Palm Beach Brain and Spine

A spike in the number of adverse event reports (AERs) associated with the da Vinci® Surgical System (Intuitive Surgical®, Sunnyvale, California) last year has prompted the US Food and Drug Administration (FDA) to survey surgeons about their experience with robot-assisted surgery. The number of AERs increased 34%, going from 211 in 2011 to 282 in 2012. During that period, the number of procedures performed with the da Vinci system in the United States increased 26%, going from 292,000 to 367,000.  Medscape spoke to Joseph Colella, MD, Director of Robotic Surgery, Magee Women's Hospital, University of Pittsburgh Medical Center, and a founding member of the Clinical Robotic Surgery Association, about the FDA survey and the current state of robotic surgery in general.

Medscape: Do you think this FDA survey is warranted? And to what would you attribute the increase in AERs?

Joseph Colella, MD: When a new technology is being used and adopted in a relatively rapid fashion, oversight of that new technology needs to be very carefully employed. Learning-curve issues can arise, just as they did when we adopted laparoscopic technology.

AERs can be due to lack of training, to inappropriate use of this technology, or to the technology itself. In the case of AERs and robotic surgery, in the numbers that you quoted, there's a roughly proportional increase relative to the AERs and to the volume of cases done. It's not quite one to one, but it is relatively close.

One can also take into account the fact that as the technology is becoming more widely adopted, the individual hospitals that are using it have also matured relative to their ability to scrutinize events as they occur, report them, and then collect the data. As the hospital systems' ability to do these things developed, of course you are going to get more AERs. They are looking in places and for events that they were not looking in before. When I talk to other robotic surgeons, we seem to have a fair amount of unanimity that the increase in the numbers of these events is really due to the maturation of the oversight process among hospitals and individual hospital systems.

Medscape: Is this different from when laparoscopy was introduced?

Dr. Colella: The curves of adoption and adverse events that occur with robotics and that occurred with laparoscopic surgery are very similar, and I would go so far as to say they are almost identical. I should add that we're still learning today about complications and adverse events that occurred in laparoscopic surgery years after its widespread adoption.

Medscape: What are some of the most common and avoidable AERs that occur with robotic surgery? And do they tend to be due to surgeon or machine errors?

Dr. Colella: I'll take the answer to your last one first. Any time that you introduce a technology, it has to be employed correctly by appropriately trained people who know how to use it. I was trained in the open era, and in the last few years of my training we began using laparoscopy. I went through the entire laparoscopic evolution from 0 to 100 miles an hour, and now I am living through and helping to lead the robotic evolution and seeing the same events. But, because robots are involved, we now seem to be chasing events that have been occurring all along throughout the course of laparoscopic surgery.

As I mentioned, the adverse events with laparoscopy and robotic surgery are almost identical. For instance, one of the more commonly reported ones with both is inappropriate arcing of a coagulation device, where it injures a piece of intestine and is not witnessed or recognized at the time of the event. Everyone is trying to capture and report this with robotic surgery, and it's appropriate to do so.  However, those same events happened and still happen with laparoscopic surgery, and you don't see the FDA investigating laparoscopic technology independently, as they do now with robotics.

Medscape: Robotic surgery adds the complexity of the machinery, however. Are there many errors that can be attributed to the technology itself?

Dr. Colella: In my experience, I have never had the robot malfunction in any way. The adverse events that I have heard about can almost universally be attributed to surgeon error, to user error, or to some other event that is related to either personnel in the operating room or a distracting event that may involve the robot but is not in fact the fault of the robot. The complexity of the machinery actually makes most operations easier.

Medscape: Of course, these are all relatively new machines. No one knows how they're going to behave over time or at what point they will begin to break down.

Dr. Colella: There is definitely some truth to that. I've had the privilege of using a brand new machine for 1 year at one hospital and then moving to another hospital where they also had a brand new machine. I've had a unique experience in that I haven't had to use the same machine for 5 years, so I can't tell you personally what those 5 years would look like. However, I can tell you that the company has built a very intense support system that we haven't had to use very often. On those rare occasions when there has been a problem with the robot, for example as part of its setup or after an operation when someone notices a fault light, the engineering teams have been very good about responding.

Medscape: One of the major issues in the use of the robotics is the price. The machine itself costs between $1.5 and $2.2 million dollars. In addition, the service contracts run from $160,000 to $170,000 per year. Then disposable instruments range from $600 to $1000, and each procedure can use 3-8 instruments. Given that, do you think these machines will ever become as cost effective as the use of laparoscopy?

Dr. Colella: This is a very general question, and it boils down to using the robot for the appropriate indications. Let's take the example of a hysterectomy: It's a major advance when you can take a patient from an open to a minimally invasive procedure using the robot. It has an impact on that patient's overall life in a very substantial, beneficial way. The cost is ultimately realized in terms of savings—from length of stay in the hospital to lower complication and readmission rates. All of these are much improved with the robot versus an open procedure for a hysterectomy.

Also consider that in bariatric robotic surgery the bleed rate approaches zero, the major complication rate is less than 0.3%, and there have been no reported deaths in robotic bariatric surgery. Then factor in the substantial reduction in stricture rates, which cause postoperative readmissions and procedures, and the use of fewer staples than in laparoscopy. You can begin to realize the cost savings with robotic surgery and that it does not take very many cases to realize those savings.

Medscape: I know that you specialize in bariatric surgery, but are there robotic procedures that you think will eventually be most or least advantageous?

Dr. Colella: Well, 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.

For instance, nobody ever thought that you would be able to resect tumors of the larynx without taking half of the face apart to get to them. With the robot in the right hands, you can do those operations in an hour, and the patient goes home the next day.

Another example that will be a tremendous game changer is when you can do robotic gastric bypass with a single 15-mm incision in a 600-lb patient, who goes home the next day with the same safety profile that I just talked about. Robotics have enormously minimized the trauma that these patients face from the surgery and have lessened the need for pain medication, which allows much quicker gastrointestinal recovery, which, in turn, reduces the incidences of pneumonia and aspirations. This technology is making impacts in ways that aren't even obvious to some of the people who employ it.

Medscape: What about the visual field? I know with laparoscopy that was one of the disadvantages compared with open procedures. Is that an issue with robotics?

Dr. Colella: 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. The slight reduction in visual field is insignificant for me, and one might argue that a bariatric operation is one of the most complex procedures done either robotically or laparoscopically. I don't perceive visual limitation to be anything of a disadvantage. As a matter of fact, with 3-dimensional vision, with the ability to see better in any spot than I ever could with laparoscopy, it changes the game in a very positive way. I don't see that a slight reduction in the visual field has any impact on my ability to perform a procedure, given the other benefits from using robotic instrumentation.

Medscape: I read some complaints about the way surgeons are being trained in robotic surgery -- that it's rushed and insufficient in many cases. Have you heard anything about that?

Dr. Colella: I've heard this. I can only speak to my experience with the development of robotic surgery at the University of Pittsburgh, which has been similar to the support and training of surgeons across all specialties there who use and employ the robot. The support provided me in learning the robot with bariatric surgery was above and beyond what I was ever expecting. Maybe there are places where they've rushed training, but my colleagues and I have not seen that.

Medscape: Do you see any competitor to da Vinci on the horizon?

Dr. Colella: No, and I'm pretty tuned in to that world because I live in it. Other technologies are attempting to enter that space, but right now the barriers to entry are very significant. It's going to be very difficult for another technology or another company to live up to the track record that has been established. I have nothing to disclose. I have no personal interest in them. I have no financial relationship with them. I just use their products.

Of course, it's inevitable that eventually there will be competition, However, I have not seen a product or a technology that I was interested in trying in any meaningful way that was even remotely comparable to the experience that I have with da Vinci.

Medscape: A major disadvantage, of course, as with any monopoly, is that they can name their price. At this point, the only competition is to return to or just stay with laparoscopy as the alternative to the open procedures.

Dr. Colella: Yes, that's right. However, these hospital systems that are continuing to adopt robotic technology are not doing so just to keep up with the Smiths and the Joneses. If it wasn't making or saving them money, they would not use it. At the end of the day, if this is a money loser, it's not going to be around.

Medscape: So you're seeing this as an almost universal technology for any kind of surgery.

Dr. Colella: Correct. Robotic surgery competes with other very well established, very safe technologies, even in the field of vascular surgeries -- by which I mean operating on blood vessels -- it's been done and it's been done successfully. Of course, the noninvasive, percutaneous vascular procedures have been around for the better part of 10 years and have evolved into a very effective, almost perfect tool, which would be difficult for the da Vinci to replace. I know of neurosurgeons who are evaluating it and looking at its use in many of their procedures because of its precision and visual capabilities.

Medscape: Is there anything else we should know?

Dr. Colella: There is one more advantage of robotic surgery that is unique, certainly, to what I do, and I think it is going to be applicable and advantageous across many other specialties as surgeons experience this. Many surgical procedures, as you know, carry the risk for deep venous thrombosis, which on some occasions can produce life-threatening pulmonary emboli. We try to prevent these using anticoagulants, which increases the risk for bleeding. Now, using the example of gastric bypass, the robot is so efficient in allowing greater use of sutures rather than staples that the incidence of bleeding is reduced to an almost infinitesimal number. As a result, we have fewer concerns about giving anticoagulants preoperatively and so achieving the greatest impact on deep venous thrombosis reduction. Nobody ever anticipated that as being a benefit to robotic surgery. This is not directly a function of the robot, but it is closely tied to what you can accomplish by using the robot.

Another advantage that gets lost on many people who don't truly understand robotic surgery is that this is computer technology. With computers rapidly expanding in terms of their capabilities, the robot follows right along. Its potential is unlimited. It's only bound by imagination and the limitations of computer processing. Laparoscopy has completed its evolution; innovation in that technology is pretty much done.

“Is Robotic Surgery Worth Its Price? An Interview With Dr. Joseph Colella” by Carol Peckham, Medscape, Jun 20, 2013, at www.medscape.com/viewarticle/806484_5