KYLE KLARICH: Welcome, everybody, to Interviews with the Experts. And I am Kyle Klarich. I'm one of the cardiologists at Mayo Clinic in Rochester, Minnesota.
And today, our topic is novel mitral valve therapies. And we have two experts with us today, Dr. Mayra Guerrero, who is an interventional cardiologist with over 15 years of experience, professor of medicine at Mayo Clinic in Rochester, Minnesota, along with me, and has a very unique interest in mitral valve transcatheter replacements.
She has also been a PI for many clinical trials, but more recently, some of the structural disease trials that have had these novel therapies actually approved now by the FDA. So we'll have a very interesting conversation about catheter-based interventions for mitral valves.
And Dr. Arman Arghami, MD, MPH, who is also a cardiac surgeon, associate professor of medicine at Mayo Clinic in Rochester, Minnesota. He has a lot of interests, and does surgery. And I can attest to this because I do a lot of the intraoperative echocardiography that we do at our clinic in every kind of heart surgery.
But he's especially adept and enjoys structural heart disease surgeries and is great at robotics and minimally invasive procedures for patients with mitral valve or any kind of surgery, for that matter. But today, our topic is, as you know, novel therapies for the mitral valve.
And one thing I found in common about both of them, they both like the mitral valve. And they both joined the Mayo Clinic staff in 2018.
So I'll get right to it here. We have all these novel therapies. And many of us are still struggling with what are available for patients with minimally invasive interests. And if you-- Arman, maybe I'll turn this one to you, because the minimally invasive world really started with a surgical approach.
What minimally invasive surgical interventions are out there for patients with mitral valve disease?
ARMAN ARGHAMI: Thanks, Dr. Klarich. Yeah. As you mentioned, mitral valve repair started with surgery. And actually, Mayo Clinic was obviously one of the pioneers in this. But over time, the traditional open sternotomy approach started-- patients not wanting it too much.
So surgeons started looking for more or less invasive techniques. And they started performing this through a mini thoracotomy. They called it mini mitral. And more recent years, the robotic platform has allowed us to offer the mitral valve repair, the standard mitral valve repair that has been done nearly 50 years now, through much, much smaller incisions.
That allows us to provide the same gold standard repair techniques through much smaller incisions and less invasive. That allows the patient to recover in almost half the time, less time in the hospital and less time off work and return to a normal life pretty quickly.
This has been shown over and over, mostly by our center and by many other places who do this procedure, to be not only equivalent to an open surgical repair, but in some aspects, even somewhat superior. For example, less blood transfusion has been associated with robotic mitral valve repair.
The other one is less atrial fibrillation and less opioid use. We've shown a lot of these benefits in minimally invasive approach, which makes intuitive sense. But it's nice to see it in data and published material as well.
KYLE KLARICH: Well, that's very interesting. So really quicker recovery, less pain, less opioid therapies, and less transfusions and less atrial fibrillation. That's that's pretty high standards now for surgery. Great.
But we have the new kid on the block, that is the transcatheter based procedures. And as I mentioned before, Dr. Guerrero has been leading the trials, the clinical trials in these. And maybe, Mayra, you could just give us an overview of what transcatheter therapies are currently available to patients with mitral valve disease.
MAYRA GUERRERO: Thank you very much. Well, you're right. It's the new kid on the block. And it's gaining popularity because it's the least invasive way to treat these patients. Transcatheter means we just utilize a catheter, a plastic tube, that we place in the vein or the artery, usually in the femoral area, in the groin.
And through that small plastic tube, we can introduce our equipment to either repair or replace the mitral valve without any surgery at all. So it's completely percutaneous, and the recovery is even faster. Patients can be walking same day. And many times, they are discharged the following day and occasionally even the same day with a completely percutaneous transcatheter repair or replacement.
KYLE KLARICH: Well, it sounds like we have great options on both sides of the equation. The transcatheter would be the quickest recovery, if all goes well, and it usually does. But yet at the same time, as a general cardiologist, we're faced with all these choices. And typically at our institution-- I know many institutions around the country-- it becomes a very important conversation with the heart valve team.
And in fact, that's really why we have both our surgeon and our interventional cardiologist talking with us today, because that's the typical way we approach referrals. And maybe we'll start with Mayra on this one and say, which-- if we refer a patient to the heart valve team at Mayo Clinic, what are the patients who benefit most from less invasive catheter-based procedures, so the transcatheter based procedures you just described?
MAYRA GUERRERO: Thank you. Well, in general, would be the patients with the highest surgical risk, the ones who would benefit the most from non-surgical approach. And we can divide the patients that we see in two main categories-- patients who had already a prior mitral valve replacement with surgery, with a tissue valve, or patients who had prior repair with a surgical ring.
Those patients, when those devices fail to control the stenosis or the regurgitation of the valve, and if they don't need to have any other intervention than other than the mitral valve, most of them could be treated with a transcatheter mitral valve replacement. And that has already received FDA approval.
So in summary, patients with prior surgical repair or replacement, they may qualify for a transcatheter mitral valve replacement that is already FDA-approved. We call that mitral valve-in-valve, which is approved for high-risk and recently approved for intermediate surgical risk patients or can be treated with mitral valve [INAUDIBLE] for patients who had a prior repair for high surgical risk patients.
So that's one main category, patients who had prior surgery. On the other side, we have patients who never had a prior surgical intervention of the mitral valve. Those patients, sometimes they require a repair. And there are FDA-approved therapies for transcatheter repair.
However, when they are not good candidates for repair and they require a replacement, that's only available currently under clinical trials. So there's no commercially approved device in the US as of today for transcatheter mitral valve replacement. It would be only under clinical trials.
But fortunately, we have several clinical trials for transcatheter mitral valve replacement for those patients.
KYLE KLARICH: If they've had prior surgery, either a repair or replacement, that's FDA approved for transcatheter in intermediate and in high-risk patients.
MAYRA GUERRERO: Yes, for valve-in-valve.
KYLE KLARICH: For valve-in-valve. But if they have a native valve disease, then you can't replace the valve right now. It's only available through trials. And we'll see how that comes out.
MAYRA GUERRERO: That's correct. And those are generally reserved for patients who have high surgical risk, because those would be the ones one who would benefit the most from an early device that has not been proven to be safe or effective yet.
KYLE KLARICH: Maybe I'll turn it back over to Dr. Arghami. Arman, which patients do you think benefit most from less invasive procedures in your practice?
ARMAN ARGHAMI: Thanks, Kyle. I think the most important thing you said earlier was the team approach, the heart team approach. And as you mentioned, there are so many options that sometimes for patients and some providers, it's hard to decide what's the best approach for the patient.
And here, we sit down together often or call each other often and go over each of these approaches that has been mentioned and come up with the best. If you have a patient who has a degenerative mitral valve disease and low to medium surgical risk, first time surgery, we have shown for decades now that mitral valve repair has such a good outcome, long-term results, low surgical risk.
And we do such a good repair that the patients have improved survival, back to normal, general population levels. But at the same time, when you get to the other categories, you have a high-risk patient that's really not good for surgery, then we turn out and turn to Mayra. Well, let's think about other options we have.
We have clips that we can offer. Many of the transcatheter approaches are novel techniques. Sometimes not all of them are based on anatomical repair. But they get the job done.
So I would say the most important part is having a team that can understand all sorts of different approaches. They're not biased towards one or the other. It makes a huge difference to offer the right technique for the right patient.
And in terms of the redo, as Dr. Guerrero mentioned, I think some of these will fall into high-risk and intermediate risk that would definitely benefit from such a small, non-invasive, almost non-invasive, I would say, approach that will save them a redo surgery.
But some eventually require redo surgery. And again, outcomes of redo surgery in most cases are not terrible either. And valve re-repair or re-replacement can be done.
KYLE KLARICH: So I think, to summarize for the general cardiologist in me, that we really have to rely on the experts in the field. It's a very rapidly evolving field with a lot of changes almost daily. I think you just mentioned that the paper was just published two days ago, that Mayra was mentioning to me earlier before we started the recording-- she may want to talk about that-- for intermediate risk, valve-in-ring or valve-in-valve.
I think that the interaction between our interventionalists and the surgeons is essential. But of course at Mayo Clinic, we always involve the patient in these decisions as well. So I don't know. I'll stop there. And maybe if Mayra or Arman want to say anything more about that. Otherwise, we could move on to when and how to refer your patient for a mitral valve intervention.
MAYRA GUERRERO: Yeah. A few words about the rapidly evolving field, because when we talk about repair in general, in prior years, we mostly were talking about a clip type of repair. Put in a clip.
But there are ongoing clinical trials, for example, one in which we participate in, where we can place artificial chords, so transseptal chordal repair. So it's not just the clip anymore. Now it's placing chord. So the field is moving fast.
KYLE KLARICH: That's a very innovative field. And it really does take people that are on the forefront to be able to offer the spectrum of options and try to put it in the context of an individual patient.
And we all know that our patients don't just come with mitral valve disease. They come with a lot of other things that are also in the background that have to be weighed in these decisions. So that is-- I think the heart valve team is an incredibly important part of the entire workup and assessment of these patients and ultimately the intervention that's appropriate for that particular one.
Well, we now have one of our-- I'm a general cardiologist. And I want to refer a patient. When do we refer-- what patients are going to qualify for these types of interventions? Mayra, I'll start with you.
MAYRA GUERRERO: Thank you. I think the "when" is very important. We shouldn't wait. So if a patient has severe mitral regurgitation or stenosis and symptoms, that's very clear. The patient should be referred as soon as possible.
Sometimes, patients have symptoms. And the echo may show that the severity of the mitral regurgitation or stenosis is only moderate. I would say, even those patients should be evaluated by a heart team, where we also have advanced imaging experts, yourself and your colleagues. Because sometimes, we may have to do a stress echo on those patients to better understand how severe the regurgitation or the stenosis is.
So I think if they have symptoms, they should be seen for sure. And also if it's really severe and there's no question about it, but the patient does not have symptoms, that may be a role for early intervention, not with transcatheter because none of those are approved for patients who don't have symptoms yet.
But I will let Dr. Arghami maybe answer that question in the surgical area because-- well, I'll let you answer that part. What do you do, Dr. Arghami, if a patient presents with clear, severe mitral regurgitation or stenosis, but there are no symptoms yet?
ARMAN ARGHAMI: As you mentioned, you're absolutely right. If there is severe mitral valve regurgitation-- and now we're talking about degenerative mitral valve [INAUDIBLE]. For the time being, we'll set aside functional mitral valve regurgitation.
But in degenerative mitral valve regurgitation, severe mitral regurgitation, you can find any-- if there is any symptoms, obviously. But some echocardiographic finding like the size of the ventricle, the [INAUDIBLE] and systolic dimension, or if the patient has new onset atrial fibrillation, any other thing that you can add to that or decreased ejection fraction.
But more importantly, even in completely asymptomatic, none of these criteria are met if you truly have a severe regurgitation because or when we can offer a proven track good repair, even in those patients, early surgery has been shown to improve survival.
So I think if you have severe mitral valve regurgitation and the patient is a reasonable risk patient, even in the absence of symptoms or any other specific criteria, in a highly trained center that has good track record of repair and low risk of surgery, still surgery is recommended.
KYLE KLARICH: Yeah. So better outcomes in survival and earlier intervention is really important. And I would throw my two-cents worth. Dr. Guerrero already mentioned the exercise echo. And I think a lot of times when patients tell me they're asymptomatic, oftentimes I looked at the spouse or the partner, and they'll be rolling their eyes.
And then you put them on a treadmill or an exercise treadmill, and you find out that they really are symptomatic. But that all being said, I think the bottom line here is that we can do really well with either surgical or catheter-based interventions.
And we know that if we get involved sooner than later, the patients will have better outcomes, both in morbidity and mortality. So I think that's the take-home point from that conversation.
Let's see. We kind of already talked a little bit about the patients that have had prior mitral surgeries. I think that's a really nice topic that you discussed very clearly. But is there anything else you wanted to add?
We usually think that they've had a breakdown of their valve or some other problem with their surgical repair that we have to go back to surgery. But now we have already heard from Dr. Guerrero that we can do transcatheter.
Is this a complex decision too, for these patients? Or how are we going to approach patients that have already had surgery? Maybe I'll let Dr. Arghami go first this time.
ARMAN ARGHAMI: Sure. Again, I think it comes back to the heart team approach. There are so many things that fall into this decision making. Whether that valve can be re-repaired is one thing. That percentage goes down significantly after the first repair, but it's not zero on the second time.
The second-- the other thing are patient's status, comorbidities, risk of redo surgery if prior bypass surgery was present makes challenging entry or whatnot, and whether there are transcatheter option available.
As Dr. Guerrero is going to mention, I'm pretty sure, there are many times that she and her team can offer transcatheter. But not everything can be done on every patient. Sometimes we don't have the alternative option, and we still have to resort back to the surgery.
KYLE KLARICH: Mayra, do you want to--
MAYRA GUERRERO: Yes.
KYLE KLARICH: --reemphasize some of the things you've already told us or-- I think it's a complicated-- I think a lot of us are struggling to keep up with the speed of the advances in this field. So it wouldn't hurt to repeat some of the things you've already said. But [INAUDIBLE].
MAYRA GUERRERO: [INAUDIBLE] I completely agree with Dr. Arghami, first of all, on the heart team approach and the multiple factors that are taken into consideration also age, for example. So from the interventional point of view, if a patient-- to us, it comes down to two ingredients-- the surgical risk and the anatomy.
So if the risk is low, there's no FDA-approved therapy yet for mitral valve-in-valve or valve-in-ring in low surgical risk patients. If they're young and otherwise healthy, they should have repeat surgery.
But if the surgical risk is intermediate or greater for mitral valve-in-valve, for example, or high risk in a patient with a prior repair, and the anatomy is favorable, I think the best approach would be to offer them a mitral valve-in-valve or a mitral valve-in-ring because it's the least invasive. And if it fails, they can have surgery.
But with good anatomy, there's more than 90% chance of technical success. And I just would like to throw one more thing. Now it can be done without anesthesia. With the advances in echo, intracardiac echo with 3D, there are some patients, when the anatomy is very favorable, they could be treated with intracardiac echo, mitral valve-in-valve, and fluoroscopy, just conscious sedation like we do TAVR.
So not only we don't need to open the chest, but they don't even need to have the risk of genital anesthesia, just conscious sedation. It's almost like a same-day procedure, even less invasive than a regular mitral valve-in-valve. So the field is moving fast and streamlined into the minimalistic approach.
KYLE KLARICH: That's very helpful. So I think this has been a fascinating conversation. And I think the take-home points that I would have as a general cardiologist is, number one, really rapidly growing field that needs an expert team of people to help guide patients that may have mitral valve disease, either prior surgery or de novo surgery.
We didn't have a chance, and we won't confuse things by talking about the-- we're just talking about degenerative processes here, not functional. But I would say that it's a really overall great review of what we need to know and who we need to refer. And regardless if it's at Mayo or other places, it needs to be a very well-developed heart team that helps guide patients through these complex decisions.
Thank you very much for your attention and joining us today for Interviews with the Experts. It's been a great pleasure to have such a comprehensive overview by Dr. Mayra Guerrero and Dr. Arman Arghami. Thank you both.