Real-World Outcomes of Transcatheter Tricuspid Valve Replacement
Year: 2026
Type: article
Study design: Observational Study
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.
Source: JAMA
Authors: Raj R. Makkar, Aakriti Gupta, Brian P. O’Neill, Christina Lalani, Rahul P. Sharma, Pradeep Yadav, Tiberio M. Frisoli, Vinod Thourani, Moody Makar, Mackram F. Eleid, James Lee, Vasilis C. Babaliaros, Christiane Haeffele, Tanvir K. Bajwa, Peter Flueckiger, Robert J. Cubeddu, Laura J. Davidson, Ratnasari Padang, Pedro Villablanca Spinetto, Suhail Allaqaband, Akhil Narang, Mathew Williams, Patrick Gleason, Gilbert H. L. Tang, Sahil Khera, John P. Vavalle, Isida Byku, Jeremiah P. Depta, Santiago Garcia, Samir Kapadia, Alan Zajarias, Jake M. Chanin, Susheel K. Kodali, Howard C. Herrmann, M. Andrew Morse, George Petrossian, Joseph A. Sivak, Rebecca T. Hahn, Yang Song, Martin B. Leon, Robert W. Yeh, Charles J. Davidson
Institutions: Cedars-Sinai Medical Center, Henry Ford Hospital, Beth Israel Deaconess Medical Center, Harvard University, Stanford Health Care, Stanford Medicine, Stanford University, Piedmont Atlanta Hospital, Mayo Clinic, Emory University, Aurora St. Luke's Medical Center, Northwestern University, Northwestern Medicine, Edwards Lifesciences (United States), NYU Langone Health, Mount Sinai Health System, University of North Carolina at Chapel Hill, Medical College of Wisconsin, Christ Hospital, Cleveland Clinic, Washington University in St. Louis, Intermountain Healthcare, Columbia University Irving Medical Center, Cardiovascular Research Foundation, Hospital of the University of Pennsylvania, Saint Thomas West Hospital, St. Francis Hospital
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7154184537