Arnold Advincula, MD - Medical Conference 2014

Arnold Advincula, MD - Medical Conference 2014

Endometriosis Foundation of America 2014
The role of robotic surgery in deep endometriosis
- Arnold Advincula, MD

To put it clearly we are really not going to get into any kind of fisticuffs here in terms of arguing or controversy. To me it is kind of surprising that we still have these discussions surrounding robotics versus conventional laparoscopy because it is a technology that is actually quite old. It has been around since about 2000. I started working with it in 2001 investigatively when I was a young faculty member at the University of Michigan and have grown up with. And since have done a lot of developmental work with it and I have really seen it evolve.

This is not exactly where I thought it would evolve towards in terms of some of the things that Jon brought up, controversies or issues that we face but I really think it is all about evolution in terms of the technology that we work with. It is something that is not for everybody. But hopefully in the next 15 minutes I can present to you a different perspective about where I think this is going and how it may impact its role with endometriosis surgery.

I do have some disclosures, they are present right there.

As I said before I would just like to talk a little bit about the limitations surrounding robotics and it really has to do with rapid technology adoption. Ultimately at the end of the day that is probably one of the key things to think about when we talk about robotics. Everybody should at least know about what the robot is. I think really if you are going to talk about it the things that separate it from traditional, conventional laparoscopic surgery is the fact that it is ergonomically a different way of operating. It utilizes three dimensional imaging and your instruments articulate; I think those are probably the biggest things. Probably one of the things that is often brought up that may be an issue is the lack of tactile feedback or sensation.

When we look at robotics to me really at the end of the day is laparoscopic surgery. You saw a lot of videos that Jon presented earlier and they are fantastic surgical videos. But if you look at this it looks like the same thing. To the person viewing it who is not in the operative console it is laparoscopic surgery. That is one of the first things I want to emphasize when we talk about it. People like to dichotomize it and split hairs but at the end of the day it is a minimally invasive surgical tool. Dr. Einarsson uses a harmonic scalpel. I utilize a robotics platform that incorporates a different energy source but it is laparoscopic surgery. It is only until you stare at it for a little while do you realize that one, my instrument is bent but you cannot tell that it is 3D because you are looking at the same kind of video quality that you saw with Dr. Einarsson. That is the first point I want to make about what you are going to be looking at.

When you look at the question mark here is robotics something that we should be thinking about as part of our surgical armamentarium. I think what it points to is a bigger pink elephant in the room. I am going to lay that out for you. It is really not about the technology it is about bigger issues that exist when you talk about surgical management of this disease and surgery in general.

I think importantly we need to have a rationale when we utilize technology and when I was starting out with this technology 13 years ago these are the questions I asked myself as an investigator, as what I called the thoughtful surgeon. Can I use this to mimic traditional tried and true surgical techniques that we are all taught as surgeons? Can I use it as an enabling technology? Can I gain a new perspective that maybe I did not have before I started using this technology? But ultimately I recognized because I knew all along this was laparoscopic surgery that was evolving – this was another tool set. As I have always said we have a lot of tools and some of them are great and some of them are good and we have to understand where they fit. To me robotics was a tool that clearly should not replace things we do well. And certainly for somebody as skillful as Jon this may not be necessarily an added benefit to his surgical armamentarium. But it does not necessarily mean that it cannot be an added benefit for somebody else.

Of course, it is applied throughout the range of GYN surgery and of course we are going to focus on endometriosis here.

Like I said there are a lot of challenges that have come up with this technology. It is not surprising and it is history repeating itself. We have seen this happen time and time again with so many different technologies. Vaginal mesh for example – a great example of a technology that really kind of came and went and hopefully the same thing will not happen with robotics because it scares me that it is following sort of the same history of what happened with rapid technology adoption and not respecting some of the challenges that I am listing here.

Clearly there are a lot of studies as Jon alluded to that have been done regarding robotics. There is really just a paucity of data in endometriosis. But the one thing I will say is that as he said it is difficult to do these studies and you really have to be carful when you interpret them.

This is a European study that compared the two modalities and as is pointed out very clearly it is tough to do the study. Here we have a study where the surgeons had been doing at least 50 conventional laparoscopic surgeries like the ones you saw Dr. Einarsson show. I do not know whether they were as complicated as the cases that Jon was showing you but they had done at least 50 cases over a decade. That is a very different experience than somebody who had done only 30 cases utilizing this new technological platform. You are clearly going to see differences. That is the difficulty of an RCT there are so many bloody variables to understand it is very difficult.

It is often looked upon as being a poor technology to use because it takes longer or there are issues. The other thing we see come up a lot is the cost. I will not argue with anyone that it costs a lot more – it clearly costs more. There is no doubt that it is a much more expensive technology but that does not mean it is one that we should ignore and figure out how to integrate. This is a study that looked at it and basically said outcomes are the same between the two approaches but it cost more. When you start to look at things in detail at a more granular level that is where you really start to understand why it is difficult to understand costs of technology.

Now this is not the only part of the picture but one thing I often bring up is that things like your ability to use the device efficiently and your cost a lot of that could be impacted by your learning curve. If you have not transcended this piece of the puzzle then you are going to struggle. It is impacted by a lot of things. Ultimately you see up there you have to have technical prowess. The technology will not make up for that. If you are a terrible surgeon and you do not understand the disease process and you do not have knowledge of anatomy it is not going to do anything for you. It is no surprise when people say, “Well, you know, it didn’t make that surgeon any better” and you read about those cases like Jon pointed out where somebody is in there for eight hours – that person clearly has no clue about what they are doing surgically. What does it do? It leaves a bad taste in everybody’s mouth about a technology that may have a positive impact.

When you look at the literature about learning curves in some cases to at least start to plateau a little bit and get through that first phase is about 91 cases. That is very different than saying you have only done 10, 20 or 30, right?

Another issue that we face a lot, and this again goes back to knowledge, is that there is so much skipping steps, the cart before the horse. If you do not understand your anatomy, if you do not know about electro-surgery, if you do not know about peritoneal access and port placement you will clearly have problems with this technology, no doubt. Just like it happens with conventional laparoscopy it is just that there is, I do not know why, but there is no spotlight on conventional laparoscopy. We all clearly know those of you who are physicians in the audience there are people in your hospital that take forever to do a case. They do conventional laparoscopy and they are there for four or five hours and there are other surgeons who can do that in like one to two hours. It is an issue that happens with all modalities of surgery. We really have to be cognizant not to fall into that issue of skipping steps and assuming that a technology will compensate for a deficiency that somebody intrinsically has.

Cost? I will not argue with cost. As I said before we need to be very cognizant of that. This does not cost pennies. This is an extremely expensive technology, we are talking in the millions, but it clearly has been shown in some institutions that they can make it work. This is my alma mater where I did my residency and fellowship and my colleagues there they looked at it across multi-disciplines and they found that it could be profitable if we are just looking at the business side of medicine. They could use this technology and they could be on the plus side. Ultimately what it boiled down to – efficiency, low complication rates, knowing what they are doing with it and then they made it work.

It is not for every hospital and I do not think every hospital can replicate what they have done and that is the problem. As Jon said people have been led to believe, based on brilliant marketing, that you can be a better surgeon if you do not have the skill set and that every hospital should have this. That is not the case and that is not true. We have got to look bigger. We have got to look at the societal impact since we are talking about ethics and politics and controversies here and what impact on society.

This is an interesting study that was published and it looked at different minimally invasive surgical procedures and let us take for example things like fibroids, which they mentioned here. I know this is not a fibroid meeting but there they looked at fibroids and we manage fibroids a lot nowadays both laparoscopically and robotically. We do that sort of minimally invasively whether it is a myomectomy or a hysterectomy. Robotics has definitely impacted that. What they found here is that that particular procedure being able to do that disease state minimally invasively has decreased the amount of payer spending and decreased employee absenteeism. From a societal perspective that is huge, really important.

But we are at a dangerous intersection. That is because we have technology, we have all these issues that practitioners face, patients demanding things, there are market pressures. This is where endometriosis started to get introduced into the robotics arena. For many and I can tell you historically because I have grown up with the technology and granted I do not agree with a lot of things that happened with it endometriosis got labeled a “pull through” application. For a lot of people they would do robotics surgery and they would start out with the most common procedure, which was a hysterectomy and then as they got going they would be convinced by certain individuals that it is time to pull another application through, let us do endometriosis. Even if the individual never did that surgery before or really was doing work in that arena they would say “that is another pull through application for you, you can do more surgery” and that can be a very deadly path to go down.

Regardless endometriosis there are a lot of us who for the right reasons and the right pathway have been looking at it in robotics. I am very glad that somebody like Jon is brave enough and willing enough to tackle the complexities of doing a randomized controlled trial because it is very difficult to do that as you saw in surgery.

Obviously things I do not appreciate about what is going on in the media are things like, “Well you can see better if you can cut it out, robotics will help you do that”. Obviously we know that unless you recognize the disease looking at it in 3D makes it no more recognizable than looking at it in 2D. You have to know what you are looking at.

We all know it takes on varying appearances. Just like footballs are not the same depending on what part of the world you are in endometriosis is not the same depending upon what part of the body you are in. We have to know that about the disease and robotics does not take care of that for you.

However, I will say that the technology in its purest form does to the surgeon, and I think this is where it really boils down to things at the end of the day, it is surgeon preference, it is surgeon bias. What are you going to do about a rectovaginal nodule that you see eroding in the vagina in a clinical exam? To me that is where my bias comes into play. I think this technology clearly has value as a surgeon. I think surgeons are really the ones who can truly evaluate the role that this is going to have, not a dabbler in surgery but somebody who lives and breathes surgery because in the operating room folks like Jon and myself and the people sitting in this panel that is what drives us everyday. That is what I live and breathe.

At the end of the day it is not a replacement for a lack of knowledge, skill and judgement. If you cannot drive a car that car is not going to help you. You are just a deadly driver behind the wheel. As I have always said, the magic is not in the wand, it is in the magician. It is who uses the tool.

Where do we go next? A lot of getting through the learning curve and understanding how to use this technology is about the surgical nuances. Recognition, understanding the surgical dissection, how will the pathology behave, is it the right patient with the right indication and the right surgeon and right technology? That is so critically important.

I will veer a little bit here just to show you that there are other things that we need to think about with new technology. This is an Institute of Medicine Report. “To Err is Human”, most of you are familiar with this it came out in 1999. What it looked at was the estimation of the number of people that die every year from preventable medical error. So when we start talking about things like technology and adoption of technology and how we can utilize it this is interesting to me, this “To Err is Human” report. And it is interesting to me that a decade after that report came out there really was not that much change that had happened.

The other disconnect that I have and I am quoting Professor Britt who is a past president of the ACS, he says, “Imagine what the public outrage would be if you had nearly five full Jumbo Jets that crashed every week!” There is no way you would tolerate that right, five jets going down every week. That is the equivalent of the 100,000 people that die every year from medical errors, complications, people not doing the right thing. Granted, stuff happens. Nobody is perfect and there is never going to be a zero complication rate but clearly some things are preventable.

The other thing I am going to plant seed-wise – since it is fun to kind of throw these little seedlings out there – Grand Theft Auto Five. Is anyone a gamer? Does anyone play video games? Maybe I guess I’m dating myself a little bit, I grew up with games. It is a game that you can play on your Playstation or your Nintendo and it was released just this past year. It is an amazing game. It simulates an environment that is like crazy, it is unbelievable, it is awesome. It grossed eight hundred million dollars in the first 24 hours of release. Within 72 hours it had grossed over one billion dollars. It is a video game that does simulation, simulates this sort of crazy, not for kids, environment. When you look at what simulation is to the medical industry the total value of simulation to the medical industry is small. This is the whole medical industry. It is less than eight hundred million. So here is a weird disconnect. I have a video game that makes over a billion in three days and I am looking at five jumbo jets crashing every week thanks to preventable medical error and as a society we have invested less than eight hundred million in medical simulation.

I am not surprised that robotics looks like crap when you put it out there because we are going about it the wrong way. As society maybe we are more interested in amusing our young generation in video games and we are not so concerned about working on things like simulation to better understand adoption of technology for a disease state.

I can tell you our pilots they simulate. I am going to be flying out of town tonight and I can definitely tell you I am not getting on a plane that somebody does not have currency in and has been simulating and doing things. I am working with certain companies just to figure out how can we take technology and utilize it like this to teach people how think through surgery now. Not only do you need technical skill, which everybody always thinks “oh you have to have technical skill to do things” but you have to have cognitive skills too. You have to be able to think through a procedure – so what if you have good hands but you have poor judgement intraoperatively to make the right decisions? I am working with a group of individuals, brilliant engineers on how to take hysterectomy, which is a common procedure, and teach people to be a thoughtful surgeon for crying out loud. Sow what if you have good technology but you cannot think through it.

At the end of the day when you look at laparoscopy went through the same kind of machinations. Let us make sure that we do not beat on it too much before we fully understand the context with which we need to evaluate it. To me that is the thing that is what frustrates me. We have to understand the context with which to evaluate it. That was my point when I did a recent editorial and actually Jon did the counter piece to this in the Green Journal. I think the glass is half full. I do not think it is half empty. We just need to be the ones driving the bus so when we think about cutting on a patient using a robot we have a lot of things to weigh. Do I do conventional laparoscopy, do I do robotics? We should be doing that.

I think it is great to have these discussions even though I joked about it at the beginning because it does keep – Jon keeps me grounded actually. I value my friendship with him because he challenges me surgically to think about what I am doing. Just like I know I challenge him to think about things differently. In fact I joke with him I say, “You talked about 3D, dude you’re one step closer already, 3D isn’t 3D with conventional laparoscopy all you need is a wrist and you are a robotic guy dude”. But I think it can impact endometriosis management.

I am going to end with a couple of quick videos here. This is just a video I am going to play in fast forward to you here. This is invasive endometriosis surrounding a ureter. To me, my surgical bias is do I necessarily need a study to tell me that it is advantageous for me to be able to see that when I am operating in 3D but to have a wrist that can turn around and shave this thing off in whatever direction I feel is necessary to carve this disease off this ureter – endometriosis on the ureter. To me, I do not need a study. I always joke with people, “I don’t think we need a study, a randomized controlled trial to tell us that jumping out of plane with a parachute – that the parachute is a good idea”. Parachutes are a really good idea if you are going to jump out of a plane. There is no randomized controlled trial that proves that that is better than jumping out of a plane without one. But we accept that for what it is worth. To me some things in life I think are self-evident. I am blanking right now on the Latin term for that, I took years of Latin. But there is a phrase for that. It says it is self-evident to me that that is a beneficial thing.

Here is one other quick video to share with you before I end here. I want to make sure I stay on time. This is just again Jon showed you rectovaginal disease. Again, you can tackle it with this technology but I know that I would not be able to do this if I did not study the biology of the disease and know my anatomy and understand how it behaves in a pelvis and be mentored properly. I would be dead in the water. I am able to do things with the technology that maybe other people cannot. To me, if somebody cannot use it that is okay. It is not for everybody. To me, again, it is a choice. It is a preference. You choose your tool, learn it well, be the master of that tool and be thoughtful about it and critical but let us not necessarily throw it out prematurely because it is not going away. It has been around now and FDA approval was in 2005 just for this one company’s technology. It is like nine years later.

Clearly, if we were having this discussion a year after FDA then I could say maybe it will not make it but nine years later? I think it is pretty much here to stay. It is going to take a new form as we move forward in the future. It is going to change its shape and morphology a little bit but clearly you can see here basically outlining the bowel. You know what is fun to do? Jon actually in his video that he showed, one of his early ones is very similar in that we do the same things. We circle the dragon so to speak. We get in laterally, we isolate those spaces. Then we go for the tough part in the middle. We take the low hanging fruit or take what the defense gives you. Then you work and then you – this particular case actually happened to be one where we did have to take the bowel because she was severely constricted. There was a big stricture evaluated together with our colorectal surgeon. We went ahead and took that out. I am not going to belabor the surgical video but again, very similar pathology to what John showed. Here it is here, the bowel is here in the posterior cervix and vagina. Again, I do not miss the haptic issue because I learned to compensate for things visually. I follow very carefully tissue deflection and how tissue behaves and what fibrosis is and what normal tissue is. If you understand those things then it is really not an issue to not be able to have your hand down there the whole time doing things like compensating for other ways.

Here we are now into the rectovaginal septum. That is a big blow for freedom right here. There is the back of the vagina, nice and freed up. Then of course, once we do that then we work on mobilization of this distal rectosigmoid. Here we are starting some of that and we basically do a retro rectal dissection right here to get this lifted up. You can see here we are retro rectally the bowel is anterior now. We are all the way down to the pelvic floor. Here is the disease segment and we come in with a stapler, staple this and we reanastomose it. We do this collaboratively with our colorectal surgeons. I am just going to fast forward so you can see what the finished product looks like. That is the before and then you can see how things are much more opened up and the diseased bowel is now gone.

There are other burgeoning technologies like Farfly which may – again I am not a big believer this is going to solve the problem – but at least people are looking at that. Can we light it up better? I do not think this is the answer I can tell you that but at least there is potential opportunity that we may be able to enhance how we visualize things.

In the end I think it is going to continually evolve – bottom line. Jon is right. We have the same goals here. We have high standards for what people need to know and do before they go in there. It is a privilege to operate on a patient and I never forget that. We need to have high standards, we need to strive for 100 percent perfection and we need to understand the technology. I think critical to the success of things like robotics will be knowing what the limitations are and knowing what is critical, what I call mission critical necessary, to make that technology succeed.

Thank you very much.