Outcomes with Post-Transcatheter Pulmonary Valve Replacement

Podcast Transcript

Announcer:

Welcome to Love Your Heart, brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute. This podcast will explore disease prevention, testing, medical and surgical treatments, new innovations and more. Enjoy.

Hani Najm, MD:

Hello, my name is Hani Najm. I'm the Chair of Pediatric and Adult Congenital Heart Surgery at the Cleveland Clinic.

Joanna Ghobrial, MD:

I'm Dr. Joanna Ghobrial. I am the Director of Adult Congenital Heart Disease, and I specialize in both ACHD as well as interventional cardiology. I work very closely with Dr. Najm on all of our patients.

Hani Najm, MD:

Well, we're delighted that this session is going to be dedicated to transcatheter pulmonary valve implantation. We'll also touch on the surgical aspects of it and what happens to both valves, whether they're implanted surgically or in a transcatheter approach.

Joanna, tell us, we've actually added so much with our longstanding history of surgical pulmonary valve implantation, but we've learned a lot of lessons also through that. In recent years now, you have the transcatheter implantation of the pulmonary valve. Tell us when would you think that it's an appropriate approach for these patients, and what do you think the outlook of these valves is?

Joanna Ghobrial, MD:

Yeah. Excellent question, Dr. Najm. I just want to start by explaining what is a transcatheter pulmonary valve replacement. Essentially, it's a minimally invasive procedure where, instead of doing an open heart surgery and a sternotomy, you're advancing a valve that is crimped onto a stent through a catheter in either the vein in the leg or the vein in the neck. With that, you can then deploy the valve, and then it starts functioning right off the bat. This is a procedure that has evolved over time from the year 2000 now.

Congenital heart disease patients tend to have many open heart surgeries by Dr. Najm at the Cleveland Clinic. We're thinking of what is the lifetime management of these patients. How many surgeries have they had? And we're trying to minimize interventions regardless of if it's an open heart surgery or a transcatheter intervention, as well. I think the answer to your question of when we think of transcatheter pulmonary valve replacement, it’s really very patient dependent. That's why you and I often do a multidisciplinary discussion of all these patients about what is the next best step for this specific patient?

Is it best that we do an open heart surgery and actually do a surgical pulmonary valve replacement, or should we actually do a transcatheter in that case? So it's very patient-dependent. That's the beauty of the Cleveland Clinic, is we tailor it to every patient as they come into this institution. As far as when do we use it, I think it depends on the anatomy. It depends on their age and it depends on the size of the patient.

But you can now use it with the advent of three different types of pulmonary valve replacement to our balloon expandable, the Melody valve and the Sapien valve. Then we also have the Harmony, which is a self-expanding valve. There's another, which is the Alterra. It's a self-expanding stent into which you can put a Sapien valve. So, you have now a quite big variety of different valve platforms that you can use, and the size changes from anywhere 18 millimeters, so fairly small, all the way up to 38 millimeters. You can actually take care of a big group of patients with congenital heart disease that have pulmonary valve disease, whether regurgitant, which is a leaky valve or stenotic, which is a tight valve.

Hani Najm, MD:

Well, this is great. This allows us to have and address really the multiple different anatomies that we are faced. I have to say that we, as surgeons, we have to think, as you mentioned, about lifetime care of the patient. That's why we have to set them up for you in the future. That is the type of valve, the size of valve, the way it's constructed. We like to put it on in a way that is phased into your hands in the next stage so we can follow this patient.

So that's why we've evolved from more valveless patches that does not allow the possibility of putting a valve in to put in a stented prosthesis, making it a size that is suitable for a subsequent transcatheter pulmonary valve. These valves do have some limitations. They can't go for life.

Can we talk a little more about what is the behavior of these valves and expectations of what can happen to these valves? What's their life? What happens to them in general?

Joanna Ghobrial, MD:

Yeah. I mean, all these bioprosthetic valves, whether surgical or transcatheter, have a certain lifespan. Right? They don't last you a lifetime. We wish we had that. That's kind of the holy grail of valves in general. We're not there yet. We are working on it with technology. But for valve durability, they tend to last anywhere between eight to 15 years. Somewhere in that timeframe, with an average of let's say 10 years. Right?

Hani Najm, MD:

Right.

Joanna Ghobrial, MD:

It had not been really clarified what happens to these valves. We just know that you get valve deterioration or degeneration. Then at the Cleveland Clinic, we started looking into this a little bit more carefully, hence this study, which is looking at HALT, which is hypoattenuated leaflet thickening and HAM, which is hypoattenuation affecting motion. What that essentially is is these little, tiny clots that form on the valve leaflets, and they're essentially subclinical, which means they're not even affecting valve function. They're not affecting patient symptoms whatsoever.

But we try and pick it up early because in a minority or a subgroup of the patients that develop HALT or HAM, it can lead to valve degeneration and deterioration. If we have this early detection mechanism and we pick it up by CAT scan, that's the main modality to pick this up, and we can then intervene early by adjusting the medication on these patients, then we can buy more years out of every valve.

That's the most important part is we're not thinking of the patient as this is one visit, one procedure. We're thinking of what is your life journey, right? Throughout your life. Then, I want to get you to your 90s, and I want you to be able to ride your bike and feel good on it with the least amount of interventions through that lifespan.

This study is really one of the important parts of the Cleveland Clinic team working together. The imaging team has been amazing in actually reading these CTs of detecting, "Okay, this is only HALT. It's not affecting the valve function, but this is something we can intervene on now to improve the valve durability and longevity."

Hani Najm, MD:

Yeah. We have shifted in the last few years into implanting surgical valves that are porcine in origin. The reason why we shifted into this, we feel that the opening pressure of these porcine valves is lower than the bovine pericardial valves, and that's why they may have a little longer longevity.

We are actually looking at one of these valves that we've implanted an excess of around 400 of these cases with great results so far. We've been implanting it for the last 12 to 15 years here at the Cleveland Clinic, and we believe that this is the way to go. Now these valves, is there any difference between implanting a transcatheter valve inside a bovine pericardial valve versus a porcine valve?

Joanna Ghobrial, MD:

I would want to add the point that you're mentioning, which is hemodynamics, right? One of the main things that causes a valve to not last as long is bad hemodynamics. If you come out of the OR or of the cath lab with higher gradients across your valve, this valve is not going to last the patient quite as long. So, the fact that we're looking into this and using porcine valves is much better.

Now, whether what type of surgical valve we're implanting the transcatheter valve in, it doesn't really affect that. Because we have a lot of patients coming from other institutions that have had a bovine pericardial valve, and then we implant our own transcatheter valve within it. I think what matters is what are my hemodynamics of the valve once I'm out of the cath lab?

So, we always look at that. Not only do we do hemodynamics at the end of the procedure, we do intracardiac echo, and then we follow them very closely within a three to six-month period to get that CAT scan for that early detection of HALT and HAM.

Hani Najm, MD:

In surgery, we have evolved into putting the largest valve possible for that reason also. So, you don't have a gradient first towards the end of the case. Also, it allows you to put a valve inside that valve. That's why we tend to put in some patches, just to enlarge the right ventricular flow tract, so we can put a bigger valve in.

Obviously, space becomes a problem when you are operating on a small child, and you may have to put in. We also put into the account the size of the patient and where do they sit in their lives.

So with all these things, I'm so glad that we at the Cleveland Clinic here, we do this in conjunction with both the surgery and the intervention. We decide which is the best approach for this particular patient, and what gives the least intervention or re-intervention on that patient. Because this really, and we explained this, the beauty of care really at the Cleveland Clinic is that we see patients with congenital heart disease from day one of life until-

Joanna Ghobrial, MD:

From even before.

Hani Najm, MD:

.... or before even birth. We diagnose them before we expect them to come in few hours until they're in their 70s and 80s and 90s, as a matter of fact, depending on what they come with. That's the beauty. It's an integrated system. We see them all along their life. They continue to be followed at the Cleveland Clinic. They just transition from being on the pediatric side to the adult side, and they continue to be followed by the same team. That's why we give them comprehensive care right from birth until their adult life.

Joanna Ghobrial, MD:

Yeah. Even the pediatric and adult side, we're essentially in the same building.

Hani Najm, MD:

Umbrella. Absolutely.

Joanna Ghobrial, MD:

We're not like two streets apart or anything of that sort. We're in the same location. It’s very easy to interact with the pediatric department, and we have our meetings all the time together. We always look at the patient, as we both said, from beginning to end, which is the key part in congenital heart disease. This is something you're born with, but now we have to get you to live with that, with the best quality of life that you should have up until your old age, your 80s, 90s.

Hani Najm, MD:

I have to emphasize one thing that is really special here at the clinic is that we work always in a heart team. It's not up to the surgeon, it's not up to the interventionist, it's not up to the cardiologist, it's not up to any one person to decide the intervention.

It's always a group of bright, amazing minds that put their minds together to decide what is the best thing that could be done for this patient. On many occasions, we pivot, we change, we flex, and we take also into account the wishes of the patient. What do they want to do, what type of life they want to live, whether they want to accept this or that. That's how we believe that we are giving the best care for our patients.

Joanna Ghobrial, MD:

The journey also, the lifetime monitoring, we follow these patients very closely. We get these regular studies on them to make sure that the valve is working well and continues to work well and if there's anything that needs to be done. Right? So, you're not coming for one procedure or intervention. This is a journey with us through your life.

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