Welcome to The Operative Word, a podcast brought to you by the Journal of the American College of Surgeons. I'm Dr. Jamie Coleman. And throughout this series, Dr. Dante Yeh and I will speak with recently published authors about the motivation behind their latest research and the clinical implications it has for the practicing surgeon. The opinions expressed in this podcast are those of the participants and not necessarily that of the American College of Surgeons.
Welcome to The Operative Word, a podcast from the Journal of the American College of Surgeons. I'm Dr. Jamie Coleman, one of your hosts for this series. In this episode, I am very excited. I'm joined today by Dr. Roi Wiser and Dr. Suzanne Kleinberg, and we will be taking an in-depth look into their current article, "Intraoperative Fluoroscopy and Breast Lesion Localization." Dr. Weiser is an assistant professor at the UT, M.D. Anderson Cancer Center in Houston, Texas.
And Dr. Klimberg is a professor and Chief of the Division of Surgical Oncology at the University of Texas Medical Branch in Galveston, Texas. Dr. Weiser, Dr. Kleinberg, welcome to The Operative Word. Thank you. Thank you very much for having us. Well, before we begin and really get into the good stuff, do either of you have any conflicts of interest that you would like to disclose? No, I would not. All right. Well, first off, congratulations to both of you on this publication.
I have to say, I was fortunate enough to be in the audience at the Southern Surgical Association, the meeting this year when this paper was presented. Full disclosure, actually, as both of you know, I'm a trauma surgeon and I was enthralled by this presentation. So, when this came across my desk and I had the opportunity to really allow us to highlight this paper, I just I jumped at the chance. So, thank you so much for doing this. And now I have to say another disclosure.
I was a history major, so I'm admittedly a bit biased that I think the history behind some of our surgical dilemmas is important to talk about because it really sets the stage for the niche of the research. The reason why we did, or you did this project and so I was wondering if we could just start there a little bit with how did this project come about? You know, you've got a woman in your office, she's got a non-palpable breast lesion. It looks suspicious.
She gets a biopsy and she needs this mass out. So, you know, Dr. Klimberg, let's start with you. Talk to me a little bit about where we are with this currently and kind of how you came to this paper. Well, just since you're a history major, historically, mammograms started to, say, in the 70's, and when they found a lesion on mammogram, they would just triangulate in the operating room.
So you can imagine taking huge amounts of tissue to try to get something out, because we didn't have needle locs. We didn't have that. So needle looks came about. And so they're rather traumatic because the patient has to usually sit up and watch the needle go in. And it's a little bit like Battleship where you go a lesion A vs numbers. And so the needle is put in there and it's put up in an upright
position. So when the patient lays down that they can't find the area, the needle moves a little bit or even comes out. And so there was a whole line of different needles that you could use. And so the missed rate was 5 to 10%. And the, in other words, not getting the lesion out. And then the the other was 40 to 75% in the literature. Of a positive margin rate. Wow. Today, the positive margin rate is a little bit less because we've changed the margin positivity criteria. So you're talking 20%
range. Right? With a needle loc. And that's in our institution as well. So originally this came about because of the vasovagal events, watching this needle go in 10 to 20%. That's a huge percentage. I was struck by that in your manuscript. And it's painful, right? It's yeah. And you have to watch it. So it's not it's not uncommon. And so. We've gone about trying to find different ways to to do this.
And there's a lot of research in this area with radio frequency and all kinds of stuff, but all of them require a second procedure. So you have to go back, get back in the mammogram vise and get another procedure. So we were in the operating room doing a needle loc, and this is probably 10 years ago now, 5, 5 to 10, I can't even remember. And my fellow pulled out the needle before we got the clip.
So usually when that happens, which isn't an uncommon thing to do, but usually you have to wake the patient up, send them back down and get it relocalized, which is a terrible thing for the patient. And you as a surgeon, you're mortified. Anyway so she pulled it out. I said, well, we said, let's try and just do a fluoro because every surgeon knows how to use fluoro. So we said, Let's see if we can see the clip. And so we could. And we took it out.
So then we started looking at all the clips because this isn't rocket science. Somebody must have thought of this before, right? Or they probably were looking for a clip that couldn't be identified on fluoro. So we looked at all the clips we had, some of them couldn't be seen. Some of them could. Thank goodness we had one that can be seen that day. And so we said to the radiologist, just use these clips and then we can see all of them.
And then the patient doesn't have to have a procedure ahead of time, which, by the way, takes an hour or two and you can never have a first start. It messes up scheduling patients. You know, it's just the coordination is a problem. So this really circumvented this. Now, before that, I developed a procedure which I actually have a patent on, using the hematoma developed by a biopsy or even injecting an hematoma.
But the problem is most surgeons don't know how to use ultrasound or are not expert at it to be able to find every hematoma. But every surgeon worth their salt knows how to use fluoro. And so you have to have to use something that everybody is comfortable with. And the other thing is you can charge for it. Yeah. So this is how FIND was born, right? So let's do this then. I mean, what let's talk about it. What does it stand for? How does a surgeon do it? Tips and tricks.
Is there a patient population in which FIND wouldn't work? So let's take one one question at a time. I guess first of all as far as patient populations, I'd say it should work on most any patient that needs a lesion localized. And this would be patients with breast cancer that are going for breast conserving surgery. It would also go for patients with high-risk lesions that need an incisional biopsy.
And in the area of neoadjuvant treatment, it can also go for patients or it can be used for patients that had a lesion that was palpable to start off with. But thanks to neoadjuvant treatment became non-palpable and they're eligible for breast-conserving surgery, the. This is also relevant for axillary nodes. And in the era of neoadjuvant treatment and targeted axillary dissection, we need to localize those positive nodes. So this works as well, and maybe we'll get to the results soon.
But I think one of the things I like the most about about our paper is the fact that in the FIND group in our cohort, 100% of clips were found, while only 80% were found using wire localization. So so this has to do with, I guess, the patient population that can can benefit from from the FIND procedure. And by the way, also we can use it for multiple lesions. So if a patient has a few clips in her breast, we can also use the fluoro and FIND for that.
And in those cases, many times with the wire localizations, they need to have multiple wires put in their breast, which you can imagine is not pleasant multiple times. And by the way, in our court, there are 30% of patients that had to have or almost 30% of patients that had have 2 or more wires put in. So I'd say actually there's a very large patient population that can benefit from this technique. And what does FIND stand for? It's fluoroscopic intraoperative neoplasia and nodal detection.
So, it can. I love it. Just using fluoroscopy to find tumors. Yes, but I you know, what really struck me with this was--and we're going to go into findings next--is it was so interesting to me that in this era now of this continuous advancement of surgery through technology, this was almost, not the opposite, but it was an advancement through technology that we already possess. Like Dr. Klimberg, you stated, you know, you're finding a clp with fluoro. Surgeons know how to do this.
So this is a technology that already existed, that's also been used to simplify and therefore advance the care of our patients with breast cancer. I just you know, it was just it really struck me. If you think of the rural surgeon or the surgeon does some, but not a lot of breast cancer, this is ideal for them because they can't afford to buy some fancy techniques that they're only going to use a little bit.
Right. I mean, this is you know, this is equipment that hospitals already own, other departments use as well. It's not something just for us, obviously, in general surgery or breast surgery, it's not surgery or specialty-specific. It's got vascular surgery, orthopaedics, urology, so many other specialties that are using it. So now let's talk about how does it work? What are the findings? What did you guys find? What did we find or how does it work practically in the OR? Let's do both.
Okay, so we start with the OR. I think it actually starts with how what Dr. Klimberg said with invasive radiology. They just simply need to know to put the right clips in. And that proved very, very simple at UT, where I did my fellowship, because simply all the clips were visible on fluoro. And then in the OR, you positioned the patient more or less like you would for any other
procedure. You just need to make sure, like for any other fluoroscopy procedure, that there's nothing obstructing the vision of the fluoroscope. And then you start surgery after you prep and drape, you bring the fluoro in, and we shoot a new image, and then you see where the the clip is on the breast and you use whatever instrument you like to localize on the skin where that clip is. Then you can plan your incision, plan your dissection.
You can also draw your dissection on the skin if you want, and then you start working around that marking that you had. And what I think another advantage that FIND has is that during or as you're working, you can re-shoot the fluoro and see where your dissection planes are compared to the fluoro because you can put your Bovie in the breast or wherever you're, you're working and shoot the fluoro and see where that is compared to the to the clip.
So you always have this feedback or live feedback on where you are compared to that clip, which I found very, very useful during surgery. And of course, you know, the surgeons are very visual. Yes, right. We are. And so you can actually choose the margins you wish to have and you put your Bovie in and you can oh, it's too close or I've taken too much. You can move closer. You can you as Roi said, you have feedback.
And the thing about it is you do the placing of a needle loc or clip in a position that's upright. Right? Right. You have a cranial, caudal, and a medial. When you lay down, the breast usually falls on the axilla. The clip totally moves where you think it should be and a needle loc you place in visually under radiograph. And then we try and palpate it at surgery. That's how a needle loc is, it totally doesn't make sense and totally I don't even know how accurate, how it is as accurate as it is.
But this it changes position. I can put my incision wherever I want and I can choose my margins. And when you open the skin on a lumpectomy, it again, the breast falls apart. So it even moves. And that's why, as Roi pointed out, it's important that you can relook and say, okay, I need to change up a little bit. So how effective is this if we're going to compare this to needle or wire localization, how well does it work?
So I guess what we did in this paper was to retrospectively go back and look at all the wire localizations that that were performed in the time period that we looked at and all the FIND procedures that were performed, both for breast lesions and for axillary lymph nodes. And what we wanted to see was, first of all, I guess oncological safety in the sense that what was our margin positivity rate or what was the margin positivity rate of the wire locs compared to the FIND?
That was our, I guess, primary outcome that we were looking at. And as secondary outcomes, we also looked at re excision rates and also the specimen weight to see if it was affected by the technique, the surgery time and also complications. And what we were able to find was that there was a significantly better, or lower percentage of margin positivity using FIND. It did lose significance on multivariate analysis, but it was still number wise, it was quite significant.
The improvement with FIND and also the re-excision rates were a bit lower with FIND. So it's better for the patient is not another procedure and it works better, it's more effective, you're getting cleaner margins and your re excision rate. So again, the number of times a woman has to go through or a patient has to go through another procedure, another surgery is better. You know, one other thing that we know that all ORs care about is how long is it taken us to
do it? You know, do you have any data? In fact, I know you do, because I read it in the paper. But can you go over a little bit about your thoughts on how long it takes for a surgeon to do this compared to what they've been doing for years and years, which obviously the majority of which is wire localization. So what I can say is that first of all, we did look at the time of surgery between these two
techniques. But I have to say that there are a few limitations that I'll tell you about, about the numbers we found. And we found that actually FIND was about the FIND procedures were about 170 minutes and the wire localization to about 155 or 7. Now it's a bit longer. That's the first thing. But I think what's more striking is the fact that both of these are very long compared to what we would expect for a simple lumpectomy.
But the thing is that this was a retrospective study, and so the time of surgery included anesthesia, the time of surgery included axillary surgery. And we had a few axillary dissections in this cohort. The time of surgery included if plastic surgery came in and did a reconstruction. And I also and also the oncoplastic reconstruction that some of our surgeons, especially Dr. Klimberg, performs during surgery. So it's difficult for me to to to be sure that these numbers are completely accurate.
Any other limitations on the paper that you would like to mention? Well, I think the limitations we have on this paper, we first of all, of course, the fact that it's a retrospective study and on top of that, the fact that the technique for localization and also the margins, how many shaved margins each one of the surgeons took was by surgeon preference. And that obviously introduced some biases.
But I have to say that I think that what's what was, at least for me as a fellow important to find out or to show in this paper is that this is a safe procedure, if it's necessarily better or not better, as far as these numbers compared to wire localization, I think it's a bit less important. And I think what is important is that this is by definition a technique that is equitable, and it is readily available and that it improves considerably the experience for the patient. Absolutely.
Absolutely. Another thing I would comment on is that it's easier to teach a resident, in other words, a needle loc is, I think, extremely hard for a resident to think in 3D around the needle, or at least that's what I have found in teaching people needle locs. But this is, you know, is straightforward in terms you can see where it is, right. And I think that's another advantage.
And I can say that I as a fellow before in residency, I've never I only did wire localizations, I only saw wire localizations. So this is a technique that I learned from the start, from Dr. Klimberg and it was, you know, maybe in the first couple of times it was a bit strange, but then it became very intuitive. And I think it's my preferred way of excising lesions at this point. I love that. And Dr. Klimberg, any last thoughts? What are your what are the next
steps for this? Do you think this is going to surpass or become so useful and so preferred by a patient even? Do you think this is the future? Well, it's hard to know how to tell this to a patient, right? When you, when you're not familiar with all the ways you can do stuff, how do you tell a patient there's an easier way to do this? Or where you don't have to use a second procedure? And, you know, there's some other techniques where they can have something put in ahead of time.
And that's certainly good for scheduling, but it doesn't prevent the patient from having to have a second procedure. And so most patients don't know how you find a lesion anyway. So really, we have to find a better way to market what we're doing. And the other problem is, as always, there's not a company behind it, so that sells something, right? Yes, But no, I think the marketing is key for this.
I mean, I think if you break it down with, "Well, do you want to have this done in two procedures in the sense of a biopsy and a surgery? Or do you want to have a biopsy and then another procedure and then a and then a surgery?" You know, I think you're right.
I mean, I think most patients, although they may not understand how they're found, they definitely understand watching needles go into them, you know, and especially with that, especially that 10 to 20% incidence of vasovagal episode, nausea, vomiting, those are real numbers. Well, thank you again both so much for your forward thinking and all that you do for the care of patients with cancer. And thank you for taking the time to discuss your recent article with us here on The Operative Word.
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