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NY Valves 25: The Tri-QOL Study: Defining an Optimal Result of Transcatheter Tricuspid Valve Intervention

Published: 27 Jun 2025

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New York Valves 25 - Quantitative findings from Tri-QOL showed a strong correlation between tricuspid regurgitation (TR) reduction and KCCQ improvement after transcatheter tricuspid valve intervention (TTVI).

Dr Suzanne Arnold (Saint Luke's Mid America Heart Institute, Kansas City, US) discusses findings from a quantitative analysis from the Tri-QOL study which aimed to assess the optimal result for TTVI by investigating the association of change in KCCQ versus change in tricuspid regurgitation. Data sets from six single-arm studies investigating TR valve interventions were acquired from Edwards Lifescinces and Abbott, and about 1,000 patients with severe or greater TR who had received a valve intervention were analysed.

Findings showed that the more TR reduction observed, the more KCCQ improvement was achieved. However, in patients who started with torrential TR, a plateau in improvement in KCCQ was seen once they achieved a below moderate TR status.

Interview Questions:
1. What was the rationale behind this research?
2. What was the study design and the patient population?
3. What were the key findings?
4. How do you envision the results of the Tri-QOL study influencing future research or clinical practice regarding TTVI?
5. What further research questions remain?

Recorded remotely from Kansas City, 2025.

Editors: Jordan Rance, Yazmin Sadik
Videographers: David Ben-Harosh

Support: This is an independent interview produced by Radcliffe Cardiology.

Transcript

"I'm Suzanne Arnold. I am a professor at University of Missouri, Kansas City, and outcomes researcher and cardiologist at St. Luke's Mid America Heart Institute in Kansas City, Missouri.

Yeah, so when we look at, transcatheter tricuspid valve intervention, there are a number of different devices that can be used. There's a lot of different techniques that can be used. And we don't really know what is the optimal result, from this, from these, interventions. They're often very difficult to do. And some say, you know, getting to moderate TR is good enough. Some say, you know, we try to completely eliminate TR. And what we wanted to do was to try to really understand the relationship between TR reduction and improvement in patient's, health status, which is the primary, indication for transcatheter valve intervention. And we knew that this might be related to kind of where patients start, so how much TR that they have at the beginning. How, much TR were we able to get to reduce? So is it about the amount of TR reduction or is it about kind of where you end, in terms of what makes an optimal result?

Yeah, so we, used what's called the TRI-QOL, study. This was a study that we did. It was funded by the FDA and it was originally designed to validate the Kansas City Cardiomyopathy Questionnaire, or KCCQ, in patients who had, triphosphate regurgitation. And as a part of this study we had collaborated with two major device, companies, Edwards Life Sciences and Abbott. And we were able to get a number of their, data sets, from their different trials of tricuspid valve interventions. So these were a number of different devices. And the data from these studies were transmitted to the FDA, who then de identified them and then transmitted them to us in a blinded fashion. So this particular study we had six different, trials, that were all single arm studies. So all patients had gotten intervention and ended up being about 1,000 patients. And all patients had severe or greater TR and had a valve intervention done. And what we looked at was kind of baseline TR, one month TR and then baseline, KCCQ and one month KCCQ. Tried to understand the relationship between the two.

Yeah, so one of the things that we found was that when you look at the amount of TR reduction versus improvement in KCCQ at one month, there was not a clear kind of threshold below which you did not see further improvement in KCCQ. So the more TR reduction the more KCCQ improvement. But when you look at specific grades, baseline grades of TR, so there you know, in kind of the six grades there is severe but then there's also massive and torrential which is you know, beyond severe. If patients started out at torrential TR, there seemed to be a bit of a plateauing of the improvement in health status, once you got below moderate. So it was sort of like the more TR reduction the better. But if you start out at torrential TR, if you can get them at least to moderate, that's probably good. Enough.

Yeah, I think that this can be really helpful. Right now when we're doing transcatheter valve interventions, we're really trying to decide between different strategies. So there's different devices, there's different ways to reduce the TR, some that essentially eliminate TR, some that reduce TR, you know, by two or three grades. And I think that this is really to me can be helpful as we're trying to plan our procedures. So you know, if we think we can get the patient to mild or last TR with a particular device, with a particular strategy, I think that it makes a lot of sense to do whatever strategy that is that gets them there. And that I think can help with device planning and procedural planning. But I think if you start out with torrential, it may not be something where you have to eliminate all TR, but I think it just a bit helps to plan the procedures, to know kind of what are we shooting for? Kind of what is the goal? Is it, you know, if we go from torrential to severe, is that good enough? Probably not. We may have, you know, some benefit to the patient, but we really want to try to get them to as less, as low of TR as possible.

I think there are, We're really at the beginning, in the transcatheter valve space and tricuspid. So I think there's a lot that we still need to learn about long term outcomes. I think that's one thing that's very important. But then you know, doing any sort of device selection I think is something we really need to know about. I think that this study adds quite a bit to helping us understand that. But there's just still so much more to learn as far as, you know, who are the right patients, to treat, you know, are we treating patients too late? Are we treating patients too early? How do we optimize results? And is there, benefit in tricuspid, intervention beyond just health status, which is hugely important to patients, but if you can also see a benefit in terms of, clinical outcomes, that would be even greater. So I think that this adds to what we know. But we're just at the very beginning of understanding who are the right patients, how do we treat them and, how do we optimize their results.”

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