We are very lucky to have the opportunity to interview Dr. Gregory Weinstein, Professor and Vice Chair of the Department of Otorhinolaryngology, Director of the Division of Head and Neck Surgery, and Co-Director of The Center for Head and Neck Cancer at the Hospital of the University of Pennsylvania .
Today we are going to be talking about a fascinating new technology available to patients at Penn: the daVinci Robotic Surgical System.
Dr. Dolinsky: Dr. Weinstein, thank you so much for joining us today. Let's start from the top – what exactly is the daVinci Robotic Surgical System, and how does it work?
Dr. Weinstein : The daVinci Robotic System has been used for a number of years, both in the United States and abroad. There are 305 of these robots nationwide as of this year. The way that the system works is that the surgeon sits at a console where he or she operates with joysticks, using his or her fingers. The surgeon looks through a scope that has a 3D picture of whatever is in the visual field. It is like looking right at the patient. It has a bedside cart that the console is wired to, and the cart has four arms, although we only use three of them. The middle arm has an endoscope on it that has two cameras that allow for stereoscopic vision. The two lateral arms are long fit arms that are either 10 mm wide, 8 mm wide, or 5 mm wide, and they are quite long. At the very end is the working end of the instrument. There are a variety of different instruments that can be used .
Essentially, the end of the instrument moves exactly like your hand does. It is as if your hands miniaturized and in whatever small cavity is being operating upon. The system has perfect movement with 6° of freedom, so it actually completely reflects the wrist.
Dr. Dolinsky: This is certainly a different approach to surgery than the traditional methods – has it been difficult to learn to use this system?
Dr. Weinstein : It has a very short learning curve. For instance, studies of this system have compared students [who have] almost no experience [with] throwing sutures in laparoscopic cases to standardized laparoscopic experts; the students were doing almost as well as the experts in a very short time because it is so intuitive. Thus the name of the manufacturer, Intuitive Surgical.
Dr. Dolinsky: Has it been used for any other surgical sites? If so, which, and how are the results?
Dr. Weinstein: It has been estimated that 10% of radical prostatectomies were done robotically last year in the United States . So radical prostatectomy is a popular procedure for this system. It is also used for cardiac procedures, other urologic procedures, and now it has been approved for gynecology. Essentially, anywhere that laparoscopes can be used - this overcomes the deficiencies of laparoscopic surgeries.
Dr. Dolinsky: What types of deficiencies?
Dr. Weinstein: Deficiencies of laparoscopic surgery are that they tend to be one-handed, because you have a video scope and you have a handing scope. Even if you have two hands, you have a fulcrum effect because of the abdominal wall. If you want your instrument to move one way, you have to move your hand the opposite way. It is counterintuitive. It does not have the degrees of freedom of your wrist at the end of the instrument, because the working end is at the tip of a long instrument that is now in the body cavity. The value of the daVinci system is that you can use both hands, and the working end of the instrument moves the way your hand does.
Dr. Dolinsky: Is anyone else using the system in a similar fashion?
Dr. Weinstein: We were the first in the world to apply it to trans-oral work. We are the only center in the world with an IRB-approved study to look at this, and in fact the only center right now reporting on this. Drs. Hockstein and O'Malley, from our department, first started with mannequin and cadaver work and figured out how to use the scopes to get into the mouth, then we moved up to animal models. We now have an IRB-approved protocol where the primary endpoint is exposure. The question is, can you achieve the exposure to do the procedure? And if you can get the exposure to do the procedure, you do the procedure. That is the way the study works. We are also looking at secondary endpoints of safety and efficacy.
Dr. Dolinsky: How many cases have you done? And how have they gone?
Dr. Weinstein: We have done 19 cases to date. That includes supraglottic laryngectomies for supraglottic cancer, numerous tongue base cancer resections, and numerous tonsil cancer resections. It included two cases so far where the resection that we did would, in typical hands, have required a jaw split and a free flap reconstruction. In one of them, we didn't do any reconstruction, and we are just letting it heal by secondary intention. In the other, we actually avoided the jaw split, did the resection, and then brought the flap up through the neck. That saved the jaw split plating, significant swallowing and dental problems for the patient, time in the operating room, and cosmetic deformity.
Dr. Dolinsky: So you answered a bunch of the initial questions I had for you. Besides yourself, who else is doing this?
Dr. Weinstein: Dr. Bert O'Malley, the Chairman of the Department of Otorhinolaryngology: Head and Neck Surgery. We do most cases together, it is important to stress that. The whole project began as a resident's project and the fundamental work was done under the guidance of Bert O'Malley. One of our former residents, Neil Hockstein, did the first mannequin and cadaver work out at the company in California . Then, Bert and I have brought it to the clinical arena. Both Bert O'Malley and I are the principal investigators on the study.
Dr. Dolinsky: Have you encountered any complications with the system?
Dr. Weinstein: We haven't had any complications so far. And we don't think the complications of this surgery, using the robot, are going to be very common. At this point, it is looking as if it is going to be no greater risk than doing standard trans-oral surgery. It also allows us to get to places we couldn't get to before.
There is no standard trans-oral technique giving good access to the back of the tongue because of line-of-sight problems. Traditionally, when you are working on the mouth, you are using long instruments through the laryngoscopes (which are very tight tubes), and you are looking straight down through a microscope which is outside [of] the patient. With this system, we have 30° scopes that can look up and instruments that can then be positioned to cut around the tongue base. In the past, the limitation of trans-oral resection of tonsil cancer was that it couldn't involve the tongue base. We are doing radical removal of the tonsil plus the tongue base through the mouth, a surgery which heretofore required a jaw split to get access. Some cases need reconstruction and some cases don't need reconstruction at all.
The key thing in head and neck cancer is that if you can get negative surgical margins, you really impact favorably on the patient's outcome. All of our margins have been negative so far. We had a close margin in one patient, but we were able to go back and re-resect.
In addition, if you can perform surgery and follow it with chemoradiation or radiation afterwards without worsening the outcome in terms of function, then there is really no downside doing the surgery to improve local control. If the surgery is not going to impact on function (which it doesn't appear to do when we perform it trans-orally in these types of cases), then there is no reason not to do it.
Dr. Dolinsky: This sounds like a great choice for patients, but I was wondering if there are specific contraindications?
Dr. Weinstein: There are preoperative and intra-operative exclusion criteria. Pre-operative contraindications include: unexplained fever, untreated active infection, pregnancy, previous head and neck surgery that precludes trans-oral robotic procedure (in other words, if the prior kind of surgical procedure does not allow me to get into the mouth), and the presence of medical conditions contraindicating general anesthesia or trans-oral surgical approach. Intra-operatively, [an exclusion criterion is] the inability to adequately visualize the anatomy to perform the diagnostic or therapeutic surgical approach trans-orally.
Dr. Dolinsky: Do these surgeries take about the same amount of time as standard oral surgeries?
Dr. Weinstein: They are taking less time. That is a very good question. For instance, a patient I did recently (my last case was a tongue base/ tonsil cancer) had his procedure in about 2 hours or so - counting resection, frozen sections, everything. He will come back to have another procedure for the neck (neck dissection), which is a staging procedure. He is going to avoid a tracheostomy, and the neck dissection will take about three hours.
The traditional approach to a tongue-based tonsil cancer, if you can use primary surgery, is a 15-hour procedure, with a jaw split, tracheostomy, and 8-day hospitalization. It is going to be much less than that for him.
I have another example. The two supraglottic cancers we did - one of them had perfect exposure and it took us about 2 hours. In another case, the exposure was not as good and it took a little longer. But, it was a good procedure and it turned out fine. A traditional laser supraglottic laryngectomy (which is very popular right now trans-orally for T1, T2, and selected T3 cancers of the supraglottis) takes me about 3 to 3.5 hours to perform.
In general, my expectation is that the robotic surgeries will be either faster, or take the same amount of time, but with better visualization because of the optics. So it will have other advantages besides time. That is my general impression at this point. It is certainly not taking longer.
Dr. Dolinsky: So what would you say the major advantages are?
Dr. Weinstein: One of the major advantages we already discussed is the length of the procedure. Another is that we are also going to have improved vision and magnification with high-end optics. The ability to use two hands, without the fulcrum effect present in standard endoscopic approaches, is certainly an advantage, as is the ability to use a miniaturized electric cauterer in places that we couldn't get to before. The high magnification 3 dimensional camera and endoscope that is very near to the surgical site allows us to see, dissect, and control critical nerves and blood vessels that we typically cannot see well or deal with when working through a tubular laryngoscope using a hand help endoscope or even with loops or a microscope used at a distance from the actual site of surgery in the mouth. Those are going to be the main benefits to the surgeon.
The main benefits to the patient are going to be (in many cases): avoidance of tracheostomy, avoidance of a long procedure that requires complex reconstruction, and a minimally invasive approach that will decrease patient's rehabilitation time. Those are the kind of things we see down the pike for patients. I am giving you a gestalt because I have not analyzed this. But that is my prediction.
Dr. Dolinsky: What do you think about the future of robotic surgery?
Dr. Weinstein: I think that the future we are going to see is very exciting. First of all, I think that there are going to be new instruments that come along that allow us to do even more robotically. Robotic surgery is going to be one additional tool that is in our armamentarium for selected patients, but it is not going to replace everything. It will take a few years for us to figure out which are the ideal cases. But, it will be an important tool for selected cases to help us eradicate cancer and improve function.
Dr. Dolinsky: Any ballpark estimates on what percent of cases will be done this way in the future?
Dr. Weinstein: It is hard to say. It is hard [to predict] with new ideas and new technology. It is always complicated to see how these things are going to catch on, but our key focus is development first, and then teaching second.
Years ago, (in the late 1980's and early 1990's), I introduced an operation called the supracricoid laryngectomy to the United States from France . I am not sure if you are familiar with it, but it is now a standard operation. It took us about 10 years for it to be in the text books, written about widely, done nationally in numerous institutions, and considered part of the standard-of-care based on practice guidelines from various organizations. The way that happened, in my opinion, was not only by doing it and proving it could work, but by spending time teaching it. A major focus is to first perfect the technique, which is what we are doing now, and then the second major focus is going to be teaching it. Teaching it by publishing, by giving lectures and CME courses. If you don't teach it and get it out there, then it's like it doesn't exist. Those who want to learn will learn it and we will see if it catches on. It will only catch on if it is of value and is used efficiently and effectively.
Dr. Dolinsky: If you encounter specific limitations to the system, is there a way for you to suggest improvement to the company,? Or do you think that, at least currently with what you have seen, everything seems to be working the way you would like it to?
Dr. Weinstein: We have everything we need right now for all that we are doing, but we are working on ways to improve the instruments and design new instruments that will be useful specifically for Transoral Robotic Surgery.
Dr. Dolinsky: If you were a patient, what do you think the best reason for enrolling in the study would be?
Dr. Weinstein: I think there are a number of reasons a patient may benefit. They may benefit by avoiding a tracheostomy. I think we are seeing faster rehab in functional recovery. When it comes to things like not having to have your jaw split, it is less surgery, less deformity, and less pain.
It is another surgical tool, it is just a highly, highly, sophisticated surgical tool. Although it is called a robotic system, remember, this is not an independent robot like you might see in the cinema. I am kind of digressing here to make a point. I told my uncle, who is 85, that we are doing this, and he replied that he didn't want a robot operating on him. The reality is that it is not a robot operating on you - it is the surgeon. Unless you are in there and your head is in the goggles and your hands are on the controls, the system will not work. It can't do the surgery for you. It is a tool. It is an extension of the surgeon. To me, the benefit is going to be allowing us to do very complex, sophisticated, successful surgical operations, without having to do very wide surgical approaches that we had to do in the past.
Dr. Dolinsky: Based on the way this works, would it be possible, with Internet connections, to operate on someone from across the country?
Dr. Weinstein: Yes. There have been a couple of experiments with that. There was one many years ago where they operated on a gall bladder across the Atlantic across telephone lines. Then there is a group in Canada using a prior iteration of this machine called the “Zeus” (which you can find on the Internet). They reported 21 cases where the patients were 400 km away, with two surgeons working across ISDN lines.
There are complexities that need to be worked out in terms of latency, broadband width, and the integrity of the connection. We are actually extremely interested in this here at Penn. But the complexity of what you are describing, which is tele-surgery -- we are very close to having the technology to do that. It is all the other issues that go along with it that will be the impediment for its success -- issues like insurance, patient acceptance, and physician acceptance.
I do see tele-surgery in the future as [a solution] to a major crisis in American healthcare, which is the lack of specialists in rural America . If you had a person who is trained as an assistant who can take care of surgical complications and who knew the rudiments of the case, while the highly-specialized person is at a hub somewhere else, actually performing the surgery - you might be able to deliver healthcare to a section of society that presently doesn't [have access to it], and I think that is an exciting prospect for the future.
In fact, trans-oral robotic surgery would be the ideal area to start that type of surgery, because remember, for every other type of surgery, you have to make incisions to get in. But here, the orifice for getting into the patient is already there - the mouth. The risks and complications for this type of approach will be much lower. It makes some sense to start in that arena. But at this point, that is science fiction. And I would prefer to limit our discussion to science fact.
Dr. Dolinsky: How would a patient go about enrolling in your study?
Dr. Weinstein : They would call the office at 215-349-5390, and we could set them up for an appointment.
Dr. Dolinsky: Very good. Is there anything else that you would like to add?
Dr. Weinstein: Did we cover all the questions that you had?
Dr. Dolinsky: We have covered all the questions I wanted to ask.
Dr. Weinstein: I think that getting the word out it is important, because I think this will have an added value. And I think for Penn and our department, it is an exciting thing that is going on. This is the only place in the world that is doing it right now.
Dr. Dolinsky: Thank you so much, Dr. Weinstein, for joining us today.
Dr. Weinstein: It was my pleasure.