Discussions in Cardiothoracic Treatment and Care: Technical Aspects of Segmentectomy and Lobectomy Including Novel Methods for Vessel Transection

Accepted Manuscript Title: Discussions in Cardiothoracic Treatment & Care: Technical Aspects of Segmentectomy and Lobectomy Including Novel Methods for Vessel Transection Author: Moishe Liberman, Faiz Bhora, Stephen Cassivi, Todd Demmy PII: DOI: Reference:

S1043-0679(17)30247-2 https://doi.org/doi:10.1053/j.semtcvs.2017.09.008 YSTCS 1020

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Seminars in Thoracic and Cardiovascular Surgery

Please cite this article as: Moishe Liberman, Faiz Bhora, Stephen Cassivi, Todd Demmy, Discussions in Cardiothoracic Treatment & Care: Technical Aspects of Segmentectomy and Lobectomy Including Novel Methods for Vessel Transection, Seminars in Thoracic and Cardiovascular Surgery (2017), https://doi.org/doi:10.1053/j.semtcvs.2017.09.008. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Discussions in Cardiothoracic Treatment & Care: Technical Aspects of Segmentectomy and Lobectomy including Novel Methods for Vessel Transection Moishe Liberman, MD, Faiz Bhora, MD, Stephen Cassivi, MD, and Todd Demmy, MD Dr. Moishe Liberman: I’d like to welcome you to Discussions in Cardiothoracic Surgery and Treatment filmed live today at the AATS Focus in Thoracic Surgery meeting in Boston. Today we will discuss technical aspects of pulmonary vascular transaction in VATS lobectomy and anatomic segmentectomy. We have put together a panel of experts from across the country to discuss this topic. To my right, I have Faiz Bhora, Steve Cassivi and Todd Demmy, and we’ll start the discussion now. First of all, can you introduce yourself, explain who you are, where you practice, and what is your clinical area of interest? Faiz. Dr. Faiz Bhora: Faiz Bhora, thoracic surgeon at the Mount Sinai Health System in New York. I’ve been in practice now for about 10 years. My focus is on thoracic oncology and airway surgery. I’ve had experiences with both the Ethicon and the Covidien staplers for vascular transection. And have also used the Harmonic Ace and the LigaSure for thermal sealing of vessels. In the chest, I have the most experience with the Harmonic Ace. So, looking forward to this panel and discussing vascular control. Dr. Moishe Liberman: Great. Steve. Dr. Stephen Cassivi: I’m Stephen Cassivi. I’m a thoracic surgeon at Mayo Clinic in Rochester, Minnesota. I have a particular interest in minimally invasive surgery, and my experience is predominantly with the conventional stapling devices. But in the ever-evolving field of minimally invasive surgery, the opportunities to innovate are great, and I’m looking forward to the discussion today. Dr. Moishe Liberman: Todd. Dr. Todd L. Demmy: Hi. I’m Todd Demmy. I’m chief of Thoracic Surgery at the Rutgers Cancer Institute of New Jersey and practiced before there at Roswell Park Cancer Institute. I have used both the Covidien and the Ethicon stapling systems. I use the LigaSure as my main energy device but have used the Enseal product and the Harmonic Ace infrequently to seal small vessels. Dr. Moishe Liberman: Great. So which devices do you guys view as critically important for successfully performing a VATS lobectomy in terms of bronchus, artery, and vein? Dr. Faiz Bhora: Moishe, I also do a fair amount of robotics. And my approach generally is a hybrid with robotic dissection and stapling with VATS, given we have the Si system. And more recently with newer data showing safety of energy sealing devices with the Harmonic Ace for transection and control of smaller pulmonary vasculature—I have used this in a few cases.

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Dr. Moishe Liberman: So as an example, if you’re doing a robotic or VATS right upper lobectomy, what would be your typical sealing choice for vein, artery, and bronchus on a standard case for you? Dr. Faiz Bhora: So, on a standard case, as of now, it’s still mostly staples. So, vascular loads for the vessels and then a heavier load for the bronchus. Dr. Moishe Liberman: Are you talking about 35mms? 45? 60? What do you use for the vein? Dr. Faiz Bhora: For the veins, we’ll typically use a 45 vascular load. The arteries either a 30 or 45. One of the drawbacks of the robotic technique is lack of tactile feedback. Whereas with VATS you get some element of feedback and are able to do a fair amount of the dissection with feel and in a blind fashion. Whereas with robotics, you’re relying for the most part entirely on visual cues. And, at least for me, I feel I need to clear a significantly larger surface area of the vessel in order to be able to get around it safely with the stapler. And with smaller vessels I have now started using the Harmonic to take those vessels. Dr. Moishe Liberman: And is that Harmonic robotic or is it conventional Harmonic? Dr. Faiz Bhora: Yes. It is conventional Harmonic through an accessory 15mm port that we place. Dr. Moishe Liberman: Steve, what are you using for a typical VATS or a robotic lobectomy? Dr. Stephen Cassivi: So typically I use staplers. Occasionally, when we have a vessel that’s small and either inconvenient for a stapler or too unwieldy for a stapler, we’ll use a clip, clips or more recently there are smaller staplers; the 5mm staplers that are now available. The ones that are currently available are able to angle a little bit more. And so they can sometimes get you in to an otherwise unwieldy position that, with the broader based staplers that angle only moderately, it becomes an issue. So again, I’ve used the Harmonic and the LigaSure energy devices outside of the chest. Inside the chest, I’ve only used it in animals and have yet to go over that leap of faith into humans in the chest that you have and others have in a thoughtful way. And I think the work that you’ve done has been very helpful and systematically thought out to demonstrate or refute the safety of energy devices in a thoughtful way. So that’s helpful. Dr. Moishe Liberman: Thanks. So if you’re doing a VATS middle lobectomy and there’s a small little branch and you want to put a clip are you using 1 clip, 2? Is it metallic? Plastic? And then are you cutting with a scissor or a cautery? How are you doing that? Just for the audience. Dr. Stephen Cassivi: So what I use is typically a metal clip. Two clips proximal, one clip distal and then I cut it. Dr. Moishe Liberman: 5mm. Dr. Stephen Cassivi: Yes. Dr. Moishe Liberman: Todd.

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Dr. Todd L. Demmy: I’d like to play off of that. Surgeons including myself who have access to locking clips are more inclined to use those. The main problem I find with clips besides damaging vessels during application is brushing them off with other instruments passed later in the case. Carefully applied clips are, in general, a good technology. Apart from what has been said so far, I like staplers that have an anvil extension, and I had a part in developing the curved tip technology. If your angles for stapler deliveries aren’t quite perfect, then that extension allows you to guide the staplers around the vessels better. One’s port placement also determines a lot about what type of stapler is used. If your port is anterior, then both a curved tip and the ability to articulate are important. One of the big innovations came from a company that most people haven’t heard of: Richard Allan (later acquired by Covidien). They were actually the first to make staplers able to articulate. Articulation is important so that a surgeon can glide the anvil around the branches of the pulmonary arteries by rotating the shaft. Another feature that hasn’t been mentioned is non-cutting. Some of the old stapler cartridges could be modified by the surgeon pulling the knife out of them. An Ethicon endoscopic stapler comes with no knife so that if you worried about taking a very large vessel like the main pulmonary artery, you can use that product to lay down staples and cut between the rows manually. There’s also a Covidien endo TA product that doesn’t articulate but it lays down just three rows. So, it is often more convenient to use energy devices for smaller vessels because you just can’t guide the big anvil around them especially if there is radiation fibrosis and similar problems. It’s important how you apply the energy. And I’m sure we’ll talk more about that, especially problems with desiccation and vessels sticking to the device. Dr. Moishe Liberman: Great. Thanks. So, walk us through a VATS right upper lobectomy for you in terms of what you are choosing on a standard case for your vein, artery and bronchus? Dr. Todd L. Demmy: So I generally use a fissure dissection approach with the bronchus last that emulates open surgery. I do this because it gives one the ability to define anatomy better for vascular division such as taking the ascending posterior branch. In some situations, I might use a fissure last approach if taking the bronchus earlier exposes a critical structure. In general, I start by dissection posteriorly inferior to the right upper lobe bronchus and open the pleura where the fissure joins the hilum. I then move anterior to divide the superior vein branch to the upper lobe to expose and take the truncus. At this point, the stapler comes in through the typical camera port in the mid-axillary line while viewing the anatomy from a camera placed more anteriorly in the typical working port. That allows me to articulate the stapler and pass around the vein and the artery. I then open up the minor fissure, often firing once outside in with a 45mm load to improve mobility. I complete the fissure by creating a tunnel with a large right angle clamp that dissects along the ongoing PA, starting beneath the divided vein and exiting in the interlobar fissure. Then I can draw back a red rubber catheter that I use as a leader. I often switch this to a stiffer latex-free catheter because it tends to guide the anvils more reliably. Once the minor fissure is open then the surgeon has an excellent view of the anatomy. You can take the remaining posterior fissure because all you have to do at that point is dissect from the ongoing PA posteriorly toward the inferior margin of the upper lobe bronchus “landing zone” dissected as the first step. That allows you to create a tunnel to divide that remaining posterior fissure. And that leaves your ascending posterior really hanging in the breeze. While you can take that with

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energy, I usually have a good angle just to take another stapler fire. And then it’s just the bronchus last. Dr. Moishe Liberman: So, you’re using 35mm vascular staplers for the vessels? Dr. Todd L. Demmy: Yes. It would be 30 for the Covidien (Medtronic) products and 35 for the Ethicon. Ethicon has 2 fewer lines of staple on its newer powered vascular linear cutter. I’ve used both products and like them both. The shaft on the Ethicon is a little bit smaller so you are more likely to another instrument beside it. And it has a little bit smaller anvil as well. Dr. Moishe Liberman: Great. I think that we have found in our practice that as in the example of the right upper lobectomy that we were talking about, we do it a little differently. In an anterior approach where we take the vein, usually using a stapler, and then the apical trunk usually using a stapler (it’s usually about 10-12 mm). And then the way we used to do it is that we would dissect the bronchus to the right upper lobe and take that with a stapler and leave the posterior ascending to do last. Which sometimes could get torn or avulsed while you’re working on the bronchus. And it’s very hard to do that artery before you’ve done the bronchus because you can’t pass a stapler there because the bronchus is right behind it. And now with energy and at least in the trials that we are doing (we are in a Phase II clinical trial right now), we take posterior ascending branch that with a Harmonic and then it makes it really easy because then all the vessels are done. You take the bronchus with a stapler and you’re done. But I think that these things are evolving. And I think that there’s many ways to skin a cat. And as long as the patient gets out of the operating room safely that’s great. Dr. Stephen Cassivi: Yes, but I think the process of the lobectomy is important because you know the two things that keep a VATS lobectomy patient in the hospital barring major issues are pain and air leak. So, it’s important being able to have a process of dealing with the hilum and the hilar structures where you’re not having to dig through the parenchyma of the lung as much; to avoid the air leak which occurs because of that. It is going to move the science forward. We need to be able to find ways to reduce pain. That’s the smaller incisions. Moving your incisions out of the lateral positions and into the midline perhaps is a solution. You know the subxiphoid extraction route potentially is one of those ways. And then dealing with air leaks. So, having devices that you’ve been looking into may help us do that. Dr. Moishe Liberman: I agree with that completely and I think it’s a very good point. We tell our patients in the clinic that if they’re going to be booked for VATS lobectomy that they’re going to stay in the hospital 24 hours. And if they stay longer than that we consider that a failure. Obviously, the majority of the time they don’t leave in 24 hours but we try to get them out in 2448 hours. So, it’s these techniques and these technologies and the forward thinking I think that’s decreasing the air leak and decreasing pain that get the patients home early and safely. Dr. Faiz Bhora: I just wanted to touch base on the two techniques again. And I think it’s critical to be able to do it both with the fissure last technique as well as if you have a well-developed fissure then I think certainly that speeds up the operation and sort of lays out the anatomy pretty nicely. And back to Stephen’s point. So, I hate the case where the fissure is fused and then one has to sort of dig through it. It kind of ruins your day, doesn’t it? And so having a device that

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perhaps helps with that part of the operation I think is critical. So again to reiterate, I think it is critical to be able to do the operation both ways. Dr. Todd L. Demmy: How does the robot compare? Because I’ve observed some cases and done a little bit of work with robotics. It seems that robotic surgeons take a lot of lymph nodes out to improve exposure to the vessels we’ve spoken about. Dr. Faiz Bhora: And that goes back to my original comment. I think in order to be able to safely dissect with the robotic technique because you do not have haptic feedback you really need to skeletonize the anatomy such that the instruments can go fairly smoothly. Whereas with VATS a gentle amount of force is really possible. You know when to stop. Whereas with the robot, and I’m teaching my junior partner this, is that you really need to be able to see everything and pass things cleanly. So, the dissection needs to be somewhat more extensive. And hence what really helps and makes a robotic operation safer is complete skeletonization of the arteries and the bronchus which in essence involves a complete clean out of the lymph nodes. So, lymph node removal helps both for exposure but also perhaps for oncologic reasons as part of the robotic operation. Dr. Moishe Liberman: Great. Dr. Stephen Cassivi: Sorry. But from an oncologic standpoint, you’re doing the same operation. It sounds like you do the dissection similarly. Not to get this to devolve into robot vs. VATS but, I’m always interested to hear the differences because, I’m still working on trying to figure out how to justify the extended cost of the robot for something that seemingly is being done by a lot of people very well with VATS. So, if I understand correctly, it’s that you’re dissecting out more tissue because the feedback loop behind putting the instrument in with VATS, where you’ve got direct tactile sense, and the lack of that with robot. You need a longer feedback loop with a robot with the haptic cues or the visual senses that you have with the robot. You’ve got visual and tactile sense with VATS. Dr. Faiz Bhora: Right. I think that’s true. There is no haptic feedback or minimal. And so it’s entirely on visual cues. So, for instance, if there is a thin veil of tissue that’s still left whereas in VATS you can just pass your right angle and go through it. Whereas with robots, that still has some risks because you really can’t gauge how much force you’re applying. Dr. Stephen Cassivi: Yes. You don’t feel it until it’s maybe too late. Dr. Faiz Bhora: Until you’re through. Right. Exactly right. But I think back to your point. I think with robotic technique in lymph nodes again, you know we can go back and forth on this but I think the robotic technique forces you to take more lymph nodes for technical reason. Now we can argue whether more or less lymph nodes is advantageous and if you can get more with robot vs. VATS but I don’t think that’s relevant to this discussion. Dr. Moishe Liberman: I would say as someone who does robotic and VATS and again robotic lobectomy in a more selective group because of the cost issue in Canada and we’re really select our patients specifically for robotic lobes. I don’t think that in my practice or in the literature

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there’s any oncologic advantage to robotic vs. VATS. And I think that both techniques are acceptable. It depends on who is doing them and the surgeons comfort level with the technique. I think that the real gain in robotic was for the surgeons that weren’t able to do VATS lobectomy or not comfortable doing VATS lobectomy where if they are comfortable doing robotics it is better than the thoracotomy. Dr. Stephen Cassivi: It’s a gateway. Dr. Moishe Liberman: But I think if you’re doing a good VATS lobectomy I can’t say that a robotic lobectomy in my hands is better than a VATS lobectomy for the straightforward lung cancer case. And I don’t think there’s any literature to show that. Moving ahead, although VATS lobectomy as we know has been, VATS and robotic lobectomy has been proven to be safe and effective in experienced hands and in people who are well trained. We know that the published conversion rates of these operations are between 2 ½ and 23% in some studies. The majority of those conversions are related to vascular injury, usually pulmonary artery and sometimes pulmonary vein. And in one study conversion rates related to PA injury were 37.5% of total conversions. I would like to talk a little bit about what you think the future of VATS and robotic lobectomy is in terms of decreasing conversion rates in terms of making these operations safer and do you see any way that we can do this using energy or staplers or different technology? Because again, a conversion in VATS lobectomy is usually not because the operation isn’t going well. It’s usually because the operation is really not going well and none of us like to be there. We’ve all been there. And I’m sure we’ll unfortunately be there again once in a while. But decreasing that incidence of emergent conversion from the disastrous situation I think it is extremely important. And I think this panel of experts will be perfect to shed some lights on how we think we can get that done. Maybe we’ll start with you Todd. Dr. Todd L. Demmy: Right. So, I think the conversion rate has to be considered with the total what I call the VATS reliability rate for that operation. So, for instance, if you’re doing peripheral tumors with easy fissures and you have a high conversion rate that’s a whole different issue then if you are trying to take on every single case post induction chemo-radiation therapy. The conversion rates have to be considered in the context of complexity. And then what is the mode of conversion? Is it something where there is out of control bleeding where the patient’s really at risk or one where anatomy is very controlled resulting in very little blood loss? Those are the things that we can talk about. I found my conversion rate has fallen despite taking on harder cases. This is because one learns after a while, the tricks to try when you think you might be getting in trouble and then do a preventative measure. There is really no reason not to emulate the stuff that we used to do open all the time. So, for instance, getting around the main PA. Surgical atlases written during the times of TB surgery has this as a prerequisite for every case because there’s was a high rate of tearing the PA. It is now possible to do with the better optics and instruments to get around the main PA. What I do is to fold a long silicone vessel loop in half, go around the main PA twice with this double loop so when pulled up, it creates a wide snare. So, that eliminates massive antegrade bleeding. And then you can decide what to do to avoid the kind of real fast conversions that have been done in the past. So, I think that’s one way around it. And then when you have that type of control you can suture. When I’m getting tissue stretch or other things that look like they’re dangerous, I try to loop the main PA. For the other situations where it’s totally unexpected, you just have to very good team plan laid out whether

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for robotics to compress with lung tissue or the rolled-up gauze “twinkie” already in place. You have an assistant knowing what to do. If it’s thoracoscopic, you have the sponge stick compression or whatever was outlined beforehand. Dr. Moishe Liberman: Great answer. And I agree completely with the first part especially, I mean all of it but especially the first part where the conversion rate of a big tumor of a neoadjuvant patient undergoing a redo is always going to be higher. And I think that you need to tell your patient that. In our practice, we don’t use epidural catheters because we’re trying to get the patients out day one and no foley catheter. And if a patient has a 7cm tumor or if they’ve had a previous wedge or lobectomy we always put an epidural. We tell them the conversion rate is going be higher, and take our time. And I think it’s definitely normal to have a higher conversion rate on a planned conversion. And I think planned conversion is not really a problem. It’s the disastrous conversion that we’re all trying to avoid and unfortunately it still happens. And I think if we can figure out ways to deal especially with small vessels that are very thin, short stump that sometimes get avulsed as opposed to torn that creates a very annoying and terrible hole in the PA that’s usually very hard to fix thoracoscopically. Not impossible, but very difficult to fix and can end up with a death on the table. Steve what do you think? Dr. Stephen Cassivi: I think you’re right. I think there’s a couple of different conversions. There’s the conversions that you figure out right away that for missed diagnosis or different stage of disease that you expected. Or there is the need to change the operation for various reasons. That’s one of them. But the one that we all worry about is the conversion because of significant PA bleeding. It’s very rare that it’s venous pulmonary vein bleeding. That’s usually manageable even thoracoscopically. But with PA bleeding and your last statement is right in that it’s often from a smaller PA vessel or it begins with a smaller avulsed vessel, either unrecognized or not dealt with in an elegant way. And having, you know, more than just one option, the one big bulky stapler for example, will help us. More clubs in our golf bag, so to speak. So, you may not always use that club but when the ball is in the right spot pulling that club out will help you. And I think clips, energy devices, or finer gauged stapling devices are all going to help us to disseminate the advance of VATS lobectomy and VATS segmentectomy. This is really the big psychological and technical hurdle that a lot of surgeons have to get over: the issue of what do I do when there’s bleeding? Dr. Moishe Liberman: Faiz. Dr. Faiz Bhora: So, I agree with the comments on conversion rates. And I just want to take us back a few steps here now where I was talking about the future and about newer modalities for doing the operation safer. And I think if you really look at how we’re doing VATS lobectomies over the last 15 years not much has really changed. And in the vast majority of cases we still go into the OR, we’re not exactly sure how many arterial branches we’re going to encounter. We’re not sure of the location of these arteries. We’re kind of digging in the fissures trying to find them. And so to me that’s still a fairly archaic way of operating. We’re also using multiple instrumentation, particularly with robotic technique in and out and and energy devices. So, I think there needs to be a way that we need to rethink this operation. And I think that starts with better preoperative imaging. And just understanding what the lay of the land is going to be. For instance, it would be nice for me to know exactly how many staplers I would need before I went

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to the OR. I sort of compare doing a VATS lobectomy or a robotic lobectomy to flying from New York to San Francisco with just 100 feet of visualization in front of you. The pilot just flying with just 100 feet of view and then reassessing the situation after… Dr. Stephen Cassivi: Each hundred feet. Dr. Faiz Bhora: Right. After each hundred feet. So, it doesn’t make a lot of sense to me at this point in time. We are doing some work with pre-operative imaging and with intraoperative imaging as well. And withan instrument that’s going to take you through the operation from start to finish for the most part. Perhaps the bronchus may need a separate instrument. But a curved, dissecting and a sealing instrument that you can continue to work from start to finish as you do this operation. And coupled with a GPS map of the anatomy that you will encounter when you doing the operation. Dr. Moishe Liberman: I think that’s excellent. And I know the Japanese have done a lot of work especially in segments where I think looking at the scan, the infused scan, if you have one pre-op can really help you. And I have to say that I have a fellow currently who’s an excellent surgeon and whenever we’re doing a VATS lobectomy he always says, oh Yes there’s one more vessel. And I’m like, what you talking about? And he’s always referring to the fact that he’s looked at this. I look at the scan just to find the nodule and then I do it like you probably. You know, I go one vessel at a time. And when everything’s done, the lobe is out and it’s fine. But he’s studied the arterial anatomy before each case. He knows where the vessels are, how many there are. And of course, you still need to be careful. But it definitely helps. And I think that you know, you can learn a lot from your trainees. I definitely am trying to plan my operations better. Dr. Todd L. Demmy: And also, to extend that one little bit further, there’s all types of technology now relating to mixed reality, augmented reality, and actual clinical liver surgery you can actually “see” the vessels beneath the surface. But the problem is the liver is a solid organ. The lung is much more flexible and floppy and harder to register. But it probably won’t be too much longer where we could have headsets that will actually guide us actually seeing a transparenchymal vascular image. Dr. Stephen Cassivi: There are options like 3D printing but I think we would all agree that it’s maybe a bit of an overkill to 3D print your vasculature for all of your VATS segmentectomies or lobectomies. That being said, there are other big names in what we do like Bill Walker in Edinburgh. When I visited him, he looks at his scans and he manipulates the CT scanner in a way that he can map out. So is not just 100 meters at a time. And so he maps out his vascular attack. Dr. Moishe Liberman: It’s not even complex to do CT 3D reconstruction imaging now. Dr. Faiz Bhora: No, it’s not. I mean we have all the images. Absolutely. And the vascular guys are doing it you know with all their aneurysms and their complex vascular cases. And so I think it’s going to happen But 3D printing, we don’t need 3D printing. I mean we can do a virtual 3D model. We don’t need to have that in our hands. What’s more important is the intraoperative road map, what you’re seeing in the anatomy. And as Todd pointed out it’s hard because the lung is floppy, we’re moving it around and it also is collapsed at the time of the operation. So, the pre-

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operative CT scan doesn’t really correlate to the intraoperative anatomy. And that’s the challenge. Dr. Moishe Liberman: So, if you do use energy for your VATS lobectomy or segmentectomy how do you use it and what do you use? Maybe Faiz we’ll start with you. Dr. Faiz Bhora: Sure, Moishe. And certainly, I was inspired by your work and by Scott’s work. So we started using it perhaps in the last 6 months or so so for energy. Now, we always have a Harmonic available and I use the Harmonic for parts of the operation. Taking down the inferior pulmonary ligament, etc. Since we have the older robot model, we just got the new XI but with the older Si model it is hard to get down to the inferior pulmonary ligament. You can’t—I mean you’re working backwards. The Harmonic speeds up that part of the operation. And I’ve been using it for vessels typically about 3mm or so or where I found that it’s a bit unsafe to perhaps get a stapler of across it. Or if there are two vessels in tandem, one smaller vessel one bigger vessel I’m concerned I’m going to tear one of the vessels as I try and get around the bigger vessel. So, we have used that in a limited number of cases. I’ve also used it when I do segments. So, particularly to take the smaller venous branches. Dr. Moishe Liberman: So, are you using it as opposed to a stapler or in… Dr. Faiz Bhora: In conjunction. Dr. Moishe Liberman: In conjunction with the stapler. And really to make the operation you feel safer or just easier or? Dr. Faiz Bhora: Safer and at times faster. If I’m feeling that the dissection around a particular vessel is going be extensive or difficult I’ve cleared up a small area and I think I can get the Harmonic around it and it’s a small vessel, then I’ll take it with the Harmonic. Dr. Stephen Cassivi: Now let’s be clear. Faster sometimes means safer. I mean Alec Patterson always taught me that, get that patient away from the anesthesiologist and get them back to the recovery room quicker and efficiently. So, it doesn’t necessarily mean less safe. It’s sometimes—the faster you’re doing it the less other injuries you’re creating. Dr. Moishe Liberman: And Faiz just going back to what you were saying, have you seen any problems bleeding post-op, intra-op, thermal damage injury from the vascular sealing device? Dr. Faiz Bhora: So, I’ve not. I’ve used it maybe in about, 40 to 50 vessels so far. I have not. But again, we’ve been conservative. We’ve used it for the smaller vessels and small veins. We also use it for a little bit for parenchymal dissection. I’ve used it forlymph node dissection as well. I had concerns about the thermal spread of the Harmonic. And I’ve actually tried it out. So, one has to be somewhat cautious because it does take a couple of seconds for the instrument, for the anvil to cool down. And so, you just have to keep that at the back of your mind. Dr. Moishe Liberman: Interesting that you said that. We just submitted an abstract to the AATS looking at heat with energy devices in VATS lobectomy on an animal model. And obviously, we

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just submitted the results so I can’t go through it all today. But we should have some clarification on that and maybe make you feel a little bit safer. And less safe depends on how you look at the data. But we’ll have that for you soon. And maybe Todd and Steve, have you used it on a PA or pulmonary veins, any energy device and how if you have, how have you chosen it compared-as as opposed to a stapler? Dr. Todd L. Demmy: Can I go first? Dr. Moishe Liberman: Go ahead. Dr. Todd L. Demmy: So, I’ve used it and like a lot of surgeons there’s been an occasional time where it hasn’t worked. And that kind of event perhaps clouds your trust to maybe go on to try more aggressive use. But I think some of the experiences have been with older thin jaw tools like LigaSure that applied crushing type of forces. There was work by Lester that showed that the adventitial was sealed but not the intima. Perhaps crushing causes the media layer to peel back so all you were getting was an adventitial closure. And then if the thin vascular wall desiccated and adheres to the device, when you pull it away it can tear. Or you if you’re applying it on a smaller vessel and the vessels are on tension it could crush and tear before the seal takes. Those are the things I think it happen from time to time. Perhaps the harmonic sealing device by the way that it applies energy, perhaps with less force is why some of burst pressures have been better than with bipolar devices. So, I really am open to do it, but there remains that sense of confidence seeing something transfixed to tissue like you get with a metal staple. It goes back to doing the extra tie and transfixing sutures we did with open surgery. I think that provided us some sense of comfort. Arguably, I’m inconsistent because in the belly I’m comfortable using energy on a left gastric. And that can also kill a patient if it gets loose. So, I’m just trying to force myself to be a little bit more comfortable understanding some of these past experiences prejudice me a little bit. Dr. Moishe Liberman: Yes, I think that those points are well taken. And a lot of the older devices that used bipolar energy and were not using ultrasonic energy and there are some hybrid devices in our ex vivo studies we had seen some failures which we had not seen at least in the human and animal work that we did using ultrasound alone. And so, we’ve gained confidence with that. And I think that that’s important. Also with ultrasonic energy at least in our data looking at electron microscopy of the specimens at 30 days after, most of the collagen in the vessel wall just becomes like a sheet as opposed to being inter-tangled like a web. And that collagen at the seal just looks like a clean sealed area with complete coalescence of the fibers. And that has given us more confidence to move ahead. And I think that there will be new devices coming out in the future that are even safer. Unfortunately, all of these devices were developed for gynecologists, general surgeons and urologists for systemic arteries and systemic veins and we’re trying to adapt these to pulmonary arteries which are nothing like systemic arteries. And we have to keep that in mind. Because all of the research published outside of thoracic literature was not looking at pulmonary arteries but more systemic arteries. Dr. Todd L. Demmy: Just real quick before Steve takes over. But I think the other thing that kind of biased us a little bit is because of all the instruments that are out there, the dolphin tipped LigaSure is popular because you’re able to really tease apart issues when you’ve got really fibrotic post-radiation changes. So, you have that device already, but probably maybe not the

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best one for sealing a vessel because of its thin jaw width. But that’s the one you were using for everything else like dissecting all the lymph nodes. And I think maybe that’s what prejudiced a number of surgeons rather than those using the blunt- the wider tipped devices, bipolar or the ultrasonic. I guess that’s the thing to discuss, not just whether it’s just the best device to seal a vessel but what’s the best thing to dissect everything-- the tissues, the lymph nodes. Dr. Stephen Cassivi: Well that’s what you’re trying to develop. Right? Dr. Faiz Bhora: I think there are instruments in the work that are going to be doing exactly that. I mean, for instance there’s a nice dissecting and sealing instrument for thyroid surgery for instance. I think we’re going to see instruments that are going to be designed for specific operations. And I certainly know that Ethicon is working on such a device. Dr. Moishe Liberman: Steve. Dr. Stephen Cassivi: So, I probably have the least experience in terms of the energy devices of anyone around this table and perhaps of those listening. But I’ve used it in large animal models. They weren’t survival models so I don’t have a really good hold on that. But I’ve been guided and encouraged by your work and the work of others who have actually done this in a thoughtful way. You know, your experience has been a great example of how to advance technology that takes a thoughtful and measured approach to the transition from theory to use in an animal and in an ex-vivo situation and then a transition to human. This was not just transitioned to human but was a concerted effort, a dedicated decision, to do it all on study so that the information then is interpretable in a scientific way. So, I applaud you for that. I do think that these will continue to evolve in useful ways for us. It’s probably a good evolutionary reflex that we have that the bad anecdotes stick with us heavier than anything to keep us from being a little bit too “cowboyesque.” Dr. Moishe Liberman: I agree with that completely. And thanks for the compliment. I would say that I always tell the residents and the anesthesiologists that if device fails when you are doing a hemicolectomy it doesn’t make any difference. Anyone can deal with that. If it fails when you’re doing a hysterectomy or an appendectomy these are systemic small vessels that are easy to reclamp. But when it fails on a short thin wall PA branch in a brittle little lady, there’s no going back. So, we need to be much more careful and understand that the risk of a hole in the PA 1cm from the heart is very different from a hole down in the pelvis in a systemic artery. And I think we all have been there and don’t want to be there ever again. So, we really need to be careful with how we do this and really prove that this is safe. And again, as was said before by everyone, these devices are getting better and better. There will be new devices. The companies are well aware that the devices need to be adapted to thoracic applications, that dissection is important to us and the old devices were rougher at the edge and sharper. And the new devices actually, even the ones available on the market today, are a lot better than the ones that were out 5 and 10 years ago in terms of smoothness at the tip and a better dissectionability. And I think these will get better and better. And hopefully our jobs will be really easy in 10 years from now compared to some times when we do a complex VATS lobectomy now.

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Dr. Stephen Cassivi: It may not be very far away that an improved device that has been tested and demonstrated to be safe is actually better than the bulky conventional stapling devices that we use now. Dr. Faiz Bhora: And I think there will be a need as we’re doing smaller lung resections, segmentectomies, etc. I think there is an increasing need to be able to control smaller vessels than just lobar arteries that we’re used to with lobectomy. Dr. Moishe Liberman: Maybe we’ll just touch for a minute on the anatomical and vascular and difference between an anatomical segmentectomy for you and a lobectomy in terms of how you decide how you transect vessels. Let’s say you’re doing a superior segmentectomy of a left lower lobe by VATS or robotic. How do you choose your vessel sealing device based on size, anatomy? What are you using Faiz? Dr. Faiz Bhora: At the moment, I’m basing it on size. So, if I can- if it’s 3mm or more and I’m eyeballing this and I feel I can get a stapler around it fairly easily that’s still my first choice. When I feel I’m going to struggle or I am struggling trying to get a stapler around it I will think about the Harmonic. And I’ll probably struggle a bit more with the stapler. And then if I can’t you know, really get at it… if I cannot get around it safely then I will use a Harmonic. I will say that curve tip or the ski tip has been helpful. We think it makes it a bit easier and safer to get around vessels. So again, my first choice is the stapler. But if it’s a small vessel or if I’m really struggling to get the stapler around it then I will use the Harmonic. Dr. Moishe Liberman: Would you ever grab a small vessel in the fissure, a tiny little segmentential vessel with a DeBakey and just burn it like you would taking a small branch of colic vessel? Dr. Faiz Bhora: Yes. If it’s a small 1mm branch and I’m dissecting in the fissure again with a robotic technique I have the bipolar cautery. And so I do a reasonable amount of dissection with a bipolar as well. So, I think 1mm vessel or so which is unusual or a vein I control with a bipolar. Dr. Moishe Liberman: Great. Steve. Dr. Stephen Cassivi: Yes. I would do a vein like that potentially with the cautery. I would typically with a smaller PA branch just use a clip. Partly because it’s easier to get the clip in there than a stapler and I think the stapler has the great chance of avulsing. Dr. Todd L. Demmy: The only thing in addition is that if I’m going to use energy, I may use it twice without cutting. So, if you’ve got just enough room to get it, you can see there’s a seal then you can burn again or cut with the device that allows you to optionally cut. Dr. Moishe Liberman: Right. There are definitely some devices that do and some that cut as they seal. So, you obviously have that limitation to certain devices. And I think that also dissecting out the vessel a little longer and leaving a stump is always safer because if you have a problem you can—

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Dr. Stephen Cassivi: Get something to grab on. Dr. Moishe Liberman: Exactly, always leaving a stump to allow putting a clip on it. Yes. And we’ve seen that before. So, in wrap up I’ll just ask all of you to comment based on today’s discussion, what guidance could you give to the broader thoracic surgery audience who’s watching this on the use of energy vs. staplers? And just a take-home, maybe one sentences each to take-home from what you think people should know who are thinking about using these devices, where we are today and where we’re going? Faiz go ahead. Dr. Faiz Bhora: I think based on your data and on Scott’s work I am reasonably comfortable with the use of energy devices, particularly the Harmonic Ace for the control of smaller vessels particularly the pulmonary arteries. And my tolerance so far has been about 5mms. Thehaft of the Harmonic is a 5mm. So, it gives me a good visual gauge as to the size of the vessel I can take. My preference is if I can take the vessel safely with a stapler I will do that. If I am struggling or if it’s a smaller vessel I am now reasonably comfortable taking it with energy. Dr. Moishe Liberman: Thank you. Steve, quick wrap. Dr. Stephen Cassivi: So, the emerging evidence that you and others are providing is demonstrating that this is probably going to be a very viable option. It’s one more instrument in our orchestra that we’ll be able to use for VATS lobectomy. Dr. Moishe Liberman: Thanks. Todd. Dr. Todd L. Demmy: I think that you can test some of these instruments when you have a better idea that you can get control, even open. A lot of surgeons use the curved tipped stapler and other staplers open. Because it just makes the operation easier. So, that might be your time to to reduce- or increase your confidence level with these technologies. Dr. Moishe Liberman: Well I’d like to thank you all very much. I think this was an amazing discussion looking at energy and staplers and different methods of controlling vessels during VATS lobectomy and segmentectomy and I really appreciate your participation today. Thank you very much.

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