Transcatheter tricuspid valve replacement feasible with acceptable safety profile
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Key takeaways:
- Transcatheter tricuspid valve replacement was feasible in most of a cohort of patients with severe tricuspid regurgitation.
- At 30 days, safety outcomes were better than expected.
SAN FRANCISCO — Transcatheter tricuspid valve replacement was feasible and had a lower-than-expected rate of safety events, according to an analysis of the first 150 patients in the TRISCEND II pivotal trial.
At TCT 2023, Susheel Kodali, MD, presented 30-day safety and 6-month effectiveness outcomes for the first 150 patients treated in the TRISCEND II trial, in which patients with severe tricuspid regurgitation were randomly assigned on a 2:1 basis to receive transcatheter tricuspid valve replacement (TTVR; Evoque, Edwards Lifesciences) plus optimal medical therapy or optimal medical therapy alone. He said the 150-patient analysis was specified as part of the product’s breakthrough device designation from the FDA. The device is not yet approved for commercial use in the United States.
“The Evoque system is a nitinol valve with bovine pericardial tissue,” Kodali, 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 during a press conference. “The valve is put in from the right or left femoral vein without any surgical cutdowns and is implanted in the native tricuspid annulus. The goal is to replace the tricuspid valve in patients where the valve is leaking significantly. All of this is done without any incisions under general anesthesia.”
The mean age was 79 years and most of the patients were women (82% in TTVR group, 76% in medical group), Kodali said.
Among the 96 patients assigned TTVR, 95.8% had successful implantation and 2.1% had to be converted to surgery, Kodali said.
The primary safety endpoint of major adverse events at 30 days occurred in 27.4% of patients in the TTVR group, with a one-sided 97.5% upper confidence bound of 36.9%, beating a historical performance goal of 43.8% based on Medicare fee-for-service claims for tricuspid valve replacement surgeries between 2011 and 2018, Kodali said.
The most common 30-day major adverse event was major bleeding, which occurred in 10.5% of patients treated with TTVR, he said. Three patients died from CV causes within 30 days of the procedure.
At 6 months, 98.8% of patients from the TTVR group had moderate or better tricuspid regurgitation, 93.8% had mild or better and 77.8% had none or trace, compared with 21.6% from the medical group who had moderate or better (difference, 77.1%; P < .001), Kodali said.
In a hierarchical comparison of 6-month quality-of-life outcomes including improvement of at least 10 points in Kansas City Cardiomyopathy Questionnaire Overall Summary Score, reduction of at least one NYHA class and improvement in 6-minute walk distance of at least 30 minutes, the TTVR group performed better than the medical group (P < .001), Kodali said. The researchers calculated a win ratio of 4.6 favoring TTVR (TTVR wins, 60%; medical wins, 13%), with a 97.5% lower bound of 2.6.
“There is a learning curve with every device, and we don’t have enough numbers to say whether that’s going to be five or 10 or 20 patients,” Kodali said. “It is a trainable, teachable procedure. The mean device times were 65 minutes plus or minus 29 minutes. Imaging is one of the major challenges for tricuspid therapy. The imaging requirements for replacement are less than they are with edge-to-edge repair because you do not need to visualize the leaflets as closely. I think that is part of the shortening of the learning curve, which is not just the interventionalist but the entire team and the imager, and the learning curve for imaging of this procedure is going to be less.”
Results from the full cohort of 400 patients, including 1-year clinical outcomes such as death and HF hospitalization, will be presented in the future, according to Kodali.
Perspective
Back to TopYousif Ahmad, BMedSci, BMBS, MRCP, PhD, FSCAI, FACC
This is a very exciting time for transcatheter tricuspid intervention. Historically, we have had very limited treatment options for these patients. We now have two therapies evaluated in randomized trials. I think that transcatheter tricuspid valve replacement is particularly attractive. There are technical aspects of the procedure that may make it more teachable, reproducible and streamlined compared with tricuspid edge-to-edge repair.
With all of these generational advances in technologies and techniques, it might not necessarily be this study, but maybe the next one, that will give us a real idea of what the clinical impact could be. There is always a learning curve and earlier-generation devices tend to be associated with higher rates of complications. We also need to learn who to apply the therapy to.
I am very excited by TRISCEND II but I want to see the results of the full cohort. I will also be interested in a sequential trial once we have techniques and technologies iterated further.
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Kodali S, et al. Late-breaking clinical trials: Session III, in collaboration with the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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