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The Use of Biologic Grafts in Surgery for Pelvic O ...
The Use of Biologic Grafts in Surgery for Pelvic O ...
The Use of Biologic Grafts in Surgery for Pelvic Organ Prolapse
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Hello, and welcome to our live webcast, The Use of Biologic Grafts in Surgery for Pelvic Organ Prolapse. Thank you for joining us. My name is Gary, and I will be your operator for today's presentation. Before we get started, I'd like to take a moment to acquaint you with a few features of this web event technology. On the right-hand side of your screen, you will see the Q&A window. To send a question, click on the text box and type your text. When finished, click the Send button or push Enter. All questions that you submit are only seen by today's presenter. Your questions will be responded to in the order in which they were received and will be addressed at the end of the presentation. At the conclusion of today's program, we ask that you complete a brief post-event survey. Please take a moment to complete the survey as it will help us plan future web events. We are joined today by our moderator, Leslie Rickey, and our speaker, Dr. Peter Rosenblatt. At this time, I'd like to turn things over to Leslie for opening remarks. Thanks so much, Gary. I would like to welcome all of you to our next installment of our AWG Virtual Forum Web-Based Lecture Series. This is a series of presentations by experts in our sub-specialty from across the country, focused on topics based on the SPMRS learning objectives, as well as relevant practice-related topics. The virtual format also provides AWG members the opportunity to interact with their speakers in real time. This presentation will then be captured and made available for view at any time on the AWG website. Upon completion of this program, you will be given the opportunity to provide some feedback, which we do value greatly. For this evening's presentation, we are so pleased to have Peter Rosenblatt, who is Director of the Uro-Venticology and Reconstructive Pelvic Surgery Program at Mount Auburn Hospital. This webinar will discuss the utilization of biologic grafts when the surgeon feels the patient may be at risk of failure with native tissue repair alone, and would like an alternative to mesh products, which, as we all know, has been sort of at the forefront of debate and clinical care issues in our patient population for the last several years. So his presentation today will be on the use of biologic grafts in surgery for pelvic organ prolapse. Thank you, Dr. Rosenblatt, so much for being with us today. Great, thank you, Leslie. And I'd like to thank Adrian from AWGS, and also Will Reed from AWGS, who have helped coordinate this. And I'd also like to thank Vince Lucente, who's the chairman of the SIGs, the Special Interest Group for mesh and grafts, who also helped coordinate this event. And obviously, what we're, as Leslie mentioned, the reason we're talking about this is grafts, biologic grafts have been around for quite a long time, but there's been a renewed interest in these grafts because of what's happened in the last couple years with the controversy that Leslie mentioned about synthetics and all the mesh litigation that is happening. So we'll dive into it right now, and then we'll have a chance for questions later. These are my disclosures. I have worked with a number of companies that make grafts in a consulting role, and so that's really where I've learned a lot about these grafts. So the objectives for the presentation today, first, I'd like to share with everyone the differences between the different types of biologic grafts available, autografts, allografts, and xenografts. And then we'll describe different techniques that have been used to prepare, obtain, prepare, and then sterilize biologic grafts. We'll actually describe the techniques used for graft augmentation, and I do have a video that I'd like to share with you, which is about a five-minute video, which goes over one of the techniques that we commonly use. Actually, just did a case today using this technique in the operating room. And then we'll review the clinical data regarding the use of biologic grafts. So what is out there in a general sense? We'll look at the Cochrane Report and the systematic reviews that have been done, as well as a couple individual studies. So we all know that pelvic organ prolapse is extremely common. We know from Susan Hendricks's article back in 2002, this was part of the Women's Health Initiative study, which was really kind of an estrogen study of a large number of women. And part of the study, they did do clinical examinations. These were not necessarily symptomatic women. In fact, most of them probably were not symptomatic. But just if you look at multiparous women, 14% of them have what the clinicians in this study considered clinically significant uterine prolapse. About a third of women have a clinically significant cyst to seal on examination. And about 20%, one in five, have what is considered a rectocele. And then we know from Jennifer Wu's study from North Carolina that in a very large group of insured women in the United States, so almost 52 million women, that the risk of having either surgery for either pelvic organ prolapse or stress urinary incontinence by age 80 is 20%. Just for prolapse is over 12%. So a lot of women are having surgery for prolapse. It's probably in the neighborhood of 200,000 to 300,000 operations per year for prolapse. And the other interesting statistic, which isn't on here, is that it's been estimated that that number will basically double to about 400,000 to 500,000 by the year 2050. So this is a significant healthcare problem that needs to be addressed. And we need alternatives or other parts of the armamentarium besides mesh and besides native tissue repairs. So let's talk a little bit about patient selection. I mean, we always have to back off and think, what are the needs and desires of the patient? You know, one of the adages is, obviously, you want to make the surgery fit the patient and not the other way around. So it's, you know, there are surgeons who, you know, the old hammer and the nail. When all you have is a hammer, everything looks like a nail. And so it's the same operation for prolapse every time. And that is not the case. You know, think about, is the patient sexually active? Is it elderly patient with comorbidities and has no desire for sexual activity? You certainly may be thinking about either a pessary or a copal cliasis or a colpectomy. And then we need to think about, you know, when is native tissue repairs indicated? What about synthetics and what about biologics? And that's often going to come down to a discussion between the patient and the clinician of what the patient's particular desires are in terms of longevity of the procedure. Obviously, we all want to have a successful procedure, but is it worth the trade-off of a greater success rate with synthetics versus the potential for mesh exposures and pain, et cetera? And then, really, when do we use biologics? And I would suggest that when you are thinking about tissue augmentation, there are cases like extreme degrees of prolapse or recurrences of prolapse. One of the more common reasons when I consider biologics is if I'm questioning whether or not the tissue quality is poor in a woman, extreme atrophy despite use of vaginal estrogen for several months. And we've all had that experience of, because it's not that uncommon, of doing, for just an example, a posterior repair, and you expect to do a native tissue repair. And when you open up the posterior vaginal wall, there's really no good fascia there. You may see just a large enterocele, you may just see fatty tissue, and there's really nothing significant to bring together. And obviously, it's understood these days that we really should avoid levator plication or levator myoraphy, which can cause a large amount of trouble, like dyspareunia. So I'll give you an example. In my clinical practice, with a patient with just a posterior repair, my consent form will say, if they don't want synthetics, posterior repair with possible use of a biologic graft. That way, I keep the options open. So if I see good fascia, which is just separated in a site-specific way, I can repair it. But if I don't see any good tissue, then I might consider using a biologic. And then the question comes, well, which biologic? And I think that's gonna come down to personal preference. We're gonna talk a little bit here about the differences in biologics. And I would recommend that you get experience with a number of them and feel whatever you feel comfortable with. But obviously, it should be data-driven as well. What are the expectations from the procedure? If the patient says, look, I just want something that's not gonna fail, sexual activity is not important to me, but I'm not ready to have a copal chleasis, then you may be thinking about synthetics. But if she expects to become sexually active again, then you may consider avoiding the possibility of dyspareunia from that. And other considerations, obviously, are abdominal versus laparoscopic versus vaginal surgery. What we don't know yet is which of the candidates that have a better chance of being successful with biologics as opposed to patients where it may not be effective at all. So we don't really have those assays yet, those determinations to figure out which patients would benefit most from biologics. So as we mentioned earlier, this was an example of one of the mesh kits that was available back in the early to mid-2000s. And we know from randomized controlled trials that there is an improved efficacy, but there is a trade-off, right, for mesh exposure, dyspareunia, pain, et cetera. And this was the FDA safety update that came out in July of 2011, but this wasn't the first one, right? Everyone knows who's been doing this for the last 10 years, that back in October of 2008, we had the first public health notification from the FDA where they discussed the possibility of serious complications associated with transvaginal mesh. The July 2011 was not that different. There were definitely more complaints that were reported on the MAW database. The main difference, in my mind, was that for the first time, the FDA said that these potentially serious complications were, quote, not rare, unquote. And that really was what kind of fueled the fire of all the mesh litigation that came out. And we're still dealing with the multi-district litigation. The lawsuits, which are in the tens of thousands, have been consolidated into these MDLs, or multi-district litigations. And this was back two years ago when AMS had settled some of their mesh cases, 20,000 of them for a large quantity, $830 million. It turns out that by the time that AMS closed shop, which happened in April, they had settled actually 2.4 billion, and that's the B. So that was one of the motivators for the parent company, Endo Pharmaceutical, for shutting down that unit, the women's health unit, which was now known as Astora. So that really has changed the landscape in a lot of ways, that some companies like AMS are no longer with us. Other companies have discontinued some of their products, like Gynecare and Coloplast. And then some of the companies, well, Coloplast and Boston Scientific and a couple others are still in the game of pelvic reconstructive surgery, but things have certainly changed. So now let's talk about the biologics. There are many different types. They come from different sources. And we'll talk about the role that they potentially have for pelvic reconstructive surgery. What we're not gonna get into, but is an interesting topic in and of itself, is other things that we can use biologics for, for augmentation of fistula repairs, for use in neovaginas, for vescovaginal, rectovaginal fistulas, as I mentioned. So there are other uses of these biologics, but we're gonna stick to prolapse surgery for now. So let's talk about autologous grafts or autografts. And the advantage certainly is it's cost-effective. You're not paying for it because it's coming from the patient herself. So it's widely available. Every patient has their own fascia. It's certainly biocompatible, and there's no chance of viral transmission, obviously. The issue is that it's really limited tissue quantity. So most grafts that have been used, such as rectus fascia and fasciolata from the thigh, have been used mostly for slings, for biologic slings. There really aren't large pieces that we can take from the patient herself and use for prolapse repairs. The other issue is that you do get pain when you harvest the tissue from the donor site itself, and that donor site can become infected. You can get hernias in the lower abdomen. And the other issue is that we have to think, well, why is the patient here in the first place? It might be because her tissue quality is compromised. And if we're just taking her tissue from another source, maybe we're using faulty tissue. So those are the arguments for and against autologous grafts. Another option is to use allografts, and allografts technically are cadaveric grafts from a donor of the same species. So the advantage there is that you don't have to harvest, you save time, you have less morbidity, and you can get larger pieces of the graft, as shown in the picture here. So there's obviously greater biocompatibility compared to synthetics and lower erosion risk, or I guess I should say exposure risk, and probably erosion risk as well. Potential pitfalls. One is that there is a potential for transmission of prions, viruses, really hasn't been seen. To my knowledge, the only transmission of prions, which are, you know, DNA particles, viral particles, has been in corneal transplants. I don't think there have been any documented, any of the types of grafts that we would come across. There is a potential for not removing all the antigens in a graft, depending on the process of the way it's prepared. So graft versus host can come up. And then there is an issue of availability and cost. So these tend to be expensive, and there have been times when there has been actually a shortage. I haven't seen that in many years, but that's always a possibility. And in general, the types of allografts that we come across are either dermal grafts or fasciolata. Finally, we have the potential of using xenografts. Xenografts are grafts that come from a different species, and in our world, usually that's either bovine or porcine. The sources, there are actually quite a few different sources. Mostly what we're going to come across is dermal grafts, and we have seen small intestinal submucosa grafts. That's the one that's shown in the picture here, and you can see how translucent it is, although they can get multiple layers of them as well. Pericardium has been used, and more recently, bladder matrix has been used as well, and that is available for us as well. They tend to be pretty available because these animals are raised for this purpose, and the cost is certainly more expensive than synthetics, but in general, they tend to be less expensive than cadaveric or allografts. There is, again, the potential for transmission of infectious agents, but to my knowledge, that has not been a significant problem or any problem with the current sterilization and preparation techniques. Now, this is, I think, probably the most important slide in this slide deck because what it shows is, depending on what type of source you have, what species, what processing, and sterilization, you get very distinct extracellular matrix. So, I guess my point here is that unlike polypropylene, like type 1 polypropylene, macroporous, lightweight mesh, we really should evaluate these graphs separately. So, if you see a study which shows that this is the best graft in the world and it works, don't assume that it works for other grafts. And conversely, if you see a study, and we'll go over a couple studies, that do not show an improvement with the use of a graft, that doesn't mean that all grafts are bad. So, just to start at about the, actually, I have a pointer here I'll use, that, you know, these tissues could come from either human, porcine, or bovine. They're either in the fetal or adult, well, obviously, we're talking about the xenografts here, not the humans, but either fetal or adult, and there are some reasons why fetal might be better. The interesting thing about this is when I first saw this, I was sort of horrified, as I'm sure you are, that, oh, my God, we're, you know, killing fetal cows. But it turns out this is actually part of the meat industry, and when they do slaughter a cow that was pregnant, they actually will use the fetus and send it off to one of these companies, so at least it's not being wasted. So, it's a nice way of looking at it. Tissue type, like we talked about, pericardium, dermis, bladder, fasciolata, there is proprietary processing to get rid of all of the antigens and to hopefully not disturb the collagen matrix, which it turns out to be important. We'll talk about that. And then there's obviously the sterilization process, and some may influence the matrix more than others. So, that's an important key here. So, here, for our field in pelvic reconstructive surgery, here's what's currently available, and there's two of the xenografts that are, well, actually, let's talk about this xenograft, so Xenform is one that's available. Repliform is human, and the Xenform is fetal bovine. They are both dermis, and you can see their thickness and hydration times here. Axis and suspend are also human. One is dermis, and one is fasciolata, and you can see the hydration times here, which are similar. And then the newest product on the market is a bladder matrix, and it tends to be kind of thin, but it hydrates in 20 minutes and has been used for various indications in reconstructive surgery. This is a study that was done on pull-out strength, so when you put a suture through this, what happens? And really, I think they're all fairly good. The one that you do have to be a little bit careful about is the last one, which is the matris stem. Because it is a thinner material, suture pull-out can occur, and we'll just have to see with studies that go on how clinically significant this is. Then we should talk about, well, what happens? What is the fate of a biologic graft? And I think this is really important. There are three potential interactions between the host and the material. The top one here that I put in this square is what I think what we really want most of the time. We have a collagen matrix which has been preserved by removing all the antigens in the cells, the DNA, and the proteins that you don't want. And what you're left with is basically a scaffolding of collagen. And what you're hoping is that it preserves the collagen in such a way that the body doesn't reject it, that the body sees it as something that it can remodel. And what will happen is, and I'll show you a really nice example of it, is that the body will come in with lay down blood and bring in blood vessels and lay down collagen and really regenerates into the tissue that you want it to. And there is good evidence that that happens. If you have some type of process, if you look at the second group down here, if you have some type of process that damages the collagen and retains some of the proteins that we don't want, the non-collagenous proteins, you basically get an inflammatory response and eventually this graft will degrade and become resorbed. That's not, and as it says here, this is like similar to a temporary synthetic like Vicryl. So that's not really ideal, although there is some evidence in one of the studies, for example, by Peter Sand in Chicago, that there is some benefit to that, but that's not generally what we're looking for. And then the third potential interaction is when you have a biomaterial that is intentionally cross-linked. And basically you can think of that because it's not very dissimilar to leatherizing. So it's like putting a piece of leather inside the body. And really what the body does is it has a foreign body response, which actually that's not bad, but in this case it encapsulates. And encapsulation is not really what we're looking for in this situation. Here's one example of a cross-linked acellular bovine dermis that was available previously, something that many of us used about 15 years ago, and it would encapsulate. And so one option, and what the company did was actually they wound up sort of perforating it to make it, to allow for more tissue ingrowth. And in my mind, it basically became a synthetic mesh because it was a leatherized biologic graft. So it didn't really have a lot of advantages and it has been taken off the market, but this was the type of thing that you'd place maybe in the vesicle-vaginal space to augment a repair just like a mesh kit might. So this is what we're sort of hoping for, that you implant the matrix, the blood comes in there, lays down growth factors, cytokines, revascularizes, and you get deposition of collagen by the host fibroblasts. And eventually, when these xenografts disappear, which typically it may be like six to nine months, what you're left with is no xenograft left. You're left with just a, hopefully a stronger material where you put it. And what we're hoping for most of the time is an endopelvic fascia that has vascularization. This is what I was talking about earlier. Now, this isn't a rat model, but you can see this is a xenograft that's been laid down on some bowel. And you can see the arborization of blood vessels within the graft. And that's bringing cytokines, fibroblasts, et cetera, which is slowly going to turn that into a remodelable tissue so that in the six to nine months, by the time this graft disappears, what's left is just a stronger endopelvic fascia by the host. Now we're gonna talk about some of the more practical, what do you do with these materials? Because you could just sort of throw it in between the vagina and the bladder, or vagina and the rectum, which is called an onlay graft. That really doesn't work. So we really, we want to fix it. And here are the potential fixation points. Sacral spinous ligament, uterus sacral ligament, pre-spinous fixation, where you might place sutures in this area here, sort of like the anterior mesh kits used to do that. Distal fixation near the bladder neck or near the perineum. And then you could do also multiple sites of fixation along the arcus. Now obviously here, this is showing the coccygeus. We would never go into the piriformis muscle because the sacral nerve roots are exiting the spine in that place, and that would be a pretty dangerous place to go. But those are the general fixation points. You know, I showed the capio there, but there are some other devices that are available, Digitex and Fixed, and there are people that will still use older systems for placing sutures in deep, dark recesses, like the MiaHook, the Choms ligature carrier. So whatever you like to use is probably fine. So let's specifically go to the anterior compartment. And the possible fixation points, again, are sacrospinous, which I tend to favor when there's an apical prolapse. The uterus sacral ligaments, not so much the cardinal. The obturator internus fascia, or the overlying arcus tendineus fascia pelvis, and you can put multiple fixation points along the arcus. This is one example of what it might look like along the, if the mesh were in the vesicle vaginal, the graft were in the vesicle vaginal space between the arcus tendineus fascia pelvis bilaterally. So what I'd like to do, Gary, if we can switch over to the video. I have a short video that's gonna demonstrate this technique, and this is a technique that we're actually using for one of the FDA studies called the 522 studies, which I'd be happy to talk to you all about. But first we're doing hydrodissection. I don't know if you saw that, but that was something called a TUI needle. A TUI needle is a side-firing needle that is really wonderful for getting to the vesicle vaginal space. And we'll inject 20 or 30 cc's in this area. This is a technique that actually I took from Vince Lucente, who was using it quite a bit in order to get to that sort of deep space between the bladder and the vagina. We are very generous with our incision. This woman still has, you can see the cervix there. And then we'll dissect back the bladder. But the reason I'm generous with this incision just makes it easier, especially with the anterior approach. And I'm not worried as much as I would if I were using synthetic mesh here. That technique there was getting down to the sacrospinous ligament, which we do bluntly, just following the levator muscles, making sure not to injure or enter the levator muscles. In the study we did, we did do actually, the protocol was to do a standard anterior culporaphy with absorbable sutures before placing the graft. So you can see here, right hand is holding back the bladder and left hand is bringing in the capio. Now, this was a study using Xenform, but this could be any graft here. And we generally have the same type of configuration, which is sort of a trapezoidal shape where it's wider at the sacrospinous ligaments and narrower at the bladder neck. This cutout is to accommodate the difference between the length of the vagina versus the length from the introitus to the sacrospinous ligament. I want you to watch this closely. These are called pulley stitches. So in each one of these arms, I'm tying a knot. This stitch has already been through the sacrospinous ligament. And this is on the other side now. So a great technique because we're creating a pulley so that when it's time to pull up, we would pull up on the other suture and it would drag the, you'll see it in a minute, it'll drag the graft up. What I'm doing now is placing a suture in the anterior portion of the cervix and tying it to the base of the graft. We're actually going to place three such sutures there, but watch what happens here when we tie up the graft. It really makes the graft disappear as it pulls the cervix up into the proper position. What I'm showing here is putting some distal sutures at the level of the bladder neck in the arcus tendineus fascia pelvis. We're doing that on each side. And very often, there is excess graft material to trim before closing it. So you'll see first putting in the sutures. Remember, the graft has to be wide enough to go from arcus to arcus. And then we're just suturing this down just to stabilize it to make sure it's not moving at all. Distally, so distal sutures with Vicryl. And then we're closing the vaginal epithelium. And that's really it for the repair. And then we'll pack overnight just to try to eliminate that dead space between the graft and the vaginal wall, which can develop a hematoma. Gary, if we can go back to the regular slides now. So just to summarize, trapezoidal graft. Here are the pulley stitches. These are Gore-Tex sutures that I'm using. They don't have to be. They could be proline. They could conceivably be PDS. And there's the pulley stitch. And here is the sutures of the base of the trapezoid to the cervix, or it could be to the vaginal vault. And then once it's pulled out, it's pulled up. And the excess distal graft would be trimmed at the bladder neck. And then the distal bladder neck sutures can be placed in the arcus tendineus if necessary. So this is sort of what it would look like if you think about it. There's the bladder on top. You see the sacrospinous ligament, SSL, graft sutures being brought down to that. And then you can see the lateral sutures along the arcus tendineus fascia pelvis, ATFP, with as many sutures as you want plus some distal sutures as well. Posteriorly, you can use sacrospinous ligament, pelvic sidewall. You can bring it all the way out to the perineal body. You don't have to worry about mesh exposures like you do with synthetics. And it's generally the same configuration. What many of us do, though, is make this a little more narrow to accommodate the introitus when you get close to the perineal body. But it should be about the same width, which is about eight centimeters in general from sacrospinous to sacrospinous with multiple fixations. All right, what about the evidence? In the remaining time we have here, let's talk about the evidence, which is a little bit disappointing. This was the 2016, this year, Cochrane Review. Lead author was Chris Marr from Brisbane. And they looked specifically at transvaginal grafts compared to native tissue repair. There was no evidence of a difference between the groups. So this is biologic grafts at one to three years compared to native tissue repairs for the outcome awareness of prolapse. But notice, and I'm gonna repeat this multiple times, low quality evidence, low quality evidence. There was no evidence of a difference between the groups for the outcome of repeat surgery for prolapse. Also, low quality evidence. The effect of either approach was very uncertain for recurrent prolapse, either native tissue or biologics. And that was very low quality evidence. And likewise, there's no evidence of a difference between groups, native tissue versus biologics, for dyspareunia or quality of life outcomes. Well, there was another group that, well, the final point, though, was that low quality evidence suggests there is no difference between biologic grafts and native tissue repairs on rates of awareness of prolapse or reoperation for prolapse. Due to the very low quality of evidence, the impact of the interventions on prolapse was uncertain. So there's not great evidence according to the Cochrane Review. SGS also has the Systematic Review Group. Vivian Sung was the first author on this back in 2008. And they were charged with, the objectives were to look at the anatomic efficacy of biologics, the symptomatic efficacy, look at the efficacy of different graft materials, report on adverse event rates, and the spectrum of adverse events. And after reviewing all the literature, they found that there was few comparative studies evaluating grafts in transvaginal prolapse repairs. Most of the comparative studies were underpowered to detect differences for clinical outcomes. The data on symptomatic efficacy was very sparse. It's unclear whether there are certain subgroups of women who may be more likely to benefit from biologics or might be at risk of developing adverse events, as we discussed earlier. And probably, I think really importantly here, as opposed to the mesh kits that are currently or formerly were available, there really is a complete lack of standardization of surgical techniques. So it's very difficult to interpret this literature. All right, so if we look at a couple of studies, one that was presented back in the mid-2000s on using Repliform, which is a human dermis. This looked pretty good, right? So 60 of 78 subjects at one year. Recurrence was defined as POPQ of state greater than or equal to stage two. And you can see that the Repliform repair had a significantly less chance of recurrence than colporaphia alone. So almost a 70% reduction in anterior recurrence with graft. And there were no vaginal erosions in either group. Another couple studies were done with small intestinal submucosa from Porcine Model. One came out of the Cleveland Clinic with Pariso as the lead author. They did an RCT, randomizing patients to either posterior repair, site-specific repair, or site-specific repair with SIS, small intestinal submucosa. So think about, that's kind of a neat study. The results of the study were actually quite surprising. Posterior colporaphy group, that's a standard posterior colporaphy group, was that there was a 14% of stage two recurrence. Let's actually just stick to that for now. 7% at the Hyman, but 14%, which sounds about right. That's what you'd expect. Site-specific repair, which became all the rage about 15 years ago, actually had a higher recurrence rate, 22% at one year, this is at one year. Most surprisingly is that when you combine the site-specific repair augmented with the SIS graft, it actually had the highest recurrence rate, almost 50%. Now interestingly, most of the patients did well. They had a good subjective outcome, but this was sort of a wake-up call that this particular graft may not be that effective. This was another study down at Brown with Vivian Sung as the lead author, where they randomized patients to either SIS, small intestinal submucosa, or control group with just a posterior repair. Basically there was no difference in either symptoms or in the anatomic failure or defecatory symptoms. So there was really no difference in that study group. So, and lastly, I thought it would be important just to point out that there has even been studies looking at fascia lata versus mesh for sacral colpopexy. This was a five-year data from Susan Tate. Actually, Pat Culligan was in his group as well. And what they found was, if you look at the objective success rate, it's significantly higher for mesh, as you might expect, compared to fascia. Although clinically, the patients didn't notice that much of a difference, 97 versus 90%. So I mentioned earlier about the FDA study. So what happened with the controversy is that the FDA is now requiring post-market surveillance studies on any transvaginal mesh, on single incision slings, and, interestingly, for xenografts, for prolapse, not for allografts. So if you have human cadaver material, you do not have to do a 522 study, but xenografts do. This is one that I'm involved in. This is the Xenform product. We're involved in the 522 study. I think we have about 28 sites around the country comparing Xenform for anterior apical prolapse. That's the video that I showed you, versus standard anterior repair with some apical suspension, like utero-sacral ligament suspension. So this is the concluding slide. Biologics are an alternative to synthetics when you feel, as a surgeon, that you need to augment with something. And we talked about the difference between allografts, xenografts, and autologous grafts. But just remember that there are big differences between grafts in all of their origin, how they're prepared, sterilized, and their quality of surgical handling. Remember, like really thin versus kind of thicker materials. I think in general, most people agree now that rather than just throwing in a piece of graft and assuming it's going to behave well, that we really need to place these grafts into reliable fixation points. And as I mentioned earlier, let's not assume that the results of one graft are translatable to others. So I think what we need is certainly more studies, more robust studies, hopefully more RCTs, to give us the answers in the future. I think I'll end there, and thanks for your attention. And if there are any questions, I'd be happy to take them now. All right, Dr. Rosenblatt, thank you very much. Just a quick reminder before we get to the Q&A portion of today's program, a reminder on how to submit a question. The Q&A box is located on the right-hand side of your screen. To submit a question, just type your question into the small text box at the bottom. When finished, click the Send button or push Enter. I'll turn things back to Leslie to handle the Q&A portion of the program. Thank you. Thank you, Dr. Rosenblatt. That was great, and as Gary said, I'll kind of just be watching the Q&A box and will go ahead and relay your questions as they come up. One of the questions I had is, patients are always concerned about transmittable diseases. Is this like a conversation you have to have over and over again? With mesh, it's more like you start bringing up a surgery and you can already tell they're gonna say, is that that mesh I hear about on TV? Do you sort of get the same thing when you're talking about using an animal or human tissue source? Yeah, that's interesting. It doesn't come up as often, I think probably because it hasn't made the airwaves. So we've all had those patients that will sit down when you have that talk about prolapse and will look you in the eye and say, you're not gonna talk to me about that mesh that's been recalled, are you? So really that hasn't happened, at least for me. Interestingly, I'm sure there are some people that would prefer one versus the other in terms of cadaveric versus an animal xenograft, but that hasn't become, at least in my practice, a big issue. And I do tell people that the graft that I use, I tell them where it comes from, but I really haven't seen much pushback at all, especially when you tell them that these are completely absorbable in time, that in nine months it's not gonna be a part of your body at all, that your body will absorb it. And I think people also know that these are the types of grafts that have been used in the past in plastic surgery, burn victims, reconstructive surgery. So I think they have a better reputation, I guess is the word I'm looking for. Yeah, that makes sense. I just wasn't sure if there was still that fear about other tissue. Another question I had is the data are not great, as you said, in terms of comparing this type of graft to synthetic or native tissue. So do you have any sense personally from your experience whether there is any difference in some of the potential side effects such as pain, maybe when you think about a biologic graft compared to a native tissue repair? One way or the other, any difference? Right, so my experience has sort of run the gamut and I wish what I'm about to say were more data-driven and it really isn't. I can tell you that I did have some experience with the cross-linked, very little experience, but I could tell you that's no longer available, cross-linked bovine dermis, and I'm sorry, porcine dermis. And when I saw those women kind of years later, you could still appreciate, especially on a rectovaginal in the septum, that the graft was still there. It almost felt rubbery. But I didn't hear complaints of pain. The interesting thing also, by the way, is that if you were to have, for instance, the hematoma and the incision line opens up for one of the modern grafts, I think, personally, what I would do is leave it alone. I'd monitor that patient, watch her, but it will usually granulate in and we don't really worry too much about exposures. I haven't ever had to remove one. In fact, I have, and I presented a video years ago, that if you do have a large synthetic mesh exposure that you have to take care of and remove a large portion of the mesh, you can actually use one of these biografts to cover the defect. And so, I know I'm not answering your question, Leslie, in terms of pain, but there are other uses of these biologic grafts. I can also tell you just anecdotally that I personally have been very satisfied in this 522 study that we're, hopefully the results will be published relatively soon, but of the patients that we've been involved with, we're very happy with the results. The graft is really undetectable. It feels very supple. People don't have kind of pressure points or banding like you sometimes would see if you pull too hard on a mesh arm. So, it seems to be a more natural pair. The question is, will it have the longevity that the synthetics did provide? And that's just going to take time to tell in following these patients. That will be my next question about, in terms of anatomic outcomes, and I guess maybe clinical outcomes are more important. Like you said, sometimes the clinical outcomes are similar despite slightly, maybe better, what we would consider better anatomic outcomes. So, it sounds like so far, do you ever see biologics supplanting synthetics? Wow. Good question. I certainly don't think we're done with synthetics at all. I mean, certainly for slings and for sacral cobalt-dexy, that's, I think, a gold standard. I really do believe there's a very good role for synthetics for prolapse when used appropriately. And the right type of patient, I don't think biologic will ever outperform in terms of efficacy, a well-done synthetic. But either because of the prevailing environment or the patient's own desires, it's nice to have another option. And especially in a very atrophic patient, you might be a little apprehensive of using a synthetic if you don't think you can have a good deep dissection. And so, I think there will be a role for this. But I also think there's a lot of potential for bioengineering and making these grafts more robust and more productive. And when I say that, there are cases where you might find you have a great repair, and you come back a year later and it looks like you were never there. And it doesn't happen that often, but wouldn't it be great to be able to screen somehow and find out who's gonna break down and not remodel this tissue? We just have no idea how to screen for those patients. Now, I agree. Maybe one of these days, hopefully we're moving towards better precision medicine. The right procedure for the right patient. But I think you're right. I think the long-term data will be very important for some of these registries for the biologic grafts. And I think they play an important role in terms of the armamentarium for treating some of these patients. So, well, if there's no other questions, I'm sorry, I've been yapping this whole time. But I don't see anybody typing any questions. So, I guess I will go ahead and give a big thank you to Dr. Rosenblatt for that great presentation. As always, we learned a lot from one of our subspecialties, great clinicians, researchers, and educators. I wanna thank you as well to all of the participants for carving time out in your busy day to participate in this virtual forum with our speaker. I do just wanna remind you all that upon completion of the program, you will be prompted to provide feedback. So, please do share your thoughts. I also just wanna remind everybody that we have our next webinar coming up. Next, oh, no, here we go. Our next webinar is gonna be Spessary Sitting, Follow-up and Management of Complications on October 12th at 7 p.m. Eastern Time. And that's gonna be given by Colleen Mellon at Hartford Hospital and Kate O'Dell at UMass Memorial. So, again, thank you, Dr. Rosenblatt. And remember that this presentation gets archived on the website. So, there are always hundreds of more views on the website, so it's really great that people can brush up on this and watch the presentation in perpetuity. So, thanks again. Thanks to everybody on the call. And if there's nothing left, then I'm gonna go ahead and close out the webinar. All right, thank you, Leslie. Thank you also, Dr. Rosenblatt. On behalf of AUGS, I would like to thank everyone else for your participation in today's event as well. Again, a post-event survey will appear requesting your feedback. Please take a moment to complete the survey as it will help AUGS plan future web events. This concludes today's program. Thank you and have a great night.
Video Summary
Summary: This video is a webcast discussing the use of biologic grafts in surgery for pelvic organ prolapse. The speaker, Dr. Peter Rosenblatt, presents different types of biologic grafts available, including autografts, allografts, and xenografts, and discusses their advantages and disadvantages. He also emphasizes the importance of proper fixation points when using biologic grafts and shares a video demonstration of a surgical technique using a biologic graft. The video presents some evidence on the use of biologic grafts, including a Cochrane Review and other studies, but concludes that more research is needed to determine the efficacy and effectiveness of biologic grafts compared to native tissue repairs or synthetic mesh. The speaker also mentions ongoing FDA studies on transvaginal mesh and biologic grafts. Overall, the video highlights the potential benefits and considerations of using biologic grafts in pelvic organ prolapse surgery.
Asset Subtitle
Peter L. Rosenblatt, MD, FACOG
Keywords
biologic grafts
surgery
pelvic organ prolapse
autografts
allografts
xenografts
fixation points
evidence
Cochrane Review
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