Tricuspid TEER shows clinical efficacy for first time in newest TRILUMINATE data
New TRILUMINATE IDE data presented at TCT 2024 confirmed efficacy for the first time for Abbott’s TriClip device in treating tricuspid regurgitation (TR). The initial results from the first 350 patients in the trial, presented as a key late-breaker at ACC.23, led to the FDA approval of the Abbott TriClip in April 2024. However, that data only showed that patients reported feeling better with an improved quality of life; it did not show clinical efficacy.
Cardiovascular Business interviewed Gilbert H. Tang, MD, professor in the department of cardiovascular surgery at the Icahn School of Medicine and surgical director of the Structural Heart Program at the Mount Sinai Health System, who presented the findings. He said the new data emphasize both clinical safety and improved outcomes in patients, further reinforcing the therapy's value.
“In the expanded cohort, all three primary efficacy endpoints for hospitalization, heart failure, mortality, and need for tricuspid surgery, showed improvement,” Tang said. “This is significant because, previously, two out of the three outcomes had shown equivalency.”
He said the data showed 88% of patients in the study had moderate or better TR reduction at one year, showcasing the sustained success of the TriClip device.
The TriClip device aims to provide a minimally invasive option for patients suffering from severe tricuspid regurgitation (TR), a condition that has traditionally been undertreated. With the full analysis now available from more than 570 patients in the TRILUMINATE IDE study, Tang highlighted several positive efficacy outcomes that go beyond the initial findings.
In addition to subjective improvements reported by patients, such as an enhanced quality of life, objective measures of functional capacity also demonstrated notable improvements. This finding addresses a prior criticism that patient-reported outcomes could have been affected by placebo effects.
“For the first time, we’ve demonstrated an objective, statistically significant increase in six-minute walk distance, confirming functional benefits beyond subjective feelings of improvement,” Tang explained.
He also acknowledged that the larger patient cohort bolstered the statistical power of the study, allowing researchers to detect these new signals of efficacy. While the initial analysis focused on 350 patients, the full cohort provided a broader scope of evidence, reinforcing the therapy’s value in improving patient outcomes.
Looking forward, Tang said there are still ongoing questions around optimizing patient selection, refining procedural techniques and investigating alternative treatments such as full valve replacement. He said the late-breaking TRISCEND II trial at TCT, comparing tricuspid valve replacement with the Edwards Lifesciences Evoque to optical medical therapy, can also shed more light one these areas.
“While the TriClip is promising, long-term follow-up is essential for understanding the full impact on endpoints like mortality and hospitalization rates. TR, unlike other valve diseases, may need extended observation to reveal meaningful survival benefits,” he noted.
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