Hi, everyone. My name is Joan Michaels. I'm the director of the Impact Registry here at the ACC. And it is my great pleasure to introduce our next speaker. Joanne Chisholm and I have been friends since 2008 when the registry began, and she has continued to be my go-to resource over the years for all things congenital heart. So it is my great pleasure to introduce Joanne, who is the director of interventional cardiology and clinical research studies at the Heart Center of Nationwide Children's Hospital from Columbus, Ohio. So I'd like to introduce Joanne Chisholm, who's a master's prepared nurse, talk to us today about pulmonary valve. Thank you, Joanne. Thanks, Joanne. I'd like to thank all of the organizers for the invitation to speak today. I've always enjoyed this meeting over the years, and I've always gotten to take something away every single time that has been helpful to our quality program at Nationwide Children's Hospital. Just as a little housekeeping, I do not have anything to disclose relating to this talk. And we'll go ahead and get started talking about the pulmonary valve and what are some relatively new things in our toolbox to fix the pulmonary valve. This is a video of a human pulmonary valve. You can see the tri-leaflet configuration here, and also the really graceful motion of those leaflets and how absolutely thin they are. And we're going to spend the next probably half hour or so talking about what we can do to fix the pulmonary valve and look at defects involving that pulmonary valve and the relatively new treatments available to us in the cardiac cath lab for treating the pulmonary valve. So by far the most frequent congenital heart defect involving the pulmonary valve is tetralogy of fallot with either pulmonary stenosis or pulmonary atresia. In addition to patients with tetralogy of fallot, we also see patients with truncus arteriosus and transposition of great arteries. And those defects also affect both the pulmonary valve and the right ventricular outflow tract. I've also added aortic stenosis to this list, and you may think that I'm a little crazy thinking what does aortic stenosis have to do with the pulmonary valve. But if you were a patient with aortic stenosis who's had a ROS procedure, the pulmonary, the native pulmonary valve was used to treat your aortic stenosis, which then leaves you with a defect that now involves your pulmonary valve. So out of the right ventricular outflow tract anomalies that we're going to talk about, it's important to understand that those anomalies account for about 22% of all congenital heart disease patients, the patients with tetralogy of fallot, all the way through those with the ROS procedure and some other defects we don't see quite as often. And we're going to talk about the surgical correction for those different defects. And first off, we'll look at the patients with tetralogy of fallot and pulmonary stenosis. That accounts for about 77% of patients with those congenital anomalies. And then the patients with truncus and transposition and pulmonary atresia account for the other 23%. And looking at those, what's important is how they're treated. And those patients are typically treated with an RV to PA conduit. And we're going to start with talking about that particular repair and what we can do later on in the cardiac cath lab. So an RV to PA conduit is a surgically placed connection between the right ventricle and the pulmonary artery. And they come in several different varieties. There is a homograft, which uses human tissue and human valves, a xenograft, which is also a tissue valve, but it's from another species. Typically we see porcine and bovine tissue used. And then bioprosthetic valves. And bioprosthetic valves are also tissue valves, but they're suspended in a metal frame that gives that valve some support and also gives the surgeon the place to sew it into place. None of these were ever meant as a forever solution to anomalies of the right ventricular outflow tract. And virtually all patients who have had these repairs require some type of a future procedure to replace that conduit. Here's pictures of what we're talking about in the upper left. Those are homografts. The one on the left is a pulmonary homograft. So that is human pulmonary valve and mean pulmonary artery tissue. The one on the right is an aortic homograft, which is using the aortic valve and the tissue from the aortic arch. In the bottom picture, we have an example of a xenograft. These are conduits that are a cloth tube that has either a porcine or bovine, this I believe is a porcine valve that's suspended inside that tube that has a metal ring as support. And then the one on the upper right is a bioprosthetic valve. And again, that's a tissue valve that is suspended in that frame. And the fabric, if you will, around that provides the surgeons the opportunity to sew that into place. So as we've talked about already, we expect that eventually all of these RV to PA conduits will have dysfunction and will not operate the way that we intended as a new repair. And what we've seen in clinical use is that we see these conduits last. In some patients we've had that have come in have had their conduit for over 20 years. We've had other patients that have had their conduit for less than a year. So it's variable depending on the patient, but it is something that we expect will happen at some point during the patient's life. So prior to a transcatheter pulmonary valve or TPV option, the options for these patients were either a reoperation, so back to the operating room, another open heart surgery procedure to remove that conduit and replace it with a new one. The second option would be for a patient whose conduit was stenotic or was narrowed, is that you could do a balloon angioplasty procedure. You could take a balloon guided with a wire across the area, inflate the balloon and do an angioplasty procedure, but the results in that procedure in this particular population were not that great. The other thing you could do if you had a patient with a stenotic or a narrowed conduit is that you could implant a bare metal stent. Implantation of a bare metal stent is really good for taking care of stenosis. However, then you trade stenosis for regurgitation. So while the patient was no longer, no longer had a stenotic pulmonary valve, they now have a regurgitant pulmonary valve. So none of the three options from a patient standpoint is probably something they'd like to choose. So what we're going to talk about are the transcatheter valve options that we can offer patients now instead of a reoperation or an interventional cardiology procedure in the lab that we know is not going to be terribly successful. So in looking at the pre-procedure workup for these patients, it's very much the same as for any other interventional cardiology procedure, whether it be an angioplasty procedure or a valvuloplasty procedure, or even another surgical procedure to replace their conduit. You look very closely at medical and surgical history, particularly looking at surgical procedures related to the right ventricular outflow tract, because that's what's going to tell us what their options are as far as the treatment at this point. Cardiovascular imaging studies are very important. An echocardiogram is going to tell you to what degree their conduit, their current conduit is dysfunctional. It's going to also give you an idea of overall heart function. We've now added cardiac MRI to our toolbox over the last number of years, which is quickly becoming the gold standard for looking at cardiac function and those types of things. We can see how well the heart is functioning, and we can also get a pretty good indication of what the valve and the outflow tract look like. When we're looking at indications for transcatheter pulmonary valve replacement in patients who have an RV to PA conduit that is dysfunctional or a surgically placed bioprosthetic pulmonary valve, so if you want to think about that as maybe the shortest RV to PA conduit ever, what we're looking for is more than moderate valvular regurgitation and or a mean gradient across the right ventricular outflow tract of 35 millimeters of mercury or more. That would tell you if the patient met those parameters and they have an RV to PA conduit that they would be indicated to have that replaced in the cath lab with a transcatheter pulmonary valve. Right now, the transcatheter pulmonary valve options in the United States, there are some other options being developed outside of the United States, would be either the medtronic Melody valve. The Melody valve has been around for a long time, we have a lot of experience with it, and also the Edwards Life Sciences Sapien 3 valve, which is in the last couple of years gotten an indication for transcatheter pulmonary valve as well. These are the two valves that would be available to the interventional cardiologist to treat these patients. We'll talk about the Melody valve first. The Melody valve is a bovine jugular venous valve segment. So what that means is that it's a segment of the jugular vein of a cow that includes a valve and that segment is prepared and thinned down and then it's placed inside a platinum iridium stent. So the stent looks like any other bare metal stent. This venous valve segment is sewn inside and then it is a balloon expandable set stent. So it's placed like any other stent and the diameter of the valve is dependent on the size of the delivery system you use. And there are three delivery systems available for this valve, an 18 millimeter, a 20 millimeter and a 22 millimeter. And the valve itself comes in two sizes, a 16 millimeter and an 18 millimeter. So the smaller of the two can be expanded up to 20 millimeters and then the 18 millimeter valve can be expanded upwards to 22 millimeters. So this is a picture of the Melody valve on top. You can see the struts of the stent and you can, if you look very closely, you can see the tiny little stitches that show that it was actually sewn into that stent. And then the bottom picture shows you the tri-leaflet configuration of this valve. And doesn't look like the video is going to play, but if it were going to play, what you would find is the Melody valve looks very, very much like the video that we saw at the beginning of the talk of the human pulmonary valve. The leaflets are very, very thin and very graceful and mobile. Yep, there you go. Now it's going to work. So you can see, I was pretty amazed when I saw this for the first time that it looks very, very much like a native human valve. The Sapien 3 transcatheter heart valve is also made with a stent type configuration. It's made out of stainless steel and cobalt chromium as part of the frame to that valve. And the valve within is a manufactured valve made out of bovine pericardial tissue. It is also balloon expandable, and it is available in four sizes from 20 millimeters through 23, 26, and then 29 millimeters. This is what the Sapien 3 valve looks like. You can see that the stent itself is a lot shorter than the stent from the Melody valve. When you look on FOSS, you can see the tri-leaflet configuration, and then the picture on the right shows you, again, that it is balloon expandable, and it shows you what the device looks like on the balloon catheter. So this is the implant procedure of the Melody valve. The Sapien valve delivers much the same way. The catheter comes up through the IVC into the right atrium, through the tricuspid valve, and then is positioned over a wire into the right ventricular outflow tract. You can see the balloon expand. You can see the little bit of stenosis that was there push away to the side. And then once the valve is in place, the balloon is deflated and then removed from the body. Here's some three separate x-rays of an implant procedure of the Sapien 3 valve. The image on the far left shows you the wire that goes out into the lung fields that is providing the security for the balloon catheter. This particular Sapien valve was being implanted into a bioprosthetic valve, so if you look really closely, you can see that metal framework that the original valve was suspended in. The middle panel shows us the balloon beginning to be expanded and how the stent is beginning to expand across that area into the bioprosthetic valve. And then the third panel shows us the complete inflation of the balloon that expands that Sapien 3 to fully expand into the bioprosthetic valve and provide the patient with a brand new valve. So this is our slide again that we looked at with our VOT anomalies, and we've spent the last little bit talking about the defects that end up with an RV to conduit repair. We're going to spend the next few minutes talking about the 77% of the patients that don't have an RV to PA conduit. So we've spent our time talking about 23% of those patients. Now we're going to kind of switch gears and talk about the rest. For a native right ventricular outflow tract transcatheter pulmonary valve, and by native we mean that the tissue in that RVOT is the patient's own, not a conduit, the surgical procedures for correction in the right ventricular outflow tract in congenital heart disease are variable with regards to both technique and anatomy. And because of that, it makes the design of a perfect transcatheter pulmonary valve in this population very challenging. And this is actually why the transcatheter pulmonary valve was developed first in patients who have RV to PA conduits, because that was a much more predictable anatomy and low-hanging fruit, if you will. So the focus was started with patients who have the RV to PA conduit, and then moved on into the more challenging arena of a patient with a native outflow tract. So this slide is going to kind of give you a good idea. This comes from Dr. Philip Bonhoeffer's team at Great Ormond Street in London, when they were first starting to develop a native outflow tract transcatheter pulmonary valve. And this was when 3D printing from a CT data set was becoming a lot more frequently seen in healthcare. And this tells you exactly why this was so challenging. These are actual 3D prints of individual patients and their right ventricular outflow tract out into their branch pulmonary arteries that was done from a 3D rendered CT scan. And when you look at this in all of the different configurations, to come up with a device that would treat all of these people and give them a new pulmonary valve was indeed quite challenging. The pre-procedure workup for these patients is very similar to the workup for patients who had had an RV conduit and were looking for a transcatheter solution to replacing that conduit. Again, very, very important to look at surgical procedures related to the right ventricular outflow tract and to indeed know that the patient did not have an RV to PA conduit because the RV to PA conduit is not amenable to the devices that were developed for the native outflow tract. And the cardiovascular imaging studies are the same with an echo and a cardiac MRI, but we add to that a CT scan that is used in doing the assessments necessary to determine whether the patient's outflow tract is indeed amenable to the available transcatheter valves today. So indications for transcatheter pulmonary valve in this population are severe pulmonary regurgitation. It's determined by either echo or cardiac MRI in a patient who has either a native outflow tract or a surgically repaired right ventricular outflow tract, and also in a patient who has a clear clinical indication for pulmonary valve replacement. So if you have a patient that meets these criterias and a surgeon would take them to the operating room to replace their pulmonary valve, then they actually are a candidate for evaluation for a transcatheter pulmonary valve. The options for transcatheter pulmonary valve in a native right ventricular outflow tract today would be the Melody Harmony valve, which was FDA approved earlier this year, and not available to us quite yet, but the Edwards Altera Adaptive Pre-Stent with a Sapien 3, the data for that particular device has been submitted to the FDA and we're anticipating approval of that device hopefully soon. The Harmony valve is an AOA treated porcine pericardial tissue valve. So unlike the Melody valve, which is a naturally occurring valve, this is a manufactured valve using porcine pericardial tissue. It has a nitinol wire frame with a knitted PET cloth covering and is available in two sizes, a 22 and a 25. What's important to notice here is that while the Melody valve and the Sapien valve are suspended within a very rigid metal frame, the Harmony valve is a nitinol frame. So that makes this device a self-expanding device rather than a balloon expandable device. So the device on the left is the TPV22, the device on the right is the TPV25. What we found throughout the clinical studies is by far the TPV25 is used more frequently than the 22, but having the two sizes gives options for more patients and the delivery system is shown on the far right of the panel. So here we have an implant of a Harmony valve. This first panel that we have is showing an angiogram with the catheter across the pulmonary valve into the main pulmonary artery and is showing the severe regurgitation of the valve. The second panel, if you have to look very closely because nitinol doesn't show up very well on x-rays, but what is happening here is that the Harmony valve is being deployed across that pulmonary valve into that position. And once it is fully deployed, it pops into its original shape because of being made with the NITINOL frame. And then this last panel is showing us a right ventricular angiogram after placement of the device. The Altera Adaptive Pre-Stent is very similar in that the frame is self-expanding NITINOL and it is covered with a PTFE fabric. The difference between the Altera Adaptive Pre-Stent and the Harmony Valve is that the Pre-Stent basically makes a landing zone and it creates that landing zone within the right ventricular outflow tract for a 29 millimeter SAPIEN3 transcatheter heart valve. The SAPIEN3 is the same device that we can place in an RV to PA conduit. So we have a lot of experience with the valve itself. The Adaptive Pre-Stent just provides a landing zone and kind of takes up the real estate within the right ventricular outflow tract to provide a nice secure place for that valve to land. The clinical study of the Altera device is complete and we're waiting for FDA approval at this time to make it commercially available for patients. This is a picture of the 3D rendered images of a right ventricular outflow trap. The top images have the Altera Pre-Stent interposed on it and the bottom images show us that the 3D printed models from the three-dimensional rendered CT are extremely helpful in preparing for patient procedures. You can see the Altera device within the patient's anatomy. You can see where it's going to fit. You're gonna see how it relates to the branch pulmonary arteries and gives the physicians a good idea of what that procedure is going to look like and whether or not the patient is a good candidate for the device because they can actually place that device within a real size model of the patient's own vasculature. This is a panel of an Altera implant that shows us the top two panels are the angiograms that demonstrate that the patient indeed has severe pulmonary regurgitation. The device is placed over a wire just like all these other devices. And then that bottom right panel shows, you can see it a little better because it's stainless and cobalt chromium, but you can see the S3, and then the bottom right panel shows it's stainless and cobalt chromium, but you can see the S3 valve that's been placed inside that pre-stent. Follow-up for these transcatheter pulmonary valve patients, regardless of whether it be a balloon expandable or a self-expandable device is very similar to post-surgical follow-up for a surgically replaced pulmonary valve. Patients are typically seen four to six weeks after surgery for mostly those are looking at in a post-catheter procedure, it's looking at access sites and make sure that those healed and there weren't any access site complications. Again, patients are seen typically after six months and then go back to what for them, most of them is normal with either an every six month or an annual follow-up with their primary cardiologist. Clinical evaluations are important as always as they move along post-procedure and are typically accompanied by cardiac imaging, very common for these patients to have echocardiograms with their clinic visits with periodic MRI imaging just to maintain a good look at cardiac function and valve function over time. Circling around to the impact registry, some additional transcatheter pulmonary valve data elements were added to impact 2.0. So when we got our new version of impact, we also had some specific data elements that were being collected for transcatheter pulmonary valves, specifically looking at indications for the procedure, some data points from the procedure and then looking at procedural anatomy and function. This looks very familiar, I'm sure to those of you who do the data collection, this is the collection form for that transcatheter pulmonary valve module. Just as a quick, if you're new to this or you're gonna be adding transcatheter pulmonary valves to your program, the top six are the most common your program. The top section looking at clinical indications, we'll just take a peek at where we can find this documentation just to make it a little bit easier for the data collection and submission. Typically that comes from clinical documentation and at our institution, we get most of this when we're looking at doing the chart review for the data submission, we find most of this in the consult note from the interventional cardiologist. They're looking at why the pulmonary valve was indicated, what the patient had in place as far as an indication of regurgitation or stenosis or both. The next thing we're looking for are the echo data points. The most recent echo report is extremely helpful in locating these as is the most recent MRI report for looking at those particular data points. At the bottom, what we're looking at is the type of RVOT procedure that the patient had previously. And honestly, what I found is the best thing if you wanna know what a surgeon did, go back to the op note and read the note and find out what he said he did. It's also a lot of times is available in clinical documentation, either from an interventionalist referral note or from the patient's primary cardiologist. The last bits of information here typically included within just a regular cath report for the device implantation. There are a couple of tricky data elements. We'll look at a couple related to echo. The data element for gradient, which is asking for the pressure difference across the structure. So in this case, you're looking for the pressure difference between the right ventricle and then the pressure out into the main pulmonary artery. In echo, this is measured as a velocity across that area of interest and is reported as meters per second. Typically, when you look at a report, it's a smaller number. So you may see something listed as 4.5 meters per second. Gradients are reported in millimeters of mercury and gradients are determined from an echo due to a calculation based on the velocity. So you may see a larger number like 45 millimeters per mercury. And if you're really lucky, you'll get the values reported as a peak gradient, meaning the difference between the systolic pressure and a mean gradient, which would be the difference between mean pressures. I know I've been doing data collection for a long, long time. It's very easy to mix it up and you may not get both of these values reported in an echo report. What I can tell you though, is that if someone has reported a velocity in meters per second, you can circle around with your sonographer and they'll be able to tell you what the gradient is so that you can report that on the form. A few more tricky data elements related to MRI. The data points that we're looking at from MRI reflect function and ventricular volumes. And the volumes that we report in the impact database are an indexed volume rather, which means that the volume is related to body surface area. But what you may find in an MRI report, particularly if it comes to you from another institution that has referred a patient to you for transcatheter pulmonary valve, is that volume may be reported without the index calculation. If the report reads just milliliters, it's not indexed, not a problem. You can do the calculation yourself. If you divide that volume that is reported by the patient's body surface area, then you can report that as milliliters per meter square. Most of the reports that I have seen now include the patient's body surface area that is calculated based on the patient's height and weight. I'm gonna spend the last few minutes just some pearls from the NCDR's frequently asked questions list that is related to the data elements for transcatheter pulmonary valve. There was a question asked that said, if the operative note refers to a conduit made from a Dacron graft tube and a pulmonary valve homograph, how do you categorize that? And the answer to that would be is that you categorize and code that as a pulmonary homograph because the valve involved is part of that homograph and the Dacron tube was something that was sewn on to extend it. Next, what we found is in a question that was asked is if an echo report does not provide an EF in a percentage value, and you will actually still see this, that it'll be reported as ventricular function being normal or good or mildly reduced or severely reduced. The kind of advice that we were given was to use these percentages to equal what those descriptions were. So if you had someone with mildly reduced ventricular function that we were directed to use a value of 45%. The patient in this particular scenario had had multiple surgical valves or conduits, and which of those surgical valves or conduits should you include in your data submission? And the answer to this one was to capture the most recent one, not the first one. In a lot of instances, when conduits are placed when patients are small children is that the conduit size increases with subsequent replacement as the child grows. So you want to actually record the information on size based on the conduit that they have currently, not the first one. And then I believe this is the last one that we gleaned from the FAQ list. And the interventionalist reinflated the delivery balloon after the valve was implanted. Does this count as a post-dilation? And actually it does not. A redilation is only if a new balloon is used. Particularly with the Melody valve, it's very common for an interventionalist after the Melody valve is implanted. The delivery for that system is a balloon and balloon configuration. So there's an inner balloon and an outer balloon. And it's very common that they will inflate the outer balloon alone without the inner balloon so that all of the force of the inflation is outward in kind of securing that valve in place. And that's what I've got for you today. And if there are any questions, I think Joan, you may have a few. Thank you, Joanne. That was an excellent presentation and I certainly learned a lot. I do have a few questions. The question comes up, I guess, and how do you handle this as to when the right timing is? Is it a conversation considering perhaps shared decision-making, obviously, with the parent and the consulting physicians as to is there a magic time when it's time to do the valve? Is there, I know you mentioned some gradient and velocities and measurements. Does that come up a lot? Or is there a clear direction as to it's time to fix the valve? I think where it starts is a conversation with the patient and their primary cardiologist. So at Nationwide, we've been doing transcatheter pulmonary valves since the Melody IDE study, so back in 2008. So our primary cardiologists have a lot of experience with patients who have transcatheter pulmonary valve who have transcatheter valves, who are looking at a transcatheter option for their valve replacement. So typically the conversation starts there. And then once they order the imaging and they look at the echo and they look at the MRI, that's when you kind of look to see if they meet those parameters, the hemodynamics and the heart function to say that they meet the indications for the pulmonary valve. And at that point, then the conversation includes the interventional cardiologist. It's actually not uncommon for us to have patients who don't know what they want and they want to hear about all of their options. So the conversation, in addition to the interventional cardiologist could also include the heart surgeon and providing the patients and their families with the information and letting them make an informed choice Any idea on age range? Your smallest patient to your oldest patient that you've seen have a pulmonary valve or over your years of experience with the Harmony or other valves? So I will tell you that by far, most of our patients are late adolescence, young adults, because they're kind of in that range for having had a conduit or having had something and needing something else. We've done patients as young as in their early teens. We've actually, I think, done a patient probably who was seven or eight. We have a gentleman that we'll be seeing in clinic next week who is 80 and has had his transcatheter pulmonary valve for two years. So it's the whole age range. Wow, that's interesting. Yeah, that's interesting. I have a greater appreciation for the leaflets in the pulmonary. It's, I mean, it's lighter than a butterfly wing. I mean, they're just so graceful. It's very impressive. It is. When we were first given that, and we used that video in our patient education presentation so that we can show patients exactly what their valve looks like. And it really is. It's very, very thin and very, very graceful and not at all what I thought a pulmonary valve looked like. Do you get, did the physicians and you and your team get a lot of questions? I know on the adult side of valve replacement, the question is, but is the valve durable? You know, surgical procedures have been out there a long time. Now we're going to transcatheter. Is it comparative with durability of the valve? And do you get a lot of, I mean, we don't know yet. These valves are new, but is that a topic of conversation for going one way or the other? Do you hear that? We actually do. And surgeons will tell their patients when they're looking at a valve replacement that the expectation is not that the valve will last forever. It's likely that it will not when you're looking at tissue valves. What I can tell you is that we've been implanting transcatheter pulmonary valves since 2008. We have patients that we're following at Nationwide that got their valves in 2008, 2009, 2010. They still have their valves. They function very well. But I do think that at some point in time, those valves will have to be replaced. And the whole technology of the transcatheter pulmonary valve was not necessarily to take the place of a surgical valve. But in these patients with the anomalies of their right ventricular outflow tract, is the expectation is that they would have numerous surgical procedures over the course of their lifetime. And the transcatheter valve therapy is allowing us to give them an option to have fewer of those procedures. So that if you look at, if you say that a surgical valve will last somewhere between 10 and 15 years, and you kind of do the math over the course of a lifetime, how many valve replacements is that? If you can replace a number of those with a transcatheter valve replacement, then you've saved the patient numerous trips to the operating room and numerous bypass runs. I always stress the value of a smart echo department. And thank you for showing the form and looking for the echo values. Is there any one adverse event, complication, worry point? Is there a point when you could breathe easier after seeing either post-implantation, pre-discharge at their three-month or whatever appointment? What's the biggest, uh-oh, out of the woods kind of thing? Is it something on echo? Is it bleeding? Is there anything that's involved that you worry most about with these patients? So in the short term, when you're looking at, you're looking at post-cath complications. So the delivery systems for these valves are quite large. So you're looking at vascular access with a fairly large introducer sheath. So post-cath, you're looking for those access complications. You're looking for rebleeds. You're looking for hematomas, those kinds of things in the short term. In the long term, it's like any other prosthetic valve. There is always gonna be a risk of endocarditis. There's gonna be a risk of valve dysfunction over time. So that's why it's really important when we're taking care of these patients in clinic is this isn't a one and done. This isn't you have a procedure and you're fixed. You don't ever have to come back. It's still important to follow them throughout the course of their lifetime. And these tools that we have with echo and MRI imaging and things like that, give us the opportunity in a non-invasive setting to look at valve function and heart function over time. You bring up a great point and I'll throw the challenge out to you or to anyone else listening. Follow-up, especially with our congenital heart patients, follow-up, they grow up. The sort of what the physicians always say is they get too large for the chair in the patient in the pediatric cardiologist waiting room. They move, they go to school, they get married. They think it's one and done. They think they're good to go. Maybe next year we could tackle long-term follow-up and what's the easiest, best way to do that. So our community of congenital heart patients could be followed in a very simple way or a compliant way. But I see that more and more. We need to track these patients throughout their lifetime. They're doing well, but not lose track of them. And maybe the final comment I'll make, I don't know if you have any comment or follow-up, but I hope that this opens the door for more specifically FDA approved congenital heart devices instead of our whole world is off label. So with the success of what's been happening in the pulmonary valve world, I'm very optimistic. I don't know if that's a conversation point that your team talks about, or was there a happy dance when things went well with the pulmonary valve? But that and follow-up, I think are, I'm very optimistic about the future of congenital heart with those two small little points. What do you think, Joanne? I agree. I think something that has really been beneficial for congenital heart patients is that now we have people who specialize in adults with congenital heart disease. So now it's less likely that patients are going to, oh, I don't go to a pediatrician anymore, so I shouldn't have to go to a pediatric cardiologist anymore. Within our program, we have a transition program for adolescents to introduce them to our adult congenital team so that they understand that, no, it's not one and done. You just graduate onto a new program and you have a new cardiologist who is trained to take care of adults with these same types of defects. So I think over the last 20 plus years, we've seen more and more of these sub-sub specialists that are looking particularly at adults that have these congenital defects. I think that's really important. And I think that it is very important that we've seen, at least over my career, lots more things that are specifically FDA approved for congenital heart disease and for use in children. And I think that that's done an amazing job at improving our outcomes over time. Thank you, Joanne. I know you're a big part of that and please stay with us, stay at Nationwide and continue to do the great work you're doing. Thank you so much for this presentation. Appreciate it. Thank you. You're so welcome.

pulmonary valve

congenital heart defect

valve types

implantation

transcatheter pulmonary valve

follow-up care

RV to PA conduits

right ventricular outflow tracts