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

IF 21.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of the American College of Cardiology Pub Date : 2024-11-20 DOI:10.1016/j.jacc.2024.09.009

João L. Cavalcante, Markus Scherer, Miho Fukui, Stamatios Lerakis, Serge Harb, Amit Pursnani, Jonathan G. Schwartz, Samir Kapadia, Mark J. Ricciardi, Omar Khalique, Susheel Kodali, Dipan Shah, Steven H. Little, Nishant Sekaran, Brian Whisenant, Peter Flueckiger, Pradeep Yadav, Abbas Emaminia, Wayne Batchelor, Peter Kellman, Paul Sorajja

{"title":"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","authors":"João L. Cavalcante, Markus Scherer, Miho Fukui, Stamatios Lerakis, Serge Harb, Amit Pursnani, Jonathan G. Schwartz, Samir Kapadia, Mark J. Ricciardi, Omar Khalique, Susheel Kodali, Dipan Shah, Steven H. Little, Nishant Sekaran, Brian Whisenant, Peter Flueckiger, Pradeep Yadav, Abbas Emaminia, Wayne Batchelor, Peter Kellman, Paul Sorajja","doi":"10.1016/j.jacc.2024.09.009","DOIUrl":null,"url":null,"abstract":"<h3>Background</h3>The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging.<h3>Objectives</h3>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).<h3>Methods</h3>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).<h3>Results</h3>Sixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (<em>P</em> < 0.0001; 70% reduction). A strong association (r = 0.90; <em>P</em> < 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; <em>P</em> < 0.001) and tricuspid annular area (11% reduction; <em>P</em> < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group.<h3>Conclusions</h3>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; <span><span>NCT03904147</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>)","PeriodicalId":17187,"journal":{"name":"Journal of the American College of Cardiology","volume":"53 1","pages":""},"PeriodicalIF":21.7000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy\",\"authors\":\"João L. Cavalcante, Markus Scherer, Miho Fukui, Stamatios Lerakis, Serge Harb, Amit Pursnani, Jonathan G. Schwartz, Samir Kapadia, Mark J. Ricciardi, Omar Khalique, Susheel Kodali, Dipan Shah, Steven H. Little, Nishant Sekaran, Brian Whisenant, Peter Flueckiger, Pradeep Yadav, Abbas Emaminia, Wayne Batchelor, Peter Kellman, Paul Sorajja\",\"doi\":\"10.1016/j.jacc.2024.09.009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3>Background</h3>The impact of tricuspid regurgitation (TR) on cardiac remodeling has not been thoroughly studied in a randomized controlled trial using advanced imaging.<h3>Objectives</h3>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).<h3>Methods</h3>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).<h3>Results</h3>Sixty-nine randomized subjects (31 TriClip, 38 control) were enrolled. TR volume significantly decreased with TriClip at 30 days (<em>P</em> < 0.0001; 70% reduction). A strong association (r = 0.90; <em>P</em> < 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; <em>P</em> < 0.001) and tricuspid annular area (11% reduction; <em>P</em> < 0.0001) were seen at 30 days and sustained through 1 year with TriClip. No meaningful changes were observed in the control group.<h3>Conclusions</h3>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; <span><span>NCT03904147</span><svg aria-label=\\\"Opens in new window\\\" focusable=\\\"false\\\" height=\\\"20\\\" viewbox=\\\"0 0 8 8\\\"><path d=\\\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\\\"></path></svg></span>)\",\"PeriodicalId\":17187,\"journal\":{\"name\":\"Journal of the American College of Cardiology\",\"volume\":\"53 1\",\"pages\":\"\"},\"PeriodicalIF\":21.7000,\"publicationDate\":\"2024-11-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the American College of Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jacc.2024.09.009\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American College of Cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jacc.2024.09.009","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

摘要

背景三尖瓣反流（TR）对心脏重塑的影响尚未在随机对照试验中使用先进的成像技术进行深入研究。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）对随机接受 TriClip 与药物治疗（对照组）的无症状重度 TR 患者的右心重塑纵向变化进行比较。方法TRILUMINATE Pivotal（三尖瓣修复系统治疗患者心血管预后评估临床试验）是一项针对无症状重度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了心脏磁共振和 4D-CT 检查，并在 1 年时进行了最终的 4D-CT 检查（所有检查均由成像核心实验室评估）。使用 TriClip 30 天后，TR 体积明显减少（P < 0.0001; 减少 70%）。30天时，TR容积的变化与右心室舒张末期容积之间有很强的相关性（r = 0.90; P < 0.0001）。使用 TriClip 30 天后，右心室舒张末期容积（减少 12%；P< 0.001）和三尖瓣环面积（减少 11%；P< 0.0001）显著减少，并持续一年。结论 TRILUMINATE Pivotal 成像子研究的高级成像显示，TriClip 能有效降低 TR。在 30 天内观察到显著的心脏重塑，并在 1 年内持续。使用 TriClip 后，心脏重塑的程度与 TR 减少的程度相关。(评估三尖瓣修复系统治疗患者心血管效果的临床试验中枢；NCT03904147）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy

查看原文本刊更多论文

Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy

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)

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Journal of the American College of Cardiology 医学-心血管系统

CiteScore

42.70

自引率

3.30%

发文量

5097

审稿时长

2-4 weeks

期刊介绍： The Journal of the American College of Cardiology (JACC) publishes peer-reviewed articles highlighting all aspects of cardiovascular disease, including original clinical studies, experimental investigations with clear clinical relevance, state-of-the-art papers and viewpoints. Content Profile: -Original Investigations -JACC State-of-the-Art Reviews -JACC Review Topics of the Week -Guidelines & Clinical Documents -JACC Guideline Comparisons -JACC Scientific Expert Panels -Cardiovascular Medicine & Society -Editorial Comments (accompanying every Original Investigation) -Research Letters -Fellows-in-Training/Early Career Professional Pages -Editor’s Pages from the Editor-in-Chief or other invited thought leaders