Transcatheter edge-to-edge repair shows benefit for severe tricuspid regurgitation
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NEW ORLEANS — Treatment of severe tricuspid regurgitation with transcatheter repair was safe, reduced severity of tricuspid regurgitation and led to improvements in quality of life at 1 year, according to results of the TRILUMINATE Pivotal trial.
“[The] TRILUMINATE Pivotal [trial] is a pioneering study as the first randomized clinical trial in this unique population of patients with severe tricuspid regurgitation,” Paul Sorajja, MD, chair of the Valve Science Center at Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital, said during a late-breaking clinical trial presentation at the American College of Cardiology Scientific Session.
Image: Katie Kalvaitis, Editorial Director
“The TriClip device was highly effective in reducing tricuspid regurgitation and led to significant improvements in quality of life at 1 year, without the high procedural risk often associated with tricuspid surgery,” Sorajja said.
The trial compared outcomes after transcatheter edge-to-edge repair (TEER) using the TriClip G4 delivery system (Abbott) or guideline-directed medical therapy alone in 350 symptomatic patients with severe tricuspid regurgitation. The procedure is performed via the femoral vein and the system utilizes a 25F delivery catheter to place one or more TriClip devices on the tricuspid valve leaflets to reduce tricuspid regurgitation.
“Tricuspid regurgitation is common and frequently associated with impaired survival and poor quality of life,” Sorajja said. “Diuretics have been the cornerstone of therapy for many years, with surgery reserved for selected patients and often performed at a high operative risk. We know that there are limited data in patients with right-sided valvular disease, and that knowledge is often inferred from an understanding of left-sided disease. Recently, transcatheter tricuspid therapies have emerged, but their benefit has not yet been examined in a randomized controlled clinical trial.”
Transcatheter repair vs. medical therapy
Tricuspid repair was associated with a significant reduction in severity of tricuspid regurgitation. At baseline, tricuspid regurgitation severity was massive or torrential in 70.7% of patients. At 30 days, 87% of patients in the TEER group reached moderate or less tricuspid regurgitation compared with only 4.8% of the medical therapy group, Sorajja reported. This reduction in tricuspid regurgitation was also evident and durable during 1-year follow-up, he said, with 88.9% of patients in the TEER group reaching moderate or less, whereas 94.4% of patients in the medical therapy group were still classified as severe.
The primary endpoint — a composite of mortality or tricuspid valve surgery, hospitalization for HF and quality of life improvement of at least 15 points using the Kansas City Cardiomyopathy Questionnaire (KCCQ), evaluated at 1 year in a hierarchical fashion — was met, demonstrating superiority of TEER over medical therapy alone (win ratio = 1.48; 95% CI, 1.06-2.13; P = .02), Sorajja said.
This demonstration of superiority over medical therapy was driven largely by significant improvements in quality of life, Sorajja said. Mean improvement in KCCQ score was 12.3 points in the TEER group and 0.6 points in the medical therapy group (P < .001). The proportion of patients with an improvement of at least 15 points from baseline to 1 year was 49.7% and 26.4%, respectively.
Sorajja reported no difference between groups in the proportion of patients free from all-cause mortality or tricuspid valve surgery at 1 year (TEER group, 90.6% vs. medical therapy group, 89.4%; P = .75) and the rate of hospitalization for HF at 1 year (85.1% vs. 87.9%, respectively; P = .41).
“The degree of tricuspid regurgitation reduction was related to degree of improvement in quality of life,” Sorajja said.
Patients who had moderate or less tricuspid regurgitation at 1 year had a better quality of life, with an average increase in KCCQ score of 16 points compared with 4 points, Sorajja said. Moreover, greater reduction in tricuspid regurgitation was associated with greater improvement in quality of life.
In terms of safety, the 30-day major adverse event rate was 1.7%. Death and pacemaker implant occurred in 0.6% each. There were no cardiac surgeries or device-related adverse events. Major bleeding occurred in 4.7%.
“The system was remarkably safe,” Sorajja said.
The results were simultaneously published in The New England Journal of Medicine.
The TRILUMINATE trial was conducted at 75 centers in the United States, Canada and Europe. The mean age of patients enrolled was 78 years and 55% were women. All patients had symptomatic severe tricuspid regurgitation, were on stable guideline-directed medical therapy and/or device therapy for HF for at least 30 days and had at least intermediate risk for tricuspid valve surgery. Ninety percent had AF and 81% had hypertension at baseline.
New treatment option
The researchers acknowledged several limitations of the trial, including its unblinded design and conduct during the COVID-19 pandemic, which may have affected clinical outcomes.
The TRILUMINATE trial will continue to follow patients for 5 years.
“These results are very meaningful for a highly symptomatic population whose quality of life is impacted by tricuspid regurgitation,” Sorajja said. “With the excellent benefit-to-risk profile of the TriClip system, a historically untreated population will have a treatment option to improve their quality of life.”
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Megan Coylewright, MD, MPH, FACC, FSCAI
It is really challenging to take care of people with severe tricuspid regurgitation. They suffer, and we have limited medical therapies to offer. Most of these patients are elderly and frail and it is very difficult for them to take high-dose diuretics. We don’t typically offer surgery for isolated functional tricuspid regurgitation. This is a huge unmet need.
Cardiologists and physicians are very hopeful that we can make people feel better. In the methods, the authors describe that an improvement in quality of life was 15 points on the KCCQ. We usually define a change of 10 points as a moderate improvement. John Spertus, MD, Suzanne Arnold, MD, and others wrote a JACC State of the Art review in 2020 that walks us through this patient-reported measure, including its use in trials. They note that mean differences can be difficult to interpret, as opposed to the proportion of patients who experienced a benefit, for example.
Results did not show a difference, at 1 year at least, in the outcomes of mortality or HF hospitalization or need for surgery. We are not seeing a large change in in quality of life either. I would say that’s counter to some of our own experiences in the clinic after performing this procedure; we really see that patients are feeling a lot better. There is a chance our own experience of people feeling better, and the trial results may be limited by not having a sham control.
One thing we’re all very curious about is what success looks like for interventional HF trials. We’re learning as we go along about how to define success when it comes to quality of life. In interventional cardiology, we have recruited tens of thousands of people and measured mortality or measured receiving another stent. We’re now partnering with our HF colleagues to understand a little bit more of this space that is driven by quality of life. When we hear the results from TRILUMINATE, we’re wondering, is an increase in a KCCQ quality of life score of 12 points meaningful enough to lead to a device approval and therefore a change in our clinical practice? People are excited that it is safe, but we also need to be helpful. If we’re going to sit a patient down and go through a shared decision-making discussion where we discuss the pros and the cons and listen to what’s most important to them, if we cannot communicate that they’re going to feel better, then there won’t be an indication to go forward with the therapy.
I don’t think this trial means that tricuspid repair is unhelpful. It’s 1-year follow-up. We have to look closely at the patients that were included but we also have to think about whether the ways that we’re measuring quality of life are adequate. Is the KCCQ quality of life score enough to reflect some of the outcomes of my patients who underwent tricuspid repair, like the ability to reduce diuretic dosing, or the ability to bend over and tie their shoes, or the ability to get out of the car without two grandkids lifting them out? These are lifechanging for the patients.
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Sorajja P, et al. Joint American College of Cardiology/Journal of the American College of Cardiology Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).
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