Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: Win ratio 1.64 (severe TR) and 2.20 (massive/torrential TR)

• Primary Outcome: Primary safety and effectiveness endpoint (win ratio) favoured TTVR over control

• Nnt Or Sensitivity: TR reduced to ≤mild in 95.2% (severe) and 95.3% (massive/torrential) of TTVR patients

• Confidence Interval: Severe TR: 95% CI 1.11-2.43; Massive/torrential TR: 95% CI 1.55-3.14

Clinical Application

Requires specialised cardiac catheterisation facilities and experienced interventional cardiology teams with transcatheter valve expertise Would require TGA approval for EVOQUE system and PBS consideration for funding. Aligns with emerging CSANZ guidelines for structural heart disease interventions Patients with symptomatic severe or greater tricuspid regurgitation who are suitable candidates for transcatheter intervention

Abstract

BACKGROUND AND AIMS: The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy vs medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. METHODS: The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133). In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan-Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. RESULTS: One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval (CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)]. At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (-11.6, 11.9), massive/torrential -5.8% (-17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (-3.0, 22.7), massive/torrential -15.2% (-28.9, -1.5)]. CONCLUSIONS: Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

References

1. 1.Lurz, P., Hahn, R. T., Kodali, S., Makkar, R., Sharma, R. P., Davidson, C. J., O'Neill, B. P., Yadav, P., Zahr, F., Chadderdon, S., Eleid, M. F., Szerlip, M., Smith, R. L., Whisenant, B., Garcia, S., Kister, T., Kipperman, R. M., Lim, D. S., Saxon, J., ... Thourani, V. H. (2026). Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial. European Heart Journal. https://doi.org/10.1093/eurheartj/ehaf676