Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial
Year: 2025
Type: article
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.
Source: European Heart Journal
Authors: Philipp Lurz, Rebecca T Hahn, Susheel Kodali, Raj Makkar, Rahul P Sharma, Charles J Davidson, Brian P O’Neill, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram F Eleid, Molly Szerlip, Robert L Smith, Brian Whisenant, Santiago Garcia, Tobias Kister, Robert M Kipperman, D Scott Lim, John Saxon, Samir Kapadia, James Hermiller, Jacob M Mishell, Andrew Rassi, Howard C Herrmann, Wilson Szeto, Jörg Hausleiter, Vasilis Babaliaros, Colin M Barker, Brian R Lindman, Azeem Latib, Kamran Muhammad, Ralph Stephan von Bardeleben, Matthew Summers, Stanley J Chetcuti, Gorav Ailawadi, Mark Russo, Michael Rinaldi, Bassem M Chehab, Georg Nickenig, Curtiss Stinis, Ignacio Inglessis-Azuaje, Abhijeet Dhoble, Adnan K Chhatriwalla, George Petrossian, Pinak Shah, Cezar Staniloae, Mathew Williams, Marcos Nores, James M McCabe, Gagan Singh, Stephan Baldus, Volker Rudolph, Ilie Barb, Charles Klodell, William Gray, Justin Strote, Anna Sannino, Paul Grayburn, Michael J Mack, Martin B Leon, Vinod H Thourani
Institutions: University Medical Center of the Johannes Gutenberg University Mainz, Columbia University Irving Medical Center, Cedars-Sinai Medical Center, Cedars-Sinai Smidt Heart Institute, Stanford Medicine, Stanford University, Northwestern University, Henry Ford Hospital, Piedmont Atlanta Hospital, Oregon Health & Science University, Mayo Clinic, Heart Hospital Baylor Plano, Intermountain Medical Center, Christ Hospital, Leipzig Heart Institute, Leipzig University, Morristown Medical Center, Atlantic Health System, University of Virginia, Cleveland Clinic, St Vincent Hospital, Kaiser Permanente San Francisco Medical Center, University of Pennsylvania, LMU Klinikum, Ludwig-Maximilians-Universität München, Emory University, Vanderbilt University Medical Center, Montefiore Medical Center, Montefiore Health System, Oklahoma Heart Institute, Sentara Norfolk General Hospital, University of Michigan, Michigan Medicine, Rutgers, The State University of New Jersey, University of Kansas, Ascension Via Christi Hospital, Ascension Via Christi, University Hospital Bonn, Scripps Memorial Hospital, Massachusetts General Hospital, The University of Texas Health Science Center at Houston, Saint Luke's Hospital, St. Francis Hospital, Brigham and Women's Hospital, NYU Langone Health, New York University, John F. Kennedy Medical Center, University of Washington, University of California Davis Medical Center, University Hospital Cologne, The Cardiac and Vascular Institute, Lankenau Medical Center, University of Colorado Health, Baylor Scott & White Research Institute
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4413807241