Preliminary results encouraging for EVOQUE tricuspid valve replacement

In patients with significant tricuspid regurgitation (TR) who received a new tricuspid valve replacement system, results at 30 days showed a reduction of TR and improvement of symptoms in the TRISCEND study. At 30 days, most patients (77.4%) had experienced no major adverse events. The device was deemed technically feasible, with an acceptable safety profile [1].

The TRISCEND study (NCT04221490) was an early feasibility study to assess the performance and safety of the Edwards’ EVOQUE tricuspid valve replacement system. This prospective, single-arm, multicentre study enrolled 56 patients with symptomatic moderate or greater TR to receive the EVOQUE valve replacement. At 30 days, 47 participants were available for follow-up.

The participants were quite elderly (mean age 79 years) and had severe TR symptomatic (92% graded as severe or greater). Aetiology of TR was deemed functional in 68% of participants, degenerative in 11%, and mixed/other in the remaining 21%. All devices were implanted via right femoral vein access. The primary outcome measure was freedom from device- or procedure-related adverse events within a 30-day time frame. Endpoints were device and procedural success, a reduction in TR, and a composite of major adverse events. Follow-up was planned at 30 days, 6 months, 1 year, and annually for up to 5 years post-procedure.

Dr Susheel Kodali (Columbia University Medical Center, NY, USA) reported the 30-day results from the TRISCEND trial. Of the 47 patients who were followed up, 46 (98%) experienced a reduction in severity of TR to none or trace; 100% achieved a ≥1-grade reduction; and 95% a ≥2-grade reduction in TR severity. Approximately 10% of patients achieved a ≥5-grade reduction in TR at 30 days.

No major adverse events were observed in 77.4% of the participants at 30 days. The most common adverse event was severe bleeding, experienced by 12 (22.6%) of the participants. None of the bleeding events were life-threatening or fatal.

Dr Kodali also noted that echocardiography performed at discharge showed worsening right ventricular function in about 25.5% of patients. At 30 days, this parameter had improved, with right ventricular dysfunction evident in only 4.5% of the participants. This parameter will continue to be monitored at the next scheduled follow-up at 6 months.

Key secondary outcomes included changes from baseline to 30 days in the New York Heart Association (NYHA) class, 6-minute walk test, and the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. At 30 days, there was a dramatic improvement in NYHA class, and both the 6-minute walk test and KCCQ scores showed significant improvement.

Encouraged by these preliminary results, researchers have now initiated TRISCEND 2 (NCT04482062), a prospective, multicentre, randomised, controlled, pivotal clinical trial that will evaluate the safety and effectiveness of the EVOQUE system with optimal medical therapy compared with optimal medical therapy alone in the treatment of patients with at least severe tricuspid regurgitation.

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   1. Kodali S. Transfemoral Tricuspid Valve Replacement in Patients with Tricuspid Regurgitation: 30-day Results of the TRISCEND Study. ACC 2021 Scientific Session, 15–17 May.

 

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Posted on 9 July 202129 July 2021