Progress in tricuspid valve care and TAVR on full display at TCT 2024
Harlan Krumholz, MD, editor-in-chief of the Journal of the American College of Cardiology (JACC), spoke with Cardiovascular Business about key late-breaking studies at TCT 2024 that focused on transcatheter tricuspid valve repair and replacement and transcatheter aortic valve replacement (TAVR).
JACC published 19 articles for the conference, and many of them examined the safety and effectiveness of new tricuspid valve devices. Examples included TRILUMINATE, about the Abbott TriClip device; the TRISCEND II study, about the Edwards Lifesciences Evoque device; and the PASTE registry, about the Edwards Lifesciences Pascal device. An additional study highlighted is the European PASTE Registry, which looked at real-world tricuspid transcatheter edge-to-edge repair (T-TEER) patients.
"The studies support the longer-term benefit of these devices for selected tricuspid regurgitation patients, showing meaningful, sustained quality of life improvements,” Krumholz said.
Key tricuspid trials at TCT 2024
The FDA approved two tricuspid devices earlier this year, the Evoque transcatheter tricuspid valve replacement (TTVR) system and the TriClip T-TEER device. These devices saw further validation with results from the late-breaking TRISCEND II and TRILUMINATE trials presented at TCT.
"This continues to be an exciting area and there's a winning streak going on here on in these trials," Krumholz said.
He emphasized that the current studies reinforce the ability of these devices to alleviate symptoms and enhance the well-being of patients with advanced tricuspid disease. However, Krumholz advised a cautious, patient-centered approach.
"While we’re seeing a surge in outcomes that improve quality of life, these devices aren’t extending life expectancy, so the focus must remain on selecting patients who will benefit most,” he explained.
Unlike, TAVR where the goal is to eliminate regurgitation, the goal in the tricuspid valve is aimed at relieving symptoms to patients can increase their quality of life. Even a reduction of one class of regurgitation can often help patients feel much better.
"What's important is, we're not showing that people are living longer. We're showing that people are feeling better. So this is going to put a real premium on the selection of patients and finding the right people who are really disabled by the condition and are going to be benefited by the use of these devices," Krumholz explained.
Early TAVR trials signal new directions in aortic stenosis treatment
Krumholz also shared overviews of two key TAVR studies that looked at earlier interventions to improve outcomes: the EARLY TAVR and TAVR UNLOAD trials.
The EARLY TAVR trial was perhaps the most important late-breaker presented at TCT this year, because it answered clinical questions about how to best manage asymptomatic patients who have clinically severe aortic stenosis (AS). The trial randomized patients to either undergo TAVR or be treated with a "wait and see" approach. The results made it clear that early intervention with TAVR reduced the risk of unplanned hospitalizations and allowed patients to recover before they became severely ill.
"Ultimately a lot of people had to move over and get a TAVR procedure even when they had initially been randomized into the group that didn't get the procedure. So some people take that as validation of we might as well do it early and get them in a good position so there aren't any unplanned procedures downstream. Other people are saying that, yeah, they're calling it positive, but maybe it means that we can wait and then make the decision when they actually really, really need it. I think it's pointing us in a direction of sitting down, talking to patients, laying out for them the options, figuring out what they value, what are their preferences," Krumholz explained.
The TAVR UNLOAD trial, meanwhile, was published in JACC when the embargo lifted.
"That was really looking at whether or not people with heart failure and moderate AS would benefit from TAVR. The interesting thing about it was, there was no difference in the end, but a lot of crossover. So what it was saying was, we have to be able to give these people some relief for their AS. It was progressing, we needed to intervene, but we could defer it safely and people didn't have to have it right away," Krumholz said.
Shaping a Patient-Centric Future in Structural Heart Disease
Krumholz praised the cardiology community for its commitment to evidence-based progress when investigating structural heart disease treatments. He commended ongoing device trials as critical for improving patient quality of life while stressing the importance of comprehensive, nuanced discussions with patients.
For Krumholz, the essence of this year’s findings lies in expanding therapeutic options without overstating their impacts.
"It’s about recognizing nuances. We now have more evidence to help us work with patients to make fully informed, personalized decisions that address their needs," he said.
Watch the video for more insights.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com