Why is this study important?

This is an interim look at the safety and performance characteristics of the Edwards EVOQUE tricuspid valve replacement system in the first 132 (of a planned 200) treated patients. Based on the safety performance of this system, the randomized TRISCEND II Trial of 775 patients was launched in April 2021. 

Should I change my practice because of these findings?

The EVOQUE Tricuspid Valve Replacement System is under investigation at this time.

What question was this study supposed to answer?

The clinical impact of tricuspid regurgitation and its contribution to patient morbidity is clear. Non-surgical treatment options are very limited. TRISCEND was intended to assess the performance and safety characteristics of this new system in a single-arm study conducted at 14 U.S. centers.

What did the study show?

The EVOQUE Tricuspid Valve Replacement System (a self-expanding nitinol frame with bovine pericardial leaflets) consists of a unique valve design that engages leaflets, chords, and annulus to achieve secure placement. It is delivered using a percutaneous 28F transfemoral venous delivery system. Patients with moderate or greater, symptomatic tricuspid regurgitation despite medical therapy or prior HF hospitalization were included in the study. Among 132 patients enrolled in TRISCEND, 6-month follow-up was available for 56. Successful device implantation was achieved in 96%. At 30 days, 19% had major adverse events (3 CV-deaths, one renal complication, 22 severe bleeding events, two reinterventions). All-cause mortality at 30 days was 3%. Eight patients required a new permanent pacemaker. At 6 months, TR was mild, trace, or none in 100% of patients; 89% had NYHA Class I or II symptoms; 96% were free from HF hospitalization; 94% were free from mortality.

How good was the approach/methodology?

This appears to be a very well-designed and run study. The patients were clearly high risk as they were elderly (79.2 ± 7.39), predominately female (74%), had severe tricuspid regurgitation (88%) with pulmonary hypertension (79%) and atrial fibrillation (90%). The etiology of tricuspid regurgitation was functional in 70.5% and mixed in 22.7 %. This is a difficult patient group to manage, and the early functional results were excellent (although echo data were complete in just 43 patients); safety measures were acceptable. Information regarding changes in pulmonary pressures or right ventricular function was not presented. Further follow-up of this initial study population will be important to understand the impact of this new system.

All editors: John T. Saxon, MD, FSCAI; Steven R. Bailey, MD, MSCAI; Kirk N. Garratt, MD, MSCAI; and David A. Cox, MD, MSCAI