EVOQUE TTVR Delivers Promising Real-World Results: Over 97 Percent Achieve TR Elimination
USA: The first large-scale real-world analysis of the EVOQUE transcatheter tricuspid valve replacement (TTVR) system has demonstrated promising safety and efficacy outcomes among patients with severe tricuspid regurgitation (TR).
Findings from 1,034 patients enrolled in the STS/ACC TVT Registry were presented as a Late-Breaking Clinical Trial at TCT 2025, providing encouraging evidence of the device’s effectiveness outside controlled clinical settings.
The results reaffirm the clinical benefits of the EVOQUE system (Edwards Lifesciences)—the first FDA-approved transcatheter valve therapy for severe TR. Notably, the improvements in symptoms, survival, and quality of life previously reported in the pivotal TRISCEND II trial were replicated in this broader, real-world cohort treated across multiple U.S. centers.
The registry captured outcomes from patients with advanced, symptomatic TR who were considered high-risk or unsuitable for surgical repair. Parameters evaluated included procedural success, TR reduction, mortality, rehospitalization for heart failure, bleeding events, and device performance within 30 days after implantation.
Key findings were as follows:
- After one month, patients treated with EVOQUE showed very low mortality and heart failure readmission rates, reflecting early clinical stability and effective TR control.
- Over 97% of patients achieved mild or lesser degrees of tricuspid regurgitation, indicating near-complete elimination of leakage.
- Functional capacity improved notably, with better NYHA class, longer six-minute walk distance, and higher quality-of-life scores.
- Procedural safety improved compared to earlier trials, with lower rates of major bleeding and pacemaker implantation than in TRISCEND II.
- Most patients recovered quickly, with a median hospital stay of just two days, and were discharged home soon after the procedure.
Tricuspid regurgitation, often referred to as the “forgotten valve disease,” affects millions worldwide and has long posed treatment challenges. Traditional surgical approaches carry a high risk in this frail population, while medical therapy alone provides limited benefit. The EVOQUE valve—a self-expanding, nitinol-framed, bovine pericardial prosthesis delivered via transfemoral access—offers a minimally invasive solution designed to provide complete and lasting TR correction.
According to investigators, this real-world registry validates that EVOQUE’s strong clinical performance and safety seen in trials translate effectively into everyday clinical practice. Procedural success exceeded 95%, with excellent valve positioning, minimal paravalvular leak, and sustained hemodynamic improvement.
Experts at TCT 2025 described the data as a “milestone moment” for tricuspid therapy, highlighting EVOQUE’s consistent results across varied patient populations and clinical settings. They emphasized its potential to reshape treatment paradigms and expand access to effective care for patients historically underserved by conventional therapies.
The registry will continue tracking long-term outcomes, including valve durability, right ventricular remodeling, and survival. Further comparisons with other tricuspid interventions, such as transcatheter edge-to-edge repair (TEER) and surgical replacement, are planned to refine patient selection and optimize treatment sequencing.
In summary, the early U.S. commercial experience confirms that the EVOQUE TTVR system delivers sustained TR reduction, improved quality of life, and strong procedural safety in real-world settings. These findings highlight EVOQUE’s role as a transformative, scalable, and safe option for patients with severe tricuspid regurgitation.
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