{"id":"ca0f7ab8540a","type":"article","url":"https://hartvaat.nl/2025/01/09/transcatheter-klepvervanging-bij-ernstige-tricuspidalisinsufficientie-nejm/","title":"Transcatheter klepvervanging bij ernstige tricuspidalisinsufficiëntie — NEJM","title_en":"Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2401918","source_url":"https://doi.org/10.1056/NEJMoa2401918","authors":["Rebecca T Hahn","Raj Makkar","Vinod H Thourani","Moody Makar","Rahul P Sharma","Christiane Haeffele","Charles J Davidson","Akhil Narang","Brian O'Neill","James Lee","Pradeep Yadav","Firas Zahr","Scott Chadderdon","Mackram Eleid","Sorin Pislaru","Robert Smith","Molly Szerlip","Brian Whisenant","Nishant K Sekaran","Santiago Garcia","Terri Stewart-Dehner","Holger Thiele","Robert Kipperman","Konstantinos Koulogiannis","D Scott Lim","Dale Fowler","Samir Kapadia","Serge C Harb","Paul A Grayburn","Anna Sannino","Michael J Mack","Martin B Leon","Philipp Lurz","Susheel K Kodali"],"significance":9,"published":"2025-01-09","source_date":"2025-01-09","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/palliatief-hartfalen/"],"congress":"","summary_en":"This NEJM trial showed that transcatheter tricuspid valve replacement significantly improved symptoms, quality of life, and functional status in patients with severe tricuspid regurgitation. The results establish transcatheter replacement as a viable option for severe TR when repair alone may be insufficient.","created":"2026-07-03T10:31:25Z","updated":"2026-07-03T13:30:26Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM-trial van transcatheter tricuspidalisklepvervanging bij ernstige TR toonde significante verbetering van symptomen en kwaliteit van leven. Dit opent een nieuw tijdperk voor transcatheter behandeling van de tricuspidalisklep.","abstract_original":"BACKGROUND: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. METHODS: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. RESULTS: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). CONCLUSIONS: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.)."}