Transcatheter tricuspid valve replacement effective treatment for severe regurgitation
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Key takeaways:
- Transcatheter tricuspid valve replacement plus medical therapy improved outcomes vs. medical therapy alone in patients with severe tricuspid regurgitation.
- The biggest impact was on quality of life outcomes.
In patients with severe tricuspid regurgitation, transcatheter tricuspid valve replacement plus medical therapy improved outcomes compared with medical therapy alone, researchers reported at TCT 2024.
For the TRISCEND II trial, whose main findings were simultaneously published in The New England Journal of Medicine and whose quality of life findings were simultaneously published in the Journal of the American College of Cardiology, the researchers randomly assigned 400 patients (mean age, 79 years; 76% women; eight were not treated after randomization) with severe symptomatic tricuspid regurgitation 2:1 to transcatheter tricuspid valve replacement (TTVR; Evoque, Edwards Lifesciences) plus medical therapy or medical therapy alone.
“Evoque is a bovine pericardial valve in a nitinol frame,” Susheel Kodali, MD, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and director of the interventional cardiology fellowship program and associate professor in medicine at Columbia University Irving Medical Center, said at a press conference. “This is a different therapy from the one in the TRILUMINATE study (TriClip G4, Abbott), a repair system in which you are clipping the leaflets trying to reduce [tricuspid regurgitation]. With replacement, the goal is to eliminate the tricuspid regurgitation.”
The results were evaluated on a hierarchical composite outcome at 1 year and expressed as a win ratio. The hierarchy was as follows: all-cause death, heart transplant or implant of a right ventricular assist device, tricuspid valve intervention after the index period, hospitalization for HF, improvement in Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score of at least 10 points, improvement in NYHA functional class by at least one class and improvement of at least 30 m in 6-minute walk distance.
After the TTVR procedure, 99% of patients had moderate or less tricuspid regurgitation and 95% had mild or less tricuspid regurgitation, Kodali said at the press conference.
The win ratio was 2.02 (95% CI, 1.56-2.62; P < .001) in favor of the TTVR group, Kodali said at the press conference, noting that it was driven by improvement in KCCQ-OS score (23.1% vs. 6%) and improvement in NYHA class (10.2% vs. 0.8%).
Severe bleeding was more common in the TTVR group than in the control group (15.4% vs. 5.3%; P = .003), as was new permanent pacemaker implantation (17.4% vs. 2.3%; P < .001), according to the researchers.
In an analysis of the KCCQ-OS score over time, the difference in the score favored the TTVR group at 30 days (difference, 11.8 points; 95% CI, 7.4-16.3), 6 months (difference, 20.8 points; 95% CI, 16.1-25.5) and 1 year (difference, 17.8 points; 95% CI, 13-22.5), the researchers found.
At 1 year, 58% of the TTVR group had a large or moderate improvement in KCCQ-OS score compared with 31% of the control group, whereas 24% of the TTVR group had worse health status or died compared with 45% of the control group (P < .001), Kodali said at the press conference.
TTVR improved health status as measured by the KCCQ-OS score to a greater degree in those with torrential tricuspid regurgitation (treatment effect, 23.3) and massive tricuspid regurgitation (treatment effect, 22.6) compared with those with severe tricuspid regurgitation (treatment effect, 11.3; P for interaction = .049), according to the researchers.
At 1 year, 64.6% of the patients in the TTVR group were alive and well, defined as KCCQ-OS score of 60 points or more and no decline of 10 points or more from baseline, compared with 31% of the control group, the researchers found.
“We’ve done a lot of work to understand how much of this is biologically mediated and how much of this may be placebo effect,” Suzanne Arnold, MD, MHA, professor of medicine at University of Missouri-Kansas City School of Medicine and clinical scholar for Saint Luke’s Mid America Heart Institute, said at the press conference. “One important thing is the magnitude of improvement. An 18-point improvement in the KCCQ is really big. That helps, and that it’s stable through 1 year also helps. The other thing interesting here is there is continued improvement between 1 month and 6 months. If it were all placebo, you would expect to see it all up front. The fact that it continues to grow is reassuring. We also found that if you had an improvement in KCCQ, you had a reduction in the risk of heart failure hospitalization and mortality, though the trial was not powered appropriately for mortality and heart failure hospitalization.”
References:
- Arnold SV, et al. J Am Coll Cardiol. 2024;doi:10.1016/j.jacc.2024.10.067.
- Hahn RT, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2401918.
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Kodali SK, et al. Late-breaking clinical trials: Session III, in collaboration with the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Oct. 27-30, 2024; Washington, D.C. (hybrid meeting).
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