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EuroPCR 25: The FATE Registry: Failed Transcatheter Tricuspid Edge-to-Edge Repair

Published: 21 May 2025

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EuroPCR 2025 - Outcomes from the FATE Registry show coapttion gaps are at the upper limit of treatability in this patient group using current tTEER devices.

Dr Fedrico de Marco (Centro Cardiologico Monzino IRCCS, Milan, IT) joins us to discuss the management and outcomes from the FATE registry, which investigated 123 case of failed tricuspid transcatheter edge-to-edge repair (tTEER) with all available TEER devices on the western market.

Findings demonstrated that this patient population experienced poorer outcomes during index tTEER procedure, with coaptation gaps at the upper limit of treatability using current tTEER devices. Patients who underwent repeat procedures showed significant reduction in tricuspid regurgitation compared to those maintained on medical therapy alone. Persistent tricuspid regurgitation following tTEER failure emerged as a significant predictor of both heart failure progression and related hospitalizations.

Interview Questions:

  1. What is the importance behind the FATE registry?
  2. What was the study design and patient population?
  3. What were the key findings?
  4. Based on your findings, what specific modifications to patient selection criteria would you recommend to minimize the risk of clip failure?

Recorded remotely from Milan, 2025.

Editors: Jordan Rance, Yazmin Sadik
Videographers:

Support: This is an independent interview produced by Radcliffe Cardiology.

Transcript

My name is Fedrico de Marco, and I'm the Director of Structural Heart Interventions at Centro Cardiologico Monzino in Milan.

What is the importance behind the FATE registry?

The FATE registry enrols patients with failed tricuspid TEER. The objective of the registry is to evaluate this patient population. We know that failed tricuspid TEER is a rare occurrence but we really don't know a lot about these patients: we don't know how they do over time, we don't know what's the best treatment strategy for these patients and we really don't know the medium and long-term outcomes of these patients.

This is the reason why we collected across 31 centres in Europe, the US and Canada all the cases of failed tricuspid TEER, and we evaluated these patients in a large registry.

We identified 123 cases of failed TEERs of which roughly half were medically managed and the remaining half was treated with different therapies: some underwent heart surgery, open heart surgery, some underwent redo TEER, some other underwent transcatheter tricuspid valve implantations and some other underwent caval valve implantation.

What was the study design and patient population?

The FATE registry is an unsponsored, investigator-initiated registry, and I appreciated my colleagues in sharing their data because I think the population we studied is really populations where we need to learn more because we really need to improve our tTEER practise, and we don't really know how to deal with these patients so we want to learn more about them.

What were the key findings?

The first finding is that this patient population is slightly different as compared to the population experiencing good tTEER results which we see in registry — they had a slightly worse outcome during the index procedure and the co-optation gap of this patient is on the high side of treatability with tTEER. And this underlines the fact that these patients are probably close to the limit of what we can do with tTEER.

Another major finding is that patients undergoing a redo procedure, be it redo TEER surgery or TTVR, have a marked reduction in tricuspid regurgitation as compared to the patient's left in medical therapy.

Another important finding is that among the predictors of a composite endpoint of death and heart failure hospitalisation, we have residual tricuspid regurgitation after tTEER failure, meaning that we really need to struggle to reduce as far as possible the residual tricuspid regurgitation in this patient population.

Based on your findings, what specific modifications to patient selection criteria would you recommend to minimize the risk of clip failure?

So in order to improve patient selection criteria and to, let's say, factor in the results of the FATE registry into patient selection criteria, I think we need to do a little bit more research and maybe compare this patient population of failed tTEERs by matching them with patients enrolled across different registries who had a good tTEER outcome, and that's our next steps as researchers.

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