Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial

Philipp Lurz¹, Rebecca T Hahn², Susheel Kodali², Raj Makkar³, Rahul P Sharma⁴, Charles J Davidson⁵, Brian P O'Neill⁶, Pradeep Yadav⁷, Firas Zahr⁸, Scott Chadderdon⁸, Mackram F Eleid⁹, Molly Szerlip¹⁰, Robert Smith¹⁰, Brian Whisenant¹¹, Santiago Garcia¹², Tobias Kister¹³, Robert M Kipperman¹⁴, Scott Lim¹⁵, John Saxon¹⁵, Samir Kapadia¹⁶, James Hermiller¹⁷, Jacob M Mishell¹⁸, Andrew Rassi¹⁸, Howard C Herrmann¹⁹, Wilson Szeto¹⁹, Jörg Hausleiter²⁰, Vasilis Babaliaros²¹, Colin M Barker²², Brian R Lindman²², Azeem Latib²³, Kamran Muhammad²⁴, Ralph Stephan von Bardeleben¹, Matthew Summers²⁵, Stanley Chetcuti²⁶, Gorav Ailawadi²⁶, Mark Russo²⁷, Michael Rinaldi²⁸, Bassem M Chehab²⁹, Georg Nickenig³⁰, Curtiss Stinis³¹, Ignacio Inglessis-Azuaje³², Abhijeet Dhoble³³, Adnan K Chhatriwalla³⁴, George Petrossian³⁵, Pinak Shah³⁶, Cezar Staniloae³⁷, Mathew Williams³⁷, Marcos Nores³⁸, James M McCabe³⁹, Gagan Singh⁴⁰, Stephan Baldus⁴¹, Volker Rudolph⁴², Ilie Barb⁴³, Charles Klodell⁴³, William Gray⁴⁴, Justin Strote⁴⁵, Anna Sannino⁴⁶, Paul Grayburn^{10

46}, Michael J Mack¹⁰, Martin B Leon², Vinod H Thourani⁷

Affiliations

¹ University Medical Centre Mainz, Mainz, Germany.
² Columbia University Irving Medical Center, New York, New York, USA.
³ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁴ Stanford University, Stanford, California, USA.
⁵ Northwestern University, Chicago, Illinois, USA.
⁶ Henry Ford Hospital, Detroit, Michigan, USA.
⁷ Piedmont Heart Institute, Atlanta, Georgia, USA.
⁸ Oregon Health & Science University, Portland, Oregon, USA.
⁹ Mayo Clinic, Rochester, Minnesota, USA.
¹⁰ Baylor Scott & White: The Heart Hospital Plano, Plano, Texas, USA.
¹¹ Intermountain Medical Center, Murray, Utah, USA.
¹² The Christ Hospital, Cincinnati, Ohio, USA.
¹³ Heart Center Leipzig at Leipzig University, Leipzig, Germany.
¹⁴ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
¹⁵ University of Virginia, Charlottesville, Virginia, USA.
¹⁶ The Cleveland Clinic Foundation, Cleveland, Ohio, USA.
¹⁷ Ascension St. Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
¹⁸ Kaiser San Francisco Medical Center, San Francisco, California, USA.
¹⁹ University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁰ Klinikum der Universität München, Munich, Germany.
²¹ Emory University Atlanta, Atlanta, Georgia, USA.
²² Vanderbilt University Medical Center, Nashville, Tennessee, USA.
²³ Montefiore Medical Center, The Bronx, New York, USA.
²⁴ Oklahoma Heart Institute, Tulsa, Oklahoma, USA.
²⁵ Sentara Norfolk General Hospital, Norfolk, Virginia, USA.
²⁶ University of Michigan Hospital and Health Systems, Ann Arbor, Michigan, USA.
²⁷ Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
²⁸ Sanger Heart and Vascular Institute, Advocate Health, Charlotte, North Carolina, USA.
²⁹ Ascension Via Christi Hospital, University of Kansas, Wichita, Kansas, USA.
³⁰ University Hospital Bonn, Bonn, Germany.
³¹ Scripps Memorial Hospital La Jolla, La Jolla, California, USA.
³² Massachusetts General Hospital, Boston, Massachusetts, USA.
³³ The University of Texas Health Science Center at Houston, Houston, Texas, USA.
³⁴ Saint Luke's Hospital of Kansas City, Kansas City, Missouri, USA.
³⁵ St. Francis Hospital, Roslyn, New York, USA.
³⁶ Brigham and Women's Hospital, Boston, Massachusetts, USA.
³⁷ New York University Langone Medical Center, New York, New York, USA.
³⁸ Florida Heart & Vascular Care - JFK, Atlantis, Florida, USA.
³⁹ University of Washington, Seattle, Washington, USA.
⁴⁰ UC Davis Medical Center Sacramento, Sacramento, California, USA.
⁴¹ University Hospital of Cologne, Cologne, Germany.
⁴² University of Bad Oyenhausen, Bad Oyenhausen, Germany.
⁴³ HCA Florida, North Florida Hospital, Gainesville, Florida, USA.
⁴⁴ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁴⁵ UC Health Northern Colorado (Medical Center of the Rockies), Loveland, Colorado, USA.
⁴⁶ Baylor Scott & White Research Institute Cardiac Imaging Core Laboratory, Plano, Texas.

PMID: 40878717
DOI: 10.1093/eurheartj/ehaf676

Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial

Philipp Lurz et al. Eur Heart J. 2025.

. 2025 Aug 29:ehaf676.

doi: 10.1093/eurheartj/ehaf676. Online ahead of print.

Authors

Affiliations

¹ University Medical Centre Mainz, Mainz, Germany.
² Columbia University Irving Medical Center, New York, New York, USA.
³ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁴ Stanford University, Stanford, California, USA.
⁵ Northwestern University, Chicago, Illinois, USA.
⁶ Henry Ford Hospital, Detroit, Michigan, USA.
⁷ Piedmont Heart Institute, Atlanta, Georgia, USA.
⁸ Oregon Health & Science University, Portland, Oregon, USA.
⁹ Mayo Clinic, Rochester, Minnesota, USA.
¹⁰ Baylor Scott & White: The Heart Hospital Plano, Plano, Texas, USA.
¹¹ Intermountain Medical Center, Murray, Utah, USA.
¹² The Christ Hospital, Cincinnati, Ohio, USA.
¹³ Heart Center Leipzig at Leipzig University, Leipzig, Germany.
¹⁴ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
¹⁵ University of Virginia, Charlottesville, Virginia, USA.
¹⁶ The Cleveland Clinic Foundation, Cleveland, Ohio, USA.
¹⁷ Ascension St. Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
¹⁸ Kaiser San Francisco Medical Center, San Francisco, California, USA.
¹⁹ University of Pennsylvania, Philadelphia, Pennsylvania, USA.
²⁰ Klinikum der Universität München, Munich, Germany.
²¹ Emory University Atlanta, Atlanta, Georgia, USA.
²² Vanderbilt University Medical Center, Nashville, Tennessee, USA.
²³ Montefiore Medical Center, The Bronx, New York, USA.
²⁴ Oklahoma Heart Institute, Tulsa, Oklahoma, USA.
²⁵ Sentara Norfolk General Hospital, Norfolk, Virginia, USA.
²⁶ University of Michigan Hospital and Health Systems, Ann Arbor, Michigan, USA.
²⁷ Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
²⁸ Sanger Heart and Vascular Institute, Advocate Health, Charlotte, North Carolina, USA.
²⁹ Ascension Via Christi Hospital, University of Kansas, Wichita, Kansas, USA.
³⁰ University Hospital Bonn, Bonn, Germany.
³¹ Scripps Memorial Hospital La Jolla, La Jolla, California, USA.
³² Massachusetts General Hospital, Boston, Massachusetts, USA.
³³ The University of Texas Health Science Center at Houston, Houston, Texas, USA.
³⁴ Saint Luke's Hospital of Kansas City, Kansas City, Missouri, USA.
³⁵ St. Francis Hospital, Roslyn, New York, USA.
³⁶ Brigham and Women's Hospital, Boston, Massachusetts, USA.
³⁷ New York University Langone Medical Center, New York, New York, USA.
³⁸ Florida Heart & Vascular Care - JFK, Atlantis, Florida, USA.
³⁹ University of Washington, Seattle, Washington, USA.
⁴⁰ UC Davis Medical Center Sacramento, Sacramento, California, USA.
⁴¹ University Hospital of Cologne, Cologne, Germany.
⁴² University of Bad Oyenhausen, Bad Oyenhausen, Germany.
⁴³ HCA Florida, North Florida Hospital, Gainesville, Florida, USA.
⁴⁴ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁴⁵ UC Health Northern Colorado (Medical Center of the Rockies), Loveland, Colorado, USA.
⁴⁶ Baylor Scott & White Research Institute Cardiac Imaging Core Laboratory, Plano, Texas.

PMID: 40878717
DOI: 10.1093/eurheartj/ehaf676

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 versus 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 randomised 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) hospitalisation 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% 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 hospitalisation 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.

Keywords: EVOQUE; TTVR; Transcatheter tricuspid valve replacement; massive/torrential TR; severe TR; tricuspid regurgitation.

© The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

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Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial

Affiliations

Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial

Authors

Affiliations

Abstract

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