{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:57:23Z","timestamp":1792803443387,"version":"4.5.0"},"reference-count":23,"publisher":"American Medical Association (AMA)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,1,14]]},"abstract":"\n Importance<\/jats:title>\n Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy of T-TEER\u2009+\u2009OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Investigator-initiated, prospective, randomized (1:1) trial evaluating T-TEER\u2009+\u2009OMT vs OMT alone in adult patients with severe, symptomatic tricuspid regurgitation. The trial was conducted at 24 centers in France and Belgium (March 2021 to March 2023; latest follow-up in April 2024).<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Patients were randomized to T-TEER\u2009+\u2009OMT or OMT alone.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was a composite clinical end point at 1 year comprising change in New York Heart Association class, change in patient global assessment, or occurrence of major cardiovascular events. Tricuspid regurgitation severity was the first of 6 secondary outcomes analyzed in a hierarchical closed-testing procedure, including Kansas City Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a composite outcome of all-cause death, tricuspid valve surgery, KCCQ score improvement, or time to hospitalization for heart failure.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women), 152 were allocated to T-TEER\u2009+\u2009OMT and 148 to OMT alone. At 1 year, 109 patients (74.1%) in the T-TEER\u2009+\u2009OMT group had an improved composite score compared with 58 patients (40.6%) in the OMT-alone group. Massive or torrential tricuspid regurgitation was found in 6.8% of patients in the T-TEER\u2009+\u2009OMT group and in 53.5% of those in the OMT-alone group (\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Mean overall KCCQ summary score at 1 year was 69.9 (SD, 25.5) for the T-TEER\u2009+\u2009OMT group and 55.4 (SD, 28.8) for the OMT-alone group (\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) (\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n T-TEER reduces tricuspid regurgitation severity and improves a composite score driven by improved patient-reported outcome measures in patients with severe, symptomatic tricuspid regurgitation.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04646811<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2024.21189","type":"journal-article","created":{"date-parts":[[2024,11,27]],"date-time":"2024-11-27T11:33:09Z","timestamp":1732707189000},"page":"124","source":"Crossref","is-referenced-by-count":171,"title":["Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid 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