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In honor of Valve Disease Awareness Day, valve specialists Dr. Paul Cremer and Dr. Christine Jellis answer questions they often get from clinicians referring patients for valve disease treatment.  Topics include patient considerations for MitraClip, use of TMVR, TAVR for aortic regurgitation, and tricuspid valve regurgitation options. In addition the doctors discuss how anatomy, imaging and a team approach impact decision making.  #ValveDiseaseDay @ValveDiseaseDay

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Valve Disease Awareness: Clinical Update

Podcast Transcript

Announcer:
Welcome to Cleveland Clinic Cardiac Consult, brought to you by the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at Cleveland Clinic.

Dr. Christine Jellis:
Good morning, everyone, and welcome to Valve Awareness Week. I'm Christine Jellis, and I'm an imaging cardiologist at Cleveland Clinic, and I'm really privileged to be joined by Dr. Paul Cremer this morning, where are we going to address some healthcare provider concerns regarding valvular heart disease, particularly paying attention to some new and evolving techniques, which I think often generate quite a few questions. So good morning to you, Paul. I'm thrilled to have you here with me this morning.

Dr. Paul Cremer:
Good morning, Christine. It's great to do this again.

Dr. Christine Jellis:
So we are always thrilled to see our patients with valvular disease, and we certainly appreciate the referrals that we're getting from both primary care and also other specialists, who certainly are providing excellent care for those patients in recognizing that they have valvular heart disease and then sending them along to us so we can further evaluate them and determine which treatment path they need. I think even since you and I went through training, this field has really evolved a lot. We have so many more percutaneous options now and as we talk with our patients, we really are giving them an individualized treatment plan. We have some common questions that we're asked and I think we might use today as an opportunity just to delve into some of those questions, a little bit rapid-fire if I can put you on the spot and get your thoughts upon what are some common themes that we see, and what can we also convey to our patients?

Dr. Christine Jellis:
So Paul, let's think about MitraClip first if you don't mind. So I think MitraClip is definitely serving an increasingly large group of patients. Maybe you would like to touch upon who those patients are who are ideal for MitraClip, perhaps some considerations that we need to be aware of, and then touching on those who perhaps are not going to be ideal candidates.

Dr. Paul Cremer:
Yeah, thanks, Christine. And certainly, as you noted, even within the past five years, we've seen such an increase in the therapies and innovations that we can offer our patients. And one of those undoubtedly is the MitraClip, which is a very good option for a lot of patients. And so who are the patients best served with that device? Well, I think it's important at the outset to just think about the mitral valve disease in terms of, is it primary MR, is it a problem of the leaflets themselves? For example, a prolapsing or a flail mitral valve leaflet, or is it secondary MR, that the left ventricle has enlarged and become dysfunctional, and as a consequence of that, the mitral valve is severely regurgitant? And it's really that latter category of patients that's best served with the MitraClip, those patients that have enlarged and dysfunctional left ventricles.

Dr. Paul Cremer:
Whereas most patients with primary MR mitral valve prolapse, mitral valve flail are still going to be best served with surgery as long as they're acceptable surgical candidates. The higher-risk patients will also get a very good result from MitraClip, but surgery would still be the standard for that category of patients. So if we're thinking about the secondary MR patients that get referred to us, what are the questions that come to mind? Well, the first is you really have to make sure they're on optimal medical therapy for their systolic heart failure. And that has to be emphasized. And because if you could look at the COAPT trial, these patients were on really good guideline-directed medical therapy. So that's a lot of what we do, is making sure that in conjunction with our heart failure colleagues, that they really are on the best medications for their systolic left ventricular systolic dysfunction.

Dr. Paul Cremer:
And then from the imaging perspective, I think you want to make sure that this seems to be a ventricle that is most likely to have been included in a clinical trial, such as COAPT. So for example, if the ventricle is very severely enlarged or very severely dysfunctional, that may be a patient that will do okay with MitraClip, but you may want to pause and again, have these patients see your colleagues in advanced heart failure and say, okay, is this a patient where we should go with MitraClip or is this a patient where we need to think about advanced heart failure options, such as LVAD or transplant? So I think those are the questions that kind of most common come up when we think about what patients are best for MitraClip, it's the patients who have secondary mitral regurgitation related to left ventricular systolic dysfunction.

Dr. Paul Cremer:
And you really want to make sure that those patients are on the best medical therapies for their heart failure, and that they're at a stage of their heart failure where there'll be best served with MitraClip versus other or advanced heart failure options. In terms of the anatomy that's amenable to MitraClip, again, that's something within a few years, there doesn't seem to be many obstacles there. So we used to look and say, okay, if there's a flail, how big is the flail? How big is the claudication gap? I have to say with our interventionists now in the newer devices, that really doesn't seem to come up very often as a concern. Those are just some initial thoughts that I have about thinking about what are the questions that commonly come up in terms of who's the best candidate for a MitraClip.

Dr. Christine Jellis:
I completely agree. And I think being aware of the limitations is always important, but we're very spoiled to now have this as a technique that we can offer patients, particularly those who are perhaps too high risk for surgery. A couple of things just to add, I think being mindful that a lot of patients will come along hoping to get a MitraClip but we, in that process of evaluating them, may uncover concurrent problems like coronary artery disease or other valve disease, which may make surgery a more viable option for them. I think it's fair to say though, that in a center of excellence with a lot of experience and high volume, you can achieve very low rates of morbidity and mortality for these patients who once we really delve into what is going to be the right option for them to deal with all of their concurrent issues, surgery may end up being the best option for them.

Dr. Christine Jellis:
And I think that's where having a heart team is really critical, and certainly, we are fortunate that we work closely with our interventional colleagues and surgeons. You're obviously in the leadership of our coronary care ICU as well, so you're well-placed and used to working in that team environment, perhaps you wouldn't mind commenting on how we have our team approach here, because I think that's really proven to be critical in the success of our programs.

Dr. Paul Cremer:
Yeah. Thank you, Christine. And I think one of the things I enjoy about being an imaging doctor is also what I enjoy about being in the cardiac intensive care unit, and that is the team-based care that you get in both environments and that I'm really the generalist, if you will, and trying to help the patient navigate what's going to be the best approach for them in conjunction with the cardiac surgeons, with the interventionalist, with the heart failure team. And so, as it relates to the cardiac intensive care unit, if there's a patient who has severe MR and they're quite ill, some of those patients are good enough to go to surgery and some of those patients aren't, and then we've done MitraClips and some of those patients in the acute setting and had really good results.

Dr. Paul Cremer:
But as you said, this is always an individualized plan, whether it's in the imaging clinic or the cardiac intensive care unit with input from many different people. And that's one of the great things about working at a place like the Cleveland Clinic is that you really have everyone at the top of their game. And I see my role as just trying to help, primarily to try and facilitate that to lead to the best outcome.

Dr. Christine Jellis:
I completely agree. I think one of the scenarios where it's clear that we're not going to be able to use a MitraClip is in the setting of valvular stenosis or significant mitral calcification. We really need to make sure that by putting on that clip, we're not going to exacerbate any further mitral stenosis. And I know that's often a question that we get, is whether this person is going to be a candidate for a clip in that scenario. Do you mind commenting on the types of calcification, the location and how we determine that, what is going to preclude us from offering that patient a clip in the setting where everything else lined up, that we should be thinking about a MitraClip?

Dr. Paul Cremer:
Sure. Yeah. And so I think as you noted, kind of the first question is, is the anatomy amenable to a MitraClip? So if it's a severely calcified leaflet or you're worried about a tear, I mean, that's going to be a conversation where you review the images with the interventionalists and say, anatomically, are you worried about putting a clip in this patient? And then the second question is, okay, if we put in a clip are the human dynamic consequences is the subsequent mitral stenosis going to cause us trouble? And again, I think that's an individualized treatment decision. I have to say in a lot of elderly patients who have severe MR and are symptomatic from it, when we treat them with MitraClip, symptomatically, they're much better. And even though they're gradients after putting in the clip across that mitral valve, there may be some degree of mitral stenosis, if you will, it doesn't really seem to symptomatically cause them too much trouble.

Dr. Paul Cremer:
So that's something that I do think factors in one, to the decision to put in a clip versus going to surgery, and two, then whether or not to put in the clip or how many is, what's the age of the patient, and do you think that the increase in gradients that you're creating are really going to cause trouble? I have to say overall, I don't know what your experience has been, but I don't see patients coming back with symptomatic mitral stenosis after these procedures.

Dr. Christine Jellis:
Look, I think you're absolutely right. I think it's something we worried a lot about in previous years and we seem to have relaxed a little bit about that now. As you say, the patients with the slightly higher gradients still seem to do much better when you resolve that mitral regurgitation, and often than not patients who are particularly active anyway, so perhaps we can maintain them with relatively low heart rates so that that mitral stenosis doesn't become too much of a human dynamic issue.

Dr. Christine Jellis:
I think it would be remiss me not to just mention that obviously in the setting of infective endocarditis, we would have a different approach to these patients for mitral regurgitation where debridement of that infected tissue obviously makes them a surgical candidate, ideally. But I think certainly it's nice to have MitraClip or the other different types of percutaneous mitral valve interventions in our armament for managing valvular disease in these patients.

Dr. Christine Jellis:
One other question that we often get, and I'm going to pivot across to the aortic valve now, is about aortic regurgitation. I think we're pretty comfortable now about the use of transcutaneous aortic replacement devices to deal with aortic stenosis. But Paul, perhaps I could ask you to comment on aortic regurgitation. Are we there yet for the TAVR-type valves, and what are some considerations that may make that person a good candidate versus unsuitable for that approach?

Dr. Paul Cremer:
Right. Thanks, Christina. That's often a question that comes up is, is there a role of TAVR in aortic regurgitation? I would say broadly speaking, we're not there yet. As we touched upon before, in my role in the cardiac intensive care unit, we sometimes have patients come in with acute severe aortic regurgitation, maybe from a patient who's had a prior surgery with an aortic homograft and there's a cracked leaflet, and there's flail, and there's severe AR, and they're in-extremis, and on individual patients like that, we've had fantastic results doing TAVR. But generally speaking, to someone walking into your clinic with severe aortic regurgitation, the standard there is still going to be surgical replacement of the valve.

Dr. Paul Cremer:
And I think that also just segues more broadly into how we think about transcatheter aortic valve replacement versus surgical aortic valve replacement in 2021. I think that the clinical risks are still important in the sense, primarily, the patient's age. So if it's a younger patient, we're still going to favor a surgical approach. And in an older patient, we'll generally consider a transcatheter-based option. So those clinical profiles is still, of course, important, but I think more and more and what's changed over the past few years is the consideration of the anatomy. And that relates to the patient with aortic regurgitation, in terms of those patients will often have an enlarged aortic root or an ascending aortic aneurysm, and that's a concomitant problem that really needs to be dealt with surgically. Or, there may be calcium that either makes SAVR or TAVR more desirable and it may be related to the size of the iliofemoral vessels, the degree of aortic calcification.

Dr. Paul Cremer:
So I think as when we're reading these TAVR CTs, we sort of have this checklist of anatomic considerations as it relates to the best approach for the patient and concomitant lesions, to try and decide, okay, what's going to be the best for this patient, either transcatheter aortic valve replacement or surgery.

Dr. Christine Jellis:
I think to add to that too, is the patient group with bicuspid valves because often we're seeing these presenting in sort of middle-age with stenosis, but it's clear because of the asymmetric anatomy that perhaps they may be better served with surgical valve replacement. And this gets onto another point I wanted to raise with you, which is about this lifetime care of the patient with valvular disease because we really want to make sure that any decision we make about intervention at one point in time sets that patient up for success long-term. And I think back in the day when TAVRs were really reserved for the elderly and those with severe co-morbidities, the long-term plan became less important.

Dr. Christine Jellis:
And so now, if we're coming back to thinking about a valve replacement in say a 50 or 60-year-old, we want to make sure clearly that we're giving them the best long-term outlook, perhaps getting in the biggest valve initially, perhaps we're more inclined to perhaps put a surgical valve in that scenario, thinking about planning for a valve-in-valve as I get older. Can I ask your thoughts on that type of outlook, Paul, and how you use that in your practice?

Dr. Paul Cremer:
Yeah. Thank you, Christine. And as you highlighted, one of the things we enjoy about taking care of patients with valvular disease is it really is a lifelong relationship. So when we're seeing the patients, we're thinking about what's the best approach here and the decades to come. And then as I touched upon, I do think the age of the patient is very important. For example, we don't really know about TAVR-in-TAVR, right? So, as you said, in a younger patient, we would be more inclined to put in a surgical bioprosthesis, perhaps a bioprosthesis that's specifically designed to accommodate TAVR in 15 years in the future.

Dr. Paul Cremer:
And then I think that also relates to the timing of intervention because a bioprosthesis is a very good option for a lot of patients, but in a way, the clock does start ticking when you place it in terms of the other longevity. And what I would say is, as we've gotten better and better at replacing these valves, be it through a transcatheter or a surgical-based approach, that the threshold for offering intervention has also decreased. So, I think in a patient who has severe symptomatic aortic stenosis, it's very clear that that valve should be replaced. But I think now more and more in our practice, we use ancillary tests to try and inform the right timing of intervention.

Dr. Paul Cremer:
So if a patient's telling you they're asymptomatic, are they truly asymptomatic? If you put that patient on a treadmill, if they perform poorly on an exercise echocardiogram, that can be an indication for intervention. If you check an NT-proBNP and that's markedly elevated, that can be another indication for intervention. So I think now in the imaging in the valve disease clinic, we have these ancillary tests to sort of better inform when we should intervene in aortic stenosis. And I would say in general, the bar is moving lower and lower, but we still want to have some objective data to really provide the optimal timing for an individual patient of when to replace that valve because as you noted, we're usually making a plan for the next 30 years, not just the next five.

Dr. Christine Jellis:
Absolutely. And you touched on it well, that often these are insidious conditions where it's easy for a patient to start minimizing their symptoms, but when you really tease it out and ask them, or how does their exercise capacity compared to what they were doing two years ago, or put them on a treadmill and see how they compared it to their age and gender-matched controls, it becomes evident that that person really is symptomatic and may benefit from intervention. Paul, one last question for you, then I'll let you escape. We often get asked about the TAVR in the mitral position. Is this ready for primetime? Where are we at, and is it a case of watch this space, but hopefully, we'll get there soon? What do you think?

Dr. Paul Cremer:
Yes. So that's a great question in terms of percutaneous approaches for the mitral position, and I'll touch upon that, Christina, and then maybe we can conclude by also talking a little bit about the tricuspid valve, which has even more wide open than the mitral space, I would say. So if we think first about dealing with the mitral valve and percutaneous options, again, it's sort of what are the anatomic considerations? And a lot of that is going to be based on the results of our transthoracic and transesophageal echocardiogram in terms of how severe the dysfunction is, be it stenosis or regurgitation is a threshold that requires intervention in conjunction with the symptom burden of the patient. And I think more and more cardiac CT in terms of planning whether or not it's feasible. So where it often comes up, I would say is in degenerated mitral valve bioprosthesis.

Dr. Paul Cremer:
So again, I think the percutaneous approach would be reserved for a patient who's not a candidate for a repeat cardiac surgery. And I would say that the results seem quite good, at least in the intermediate-term, and the procedural success rate is quite high in terms of putting in a transcatheter valve within the scaffold of the degenerated bioprosthesis. And we can know very well from the CT scan how that's going to look by modeling that and ensuring that we're not going to obstruct the neo-left ventricular outflow tract with that intervention. Do I still think there's a lot to be learned in terms of what is the best cutoff and sizing thresholds there? So, that I would say is fairly well-established. And similarly, I think putting a mitral valve percutaneously within a mitral valve ring, it seems like the interventionists are doing quite well with that.

Dr. Paul Cremer:
I think the cases that frankly are a little bit more challenging are the patients with severe MAC and then trying to figure out what the best approach for that patient is. Do have a treatment option in terms of a percutaneous valve? Is this someone where you should reconsider a high-risk surgery to try and get the best approach? And those, as we, I think have emphasized throughout this discussion, those are individualized patient decisions that involve the input of the heart team, with the imaging cardiologists, the interventionalists, the surgeon, and the heart failure specialist as key members of that. So I think it's certainly a very exciting space and I think there's been a lot of innovation there within the past few years.

Dr. Paul Cremer:
And then I just wanted to also touch upon the tricuspid valve space. Because I sort of feel that where we are with tricuspid valves now is kind of where we were with mitral valve four or five years ago. In terms of there's certain things that we're continuing to innovate on the tricuspid side, it's reminiscent of where we were on the mitral side, where certain of these procedures such as putting a transcatheter valve within a degenerative bioprosthesis, as I think become a fairly standard, a patient can be discharged like the next day I've often seen. So I don't if you have any thoughts just in terms of where you think we're going in terms of the tricuspid regurgitation, and in terms of which patients to select, and what are some considerations that go through your mind when you're seeing these patients in clinic?

Dr. Christine Jellis:
Yeah, it's a really good question because I think a lot of us have a list of these patients with severe isolated tricuspid regurgitation. They're often middle-aged to elderly women who are relatively small in terms of their body size. And traditionally, we've not sent these patients for surgery lightly, unless they were really symptomatic or we were seeing signs of liver dysfunction, or there were issues with a right heart. And even then, they were at that point, higher risk. So I think to have a less invasive option for these folks where they can avoid open-heart surgery is going to be an absolute game-changer. And I hope that with the knowledge we've gained from the development of the mitral options, that we will sort of skip ahead a little bit faster as these tricuspid technologies evolve, I guess, being mindful that it tends to be a bigger annulus and there can be issues with visualizing all three leaflets and so forth from a technical perspective.

Dr. Christine Jellis:
But I think for us as imaging cardiologists, the opportunity to use 3D imaging is just phenomenal because we get a much better view of the tricuspid valve. And if the imaging hadn't evolved so well with 3D technology, I don't think we would be where we're at with the interventional piece. So they're so intertwined and I think if we can continue evolving the imaging from our end hopefully, to help our interventional colleagues, they'll continue moving ahead in leaps and bounds, which can only benefit our patients long-term.

Dr. Christine Jellis:
I think we probably need to leave it there. It's been great talking with you this morning. Wishing everyone a happy Valve Disease Awareness Week, and hopefully, we can do this again soon.

Dr. Paul Cremer:
Excellent. Thanks, Christine. This is great.

Dr. Christine Jellis:
Thanks, Paul. Take care.

Announcer:
Thank you for listening. We hope you enjoyed the podcast. We welcome your comments and feedback. Please contact us at heart@ccf.org. Like what you heard? Subscribe wherever you get your podcasts or listen at clevelandclinic.org/cardiacconsultpodcast.


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