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

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 Smith, Brian Whisenant, Santiago Garcia, Tobias Kister, Robert M Kipperman, 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 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

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.

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PMID: 40878717

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