Real-world outcomes of transcatheter tricuspid valve replacement: Analysis from the STS/ACC TVT Registry

Authors

• Raj R. Makkar, Cedars-Sinai Medical Center, Los Angeles, California.
• Aakriti Gupta, Cedars-Sinai Medical Center, Los Angeles, California.
• Brian P. O'Neill, Henry Ford Heart & Vascular Institute, Henry Ford Hospital, Detroit, Michigan.
• Christina Lalani, Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
• Rahul P. Sharma, Division of Cardiovascular Medicine, Stanford University/Stanford Health Care, Stanford, California.
• Pradeep Yadav, Piedmont Heart Institute, Piedmont Atlanta Hospital, Atlanta, Georgia.
• Tiberio M. Frisoli, Henry Ford Heart & Vascular Institute, Henry Ford Hospital, Detroit, Michigan.
• Vinod Thourani, Piedmont Heart Institute, Piedmont Atlanta Hospital, Atlanta, Georgia.
• Moody Makar, Cedars-Sinai Medical Center, Los Angeles, California.
• Mackram F. Eleid, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.
• James Lee, Henry Ford Heart & Vascular Institute, Henry Ford Hospital, Detroit, Michigan.
• Vasilis C. Babaliaros, Structural Heart and Valve Center, Emory University School of Medicine, Atlanta, Georgia.
• Christiane Haeffele, Division of Cardiovascular Medicine, Stanford University/Stanford Health Care, Stanford, California.
• Tanvir K. Bajwa, Advocate Health - MidwestFollow
• Peter Flueckiger, Piedmont Heart Institute, Piedmont Atlanta Hospital, Atlanta, Georgia.
• Robert J. Cubeddu, Naples Comprehensive Health Heart Institute, Naples, Florida.
• Laura J. Davidson, Bluhm Cardiovascular Institute, Northwestern University Feinberg School of Medicine/Northwestern Medicine, Chicago, Illinois.
• Ratnasari Padang, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.
• Pedro Villablanca Spinetto, Henry Ford Heart & Vascular Institute, Henry Ford Hospital, Detroit, Michigan.
• Suhail Allaqaband, Advocate Health - MidwestFollow
• et al

Recommended Citation

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

Affiliations

Aurora St. Luke's Medical Center

Abstract

Importance: Transcatheter tricuspid valve replacement (TTVR) demonstrated superior outcomes over medical therapy in patients with severe tricuspid regurgitation (TR) in the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device II (TRISCEND II) randomized clinical trial, and received regulatory approval in the US in 2024. Contemporary real-world data on its effectiveness and safety remain limited.

Objective: To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use.

Design, setting, and population: Retrospective cohort study of all consecutive patients who underwent TTVR in the US from February 2024 through March 2025 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients had symptomatic, severe TR despite optimal medical therapy and TTVR was deemed appropriate by a heart team. Statistical analysis was conducted from September 2025 to February 2026.

Exposure: Device-enabled TTVR.

Main outcomes and measures: Thirty-day event rates (all-cause death, stroke, bleeding, new cardiac implantable electronic device [CIED] implantation, heart failure hospitalizations), TR reduction, and changes in health status (New York Heart Association [NYHA] functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS] score) are reported. Subgroup analyses examined the impact of baseline CIED status on outcomes.

Results: Among 1034 attempted procedures at 82 centers (mean [SD] age, 77.1 [10.6] years; 69.1% female; 73.2% NYHA functional class III/IV), a valve was successfully implanted in 1017 patients (98.4%). Mild or less TR was achieved in 98.4% of patients post procedure and in 97.7% at 30 days. At 30 days, all-cause mortality was 3.1%; stroke, 0.2%; bleeding, 7.9%; new CIED, 15.9% in CIED-naive patients; and heart failure hospitalization, 3.1%. There were significant improvements in NYHA functional class (class I/II, 82.7%; P < .001) and mean KCCQ-OS score (22.4 points; P < .001) from baseline to 30 days. There were no significant differences in 30-day mortality (P = .47), heart failure hospitalization (P > .99), and functional outcomes (P = .55) when patients were stratified by baseline CIED status.

Conclusions and relevance: Early US real-world experience with TTVR confirms safety and effectiveness in patients with severe TR. Thirty-day outcomes are consistent with the TRISCEND II pivotal trial, demonstrating acceptable safety, near-complete TR elimination, and significant health status improvements in an older, comorbid population. Rates of new CIED implantation and bleeding were lower than randomized clinical trial experience.

Type

Article

PubMed ID

41973411