Sabina Istratoaie, Pascal de Groote, Nicole Karam, Jean-Noel Trochu, Guillaume Leurent, Augustin Coisne, Pierre-Yves Le Roux, Anne Ganivet, Anne Bernard, Antoinette Neylon, Romain Pierrard, Florent Le Ven, François Picard, Nicolas Piriou, Thierry Laperche, Jerome Jouan, Amedeo Anselmi, Vincent Auffret, Emmanuel Oger, Erwan Donal
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The purpose of this study was to describe the longitudinal impact of T-TEER on different dimensions and items of quality of life compared with guideline-directed medical treatment (OMT) alone.</p>\n </section>\n \n <section>\n \n <h3> Methods and results</h3>\n \n <p>Patients were randomized to T-TEER +OMT (<i>n</i> = 152) or OMT alone (<i>n</i> = 148). Health status was assessed at baseline, 6 weeks, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Minnesota Living with Heart Failure (MLHF) Questionnaire. Mixed effects linear regression analysed changes over time. Patients receiving T-TEER + OMT experienced a significant increase in KCCQ overall summary score (KCCQ-OS) at all time points: +17.0 points (95% confidence interval [CI] 13.1–21.5) at 6 weeks, +15.9 points (95% CI 11.2–20.6) at 6 months, and +18.7 points (95% CI 13.8–23.6) at 1 year. The mean between-group difference in KCCQ-OS was +10.3 points (95% CI 5.6–15.0) in favour of T-TEER + OMT, evident at 6 weeks and sustained for 1 year. Similarly, MLHF total scores improved significantly in the T-TEER group (mean between-group difference −8.61 points, 95% CI –12.6 to −4.6), including physical (−3.9, 95% CI –5.9 to −1.9) and emotional (−2.2, 95% CI –3.4 to −1.0) subscales.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Compared with OMT alone, T-TEER resulted in substantial, multidimensional, and sustained improvements in patient-reported quality of life. 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引用次数: 0
摘要
目标:在三。FR试验中,三尖瓣经导管边缘到边缘修复(T-TEER)降低了三尖瓣反流(TR)的严重程度,并提高了综合临床评分,由患者报告的结果驱动。本研究的目的是描述T-TEER对生活质量不同维度和项目的纵向影响,并与单纯的指导医学治疗(OMT)进行比较。方法和结果:患者随机分为T-TEER +OMT组(n = 152)和OMT组(n = 148)。使用堪萨斯城心肌病问卷(KCCQ)和明尼苏达州心力衰竭患者问卷(MLHF)评估基线、6周、6个月和1年的健康状况。混合效应线性回归分析了随时间的变化。接受T-TEER + OMT的患者在所有时间点的KCCQ总总结评分(KCCQ- os)均显著增加:6周时+17.0分(95%置信区间[CI] 13.1-21.5), 6个月时+15.9分(95% CI 11.2-20.6), 1年时+18.7分(95% CI 13.8-23.6)。KCCQ-OS组间平均差异为+10.3点(95% CI 5.6-15.0),有利于T-TEER + OMT,在6周时明显,持续1年。同样,T-TEER组MLHF总分显著提高(组间平均差为-8.61分,95% CI为-12.6至-4.6),包括身体(-3.9分,95% CI为-5.9至-1.9分)和情绪(-2.2分,95% CI为-3.4至-1.0分)。结论:与单独的OMT相比,T-TEER在患者报告的生活质量方面产生了实质性的、多方面的和持续的改善。这些发现强化了T-TEER在治疗严重症状性TR中的价值。
Quality of life after transcatheter tricuspid valve repair: results from the Tri.FR trial
Aims
In the Tri.FR trial, tricuspid transcatheter edge-to-edge repair (T-TEER) reduced severity of tricuspid regurgitation (TR) and improved the composite clinical score, driven by patient-reported outcomes. The purpose of this study was to describe the longitudinal impact of T-TEER on different dimensions and items of quality of life compared with guideline-directed medical treatment (OMT) alone.
Methods and results
Patients were randomized to T-TEER +OMT (n = 152) or OMT alone (n = 148). Health status was assessed at baseline, 6 weeks, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Minnesota Living with Heart Failure (MLHF) Questionnaire. Mixed effects linear regression analysed changes over time. Patients receiving T-TEER + OMT experienced a significant increase in KCCQ overall summary score (KCCQ-OS) at all time points: +17.0 points (95% confidence interval [CI] 13.1–21.5) at 6 weeks, +15.9 points (95% CI 11.2–20.6) at 6 months, and +18.7 points (95% CI 13.8–23.6) at 1 year. The mean between-group difference in KCCQ-OS was +10.3 points (95% CI 5.6–15.0) in favour of T-TEER + OMT, evident at 6 weeks and sustained for 1 year. Similarly, MLHF total scores improved significantly in the T-TEER group (mean between-group difference −8.61 points, 95% CI –12.6 to −4.6), including physical (−3.9, 95% CI –5.9 to −1.9) and emotional (−2.2, 95% CI –3.4 to −1.0) subscales.
Conclusions
Compared with OMT alone, T-TEER resulted in substantial, multidimensional, and sustained improvements in patient-reported quality of life. These findings reinforce the value of T-TEER in managing severe symptomatic TR.
期刊介绍:
ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.