EuroPCR 2021: The TriClip bRIGHT Study
Published: 07 Jun 2021
Prof Philipp Lurz (Heart Center of Leipzig, Leipzig, DE) shares his insights from the the TriClip bRIGHT Study. This observational real-world study assessed severe tricuspid regurgitation patients treated with the Abbott TriClip™ device.
1. What was the device studied? Could you tell us more about the procedure?
2. What was the study design, endpoints, and patient population?
3. What are the key results?
4. What conclusions can be made?
5. What are the next steps?
Recorded remotely from Leipzig, 2021.
Interviewer: Mirjam Boros
My name is Philipp Lurz, I'm a cardiologist at Heart Centre Leipzig at University Leipzig.
What was the device studied? Could you tell us more about the procedure?
The device and procedure, which was started in the bRIGHT registry is the TriClip device. That's a device for transcatheter tricuspid valve repair. It's an iteration of the mitral clip device. And it's designed to treat patients with relevant tricuspid regurge who have high surgical risk and therefore are better candidates for transcatheter approaches.
What was the study design, endpoints, and patient population?
So this is a registry looking probably for the first time at real world data with the TriClip system to treat tricuspid regurgitation patients where, and are still included when they have at least severe tricuspid regurgitation and the highest surgical risk. And we do exclude those patients with very high primary artery pressures and the threshold is 60 millimetres of mercury. And the endpoints we're looking at is the primary endpoint is successful procedure with survival to discharge and a reduction in tricuspid regurgitation of at least one grade.
What are the key results?
So the first analysis and presentation included 75 patients. As expected the baseline characteristic of these patients they demonstrate clearly a cohort with an increased risk about one third had previous left side heart above surgery about 80% were in NYHA class three and four. What's interesting and that's a little bit different to other studies, there was, the proportion between men and women enrolled in that trial was quite balanced. And in the previous studies, there were more female patients enrolled, but it demonstrates that these patients are clearly at high risk. With regards to the results, procedure success was 100%. So this is very promising and reassuring considering that in that trial several new sites are also participating with with less experience, but despite that very safe procedure very good procedure success. And when it comes to place the clip safely into tricuspid valve, and when looking at the first about 40 patients, there was a reduction of tricuspid regurge down to moderate in 84% of patients.
What conclusions can be made?
So the preliminary and first analysis of the bRIGHT Registry suggest that the positive results scene in TRILUMINATE trial, and the CE Mark trial that these results can be not only reproduced across different countries and the different sites and with less experience, but it actually suggests that and the results in the registry are even better than in the previous TRILUMINATE trial. Maybe also, because we now have the TriClip device in different sizes available in a bit larger and shorter clip arms. And the next steps will be to include at least 200 patients and then keep on analysing the results of that procedure.
What are the next steps?
The next steps will be to continue enrolling the, we would like to enrol at least 200 patients and we will keep on analysing the data. And obviously patients will also be followed up for a longer follow-up up to 12 months.