gynecology, thoracic surgery, general surgery, and head and neck surgery. The da Vinci® Surgical System (Intuitive Surgical®; Sunnyvale, California) is the only FDA-approved robotic system on the market. The system has now been installed at more than 2000 hospitals around the world, according to Intuitive Surgical. Between 2011 and 2012, the number of associated adverse event reports (AERs) increased by 34%, from 211 to 282.^[1] This has prompted the FDA to survey robotics-using surgeons about their experiences. During that period, the number of procedures performed with the da Vinci system increased by 26%, from 292,000 to 367,000.

Image from da Vinci® Surgical

AERs With Robotics: Any Worse Than After Laparoscopy?

The robotic platform is only 8 years old, so any surgeon who has used the device has, at most, only 8 years of experience, and so the rate of AERs in general still is likely to be high.^[2] Medscape interviewed Joseph Colella, MD, founder of the Clinical Robotic Surgery Association, who believes that curves of adoption and adverse events that occur with robotics, and that occurred with laparoscopic surgery, are very similar, if not almost identical. As an example, he said, "One of the more commonly reported errors with robotics is inappropriate arcing of a coagulation device, where it injures a piece of intestine. Those same events happened and still happen with laparoscopy." To date, studies comparing laparoscopy and robotic procedures are of poor quality and suffer from significant heterogeneity and control bias.^[3]

Photo from Wikimedia

What About Machine Errors?

Recent studies^[4,5] and lawsuits involving microcracks in the insulation, which may cause burning, have triggered questions about the safety of robotic surgery, which subsequently has been covered in the popular media.^[6] Dr. Colella believes that machine errors are rare. "In my experience, I have never had the robot malfunction in any way." A 2008 review looked at the FDA Manufacturer and User Facility Device Experience (MAUDE) database, a valuable source of information on adverse outcomes associated with devices.^[7] It reported an estimated rate of device malfunctions of 0.38%, and only a small percentage of these were associated with patient injury.^[8]

Illustration from Thinkstock

The robotic approach provides surgeons with multiple advantages compared with open procedures and other minimally invasive approaches, notably a 3-dimensional perspective and improved dexterity and precision.^[9] Dr. Colella described the advantages for the patient. "As a potential patient, stop for a moment and put on the common-sense hat. Your surgeon tells you that he can see 100% better in 3 dimensions, that he can sew better, and probably within 1-2 years he will be able to do every procedure through 1 incision. You can imagine that the sky is the limit in employing robotic surgery. It's an enabling technology. I firmly believe that we are finding new and beneficial applications almost on a monthly basis."

There are also a number of disadvantages.^[9] Dr. Colella mentioned, "The robotic visual field is somewhat smaller than the laparoscopic visual field. However, you quickly adapt and know the limits of your vision or the lack of them." Training and experience typically resolve this problem, and surgeons learn to compensate for loss of tactile and force feedback. For surgeons in training, however, the latter challenge increases the risk of rupturing sutures during knotting.

Is Insufficient Training a Serious Problem With Robotic Surgery?

Intuitive Surgical is currently facing various lawsuits involving improperly trained surgeons.^[10] In a Medscape interview, J. Kellogg Parsons, MD, Associate Professor of Surgery, Department of Urology, Moores Cancer Center, University of California, San Diego, pointed out that "there is no standardized process for credentialing, teaching, proctoring, or obtaining hospital privileges for robotic-assisted surgery." Both the Institute of Medicine and the FDA have recognized that the process by which new devices enter into practice needs to be revised.^[11,12]

Photo: da Vinci Skills Simulator; courtesy of Intuitive Surgical, Inc.

Statement From James T. Breeden, MD, President, ACOG

In March 2013, James T. Breeden, MD, President of the American Congress of Obstetrics and Gynecology (ACOG), issued a statement that recommended against using robotic devices in routine gynecologic procedures.^[13] A 2013 study in JAMA reported that the percentage of robotically assisted hysterectomies increased from 0.5% in 2007 to 9.5% in 2010.^[14] Three years after the first robotically assisted hysterectomies were performed, the approach accounted for 22.4% of all hysterectomies where robotic surgery was available. Studies suggest that robotic and laparoscopic hysterectomy have similar morbidity profiles, but the use of robotics substantially increases costs.^[9,15] In the JAMA study, costs associated with robotically assisted hysterectomy were $2189 more per case than for laparoscopic hysterectomy.

Robotic Surgery for Hysterectomy

In the ACOG statement, Dr. Breeden said, "Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated." Some centers have reported shortened length of stay and reduced pain, operative time, and blood loss with robotic compared with nonrobotic hysterectomies, as well as fewer complications, but larger studies are needed to confirm its value compared to other minimally invasive procedures.^[15-17]

Source: Kho RM, Hilger WS, Hentz JG, Magtibay PM, Magrina JF. Robotic hysterectomy: technique and initial outcomes. Am J Obstet Gynecol. 2007;197:113.e1-e4.

Robotic Surgery in Bariatrics

Robotic surgery is showing promise in complex bariatric cases, including in the superobese.^[18-20] Dr. Colella reported that the bleeding rate approaches zero, the major complication rate is less than 0.3%, and there have been no reported deaths. Stricture rates are substantially reduced and the procedure requires fewer staples than does laparoscopy. Dr. Colella added, "Robotics have lessened the need for pain medication, which allows much quicker gastrointestinal recovery, which, in turn, reduces the incidences of pneumonia and aspirations. It will be a tremendous game changer when you can do robotic gastric bypass with a single 15-mm incision in a 600-lb patient, who goes home the next day." Robotically assisted revision can be done safely but has a high postoperative complication rate.^[21]

Robotic Surgery for Prostatectomy

The European Association of Urology (EAU) has issued guidelines on robotic and single-site surgery in urology,^[22] which conclude: "Robot-assisted urologic surgery is an emerging and safe technology for most urologic operations." The evidence was best for prostatectomy. Nonetheless, the guideline authors also note that the evidence to support EAU's conclusions was generally poor and based on expert consensus. Even with prostatectomy, studies are not showing better long-term effects on incontinence and erectile dysfunction than with open prostatectomies. However, perioperative benefits were generally confirmed.^[23]

Courtesy of Vattikuti Urology Institute - Henry Ford Health Systems

Other Procedures

Some studies have found robotic surgeries to be beneficial for specific complex procedures, including those for gastric cancer^[24] and transoral surgeries.^[25-27] A study on gastrectomy, however, found higher rates of anastomotic leaks in both robotic and laparoscopic surgery compared with the open procedure.^[28] It is still unclear whether robotic surgery has a superior advantage in most general surgeries. In a recent analysis, the robotic approach appeared to be cost-effective and as safe as nonrobotic surgery, except in cholecystectomy and esophagogastric procedures.^[29] Robotic surgery is being used in many urologic procedures in addition to prostatectomy,^[30] but, as with other robotic procedures, even with its advantages cost remains an issue.^[31,32]

Photo from Wikimedia

Cost and Overmarketing: The Elephants in the Room

The major issue in the use of robotics is the price. The machines themselves cost between $1.5 and $2.2 million, and service contracts run from $160,000 to $170,000 per year. Disposable instruments range from $600 to $1000, and each procedure can use 3-8 instruments. It is not yet known whether costs will be recouped downstream. An analysis published in March reported that da Vinci surgeries add incremental costs of 20% per procedure, which are absorbed by the hospitals.^[3] There is also some indication that hospitals overmarket their robotic capabilities. In a 2011 study, investigators reported that 41% of hospital Websites described their capabilities; clinical superiority was claimed on 86% of these sites, and none mentioned risks.^[33]

Competitors and Future Robotics

At this time, there is no competitor to the da Vinci robotic system, although systems are in development in Canada, Europe, and Asia. Dr. Colella said, "Other technologies are attempting to enter that space, but right now the barriers to entry are very significant. Of course, it's inevitable that eventually there will be competition."

Illustration from Thinkstock