VIDEO: Transcatheter tricuspid devices likely to gain FDA clearance before new mitral advances

It was clear at TVT that tricuspid valve therapies will likely move ahead of new mitral therapies coming to market. Several structural heart thought leaders, including Latib, shared this opinion, saying the tricupid is an easier valve to problem solve for, having the more complex anatomy and higher pressure environment of the left ventricle. The tricuspid valve is certainly no longer the forgotten valve, with many technology advances and new trials starting in this space, Latib said.

Over the past several years, there have been high hopes that mitral valve interventions would follow a similar path to clinical trial successes and the rapid adoption of transcatheter aortic valve replacement (TAVR). However, progress has been frustratingly slow. He noted that the first MitraClip device was implanted in a patient in 19 years ago in 2003, and today it remains the only U.S. Food and Drug Administration (FDA) cleared transcatheter device to treat the mitral valve. 

"When we talk about when a transcatheter replacement valve that might gain FDA approval, we are talking about three or four years, but when we come talk about the tricuspid valve, it is completely flipped around," Latib explained. "The tricuspid has completely revolutionized the way we are thinking about valves because the space has grown incredibly quickly. This s because of a couple of reasons. First, it is important and we should not forget about it and we should stop calling it 'the forgotten valve.' Two, these patients have very few options."  

The rapid advance in tricuspid technology is evident in Europe, where there are already three Transcatheter catheter repair devices approved. These include the Abbott TriClip, Edwards Pascal and the Edwards CardioBand. Latib expects the first fully implantable transcatheter tricuspid valve to be cleared in Europe in the next couple months. 

"That is incredible if you think about the short time it has taken to get to that compared to mitral," Latib said. 

In the U.S., he said there are three FDA pivotal trials on the way that could pave the way toward the first FDA device approvals. These include the TRILUMINATE trial for the TriClip, the PASCAL TR trial for the Pascal clip device, and the TRISCEND II clinical trial for the Edwards Evoque transcatheter tricuspid valve. 

"These studies are enrolling incredibly quickly and two of them are close to finishing, so I suspect in the next one to two years we will have the first approved devices in the United States for tricuspid regurgitation," Latib said. 

Latib said the tricuspid valve is complex, similar the mitral valve, but it has some advantages making it easier to design devices and get trials completed more quickly. 

"There are important differences that have made it easier for designing valves," Latib explained. "The fact that we are dealing with a lower pressure state compared to the mitral, and there is no risk outflow tract obstruction, which makes it easier to put valves in the right side of the heart."

The results with these valves have also been fantastic.

"The patients go from torrential tricuspid regurgitation to zero with the valve procedures, so it has been really phenomenal," Latib said. 

Realizing the possible rapid advances that can be made in the tricuspid space, the FDA has been very open to working with physicians on to answer many remaining questions of the valve to speed the science and approvals of devices, Latib said. He delivered the keynote in the FDA session at TVT.

"I realized when writing the keynote for that session, there is still so much we don't know and many questions we still need to answer, and it has been great how the FDA has been open to working with physicians an scientists to try and answer those questions."

Questions remaining include what is the measure that should be used in figuring out what is the best measure for success in patients. Is it mortality benefit, reducing hospitalization or just making patients feel better, Latib said. 

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