Baptist HealthTalk

Cardiac Procedure Innovations: TAVR & Beyond

March 16, 2021 Baptist Health South Florida
Baptist HealthTalk
Cardiac Procedure Innovations: TAVR & Beyond
Show Notes Transcript

Minimally invasive heart procedures like TAVR and MitraClip have made headlines in recent years. What makes these innovative approaches so remarkable? And what other advanced techniques are available to make heart surgery less traumatic while changing lives for the better?

Host, Dr. Jonathan Fialkow, deputy medical director and chief of cardiology at Baptist Health’s Miami Cardiac & Vascular Institute, (MCVI), and Dr. Ramon Quesada, medical director of interventional cardiology at MCVI, delve into the fascinating world of heart procedure innovations.

 Dr. Quesada was the first physician in Florida to perform a percutaneous mitral valve repair with MitraClip. He’s been a clinical investigator on multiple trials for coronary interventions and structural heart disease and a leader in developing minimally invasive techniques.

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Welcome to the Baptist HealthTalk podcast, where our respected experts bring you timely practical health and wellness information to improve your family's quality of life.

Dr. Jonathan Fialkow:

Welcome Baptist HealthTalk podcast listeners. I’m your host , Dr. Jonathan Fialkow, I am a preventative cardiologist and lipidologist at Baptist Health’s Miami Cardiac & Vascular Institute, where I am also Chief of Cardiology at Baptist Hospital and the Chief Population Health Officer at Baptist Health.

Over recent decades, new ways of providing cardiovascular care have saved countless lives, and I’m proud to say that at Baptist Health’s Miami Cardiac & Vascular Institute, that spirit of innovation is stronger than ever. There is a lot of incredibly innovative stuff happening here, and today I’m happy to welcome Dr. Ramon Quesada to bring us up to date with the latest, exciting developments. 

 

Dr. Quesada is Medical Director of Interventional Cardiology and the Cardiac Research and  Structural Heart program at the Institute, and Clinical Associate Professor of Medicine at the Herbert Wertheim School of Medicine at Florida International University.

Welcome, Ramon.

Dr. Ramon Quesada:

Thank you John. It's a pleasure to be here.

Dr. Jonathan Fialkow:

So Ramon, this is great stuff that you and the team have been doing. I mean, much of it's nationally and internationally recognized. And sometimes in our local catchment area, we don't know as much of what we're doing as others around the country. So this is a great opportunity for us to explore and educate [inaudible 00:00:18] instructional heart disease, the incredible accomplishments that are you and others have achieved in cardiology. Then maybe a little bit about where we're going as in the future. So let's start with some basic concepts. You use the term structural heart disease. What is that and how is that a relatively new concept compared to previous forms of heart disease assessment?

Dr. Ramon Quesada:

So it's very... It's fascinating because really our field is a young field. It started in 1979 when Andreas Gruentzig did the first balloon angioplasty in Zurich, and then it evolved to what is today a field of interventional cardiology that involve what is called a structural. The structure means the heart itself. So if the valves are broken, we try to fix it. And if you have congenital defects in the heart, all this was done only with surgical procedures in the past. Now, we can take and do that with minimal invasive. The patients are awake sedated only, and we can intervene with minimal trauma to the body and using catheter techniques. That's basically what a structural means.

Dr. Jonathan Fialkow:

So I think that's really a great perspective because I think it's not that we couldn't help people with these cardiac conditions before, but it generally required a surgical procedure, which certainly had a higher complication concern and a higher recuperation rate. Part of the innovation Dr. Ramon is really not just we're able to do it, but the patient experience, the patient recuperation, the patient getting back to the quality of life is quicker and enhanced isn't... Would that be the case?

Dr. Ramon Quesada:

That is the case exactly that because now we can treat patients who are very frail and they were very elderly. Before they were not candidates for surgery now with all this transcatheter techniques, we can help them to have better quality of life and better outcomes.

Dr. Jonathan Fialkow:

Let's talk about a couple of the main structural procedures and I know this world is expanding rapidly as we mentioned. So first TAVR, lots of reported data in the press, lots of studies going on regularly regarding TAVR, but go back a little bit about the TAVR history, what it is, who qualifies for it and your personal experiences so you are in the leading edge of developing TAVR going back years ago.

Dr. Ramon Quesada:

So, it's fascinating. We started back in the concept of opening the aortic valve is with all the blood comes out of the heart it goes to the brain, to the rest of the body. If you have an obstruction in the [inaudible 00:02:56], it becomes like a pinhole. It is the heart has to fighting and it can be very difficult. So the only way to fix that in the past was replacing the valve surgically. It's a very traumatic operation, but it was very successful and that's the only way to do it in the past. Today, we can replace the valve without opening the chest and that's what power is all about.

Dr. Jonathan Fialkow:

So aortic stenosis, we'll talk a little bit later on stenosis because that's obviously what TAVR is for so just to speak to that quickly.

Dr. Ramon Quesada:

Yes, aortic stenosis of structural of the aortic valve and not really a disease that takes time and to build up is a disease that you see in the elderly population, but can happen in the young people who have anomalous or congenital, the formation of the aortic valve. We call it bicuspid valve, younger patient in their fifties, sixties. For those group of patients is still surgical as an alternative and a very good alternative to percutaneous approach. But for the elderly patient, for the patient with high risk for surgery, even the low risk for surgery, today we can do it without surgery. [crosstalk 00:04:06]

Dr. Jonathan Fialkow:

Right. People think a TAVR is a disease... I think people think aortic stenosis, I apologize, is a disease of the elderly and it is more common as one gets older, but we do have younger people who otherwise have these abnormal valves that require replacement. As you're saying, the evolution is this is done without general anesthesia. People go home within a few days, people don't have that incision in their chest. It's just remarkable. And the other thing you just mentioned, speak to this a little bit, when it first came out, it was really for those high risk people, the people who had... They would die in surgery. They had no other options so it was kind of like a salvage procedure. But now even lowest surgical risk people, you're doing TAVRs on. Is that right?

Dr. Ramon Quesada:

That is totally correct. This is one of the most incredible fields in medicine, I would say because we prove with scientific data, randomized clinical trials, that number one, replacing the valve percutaneously was better than doing only observational medicine because the patient who did observational medicine, they die. They have a lower survival rate that the patient would change the valve. This is a high risk patient. Super high risk patient. Then we-

Dr. Jonathan Fialkow:

Right. Let me stop you there for a second. So basically people with this condition, when we try to follow them medically and you don't look so bad, don't worry about it. They don't do as well than if we intervene to fix the valve earlier in that disease state. That's what you're saying, right?

Dr. Ramon Quesada:

That is correct. There's no medical therapy for this condition.

Dr. Jonathan Fialkow:

Right.

Dr. Ramon Quesada:

Medical therapy for this condition is we proved it. It's not a good thing. The best option is replace the valve as long as you're a candidate because if you're in the extreme, then there's no benefit of doing this. And I know I'm probably not going to get into that because it's complicated, but that's a decision that we make in a multidisciplinary approach. So it's not one mind deciding. It's a multiple minds deciding. That is very interesting and I'm going to take a pause here.

Dr. Jonathan Fialkow:

Yeah, please.

Dr. Ramon Quesada:

Because in 1987, when [inaudible 00:06:11] was founded, it was founded in the concept of multidisciplinary approach to cardiovascular disease and that was a very innovative concept. Nobody was doing that. Everybody was practicing medicine in silence. The surgeons here, the cardiologists here, the vascular surgeons, everybody was in their own little world but we brought a different approach. Let's have all these minds work together for the best solution, which should the patient's wellbeing. And that's the multidisciplinary approach to cardiovascular disease. That was... [inaudible 00:06:47] actually was a pilot in the country doing this. Today is mandate. Once [inaudible 00:06:54] was approved, it is mandated that the decision to put a patient through this procedures has to be decided in a multidisciplinary consensus form, which is great, which is the best thing that happens. But at least we started with this 20 years before-

Dr. Jonathan Fialkow:

Yeah, no, that was very innovative and now the others are caught up and we're further innovating and they'll catch up for the newer things we're doing down the road.

Dr. Ramon Quesada:

That's right so-

Dr. Jonathan Fialkow:

But I do think for the listeners is important if you have aortic stenosis and you may be a candidate for this TAVR, this percutaneous rather than open surgical replacement of the valve. It's a multi... It's not one person saying, "You need a TAVR. I'm going to do it tomorrow." There's a lot of assessments of the person between surgeons and the cardiologists, interventional cardiologists, anesthesiology. We have imagers. Maybe you want to talk for a second before we talk about other procedures the importance of having high level cardiac images. How does that help you and differentiate the Miami Cardiac and Vascular Institute to have a program that you lead from others? Talk about that a little bit.

Dr. Ramon Quesada:

So, one thing is like everything in life, one things take you to the other things, and then when you put it together, it's a beautiful combination. It's like an orchestra unless it is the same thing. When we start the field of structural interventions, we were like the Lone Rangers, the individual that [inaudible 00:08:10] was doing the whole procedure, doing images, everything. But you cannot do everything. You need to have expertise in different fields. And then your specialty in our field is structural imagers. These are cardiologists who are dedicated a hundred percent of their time to do imaging. And I always say, if you can see it, you can do it. So they bring to us the expertise to join us the imaging quality so we can do these complex procedures and it will work as a team. It will also with the cardiac surgeons and the interventional cardiologists who are dedicated to this field and that bring the results and in reflecting the outcome of these patients. [crosstalk 00:09:01]

Dr. Jonathan Fialkow:

Patients will do better. They'll feel better. The results will last longer. They'll have less complications when you're able to actually see using ultrasound technology and various other technologies at the time of the procedure what actually is going on. And that is a high level of performance that not a lot of centers have, these high level cardiologists dedicated to imaging. It's interesting to me sometimes when patients, they'll search around. How many hips have you done if I'm going to pick my hip surgery? How many open hearts have you done? But certain things, even like echo cardiography now, there's really a differentiation between the people who really dedicate their careers to its performing interpretations of these cardiac echos at a very high level versus you go to some diagnostic center down the block and there's some tech who does part-time echos.

Dr. Jonathan Fialkow:

So I think that's a higher level of understanding as we move forward towards that subspecialization expertise. But again that we bring it together in the team. So TAVR was kind of the first of the structural procedures to really take off and it's still growing and developing. And we have again, that team-based approach with great outcomes. Let's talk about MitraClip because to me, again, that's almost more exciting because we can offer people again, a non-surgical approach to a very serious concern. So can you talk a little bit about mitral regurgitation and then what you're able to do with the MitraClip?

Dr. Ramon Quesada:

So listen, this is totally fascinating. Let me think, the aortic valve, if you compare the complexity of the valves, the aortic valve is like an odometer of a car. It's broken, you take it out and you put a new one, simple. The mitral valve is more complex. It's like a cockpit of a 747, very complicated, multiple pieces. They have to look at them and you have to put them all together and think about it. How are you going to repair when it's broken, okay? So we repair the valve, meaning that you don't put a new valve, you're repairing the valve, you're repairing something that is wrong with the valve and then you replace the valve. You have to decide when you repair it and when you replace. I'm going to get to mention that the tricuspid valve was a forgotten valve, and now you're also involved in the tricuspid valve.

Dr. Ramon Quesada:

So it's an evolution of all the structural part of the heart that we can repair if necessary. So the mitral valve, it was very complex. This happened almost simultaneously. So the surgeons use I think, [inaudible 00:11:23] that they put a stitches and the mitral valve making like a bow tie. And for that, you reduce the regurgitation or the insufficiency of the valve. So there's two types of insufficiencies. One is a disease of the valve itself, meaning that we call it primary because the valve is defective or is degenerate and the valve leaks. It's like it doesn't close when it's supposed to be closed in. It stays open so you have leaking blood. And the other one is secondary, which the valve is normal, but then it's the muscle of the heart, which is abnormal and that dilates the items of the valve and the valve stays open. So it's primary and secondary. [crosstalk 00:12:05]

Dr. Jonathan Fialkow:

So the secondary is more seen in patients who also would have heart failure. [crosstalk 00:12:10]

Dr. Ramon Quesada:

Heart failure, stuff like that. The heart is dying.

Dr. Jonathan Fialkow:

Right, the dilating heart makes the valve leak and the leaky valve makes the heart worse. So this is the situation.

Dr. Ramon Quesada:

Back in 2000, because if you allow me, I'm going to go back to the beginning because [crosstalk 00:12:24].

Dr. Jonathan Fialkow:

Go ahead and say it and we'll decide if we edit you out afterwards.

Dr. Ramon Quesada:

So, we started at the very, very beginning with our interest wasn't... How can we reproduce things done in the operating room, done in the cath lab without cutting the chest open and we can do the same that the surgeon do? So this is this operation that the surgeon did that they put a ring and then they put stitches in the leaflets. So it's called Alfieri technique because Alfieri was an Italian surgeon who described this. So then biomedical engineers, they develop this concept with interventional cardiologists that how can we get to the heart and do the same thing, but without cutting the chest? So the idea came and put a clip, the clip, that's the work of the ring because it's more than stitch. So bring them back together and also reduce the amount of leaking on the valve.

Dr. Ramon Quesada:

So that's the way you start it. And then in 2005, around 2005, we were involved in a study called Everest trial and we use old comers, good patients, low risk patient, high risk patient, everybody. We learned several things. Number one, that the surgeon do a beautiful operation. So surgical mitral valve repair is the ideal way of repairing the mitral valve. But by the high risk patients, those patients who have... who are very high risk of surgery with higher mortality, this procedure was superior if you have primary mitral insufficiency. And also in the patient who have secondary MR which surgery is not a good alternative, it's not the best alternative. We proved that it was if patient who failed medical therapy, there was the best way to improve this patient's quality of life and survival and that's why you got to prove. Now we're in the fourth generation of clips. We have the small clip, big clips and whatever. So the combination we can achieve incredible results and very, very, very complex anatomies in very high risk patients. But this is [crosstalk 00:14:42].

Dr. Jonathan Fialkow:

Well, I think that's an important evolution. So TAVR started when we did this again, this percutaneous nonsurgical approach to replacing the mitral valve. Only, like I said, that people who had no other choice. They were going to die. They couldn't get surgery because they're so frail and sick, let's just salvage them. Then we started doing it to the patients who had a higher surgical risk, but not that sick and we found it was just as good as surgery. And then we lowered it, lowered it, and lowered it and now anyone who needs an aortic valve, TAVR is a particularly viable opportunity even if you're relatively healthy.

Dr. Jonathan Fialkow:

We're kind of going through the same thing with MitraClip when you say, where it starts out with just the only high risk people. They can't get surgery because they're so frail because they won't survive surgery, but we're finding that there might be benefits going forward in people less of a surgical risk with certain mitral valve conditions. And again, the benefit would be you're avoiding an open-heart or a surgical procedure. I shouldn't say open heart, a surgical procedure otherwise. Is that where you see the MitraClip going?

Dr. Ramon Quesada:

Well, the guidelines has changed. So the guidelines changed for secondary MR for secondary mitral insufficiency, transcatheter mitral valve repair with MitraClip is that we have a classification with the indication. One [crosstalk 00:15:57] indication with the best evidence. 2A is really where we have evidence. So we are at 2A indication with mitral clip. Surgeries' at 2B, so we were above surgery. So if you have functional MR, which medical therapy is still the goal, but if your medical therapy is not doing the job, then you should move into mitral valve repair with MitraClip.

Dr. Jonathan Fialkow:

[crosstalk 00:16:25] So again, take home point is if you have mitral regurgitation with a normal heart, if you have heart failure with a lot of mitral regurgitation, determine if you're a candidate for this less invasive procedure which has indications now. This is not an experimental procedure, but certainly you were involved in those early stages. Last one I want to talk to just briefly is the Watchman procedure. Again, we're talking about percutaneous non-surgical procedures that can affect the structure of the heart. So I'll let the listeners know atrial fibrillation, which is arrhythmia. We've had previous discussions about this in podcasts and elsewhere, very common as we get older leads to a fast heart rate and leads to an increased stroke risk.

Dr. Jonathan Fialkow:

This little pocket off the upper part of the heart, where blood clots can form an atrial fibrillation called left atrial appendage. And previously all we could offer people were very intense anticoagulations, which still work. The majority of people still benefit from that but there are people that can bleed. There are people that can have the contraindications, can't handle the anticoagulation. So rather than just say, "Good luck, hope you don't have a stroke." Talk about the Watchman and where that's coming into play.

Dr. Ramon Quesada:

This is another field that really we were lucky enough that we were really at the very beginning. We have participated in the Institute and all the trials from the first trial that was called [inaudible 00:17:41]. So we have this is structured that John is talking about. It's called left atrial appendage. 90% of the strokes induced by clot formation and atrial fibrillation come from this structure. And the reason to anticogulate patient is to prevent the formation of clots and this left atrial appendage. But what happened if we just close it, isolate it? You can do it two ways. You can open the chest and cut it, or you can isolate it, putting a device that will seal the appendage. We did four randomized trials trying to prove that these little basket called Watchman number one, has prevent the complications of atrial fibrillation which is a stroke or is equal to anticoagulation or superior.

Dr. Ramon Quesada:

The story is that we prove that closing the left atrial appendage with a Watchman device, which is a totally percutaneous approach at the... When we started we didn't know what the appendage was to be honest with you. We thought it was a little bag. And we learned that through imaging, that each appendage is different for every patients. We know that depending on the morphology of the appendage, you may have a higher risk of having strokes than with other morphology or appendage. We learned all the stuff through the years of studying this, but this is the thing that we do know. Number one, if you close the appendage, you reduce the chances of having complications of oral anticoagulation by 98% and what is the worst complication? Bleeding into the brain. That's number one. Number two, you reduce the chances of having a stroke compared to oral anticoagulation by trauma by 30%.

Dr. Ramon Quesada:

The most important problem is that patients who are in oral anticoagulation, they do not tolerate for a long time. The older the patients, the less they can have oral anticoagulation for long periods of time. And when they become more susceptible to have strokes from clots is when they stop taking the oral anticoagulation. And fourth, the complications of anticoagulation was [inaudible 00:19:53]. So the drawback of using a device to prevent this is because it's a procedure. You have to go through the heart. You have to put a device in their heart. That by itself carries a risk of complications which today is very, very low. The complication [inaudible 00:20:17] risk of heart perforations is less than one percent. Embolization is almost zero percent.

Dr. Jonathan Fialkow:

It is, but I do want to emphasize surgery. It is a procedure. I mean, that's like, well, why doesn't everyone get this?

Dr. Ramon Quesada:

That's the thing. [crosstalk 00:20:29]. Yes.

Dr. Jonathan Fialkow:

And down the road but it's a procedure versus taking a medication. But again, as you said, it's superior to the medication in a lot of ways, but it's early in its development. So down the road, we may find with either improved techniques that might be a lower threshold to do. But my point is you're talking about TAVR, which is the aortic valve replacement through a catheter procedure, MitraClip, these clips on the valve that pulled them together to decrease the leak for people who have various medical conditions related to that, and the ability to close off this appendage to seal it off so blood clots don't cause stroke. These are your bread and butter stuff.

Dr. Jonathan Fialkow:

Quite frankly, you do this routinely. This is not... No one's writing up these cases in the newspapers because this is what you do. This is what we do at the Miami Cardiac and Vascular Institute. So certainly, people have any of the medical conditions, which might be a candidate to that. It's certainly whether they call it through their primary care doctor, through cardiologist, or they can call through a Miami cardio and vascular surgery structural program or atrial fibrillation. We're bringing these people, these technologies. And again, it's a credit to you and the leadership team. Final point Q, I'm sorry. That's our common call [crosstalk 00:21:38]. Final point so, we know you've been involved with research and we've led a lot of research initiatives. We have innovation, as you talked about doing new techniques and learning from that and bringing it to the broader community. You did mention the unique aspect of Miami Cardiac and Vascular Institute's multidisciplinary approach? Can you just... What differentiates in your mind, Miami Cardiac and Vascular Institute from other cardiac programs in the South Florida?

Dr. Ramon Quesada:

I think that the concept and I'm going to give the credit to the founder, because really that was, Barry Katzen who believe when he founded the Institute, that the dialogue among colleagues is the most important thing is multiple minds think better than one mind and that was the multidisciplinary approach. And if you look at even at the design of the cath labs of the institute, they are open not because they look nice. They open for the same, the only reason that means that our philosophy. We don't hide anything. We are open. Everybody can come and look at it in the most important thing you can ask for help in any moment. And that is, I think the most important aspect of the multidisciplinary approach. You don't have to be afraid of asking. As a matter of fact, we-

Dr. Jonathan Fialkow:

And you mean that and again, that's a brilliant point and that's the doctor we're talking about. I mean, to me, it's okay for a doctor say, "I don't really know, or let me find out or let me ask someone." When the doctor treats the patient with that ego-driven I have all the answers again that's where sometimes people get into trouble. So I do think that's worth emphasizing.

Dr. Ramon Quesada:

And I think that's a change and I think that's the philosophy, even in our own group.

Dr. Jonathan Fialkow:

Yeah, I agree.

Dr. Ramon Quesada:

We have multiple specialties or subspecialties within cardiology in our own group. So you mentioned yourself, you're a Announcer:

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If I have a question with a complex patient, I will ask you immediately. What do you think about it? How do we manage this? We have that opportunity. That's the philosophy of us of Miami [inaudible 00:23:43], Miami Cardiac and vascular Institute and I think that brings it a difference in everything that we do as a multidisciplinary approach for the best of the patient care.

Dr. Jonathan Fialkow:

Well said, Ramon. And again, I just personally, I take such pride and honor, working with you and the team and being able to see and participate in support the incredible, innovative work that you have done. I think your passion and knowledge has come through, and hopefully the listeners can take that away, which is seek options out there for any cardiac conditions. We want to provide the best outcome with the least invasive approach when eligible. Before we sign off listeners, we can really use your help and feedback. Please take a moment to give this podcast a five-star review on whichever platform you listen to us. Listen to some of our older podcasts as well. Email us with comments and suggestions for future topics at Baptist Health Talk at baptisthealth.net. That's Baptist Health Talk at baptisthealth.net. We'd love to hear from you and thanks for listening and until next time stay safe and mask up.