Background

The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging.

Objectives

The goal of this analysis was to provide comparative longitudinal changes in right heart remodeling using cardiac magnetic resonance and time-resolved functional computed tomography (4D-CT) in patients with symptomatic severe TR randomized to TriClip vs medical therapy (control).

Methods

TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is an international randomized controlled trial in symptomatic patients with severe TR. A prospective imaging substudy was performed on TRILUMINATE Pivotal subjects at 10 sites. Cardiac magnetic resonance and 4D-CT were performed following dedicated imaging protocols at baseline and at 30 days, and a final 4D-CT at 1 year (all assessed by an imaging core lab).

Results

Sixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (P < 0.0001; 70% reduction). A strong association (r = 0.90; P < 0.0001) was observed between changes in TR volume and right ventricular end-diastolic volume at 30 days. Significant reductions in right ventricular end-diastolic volume (12% reduction; P < 0.001) and tricuspid annular area (11% reduction; P < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group.

Conclusions

Advanced imaging from the TRILUMINATE Pivotal imaging substudy demonstrated that TriClip effectively reduced TR. Significant cardiac remodeling was observed at 30 days and sustained at 1 year. With TriClip, the extent of cardiac remodeling was associated with the degree of TR reduction. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal; NCT03904147)

中文翻译：

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三尖瓣反流对心脏重塑影响的高级成像评估：TRILUMINATE 关键成像子研究

 背景

三尖瓣反流 （TR） 对心脏重塑的影响尚未在使用先进成像的随机对照试验中得到彻底研究。

 目标

本分析的目的是使用心脏磁共振和时间分辨功能计算机断层扫描 （4D-CT） 对随机分配到 TriClip 与药物治疗 （对照） 的症状性严重 TR 患者进行右心重塑的纵向变化。

 方法

TRILUMINATE Pivotal（评估接受三尖瓣修复系统 Pivotal 治疗的患者心血管结局的临床试验）是一项针对有症状的严重 TR 患者的国际随机对照试验。在 10 个地点对 TRILUMINATE Pivotal 受试者进行了一项前瞻性成像子研究。在基线和 30 天时按照专用成像方案进行心脏磁共振和 4D-CT，并在 1 年时进行最终的 4D-CT（均由成像核心实验室评估）。

 结果

纳入了 69 名随机受试者 （31 名 TriClip，38 名对照）。TriClip 在 30 天时 TR 体积显著降低 （P < 0.0001;减少 70%）。强关联 （r = 0.90;P < 0.0001） 在 30 天时 TR 体积和右心室舒张末期容积的变化之间观察到。右心室舒张末期容积显著减少（减少 12%;P < 0.001） 和三尖瓣环面积 （减少 11%;P < 0.0001） 在 30 天时出现，并使用 TriClip 持续 1 年。在对照组中没有观察到有意义的变化。

 结论

来自 TRILUMINATE Pivotal 成像子研究的先进成像表明，TriClip 有效减少了 TR。在 30 天时观察到显着的心脏重塑，并在 1 年时持续。使用 TriClip，心脏重塑的程度与 TR 减少的程度相关。（评估接受三尖瓣修复系统 Pivotal 治疗的患者的心血管结果的临床试验;NCT03904147）