Ani Anyanwu, MD, and Randy Martin, MD, discuss recent findings about the safety and morbidity findings in over 53,000 patients who underwent surgical mitral valve repair for primary regurgitation over a 6-year period. This information was published in JACC by Dr. Vinay Badhwar. Dr. Anyanwu and Dr. David Adams at Mount Sinai’s Mitral Valve Repair Reference Center have had extensive experience over decades in surgical repair of primary mitral regurgitation. Dr. Anyanwu highlights that low 30-day mortality and morbidity, while encouraging, is not a surrogate for quality. He and Dr. Adams feel the quality metrics should be based on procedural success at 30 days, procedural effectiveness at 1 year and durability over 5 years. Dr. Anyanwu also emphasizes the importance of eliminating MR at the initial operative intervention as well as paying attention to treating atrial fibrillation and coexistent tricuspid regurgitation. Hi, I'm doctor Randy Martin. We're here at Mount Sinai. I'm a clinical professor of cardiovascular surgery. I'm thrilled to be joined by doctor uh Aie. Anan Wu. Aie is the vice chair of and a professor of cardiovascular surgery here also as a incredible surgeon in all aspects but runs the mechanical support and heart transplantation program. So, Anne, I appreciate you for visiting with me at, at us. But really, I want to ask you about a recent editorial that you and David did about a paper that was by Vinne Badar looking at 53,000 people from the S CS data bank who had primary mitra regurgitation valve repair and comment about its safety. But you all had a really interesting editorial. Tell me a little bit about that. Thanks Randy for the introduction. Uh V's paper was interesting because it was the whole aim of his paper was in the advent of trans catheter therapies and trials comparing catheter therapies with surgery. A lot of the trials based on some of the trials based entry points on surgical risk so bad. And colleagues were trying to say, well, how many patients are there that will fulfill, for example, a high risk cohort to test therapies. So they looked at the TS database and they actually found what they found was surprising in that first of all, the mortality rate for mitral valve repair for all commerce was very low. I think it was something like 1.1% for all commerce in the United States. There's 53,000 patients, we had 2400 different surgeons. So, and so what makes that interesting is that the number of operations that were done per surgeon a lot. It varied a lot. And there was some very low volume surgeons who did about one mi operation every year because it was a six year study. And um and there were some who did over 100 a year. And even if you looked at the low volume surgeons, they had a very low mortality. So doctor Bar and colleagues then said, well, let's see how many patients are high risk, high risk would be operative mortality of say about 4% 5%. And it was something like less than 2% of patients. So it led us to write, write this editorial because it struck us that mitral valve repair is a very safe operation no matter who does it. The operation itself is actually very safe. What that means is that the um pursuit for alternatives should not be based on looking for something safer. It should be based on other factors that was the essence of editorial. They were really talking about the risk of death, obviously at 30 days and the risk of stroke and things like that. And you're saying that they found that it was, it was pretty safe and a pretty low risk of, of morbidity stroke, et cetera. Yes. Yes. But, but they did also, then they find that it, the more you did, the better it was as far as a better outcome, is that correct? It was, but the effect was relatively marginal. So the very high volume centers had a mortality rate of less just below 1%. And the lower volume centers had just above 1%. But it wasn't a striking difference. Like you see, for most of the procedure, I don't mean to get you off track. But one of the things that struck me is that the, that they did look at uh I guess what they said the intent to repair, but then having to go to mitral valve replacement and when that occurred, because it was complex anatomy that the, that the risk of mortality and adverse events went up. Yes. So for patients who the intent was to repair but ended up with a replacement, the mortality went up, which goes with what we know as surgeons was, the main reason to move from a repair to replacement is a complication that has happened. For example, it could be things like the heart rupturing during surgery and that's a big problem to have, or it could be that we fix the valve and the valve is still leaking. And then by then you've been on the long machine for an hour or two and that increases your risks. But of course, a floor of the paper doesn't include patients in whom the intention was a valve replacement from the get go. So we don't know how many patients those are and, uh, and and how that would impact uh you know, in general interpretation, you all made, you made a, you made some some excellent points in there. But you really looked at this whole uh concept that quality equals your risk of dying at 30 days or mortality at 30 days is not, is not quality. No, it's not because most patients are very much alive when they come to surgery for mitral valve repair, many of them are asymptomatic or have minimal symptoms. If the younger patients are still going to work, still, you know, doing their day to day activities with their family. So if they're still alive 30 days later, you've actually achieved nothing because they were alive before. It's very different from other certain life saving operations we do as heart surgeons. So for example, if patients come in with a with a myocardial infarction, that's a fatal condition if it's not treated and then for myocardial infarction, you can use 30 day survival as a good outcome because the patient was dying when they came for the procedure, but not for mitral valve repair. And I think with light valve, a lot of parallel is drawn with the trans catted aortic valve replacement. Aortic stenosis is a different disease. That is a fatal disease. If you have patients with critical aortic stenosis, if you look at both um observational data and data on clinical trials, depending on how critical it is. Some of them face up to 10 20% mortality within a year. So for those kinds of surgeries, you can use mortality as an outcome, but not 30 days, you probably need to go to at least 9180 or 33, 65 days. You have, we are working at the, at your editorial, you have some other information that we can share with the, with the viewers on this presentation. When once we accepted that mortality is not the outcome of interest. And the question then arises, what is the outcome of interest? What should be our benchmark when we're doing a mitral valve repair? And we, we then asked ourselves, well, what are the objectives of mitral valve operation? Why, why is the patient there? So the patient is there because they have a leak in mitral valve or a stenotic narrow mitral valve? And that we want to relieve that leakage or relieve the narrowing. That's the first thing we want to do and we want to do it in a durable fashion. So we want whatever solution we have to last the patient a long time, hopefully their lifetime. But sometimes we can't get there. But at least several years and we want to do this without causing harm to the patient. So we want the patient to survive and we don't want the patient to have a stroke or any, any, any life limiting complication. And we want to do without any harm to the heart. So we want the heart to keep working as well as it was working, working beforehand. And we also want to look at the heart and provide the patient with a heart that is likely to allow them to gain the long term benefits of the surgery. So we don't want to leave the heart with any conditions that might impact the long term survival. And the common things would be a leak in tract hospital valve and abnormal heart rhythm. That is what we call a atrial fibrillation. That's a problem. And if, if you get that in the long term, so we do procedures to prevent this from happening. And those are the key, key goals of what we're trying to do. And I think if we focus on those goals, then we will maximize the benefit in your editorial. You had you, you developed, what do you think, how, how we should look at my well surgery more? I mean, we, we're not minimizing the 30 day survival. You know, that's, that's important but you're really looking at those things like procedural success durability, long term outcomes you had, you want, did you, do you have a slide that shows that? So we, we try to, to um look at the outcome of a mitral valve operation at in 33 different time points. So we talk of the procedure itself. So how do we say we've done a successful procedure? So you're talking about over a 30 day, have a 30 day period. Yeah, 30 day period. So you can say, well, the procedure has been successful. So obviously, the patient has to be alive at the end of 30 days and hasn't had a stroke, not on dialysis, nothing major, but then the focus is on the valve. So we want a valve that doesn't leak at 30 days. So by not leaking, we mean there's nothing worse than a trivial or mild leak. So, because there a lot, they could always be a little leak, but that's fine, but you don't want a severe leak and you don't want a moderate leak. I mean, you all have been really pioneers and, and trying to make sure that when the patient leaves the operating room after module mal repair that they're leaving with zero would be good, but maybe something trivial at most, not moderate. And to achieve that, that means that you have to accept that sometimes you, you have to go back uh and open the heart again to fix a leak. So, as you know, during the surgery, we have an echocardiogram, done what we call trans esophageal echocardiogram through the mouth. And then after we've done the repair, we examine the valve. If there's a leak, uh still present, then we go back and open the heart again and try to fix it. And we do that in about 2 to 3% of patients. But it's with this goal, with this goal, did you know that procedural success, you know, is, is based upon not having a moderate or worse week or in 30 days? Yeah. And the basis of that goal is that we do know that patients who have what we call residual natural regurgitation, which means that 30 days, the valve still leaks. They have a worse long term outcome. So if you want to maximize the long term, you have to have a good short term and a good short term means a vow that's not leaking at 30 days. Ok. Ok. Then you're talking about procedural effectiveness. Now you've gone from 30 days to one year. What's that mean? Yes. So we're then saying that you also can't tell that the procedure is effective at one month. So even though I'm saying, well, the valve is not leaking at one month, that's not the same as saying we've had an effective procedure because two months later, the valve could fall apart or the heart could for the ventricle, the function of the ventricle could fall apart. So we the real assessment for mitral valve in terms of, is it effective? Not, is it safe? Is it effective should be at one year? And at one year, you want to take a look at the valve with an echocardiogram and look at the heart with an echocardiogram. You want a heart that's functioning well, you want a mitral valve that's not leaking. You want to try cons valve that's not leaking. You want a patient that's out, that doesn't have symptoms or has only mild symptoms and hopefully doesn't have atrial fibrillation, which you also put in there that you want, that they don't have, they haven't had reintervention that would mean needing to go back for a surgical or other procedure on the mouth. Yes. So if a patient within the first year has had to have another procedure related to valve, heart disease or indeed related to the heart, then chances are that they didn't have an effective procedure. So even if it's an intervention on the coronary artery or on another valve, like the aortic valve, chances are that that happened because we did not address it at the first operation. So we did not do an effective operation. That's correct. You know, I've sent you and David and the team up here, a lot of patients who were asymptomatic but had significant moderate oration and I could prove they were asymptomatic. So, the real argument is durability, especially as you get in the younger and younger patients. So how do you judge the durability, which is the 3rd, 3rd leg in your stool here for it. So I think the durability at, at various points in the longer term, we would like to know if the valve is holding up, whether the, whether there's been any an any leakage and whether there's been any stenosis, stenosis is narrowing of the valve. So basically, and, and you can't tell that till at least 5 to 10 years later. So I would say that to say a repair is durable, then you need to know that at least that five years or probably later than that, that the valve still opens very well functions. Normally there's no narrowing of the valve and the valve is not leaking. Then that then you would say you have a durable repair. It's interesting that you always are coming back to in 30 days, one year and five years to having no more than moderate Mr to have effectiveness. Is that correct? I mean that really is there, I mean, one of the benchmarks and that's born out of data from various clinical settings that show that patients who have moderate lateral regurgitation don't have as good and long term prognosis as those who have mild and patients who have severe micro regurgitation don't have as good a long term properties as those who have moderate. So we know that any degree of micro regurgitation is not good for you. So we, we, we strive to get a patient at 30 days where the valve doesn't leak. So that the, the surgery has worked, we strive for an effective operation. So a year the valve is still not leaking and the house is working well and you have a patient who is out of hospital without symptoms. And we aim for durable repair, which means we want that state at one year to persist into the long term. And it's not, it's not easy to achieve because we did write an early editorial a few years ago on a paper from Dr Tyrone David where he looked at 20 year outcomes, one surgeon over 20 years, over 20 years and he found out about a third of patients by that 20 year mark, end quote failed in these effectiveness criteria. So pres are not as good as we think they are. So we still have work to do to achieve that. Holy grail of an excellent and you all, and you all learn, I mean, you know, you're doing a high volume, I mean, you, you and the team, you're doing high volume, you are, you progress to improve over time. Is that correct? If you walk back? I mean, if you all walk back, although I've got patients that I sent up to you all um 1517 years out now and their valve looks really good, but you learn how to improve your technique. Yes, we do because although their valves look good, there are also some patients that you've had and you've told us and said, look, you know, the valve is ok, patient is ok. But the gradient is creeping up all the posterior leaflet is very thick. So that things that we still learn that we aim to perfect to see how we can push the bar from say a 10 year effectiveness to 15. And for the younger patients, 2030 are lifetime effectiveness of surgery. So you made reference to the editorial you wrote about, I think you've got it in this presentation about the long term goal. So I mean, the ba then is uh the bad, the bad wire paper is really good because it shows that much of valve repair in, in all hands is it is pretty safe and you made the valid point that any transcatheter therapy should be, you know, while people are pushing those or that they have to be of equal safety and uh and effectiveness. But this is really talking about now, you're really talking about what you need for a long this durability, long term life, you know, life, long term care. Yes. So basically if one is saying in the forties or thirties, forties, fifties with microbial regurgitation and you're going to your doctor, you want treatment. The I think these four things are the critical things for you because in terms of fixing the mitral valve safely. As we've said, almost any surgeon in the world can do a safe operation in terms of an effective operation that gets a bit trickier. Then you need probably a mitral valve, someone at least with an interest in micro valve surgery who can fix a valve and is likely to fix it well. But then you have to go beyond that and say, well, when am I going to be 10 years from now, 15 years from now 20 years from and the things that will get you through, I think are these four points that we made. And, and this was based on our observations from Tyrone Davies 20 year outcome because we then looked at his data and asked the question, what is it that makes patients uh not do well, say 10 to 20 years after surgery. And it's these four things, either they're getting the the mi regurgitation has come back, the atrial fibrillation, they have tricho uh regurgitation or they've had some kind of thromboembolic event like a stroke. Those are the things that limits the long term success for a young patient who has my research. So this is, this is what you would say your road map. I'm looking at if you know, minimize recurrent Mr, so you want a surgeon again, is the more complex it is you, you would ideally want to go to a center that deals with complex. Ideally, you would, you'd want to go to center or a surgeon who deals with complex. So the surgeon might not necessarily be in a reference center, but you just need a surgeon who does complex. And that's what I was referring to you. You've figured out the techniques that uh not a proven durability for the valve to make the valve function as close to normal and the heart. Yes. So, so there are some techniques, for example, the the Carpentier techniques are time tested and we know they work. There are some newer techniques and I think surgeons have to be more cautious in adopting newer techniques unless there's a biological explanation that will support their existence and equivalent to establish techniques. Otherwise a lot of things being tried may or may not be successful in the long term. And I think for a younger patient, you really want time tested tech techniques. And I think the issue, the other point is what we talked about earlier, you should have zero tolerance for residual my saying. So don't leave the operating room with any regurgitation or anything more than a trivial regurgitation. Then you're talking about thrombo boycotts basically analyzing and you're really talking about coming from the left atrium of the valve repair or the atrial appendage. So there's there's still controversy about what we do with the atrial appendix. Atrial appendix is a blind sack in the left atrium as you know where that forms blood clots. So if a patient has had atrial arrhythmias in the past. Then we should close that appendix and remove that source of thrombo emboss and some surgeons. A lot of surgeons increasingly are closing that appendix even in patients who who do not have atrial fibrillation. But we're still waiting for data to compare that strategy. And at least for the first three months after valve surgery, patients should be on some kind of anticoagulant or antiplatelet therapy. And there's a debate as to whether we should push that beyond three months as well. Ok. But, but there you're trying to minimize that risk and then you uh you know atrial fibrillation is not a benign arrhythmia to patients. I mean, it compromises their function and puts them at risk. So what are you doing for that in that regard? So in that regard, any patient who has micro regurgitation, having surgery and has atrial fibrillation should get an abal procedure, what we call a maze procedure. There has to be a strong reason not to do that. So there, there are some occasions, for example, if we have an 85 year old patient who has been in a fibrillation for 10 years, fine, you don't and you think it's going to add a lot of risk to the surgery. We don't need to do a maze, but for most young patients with atrial fibrillation. So the first is if you have atrial fibrillation, we do a maze ablation. And the second is for patients who have a history that suggests that they may have atrial fibrillation, anything in the history of findings. So for example, a patient with a very enlarged left atrial. Yeah, a patient who has a history of power patients. Those patients we think hard. I saw you yesterday talking to Mark Miller who is our electrophysiologist in our clinic. So we have a valve clinic every Wednesday and we have an electrophysiologist. Any patient, we have doubts, we have mark, see the patient and he looks at the patient that if he has a moderate or higher index of suspicion that there might be atrial arrhythmia, he puts an event monitor and therefore to document that. And if we find proal atrial fibrillation, we treat that as well. Ok, then this whole question, which is a big debated question now and more is that if the tricuspid valve is leaking a fair amount, you need to do something about it. Yeah, I mean we do know that the tricho regurgitation is one of the factors that limit the long term benefit of microvalve surgery. We saw that in Tyrone Day is serious. So a lot of the patients who die late after microsurgery also have tricho regurgitation. Whether one cause the other is, is uh is out to debate. But we do know from um epidemiological data that people with severe tr cos regurgitation don't live as long as people who don't have severe. So it's a bad thing. I wouldn't want to, you wouldn't want it. So the question is, can we prevent it? And we probably can surgeons debate it. But I think the guidelines now are now coming to the consensus that if you have moderate tricho regurgitation and you're having micro valve surgery that should be addressed, we shouldn't leave it alone. And we are also of the view that if you have the substrate for tricuspid regurgitation, which is a dilated animals, we should also fix that. So the analyst doesn't dilate further to cause Trichosporon the results of this operation. You know, I mean, it's, it's a great thing that patients should know. And, you know, basically, I mean, and what a lot of people don't recognize a lot of, I mean, I think a lot of cardiologists known is that atrial fibrillation begets tricusp of regurgitation, how much and much regurgitation. And so it's not an innocuous thing. And so by walking through this, um, you also had, as I've, I had a chance to look at these early, an interesting quote from Doctor Robert Dion who's a, a call. Got a, and a, and a good friend from, uh, France and Belgium and other places. Yeah. Yes, I did because it's a, it's a quote that I like, he just before he retired a few years ago. He was happy to have him as an honored speaker at the Metro and he gave a very nice talk and, and, and this was my take home from his talk and he said what he defines as a complete operation. And I put this up because there's a lot of focus now on how surgery is done. Is it done by a robot or a human being? Tristen Trom in New York? And you know, Leiden or Tyron, wherever you go. But that's not the point. He says, he, he wants to remind us why a patient comes to us for an operation. They're not coming because they want the operation done. They might think that's what they want, but they're not coming to us to have the operation done through a particular incision, the size of the incision um with a particular technique to have a quick operation to have an operation without bypass, to have it done through the groin, we have to go back to the base and ask why is the patient here and the patient is here because they want to be cured of their disease in a safe, complete and durable fashion. Everything else is secondary and our focus, we, we must not lose sight of our goal. And our goal is to give patients a safe care, a complete care and a durable care. It's not to do it through the groin or do it through the chest, small incision, long incision, short bypass, long bypass. It's not for our reputation. And so provided we keep that goal in mind and we ask ourselves, what's the ideal approach for the patient in front of us to achieve that goal. It might be that it's with a catheter, a clip. For example, it might be that it is a trans catheter valve replacement. It might be that it's a stoy and a valve repair. It might be that it's a robot and a valve repair or something else. But I think we should not lose, lose focus on that. You're doing what I mean, what what I like here and obviously, Professor Dion did this is that you're really looking at what's best for the patient for this durability and safe outcome. And even at a place that's really world renowned for mitral valve repair, you look at transcatheter therapies and you have patients that you do. But mitral valve replacements then because that's, that's gonna be best for the patient. So you, you're telling the patient and referral physicians what they need to think about a safe kit, complete kit and a gen kit. If we focus on those three things, then we'll do right for the patient having had a chance to, you know, uh watch, you watch you all develop over the years and everything is why, you know, because you do go by these tenants. That's why I've sent a lot of patients to you. So this is great information. As I told you, you and David, uh that the editorials, both those editorials were excellent because they, they look at this principle that you're putting out. So thanks for uh sharing it with us and sharing it with the audience and we're glad that you could join us. I hope that you've learned a lot too.