Novel tricuspid valve replacement system improves symptoms, survival at 2 years
Key takeaways:
- Transcatheter tricuspid valve replacement using the EVOQUE system was associated with high survival and procedural success.
- Adverse events were low and reduction of tricuspid regurgitation was durable.
For adults with severe or greater tricuspid regurgitation, use of a novel transcatheter tricuspid valve replacement system was associated with high procedural success, symptomatic improvement and survival at 2 years, researchers reported.
The findings were presented at EuroPCR and simultaneously published in the Journal of the American College of Cardiology.
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“Transcatheter tricuspid valve replacement using the EVOQUE tricuspid valve replacement system (Edwards Lifesciences) has emerged as a new treatment option in patients with severe or greater tricuspid regurgitation,” Jorg Hausleiter, MD, professor of medicine and deputy clinic director at Ludwig Maximilian University of Munich, Germany, and colleagues wrote in the simultaneous publication. “The early compassionate use report of the EVOQUE transcatheter tricuspid valve replacement system showed tricuspid regurgitation reduction to 1+ intraprocedurally in 92% and maintained in 88% and 87% of patients at 30 days and 1 year, respectively. NYHA functional class II was observed in 70% of patients after 1 year compared with 11% before treatment, indicating a substantial symptomatic benefit following transcatheter tricuspid valve replacement.”
In a retrospective study, Hausleiter and colleagues evaluated survival, symptomatic and echocardiographic outcomes and adverse events at 2 years for 38 patients who underwent transfemoral transcatheter tricuspid valve replacement using the EVOQUE system in a compassionate use setting between 2019 and 2021 at eight centers across Europe, the U.S. and Canada. The mean age of patients was 77 years; 74% were women and the mean EuroSCORE II was 7.9%. Tricuspid regurgitation severity was at least 5+ for 55% of patients, at least 4+ for 34% of patients and at least 3+ for 11% of patients. Researchers followed patients through December 2022.
Researchers found that tricuspid annular plane systolic excursion was reduced to less than 17 mm in 53% of patients. Tricuspid regurgitation was successfully reduced to 1+ or less for 97% of patients at the end of the procedure, with good durability (94%) at a median of 520 days follow-up.
At 1 and 2 years, survival rates were 86% and 71%, respectively, with CV causes reported in six of 10 patients.
Researchers found that transcatheter tricuspid valve replacement was associated with a significant reduction in symptoms of right HF, with peripheral edema decreasing from 71% to 37% and ascites decreasing from 50% to 14% (P < .001). There was no incidence of MI, stroke or pulmonary embolism among patients.
“In our study, we observed high rates of procedural success and promising durability of tricuspid regurgitation reduction over the course of follow-up,” the researchers wrote. “Transcatheter tricuspid valve replacement was associated with a remarkable reduction in HF symptoms and significant improvement in NYHA functional class up to a maximum of 1,074 days after the intervention. Right ventricular reverse remodeling, which has been reported to occur as early as 30 days after transcatheter tricuspid valve replacement, was maintained at long-term follow-up.”
The researchers also noted that despite having advanced surgical risk, they observed a lower rate of major bleeding events compared with previously published data.
Reference:
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Hausleiter J, et al. TTVR using the EVOQUE system: two-year compassionate use outcome data. Presented at: EuroPCR; May 16-19, 2023; Paris (hybrid meeting).
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