Mitral and Tricuspid Therapies

Additional Info

• Audio File:uab/ua152.mp3
• Doctors:Lewis, Clifton;Ahmed, Mustafa
• Featured Speaker:Clifton Lewis, Sr. MD | Mustafa Ahmed, MD
• CME Series:Clinical Skill
• Post Test URL:https://cmecourses.som.uab.edu/mod/quiz/view.php?id=4062
• Guest Bio:Dr. Clifton Lewis has been board certified since 1991 in adult cardiac surgery. He has special interest in the treatment of valvular heart disease and especially in minimally invasive and robotic approaches to valvular operations. 
  
  Learn more about Clifton Lewis, Sr. MD 
  
  Mustafa Ahmed, MD, is an interventional cardiologist who treats heart valve and structural heart disease, which are conditions involving defects or damage in the walls, muscles, or valves of the heart. 
  
  
  Learn more about Mustafa Ahmed, MD 
  
  Release Date: July 21, 2020
  Expiration Date: July 21, 2023
  
  Disclosure Information:
  
  Planners:
  Ronan O’Beirne, EdD, MBA
  Director, UAB Continuing Medical Education
  
  Katelyn Hiden
  Physician Marketing Manager, UAB Health System
  
  The planners have no commercial affiliations to disclose.
  
  Faculty:
  
  Mustafa Ahmed, MD
  Associate Professor of Medicine, UAB Interventional Cardiology
  
  Clifton Lewis, MD
  Associate Professor of Medicine, UAB Cardiac Surgery
  
  Dr. Kazamel has disclosed the following commercial interests:
  · Abbott, Medtronic, Edwards' Lifesciences – Consulting Fee
  · Abbott, Medtronic – Payment for Lectures, including Service on Speakers Bureaus
  
  Dr. Lewis has no commercial affiliations to disclose.
  
  There is no commercial support for this activity.
• Transcription:UAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
  
  Melanie Cole (Host):  Welcome to UAB Med Cast. I’m Melanie Cole and today, we’re discussing mitral and tricuspid therapies. Joining me in this panel are Dr. Clifton Lewis, he’s a Cardiothoracic Surgeon and an Associate Professor and the Chief of Adult Cardiac Surgery and Dr. Mustafa Ahmed; he’s a Cardiologist and Associate Professor and the Section Chief in Interventional Cardiology. And they are both at UAB medicine. Gentlemen, I’m so glad to have you join us today. And Dr. Lewis, I’d like to start with you. What problems can occur with the mitral and tricuspid valves and tell us about the idea of treating valve disease percutaneously.
  
  Clifton Lewis, Sr., MD (Guest):  In terms of types of problems you can have, the issue typically is the valves go bad in one of two ways. Either they leak or they won’t open and it’s really about the only two problems you can have outside of getting one infected. And the heart’s a pump and for a pump to work appropriately, it’s got to have valves that will open and close. In the old days, the most common diseases of the mitral valve in particular but also the tricuspid were related to rheumatic disease. Now that’s still the case in developing countries but in the western world, that’s not completely gone away but it’s not near as common as it used to be. And a lot of the problems we have with the mitral valve disease are either genetic in origin, something we call degenerative disease or myxomatous degeneration of the mitral valve or they are related to what we call ischemic heart disease or coronary disease, blocked arteries where you damage the mitral valve and it leaks. In terms of the tricuspid valve, most tricuspid valve disease is related to either chronic, long term untreated left sided or previously treated left sided valve disease principally mitral valve disease or it’s related to what we call pulmonary hypertension that you see in people with chronic lung disease and some other entities. And then finally, we see a far amount of mitral valve disease that’s related to atrial fibrillation. And for the most part, what we see is leakage of both of them.
  
  And in terms of the tricuspid valve, it’s very rare to have it blocked; it’s almost always leaking. In terms of therapies, all these percutaneous therapies and minimally invasive operative approaches are leveraged off of prior surgical experience. Because for decades, the only way you could approach valvular heart disease was by operating on the heart for the most part through the midline sternal incision then later through the minimally invasive approaches primarily through the right chest. And then, even then we came across a fair number of people that you just not treat surgically. They just would not survive open heart surgery whether it was through the midline incision or through small ones. And so percutaneous therapies were developed because there were millions of people every year in the western world that were dying from untreated mitral valve tricuspid valve disease. And that’s where Dr. Ahmed comes in. He’s part of a movement in cardiology and almost like a hybrid cardiologist/cardiac surgeon that are called structural cardiologists and those are the people that do percutaneous treatments of the valves that mirror old cardiac surgery operations. And it’s really been revolutionized the treatment of valvular heart disease. Do you have anything to add to that Mustafa?
  
  Mustafa Ahmed, MD (Guest):  About 15 years ago, there was an important piece of work that came out and it basically said valvular heart disease in the western world is an epidemic. And so, what that means is a very large amount of people when you look at their hearts, they have at least a bad or very bad leaky valves or tight valves. And it was much, much more that we ever thought. And what’s also noticeable about medicine now is the older population continues to get older. And in many ways, in addition to what Dr. Lewis was talking about; as we get older, the prevalence or the amount of people that have bad valve disease increases exponentially. But when you look at the younger population, almost always, surgery – open heart type surgery is the best option whether that’s you do it minimally invasively or not. But as you look at a much older population, open heart surgery takes a very different toll on a patient and you are left with these millions of people without a treatment and the movement of – there’s no good medical therapies. So, there’s no medicine that fixes the valve itself.
  
  When it comes to valves going bad, whether that’s the mitral or the tricuspid valves; it can be either because the hearts gone bad in which case, we try and give medicines that focus on the heart or it’s because the valve’s gone bad but when it comes to the valve being bad, there is not a single medicine that we have been able to find that can fix or reverse that and so the only way to do that is either an operation or to do one of these percutaneous. Which means through a small tube typically through the leg to fix it. and the technology over the last ten years has grown faster than we ever could have imagines. And that’s what Dr. Lewis was saying. It’s lead to this hybrid approach where cardiac surgeons, interventional structural cardiologists are getting together, looking at every single valve which might be different and trying to come up with what’s the single best thing for that patient.
  
  Host:  So, then Dr. Ahmed, speak about some of those percutaneous minimally invasive options that UAB specializes in whether it’s mini or robot. Tell us a little bit about the latest in transcatheter mitral valve replacement field. Tell us what’s going on.
  
  Dr. Ahmed:  I’m going to start talking about this then let Dr. Lewis come and take over and that’s because – I’ll give you an example of a patient then we’ll commence. So, we see hundreds if not thousands, fully thousands of these patients with valve disease per year and when each patient comes in, there used to be that patient would go to a heart surgeon or that patient would go to a cardiologist and a decision would be made about what to do by that individual. Now what happens is, we’ll give you an example of someone that comes in that may be 70 or 80 years old and has a bad valve. Let’s talk about the mitral valve. So, the first thing to do is to say okay how bad is that valve. So, there are two very important things here. One is to say let’s really look in a lot of detail at that valve using three dimensional echocardiographic techniques, MRI techniques, maybe CT techniques and others to really get it right. Because what’s done wrong a lot is people with not bad disease actually have severe disease, people sent for operations may not have severe disease and so the whole focus of a modern valve program is this heart team approach which involves surgeons, cardiologists, interventionalists, imagers, get together and say okay first lets assess this and see what’s happened.
  
  So, let’s look at the situation where we have a valve, we know it’s bad and something needs done. So, what happens is then I will sit for example with Dr. Lewis and we’ll say we’ve got this patient and we’ll talk about the advantages and disadvantages of each approach. So, in a minute, Dr. Lewis is going to talk about not just open heart surgery, but one of the things that is very important to realize is a lot of that can be done through a very small incision. So, he’s going to talk about minimally invasive mitral and tricuspid valve therapies and even robotic where you just basically have tiny incisions on the chest wall. But then we talk about percutaneous approaches also. What does percutaneous mean? It basically means you go through the skin into a blood vessel, you get to avoid making cuts and having to stop the heart and you go up typically a vein, you go through a very small tube and you go to the valve itself and stop to fix that valve.
  
  And what was no options ten to twelve years ago has now become multiple options. One of the options for leaking valve for example would be the mitral valve clip where we would go, take a bit of the valve that’s come apart and causing the leak and put a clip on there and bring it together. We are no on the fourth generation of the mitral valve clip and UAB is one of the leaders in the world in MitraClip programs, a very mature program that allows for treatment of a lot of patients but what we have realized also over the years is there’s a right and a wrong patient for the mitral valve clip. So, selecting the right patient, doing it in the right way with an experienced team is key. But then when you’ve got the patient that is not the right patient for a clip, there’s now other options. There’s a number of trials ongoing which we are fortunate enough to be able to enroll a lot of people in for example working together with Dr. Lewis and the surgical team to go in through the heart, while the heart is still beating and put a whole new valve there and we are one of again the country’s most mature programs when it comes to putting those in. And what was one option has now become three or four different options of valves. For example, people that had old heart valves that have now degenerated we can go in in about 20 minutes time, go through into the heart and put a whole new heart valve in, be done and wake that patient up within 20 minutes after that and they can be walking around one or two hours after the procedure.
  
  And even for us, who do this, and we do a lot of these procedures together, even we get shocked at the impact you can make through such a small incision and have that patient literally going home the next morning. Dr. Lewis, I’m going to hand it over to you to talk about some of the surgical approaches.
  
  Dr. Lewis:  The issue that Dr. Ahmed is talking about really is tailoring the treatment to the patient instead of trying to tailor the patient to the treatment. And that’s basically what we did when all you had was a surgical approach. Now that having been said, surgical mitral valve repair remains sort of the gold standard of mitral valve surgery particularly for mitral valve leakage and even replacement remains a gold standard as opposed to percutaneous. And the reason for that is we know the long term outcomes of those and I’m speaking about 15-20 year outcomes. If you are going to do a percutaneous or a minimally invasive option; you’ve got to reach those standards. You can’t compromise those in a healthy patient. Our issue has always been the elderly, infirmed and unhealthy patient that really desperately needed a heart operation, but you knew they wouldn’t withstand it. Like the old saying, you know the operation is a success and the patient died, that’s always a bad deal. It’s a bad tradeoff. So, what we do is we look first and say well does this valve need to be treated.
  
  If it does, can you operate on them with a margin of safety. It’s never perfectly safe, there’s always some risk. And you can risk stratify people and if the risk for an operation is excessive; then we look for alternatives and we say, well can we clip them, can we replace them percutaneously through the groin? Do they need to be enrolled on one of these mitral valve replacements where we do it through a beating heart in the apex or the bottom of the heart. What we’re trying to do is avoid exposing people to unnecessary risk but still give them a quality result. And one of the interesting things about that is that not only have we been able to treat a lot more patients, we’ve also been able to lower the operative mortality, not eliminate it but lower the operative mortality for mitral valve surgery.
  
  In the old days, your risk would vary from about half a percent for somebody that’s young and healthy for mitral valve repair to upwards of 40 or 50% for desperately ill old people that needed a mitral replacement. So, we’ve been able to get rid of some of those 40 or 50% operative risk patients, move them into percutaneous, minimally invasive approaches and lower our overall risk. And so we treat more people and we have fewer deaths and that’s really been revolutionized the treatment. So, in terms of minimally invasive surgery or standard surgery; the thing to know is there’s nothing wrong with a full sternal incision for heart surgery. It’s really hard to die from opening a person’s sternum. So if you need it and patients need to know that it’s not the end of the world to have your breastbone opened. Now if you can do an equivalent job, if you are going to do open heart surgery on people, if you can do an equivalent job through small incisions and not divide the sternum; it’s certainly advantageous for the patient. And it doesn’t necessarily decrease risk but what it does do is decrease misery.
  
  The primary problem with a sternal incision is it takes two months to recover from it. It’s unsightly. It’s really unpleasant. So, if you can do the same quality operation through the right chest, through a robotic minimally invasive approach; it’s helpful but it’s not necessarily less risky. If you have somebody that’s high risk what you want to do is not do open heart surgery be that sternal incision or robotic minimally invasive approach. Then you want to start looking for percutaneous options and that’s really what Dr. Ahmed’s talking about in terms of cooperative approaches is sort of hybrid medical doctor surgeon where you tailor again the therapy for the patients instead of the other way around.
  
  Dr. Ahmed:  And I’ll add to that. If you want to have the best valve program you can possibly have, there’s a few very important things. I mean you have to have a very strong team that can assess valve disease and actually make the right call, because if the wrong call is made in the first place; the entire train starts and you can end up doing things on people that never needed doing in the first place and this is prevalent in the United States. One very sobering thing about valve disease is there are very few experts. When you look at cardiac surgery and this is an important point; most cardiac surgeons in the United States will list as doing valve repair, very few do a meaningful amount. The majority of cardiac surgeons might do less than five mitral valve operations a year and this is an important point, because a lot of job as a valve specialist on our side is to make sure when you send a patient for procedure or repair, you get a repair and or a replacement. When you send a patient for replacement, that is durable and done in the right way with the right size and that takes experience so, that experience and team approach is important.
  
  You need the people assessing the valve. You need the surgeons to be world class and experienced surgeons and you need the interventionalists to have had training and experience which allows you to come to the table and give the right option because if not, what happens is you get a patient and say for a surgical valve that can be repaired, the gold standard is to go and have that valve repaired unless the patient is not a surgical candidate but if you are in a program where oh the surgeons are not used to doing that, then of course what happens, you end up having it done what sounds a better way, but you may be back in that operating room in a much worse position in a few years because you made the wrong decision up front. So, that’s really what’s the most important part. It’s called program. There’s no individual in a valve program that can make that valve program run on its own. It’s a collection of experienced and trained individuals that really do present every option.
  
  So, the typical even this week, a typical option would be okay, someone comes in, do you need a sternotomy open heart surgery, are your arteries bad? If your arteries are bad, you may need an opening and you may need the bypass surgery and a valve done or you may need a valve replacement, or you may need the valve repaired. That may need to be done robotically. Or it may need to be done through a very small incision. Or it may need to be done through a slightly larger incision or both valves may need addressing or, the patient might need stents and need done in a percutaneous way because they are not a good surgical candidate. You really, really need to be careful not to have a one size fits all program. It needs to be is that the best patient for a clip, yes or no. Is that the best patient for a new valve, yes or no. And that decision at UAB, we actually have a dedicated meeting and we have several surgeons, a lot of cardiologists, imagers, radiographers, ultrasound specialists. We actually sit now on social distancing, we sit on Zoom, but we actually get together as a group for an hour every single week at least once if not several more times and discuss almost every single case to make sure everyone is in agreement that that is that patient’s best option and that’s the movement where this needs to head and that’s where the model of a Center of Excellence comes up.
  
  Host:  What an exciting time to be in your field and such important points for referring physicians doctors. So, I’d like to give you each a chance to wrap up. Dr. Lewis, starting with you here, do you have any clinical trials research you’d like to mention or let other providers know about? Tell us a little bit about the future or areas of work being developed at UAB.
  
  Dr. Lewis:  So, we’re involved in a number of trials. Almost all of the research trials are percutaneous options or beating heart surgery valve replacement. The one we’ve had the most experience in thus far are the following. What’s called the ten dime mitral valve replacement that’s done through a small incision in the left side of the chest and through the bottom of the heart and you basically poke a whole in the heart and the tube and replace the mitral valve. And then the other one is there’s some ongoing MitraClip trials that Dr. Ahmed is running. Out part in it is to help him decide who needs a clip and who doesn’t. There are some what’s called a Triclip where you can repair the tricuspid valve percutaneously and we have just now started enrolling patients in that study.
  
  And there are some other ones that are coming down the pike, particularly involving transcatheter aortic valve replacement that we will be a study center for. One of the most interesting ones really is what’s called the Triclip, that’s where you put an essentially modified MitraClip on the tricuspid valve. The tricuspid valve is what’s commonly referred to as the forgotten valve. We used to think that tricuspid leakage was number one innocuous until it got really bad and then once it got really bad, we thought it was deadly and you couldn’t do anything about it. We’ve increasingly been able to recognize how bad it is for people to be left with severe tricuspid insufficiency and a large part of our practice now is devoted to repairing tricuspid valves. A lot of them have been operated on before, but we are able to fix them with a tricuspid valve unless they are just really sick and then we can enroll them in this Triclip research trial.
  
  And there are some other ones that I think Dr. Ahmed can tell us about that he’s getting ready to start enrolling as well. Mustafa.
  
  Dr. Ahmed:  Research is very important. When we talk to patients about research, research doesn’t mean that we are going to try something experimental. What research means is technologies that have had- that have gone through robust testing that have been used in trials already typically in order for them to be made widely available and a lot of these therapies have just changed the way medicine is. It’s exciting to be able to get access to those but patients in trials are watched more closely than any other patient in medicine. I mean it’s incredible the care and the attention that someone gets. It’s actually much harder to get into a trial and most people – you can’t necessarily get in but we try our hardest to get people in.
  
  So, with the MitraClip, we have the MitraClip G4. We were one of the first in the world to use that system and it’s the latest version of the clip which has really changed the way MitraClip is done. It allows harder cases to be performed. It allows a more probably lasting result and it allows technically a very different and more straightforward approach to fixing the valve. So, that is ongoing now and we’ve enrolled several patients in the MitraClip G4 registry. The ten dime valve that Dr. Lewis was talking about is still ongoing. That should be ongoing for a good while. We’ve had good experience with implanting this and we work together to do that. That’s putting a new valve in while keeping the heart beating. There’s one or two other trials which we are considering starting soon.
  
  The goal is not to have so many trials that you just have them. The goal is to get the right trials in so there’s all the different options and having experienced team that does it again and again and again and so there are several options on the mitral side. On the tricuspid side, the main excitement now is about the Triluminate trial. We really strongly do advise patients that are getting tricuspid clip go to your local, if you have that- I know there are a few sites in the county now that have the Triluminate trial. That is where you should go and get that done because you are watched carefully. You have large teams of people in there making sure the result is good but importantly, rather than just using the MitraClip, which is not designed for the tricuspid valve; that’s what’s being done now, it’s actually a dedicated system for the tricuspid valve and the results preliminarily are just very exciting for that. And the Triluminate trial is ongoing. And then there’s talks of trials where we are actually going to place new valves in the tricuspid position. So, those trials are ongoing too as well as the Paravalvular leak trials which we are shortly starting. Which is where a new plug that can – holes around the valve that have been place surgically previously, we’re going to have very early access to the newest generation of plug which is potentially designed just to try and fit in those leaks that get rid of those leaks and be done in a way which is very minimally invasive. And they amazing thing about this field if we talked to you in a six month time, twelve months’ time, 24 months’ time; that whole field would be changing again and it’s just moving at such a fast pace. Very exciting time for patients and for valve disease in general.
  
  Host:  Wow, it certainly is and thank you gentlemen so much for joining us today and sharing your incredible expertise for other providers. What a fascinating topic today. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That concludes this episode of UAB Med Cast. For more information on resources available at UAB Medicine, please visit our website at www.uabmedicine.org/physician. Please remember to subscribe, rate and review this podcast and all the other UAB Medicine podcasts. I’m Melanie Cole.
• Hosts:Melanie Cole, MS