Originally Broadcast: June 23, 2022 at 7:00 PM ET
Watch now a prerecorded case-based discussion among mitral valve thought leaders. Where the panel of recognized mitral valve surgeons will examine:
Review of current clinical literature.
Review of mitral valve reoperation case videos
Discuss conventional mitral valve redo scenarios.
Best practices for redo mitral valve surgery.
What are the outcomes of redo mitral valve surgery?
New redo challenges in current times.
What does the future hold?
Prosthesis selection in times of flux.
A. Marc Gillinov, MD
Moderator
Marc Gerdisch, MD
Rochus Voeller, MD
Please Note:
On-X Life Technologies, Inc. is a wholly owned subsidiary of Artivion, Inc. The On-X® Prosthetic Heart Valves are manufactured by On-X Life Technologies, Inc. The snowflake design, CryoLife, Life Restoring Technologies, and On-X are registered trademarks owned by Artivion, Inc. or its subsidiaries. All other registered trademarks are owned by their respective owners. © 2022 Artivion, Inc. All rights reserved.
it's my great pleasure to introduce our moderator for tonight. Dr Mario Castillo Sang from ST Elizabeth Healthcare in Edgewood Kentucky. Thank you donna. And I want to thank our tv and for putting this together. And I also want to thank all the panelists who are here today. An incredible group of panelists that will be discussing a fascinating topic of re operative mitral valve surgery. It's a vast topic. I do not think we will be able to fit it all in one hour. We will do our best. Today. We have Dr Rojas Vogler who is social professor of surgery and director of minimally invasive surgery at the University of Minnesota Department of Surgery Dr Mark Kurdish who is Chief of cardiac surgery at Franciscan healthcare in Indianapolis indiana dr Mark Ulanov who is department chair of the department of thoracic and cardiovascular surgery at the Cleveland clinic in Cleveland Ohio and myself and I want again thank everybody here today for participating in this panel Today. We're going to be talking about different aspects of re operative mitral valve surgery and we want to talk about conventional reduce in areas the best practices for redux mitral valve surgery. According to all of us here in the panel. What are the outcomes. What does the data say about outcomes and look at new redo challenges that we are facing in our times as the demographics change and as the technology is advanced and then also look at the future and see what the future holds for all of us as surgeons practicing Metro health care and then we'll finalize by talking about at the end hopefully a conclusion to this election and how do we decide what our data points with this. We'll start with the case. But these are this is the gamut of cases that we will be looking at from redux repairs. We do replacement bio prosthetic to mechanicals and let's start with this case Rocca's. Why don't you tell us about this case? Thank you Mario. So this is a 49 year old gentleman was recently who under when two previous failed mike robot repairs that are referring hospital. Both were done through astronomy approaches and this planet was by leaflet prolapse more poster than the anterior. But fortunately the second repair failed within a year and presented to us for consideration for a third time. Second time re operative might evolve. Surgery is very symptomatic. So let me let me ask this to the panel. We have this patient who is young who has had a previous much about prepare for bachelors. I assume that there was some form of quarter reconstruction posterior early and before we have talked and Mark referred you say that one of the things that can happen with reconstruction is in the future is potentially having that lack of the courts. What are your thoughts on that? I think it's relatively uncommon but I have seen a small handful of cases in which we did cords to the post relief but it looks like that's what this patient has had And in the operating room and pre discharge it looked great, no residual prolapse and then here you see, clear prolapse of the post care leaflets. And seeing a small number of these has led me to go back to resection as my primary treatment for post air prolapse. Mark Curtis. What are your thoughts? What are your observations on this? So I think we're evolving a little bit on this, you know Mark Gillan Aww does so many valve repairs that he can he can really speak to this with authority with respect to having that experience. I think all of us though have a little bit drifted heavily toward chords for a while and then drifted back a bit. So my approach now is a combined approach with resection and Kordell replacement. Most of people have been in my operating room will see that I'll take some at leaflet out and then play some chords. Um you know this fella, it looks like you're going to run into a double whammy with that poster leaflet. And now as anti relief it's taken a pounding. So I'm interested to see where this goes. So the question to the panel again is in this situation, this would be the third time operation for this gentleman. Would you, what would you discussion be with them? Are you thinking of re re re repairing or replacing out of the gates. I had a case like this today. Um Someone who had two previous operations and I told the scrub nurse when I'm looking at the valve remind me not to try to re repair this valve because I'm going to be tempted. I didn't do the first two operations, remind me not to do it because there's a signal here if surgeons have tried to repair it and good surgeons and it did not work out. I think there's a message in those results. I'd agree. What about you, Mark Kurdish? I agree completely. And uh and we've all been presented with redux micro valve repairs. And so first time redo, I think it's still a very legitimate operation even in what they've had congenital repairs or there, whether they're far out or near in time with respect to their first repair. Second time around like Mark Gillan off just said um you really have to think that it's time for development to be replaced. I couldn't agree more. I think Sarah, just tell us what happened here. Thank you. Uh and going back to the no quarter resection. I think it is critical to restrict that poster leaflet to and not leave any prolapse or Puccini's when you're done with the case and you you're at a risk for developing this later when the ventricle remodels, particularly with a dilated ventricle. So so we did. So I didn't even think about repairing this and this was easy decision because the patient begged not to attempt to have a third time repair. So we did opt for a minimal invasive approach, avoiding a third time strain on to me did write me through economy and this coptic assisted and right straightforward replacement. And that's what you see. The exposure was actually quite difficult and this probably would have been the case the astronomy as well. The annual plane is very vertical in this situation and that's not that uncommon for a redo. Um But let me ask you this to the panel, this is a re operative approach. Any um any difference in decision making here in terms of going back to the sternum or going through the right chest. What would you do mark? I tend to do re operations through the sternum and I might have gone trans septal or combined spirit transept of an incision. I had a question I saw you had a pretty cool looking retractor in that left atrium. What was that? This is the ah the C. B tractor Mario, right. It's USB Medical Medical and it has a flap that goes to kind of retract that side of the left wall which I think is very helpful particularly when I have a really redundant large left atrium. And it also allows you to put the vent, get rid of all that homer events return on a review. I think that's very nice. Mark Curtis. What are your thoughts? Yeah. So I tend to not give people a new incision. We're pretty comfortable with multi time reduce through the same incision. Whatever it happens to be. And frequently obviously astronomy. I agree with marc Dylan off. We would almost invariably go trans septal for this scenario. Um And I would add that. I just got that retractor after I asked Rocca's where to get it. So that's great. one more question up. Any calculation strategies that you use through astronomy Like some people would put a femoral venus or do you do everything in the chest? I do it all. Perky titanius lee ahead of time. So I will pertain hisley candidate including an anti grade stick into the superficial thermal artery. Everything is done with per close I get the incision done. Take the wires out or whatever hardware is there and I just go on pump open the sternum and go and do the surgery. Perfect. Perfect. Mark. Anything you wanted to mark anything you want to add by the way for the audience. This is a struggle. Mark Gillan off and Mark kurdish. It's difficult. So it's that's why it's first and last name. I always love being on a panel with Mark kurdish. I invariably learn a lot we would if it appears to be a reasonably safe re entry simulate centrally. If we're concerned that the reentry might be hazardous. The C. T. Scan and always get a ct scan on these relapse. I presume we all do that. If the C. T. Shows that any structures like the nominee vein. right ventricle, right atrium are close to the back of the sternum we would actually favor exposing the axillary artery and SIA graph to it. And I'm going from venus. Very good, very good. I think that we've been in this case to the end but I want to show another case. Um Well before we go to another case let me show you just that clip that last clip there which was basically meant to as we have discussed before, what do we do about that pushiness? What can happen there? And the fact is that restricting that posterior leaflet? I think that clip went too fast but I can't get back to it. But restricting that posterior leaflet more especially in those bigger ventricles can be a solution to that recurrence of the mark. This second case is another person who had to repair the ring. Is the is the band is the his and there's some problem with the anterior leaflet there too. But what I wanted to showcase in this case is the official appendage and I think we've all faced this. What is your management of the left atrial appendage in a re operative mitral valve operation? Focus. Yeah so in a re operative setting I tend to leave it alone because when I do close the appendages, primary operation. I I use a clip so I close it externally. I just think from a rehab standpoint that's difficult to do through a. Mini approach and I don't tend not to close it from the inside. So I would just leave it alone for re operative cases. Mark kurdish. So Mark Gillan off is going to be thrilled that we actually have three people saying the same thing because we're all gonna agree with rockets. There's so much data that tells us that you cannot effectively close the appendage, sewing it shut from the inside and absolutely not on a redo with all the traction of the adhesions. When I just looked at the beginning of that case, there was that a case of a ring that was too short and and the rest of the analysts expanded because it looks like to our left. Yeah. And we've seen it before. Right? Mark Gillan off. We've seen that before. Yeah. Yes. I tend to agree with your assessment of that failure. Yeah. They look they missed the trick down on the left or at least the commissioner. Yeah. So anyway, the appendage, like I said, I've spoken for Guillen off inadvertently, but I couldn't help but saying because he and I have spoken on this so many times, I know what he's gonna say. Yeah, I almost always agree with you because you're right. Yeah, I would um I would leave the appendix alone, especially a situation like this That said tomorrow, I'm going to re operate on someone I did a robotic repair on in 2016 and I don't know the mechanism of his failed repair. But suffice it to say his valleys again and he's had a hip since then. And if there are not very many adhesions on the left side of the heart, I'm going to have a look and if I can safely and fairly easily dissect out the appendage, I'm gonna try to clip that from the outside. But he asked about this on the instruction of his cardiologist, what are you gonna do to my appendage? And I said if I can see it and safely get it from the outside, I'll do something. But if not, as Mark Curtis said, if it looks like that, I'm not going to try to close that with you because it won't work. Well, that's fascinating. Haven't been lucky enough to be able to or courageous enough to get through the transfer sinus and clip it. But but I'm very curious about it and hopefully get to it. Um So we also wanted to talk about some data and we put out three studies for major institutions. This is a study from the Mayo clinic which they look at two cohorts of re operative re mitral and aortic valve. But for the cohort of mitral valve Patients who have had previous bio prosthetic valves. The survival at five years was 61% in 10 years or 32%. These were older patients and in the series of you'll see these were 71 average age, they had a high rate of pacemaker implantation And as well as a high rate of ibp and balloon pump support with 13%. Another paper from the Brigham in boston showed this one was looking specifically at just mitral valve surgery. Previous mitral valve surgery whether repair or replacement and then they re replaced these valves. The average age of re replacement was 63 years old. And if you look at the median time or the meantime actually To re replacement was about 10 years for both groups. So some of these patients were implanted with a biological valve at you know early 50s late 40s. And so I think we will discuss that we will have a lot of discussion on that up to come. And the mortality for these patients for re too isolated mitral valve replacement was highest for those who had a previous replacement. Mark. I'd love for you to talk to us about your paper from the Cleveland clinic on re operative my valve. This paper has two groups of patients. These are all patients who have structural valve deterioration of a bio prosthesis. So this is S. P. D. Bio prosthetic valves. But about a quarter of them that's all they had. They just did a new mitral valve and three quarters of them needed other things like bypass surgery. Tri caster valve, aortic valve. And I think to me the key message here is amongst those who just needed a new mitral valve. They didn't need anything else. Their bio prosthesis had degenerated The operative mortality. That was about 130 133 patients. Actually The average mortality amongst those 133 who just needed a mitral valve Was less than 1%. So these are obviously selected people reasonably healthy. Their track customers are good. They don't need bypass surgery. Mean age was 66. On the other hand, people who had degenerated bio prosthesis who needed other procedures like bypass surgery, aortic valve, bicuspid valve. They were roughly the same age but their operative mortality was 7%. So a big difference. And the message to me concerning those patients was two fold and in the paper we discussed this one is be careful about deciding I'm gonna fix everything because let's say someone needs a new metro valve bio prosthesis is deteriorated. They've got moderate A. S coronary lesions that aren't too bad and you decide I'm going to do it all that might be too much surgery. So first thing is figure out what does that patient really really need. And then if the patient is will be very high risk. I know will come to this. If the mitral valve is the primary predominant lesion that's causing problems. Start thinking about the valve and valve for those people. Very good. So let's let's look at the guidelines brokers. If you want to tell us about the guidelines. Of course yes. The first guideline is we all know is the american H A C C guidelines and we can all see the screen. But basically the numbers they They are the age 65 as a cut off. So less than 65 we're unable to go under a repair, they quote it is reasonable to choose a mechanical mitral valve prosthesis over a tissue valve And similarly age 65 or curator require a replacement. That would say it would be reasonable to choose a prosthetic valve or a mechanical valve. So those are class two a evidence. That's the American guideline and the European island similar. So they again put out the number 65 for the mechanical for their prosthesis in the Mitral position. So less than 65 they say um mechanical prosthesis should be considered. And similarly actually the slight difference between this and the American guidelines is that 65-70, they basically say you can go either way will be acceptable. Mechanical prostheses should be considered in patients with a reasonable life expectancy for anybody. So that that's I want to pause there and I want to ask all the panelists what your conversation goes like when you're sitting with outpatient who needs a by mitral valve replacement. Let's start with Mark Dylan off. It seems to me that somehow the idea has been implanted in everyone's mind that no matter your age, no matter your age, no matter how young you are you need to think of bio prosthesis first. And so so many people in their 40s and 50s come in and say I want to buy a prosthesis. I absolutely positively don't want to be on warfare and I I don't know whether this is from blogs or from the internet or somebody's put a chip in the vaccine that they all got to prevent covid different theory. But but in the US absolutely mayo clinic where they put in more mechanical valves, There is this broad desire to have bio prosthesis and to kind of kick the can down the road and say, well if I need any re operation it's not for 10 years. And there is a paper and I'm going to show from stanford suggesting that that in younger patients are going to get a survival benefit from mechanical valves. So I make sure that patients have that data in hand. And of course we all want to say if you need a re operation we can do it and it's very safe But it's not 100% safe a re operation. If it were not a big deal, we would not be having this webinar, it's a pretty big deal. So I just want to make sure that patients understand all the data and what they are buying, especially when the 44 year old says, I want to buy a prosthetic valve. I mean you can say if your heart surgeon perhaps that's good for business as you're gonna be seeing this guy every 10 years but that may not be the best thing for the patient, yep, Mark kurdish. Um So first of all, I want to harken back a little bit for a second, just for a second back to Mark Illinois Guillen odds, description of the paper from, from Cleveland clinic, because I think it's important to, I think the punch line was think about it, pay attention to what you're about to do. Um and if you select the patients properly, admittedly, the Cleveland clinic has some of the best surgeons on the planet, but what he said was think about it and select those folks that make sense for a valve in valve versus those folks that make sense for a redo surgery and that's the ticket to success. So, kind of following that same path with respect to just being a little bit cerebral about things. I think that there are some parallels to eric valve disease management in the sense of tissue valve versus mechanical valve and the constraints of the space and the and the organism that receives the valve. So, if you're talking about a woman who has has inflammatory markers up and she's diabetic and obese and she's gonna get a small tissue valve because there's no room in there. That's a recipe for disaster in short order for her redo surgery. So I think you have to be realistic about what the trajectory is for the human being. A robust person with a large outflow tract who's got, you know, a good ventricle and plenty of room to put a big valve in. It makes a little more sense to put a tissue valve in. So these are all kind of tight tradable parameters for the person. The other thing is I have a have kind of a heart to heart about what their, how they want to live their life. And I think you have to include probably mention this again later. You have to include surveillance when you put a tissue valve in somebody. You are committing them to a life time of surveillance, mechanical valve. And that's not true. The guidelines don't tell you you have to get an echo every year. The guidelines actually say that you should get something if something changes symptomatically, but otherwise, you know, every five years, maybe take some pictures of the valve and if they do go down the road to a valve and valve, there's more surveillance. And there's other things that go into that. So medical care gets ramped up over time. So I have, I talked about all that and I really look at them as the person that's receiving it, their biologic milia and the construct or structural limitations that will prevail when they go to have another operation, whether that be surgery or a trans Catherine, that's that's fantastic, broke us totally agree with that. You know, as an example I saw a 67 year old female today, not quite end stage renal failure about that kidneys and she's smaller and she's 67. But my recommendation would have been a mechanical valve because I do not want to see her 10 years later when she's 80 and undergo a redo metro operation. So I think it needs to be tailored to the individual and guidelines are guidelines but uh individualized to the patient. Yeah. So we'll illustrate that with this case is a 47 year old as mark mark in dr enough to 47 year old who really really push to get a bio prosthetic valve on her surgeon for whatever reason. And four years later the valve is too thick as you can see on this echo. Ah definitely cyanotic and she is very symptomatic. So at this point this was a re operation to remove this valve and change the valve to a working mechanical valve. And these operations are tedious and we all know that. And like Mark Gillan off said they are not free. They carry a risk even if it's not very high when it happens to you, it's 100%. And so in this circumstances this was the right sided approach. Endoscopic assisted with peripheral bypass. And the idea here was to replace the mechanical bob. One of the things I wanted to highlight is um we see the adhesions of for example this post to the tissues underneath the survival apparatus. And this is something we're very used to doing which is removing prosthesis from the heart in the micro position. But things are changing and we'll see another case like that. We see that when we remove that prestigious, there's a lot of raw tissue scar tissue down there. Sometimes posterior leaflets has to be removed if it's stuck to the post. And so all these things I think impact the conduct of the operation. Anything you do particularly different or any tips you can give the audience in terms of removing prosthesis in the mitral position. Mark Curtis. Well I think you're going to illustrate it quite nicely here and it's really a function of being aware of how the valves have planted the first time. Because sometimes you you get in there and you find that there's so much tissue from the atria in that's been taken with the valve. And then as you take it out you excavate you find yourself in the same situation as you do when you de calcify a valve and you look at your peering into that tissue between the atrium and the ventricle. So it's really this is this is about experience and it's really about being able to fashion a space safety for the new valve without getting into the adjacent structures I think. Is this the one also where you put some chords on the that's another case because I think that's an important point. I would also ask though of the panelists if you don't mind uh when you do put a bio prosthetic mitral valve in, do you prefer porcine or bovine? I prefer forcing valve only because the porcine valve we use has a very generous fluffy selling ring. And also when a person belt fails it's gonna tend to fail with regurgitation versus the bovine will sometimes fail with stenosis, which I think is a more symptomatic lesion. And one comment just ahead on this case, I like the way you put the pledges on the ventricular side so that you move the tissue away from the discs of the valve and preventing entrapment. When you guys do a redo my train your pretty mechanical valve. Do you have any particular preference for where you put the budgets bogus? You know, I tend to go I've done both ways but in my current practice unless there's significant mac or really really just bulky scar tissue around the annual list. Um I tend to go eight year old ventricle and put the pledges in the on the top but I just thought it happened. I don't really have a good explanation for it but I've done either way but you know, seeing the valve anti anatomically is I'm sure you'll get to that is a critical part of part of doing this case as well. Yes. Mark kurdish and at that point that yeah, it's actually the same as ruckus. It's exactly the same. Okay, so going back to this, what Mark Curtis was saying about making sure that your debris tissue, if you look here closely, this would appear to be very close. And so be careful with that. Always be careful. This is a peanut and peanut and you can see that the mechanism is free, but it's very crucial that you make sure that that tissue is removed if it's going to impede the mechanism, the guards on the onyx valve are kind of handy there too. Right, very good. And that's a very good point, mark. That's one of the reasons I choose this valve over other mechanical valves in all circumstances, specially readers, because the housing of the valve is perfectly designed to prevent material from coming and getting into contact with the mechanism that said was brought up the point of the anti anatomical position of the valve. Um and and that is to prevent ele bot obstruction to um And again, this is a young patient. Right. One of the things that people ask is oftentimes, why is this valve only 25. Right. And so, Mark kurdish, if you want to tell a little bit about that. Sure. And just because and just in case folks who are listening don't recognize what Mario is referring to. There is only one size of the hardware. The carbon portion of the valve. The valve. Carbon coated valve, there's only one size. It's a 25 and the reason for that is under all forms of human Hammock testing, they found that they achieved optimal human dynamics. The lowest gradient at that point, there was no point in making the housing bigger. The reason for that is because the valve is deciding to create laminar flow and in so doing it lowers the resistance across the valve. This is really handy because uh in no matter what size patient you're operating on, you have the highest performing valve, the best effective orifice area. In other words, functional orifice area. And the and the the device is designed with two different cuffs, as everybody knows that then gives you there might be three, but I have to that then give you the option to, for example, in a rheumatic patient where you might have a very small space, you're still putting in that same high performing uh effective orifice area as opposed to somebody who has, you know, more room to fill in. And then you got that nice big fluffy cuff. Uh The outcome is always the same. You can see here with the gradients are across the valve and you might have a slide also comparing, but at the end of the day it has the best effective or office area of any mechanical valve you have in the mitral position that comes in hand and I wanted to bring this up because today I was talking to Rocca's earlier on about a case he has with severe macro cause right showed me the cats and Big Macs severe and if you're facing something like that or something, somebody with a small orifice, I mean it comes in great hand. Er 25 valve will give Great gradients for even somebody with the BSA of 2.4, even though the orifice may be small to put in the valve. So it comes in handy. Um This is one of the papers that we wanted to also bring up as important data pertinent to re operative mitral valve surgery brokers. So, this is a stanford paper that marc was referring to just a bit ago. Very powerful study actually. So basically looked at retrospectively and looked at a cohort of patients From over 100 non public hospitals in the state of California. And all these patients had first time either aortic or mitral valve replacements, either mechanical or biologic. And they followed these patients retrospectively over a 15-year period from 1996, one big powerful uh data from the study is that the use of biological prosthesis At the beginning of the study. So, in 96 was 11% out of all all valves. But at the end by 2013 it was over half. So there was a dramatic increase in use of biological valves. There's really no evidence to support that This is before the valves. Finding that was really, really surprising and important. But the other thing is also, they clearly showed that when they follow these patients who had either mechanical or tissue valve and they combined and Michael's together and they divided into three different age groups, 40-49, and 70-79. The first two age groups clearly had a survival advantage. So the risk of your probably death was statistically less if you had a mechanical belt. And this again summarized that. So that mechanical valve advantage was there uh, and uh, for the two age groups and for the patients who were in the 70 to 79 age category, there was no survival difference between the biological or mechanical, But there is no advantage in having a tissue valve, even if you're above age 70. And this is another summary of the data showing that the hazard ratio with biological prosthesis didn't reach one until you're 70, age 70. So the long-term benefit, mortality benefit associated with the mechanical prosthesis was really persistent until age 70, which is a pretty powerful sort of data that I try to remind myself and talk about it when I see these patients. So that I think that's a pretty important paper not to belabor the point, but I think we've seen now in two cases and talked about the guidelines and talked about the outcomes of reading surgery. And I think that what Mark said about in the overall impression in society about biological valves in younger patients with the promise of a valve involved in the future. And Mark kurdish will talk about that in a second. It's important to temper that argument or that feeling. Let's look at this case. This case is very related to that. This is not the angiogram the floor of the city of this case. But this is a young woman who had a valve in ring implanted as a solution to a low E. F. Were fairly low E. Ev. After a mitral valve repair that had failed. This lady was very symptomatic and it was felt that it was very risky to take her to the operating for a re operation for that valve. And so she received a valve in ring. And although this is not the angiogram for that patient, what I wanted to showcase here is that um if you think about the sewing ring of this valve, that's where the ring, the the the annual ring would be sitting in a repair. Um and you can see how much hardware protrudes into the ventricle from the analyst. And so with that said, um this is her echo, the motive failure here. Like Mark Gillan off said, there's there's some degree of stenosis, but more importantly there's also regurgitation and if you look at the re operation, this was a re operation for this particular patient. This is this is the only way I can describe it is gruesome. It was perhaps one of the most difficult dissections of a prosthesis out of the heart that I've ever done because there's so much material deep into the ventricle that all the leaflets and even the pabulum muscles were to some degree attached to them. And so these circumstances are something that we have not yet seen. And the purpose of this webinar wants to talk about what we see today and what we will see tomorrow. If we if we go back here this patient, this is that case. Let me see if I can go back here a little bit. So this is the patient where the case where we the popularity muscle was bare and I had to recreate with some gortex cords, some form of annual reconstruction to the popular muscle, mechanical valve, onyx valve implanted, great gradients. And she did. Well, what are your thoughts on a case like this mark? Today? I was looking at animals and the clinic, you guys published a paper on the time to read re replacement of or replacement of failed trans catheter devices in the aortic position and at that time was getting shorter. What do you what do you think of that? And how does that translate to the mitral space? I think the reason at times getting sugar is that the operators, the interventionists are becoming more aggressive and really trying to see what they can do. This is a remarkable case and congratulations On doing such a difficult operation successfully. I read this history and I say, Oh my gosh, 32 years old. Well maybe she was 30 when she had her first one. If she just had an onyx valve that time She would have been done with heart surgeons and valves and valves and the whole nine yards. But she was probably presented with this idea that we can stick a valve and valve in there. It's feasible. We can do it. It's not going to work and work in this case. But I think that there is a lot of to your point, why is this happening? There's a lot of very short term thinking based upon what do we think we can do? Can we get away with that? And I believe as cardiac surgeons, we don't think that way. We don't think about what we can do or what we can perhaps get away with. We think rather what is the safest best, most durable Operation for this person? And if I were you or if this 32 year old woman were my wife when she was 32, what would I advise her to have very good Mark kurdish, You're going to talk to us about this data and that's next. So Mario, is it possible for you to go back and just show that anti an atomic valve is positioned perfectly with respect to the outflow track. And I think folks need to see that they are not fully aware. I don't know if it's going to be tricky to get to that point in the video and reactivate that because they're the advantage of having the ferrying of the skirt is that it blocks that in growth of tissue. The there is the small possibility in a small ventricle that that's it. So you need to position that so that the line of the opening there is lined up with the outflow track because the skirt does go in a little deeper on on each side of that. So folks just, you know, they can look at the valve themselves and understand what I'm talking about but pay attention to it. When you put the valve in in a very small ventricle. I think you could possibly create a little bit of outflow direct construction. There's not gonna be something to re operate but you might see a little gradient agree. Very good point. Very good point mark. Yeah. My turn. Right. So these are a little bit rapid fire. And I've looked at these papers multiple times. And one of the things that I think is interesting is how little we know, but so these are 30 day outcomes. Um This was in 2013 to 2017 TVT registry which basically is S. T. S. A. C. C. Data uh and balloon expandable valves implanted in valve in valve valve in ring valve in Mac. Take home message from this paper. They make a point of pointing out that the mortality of 30 days is 8.1% versus what would have been an sts predicted of 11%. It's better. Um You notably they don't spend a lot of time talking about the disastrous outcomes of Alvin Mack and we don't have to go there. But I do think it's super important that people recognize that when people start talking about doing valve and MAC make sure that the patient has had the opportunity to talk to a surgeon that does mitral valve replacement in heavy duty mitral annular calcification micro valve in rain. You just showed us a disaster. The disasters are frequent But they make the case that that 30 day mortality is potentially better than it is for straightforward surgery for a redo. And I think we have another flash up for this. There you go. So this this is a similar look. Right? So this is 900 patients looking at 2015 to 2019 trying to get a grasp of one year outcomes And all cause mortality 5.4% of 30 days. That's pretty good. Keep in mind that just like when we talk about trans catheter therapy for bicuspid aortic valve disease and how good those outcomes are. Those are especially selected patients with favorable anatomy that we do travers on sometimes when they've got great anatomy thereby customers. They don't have that stalactite in the in the in the fuse leaflet. So these are selected patients based on their anatomy that suited the therapy, right? They made this choice based on thinking it through doing anatomical assessment and this was their outcome. So 17% mortality at one year next, The mean gradient is seven. So not only is it an operation that we don't have a long game for, because now we've put this in there and also keep in mind there's nothing, there's something to notice in all of these papers. A predominance of women. First time operations. When you look at our literature, are they ever predominated by women? They're not they're predominated by men. Second time operations. People in trouble valves going south valves are curating more rapidly. We might see that a little bit more than women. There's a good p. r. o. paper looking at the effects of inflammatory conditions, female gender and the other the other things that we think might contribute to the demise of a valve. So keep that in mind as we look forward because these other papers get up to 70% are women. So one year you've got to mean grading of seven and we don't have the long game for the belt next. And when I talk about long game, we're gonna back up into that first valve that they had. Right? So one of the signals in this paper, which is, you know, admittedly is a single settler experience signal center experience. But, you know, good operators, people that are well recognized in the space so time to requiring that intervention. How many months is that? You've got people at 33 months at 86, months getting their second valve, getting their valve and valve. And these folks, as I recall, their mean age is in the 60's And you can see it's got a one year mortality 27%. So how do you paint that picture for the lady I talked about earlier? You say, well, you know, I can put the bio prosthetic valve in your 63 now, uh, you know, the valve might last you seven or eight years and then when we'll have this option where we might be able to do a valve and valve for you. But you know, the one year mortality might be 27% maybe 20 quarter percent of the chance that you might be dead a year later. This gets complicated because when I back up to that same patient and I put Mechanical valve and four if you can just manage and coagulation, then we don't. This drama doesn't occur. I'm just saying that on an individual basis we have to think about what the consequences are and what the likelihood of a durable outcome is next. And if I can make one comment on that previous slide, I was looking at the sizes of the original valves and there are a lot of small valves. 25, I mean you are much more versatile or facile with tavern than I am, but Won't you wind up with a predictably high gradient if you're taking 25 bio prosthesis and putting something in the middle of it. And I think that's that's evidenced by the previous paper where, where the outcome of the gradient was seven point something after you had done a valve in valve, right? Yeah. And and those are the optimal scenarios they had, you know, kind of prepped for them. Mark makes the great point that a smaller valve wears out faster. We know that. Right? Mhm. Next. So let's say that it does last, let's say the thing works out pretty well. You get the size in there. You don't have an outflow track gradient. What's, what is that picture then look like? Because often the argument is made. Well, you know, if you put a tissue oven, you don't have to be on blood thinner. If I put a tissue valve in you and I don't, you know, paint gloom and doom. But the reality of it is you got to get a knuckle every year when the valve fails. You have to have something else done if you have a valve and valve. Uh the overall thinking at this point is that folks need to be in cumin and this is just an example where they looked, They looked after a year. They saw that there were 6.6% of the patients who were not on warfarin at the time developed thrombosis of the leaflets had promised on the leaflets. They all went on warfarin, they did clean up over time, but now they're on Warfarin. So the promise of staying away from anti coagulation, whether it be for a fib or thrombosis on the leaflet or a gradient or whatever it is, we have to be judicious about making that promise next. Um so this this slide and the next one kind of hammer home the same concept. So cumulative two year rate of welfare imposes 14%. So we looked at a year, 6.6% 2 years, 14.4% they're all asymptomatic, they all got better after they put them on Coumadin, but they all had to go on Coumadin. And there's a reason that Claude is forming right? It's not because the valve is working perfectly or the flow dynamics are great because the flow dynamics are not great. So there's a reason that their platforms next. This is kind of the summary paper and up in that corner, it just tells us that according to the current evidence, we're supposed to manage these people with primitive. Uh and if we back up through all those papers, we're gonna see the same thing with respect to Velvet Ring and Alvin Mack, that not only they need to be articulated, but the outcomes are fairly dismal at this point. So bottom line, one of my favorite slides? So, you know, I when I trained as a general surgeon, I had an attending Jack Michelman and somebody would come up with a great idea and dr piccolo would just say fine, That sounds great. But show me the data. So, because I'm not because I have to uh look at things through, through the eye of science. I think that if we look at the data, we see that it's clear that there are some papers that say that it's not a survival difference and it depends on age selection and other comorbidities and elements of the organism that receives the valve. But we don't have a single paper that shows a survival benefit to buy a prosthetic valve. You can't say that there's a survival benefit. You can say that there might be some, they might approximate each other in certain subgroups, but you can't say there's a very good any thoughts on this raucous and Mark Gillan off everything that Marcus said, which I think is well in 0.1 question I actually have for the for for everybody on the panel is, you know, the valve o Matic is a particularly challenging group of population patients and as evidenced by the mortality The one, your outcomes are very poor. What would your practice be for patients with severe Mac? They're not prohibitive surgical risk, but high risk surgical candidates. What would you do? Would you put them through a high risk? You know, my replacement or do a hybrid open trans catheter valve deployment or valve in valve valve. Um, excuse me, My first question for those patients is how limited are you? How much does this interfere with your life? Because if you are, let's say 84 years old and your limitation as you're moving a little bit more slowly through the supermarket this year than last year, I might say, get a scooter Because you'll be alive. And if you're 84 and I put you through this operation, it could use up a substantial proportion of the rest of your life recovering. That's it. If somebody says I think the magic words to me, I cannot live like this. This is so troubling. I cannot live with this. We would do a conventional operation. Almost always our forays into valve in MAC. Hybrid valve in Mac have sometimes been really exciting in a bad way. My great, so very similar. Um, it's it's actually, you know, an operation we're pretty comfortable with. I think that Mark makes a very important point that the patient has to be experiencing real symptoms and then, you know, you kind of have to put in the framework of where they are in the arc of their age, what their comorbidities are etcetera, we generally will just de calcify the valve and implant an appropriate device thereafter. I have done one of the, the open sapiens. They did an 84 year old school teacher wanted to go back to work and replaced her eric valve with a tissue valve and then she had circum frontal calcium. Cut out her anti relief and put a big SAPIEN in there. It was kind of perfect. But those perfect scenarios I think are very few and far between. And I would always first look at the calcified development and planning an appropriate device. I would agree I'd second that too. I think great comments. We're getting very close to the end and we have some questions but I think we have time for another case perhaps to This is an 85 year old female because everyone tells about her. Yeah so this is an 85 year old female with multiple medical comorbidities. The moderate risk surgical recitation, moderate LV dysfunction. She had a trans catheter actually repair close to two years ago and presented with recurrent severe symptomatic M. R. And the article shows that C1 clip and a very centric jet. And this is an entropic findings some through media approach. And you see the clippers ds from the poster leaflet. Um If I may interrupt and now this doesn't really I don't know if we can qualify this as a redo mitral valve re operated much about surgeon but I guess it falls into space? Right. We're talking about things that are coming that are here. Um What are your thoughts on, have you ever been able to repair a valve that has had a clip put on it. Mark Gillan off only twice. And I remember them both because I feel like I got lucky. One was a very early single leaflet detachment where it was still attached to the flail portion of the poster leaflet. So that was easy. Just do a resection as I would if they were not there and the other one wasn't a younger person who hard to understand why he was sent for a clip in the first place and we put a pericardial patch in the anterior leaflet after taking it out, put Neil cords and I would have to say we got kind of lucky because it worked out most of the time we have to replace these valves and joe chick has got a nice paper demonstrating that across the country replacement is what happened correct? Very similar. I've only had four of these. One of them I was able to repair and the other three I had to replace. So in this case I think you ended up replacing this valve. Right? Yeah. My repair rate has been zero for these out of about half a dozen of them. But it's it's an older patient. Higher risk just replaced. Very good. This is the last case and then we'll have some questions for the panel in the last five minutes of the Webinar. This is a 64 year old male who 20 years ago had a mechanical micro valve replacement and now has a frozen panels. I think this right this is your case. The mean grading is 13 with moderate M. R. I think you gave us excellent pictures of what's happening here because you can see the frozen leaflet and you can see the M. R. Jet. I mean right around where that hinge point would have been. The leaflet is not moving. This is not the profile of an onyx valve just for the for the audience. Um making that clear um and the angiogram also shows one of the leaflets being frozen. What did you do here? What what did you replace the previous strain on to me 20 years ago. So I elected for a minute or economy approach and in the section was actually not too difficult for this. Redo 20 years out, an explosion was great ginormous left atrium. You can see the the mechanical valve there. So from a re offer standpoint, very straightforward. The mechanism of failure was very typical for a mechanical valve as such. Get a huge panels formation and one of the leaflets is completely stuck. So I wanted to put this picture here and this is not the picture for that case. But just to show what can happen with panels through these mechanical valves and why selection and insurgents will implant what they feel comfortable with, which is totally fine. But bear in mind that panels does creep and you can see how invasive it can get and really block about in a bad way. Um We have some time for questions. I'd like to really get to the questions and there is the first question that we have if you're okay with that is ah this is steve wise. I don't see the city but steve wise asked What Valve did you implant in the 50 year old with Marlo's case at the beginning and the first case. Uh you like to use the onyx self. Um You know this is a pretty important patient came in for a second or third opinion attempt member. Third time surgery is very specific on what he wanted. Didn't want to consider re repair. He was pretty straightforward what with what he wanted which is on expelled. And I would have chose that myself as well. Have a question regarding that. I've heard some surgeons say they're a bit confused about the sizing of an onyx valve because of these different sizes. Would you mind describing how do you size the onyx valve? And then choose your particular. So income. Mm hmm. So the onyx as we all know comes in one size only. So basically the 25, 33 fits everybody. So the soaring ring is really made to be like a top hat. So it'll fill any size. Annual us within reason of annular size. So you really don't have to choose your mechanical valve size when we use an onyx valve and the mitral position. So what you're choosing is really the cough that slowing cough to to do that. Yeah so ross straws from L. A. He's a cardiologist. Um. Right this is just a curiosity only. I've noted when patients have M. V. R. With bio prosthesis on post tobacco's. The valve invariably is directed towards the septum and not really straight as in the native valve. Any thoughts on this with multiple surgeons, multiple institutions? Mark Dylan off is he saying the one of the struts is directed toward the septum? The overall orientation of the valve is candid towards the septum. Um I suppose that could be I haven't really thought about it because I think the key point is something Mark Curtis was talking about earlier which is to avoid a strut or anything frankly obstructing the outflow tract. Otherwise I don't think it matters. Mhm. I agree with that as well. I agree with that. I mean if the strut is not in the L. Bot it will not cause any harm that we talked about this before me to the ele bot can be slightly different in terms of angle depending on the patient. So if you really want to get accurate you could even pro B. L. B. L. T. With the right angle to see exactly where L. B. L. T. Is for that patient to align your strokes. I agree. I agree. Um 1 1 other comment here is and I'm going to change here so that I can show you just to answer one of the questions to his. This is the panel's growth on a mechanical valve. One of the things that happens with the onyx valve. I personally prefer that the conformance cuff, but the housing of the valve is such that it protects. I didn't imagine makes it really difficult for panels to actually creep up to it and invade the mechanism both at the top and at the bottom. Another question that we have is I think this is the last question that we have time to answer just to comment. I don't have a name. Uh was ross ross. I'm so glad that after decades of practice, my initial intuition was that if a patient can have a mechanical valve they should. This is a comment I've never subscribed to the bugaboo of fear of anti coagulation when Rio is the alternative, especially in younger patients including up to 60 years. This is a great ratification for me ross straws. This is a well received comment before we leave and we have one minute Mark kurdish, her closing remarks about how you select your patients and what tips you can give to surgeons. Um So I think I think I really kind of spoke to how I select the patients and what I offer them and I do think it's important to to respect what they come in with as far as the knowledge that they've already garnered. But then I think that once you can have that intimate conversation between the two of you because now they are selecting the person's heart surgery on them that you really provide them insight that you think is valuable as a person what you would do for yourself, your sister, your mother, whatever from a technique standpoint. I think we covered some of the most important points which I would emphasize again, making sure that valve is oriented in the proper direction and taking advantage of the fact that as you just described, the skirt of the valve protects us from from in growth. I would mention that when I last looked in the literature I could only find one report of pandas in growth for an onyx valve and it was in the position, I don't know if any further cases have come up but that was a long time ago. Focus next year. So val prosthetist this election I think is very complicated and it is potentially life changing. So it's a serious, serious decision making and I definitely, you know, start off with the guidelines but it has to be tailored to the patient. I usually have a long discussion with them and oftentimes patients will decide that they would meet in the clinic, you know and let them think about it. Most of these patients are well informed and I tell them come back and think about it and you let me know what you want the day of surgery. So that's not that uncommon in my practice Age cut off, you know 65 guidelines. Say. But again I don't definitely go by that. And I do think with the data and papers talked about today, I think there's a stronger argument for mechanical prosthesis in the management positions for a lot of these patients technical pearls for re operative surgery. I think for the surgeon it's whatever you're comfortable with and whatever is the safest for that patient, whether it's astronomy or a mini. Um that's very good. I begin by framing it as a choice between possibility of re operation and need for anti coagulation. And then I I tell them that the re operation is a if it becomes necessary and we discussed related hemorrhage which was actually relatively uncommon. I'm glad that the audience is like it. I take those as cheers from Mark british dog. They love the the webinar which is great. But I do tell them that anti coagulation is not terrible. That anti coagulant hemorrhages quite uncommon that human and management can be done at home with finger sticks. So I give them that choice possibility of re operation certainty of anti coagulation. And then I like to bring in the data from that stanford and say it's not a choice between life and death. But you have to understand the statistics and I finish by saying what I would do And I do that because one of my kids need orthopedic surgery years ago. And the surgeon said, I said what do you think? And he said well you know, you could either have surgery or not. So yeah, I I understand that. What would you do? And he said, well, I'd have to think about it because you could either go for the surgery or not have it and say, right, okay, I'm not gonna do that to patients. I'm gonna tell you what I would do if I were you. That's that's also it's a great Story. I want to 2nd a couple of things. The conversation with the patient and what is said about often times I find myself telling the patient who is confused or struggling with the decision. I do tell him go home, think about it And call us back. And if you have questions right? And we'll try to answer your questions. But I do think that it's making a lot of time decision in 10 minutes, right? Even the brightest person who have trouble assimilating all this data. So think about that. I really want to thank all three of you. This was awesome. I had a blast. My Guillen off Mark kurdish. Let's do it again another time. This was fantastic. And thank you for putting this together. Thank you guys. Thanks a lot. Great, seeing you. Fantastic, thank you, goodbye
A. Marc Gillinov, MD
Moderator
Marc Gerdisch, MD
Rochus Voeller, MD
