Chapters
Transcript
DONNA: It's my great pleasure to introduce our moderator tonight, Dr. Mario Castillo-Sang from St. Elizabeth Healthcare in Edgewood, Kentucky.
MARIO CASTILLO-SANG: Thank you, Donna. And I want to thank Artivion for putting this together. And I also want to thank all the panelists who are here today, an incredible group of panelists. We'll be discussing a fascinating topic of reoperative mitral valve surgery. It's a vast topic. I do not think we will be able to fit it all in one hour, but we will do our best.
Today, we have Dr. Rochus Voeller, who is associate professor of surgery and director of minimally invasive surgery at the University of Minnesota, Department of surgery Dr. Marc Gerdisch, who is chief of cardiac surgery at Franciscan Healthcare in Indianapolis, Indiana, Dr. Marc Gillinov, who is department chair of the Department of Thoracic and Cardiovascular Surgery at the Cleveland Clinic in Cleveland, Ohio, and myself. And I want to, again, thank everybody here today for participating in this panel.
Today, we're going to be talking about different aspects of reoperative mitral valve surgery, and we want to talk about conventional redo scenarios, the best practices for redo 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 technologies advance, and then also, look at the future and see what the future holds for all of us as surgeons practicing mitral valve care. And then we'll finalize by talking about at the end hopefully a conclusion to prosthesis selection and how do we decide, what are data points.
With this, we'll start with a case, but this is the gamut of cases that we will be looking at from redo repairs, redo replacement, bioprosthetic to mechanicals. And let's start with this case. Rochus, why don't you tell us about this case?
ROCHUS VOELLER: Thank you, Mario. So this is a 49-year-old gentleman recently who underwent two previous failed mitral valve repairs at a referring hospital. Both were done through sternotomy approaches. And this probably was by a leaflet prolapse, more posterior than the anterior. But unfortunately, the second repair failed within a year and presented to us for consideration for a third time, second-time reoperative mitral valve surgery. He was very symptomatic.
MARIO CASTILLO-SANG: So let me ask this to the panel. We have this patient who is young who has had a previous mitral valve repair for Barlow's. I assume that there was some form of chordal reconstruction posteriorly. And before, we have talked, and Marc, we've heard you say that one of the things that can happen with neochordal reconstruction in the future is potentially having that slack of the chords. What are your thoughts on that?
MARC GILLINOV: I think it's relatively uncommon, but I have seen a small handful of cases in which we did chords to the posterior leaflet. 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 posterior leaflet. And seeing a small number of these has led me to go back to resection as my primary treatment for posterior prolapse.
MARIO CASTILLO-SANG: Marc Gerdisch, what are your thoughts? What are your observations on this?
MARC GERDISCH: So I think we're evolving a little bit on this. Marc Gillinov does so many valve repairs that 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 chordal replacement. Most of the people who have been in my operating room will see that I'll take some of that leaflet out and then place some chords. This fella, it looks like you're going to run into a double whammy with that posterior leaflet, and now his anterior leaflet is taking a pounding. So I'm interested to see where this goes.
MARIO CASTILLO-SANG: So the question to the panel, again, is in this situation, this would be the third-time operation for this gentleman. What would your discussion be with him? Are you thinking of re-re-repairing or replacing out of the gates?
MARC GILLINOV: I had a case like this today, 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.
MARIO CASTILLO-SANG: I'd agree. What about you, Marc Gerdisch?
MARC GERDISCH: I'd agree completely. And we've all been presented with redo mitral valve repairs. And so first time redo, I think is still a very legitimate operation even if they've had congenital repairs or whether they're far out or near in time with respect to their first repair. Second time around, like Mark Gillinov just said, you really have to think that it's time for the valve to be replaced.
MARIO CASTILLO-SANG: I couldn't agree more. I think-- so Rochus, tell us what happened here.
ROCHUS VOELLER: Thank you. And going back to the neochordal resection, I think it is critical to restrict that posterior leaflet, too, and not leave any prolapse or poochiness when we're done with the case. And you're at a risk for developing this later when the ventricle remodels, particularly with the dilated ventricle.
So what we did-- so I didn't even think about repairing this, and this was an 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 sternotomy. Did a right minithoracotomy endoscopic 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 through a sternotomy as well where the annular plane is very vertical in this situation. And that's not that uncommon for a redo.
MARIO CASTILLO-SANG: Let me ask you this to the panel. This is a reoperative approach. Any difference in decision making here in terms of going back through the sternum, we're going through the right chest? What would you do, Marc Gillinov?
MARC GILLINOV: I tend to do re-operations through the sternum, and I might have gone transseptal or combined spear transseptal, a [INAUDIBLE] incision. I had a question. I saw you had a pretty cool-looking retractor in that left atrium. What was that?
ROCHUS VOELLER: This is the [INAUDIBLE] retractor, right?
MARIO CASTILLO-SANG: It's USB Medical.
ROCHUS VOELLER: USB Medical, and it has a flap that goes to retract that side of the left atrial 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 to get rid of all of that pulmonary venous return out of your view.
MARC GILLINOV: I think that's very nice.
MARIO CASTILLO-SANG: Marc Gerdisch, what are your thoughts?
MARC GERDISCH: 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, a sternotomy, I agree with Mark Gillinov. We would almost invariably go transseptal for this scenario. And I would add that I just got that retractor after I asked Rochus where to get it so.
MARIO CASTILLO-SANG: That's great.
MARC GILLINOV: I want one of those, too.
MARIO CASTILLO-SANG: One more question up. Any cannulation strategies that you use through a sternotomy like some people would put out femoral venous? Or do you do everything in a chest?
MARC GERDISCH: I do at all percutaneously ahead of time. So I will percutaneously cannulate including an antegrade stick-in of the superficial femoral artery. Everything's done with Perclose. I get the incision done, take the wires out or whatever hardware is there, and I just go on pump, open the sternum, and do the surgery.
MARIO CASTILLO-SANG: Perfect, Perfect. Marc, anything you wanted to add-- Marc Gillinov, anything you wanted to add? By the way, for the audience, this is a struggle, Marc Gillinov and Marc Gerdisch. It's difficult. So that's why it's first and last name.
MARC GILLINOV: I always love being on a panel with Mark Gerdisch. I invariably learn a lot. If it appears to be a reasonably safe reentry, mainly centrally. If we're concerned that the re-entry might be hazardous, the CT scan-- and I always get a CT scan on these re-ops. I presume we all do that. If the CT shows that any structures like the [INAUDIBLE] vein, right ventricle, right atrium, are close to the back of the sternum, we would actually favor exposing the axillary artery and sewing a graft to it and then going femoral venous.
MARIO CASTILLO-SANG: Very good, very good. I think that we've been in this case to the end, but I want to show another case. Well, before we go to another case, let me show just that clip, that last clip there, which was basically meant to, as we had discussed before, what do we do about that poochiness, 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 MR.
This second case is another person who had a repair. The ring is dehisced. The band is dehisced. And there's some problem with the anterior leaflet there, too. But what I wanted to showcase is in this case is the left atrial appendage, and I think we've all faced this. What is your management of the left atrial appendage in a reoperative mitral valve operation, Rochus?
ROCHUS VOELLER: Yeah, so in a reoperative setting, I tend to leave it alone because when I do close the appendages primary operation, I use a clip. So I close it externally. I just think from a re-op standpoint, that's difficult to do through a mini approach. And I tend not to close it from the inside. So I would just leave it alone for reoperative cases.
MARIO CASTILLO-SANG: Mark Gerdisch?
MARC GERDISCH: So Marc Gillinov is going to be thrilled that we actually have three people saying the same thing because we're all going to agree with Rochus. 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 the rest of the annulus expanded because it looks like to our left--
MARC GILLINOV: Yeah.
MARC GERDISCH: And we've seen that before, right, Marc Gillinov? We've seen that before.
MARC GILLINOV: Yeah.
MARC GERDISCH: Yeah.
MARIO CASTILLO-SANG: Yes, I tend to agree with your assessment of that failure. I agree.
MARC GILLINOV: Yeah, they missed the trigone on the left.
MARC GERDISCH: Or at least the commissure.
MARC GILLINOV: Yeah.
MARIO CASTILLO-SANG: Yeah.
MARC GERDISCH: So anyway, the appendage, like I said, I've spoken for Gillinov inadvertently, but I couldn't help but saying because he and I have spoken on this so many times, I know what he's going to say.
MARC GILLINOV: Yeah, I almost always agree with you because you're right.
MARIO CASTILLO-SANG: He'll hear it.
MARC GILLINOV: Yeah, I would leave the appendage alone, especially in 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 valve leaks again, and he's had AFib 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 going to try to clip that from the outside. But he asked about this on the instruction of his cardiologist, what are you going to 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 Marc Gerdisch said, if it looks like that, I'm not going to try to close that with sutures because it won't work.
MARIO CASTILLO-SANG: Well, that's fascinating. I haven't been lucky enough to be able to or courageous enough to get through the transverse site as in clip it. But I'm very curious about it and hopefully get to it. So we also wanted to talk about some data. And we put out three studies from major institutions. This is a study from the Mayo Clinic in which they look at two cohorts of reoperative mitral and reoperative aortic valve.
But for the cohort of mitral valve patients who had had previous bioprosthetic valves, the survival at five years was 61% and at 10 years were 32%. These were older patients, and in the series that you'll see, these were 71 average age. And they had a high rate of pacemaker implantation as well as a high rate of IABP insertion or balloon pump support with 13%.
Another paper from the Brigham in Boston showed-- and 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 at re-replacement was 63 years old. And if you look at the median time or the mean time actually to re-replacement, it was about 10 years for both groups. So some of these patients were implanted with the biological valve at 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 then mortality for these patients for redo isolated mitral valve replacement was highest for those who had a previous replacement. Marc, I'd love for you to talk to us about your paper from the Cleveland Clinic on reoperative mitral valve.
MARC GILLINOV: Sure, this paper has two groups of patients. These are all patients who had structural valve deterioration of a bioprosthesis. So this is SVD bioprosthetic valves. But about a quarter of them, that's all they had. They just needed a new mitral valve. And 3/4 of them needed other things, like bypass surgery, tricuspid 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 bioprosthesis had degenerated, the operative mortality of that was about 130, 133 patients actually. The operative mortality amongst those 133 who just needed a mitral valve was less than 1%. So these are obviously selected people, reasonably healthy. Their tricuspid valves are good. They don't need bypass surgery. Mean age was 66.
On the other hand, people who had a degenerated bioprosthesis who needed other procedures, like bypass surgery, aortic valve, tricuspid 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 twofold. And in the paper, we discussed this.
One is be careful about deciding, I'm going to fix everything, because let's say someone needs a new mitral valve, bioprosthesis is deteriorated. They've got moderate AS, 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 only very high risk-- I know we'll come to this-- if the mitral valve is the primary predominant lesion that's causing problems, start thinking about valve in valve for those people.
MARIO CASTILLO-SANG: Very good. So let's look at the guidelines, Rochus, if you want to tell us about the guidelines.
ROCHUS VOELLER: Of course, yes. So the first guideline, as we all know, is the American AHA/ACC Guidelines. And we can all see the screen. But basically, the numbers, they are the age 65 as a cutoff. So less than 65 who are 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 greater that require a replacement, they would say, "it would be reasonable to choose a bioprosthetic valve over a mechanical valve." So those are class 2a evidence. So that's the American guideline.
And the European Guideline's 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 mechanical prosthesis should be considered. And similarly, actually, the slight difference between this and the American Guidelines is at 65 to 70, they basically say you could go either way would be acceptable. And mechanical prosthesis should be considered in patients with a reasonable life expectancy for anybody.
MARIO CASTILLO-SANG: So 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 that patient who needs a mitral valve replacement. Let's start with Marc Gillinov.
MARC GILLINOV: 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 bioprosthesis first. And so, so many people in their 40s and 50s come in and say, I want a bioprosthesis. I absolutely positively don't want to be on warfarin. And 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.
No, but in the US absent the Mayo Clinic where they put in more mechanical valves, there is this broad desire to have bioprostheses and to kick the can down the road and say, well, if I need a re-operation, it's not for 10 years. And there is a paper I know you're going to show from Stanford suggesting that in younger patients, they're 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 a bioprosthetic valve. I mean, you can say if you're a heart surgeon, perhaps that's good for business because you're going to be seeing this guy every 10 years. But that may not be the best thing for the patient.
MARIO CASTILLO-SANG: Yup, Marc Gerdisch?
MARC GERDISCH: So first of all, I want to hearken back a little bit for a second, just for a second, back to Marc Gillinov's description of the paper 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. 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 following that same path with respect to just being a little bit cerebral about things, I think that there are some parallels to aortic valve disease management in the sense of tissue valve versus mechanical valve and the constraints of the space and the organism that receives the valve.
So if you're talking about a woman who has inflammatory markers up, and she's diabetic and obese, and she's going to 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 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 titratable parameters for the person.
The other thing is I have a heart to heart about how they want to live their life. And I think you have to include, and I'll probably mention this again later, you have to include surveillance. When you put a tissue valve in somebody, you are committing them to a lifetime of surveillance. Put a mechanical valve in, 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, every five years, maybe take some pictures of the valve.
And if they do go down the road to a valve in valve, there's more surveillance, and there's other things that go into that. So medical care gets ramped up over time. So I talk about all of that, and I really look at them as the person that's receiving it, their biologic milieu, and the construct or structural limitations that will prevail when they go to have another operation, whether that be surgery or a transcatheter intervention.
MARIO CASTILLO-SANG: That's fantastic. Rochus?
ROCHUS VOELLER: Totally agree with that. As an example, I saw 67-year-old female today, not quite end-stage renal failure but bad 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 mitral operation. So I think it needs to be tailored to the individual. And guidelines are guidelines, but you individualize it to the patient.
MARIO CASTILLO-SANG: Yeah. So we'll illustrate that with this case. This is a 47-year-old that is Marc Gerdisch [INAUDIBLE] and Dr. Gillinov, too-- 47-year-old who really, really pushed to get a bioprosthetic valve on her surgeon for whatever reason. And four years later, the valve is stenotic as you can see on this echo. Definitely stenotic, and she is very symptomatic.
So at this point, this was a real 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 Marc Gillinov 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 these circumstances, this was a right-sided approach endoscopic assisted with peripheral bypass, and the idea here was to replace the mechanical valve. One of the things I wanted to highlight is we see the adhesions, for example, to this post to the tissues underneath the [INAUDIBLE] apparatus.
And this is something we're very used to doing, which is removing prostheses from the heart in the mitral position. But things are changing. And we'll see another case like that. We see that when we remove that prosthesis, there's a lot of raw tissue, scar tissue down there.
Sometimes posterior leaflets has to be removed if it's stuck to a 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 prostheses in the mitral position, Mark Gerdisch?
MARC GERDISCH: Well, I think you're going to illustrate it quite nicely here. And it's really a function of being aware of how the valve was implanted the first time because sometimes you get in there, and you find that there's so much tissue from the atria end 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 decalcify a valve and you're peering into that tissue between the atrium and the ventricle. So it's really, this is about experience, and it's really about being able to fashion a space safely for the new valve without getting into the adjacent structures. I think-- is this the one, also, where you put some chords on the papillary muscle?
MARIO CASTILLO-SANG: That's another case.
MARC GERDISCH: OK, fine, because I think that's an important point. I would also ask, though, of the panelists if you don't mind, when you do put a bioprosthetic mitral valve in, do you prefer porcine or bovine?
MARC GILLINOV: I prefer a porcine valve only because the porcine valve we use has a very generous, fluffy sewing ring. And also, when a porcine fails, it's going to 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 I had on this case, I like the way you put the pledgets on the ventricular side so that you move the tissue away from the disks of the valve and prevent the entrapment. When you guys do a redo mitral and you're putting a mechanical valve, do you have any particular preference for where you put the pledgets?
MARIO CASTILLO-SANG: Rochus?
ROCHUS VOELLER: 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 annulus, I tend to go atrial to ventricle and put the pledgets on the top. But that's just out of habit. I don't really have a good explanation for it. But I've done either way. But sealing the valve anti-anatomically, as I'm sure you'll get to that, is a critical part of doing this case as well.
MARC GILLINOV: Yes.
MARIO CASTILLO-SANG: Marc Gerdisch, at that point?
MARC GERDISCH: Yeah, it's actually the same as Rochus. It's exactly the same.
MARIO CASTILLO-SANG: OK. So going back to this what Marc Gerdisch was saying about making sure that you debride 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 [INAUDIBLE], an endo [INAUDIBLE], 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. And some of the--
MARC GERDISCH: The guards on the annex valve are handy there, too, right?
MARIO CASTILLO-SANG: Very good, and that's a very good point, Marc. That's one of the reasons I choose this valve over other mechanical valves in all circumstance, especially redos, because the housing of the valve is perfectly designed to prevent material from coming and getting into contact with the mechanism. That said, Rochus brought up the point of the anti-anatomical position of the valve, and that is to prevent LVOT obstruction, too.
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 Marc Gerdisch, if you want to tell us a little bit about that?
MARC GERDISCH: Sure, 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's a carbon-coated valve. There's only one size. It's a 25. And the reason for that is under all forms of hemodynamic testing, they found that they achieved optimal hemodynamics, the lowest gradient at that point. There was no point in making the housing bigger.
The reason for that is because the valve is designed to create laminar flow, and in so doing, it lowers the resistance across the valve. This is really handy because 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 device is designed with two different cuffs, as everybody knows, that then give you-- there might be three, but I have two-- that then give you the option to, for example, in a rheumatic patient where you might have very small space, you're still putting in that same high-performing, effective orifice area as opposed to somebody who has more room to fill in, and then you got that nice, big, fluffy cuff. The outcome is always the same. And you can see here what 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 orifice area of any mechanical valve we have in the mitral position.
MARIO CASTILLO-SANG: That comes in handy. And I wanted to bring this up because today, I was talking to Rochus earlier on about a case he has with severe MAC, Rochus, right? Showed me the cat scan. Big MAC, severe MAC. And if you're facing something like that or somebody with a small orifice, I mean, it comes in great handy. A 25 valve will give great gradients for even somebody with a BSA of 2.4 even though the orifice may be small to put in the valve. So it comes in handy.
This is one of the papers that we wanted to also bring up as important data pertinent to reoperative mitral valve surgery, Rochus.
ROCHUS VOELLER: Thanks, yeah. So this is the Stanford paper that Marc Gillinov was referring to just a bit ago. Very powerful study, actually. So basically, it looked at-- retrospectively 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 to 2013.
The one big, powerful 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 valves. But at the end by 2013, it was over half. So there's a dramatic increase in use of biological valves with really no evidence to support that. And this is before the valve in valve--
MARIO CASTILLO-SANG: Marc Gillinov brought up-- sorry to interrupt.
ROCHUS VOELLER: Yeah. That's one of the findings that was really, really surprising and important. But the other thing is also, they clearly show that when they follow these patients who had either a mechanical or tissue valve and they combine aortic and mitrals together, and they divided into three different age groups-- 40 to 49, 50 to 69, and 70 to 79-- the first two age groups clearly had a survival advantage. So the risk of-- probability of death was statistically less if you had a mechanical valve.
And this, again, summarized that. So that mechanical valve advantage was there and for the two age groups. And for the patients who are 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 1 until you were 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 set of data that I try to remind myself and talk about it when I see these patients. So I think that's a pretty important paper.
MARIO CASTILLO-SANG: Not to beleaguer the point, but I think we've seen now in two cases and talked about the guidelines and talked about the outcomes of redo surgery, and I think that what Marc Gillinov said about the overall impression in society about biological valves in younger patients with the promise of a valve in valve in the future, and Marc Gerdisch 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 fluoro, the [INAUDIBLE] of this case, but this is a young woman who had a valve in ring implanted as a solution to a low EF or fairly low EF 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 room 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 if you think about the sewing ring of this valve, that's where the ring, the annular ring would be sitting in a repair. And you can see how much hardware protrudes into the ventricle from the annulus.
And so with that said, this is her echo. The mode of failure here, like Marc Gillinov said, there is 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-- the only way I can describe it is gruesome. It was perhaps one of the most difficult dissections of a prosthesis out of a heart that I've ever done because there's so much material deep into the ventricle that all the leaflets and even the papillary 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 was to talk about what we see today and what we will see tomorrow. 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, the case where the papillary muscle was bare, and I had to recreate with some GoreTex chords some form of annular reconstruction to the papillary muscle. A mechanical valve, On-X valve implanted, great gradients, and she did well.
What are your thoughts on a case like this, Marc? Today, I was looking at annals, and the clinic, you guys published a paper on the time to re-replacement of or replacement of failed transcatheter devices in the aortic position. And at that time, it was getting shorter. What do you think of that, and how does that translate to the mitral space?
MARC GILLINOV: Well, I think the reason the time is getting shorter is that the operators, the interventionalists are becoming more aggressive and really trying to see what they can do. I mean, 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 On-X valve that time, she would have been done with heart surgeons and valve in valves and the whole nine yards. But she was probably presented with this idea that we can stick a valve in valve in there. It's feasible. We can do it. It's not going to work, didn't work in this case.
But I think that there is a lot of-- to your point, why does this happen, there's a lot of very short-term thinking based upon what do we think we can do. Can we get away with it? 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?
MARIO CASTILLO-SANG: Very good. Marc Gerdisch, you're going to talk to us about this data, and that's next.
MARC GERDISCH: So Mario, is it possible for you to go back and just show that anti-anatomic? That valve was positioned perfectly with respect to the outflow tract, and I think folks need to see that if they're not fully aware. I don't know if it's going to be tricky to get to that point in the video.
MARIO CASTILLO-SANG: Let me see if I can reactivate that.
MARC GERDISCH: Because the advantage of having the fairing or the skirt is that it blocks that in-growth of tissue. 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 tract because the skirt does go in a little deeper on each side of that.
So folks, just 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 obstruction. It's not going to be something you're going to re-operate, but you might see a little gradient.
MARIO CASTILLO-SANG: I agree. Very good point, very good point. Marc?
MARC GERDISCH: 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. This was in 2013 to 2017 TVT Registry, which basically is STS, ACC data, 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 at 30 days is 8.1% versus what would have been an STS predicted of 11%. It's better.
Notably, they don't spend a lot of time talking about the disastrous outcomes of valve in MAC, 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 in MAC, make sure that patient has had the opportunity to talk to a surgeon that does mitral valve replacement in heavy-duty Mitral Annular Calcification. Valve in ring, you just showed us the disaster, that 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 is a similar look. 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% at 30 days, that's pretty good.
Keep in mind that just like when we talk about transcatheter therapy for bicuspid aortic valve disease and how good those outcomes are, those are specially selected patients with favorable anatomy that we do TAVRs on sometimes when they've got great anatomy. They're bicuspid. They don't have that stalactite in the fused 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 7. 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 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 deteriorating more rapidly, we might see that a little bit more in women. There's a good [INAUDIBLE] paper looking at the effects of inflammatory conditions, female gender, and 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 at one year, you've got a mean gradient of 7, and we don't have the long game for the valve. Next.
And when I talk about long game, we're going to back up into that first valve that they had, right? So one of the signals in this paper, which admittedly, is a single-center experience, but 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, 66 months getting their second valve, getting their valve in valve. And these folks, as I recall, their mean age is in the 60s. And you can see it's got a one-year mortality of 27%.
So how do you paint that picture for the lady I talked about earlier? You say, well, I can put the bioprosthetic valve in. You're 63 now. The valve might last you seven or eight years. And then we'll have this option where we might be able to do a valve in valve for you, but the one-year mortality might be 27%. It may be a quarter of the chance that you might be dead a year later.
This gets complicated because when I back up to the same patient and I put a mechanical valve in for her, and if she can just manage anticoagulation, then 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.
MARC GILLINOV: And if I could 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, 25s, 27s. I mean, you are much more facile with TAVR than I am, but won't you wind up with a predictably high gradient if you're taking a 25 bioprosthesis and putting something in the middle of it?
MARIO CASTILLO-SANG: And I think that's evidenced by the previous paper where the outcome of the gradient was 7 point something after you had done a valve in valve, right?
MARC GERDISCH: Yeah, and those are the optimal scenarios. They had prepped for them. But Marc makes the great point that a smaller valve wears out faster. We know that, right? Next. So let's say that it does last. Let's say the thing works out pretty well. You get a decent size in there. You don't have an outflow tract gradient. What does that picture then look like because often, the argument is made, well, if we put a tissue in, you don't have to be on blood thinner?
If I put a tissue valve in you, and I don't paint gloom and doom, but the reality of it is, you got to get an echo every year. When the valve fails, you have to have something else done. If you have a valve in valve, the overall thinking at this point is that folks need to be on Coumadin.
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 develop thrombosis of the leaflets, had thrombus 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 anticoagulation, whether it be for AFib or thrombus on the leaflet or a gradient or whatever it is, we have to be judicious about making that promise. Next.
So this slide and the next one hammer home the same concept. So cumulative two-year rate of valve thrombosis, 14%. So we looked at a year at 6.6%, two 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 the clot is forming, right? It's not because the valve is working perfectly or the flow dynamics are great. It's because the flow dynamics are not great. So there's a reason that that clot forms. Next.
This is 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 Coumadin. And if we back up through all those papers, we're going to see the same thing with respect to valve in ring and valve in MAC, that not only they need the anticoagulant, but the outcomes are fairly dismal at this point.
So bottom line, one of my favorite slides, we've got-- so when I trained as a general surgeon, I had an attending, Jack [INAUDIBLE], and somebody would come up with a great idea, and Dr. [INAUDIBLE] would just say, fine. That sounds great, but show me the data. So because I have to look at things 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 there is 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 a bioprosthetic valve. You can't say that there's a survival benefit. You could say that there might be some-- they might approximate each other in certain subgroups, but you can't say that there's a benefit.
MARIO CASTILLO-SANG: Very good. Any thoughts on this, Rochus and Marc Gillinov, everything that Marc has said, which I think is well in point?
ROCHUS VOELLER: Yeah, one question I actually have for everybody on the panel is the valve in MAC is a particularly challenging group of population patients, and that is evidenced by the mortality. The one-year outcomes are very poor. What would your practice be for patients with severe MAC that are not prohibitive surgical risk but high-risk surgical candidates? What would you do? Would you put them through a high-risk mitral valve replacement or do a hybrid open transcatheter valve deployment or valve in valve-- valve in MAC, excuse me?
MARC GILLINOV: 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 is 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 said, if somebody says 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.
MARIO CASTILLO-SANG: My goodness.
MARC GERDISCH: So very similar, it's actually an operation we're pretty comfortable with. I think that Marc makes a very important point that the patient has to be experiencing real symptoms, and then you have to put it in the framework of where they are in the arc of their age, where their comorbidities are, et cetera. We generally will just decalcify the valve and implant an appropriate device thereafter.
I have done one of the open SAPIENs. I did an 84-year-old schoolteacher who wanted to go back to work and replaced their aortic valve with a tissue valve. And then she had circumferential calcium cut out her anterior leaflet, and put a big SAPIEN in there. It was perfect. But those perfect scenarios, I think, are very few and far between. And I would always first look at decalcifying the valve and implanting an appropriate device.
MARIO CASTILLO-SANG: 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, too. This is an 85-year-old female. Rochus, you want to tell us about her?
ROCHUS VOELLER: Yeah, so this is a 85-year-old female with multiple medical comorbidities, moderate risk surgical risk patient, moderate LV dysfunction. She had a transcatheter edge to edge repair close to two years ago and presented with recurrent severe symptomatic MR. The medical shows that the C1 clip and a very centric jet, and this is an intraoperative finding. This is done through a mini approach. And you see the clip has dehisced from the posterior leaflet.
MARIO CASTILLO-SANG: If I may interrupt, and this doesn't really-- I don't know if we can qualify this as a redo mitral valve, reoperative mitral valve surgery, but I guess it falls in the space, right? And we're talking about things that are coming, that are here. What are your thoughts on have you ever been able to repair a valve that has had a clip put on it, Marc Gillinov?
MARC GILLINOV: Only twice. And I remember them both because I feel like I got lucky. One was a very early single leaflet attachment where it was still attached to the flail portion of the posterior leaflet. So that was easy. Just do a resection as I would if the clip were not there.
And the other one was in 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 neochords in. I would have to say we got lucky because it worked out. Most of the time, we have to replace these valves. And Joe [INAUDIBLE] has got a nice paper demonstrating that, across the country, replacement is what happens.
MARIO CASTILLO-SANG: Correct.
MARC GERDISCH: 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.
MARIO CASTILLO-SANG: So in this case, Rochus, I think you ended up replacing this valve, correct?
ROCHUS VOELLER: Yeah, and my repair rate's been zero for these out of about half a dozen of them. But it's older patient, high risk. It gets replaced.
MARIO CASTILLO-SANG: 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 mitral valve replacement and now has a frozen pannus. I think this, Rochus, is your case. And the mean gradient is 13 with moderate MR.
I think you gave us excellent pictures of what's happening here because you can see the frozen leaflet, and you can see the MR jet coming right around where that hinge point would have been. The leaflet, it's not moving. This is not the profile of a On-X valve just for the audience, making that clear. And the angiogram also shows one of the leaflets being frozen. Rochus, what did you do here? What did you replace?
ROCHUS VOELLER: Preoperative previous sternotomy 20 years ago so I elected for a minithoracotomy approach. And the dissection was actually not too difficult for this redo 20 years out. And [INAUDIBLE] was great, ginormous left atrium. You can see the mechanical valve there. So from a reoperative standpoint, very straightforward. The mechanism of failure was very typical for a mechanical valve as such, get a huge pannus formation, and one of the leaflets is completely stuck.
MARIO CASTILLO-SANG: 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 pannus to these mechanical valves and why selection-- and surgeons will implant what they feel comfortable with, which is totally fine, but bear in mind, that pannus does creep, and you can see how invasive it can get and really block a valve in a bad way.
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 OK with that is, 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 Barlow's case at the beginning and the first case? Rochus?
ROCHUS VOELLER: We opted to use the On-X valve. This was a pretty important patient, came in for a second or third opinion. I can't remember. Third-time surgery, he was very specific on what he wanted. Didn't want to consider re-repair. He was pretty straightforward with what we wanted, which is the On-X valve. And I would have chose that myself as well.
MARIO CASTILLO-SANG: OK.
MARC GILLINOV: I have a question regarding that. I've heard some surgeons say they're a bit confused about the sizing of an On-X valve because of these different sizes. Would you mind, Rochus, describing how do you size the On-X valve and then choose your particular sewing cuff?
ROCHUS VOELLER: So the On-X, as we all know, comes in one size only. So basically, the 25 [INAUDIBLE] fits everybody. So the sewing ring is really made to be like a top hat. So it will fill any size annulus within reason of annular size. So you really don't have to choose your mechanical valve size when you're using an On-X valve in the mitral position.
MARIO CASTILLO-SANG: What you're choosing is really the cuff, the sewing cuff to do that, yeah. So Ross Strauss from LA-- he's a cardiologist-- writes, this is just a curiosity only. I've noted when patients have MVR with bioprosthesis, on post-op echoes, 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? Marc Gillinov?
MARC GILLINOV: Is he saying one of the struts is directed toward the septum?
MARIO CASTILLO-SANG: The overall orientation of the valve is canted towards the septum.
MARC GILLINOV: I suppose that could be. I haven't really thought about it because I think the key point is something Marc Gerdisch was talking about earlier, which is to avoid a strut or anything frankly obstructing the outflow tract. Otherwise, I don't think it matters.
ROCHUS VOELLER: I agree with that as well.
MARIO CASTILLO-SANG: I agree with that. I mean, if the strut is not in the LVOT, it will not cause any harm. There will be ample space for that to flow.
ROCHUS VOELLER: [INAUDIBLE] talked about this before me, too. The LVOT can be slightly different in terms of angle depending on the patient. So if you really want to get it accurate, you could even probe the LVOT with the right angle to see exactly where the LVOT is for that patient to align your struts.
MARIO CASTILLO-SANG: All right, great, great. One other comment here is, and I'm going to change here so that I can show you-- just to answer one of the questions, too, is this is the pannus growth on a mechanical valve. One of the things that happens with the On-X valve-- I personally prefer the Conform-X cuff. But the housing of the valve is such that it protects-- I'd imagine it makes it really difficult for pannus to actually creep up to it and invade the mechanism, both at the top and at the bottom.
Another question that we have is-- and I think this is the last question that we will have time to answer. Just a comment, I don't have a name, or it's Ross Stross. "I am 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 boogabooga fear of anticoagulation when re-op is the alternative, especially in younger patients, including up to 60 years." This is a great ratification for me, Ross Stross. This is a well-received comment. Before we leave, and we have one minute, Marc Gerdisch, your closing remarks about how you select your patients and what tips you can give to surgeons.
MARC GERDISCH: So I think I really spoke to how I select the patients and what I offer them. And I do think it's important 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're selecting the person that's going to do 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 the 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 in-growth. I would mention that when I last looked in the literature, I could only find one report of pannus in-growth for an On-X valve, and it was in the tricuspid position. I don't know if any further cases have come up, but that was a long time ago.
MARIO CASTILLO-SANG: Rochus?
ROCHUS VOELLER: Thanks. Yeah, so valve prosthesis selection, I think, is very complicated and is potentially life changing. So it's a serious, serious decision making, and I definitely start off with the guidelines. But it has to be tailored to the patient. I usually have a long discussion with them.
And oftentimes, when patients don't decide the day we meet in clinic. And I 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 cutoff, 65 guidelines say, but again, I don't definitely go by that. And I do think with the data and papers we talked about today, I think there's a stronger argument for mechanical prosthesis in the mitral positions for a lot of these patients. And the technical pearls for reoperative mitral surgery, I think for the surgeon, it's whatever you're comfortable with and whatever is the safest for that patient, whether it's a sternotomy or a mini. That's it.
MARIO CASTILLO-SANG: Very good. Marc Gillinov?
MARC GILLINOV: I begin by framing it as a choice between possibility of re-operation and need for anticoagulation. And then I tell them that the re-operation is appropriate if it becomes necessary.
[BARKING]
And we discuss anticoagulant-related hemorrhage, which is actually relatively uncommon. I'm glad that the audience is like that. I take those as cheers from Marc Gerdisch's dog. They love the webinar, which is great. But I do tell them that anticoagulation is not terrible, that anticoagulant-related hemorrhage is quite uncommon, that Coumadin management can be done at home with finger sticks. So I give them that choice, possibility of re-operation, certainty of anticoagulation. And then I like to bring in the data from that Stanford paper 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 had orthopedic surgery years ago. And the surgeon said-- I said, what do you think? And he said, well, you could either have surgery or not. I said, yeah, 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, OK, I'm not going to do that to patients. I'm going to tell you what I would do if I were you.
MARIO CASTILLO-SANG: That's awesome. It's a great story. I want to second a couple of things. The conversation with the patient and what Rochus has said about oftentimes, I find myself telling the patient who is confused or struggling with the decision, I do tell them, go home, think about it, and call us back. And if you have questions, write, and we'll try to answer your questions. But I do think that it's making a lifetime decision in 10 minutes, right? Even the brightest person will 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. Marc Gillinov, Marc Gerdisch, Rochus Voeller, let's do it again another time. This was fantastic. And thank you, Artivion, for putting this together.
ROCHUS VOELLER: Thank you, guys.
MARC GILLINOV: Thanks a lot. Great, seeing you.
MARIO CASTILLO-SANG: Fantastic.
ROCHUS VOELLER: Thank you. Bye-bye.
MARIO CASTILLO-SANG: Y'all have a good night.
ROCHUS VOELLER: You, too.
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:
A. Marc Gillinov, MD
Professor and Chair
Department of Thoracic and
Cardiovascular Surgery
Cleveland Clinic
Cleveland, OH
Moderator
Mario Castillo-Sang, MD
Surgical Director
St. Elizabeth Healthcare
Edgewood, KY
Marc Gerdisch, MD
Chief of Cardiothoracic Surgery
Franciscan Health
Indianapolis, IN
Rochus Voeller, MD
Associate Professor
Division of Cardiothoracic Surgery
University of Minnesota
Minneapolis, MN
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