{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T02:45:34Z","timestamp":1791945934515,"version":"4.3.4"},"reference-count":23,"publisher":"American Medical Association (AMA)","issue":"18","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2026,5,12]]},"abstract":"\n Importance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Population<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Exposure<\/jats:title>\n Device-enabled TTVR.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n 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%;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) and mean KCCQ-OS score (22.4 points;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) from baseline to 30 days. There were no significant differences in 30-day mortality (\n P<\/jats:italic>\n \u2009=\u2009.47), heart failure hospitalization (\n P<\/jats:italic>\n \u2009&amp;gt;\u2009.99), and functional outcomes (\n P<\/jats:italic>\n \u2009=\u2009.55) when patients were stratified by baseline CIED status.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2026.3446","type":"journal-article","created":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T15:30:29Z","timestamp":1776094229000},"page":"1606","source":"Crossref","is-referenced-by-count":8,"title":["Real-World Outcomes of Transcatheter Tricuspid Valve Replacement"],"prefix":"10.1001","volume":"335","author":[{"given":"Raj R.","family":"Makkar","sequence":"first","affiliation":[{"name":"Cedars-Sinai Medical Center, Los Angeles, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aakriti","family":"Gupta","sequence":"additional","affiliation":[{"name":"Cedars-Sinai Medical Center, Los Angeles, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian P.","family":"O\u2019Neill","sequence":"additional","affiliation":[{"name":"Henry Ford Heart & Vascular Institute, Henry Ford Hospital, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Lalani","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. 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