"Hello, my name is Paul Grayburn. I'm, a cardiologist at Baylor, Scott and White Healthcare System.


Well, first of all, this is a sub study of a major clinical trial that was published in the New England Journal last fall. And the study is called TRISCEND II. The purpose of the overall study was to see if tricuspid valve replacement by a transcatheter device, was superior to medical therapy alone in patients with severe massive or torrential tricuspid regurgitation. And the study was positive in that the primary endpoint was met. This study is a substudy of that in which we tried to look at what happens to the right ventricle, to forward and backwards flow once you implant this device and eliminate, tricuspid regurgitation.


So it's essentially the same as the main trial. So 400 patients were randomized to either get the EVOQUE tricuspid valve replacement device, and we'll call that TTVR, short for transcatheter tricuspid valve Replacement or medical therapy alone. And medical therapy for tricuspid regurgitation is basically diuretics, although there's also therapies for other diseases that might be present.


The key outcomes of the sub study are really several. First, the TTVR device essentially eliminates tricuspid regurgitation, such that by discharge out to one year, 95% of the patients had mild or less tricuspid regurgitation and actually almost three quarters had none or trace. In other words, it eliminated TR, compared to the control group, which, for the most part continued to have severe or worse, TR.


The other findings were having successfully relieved TR or eliminated it. We see that venous congestion improves. And that is measured echocardiographically. Excuse me, by the, inferior vena cava diameter, which got smaller in TTVR and remained very dilated in the control group. And also by flow reversal in the hepatic vein, which also improved in the TTVR group.


And then we also looked at, forward cardiac output which improved, but very importantly that improved despite RV function declining. And we have an explanation for that. When you eliminate TR, you reduce the volume overload on the right ventricle. And so the right ventricle gets smaller. And as it gets smaller, we call that RV reverse remodeling. And that in turn, causes a fall in overall RV function. However, since all the flow is going forwards instead of backwards now, the actual cardiac output increases. And that's kind of a brief summary of what we found in the study.


I think, first of all, one of the main things is we already know that we should be treating tricuspid regurgitation in these patients that are symptomatic because we can relieve symptoms and make the patients feel better. But this study shows that we don't have to worry so much about, about the right ventricle failing, after the TTVR. Now, to be, certain, we did eliminate severe RV dysfunction from the trial. So this was not a trial of patients who already had severe right ventricular dysfunction.


I think there's a lot of things coming in this area. One of the things that we need to do is determine if there are specific patients who are either super responders, that is to say they're alive, haven't been hospitalized, and they have an increase in their KCCQ overall summary score of at least 20 points, meaning they feel a lot better. And we also need to look at the possibility that there are patients who are too far advanced and, doing TTVR is futile. And those studies need to be done. And in addition to that, there are new devices coming out. So I think, what we've seen with TAVR and other conditions, are these devices get better over time. And so with that, we hope to see even better results in the future.”