What I am going to do is take you through a little bit of this literature by way of, I think, trying to be challenging. Here are the guidelines that Bob and Blase among others provided us. If you noticed my question, it really wasn’t a trick question. I asked you about a stable patient with an EF of 54%, who had been followed for a year now with an EF of 54% who obviously was asymptomatic. But the way I read the guidelines, he probably needs surgery. There weren’t any tricks. The data is pretty clear, 60% is an absolute cut-off and you can talk about, well stability, and even a 60-year-old runner is not an unstable patient and I think that you are not alone by the way and those of you that thought more workup was needed, I would say absolutely not. I would have recommended surgery. This paper polled 300 cardiologists in Canada two years ago, half University, half in private practice and asked them a very similar question that I had just asked you. The first thing was an asymptomatic referral, what was their cut-off for EF? And you noticed there were a lot of cardiologists in Canada who thought your EF can be less than 50, less than 40, or some even wait until you become symptomatic. It doesn’t matter how bad your LV function declines and maybe worse in patients who were class II. Look at the percent of cardiologists that were missing a class I indication for referral. So when we talk about reference mitral surgery, we really should talk about reference mitral care, and there is a huge need as this paper concluded to continue our ongoing education of when to refer patients because they are asymptomatic. It is so easy to refer people with crushing chest pain that you are worried might die. It is hard to refer totally stable patients that may not die for 10 or 15 years, but we have to really do that and that is what they concluded here. We need to change and educate more and follow our guidelines. That same issue, Bob mentioned in this paper, in the Euro Heart Survey published last year in 2007. A lot of people used age as a decision not to operate, and in the same finding, ejection fractions were poorly understood. People weren’t weighting ejection fraction correctly in terms of referral for surgery in many circumstances and that’s up, and again, maybe we can talk about during this next panel, why are we seeing so little application of guidelines by cardiologists, and we all need to do that and the data is very clear. These are recent papers.
Now, the next thing was surgery; you noticed we’ve highlighted before. Bob mentioned mitral valve repair, mitral valve repair, mitral valve repair throughout the guidelines, yet we saw some of the answers to these questions where surgeons are saying they are not referring to the super specialists and a lot of cardiologists, I am sure, will follow that same pattern, that’s where the patients come from and guidelines are easy to interpret. There is no one in this room who doesn’t want a mitral valve repair. Every time you look in the literature I am sure you can find 5 or 10% of cases in Cleveland saying this for doing that because they have a huge database that might answer a lot of questions. You can find 10% of patients who doesn’t matter; you are too sick, you are too complex, and it doesn’t matter, but for most patients with most mitral valve diseases your survival improves when you keep your own valve versus have valve replacement. In this paper, just published in JACC from the Mayo Clinic talking about stroke, it is not just death and not just quality of life or do you have to take a pill, it’s do you want to have a stroke. Your stroke rate increases with mitral valve replacement. So, it is a huge decision for the patient what they are going to get. Unfortunately as the data shows, we are not doing a very good job. Most, a lot of us agreed, was 50%, so at least we recognize the problem. The reality is surgeons improve a little bit every year; in 2007, by the way, it still was under 60, but it increases 2% or 3% per year. It is obviously not fast enough and why this sort of topic deserves to be front and center here.
Let me tell you a secret. When you go to a cardiac surgery meeting, we put CABG versus PCI front and center. We love to talk about it. We love to say, these cardiologists, can you believe them, they do this PCI and it may cost the patients 5% absolute survival over 5 years or 8 years. How dare they do that. Right? True? This is a common complaint in our specialty, complaining how those PCI guys do intervention and may rob the patient 5% chance of 5-year survival. Well, here’s the absolute survival benefit well demonstrated, and again, a current series operated all in the last decade in the anterior, posterior or bileaflet prolapse or both leaflet prolapse showing a real survival benefit of 10% over 5 years and there is not a lot uncommon about this in our meetings. Very different response when it is a surgical field as to criticize surgeries opposed to criticize cardiology, we have to do better. It can’t be 50-50 when it’s a class I indication and survival and stroke rates are all better with valve repair. Valve repair is complex. I love this quote from Bill Parcells. He used to tell us, we saw this when he was in New England, “Don’t tell me about the pain, just show me the baby.” It is hard.
When you do a valve replacement this is what it looks like. You cut two leaflets out, you put some pledgets around the circle, you tie a valve. I can teach any cardiologist and show him to do that in three or four months. I will run the pump, I will get the valve out for you, I promise you I can teach you the rest of it in three months. That is what mitral valve replacement is, that takes 45 minutes. You want to plan your day, and you think the patient is getting a valve replacement, go to the ICU at 11 am because he should be there. It is very simple to do. It has to be done correctly. It is simple. This is mitral valve repair. This is P2 prolapse. This is the simplest lesion we tackle, single segment fibroelastic deficiency P2 prolapse. These are the options. You can resuspend the valve with no resection, you can do a limited triangular resection, you can do a partial quadrangular resection, annular plication, or large resection and sliding plasty or in very common circumstances you actually have hyperplastic adjacent segments and you really need to think a little more carefully about how to have an even coaptation surface across the valve. That is the simplest valve repair we do. That is what valve repair surgeons have to think about. That is why it is complex. There is no hiding that. That is why guidelines talk about reference mitral centers. It is complex. It is a reference procedure. We need to get there. As we saw before, most surgeons, let us at least agree, most surgeons perform less than 12 complex mitral valve repairs per year. We just saw that from our own audience poll.
Bob mentioned, in this paper from Bridgewater, where they started this discussion, the first thing they said was ‘let us look at numbers in pure volume,’ 25 repairs per year, 50 per center. That will help us get started in defining reference centers and it’s a first step. Bob mentioned in this paper that the repair rate goes up with volume. Of course, I will, just to play the devil’s advocate, say I am surprised centers with a volume over 300 are just at the 80% mark of valve repair. I think all of us still have to reach for a higher standard for these patients; and Bob mentioned the mortality rate. We don’t talk about mortality enough. There is no question this is a more difficult surgery and databases that look at it show that mitral valve mortality decreases in high volume centers. I just want to go over this echo for a second with you, just to show, I mentioned today again, I know this is an echo by the way of a patient I saw last week. I just pulled it up. I am sorry if it is hard for you to read, but let me read it for you; mitral valve repair; severe mitral regurgitation, and they did a PISA and they calculated an ERO and they concluded there is severe mitral regurgitation and it wasn’t changed very much, but the left atrium was increased. That is the complete report and that is what I mean when I say in the future that is not going to be enough. We are going to need more data than that to make decisions about when to operate and how to operate and who should operate and that is why I like this phrase. Roberto Lang actually came up with degenerative mitral valve repair in surgical echocardiography, thinking more like a surgeon when you do echocardiography. I think that is where we need to move this field and we have already seen, I think, this morning’s excellent talks talking about that, and what that is going to do is place the responsibility more on you, the cardiologist. We actually summarize this in this paper, the cardiologist’s role in increasing the rate of a surgical procedure and what we said is here it is, simple, look guys, we love experienced cardiac surgeons. I happen to be one for a long time. I have only been a reference mitral valve surgeon for a short time. I am not against highly trained great cardiac surgeons, but what we have to recognize is that as the complexity of disease increases you need to start thinking about who is your reference mitral valve surgeon in your area if you want to have a successful valve repair and that is going to start again with the cardiologist understanding the degenerative process. When you do that, valves get repaired. This was our series of the most complex sub-group of degenerative disease, Barlow’s Disease, where we had mitral valve repair in all patients in a consecutive series. I want to contrast that to this paper published this year from a very high volume center talking about minimally invasive mitral surgery, and it will say; It was almost 200 patients over an 18-month period of time, all having mitral valve surgery in one center and they have beautiful incisions. I mean you can see this is an older man, but boy he is going to look great on the beach.
Here is the data, and this is a good paper in terms of giving us the data; so we can all interpret it. Here is the data, here is all they did, it is hard to read, I will help you out; 37% repair rate in a center that did 200 mitral valve operations over a two year period and when you look in between the lines of myxomatous disease, I helped you with the answer here. Their posterior leaflet repair rate was 96%; their anterior leaflet or bi-leaflet repair rate was 21%. And this is where informed consent is so important. What is the patient told? Are they told that ‘our repair rate was almost 70% and the national average is less than 50%’? Are they told ‘you have bi-leaflet prolapse. In our hands, you have less than a 1 in 5 chance of a valve repair’, and I think this is again why the cardiologists have to engage in this conversation and understand this data. Bridgewater again, talked about this. Surgeons that want to do this need to undergo regular audit and the audit should include residual and recurrent regurgitation, not just mortality or valve repair rates, and I think you are going to finally see the day when this does become more public so that you really can make better referral decisions for these young patients that have disease. I just will contrast that with this series published by Randy Chitwood, also very recently looking at a robotic series of consecutive patients undergoing mitral valve repair or referred for mitral valve repair robotically and what you can see is there were no conversions in a 100% repair rate and when you look at the residual and more very high quality, 97% of patients with grade zero or trace mitral regurgitation. Again, reference center mitral surgery works; it’s a question of us accepting the need for it.
My last point about that comes from this paper, also published very recently from the Cleveland Clinic where they were looking at their data, and over 3000 patients that had undergone valve repair. Just look at their power analysis where they considered factors associated with the likelihood of valve repair and you notice that not surprisingly; surgeons, in fact one surgeon in particular, who we all know was a strong predictor of valve repair. So they found it is not reference center, it is reference surgeon. Going to a reference center doesn’t necessarily mean you are going to get a valve repair. In fact, sometimes it may increase your rate. It is not reference center; it is a reference surgeon to improve the rate of mitral valve repair.
And the last point I will make is about durability. Bob talked about durability from Tyrone David. This has been shown again in a recent publication from Flameng, a follow up to his all circulation paper, again even without patients that have what you consider good operations and were low risk; it was about a 2% per year linearized rate of return of mitral valve regurgitation. I don’t see that as a damning of the procedure; I see it as a challenge and that is why I showed you this ink test. We as surgeons have to, and that is why we talk about new shaped rings, we have to keep looking for better ways to do mitral valve repair and we need better imaging. All the things you are hearing about are the ways that we can improve that. This is my mitral valve repair, the patient I actually presented in an international meeting who got a big round of applause in 2004. Today, I would not leave the operating room like that. I have left too much posterior leaflet, I do not have a symmetric closure line, and I am sure if I put ink on that valve I could show that to you. This is the kind of symmetry you have to achieve if you want a durable result. So I don’t look at that data of recurrence as a negative, I look at it as a challenge to do better mitral valve repair and one thing I always say and this is coming out in an article next month. The beginning of this is going to be a higher standard for degenerative mitral valve repair, and it is going to start with all of us embracing this concept of etiology. We have got to follow guidelines, we have got to differentiate the disease, and we need to differentiate the surgeon.
Thank you.
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