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NY Valves 25: TRISCEND II Substudy: Effect of TTVR on Preference-Weighted Health Status
Published: 27 Jun 2025
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New York Valves 25 - A substudy of TRISCEND II investigating the effect of transcatheter tricuspid valve replacement (TTVR) on preference-weighted health status showed significant benefits in patients who received TTVR.
We are joined by Dr Suzanne Arnold (Saint Luke's Mid America Heart Institute, US) to discuss the findings from a substudy of the TRISCEND II trial, which aimed to create an individualised health status measure that can be tracked over time. The substudy surveyed 400 patients from TRISCEND II who were randomised 2:1 to either TTVR or optical medical therapy, investigating which symptoms were most important for the patient to be relieved of with intervention and which activities were most important for them to be able to complete.
The findings showed that dyspnea and then fatigue were the most important symptoms to be improved with intervention, and it was found that the ability to independently care for oneself was the most important activity for patients. Furthermore, significant benefits were observed in patients who received intervention compared to optical medical therapy.
Interview Questions:
1. What is the importance behind this substudy of TRISCEND II?
2. Could you tell us about the study design and patient population?
3. What were the key findings?
4. How should these findings impact future research and clinical practice?
5. What further study is needed?
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.
I'm Suzanne Arnold. I am a professor of medicine at University of Missouri, Kansas City and a cardiologist at St. Luke's Mid America Heart Institute in Kansas City, Missouri.
What is the importance behind this substudy of TRISCEND II?
When we look at transcatheter tricuspid valve interventions, the primary benefit of these at least thus far, has been health status or symptom improvement. The primary way that we have looked at this is with an instrument called the Kansas City Cardiomyopathy Questionnaire, KCCQ, which is a heart failure disease specific health status measure.
It's been validated in patients with tricuspid regurgitation, but interestingly, it considers all symptoms and activities of equal importance to patients. So things like dyspnea, edema, fatigue, being able to walk one block, visiting with families and friends. It considers them all as having equal importance. And we know that some patients may value relief of certain symptoms more than others.
And so what this study tried to do was they surveyed patients ahead of time and said, what are the symptoms that are most important to you to be relieved with intervention? What are the most important activities? And we use those data, those survey data to kind of weight the health status results. So we're kind of creating a patient specific or an individualised health status measure that we can then track over time.
Could you tell us about the study design and patient population?
Yeah, so this was coming from TRISCEND II. So these are 400 patients who were randomised 2:1 to either transcatheter tricuspid valve replacement or optimal medical therapy. And again they were surveyed ahead of time.
And then what we did was we mapped the particular items on that patient preference survey to specific items in the KCCQ as well as the SF-36. And then we created this patient specific symptom and activity score for each individual patient and then compared those over time between the valve intervention and medical therapy.
What were the key findings?
Yeah, so I think just going back to the survey itself, I think it's important to look at what are the symptoms and activities that patients most value. And what we found was that dyspnea was the most important symptom, with fatigue being a close second, in terms of the symptoms that were most bothering these patients that they most hoped to improve with intervention.
And then if you looked at the activities, by far being able to care for oneself, doing one's activities of daily living, dressing oneself. Those were the things that mattered most to patients.
When we looked at the impact of intervention on these kind of patient specific scores, there was a significant benefit with intervention over medical therapy that was present at one month. It grew to between one month and six months and then was stable through about 12 months. The pattern was actually fairly similar to what we have seen with the primary KCCQ results in the original TRISCEND quality of life paper.
How should these findings impact future research and clinical practice?
These types of analyses, this was a fairly, just an interesting methodologic question. Could we create a patient specific personalised health status measure?
I don't think that this should be the primary health status assessment when we look at subsequent studies, but it can just provide additional context to how interventions on different valves, particularly in this situation with the tricuspid valve, can impact patients and just provide a more personalised assessment based on patients individual wishes for symptom improvement with intervention.
What further study is needed?
Within the transcatheter tricuspid valve replacement, I think that this is probably enough. I mean, I think that we have shown that with general KCCQ we see improvement. This is looking at personalised evaluation.
I think it would be interesting to look to use the same kind of methodologic approach in other valve areas. So other valve technologies, whether that's mitral or aortic or other tricuspid valve interventions. This is sort of a proof of concept to understand, could we do this type of analysis and does it provide additional benefit above just the KCCQ? And while I think the KCCQ should still be primary, I think it'd be really interesting to kind of build these types of analyses to subsequent valve studies.
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