Transcatheter tricuspid valve replacement system successful at 30 days
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A transcatheter tricuspid valve replacement system was associated with high rates of reduction in tricuspid regurgitation severity at 30 days, according to findings presented at the American College of Cardiology Scientific Session.
For the TRISCEND trial, Susheel Kodali, MD, director of the Structural Heart & Valve Center, director of the interventional cardiology fellowship program and assistant professor of medicine at NewYork-Presbyterian Hospital/Columbia University Medical Center, and colleagues enrolled 56 patients (mean age, 79 years; 77% women) with symptomatic moderate or worse tricuspid regurgitation. All patients underwent treatment with the transcatheter tricuspid valve replacement system (Evoque, Edwards Lifesciences). The system is not yet approved for commercial use in the United States.
“Over the last decade, a lower-risk alternative for treatment of tricuspid regurgitation has emerged as an important unmet need,” Kodali said during a presentation. “There have been several initial studies with transcatheter tricuspid repair options that have demonstrated feasibility, but they have also demonstrated challenges in achieving predictable reductions in tricuspid regurgitation in all patients. Therefore, transcatheter tricuspid valve replacement may offer an alternative to transcatheter repair in elderly high-risk patients.”
Among the cohort, 92% had severe or worse tricuspid regurgitation and 91% had atrial fibrillation, Kodali said.
During the procedure, right femoral vein access was achieved in all patients, device success occurred in 98% and procedural success, defined as device success without paravalvular leak, occurred in 94%, Kodali said.
Median length of stay was 3 days and 89.3% of patients were discharged home, he said.
At 30 days, there were no major adverse events in 77.4% of patients, and the most common major event was severe bleeding (22.6%), none of which were life-threatening or fatal, according to the researchers. Two patients died, one from a CV cause.
Kodali said 98% of patients achieved mild or less tricuspid regurgitation severity (P < .001), all patients achieved at least a one-grade reduction in tricuspid regurgitation severity and 95% achieved at least a two-grade reduction at 30 days.
NYHA class (P < .001), 6-minute walk distance (P = .001) and Kansas City Cardiomyopathy Questionnaire score (P < .001) all improved at 30 days, he said.
“The early tricuspid replacement experience with the Evoque transfemoral system demonstrated technical feasibility, safety, effective tricuspid regurgitation reduction and symptomatic improvement in patients with clinically significant tricuspid regurgitation,” Kodali said during the presentation.
He said based on the results of TRISCEND, a randomized pivotal trial, TRISCEND II, is planned.
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Kodali S, et al. Featured Clinical Research I. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
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