Transforming Valve Therapy from Research to Real-World Application

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[Dr. Daniel Simon] Hello everyone, this is your Science@UH host Dr. Dan Simon. Today I am here with the special guest Dr. Guilherme Attizzani, Co-Director of the Valve and Structural Heart Disease Center and the Alexander and Marianna McAfee Chair in Innovative Cardiac Interventions at University Hospitals Harrington Heart and Vascular Institute.

Welcome, Dr. Attizzani.

[Dr. Guilherme Attizzani] Thank you so much, Dan. It's a pleasure to be here with you today.

[Dr. Daniel Simon] So Guilherme, you know your story of getting to Cleveland and UH is incredibly interesting, and your overall journey in cardiovascular medicine. First of all, tell us a little bit about yourself, how you got to UH as a research fellow and how you ended up doing structural heart disease intervention.

[Dr. Guilherme Attizzani] Yeah, Dan, this is an interesting story. I'm going to try to summarize it very briefly to you, but I did my Interventional Fellowship, I’m Brazilian, as you know and did my interventional Fellowship and finished 2007, and then I met Marco Costa on the hallway of a conference, and I literally came to him and said, Dr. Costa, “I don't know you, you don't know me, I know of you, and I would like to become somebody one day. So, can I come to Cleveland to do research in intravascular imaging?” This was back in 2009. And then I came, stayed here for one year - I was supposed to stay for a year – but I ended up staying for 2 1/2 years. Back then it was when structural heart was becoming like a hot topic in interventional cardiology. And as you know in Europe, the experience was larger because of the FDA regulations and approval. So, they approved all of those devices earlier in Europe, and then I ended up going there. I talked to Marco, to you back then, and I ended up going to Catania, Italy. Spent two years there and came back in 2014. So, it was an excellent opportunity for me because I was exposed to different procedures that a lot of them were not even being done in the United States back then. And the volume in Europe back then was larger. So, I came here with a lot of experience in 2014, everything started back at UH and I'm here for 11 years.

[Dr. Daniel Simon] You know, it's an amazing story and I think it's something that as an interventional cardiologist that I had noticed, just even in the coronary space. So, as you know, regular stents were developed by Palmaz-Schatz and drug eluting stents from Brazil with a variety of people who really drove that technology. And so, it was very clear to us that if you wanted to be successful, you need to go OUS - outside the U.S. So, that was one of the reasons why I recruited Dr. Costa and your story is so reminiscent of Marcos when he told me that he sort of stalked Patrick Seroy at a meeting and convinced him to train with him. And then, you know, as you say, the rest is history and the same for you. So, it's so incredibly inspiring to me to look at you and remember when you came here as a fellow in our imaging center and now lead all of our programs in this space that are in our international authority that we'll get to in just a moment. So, for the audience, maybe you could explain to them what..what is a structural heart disease center do, what kind of procedures and what kind of team is present in those procedures?

[Dr. Guilherme Attizzani] Yeah, that's very important and it's a comprehensive team. There are multiple different healthcare professionals involved in structural heart interventions, and basically what we do, we repair and replace dysfunctional heart valves as well as correct, for example, popular leaks of surgical as well as transcatheter valves. We do PFL closures, ASD, VSD, VSD closures. So, there are multiple different types of procedures. Now, also, we do alcohol septal ablation for hypertrophic cardiomyopathy. So, there are different types of procedures that we perform and the importance of having a multidisciplinary team working together is because there are multiple options that are either transcatheter or surgical options, or sometimes even hybrid options that we can offer to these patients, right? So that's why it is important to have this multidisciplinary team working together. But not only surgeons and interventionalists are part of this, of course, our nursing team is extremely important as well as. For example, other areas such as hypothenar hypertension for detracted patients, heart failure physicians for the tricuspid, as well as mitral regurgitation patients. We have also the EP team that we engaged now for our tricuspid interventions with the complexity of transcatheter replacement and repair of tricuspid, understanding what to do with the pacemaker leads through the tricuspid valve they're going to have to replace. So, it is really the definition of a multidisciplinary team that working together ultimately delivers the best to our patients.

[Dr. Daniel Simon] So you know, Guilherme, I think it's hard for people to imagine and I know that if you had said to me back in 2010 and 11 when we traveled to Portugal to see and do our first TAVR cases where as you would as you mentioned the technology had advanced in Europe quite quickly, it was unimaginable to do a valve replacement in an awake and talking patient without no incisions and no cardio, pulmonary bypass. Never in a million years would I have imagined in medical school that you could replace a valve in an awaked talking patient. Maybe you could walk the listener through what exactly is a TAVR, how is it done, like in in a quick description, and how did this develop? I know Dr. Cribier started this procedure from France, but maybe you could give a little bit of background on how this procedure has now come, become the majority of how we treat aortic stenosis.

[Dr. Guilherme Attizzani] Yeah, this is a fascinating story Dan, because as you said, Alain Cribier developed a balloon expandable valve, and in an adjacent lab, another French physician, Jean-Claude Laborde, which who partnered with an engineer, developed a self-expandable valve. So, there are two different devices, and they developed those valves in 2002 the very first implant was done. And since 2002 to today, it was a really an overwhelming grow of this procedure because the techniques have improved. Of course, the device is also became better and the expansion of the indications came from prohibitive surgical restorations all the way to low surgical restorations. In fact, TAVI today is performed more often than open heart surgery for aortic valve replacement. Most of these procedures are done via transfemoral. And as you said, we pioneered actually at UH back in 2013, 2014, we were doing already TAVI under local anesthesia with sedation, right? And back then we had the anesthesia team in the room. Today, it's a nursing-led sedation. It's a procedure that there is a cardiac surgeon, an interventional cardiologist -transfemoral, minimum sedation, local anesthesia patient - patient gets the valve replaced, takes like one hour, roughly to proceed, one hour and a half and most patients - 95% of our patients go home next day. Most patients do not go to an ICU, they just go to a regular telemetry bed. And it became, it's when you look at the procedure from outside, it seems to be like a simple procedure because we perfected this procedure overtime and indeed then, as you know, right, we have taught more than 800 healthcare providers from all over the world that they come to UH to learn from us - folks from the West, from Latin America, from Asia, from everywhere, to learn from us how to perform this procedure in the most efficient way while the patient is awake and the whole pathway of the procedure, not only the actual procedure, but also what we do in clinics, how do we handle the procedure and the leanest possible way while delivering excellent outcomes. And also, how do we handle the patient post procedure? Where does the patient go to? What are the things that we have to look for? So, we are very proud that UH became a reference, an international reference on optimal practices for TAVR. Yeah, which we too…in addition to that, another important aspect to that - to this conversation is that we do live cases for the most important congresses in the world, very frequently. Just one month ago actually, I did two life cases for Sydney, Australia, another life case for India. Two days in a row, one Thursday and one Friday, and we do a lot of live cases to showcase again, the leadership of University Hospitals in this procedure done that way.

[Dr. Daniel Simon] Well, congratulations to you and your team and I think I remember when we became a center of excellence for Medtronic and we started having hospitals come to the cath lab and they just couldn't believe first of all, that we were doing the procedure in the cath lab and not in the operating room or the hybrid OR, and that the patients were all awake. And so, you and Dr. Costa and many others played a critical role in changing the way that procedures were done in the United States. So, the valve is a stent associated with bioprosthetic material, typically the pericardium of a pig or a cow and these valves work really well, but like any bioprosthetic valve, they have a defined a lifetime and you've been very, very much involved now that we've had patients who've had these valves for more than a decade, tell us a little bit about what is the longevity like. And then of course, what leads to your role now, as the National PI of the RESTORE study for repeat TAVR. So, when the valve runs out, what do we do? So give us a little bit about the longevity performance of the valve and what is RESTORE.

[Dr. Guilherme Attizzani] Yeah, that's very important, Dan. It is fascinating how when you see the whole story of a procedure, how the procedure evolves and how the challenges change, right? In the beginning when we - we brought these patients in for this procedures, we would want to make sure that the patient was gonna leave the room with no paravalvular leak, with no stroke and - and with .. a good echo result. Today the challenges are very different, right? They - we have the challenges now of, as you said, treating these valves when they fail. In terms of the durability, there's no data that indicates that this valves would last less than a surgical valve, so there have been studies now with like 10 years of follow up - we published some meta-analysis two years ago looking at the durability of this, and when we talk to patients, the conversation goes as that the durability is potentially the same as a surgical valve, biological surgical valve and data is showing more and more once patients live longer -we have this data. As you know Dan, in the beginning when we treated those - those very high risk and prohibitive surgical patients obviously, they wouldn't follow these patients for that long because they would die for other reasons and not because of the valve, but today we have good robust data showing that good durability and good valve performance overall. Then to address the failed transcatheter valve with another transcatheter valve, we call it TAVR-in-TAVR, right? That's a very different procedure, it's a very complex procedure, not the procedure itself, but the planning for this procedure. And because of that, because nobody in the world has a large amount of experience with TAVR-in-TAVR down, right? So, we're doing this study in the United States and Canada called RESTORE, in which we're going to include around 400 patients and it's hard to include 400 patients for TAVR-in-TAVR because this is not very common, thankfully, to see failed transcatheter valves as of yet, right? So, we're doing this study to understand, it's a very comprehensive study in terms of the planning, the CT procedural planning. So, we have an idea that, very differently from surgical valves, these valves when implant, it's pretty much very similar to a coronary stent, right? The expansion of the valve not necessarily is going to happen as if you were implanting in a rounded tube, right? So basically, that's going to depend on the interaction of cows and etcetera, right? So, when we do the planning for a TAVR-in-TAVR, we have to take all of these factors into account. We have to measure in different levels because in different levels of the failed valve, you may need to implant a different size valve, so you have to be precise in your measurement, in the landing zone, so it's a very, very complex procedure that I'm proud to be the PI, the national PI of this study that we're going to learn very much from. We have started already, we have treated 4 patients. We just started the study, and I'm very excited about it. It's really going to be a very important learning process for everyone in the world, the results of RESTORE.

[Dr. Daniel Simon] Well, I can't tell you how proud we are of you, Guilherme. To think that you came here as a bright eyed and bushy tailed fellow and now you're a chaired professor and the National PI of a national trial, it’s just, I mean it just warms our hearts and we're so lucky to have you and your team. Before we conclude, maybe you could just run us through a little bit of this early, I think last week I got a beautiful picture from your group of a totally implanted valve in the tricuspid position, and obviously you've now moved from the aortic valve to the mitral valve and now we're in this tricuspid space. Tell us a little bit about the future and how you think you're going to be managing all these valves going forward?

[Dr. Guilherme Attizzani] Yeah, that's really fascinating Dan. Before I go on there, I would like to really express my gratitude to you and how much you and others Alan Markovitz, and other friends and now Mehdi as the President of the Institute, so you all supported my career tremendously, so I'm very grateful to you. Really, truly appreciate you all.

Then going back to the interventions, Dan. It's really fascinating what we can do percutaneously today, right? So, in the mitral space, we can do as you know, mitral clips with very complex valves, but also there are other two other clinical trials that we have that they are replacing mitral valves and there are two different valves that they actually complement each other. So, it's fascinating how we can do percutaneously and full replacement of the mitral valve, Dan, in the tricuspid space, which is a very different space in terms of the imaging, in terms of the multidisciplinary team that is involved, and my colleague and coworker, Dr. Ukaigwe, Anene Ukaigwe, is leading the our tricuspid intervention. So, she and I are performing these procedures and basically there are three procedures that we can do. One of them is a triclip, which is similar to the mitral clip, so we put a clip in the tricuspid valve and that's an FDA approved procedure. As well as the full replacement with the EVOQUE valve, which is a full replacement of the tricuspid valve. It's a very intuitive procedure, very much imaging driven, but it's a very beautiful procedure that you end up with zero TR in most of the patients. And we also have a clinical trial with a different valve with Medtronic, which is called the intrepid valve there; it's Apollo, it's the same valve, there is in mitral position, but using tricuspid. And we are about to start another trial with a different device and tricuspid. So, there are multiple different devices, and I think the due to our leadership on the field we are, we have all of these different devices to offer to our patients and basically able to treat most of the patients that need either mitral or tricuspid intervention. And I would like to also add then to the fact that our last appendage group, we just did our 1000 left atrium appendage closure, and we do all of these cases under local anesthesia also and ice guided. So, these patients are – are on ice, meaning intracardiac ECHO guided, so these patients are awake and I'm very proud of our team, led by Steve Philby, the LAO closures. I'm very proud that we have been leaders in the United States on how to do left atrial appendage closure with the awake patient similar session that we used to do TAVR, or we that we do TAVI patients, I should say.

[Dr. Daniel Simon] Well, you know Guilherme, it's just amazing to think that these technologies have developed allowing us to treat patients who are older, right? So, these tend to be much older patients, and they dramatically improve quality of life and duration of life, especially in severe aortic stenosis. And yet, they save lives, and they also save healthcare expense which is amazing. So, it really hits our goal, which is to treat patients with greater value, better outcomes, even at a lower cost. It's so great to be with you. I'm always just, I always learn so much from you and I'm so proud of you.

So, thank you all for listening today. To learn more about research at University Hospitals, please visit Uhhospitals.org/UHresearch.

Thank you, Guilherme.

[Dr. Guilherme Attizzani] Thank you very much, Dan, for the opportunity.

The Science@UH Podcast (the Podcast) is intended for informational and educational purposes only. It should not be used as a replacement for medical advice. The statements about devices, drugs, software, or other products may not have been reviewed by the Food and Drug Administration (FDA). The effectiveness of these products may not have been verified by FDA-approved studies. These products are not designed to diagnose, treat, cure, or prevent any disease. University Hospitals (UH) or a guest on the Podcast may have ownership of licensed intellectual property of this research study. As such, UH or a guest could receive financial gain from the outcomes of this research.