da VINCI ROBOTIC-ASSISTED PROSTATECTOMY SENTARA NORFOLK GENERAL HOSPITAL NORFOLK, VIRGINIA August 8, 2007

Transcription

1 da VINCI ROBOTIC-ASSISTED PROSTATECTOMY SENTARA NORFOLK GENERAL HOSPITAL NORFOLK, VIRGINIA August 8, :00:11 ANNOUNCER: Welcome to Sentara Norfolk General Hospital in Norfolk, Virginia. Over the next hour you'll see a da Vinci Robotic-Assisted Prostatectomy. The da Vinci Prostatectomy is setting a new standard for the surgical treatment of prostate cancer. Doctors are able to perform surgery through a few small keyhole entrances in the patient's abdominal area. The da Vinci system uses very tiny and precise instruments that allow the doctor to operate with great precision. The patient's prostate gland is removed while the surrounding tissue is preserved. The potential benefits include a shorter hospital stay, less pain, less blood loss, and a quicker return to normal activities. OR-Live makes it easy for you to learn more. Just click on the "request information" button on your webcast screen and open the door to informed medical care. Now let's go live to the operating room. 00:01:07 MICHAEL D. FABRIZIO, MD: Hi, I'm Mike Fabrizio. I'm an urologist here at Sentara Norfolk General Hospital, and we'd like to welcome you to the program. We are in the midst of a live robotic radical prostatectomy for a patient with prostate cancer. We're joined by my partner, Dr. Ray Lance, who will be performing the operation, and I'll be commenting. I'd like to tell you a little bit about the Sentara organization. It's a not-for-profit healthcare system with seven hospitals in our region. It has a 325-member physician health group and a 340,000-member health plan. We serve a very large area in eastern Virginia and eastern North Carolina, and we'd just like to welcome you today. We're the largest robotic program in the state of Virginia. We've performed over 580 robotic radical prostatectomies as well as another 168 laparoscopic radical prostatectomies, bringing us over 750 procedures to date. We also are one of the few programs in the United States that keep a prospective longitudinal quality-of-life outcome database comparing all of our treatment modalities and our outcomes. We currently have three fellowship-trained urologists performing this procedure: myself, Dr. Ray Lance, and Dr. Robert Given. And there are many benefits, really, to this procedure as I see it. It really is involving recovery: we have smaller incisions, shorter hospital stay, shorter catheter times, and significantly less blood loss compared to the standard open operation, which I think equates to faster return to normal activities. Additionally, the robot offers 10x magnification with a three-dimension view, and it also allows us to articulate the wrist in at least six degrees of freedom so we can move the wrist just like our hands, and I think that is a benefit to us. As you know, prostate cancer is very common, one of the leading causes of cancer in men. It's detected by a digital rectal examination and a prostate-specific antigen. Unfortunately, a majority of men do not have symptoms, and that's why it's very important to be screened for prostate cancer. And those screening recommendations are really based on a family history: if you have a positive family history with a father who had prostate cancer, you should be screened starting at the age of 40. If you're African American, you should also start screening at the age of 40 with a PSA blood test and a rectal exam. So I'd like to bring you to the operating room now and introduce my partner, Dr. Ray Lance, who is in the midst of the procedure. Ray? 00:03:40

2 RAYMOND S. LANCE, MD: Thank you very much. Appreciate the opportunity to be part of today's program. My name is Dr. Ray Lance. We are in the operating room in the midst of this operation. I'd like to take a few moments to introduce some of the other team members. I'm obviously seated at a console removed from the operating table. At the operating table assisting me are Dr. Tristan Barry, one of our fellows here in laparoscopic urology, as well as our chief resident, Dr. Christopher Toperra, also operating room nurse Shannon Miller as well as our technician, Jennifer Danner, and our anesthetist, Roxanne. So at this point I'd like to take a couple minutes if I could and show you where we're at in the operation. What you can see here at this point is that we have divided the dorsal vein complex. We're taking the bladder down. The urethra can be seen here very nicely. The dorsal vein complex has been stapled. The shoulders of the apex of the prostate are evident here. You can see essentially where the division between the bladder and the prostate gland exist and we'll slide the catheter down a little bit now so you can see that. There's a Foley catheter with a balloon in. You can see the balloon of the catheter as it slides down it shows us very nicely that arrangement. And you can see to the sides the prostate gland there's neurovascular tissue that's out here on either side of the prostate, which we've dissected away. Now we will further delineate that as the operation proceeds. So at this point our next steps will be to proceed now with the division of the bladder and the prostate gland. 00:05:27 MICHAEL D. FABRIZIO, MD: So that's beautiful, Ray. I'd like to switch to the opening of the operation. We'd like to show you how we got to this point in the setup. And we'll go through that with you right now. So as you can see, we have to make several small little holes in the abdomen. It requires some precise measurements. We use a ruler to actually mark the distances between what we call the ports, or the trocars. These are the devices which allow the instruments to be placed in and out of the abdomen. We have to have some very specific measurements in order to allow room for these instruments to be placed. We make an incision, we place our first instrument, which is the camera port, and it's right around the belly button, or the umbilicus, and we place this port into the abdominal cavity, which has actually been blown up or insufflated with carbon dioxide. So his entire abdomen is filled with carbon dioxide right now and we're placing this port into the abdomen. And now we're going to place a camera into this port and under visualization we're going to place the remaining trocars into the abdomen. These are 8-millimeter incisions that we're making now, so they're not very big. And once again, all placed under visualization to avoid any injury to any of the vital structures. Once we get all these ports placed into the abdomen, the patient is tipped a little bit, so some of the abdominal contents go away from the pelvis. We're operating in the pelvis, which is far away. And you'll see that in just a second. Once all these ports are placed and the patient's in the proper position, then we bring the robot, which you'll see in just a minute, to the patient. Dr. Lance is operating at a console in the corner of the room. You can see the console there. Here comes the robot with the multiple arms. We have four arms on this robot. We use one for the camera and the other three to hold our instruments which perform the operation. And we bring the robot, which weighs about 2,000 or 3,000 pounds, over top of the patient in a very secure fashion and dock the robot. Here we're docking the robot to these ports. They snap into place. And that takes a few minutes. From the time that we actually get into the room and the patient goes to sleep and we get everything positioned, ready to start the operation, it typically takes 20 minutes to a half-hour of time. So the next step here, I wanted to show you a brief animation -- okay -- we wanted to show you a brief animation of what we're actually doing in this operation is Dr. Lance nicely illustrated the anatomy beautifully, has done a great job with this procedure. The prostate sits in front of the bladder and you're taking the prostate out and sewing the bladder back up to the urethra, so you're disconnecting the prostate from the urethra and the bladder and then sewing the bladder back up to the urethra. And we're going to go ahead and show you this animation right now. Here you can see the console on the left and the robot on the right. And the surgeon is looking in the console. And that

3 console, once again, when we're looking in there, we're seeing the entire procedure in three dimensions. It's like a 3-D movie. When you're looking at it here on the screen on the Internet, you're not quite seeing that. You're in two dimensions. We use our fingers to control the instruments. We essentially use two fingers in each arm to control the entire instrument. As you can see, it moves and rotates and articulates around in a very precise fashion. We use our foot pedals to alternate between the instruments, and we use our foot pedals to help us control the camera as well. This is a diagram of the prostate, which sits in front of the bladder. The bladder's to the screen right, the prostate is sitting right there, the instruments are pointing at it. There are nerve bundles that run alongside the prostate which in some cases should be spared to help with erectile function after the operation. Dr. Pat Walsh described this many years ago. And essentially what we're trying to do is remove the prostate gland, separate it from the bladder, which is right there, and separate it from the urethra, which is on the other side, and essentially remove the prostate and then sew the bladder back to the urethra. And in some cases in selected patients, we do spare the nerves. In fact, in a majority of our patients we'll spare the nerves. And here you see very easily depicted the prostate removed. It's unfortunately not that easy. There's a catheter that's placed and then we sew the bladder back to the urethra at the end of the procedure, and that catheter stays in about five days to seven days. And that's one of the benefits. So without further adieu, I wanted to go back to Ray and see where you are in the operation, Ray. 00:10:40 RAYMOND S. LANCE, MD: Yeah, basically where we're at now we've just already divided the bladder and the prostate. What you can see is the catheter here is -- the bladder neck has been disconnected from the prostate. That Foley catheter, which is now inside the prostate, has been brought up to the abdominal. We secure it with a little suture that we pass with a little special device called a Carter-Thomason system, and essentially the opening of the bladder can be seen here very nicely, the mucosa. 00:11:08 MICHAEL D. FABRIZIO, MD: So that's the bladder. That's the portion that we're connecting back down to the urethra at the end of the operation. 00:11:14 RAYMOND S. LANCE, MD: So essentially we're going to now begin to dissect down toward the -- toward the ampulla of the vas deferens. 00:11:21 MICHAEL D. FABRIZIO, MD: Right, so beneath the prostate gland -- underneath the prostate gland are the vas deferens, which carry the sperm from the testicles, and those have to of course be separated as part of this operation. And the seminal vesicles, which store the sperm and provide fluid, are also located in that area, which also have to be dissected. So right now he's trying to separate the bladder neck from the base of the prostate. The prostate's very close, just on the front edge of where he's cauterizing. And you'll notice here that he uses cautery only in the very center portion. He tries to limit his cautery as he goes out towards the sides because that's where the nerves are getting close. And you can see right now he's in the right plane, he's gone right into the plane there underneath the prostate, very nice. And the bladder is separating. The -- on either side of this screen, the right and left-hand sides, are the vascular pedicles. They're the blood supply to the prostate gland.. Those will also have to be divided, and we typically use clips, as you'll see in just a minute. But the first step is to actually get in here and dissect out the vas deferens and the seminal vesicles, and that takes a little bit of time. This is a part of the operation when you're sparing the nerves and dividing the vascular pedicles and dissecting out the seminal vesicles, you know, can take a little bit of time. Beneath that area is the rectum, and we want to avoid any injury to the rectum, and that's why great care is taken to perform this. I wanted to briefly talk about prostate cancer and why we may be seeing more and more of it in the future. As you know, the baby boomers are aging, and as you

4 can see from this slide, in the year 2020 we're going to have a large number of patients who are in that age range who have prostate cancer. Also, the death from other illnesses, including heart disease, is plummeting. So patients are not dying of heart attacks and cardiac disease as much as they were previously, so they're living longer, and when you live longer you're more at risk to develop prostate cancer. And there may actually be a rising incidence of prostate cancer. Here you can see the number of predicted cases that we'll have in the year 2025 and So it's an important health issue and I think something to take note of. What I wanted to show with this slide is that prostate cancer treatment options are somewhat confusing to the patient and also the physicians. The problem with deciding which treatment to have for prostate cancer, whether it be watchful waiting, hormonal therapy, cryo-ablation, which is freezing, radiation, either the seeds or the external beam or the radical prostatectomy, is the fact that we have very few trials -- and we call them level 1 trials, which are actually the best studies in medicine -- that actually compare one particular method to another. And in fact, in all of urology, we only have three of those trials, and two are with just comparing watchful waiting and one is external beam. That's it. So that's -- it's difficult, and it's difficult to actually tell the patients exactly what the right approach is. It's a very individualized decision. So I wanted to go back to the operative footage. You're seeing that now. Ray is taking out the ampulla vas deferens here. He's dissecting it out, and you can see it's a tubular structure, and that's what he's trying to do. 00:15:22 When you look at the treatment options for prostate cancer, the first thing patients want is cure. And then they -- once they get the cure, then they're worried about the quality of life issues: continence, the ability to stay dry, not leak on yourself; and potency, the ability to maintain erections. And those are very important when you're looking at the outcomes. And what I wanted to basically talk about is quality of life, and that's really what we're talking about here. Because if you choose cryosurgery or radiation or radical prostatectomy for patients with clinically localized disease, the majority of those patients will be cured by those methods. So then you're left with what gives me the best quality of life, and that is an important -- I think that's going to be very important down the road in patients selecting their treatment. And I'll go through some of those slides. 00:16:19 Right now if you could look at the webcast, you'll see that Dr. Lance is now dissecting out the vascular pedicles. He's trying to gain a little space in order to isolate the vascular pedicles and the seminal vesicles. Now once again, this is a more time-consuming part of the operation and it takes great precision to do it. But the first thing you can also see is that those instruments are moving. He's able to articulate those in different planes, all with the control of his fingers. Additionally, you can see the magnification that we're at right now just based on the footage that you're seeing. 00:17:07 I'm going to switch over to some slides again and just basically briefly touch upon our program here. We attempted our first two cases in 2000, so we've been doing it a long time. And in 2001, we actually had a mentor from Berlin, Germany, who had one of the largest experiences in the world, Dr. Turk, come and mentor us through the laparoscopic radical prostatectomy. And at the time, there were less than a handful of people doing it in the United States. And we continued for about 168 cases and then became involved in the FDA trial with the ZEUS robot and subsequently purchased a da Vinci robot in That company, Intuitive Surgical, bought Computer Motion, the other company, and essentially eliminated that robot platform, the ZEUS system. So right now there's really one robotic platform out there. 00:18:06 The technique for the procedure, we're using general anesthesia. The patient is positioned appropriately and the ports are placed as we described. And here you can see once again

5 these are the ports that he's working with if you just wanted to see on the web here this picture of the various trocars. These are the distances we typically mark between port sites. The first thing that Dr. Lance did before we went on the web, he dropped the bladder, he freed up the bladder, and mobilized the prostate. And he also divided the dorsal venous complex, which is the main venous complex actually that drains the penis and actually has to be divided at the time of the procedure. And then he opened what's called the endopelvic fascia, and that's where you joined us. He had opened the endopelvic fascia and now is separate the bladder neck from the prosthetic base. He's trying to mobilizing those ampulla and the vas deferens and the seminal vesicles, and we'll go back to that in just a minute. 00:19:19 His next step after mobilizing that will be to free the prostate off the rectum and open up what's called Denonvilliers fascia. And once the prostate's mobilized off the rectum, he can free the neurovascular bundles, which are basically those bundles of nerves that help with maintaining erections. And he'll also secure the blood supply to the prostate gland and divide the blood supply to the prostate gland. And then the last couple steps, he'll immobilize the urethra, dissect out the urethra, and then perform the anastomosis, which is the connection between the bladder and the urethra. All right. 00:20:04 We have some Internet question which we thought may be useful. And the first question that we had was, "My father and my uncle both had prostate cancer. What are my chances of getting prostate cancer? When should I start screening?" And as we stated earlier, if you have a strong family history like this gentleman, you should start screening at the age of 40 with a digital rectal examination and a PSA blood test. That age actually may even be creeping down to getting a screening PSA at 35, 38 years of age. And then if that's very reasonable or well within normal limits, you can wait until the age of 40 to start on a yearly basis. A second question was, "Are there some prostate cancer patients who are not good candidates for robotic surgery?" And the answer to that is yes, but most patients are good candidates. The ones that aren't good candidates are the ones who have significant lung problems. Any patient who has a life or survival -- potential survival of 10 years or more is a candidate for treatment of prostate cancer and prostate cancer surgery, so unless you have significant lung disease, history of cerebral aneurysms, history of multiple abdominal procedures which may make a lot of adhesions, you are a candidate for that surgery. 00:21:30 We have another question: "With the regular way of removing the prostate, is there -- there was a chance of impotence with the open radical prostatectomy. With this procedure does the risk of impotence decrease?" And that's a great question. And the answer is no. The risk of impotence is the same. If you go to a very good open surgeon, a good robotic surgeon, a good laparoscopic surgeon, the risk of impotence is about the same in those series. So this probably doesn't improve the impotency or the potency rates dramatically, but what it does give us is less blood loss. We can virtually guarantee -- and I say virtually because nothing is 100% -- that we will lose very little blood and that you will leave the hospital the next day and your catheter will be in five to seven days and that your recovery will probably be a little quicker than if you had an open operation in most series. But the chance of potency and the chance of incontinence if you go to a very good surgeon are probably equal. 00:22:37 And we have a question here about "What is the size of the incision that actually removes the prostate gland?" We make a very small incision, probably on the order of an inch or two, to extract the prostate at the level of the belly button, or the umbilicus. And the last question we have here is "What is the risk of prostate cancer spreading?" And that all depends on the amount of cancer that you have and the grade of cancer, which we won't go into here. And I think that's it for the questions for now. 00:23:13

6 I'd like to go back to the operative footage here, and you can see that Dr. Lance has dissected out the vas deferens. Those are the ampulla of the vas deferens. And he's getting ready right now on the right and left-hand sides, you see those two white structures. Those are the seminal vesicles, which store the sperm, and he's going to dissect those out as part of the procedure, and those will be included with the rad-- with the prostate itself. And so he's going to grasp those and dissect these out. There's a very thin layer over top of these, and he's judiciously using electrocautery here in order to dissect these structures out, once again, thinking about the neurovascular bundle. There are several subtle differences in the way you can perform this operation, all accomplishing the same task. There's different instruments. Here he's using a [Maryland] bipolar. The other instrument, you can use a different type of bipolar, a wider grasper. There's minor differences in techniques. But here you can see he's working his way down to the seminal vesicle. The assistant, Dr. Toperra or Dr. Barry, are retracting the bladder with the sucker there. You can see that in the foreground. 00:24:48 I wanted to show you our trends of radical prostatectomies at Sentara. Our volume significantly increased, as you can see from this slide. In 2004, the number of robotic procedures and laparoscopic procedures exceeded our open and peritoneal series, and that has continued to date. I wanted to go through quality of life. And I think that's important, and I think our institution prides itself, and Dr. Paul Schellhammer created our quality of life database many years ago. He's president of the American Urological Association at this time. And he was instrumental in developing our quality of life database, which we keep prospectively and longitudinally, so we're keeping it on an active basis on all of our patients. The data's blinded from us. We don't see it as surgeons until we extract the data from the database. And we started doing this, comparing all the treatment modalities, in 2001, and I think it's very important. So we're looking at our open operations, which we used to perform, our laparoscopic, and we're comparing that to our da Vinci series. We're also looking at our patients who undergo brachytherapy, which is the seed therapy, as well as cryo-ablation. And I'll comment briefly on these studies. We use a patient survey, and the patients in our program are so dedicated. We're very thankful that we have great patients who complete these questionnaires. They feel out essentially a very detailed questionnaire every three months for two years, and we use that data to look at their urinary function and bother, their bowel function and bother and their sexual function and bother after the operation. And you can see it's a 56-item questionnaire, and these are the specific things that it looks at here of urinary function and bother and sexual function and bother and bowel function and bother. Once again, this is how we are administering these quality of life studies right now. 00:27:00 So when we looked at our data, we really had no differences between age and preoperative treatment PSAs and our cancer scores. And it's very interesting to note that when we compared our laparoscopic approach, our robotic approach, and our open operations compared to seeds and cryo-ablation when you look at urinary function, you can see that the surgical procedures are quite similar when you look at the data. There may be a little bit better function when you have seeds and cryosurgery on a two-year basis. This doesn't capture the radiation complications that may occur after two years. 00:27:48 These are comparing our open laparoscopic and robotic procedures. You can see they track each other. And once again, as I said at the beginning of the operation, if you go to a very good open surgeon, a very good laparoscopic surgeon and a very good robotic surgeon, you're probably going to get same long-term outcomes. The benefit compared to the open operation, and I think even the pure laparoscopic operation, with the robot is a little greater precision, less blood loss, recovery, and perhaps less overall complication rates. 00:28:22

7 These are our baseline functions. If you look here, these are our data, and we keep -- this is just six-month data comparing our open and our laparoscopic and robotic procedures when it comes to function: sexual function, urinary function, and bowel function. And there are really no differences when you look at good series, and that's what this is illustrating. 00:28:45 We also looked at our 12-month baseline scores, and you can see really no big differences here as well. And hopefully you guys can see that here on the web. When you look at the percent of baseline score, and the way we do this is we like to administer these questionnaires before surgery, so we like to know how our patients are doing before surgery and compare them to how they're doing after surgery. And we look at the percent return to baseline score. And here you can see from our urinary function and sexual function and bowel function that the surgical approaches are all fairly comparable and there's no difference, as I pointed out. There may be a slight difference in the seeds and the cryoablation because simply those procedures are outpatient, they don't have to go through the initial hit of recovering from surgery, catheters, gaining their continence back. What this doesn't capture is the longer term sequelae of radiation therapy that typically occurs after the two-year period. And once again, we just followed these out now to 18 months. 00:30:10 So we'll go back to the procedure here for a minute. This is Dr. Lance. He's now almost has the seminal vesicles up and out. You can see the seminal vesicles here are being dissected out quite nicely. They're fairly large structures typically. And once again, they sit really near the rectum, on top of the rectum, so he's carefully dissecting these out. Sometimes after a biopsy, this area can be a little bit scarred in, can make the dissection a little bit more difficult. In the open operation, we would actually sometimes not be able to remove the entire seminal vesicles to their tips. We actually don't see that robotically. We're usually able to get there almost 100% of the time and remove the tips of the seminal vesicle. 00:31:03 This is some great footage here of Dr. Lance operating. His head is in a console looking at the view in three dimensions. His hands are underneath the console controlling the robotic arms. And in this particular instance, he's actually in the corner of the room and the patient is to his back. Here's a great shot of that. The robot is docked to the patient. We keep the room dark so he can see. If we could, I'd like to switch and show what the assistants are doing if that's possible. 00:31:48 These are the assistants, Dr. Barry and Dr. Toperra. Dr. Toperra is now the one actively participating in the case, and he is assisting at the bedside. Jennifer is in the background assisting with the instrumentation. She is helping with the fourth arm, which is on the other side, and Dr. Toperra is actually the one controlling the sucker and helping with the retraction using those devices. So this is really a two-man operation. It is in an open operation as well. You need a good assistant. So it is a total team approach. You need great nurse and circulator and great OR tech. We have two -- we're fortunate here. We have two dedicated teams that are with us all the time. We typically perform two operations. We could do three if we wanted to a day, but we typically do two a day. And there's Dr. Lance again getting ready to operate. 00:33:06 Before I go back to some slides, there are some other questions here that are coming in fast and furious. This question is, "Does the patient need postoperative radiation therapy?" And that'll be determined -- in all likelihood, if the prostate cancer is organconfined, margins are negative, the odds are that patient will not need postoperative radiation therapy. This is a great question: "How many da Vinci operations should a surgeon have completed to be considered experienced?" And a follow-up: "How does one find out how many operations a doctor has accomplished other than by asking him or her?" That's a great question. First, this operation is probably one of the most technically demanding

8 operations. We had the experience of doing it purely lap before really the robot was in existence in 2000, And I think -- and we have actually published an article, the minimum learning curve is 50 operations, and in reality, 100 operations before you feel completely comfortable. Additionally, the -- as Dr. Catalona and others have expressed who have done thousands of open operations, every operation is a learning experience and a learning curve. You're learning something from every procedure. But to answer this question specifically, I would feel comfortable if my surgeon had done 100 of these procedures that they know what they're doing. How does one find our how many operations? Hopefully the surgeon is honest enough to tell you that data and tell you how many operations they've performed. The other way that you can gain access to that information is perhaps the Intuitive Surgical website. They do keep those numbers, I believe. 00:35:00 And another question: "Compared to the open procedure, is it faster to have this done with the robot?" And the answer to that is probably no. It's comparable to a very good open surgeon, once again, or a very good laparoscopic surgeon as far as operative times, once again, with that benefit of low, low blood loss. A question here about prostatitis and whether you're at increased risk for prostate cancer and there's no definitive data to show that you're at increased risk for prostate cancer with prostatitis but you should be screened. The role of tumor markers in the detection of prostate cancer and its prognosis. Another great question. The tumor marker is prostate-specific antigen. That's what we use to detect and screen patients with prostate cancer. It's probably one of the best screening tools in medicine for cancer and it does provide us some prognostic capabilities, very high PSAs, tend to notate metastatic disease. 00:36:21 I'll answer a few more questions and we'll go back to Dr. Lance's operation when he's going to get ready to start the neurovascular bundle dissection, which I think is an important part of the operation. The question here, "What is the growing rate of rural hospitals who perform radical prostatectomies on a regular basis and what is the rate of these hospitals gaining the da Vinci technology?" This technology is growing very, very fast, but once again the problem with rural hospitals is this is a very expensive technology. This robot is $1.5 million and also has a six-figure maintenance contract a year, and for a small rural hospital that may be a lot to absorb. You need a lot of volume to maintain these robots and also to maintain your proficiency, so I think that despite the fact that it is growing, it's probably not growing as fast at rural hospitals as opposed to tertiary care hospitals. Question about kind of pain management used. Well, the patients go home the next morning, so they take some narcotic analgesics by mouth typically and that's about it. So we'll go back to some questions perhaps a little bit later. 00:37:35 Wanted to show you the robot in the room once again. These are the drapes on the robot, the sterile drapes for the robotic arms. You can see Dr. Lance is in the corner of the room concentrating on the operation and once again getting ready to open up what's called Denonvilliers fascia. 00:37:56 RAYMOND S. LANCE, MD: Still working on the seminal vesicle here. 00:37:59 MICHAEL D. FABRIZIO, MD: Okay. The seminal vesicle's a little stuck maybe. 00:38:01 RAYMOND S. LANCE, MD: Yeah. 00:38:02 MICHAEL D. FABRIZIO, MD: Yeah, it looked like it was a little stuck there, which can happen after biopsies. He's now going to open up -- yep, he's got a nice plane there. You can see he's got a lot of space there to go ahead and get that seminal vesicle. We usually grab these seminal vesicles toward the tip and lift them up and basically peel them out of the

9 plane. Dr. Toperra, the assistant, has an important role in retraction right there, and that's how it's a two-person operation. I think Dr. Barry is actually now assisting, who's our fellow in endoneurology. 00:39:10 Okay. While he finishes up with that seminal vesicle and gets ready to start the nerve dissection, I'll go through some of the conclusions and try to put things in perspective here. And really, from our studies what we've gained is that the open procedure to remove the prostate gland, the laparoscopic, and the robotic procedure all impact quality of life in an adverse fashion. No matter what treatment you get, all the patients have some sort of quality of life hit after the procedure. The good news is most men trim back towards baseline. The quality of life parameters appear to be equivalent among all three surgical modalities. And really, I think the future direction of these type of procedures is going to be standardization of training through simulation. And some people would say, "Well, if you're really only equivocal, if it's an equal approach to a very good open series or laparoscopic, why should you do the robot? And if it's more expensive because of the cost of the robot, why should we do it?" I think this is an important slide. Here you see the patient doing dishes in the hospital to try to pay for his bill, and that's I think where we are. But really what we don't look at oftentimes is global recovery. With these minimally invasive approaches patients return back to work earlier and that can save thousands of dollars. And Dr. Bayani had a nice study showing that the earlier return to work with these robotic procedures eliminated the incremental cost of the robot. And the other thing that I think is going to be very important is simulation. NASA, of course, has a simulator for the space shuttle, and if you think about it, astronauts will fly the shuttle back and forth from outer space without ever having flown the shuttle in real-time. They learn all that through simulation. And if they can fly the shuttle back and forth from outer space without actually having done so based on simulator, we can certainly teach physicians how to do this operation with simulation, and that's where we're probably going with these devices. Now that we have a robotic procedure, we're going to be able to do that quite effectively. 00:41:25 I'm going to switch back now to Ray Lance, and this is a very nice image of the seminal vesicle being lifted up. This is towards the end of the seminal vesicle, and there's this layer of tissue over top of it, which he's nicely dissecting out. I think the one thing to note on this procedure when he went to show you the initial procedure, there was not any blood in the operative field, and that wasn't because we prepped it for this Internet connection. There was just no blood loss. And you could see those pelvic nerves, those pelvic plexus, very nicely, and that's the big benefit. And here you can see once again this is typically a bloody portion of the operation in an open procedure. Once again, very, very little blood loss. You may occasionally get a small vessel that you have to cauterize or clip, but very little blood loss. And once you get this last tip of the seminal vesicle out, his assistants will lift those up and he'll go to the next portion of the operation, which is sparing the nerve, which I think a lot of people want to see. Right at the tip of that seminal vesicle is commonly a small artery which he just cauterized, and this seminal vesicle is almost up. 00:43:23 RAYMOND S. LANCE, MD: This is an ampulla that's connected. 00:43:24 MICHAEL D. FABRIZIO, MD: I see. So really looking beyond this actual procedure itself, if we go back to these -- to a few slides that we have here, surgical simulation is going to be used in all aspects of surgery here in the very near future. We're already using it in vascular surgery and even in ureteroscopy, which for stone disease. We're using laparoscopic simulators and soon we'll have robotic simulation. We're also going to have a skill verification. So really, the person is going to be able to perform the procedure 500 times before actually doing it for the first time, and we're involved in some of that research. So that is, I think, the big benefit of these procedures. We're going to have the ability to assess

10 surgeon's skill-set, have a uniform evaluation, we're going to be able to credential surgeons better. Payment may be eventually based on outcomes, so the better your outcomes, the better payment hospitals and physicians will receive that, and that makes sense in today's cost-driven environment. 00:44:55 So right now Dr. Barry is retracting -- getting ready to retract those seminal vesicles up. This seminal vesicle looks like it's going on pretty deep into the pelvis. It's almost up. If any viewers have any more questions, you can them live right now and we'll be happy to answer those questions. And the instructions are on your screen. Dr. Lance has just rounded the corner here on this last seminal vesicle and is starting to get it elevated. We'll see the posterior plane underneath the prostate gland and that so-called Denonvilliers fascia. This seminal vesicle is almost up. We have another 16 minutes or so of live footage, and he'll be on the neurovascular bundles, working on those. The last step would be after that is to connect the urethra to the bladder simply by sewing them together. But this part of the procedure where he's dissecting out the seminal vesicles and then doing the neurovascular bundles and the vascular pedicles is very important, especially to patients who want to preserve their potency. There are multiple important places where this operation -- or steps become important. But you can see that seminal vesicle nicely coming up. And the rectum is not far away from this location, so you can see it's a very intricate space. Dr. Barry is going to grab those seminal vesicles and lift that up. And Dr. Lance is going to incise Denonvilliers when he lifts that seminal vesicle up. 00:47:50 RAYMOND S. LANCE, MD: Just take that seminal vesicle and just lift up. Just make sure you make the turn. No, no, the other way. Gently, please, and on the other side. Just like that. Okay. 00:48:04 MICHAEL D. FABRIZIO, MD: Very nice. And now another very important step is to open this Denonvilliers fascia. This now separates the prostate from the rectum. He separate it from the bladder. We now have to separate it from the rectum. And the last two things, we have to separate it from the nerves on the side as well as the urethra, really fixated in several different points. Okay. Now he's incising Denonvilliers fascia there. I wanted to while he's doing that just a second go to a slide here on the screen where we're looking at blood loss. And on the left-hand side of the screen we have blood loss from our robotic series, and on the right-hand side of the screen we have blood loss from a very large single-surgeon series at a major university hospital well-known for radical prostatectomies. And here you can see that the first thing you notice is the scale is different. If you look at their scale, the mean blood loss is drawn there in the first 350 cases of a liter or so. And even after case 400 and 500, you see that there are still many cases over 1,000 cc's of blood loss. If you go back and look at the left side of the screen, we see that the robotic procedure, first the scale's different. Our blood loss typically ranges between 0 and 500, and as I said, most of our average blood loss about 175 cc's to 200 cc's. We rarely have an aberrant blood loss of over 500 cc's, certainly even rare to have it over 1,000 cc's, but if you look at that screen on your right-hand side, there are many, many cases over 1,000 cc's blood loss. And once again, this is a very experienced surgeon performing this operation. The take-home message is that many of those patients are transfused their own blood or they may even be given something called Epigen to boost their blood count before surgery. But what it does is it will fatigue the patient, it will cause a longer recovery if you lose more volume of blood. So I think that's one thing that is a benefit, and it's consistent from series to series in my opinion. We're going to go back the screen and look at Dr. Lance now. He is getting probably ready to start the neurovascular bundles, lifting up these seminal vesicles. He's going to lift all of that anteriorly towards the abdominal wall. 00:51:33

11 RAYMOND S. LANCE, MD: Go ahead and grab that with your grasper, please. Get both of these. Yeah. Gentle, please. This is access ampulla to the vas deferens. 00:52:00 MICHAEL D. FABRIZIO, MD: So now he's trimming the last portion of the ampulla of the vas deferens. He may use that as a part of a stitch. He's now lifting up the seminal vesicles. 00:52:21 RAYMOND S. LANCE, MD: Suction, please. Suction right in here. So I'll take down this pedicle now. 00:52:31 MICHAEL D. FABRIZIO, MD: Okay. Now he's going to start taking down the left vascular pedicle. There's actually a very sizable artery in here which we saw just prior to coming live here. He's going to dissect this out and get a little window there and place a clip. While he's getting ready to place that clip you can watch it online and we'll answer a couple of questions. The question was, "We indicated that a very high PSA indicates the surgery would be necessary." No, we actually didn't say that. A high PSA may portend to metastatic disease or be a sign of having disease outside the prostate gland, so depending on the level of the PSA, if it gets over 10 we need to make sure we have staging studies and screen you to make sure this cancer is not outside the prostate gland. We were asked about the advantages of doing this procedure over seeds, and I think it really comes down to do you want your prostate gland removed or do you want your prostate gland still present after a treatment modality such as seeds? Radical prostatectomy removes the affected organ. When you have seeds, the prostate gland is still in place, but the cancer is theoretically treated. They wanted us to clarify the two-year problem that I mentioned with radiation. The typical effects from surgery occur right after surgery, but after the recovery period of several months, a month, two months, three months, those side effects are gone. The side effects from radiation tend to occur in a delayed fashion. They don't occur immediately. The way radiation works is it destroys the tissue, and with time fibrosis sets up. So that's why those side effects can occur with radiation after a two-year period. What is the role of gene therapy? That's a great question. And right now we don't have any definitive gene therapy for prostate cancer, but certainly we may have that down the road. And finally, a recent newscast indicated significant results when prostate cancer patients used erectile dysfunction drugs such as Viagra, Levitra, Cialis after surgery. Do we have any of this data on our patients? And yes, we do. Certainly using vacuum erection device or Viagra, Levitra, Cialis after surgery do help with the recovery of erectile dysfunction. We'll go back to Ray in the operating room now, see where they are in our remaining six or seven minutes. 00:55:39 Now here Ray is -- looks like he has divided the vascular pedicle on the left. You can see the clip right there. That's very nice. He is now incising the plane between the prostate and the neurovascular bundle. He's also opening up what's called Denonvilliers fascia on the underside of the prostate gland. He's going to take that down. And as we mentioned earlier, it took a little longer to take these seminal vesicles down because they were a little bit adherent, especially the left one, and here you can see that it is a little bit dense underneath the prostate gland here, and some patients may get a more dense reaction or a fibrotic reaction after a prostate biopsy. I'm not sure how many [cores] he had, but that certainly could be the case here. And so he's taking his time going through because right here the plane between the prostate and the rectum are just millimeters. Ray, everything going okay? 00:56:40 RAYMOND S. LANCE, MD: Yep. Just the posterior plane, as you pointed out, there's a lot of reactive probably from the previous biopsy, but it isn't separating as easily as they many times do. 00:56:54

12 MICHAEL D. FABRIZIO, MD: Right, right. And it's interesting with surgery, the first part of this procedure there were no difficulties with tissue planes. It was pristine, as we showed you. And this is the side where the actual needle went through the rectum into the prostate, and in some gentlemen that can create a problem. 00:57:15 RAYMOND S. LANCE, MD: Release. I'm going to take this pedicle down also. 00:57:20 MICHAEL D. FABRIZIO, MD: Right. Okay. 00:57:27 RAYMOND S. LANCE, MD: You might be able to show some footage of what this -- 00:57:31 MICHAEL D. FABRIZIO, MD: Oh yeah. That's great footage right there. So that's great footage right there of Ray coming on the lateral side of the prostate gland, and he is now dissecting what's called the lateral prosthetic fascia, and he is going to incise that and try to free that up, because within that are the microscopic nerves that help control erections. When he first switched over to this position, you could actually see some of the pelvic plexus. That's the vascular pedicle that he's going to work on right here. He's also trying to still get a plane in that Denonvilliers fascia. 00:58:21 RAYMOND S. LANCE, MD: Let's put this -- you can see there's a [plasmic] reaction here. 00:58:30 MICHAEL D. FABRIZIO, MD: Yeah. You can see the very, very well defined plane here, almost a fibrotic plane just from the biopsy, which he'll be able to dissect very easily, but it just will take a little time. 00:58:52 RAYMOND S. LANCE, MD: Okay, just grasp the entire -- yep. Okay. 00:58:56 MICHAEL D. FABRIZIO, MD: Hey, Ray, before we sign out can you go to that right side again and show them sort of where the neurovascular bundle is sitting? 00:59:04 RAYMOND S. LANCE, MD: Yeah. Basically just below -- this is the posterior pedicle of the prostate gland, and just beneath that and running in this distribution would be the neurovascular bundle, so we began to release this lateral pelvic fascia. We'll follow that all the way to the urethra. And you can see this nice fatty tissue here. This is going to be a nice plane to allow us to separate -- all that tissue will stay behind once that's released, just a matter of us very carefully obeying these tissue planes so that we don't inadvertently wander into cancer. We're actually now able to separate here very nicely the rectum from the other surface of the prostate gland. This is going to allow us to be safe in that remaining dissection. And the other probably important point is that patients can understand is that this is an individualized situation. Everybody's different. Their anatomies are different, and sometimes it takes a little longer based on different anatomy, but we certainly recognize that by our experience and are careful with it. 01:00:08 MICHAEL D. FABRIZIO, MD: That's right. And now that plane is coming down very nicely. And he'll separate that, and essentially he'll have those two sides, the right and left-hand sides, to take down and spare the nerve. 01:00:26 RAYMOND S. LANCE, MD: Place the sucker right here, please. 01:00:45 MICHAEL D. FABRIZIO, MD: Now he's making his way toward the front of the prostate gland. 01:00:53 RAYMOND S. LANCE, MD: I'm using very precise cauterization called bipolar cauterization, which does not allow cautery to spread beyond where it touches. It allows us to define this

13 posterior pedicle very well. All right. Let's come in with the left clip, please, right across here. Let go. Yep. 01:0:37 MICHAEL D. FABRIZIO, MD: So what he's doing now is he's going to have his assistant place a clip along the neurovascular bundle. 01:01:50 RAYMOND S. LANCE, MD: There you go. 01:01:51 MICHAEL D. FABRIZIO, MD: Top side of that. 01:01:52 RAYMOND S. LANCE, MD: Okay. And this is a special locking clip, very secure. Come back in with the grasper, please. Okay. Grasper, please. Right here. Get all of it. Yeah. There you go. Gentle upwards. 01:02:28 MICHAEL D. FABRIZIO, MD: And now he's going to basically divide the tissue that's still connecting the prostate, sort of separating the neurovascular bundle off of that portion of the prostate. He's already freed the lateral prosthetic fascia. 01:02:43 RAYMOND S. LANCE, MD: And we'll cauterize the prostate side, which is a backbleeding situation. Okay. Suction here, please. 01:03:12 MICHAEL D. FABRIZIO, MD: That's nice, Ray. That looks good. 01:03:18 RAYMOND S. LANCE, MD: Suction here, please. Right over here. Yeah. This is the backbleeder area. Okay. 01:03:32 MICHAEL D. FABRIZIO, MD: So what he doesn't want to do is just run through here with all kinds of cautery and go quickly. He really wants to take his time and drop the neurovascular bundle down. 01:03:54 RAYMOND S. LANCE, MD: Suction right here. Okay. Please pull. Let's release the catheter and draw it within the prostate, please. Pull the catheter back inside. Excellent. Okay, lift back up, please. 01:04:25 MICHAEL D. FABRIZIO, MD: We were asked a question about what dissection means, and what he's doing is he's taking and removing the tissue away from the prostate gland to accomplish the task of saving the nerve. 01:04:44 RAYMOND S. LANCE, MD: There's still a little bit of pedicle right here. 01:04:56 MICHAEL D. FABRIZIO, MD: We were asked if it was appropriate for a surgeon to do a lymphadenectomy prostate cancer and whether the robot could do it easily, and yes. Laparoscopically it is very easy, robotically it's very easy to perform a pelvic lymph node dissection, and those patients we do that on are the patients who are at higher risk to have nodal metastasis, such as PSAs greater than 10 or high-grade cancers, Gleason pattern 4 located in the specimen. And that's how we would do it. "When can somebody who has a desk job return to work?" And I've had patients return to work within days of the operation, even with their catheter in place, so that can happen. 01:05:46 So the recurrence rate for patients who have organ confined prostate cancer at the time of operation is less than 10%, so it provides a very good cure as far as prostate cancer goes. And we were asked if there's a weight limit for the patients, and typically patients who have a body mass index of greater than 32, 33, 34, when you get up to the body mass index of