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Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation

2024; American Medical Association; Volume: 333; Issue: 2 Linguagem: Inglês

10.1001/jama.2024.21189

1538-3598

Erwan Donal, Julien Dreyfus, Guillaume Leurent, Augustin Coisne, Pierre-Yves Leroux, Anne Ganivet, Catherine Sportouch, Yoan Lavie‐Badie, Patrice Guérin, Frédéric Rouleau, Christelle Diakov, Jan Van der Heyden, Stéphane Lafitte, Jean‐François Obadia, Mohammed Nejjari, Nicole Karam, Anne Bernard, Antoinette Neylon, Romain Pierrard, Didier Tchétché, Saïd Ghostine, Grégory Ducrocq, Thiziri Si Moussi, Antoine Jeu, Marcel Peltier, Bernard Cosyns, Yvan Le Dolley, G. Habib, Vincent Auffret, Florent Le Ven, François Picard, Nicolas Piriou, Thierry Laperche, Elena Galli, Sabina Istrătoaie, Jérôme Jouan, Guillaume Bonnet, Pascal de Groote, Amédéo Anselmi, Jean‐Noël Trochu, Emmanuel Oger,

Cardiovascular Function and Risk Factors

Importance 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. Objective To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation. Design, Setting, and Participants Investigator-initiated, prospective, randomized (1:1) trial evaluating T-TEER + OMT 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). Intervention Patients were randomized to T-TEER + OMT or OMT alone. Main Outcomes and Measures 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. Results Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women), 152 were allocated to T-TEER + OMT and 148 to OMT alone. At 1 year, 109 patients (74.1%) in the T-TEER + OMT 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 + OMT group and in 53.5% of those in the OMT-alone group ( P < .001). Mean overall KCCQ summary score at 1 year was 69.9 (SD, 25.5) for the T-TEER + OMT group and 55.4 (SD, 28.8) for the OMT-alone group ( P < .001). The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) ( P < .001). Conclusions and Relevance 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. Trial Registration ClinicalTrials.gov Identifier: NCT04646811