Treating Tricuspid Regurgitation with Transcatheter Tricuspid Heart Valve Procedures
Laura J. Davidson, MD, MS describes the seriousness of tricuspid regurgitation and how the treatment option of transcatheter tricuspid valve replacement and repair, currently being evaluated via clinical trials, may revolutionize the care of these patients. She shares the evolution of this therapy, the indications for and how patients are evaluated for transcatheter tricuspid valve procedures.
Featured Speaker:
Learn more about Laura J. Davidson, MD, MS
Laura Davidson, MD
Laura J. Davidson, MD, MS: interventional cardiologist at Northwestern Memorial Hospital and assistant professor of medicine (cardiology) at Northwestern University Feinberg School of Medicine.Learn more about Laura J. Davidson, MD, MS
Transcription:
Treating Tricuspid Regurgitation with Transcatheter Tricuspid Heart Valve Procedures
Melanie: Welcome to Better Edge, a Northwestern Medicine Podcast for Physicians. I'm Melanie Cole. And today we're examining treating tricuspid regurgitation with transcatheter tricuspid heart valve procedures. Joining me is Dr. Laura Davidson. She's an Interventional Cardiologist at Northwestern Memorial Hospital and an Assistant Professor of Medicine and Cardiology at Northwestern University Feinberg School of Medicine. Dr. Davidson, I'm so glad to have you join us today. Tell us a little bit about the seriousness of tricuspid regurgitation and what have you been seeing with patients?
Dr Laura Davidson: Thank you so much for having me today. Tricuspid regurgitation is a really big problem that's unfortunately somewhat under-recognized in the medical community. It's associated with very serious morbidity and mortality. And we know that a lot of patients, because they're being undertreated, really are suffering from this disease a lot. Most patients at this point in time, are being treated just with medical therapy alone. They're being treated with diuretics and that might make them feel better, but ultimately isn't a solution to the long-term problem. Prior to transcatheter therapies, the only options that were out there for these patients were surgical options. And while these do work, in some patients, the surgical transcatheter tricuspid valve repair and replacement can be a high-risk operation with serious morbidity and mortality in and of itself. And often does not result in great outcomes. And so these new therapies that we have available that are undergoing clinical trials right now could be really revolutionary for our patients. And so far, we've seen a lot of positive results from them.
Melanie: How interesting. Well thank you for telling us that. So tell us a little bit how they've been evolving over the years. You said, that there's been a big shift. Tell us what that shift is. What have you seen?
Dr Laura Davidson: Well there are multiple different types of transcatheter tricuspid valve therapies that are being evaluated right now. Some of those are repairs and some of those are replacements, and we've seen the technology changing over time and evolving in a way that's positive for our patients. So just to back up about those types of therapies, the transcatheter tricuspid valve repairs, there's a number of different types. Some of them involve using coaptation devices to bring the tricuspid valve leaflets closer together and decrease the regurgitant orifice area. But there's also annular reduction techniques which will mimic a lot of the surgical techniques in that they will use a band or a ring to actually decrease the size of the regurgitant area.
And while we often prefer to use a tricuspid valve repair techniques, if we can, there are also replacement devices that are becoming available in clinical trials. And these are really important for our patients because sometimes patient's anulus are so big that they really cannot undergo repair. And this is an opportunity for transcatheter tricuspid valve replacement. And we've been evaluating those in clinical trials and that's sort of an evolution of where things are and we expect it to evolve even further over the next several years.
Melanie: Well then briefly describe for us the clinical indications for this type of valve replacement or repair.
Dr Laura Davidson: We are evaluating patients who have severe tricuspid regurgitation that is refractory to medical therapy and are symptomatic from that. There is a number of different criteria that patients need to meet in order to enroll in the clinical trials that are available right now. But right now we are treating people with symptomatic, severe tricuspid regurgitation, and finding that can be very positive for them.
Melanie: At Northwestern, how were patients evaluated? Tell us a little bit about patient selection and who could benefit from this type of procedure.
Dr Laura Davidson: At Northwestern, we have a really wonderful heart team and, the heart team consists of a very big multidisciplinary effort, including myself with interventional cardiology and my other interventional cardiologist colleagues, people that are congestive heart failure specialists, cardiac surgeons and advanced imaging physicians. And together we all meet and discuss each of our patients who are referred for transcatheter tricuspid valve repair or replacement. And what we'll do is we'll discuss their clinical history. We'll discuss their imaging, which often includes transesophageal echoes, transthoracic echoes and CT scans. And we will discuss all of these things together and decide, come to a consensus about what is the best way to treat this patient. We will look at all the different clinical trials that we have available and see what they may qualify for. And of course, most importantly, taking into account what the preferences of our patients are, to decide what clinical trial might be best for them.
We like to see these patients early in clinic and early in the course of their disease course so that we are able to capitalize on a moment that is good for them to undergo these therapies and pick the right therapy for them when we have a lot more options, which may not be options as they progress throughout this very devastating disease course.
Melanie: Well, then tell us a little bit about some of the various transcatheter repair techniques available. And do you have any technical considerations you'd like other providers to know about?
Dr Laura Davidson: So right now we have a number of different repair techniques. And, we also have some replacement techniques that we're evaluating. So first of all, there are, of course the surgical option, which is the traditional way of doing this and is still available to patients. But again can be very high risk for patients. And that's why we often are forced to look at these transcatheter options, which may be better options for patients. From a repair standpoint, we do have coaptation devices, which will work to take the leaflets together of the tricuspid valve and decrease the orifice area. We have annular reduction techniques as well, which will use a ring to decrease the orifice area, or other similar devices like that.
Or we have some replacements as well. Sometimes patient's annulas become so big that they really cannot undergo repair techniques. And another issue with repair techniques is at least for some of the trials, you're unable to undergo a repair technique if you have a prior pacemaker. And so in that case, thinking about things like a replacement might be a better option for some patients.
I should say that a lot of our patients who have severe tricuspid regurgitation, may have it because they have a history of a pacemaker being placed. And that's something that really needs to be taken into account as to how we're going to manage that person's pacemaker while they're undergoing these transcatheter techniques.
Melanie: Dr. Davidson, tell us about some of the clinical trials that are going on at Northwestern Medicine. Which ones are you most excited about?
Dr Laura Davidson: It's really hard to choose, honestly. We have a number of different clinical trials that people are enrolling in right now. And I'm honestly excited about all of them, because I think that there's not one clinical trial that we're going to be able to say, this is the device that's right for everybody. The tricuspid valve has a very complex anatomy. It has three leaflets rather than the two leaflets that the mitral valve has. And that makes for more complex decision-making as to how to best decrease the amount of tricuspid regurgitation. For a patient who let's say has carcinoid disease or something that causes a really, really large annulus or some sort of primary RV dysfunction; that person may benefit more from a transcatheter tricuspid valve replacement. However, somebody who has a flail leaflet or something, that is more of a structural problem with the valve, that's not necessarily so much to do with annular dilatation; these patients might benefit more from transcatheter tricuspid valve repair. And so I think it's hard to say that I'm excited about just one of them, because they're all really important devices and all of them need to be really individualized to the patient.
Melanie: Well then tell us a little bit, as we're getting ready to wrap up, in the next year, how do you see these clinical trials changing and why should referring physicians consider Northwestern Medicine for their transcatheter tricuspid valve replacement or repair?
That's a great
Dr Laura Davidson: question. So a lot of these trials, several of them recently have published data on their early feasibility studies. And so these were some of the very first procedures that were done in patients. And now we're moving into an era where we're enrolling patients more in pivotal trials. And so this is really exciting because, it means that we're moving forward, with these therapies and getting more and more patients enrolled, and hopefully with us to even be able to provide these outside of clinical trials in the future.
At Northwestern, we are the most experienced center in the state in transcatheter tricuspid valve repair and replacement. We are also amongst the most experienced in the nation because we've been doing a lot of these trials, along with some other big centers in the United States. And that we've been some of the first ones to adopt some of these trials.
And so I would say that patients should consider coming to Northwestern because we do have a lot of experience with these trials that are still in their early stages, but we have been there since the beginning and can offer them a lot of different options. And as they evolve, we'll have more options come available at Northwestern.
Melanie: Thank you so much Dr. Davidson for joining us today. What an interesting procedure you were discussing today, and to refer your patient, please visit our website@heart.nm.org to get connected with one of our providers. That concludes this episode of Better Edge, a Northwestern Medicine Podcast for Physicians. Please remember to subscribe, rate and review this podcast and all the other Northwestern Medicine podcasts. I'm Melanie Cole.
Treating Tricuspid Regurgitation with Transcatheter Tricuspid Heart Valve Procedures
Melanie: Welcome to Better Edge, a Northwestern Medicine Podcast for Physicians. I'm Melanie Cole. And today we're examining treating tricuspid regurgitation with transcatheter tricuspid heart valve procedures. Joining me is Dr. Laura Davidson. She's an Interventional Cardiologist at Northwestern Memorial Hospital and an Assistant Professor of Medicine and Cardiology at Northwestern University Feinberg School of Medicine. Dr. Davidson, I'm so glad to have you join us today. Tell us a little bit about the seriousness of tricuspid regurgitation and what have you been seeing with patients?
Dr Laura Davidson: Thank you so much for having me today. Tricuspid regurgitation is a really big problem that's unfortunately somewhat under-recognized in the medical community. It's associated with very serious morbidity and mortality. And we know that a lot of patients, because they're being undertreated, really are suffering from this disease a lot. Most patients at this point in time, are being treated just with medical therapy alone. They're being treated with diuretics and that might make them feel better, but ultimately isn't a solution to the long-term problem. Prior to transcatheter therapies, the only options that were out there for these patients were surgical options. And while these do work, in some patients, the surgical transcatheter tricuspid valve repair and replacement can be a high-risk operation with serious morbidity and mortality in and of itself. And often does not result in great outcomes. And so these new therapies that we have available that are undergoing clinical trials right now could be really revolutionary for our patients. And so far, we've seen a lot of positive results from them.
Melanie: How interesting. Well thank you for telling us that. So tell us a little bit how they've been evolving over the years. You said, that there's been a big shift. Tell us what that shift is. What have you seen?
Dr Laura Davidson: Well there are multiple different types of transcatheter tricuspid valve therapies that are being evaluated right now. Some of those are repairs and some of those are replacements, and we've seen the technology changing over time and evolving in a way that's positive for our patients. So just to back up about those types of therapies, the transcatheter tricuspid valve repairs, there's a number of different types. Some of them involve using coaptation devices to bring the tricuspid valve leaflets closer together and decrease the regurgitant orifice area. But there's also annular reduction techniques which will mimic a lot of the surgical techniques in that they will use a band or a ring to actually decrease the size of the regurgitant area.
And while we often prefer to use a tricuspid valve repair techniques, if we can, there are also replacement devices that are becoming available in clinical trials. And these are really important for our patients because sometimes patient's anulus are so big that they really cannot undergo repair. And this is an opportunity for transcatheter tricuspid valve replacement. And we've been evaluating those in clinical trials and that's sort of an evolution of where things are and we expect it to evolve even further over the next several years.
Melanie: Well then briefly describe for us the clinical indications for this type of valve replacement or repair.
Dr Laura Davidson: We are evaluating patients who have severe tricuspid regurgitation that is refractory to medical therapy and are symptomatic from that. There is a number of different criteria that patients need to meet in order to enroll in the clinical trials that are available right now. But right now we are treating people with symptomatic, severe tricuspid regurgitation, and finding that can be very positive for them.
Melanie: At Northwestern, how were patients evaluated? Tell us a little bit about patient selection and who could benefit from this type of procedure.
Dr Laura Davidson: At Northwestern, we have a really wonderful heart team and, the heart team consists of a very big multidisciplinary effort, including myself with interventional cardiology and my other interventional cardiologist colleagues, people that are congestive heart failure specialists, cardiac surgeons and advanced imaging physicians. And together we all meet and discuss each of our patients who are referred for transcatheter tricuspid valve repair or replacement. And what we'll do is we'll discuss their clinical history. We'll discuss their imaging, which often includes transesophageal echoes, transthoracic echoes and CT scans. And we will discuss all of these things together and decide, come to a consensus about what is the best way to treat this patient. We will look at all the different clinical trials that we have available and see what they may qualify for. And of course, most importantly, taking into account what the preferences of our patients are, to decide what clinical trial might be best for them.
We like to see these patients early in clinic and early in the course of their disease course so that we are able to capitalize on a moment that is good for them to undergo these therapies and pick the right therapy for them when we have a lot more options, which may not be options as they progress throughout this very devastating disease course.
Melanie: Well, then tell us a little bit about some of the various transcatheter repair techniques available. And do you have any technical considerations you'd like other providers to know about?
Dr Laura Davidson: So right now we have a number of different repair techniques. And, we also have some replacement techniques that we're evaluating. So first of all, there are, of course the surgical option, which is the traditional way of doing this and is still available to patients. But again can be very high risk for patients. And that's why we often are forced to look at these transcatheter options, which may be better options for patients. From a repair standpoint, we do have coaptation devices, which will work to take the leaflets together of the tricuspid valve and decrease the orifice area. We have annular reduction techniques as well, which will use a ring to decrease the orifice area, or other similar devices like that.
Or we have some replacements as well. Sometimes patient's annulas become so big that they really cannot undergo repair techniques. And another issue with repair techniques is at least for some of the trials, you're unable to undergo a repair technique if you have a prior pacemaker. And so in that case, thinking about things like a replacement might be a better option for some patients.
I should say that a lot of our patients who have severe tricuspid regurgitation, may have it because they have a history of a pacemaker being placed. And that's something that really needs to be taken into account as to how we're going to manage that person's pacemaker while they're undergoing these transcatheter techniques.
Melanie: Dr. Davidson, tell us about some of the clinical trials that are going on at Northwestern Medicine. Which ones are you most excited about?
Dr Laura Davidson: It's really hard to choose, honestly. We have a number of different clinical trials that people are enrolling in right now. And I'm honestly excited about all of them, because I think that there's not one clinical trial that we're going to be able to say, this is the device that's right for everybody. The tricuspid valve has a very complex anatomy. It has three leaflets rather than the two leaflets that the mitral valve has. And that makes for more complex decision-making as to how to best decrease the amount of tricuspid regurgitation. For a patient who let's say has carcinoid disease or something that causes a really, really large annulus or some sort of primary RV dysfunction; that person may benefit more from a transcatheter tricuspid valve replacement. However, somebody who has a flail leaflet or something, that is more of a structural problem with the valve, that's not necessarily so much to do with annular dilatation; these patients might benefit more from transcatheter tricuspid valve repair. And so I think it's hard to say that I'm excited about just one of them, because they're all really important devices and all of them need to be really individualized to the patient.
Melanie: Well then tell us a little bit, as we're getting ready to wrap up, in the next year, how do you see these clinical trials changing and why should referring physicians consider Northwestern Medicine for their transcatheter tricuspid valve replacement or repair?
That's a great
Dr Laura Davidson: question. So a lot of these trials, several of them recently have published data on their early feasibility studies. And so these were some of the very first procedures that were done in patients. And now we're moving into an era where we're enrolling patients more in pivotal trials. And so this is really exciting because, it means that we're moving forward, with these therapies and getting more and more patients enrolled, and hopefully with us to even be able to provide these outside of clinical trials in the future.
At Northwestern, we are the most experienced center in the state in transcatheter tricuspid valve repair and replacement. We are also amongst the most experienced in the nation because we've been doing a lot of these trials, along with some other big centers in the United States. And that we've been some of the first ones to adopt some of these trials.
And so I would say that patients should consider coming to Northwestern because we do have a lot of experience with these trials that are still in their early stages, but we have been there since the beginning and can offer them a lot of different options. And as they evolve, we'll have more options come available at Northwestern.
Melanie: Thank you so much Dr. Davidson for joining us today. What an interesting procedure you were discussing today, and to refer your patient, please visit our website@heart.nm.org to get connected with one of our providers. That concludes this episode of Better Edge, a Northwestern Medicine Podcast for Physicians. Please remember to subscribe, rate and review this podcast and all the other Northwestern Medicine podcasts. I'm Melanie Cole.