My name is Thomas Modine, I'm Professor of Cardiac Surgery and Interventional Structure Heart Therapies in Bordeaux University Hospital in France.

What are the current treatment options for patients at high risk for conventional tricuspid surgery?

Tricuspid surgery is at a very high risk because patients are usually referred late, and if they are not referred late, they are referred because of some other disease. So if we speak strictly about the tricuspid regurge as an independent disease, we as surgeons try to avoid it. So there are very little options.

I mean we can do minimally invasive surgery, we do it. You can do a beating heart surgery, we do it. But still, the outcomes are not as good as we would love them to be and as they are with other valve treatments, surgical treatments. So the future and the needs today are more into developing and the development of transcatheter therapies, that's for sure, repair or replacement.

Could you describe the study design and patient population in the TRINITY trial?

So the TRINITY trial is exploring a new transcatheter tricuspid valve replacement. In this landscape, this study will be using a valve called LuX Plus that comes from China. This is a Chinese innovation, which has some particularities: it uses transjugular axis, percutaneous transjugular access which is very new, and it has some particular features which renders this valve very adapted to the tricuspid regurge itself.

The design still today, this is a pivotal trial, this is designed for Europe and European patients. It's a single arm. We treat tricuspid regurge patients who are severe and above. And almost it's all-comers actually — there are very few exclusion criterias, which is a good chance for our patients who are referred to us at high risk but also, I mean, can use for other risks of patients, but TRINITY is focusing on high risk patients.

What were the key findings from the 30-day outcomes data?

So we found that this therapy covers a real need in the market of tricuspid regurgitation today which is large anatomies. More than 70% of the patients needed a large size valve which is not covered by any other device today: 55, 60, 65 or even 70. A large range of anatomy.

Less conduction abnormalities which translates in less pacemaker rate implant. No bleeding or almost no bleeding complications that we can observe also with other therapies. Very short hospitalisation, very impactful in terms of quality-of-life recovery even after one month, as reflected by KCCQ, but also NYHA and six-minutes walking test. No thrombogenicity that we have been observing today and a valve that you can implant with the same outcomes even if you have a pacemaker leads.

Were there any surprising or unexpected findings?

Yeah, it is very surprising because this is not the first comer in this therapy. So they arrived very lately in Europe because they, as I said, they were in China. And then I must admit that when I started, when I looked at this device and I immediately said, wow, this has a potential, when I started talking about it with some other colleagues, there were some limitations. I would say they are more interventionalist cultural limitations.

The jugular access for example, we are not used to work from the jugular. I mean me as a surgeon, I'm used to do carotid access for TAVR, we developed it. So it was obvious for me, but for the majority of colleagues, they work from the groin: femoral access, easy, safe. The land and the environment of the cath labs are designed for this but not with this valve. So this one was one of the major limitations.

And to be honest with you, there was also a doubt about the efficacy of this valve because it's coming from China. We don't know much about data, which is true. So we had to overcome all this. And actually, the adoption was super quick, super fast and more importantly the therapy was super efficient and safe for the patient. And that's what we are looking for.

What are your take-home messages?

Don't ignore tricuspid regurge — it's a killer disease. And if it's not a killer disease, it has a major impact on the quality of life of patients. They don't suffer from pain in the chest, no pulmonary oedema, but they don't feel well. They tell you they are tired; they don't go out. It really impacts their quality of life beyond what we expect.

So tricuspid regurge should be explored, followed, treated. If medical treatment is not enough, refer the patient to the cardiologist who's a specialist in tricuspid regurgitation treatment. Transcatheter replacement, unlike other valve diseases, is a chance for the patient. And we have been able to show this because it eliminates tricuspid regurge, it doesn't only reduce it. And with this TRINITY trial using LuX-Valve Plus, we have been able to show the efficacy, the safety of eliminating tricuspid regurge with a device that has a very, very low rate of any complications we observed in the past.

What further research is needed, and what are the next steps for the LuX-Valve Plus system?

We have to follow the patients for at least five years. So the one-year follow-up data is going to be presented hopefully at the end of this year, and if not, early next year — this is one. [illegible] application for this device, which I think it's very good thing for our patients in Europe. A pivotal FDA randomised control trials on which the company is working on today, and in which there will be other European centres also who will be involved. So it's an international approach for global disease and that we will be using this promising device.