MRI of Mechanical Activation and Scar for Optimal Cardiac Resynchronization Therapy Implementation

机械激活和疤痕的 MRI 用于最佳心脏再同步治疗的实施

基本信息

批准号：
9544361
负责人：
Kenneth C Bilchick
金额：
$ 71.1万
依托单位：
UNIVERSITY OF VIRGINIA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-01 至 2020-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9544361
关键词：
Address Anatomy Area Breathing Bundle-Branch Block Cardiac Characteristics Cicatrix Clinical Clinical Trials Complement Contracts Data Defibrillators Development Devices Diagnosis Dimensions Disease Equipoise Evaluation Financial compensation Gadolinium Generations Goals Guidelines Health Heart Heart Diseases Heart Valve Diseases Heart failure Hospitalization Image Image Analysis Imaging Techniques Implant Individual Intervention Lead Left Left Ventricular Function Life Location MRI Scans Magnetic Resonance Imaging Measurement Measures Mechanics Methods Mission Morphologic artifacts Motion Myocardial Infarction National Heart, Lung, and Blood Institute Nature Pacemakers Patients Performance Positioning Attribute Predictive Factor Procedures Protocols documentation Pump Randomized Randomized Clinical Trials Recovery Reproducibility Research Research Personnel Savings Signal Transduction Site Structure of left gastric vein Subgroup System Testing To specify United States Ventricular Ventricular End-Systolic Volumes Width base cardiac resynchronization therapy cardiovascular visualization congenital heart disorder contrast enhanced data space design functional improvement group intervention heart disease risk heart function high resolution imaging imaging modality implantation improved improved outcome novel outcome forecast programs randomized trial response statistics two-dimensional

项目摘要

Project Summary The overarching goal of this project is to use MRI guidance of cardiac resynchronization therapy (CRT) to improve outcomes for heart failure patients selected to undergo this procedure. The importance of using advanced cardiac imaging to make CRT more effective is highlighted by the following statistics: at least 5 million people in the United States have heart failure, 2.5 million require hospitalization, and more than 500,000 are diagnosed with heart failure each year. As a result, this research is highly aligned with the mission of the National Heart, Lung, and Blood Institute to enhance the health of individuals with heart disease or at risk for heart disease so they can live longer and more fulfilling lives. Over the past decade, CRT has emerged as a highly beneficial treatment for many patients with heart failure. CRT involves implantation of an advanced pacemaker/defibrillator attached to three wires in the heart designed to make unevenly pumping hearts contract more synchronously and effectively. Unfortunately, 35-50% of patients do not have improved heart function after CRT, often because of suboptimal positioning of the pacing wires with respect to scar and mechanical activation. In this regard, we have previously demonstrated how MRI strain imaging with the DENSE (Displacement Encoding with Stimulated Echoes) method and contrast-enhanced MRI assessment of scar and coronary veins in the heart can identify the optimal location of the left ventricular CRT pacing site relative to scar and mechanical activation. As a result, there is clinical equipoise for a systematic evaluation with a randomized clinical trial of CRT guided by cardiac MRI for assessment of mechanical activation, scar, and coronary vein anatomy in the heart in order to improve outcomes after CRT. We will randomize 105 patients in a 1:1 ratio, and the primary endpoint will be improvement of left ventricular function as measured by the percent reduction in the left ventricular end systolic volume 6 months after CRT implantation. In the project, we will further refine DENSE strain imaging by improving both three-dimensional and multislice two-dimensional imaging during free breathing by employing imaging-based and projection-based “navigators.” This is very important because breathing during conventional imaging leads to artifacts in the images, and a significant number of patients with heart disease and heart failure have difficulty holding their breath. In addition, there are an increasing number of CRT pacing settings, and the project also addresses an unmet need for evaluation of the optimal CRT pacing strategy using reproducible assessments of cardiac functional improvement with cardiac MRI to complement echocardiographic assessments. In addition to the application of these methods in CRT, we also emphasize that the improved MRI methods have potential far- reaching applications for other patients with myocardial infarction, valvular heart disease, congenital heart disease, and other types of heart disease. 1

项目概要该项目的总体目标是利用 MRI 指导心脏再同步治疗 (CRT) 改善选择接受该手术的心力衰竭患者的治疗效果。以下统计数据强调了先进的心脏成像使 CRT 更加有效：至少 500 万美国有250万人患有心力衰竭，需要住院治疗，超过50万人需要住院治疗每年都会被诊断出心力衰竭，因此这项研究与国家使命高度一致。心肺血液研究所致力于增强心脏病患者或有心脏病风险的人的健康使他们能够活得更长久、更充实。在过去的十年里，CRT 已成为一种非常有益的疗法。许多心力衰竭患者的治疗包括植入先进的起搏器/除颤器。连接到心脏中的三根电线，旨在使不均匀泵血的心脏更同步地收缩不幸的是，35-50% 的患者在 CRT 后心功能并未得到改善，这通常是因为起搏线在疤痕和机械激活方面的次优定位在这方面，我们。之前已经演示了如何使用 DENSE（带受激位移编码）进行 MRI 应变成像 echoes）方法和对比增强 MRI 评估心脏中的疤痕和冠状静脉可以识别左心室 CRT 起搏部位相对于疤痕和机械激活的最佳位置。心脏指导下的 CRT 随机临床试验的系统评估具有临床均衡性 MRI 用于评估心脏的机械激活、疤痕和冠状静脉解剖结构，以改善心脏功能 CRT 后的结果我们将以 1:1 的比例随机分组 105 名患者，主要终点是改善。通过左心室收缩末容积减少百分比来衡量左心室功能 6 CRT 植入几个月后，我们将通过改进两者来进一步完善 DENSE 应变成像。通过采用基于成像的方法，在自由呼吸期间进行三维和多层二维成像和基于投影的“导航器”。这非常重要，因为传统成像期间的呼吸会导致图像中的伪影，并且大量患有心脏病和心力衰竭的患者难以另外，还有越来越多的CRT调速设置，以及项目也越来越多。解决了使用可重复评估来评估最佳 CRT 起搏策略的未满足需求除了超声心动图评估之外，心脏 MRI 还可改善心脏功能。在这些方法在 CRT 中的应用中，我们还强调改进的 MRI 方法具有潜在的远达到其他心肌梗死、瓣膜性心脏病、先天性心脏病患者的应用疾病和其他类型的心脏病。 1