So I'm Julien Dreyfus, I'm an imaging cardiologist, at Centre Cardiologique du Nord—it means in France, close to Paris. And we are a large centre only dedicated to cardiology and cardiovascular disease. And I'm very involved in the tricuspid regurgitation field since more than 15 years.

What is the importance behind the TRICURE EU study?

So the TRICURE is the first in-human trial showing the Topaz Transcatheter Tricuspid Valve Replacement System. So it is the first one with a very early experience, and we showed very promising results. It means that then we are currently conducting other studies with more patients and I hope we will confirm those results.

Could you tell us about the unique features of the TRiCares Topaz Tricuspid Valve Replacement System?

So the Topaz valve is a self-expanding by prosthesis with a design that has been specifically built for the tricuspid valve and which is unique with a dual stent design. There is an inner stent and the inner stent is a rigid one, a circular one in which there are three leaflets. And the inner stent is fixed to an outer stent which is soft and which safely fix anchor to the tricuspid valve with atraumatic anchors.

And one particularity is that the outer stent shape will change during the cardiac cycle to adapt to the morphology of the tricuspid [illegible], the right ventricle, the right atrium. So that is specific of the device.

And for the procedure, during the study all procedures were performed through transfemoral approach, but now you can also perform transjugular approach. So you have both possibilities.

What was the study design and patient population?

So in the study I would say it's as usual, meaning patients with severe TR who were symptomatic and were not eligible for surgery. So very as usual, I would say.

What were the key findings, and were there any unexpected results?

What we found, nothing unexpected. I would say that there are three important points. The first one is regarding the feasibility and the mean procedural time was 35 minutes, meaning that it's pretty short. This is very very easy to implant. You could do it with a junior echocardiography. It's really easy.

The second point is regarding performance. Performance is really good as all patients had a significant reduction of TR. And when I mean significant reduction, it was none or mild. So it was very, very impressive.

And the third point is regarding safety and this is unique because there was no device-related pacemaker implantation—not one. And that is unique for a TTVR system.

How should these findings impact clinical practice?

To be fair, it's the first-in-human study so it will take time to move from a first-in-human to clinical practise. But what we have observed, as I described about feasibility, it's very easy about performance, which is very good, and about safety, it's very promising.

And so we have to perform as they are currently ongoing trials and they will give us, because if they confirm the excellent performance and if we keep on moving to improve also the safety, then it will be very impactful for our daily practise.

What further research is needed in this area, and what are the next steps?

So the future is no, it's the present with ongoing studies: one in Europe, which is a pivotal trial with 77 patients that are and will be included, and an early feasibility study in North America, US and Canada with 15 patients that will be included. And what we are aiming is to confirm the excellent results about performance and also improve the safety, because we learn a lot about the procedure and how to improve the procedure to make it very, very safe.