TTVR Tied to Safe and Effective Real-World Outcomes in Severe TR, Finds Study
USA: Researchers have discovered in a new research that transcatheter tricuspid valve replacement (TTVR) is safe and effective for patients with severe tricuspid regurgitation (TR). Thirty-day outcomes align with the TRISCEND II trial, showing near-complete TR reduction and improved health status, with lower rates of device implantation and bleeding compared to clinical trials.
Transcatheter tricuspid valve replacement has emerged as a promising therapeutic option for patients with symptomatic severe TR, particularly those who are high-risk candidates for surgery. While earlier randomized trials such as TRISCEND II demonstrated its clinical benefits, real-world data following regulatory approval have remained limited. Addressing this gap, Raj R. Makkar and colleagues conducted an analysis using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, with findings published in JAMA.
This large retrospective cohort study evaluated outcomes in 1,034 patients who underwent TTVR across 82 centers in the United States between February 2024 and March 2025. The study population was elderly, with a mean age of 77 years, and a majority presented with advanced symptoms, as over 70% were classified as New York Heart Association (NYHA) functional class III or IV despite optimal medical therapy.
The researchers reported the following findings:
- Successful valve implantation was achieved in 98.4% of patients, indicating high procedural success.
- Mild or less tricuspid regurgitation was observed in nearly all patients post-procedure and in 97.7% at 30 days.
- Findings demonstrate near-complete elimination of regurgitation in routine clinical practice.
- At 30 days, all-cause mortality was 3.1% and stroke incidence was 0.2%.
- Bleeding events occurred in 7.9% of patients.
- Heart failure hospitalizations were reported in 3.1% of patients.
- Among patients without prior devices, 15.9% required new cardiac implantable electronic device placement.
- Overall safety outcomes were acceptable and in some cases lower than those seen in clinical trials.
- Significant improvement in functional status was observed, with over 80% of patients in NYHA class I or II at 30 days.
- Quality of life improved markedly, with an increase of more than 22 points in KCCQ score.
- Results indicate substantial symptom relief and better daily functioning.
- Baseline presence or absence of cardiac implantable electronic devices did not affect short-term mortality.
- No significant differences were observed in heart failure hospitalization or functional outcomes across subgroups.
- The benefits of TTVR were consistent across different patient groups.
Overall, this real-world registry analysis reinforces the clinical value of TTVR in managing severe tricuspid regurgitation. The findings confirm high procedural success, marked reduction in regurgitation, and significant improvements in symptoms and quality of life, with an acceptable safety profile. These results support the broader adoption of TTVR in appropriately selected patients while highlighting the need for continued long-term evaluation.
Reference:
Makkar RR, Gupta A, O’Neill BP, et al. Real-World Outcomes of Transcatheter Tricuspid Valve Replacement: Analysis From the STS/ACC TVT Registry. JAMA. Published online April 13, 2026. doi:10.1001/jama.2026.3446
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