Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation

心脏移植中全面的心脏结构功能分析

• 批准号: 9229057
• 负责人: James Carr
• 金额: $ 68.07万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-04 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9229057
• 关键词: Acute; Allografting; Ambulatory Care Facilities; Angiography; Area; Biopsy; Blood Vessels; Cardiac; Catheters; Cause of Death; Clinical; Clinical Research; Coronary; Coronary Angiography; Cost Effectiveness Analysis; Cost utility; Coupled; Data; Decision Modeling; Decision Trees; Detection; Diagnostic; Diagnostic tests; Diffuse; Disease; Early Diagnosis; Echocardiography; Edema; Evaluation; Event; Fibrosis; Follow-Up Studies; Functional disorder; Goals; Gold; Healthcare; Heart; Heart Transplantation; Impairment; Individual; Left; Life; Longitudinal Studies; Magnetic Resonance Imaging; Modality; Modeling; Monitor; Multimodal Imaging; Myocardial; Nature; Operative Surgical Procedures; Outcome; Patient Monitoring; Patients; Perfusion; Phase; Procedures; Protocols documentation; Quality of life; Reference Standards; Resources; Risk; Risk Factors; Sampling Errors; Savings; Sensitivity and Specificity; Standardization; Structure; Techniques; Testing; Thick; Time; Tissues; Transplant Recipients; Transplantation; Ultrasonography; Vascular Diseases; Visit; base; comparative cost effectiveness; cost; extracellular; follow-up; heart allograft; imaging study; improved; markov model; mortality; non-invasive imaging; novel; post intervention; public health relevance; standard of care; two-arm study

DESCRIPTION (provided by applicant): Heart transplant (Tx) surgery is a well-established life-saving procedure, but is associated with post- interventional risks such as acute cardiac rejection (ACR) which is one of the leading causes of death in the first year after transplant. Beyond the first year, cardiac allograft vasculopathy (CAV) is the single greatest risk factor for 5-year mortality. Monitoring the patient for post-transplant events is thus paramount. The standard monitoring strategy, however, relies on frequent (12-16 monitoring nodes during year 1 alone) invasive and costly procedures including endomyocardial biopsies (EMB) and catheter angiography. Since EMB and catheter angiography have limited sensitivity due to sampling errors (ACR) or the diffuse nature of the disease (CAV), a reliable non-invasive alternative for the early detection of ACR and CAV would be desirable to reduce the need for invasive procedures, improve sensitivity, and reduce cost. We have recently developed and applied cardiac MRI techniques for the non-invasive assessment of myocardial edema (T2-mapping), diffuse fibrosis (pre- and post-contrast T1-mapping), myocardial velocities (tissue phase mapping), and microvascular quantitative perfusion. We have shown that these techniques can identify distinct regional structural and functional alterations in the heart that correlate with te status of the allograft. Based on these findings, a detailed cost-effective analysis using Markov modeling and decision tree analysis has demonstrated that cardiac MR has tremendous potential to reduce monitoring costs by 40-50% during the first year after Tx alone. This proposal builds on these promising findings and our aim is to develop an new 15-minute structure-function cardiac MRI protocol for the improved detection regional abnormalities associated with ACR (edema, fibrosis, dysfunction) and CAV (perfusion, dysfunction). Integration of MRI with echocardiography and intravascular Ultrasound (IVUS) will provide unique multi-modality assessment of the allograft. The application in a longitudinal clinical study coupled with state-of-the-art cost-effectiveness analysis will allow redefining the most effective post-Tx mixed monitoring strategy. The aim is to to help clinicians identify the optimal mixed monitoring strategy, i.e. the optimal combination of multi-modality imaging (structure-function MRI, echo, IVUS) and invasive procedures (EMB, catheter angiography) which provide best outcome (quality adjusted life days) and lowest cost for the individual cardiac transplant patient.

描述（由申请人提供）：心脏移植（Tx）手术是一种成熟的挽救生命的手术，但与介入后风险相关，如急性心脏排斥反应（ACR），这是移植后第一年死亡的主要原因之一。超过第一年，心脏移植物血管病变（CAV）是5年死亡率的单一最大风险因素。因此，监测患者的移植后事件至关重要。然而，标准监测策略依赖于频繁的（仅在第1年期间就有12-16个监测节点）侵入性和昂贵的程序，包括肌内膜活检（EMB）和导管血管造影术。由于EMB和导管血管造影术由于采样误差（ACR）或疾病的扩散性质（CAV）而具有有限的灵敏度，因此期望用于ACR和CAV的早期检测的可靠的非侵入性替代方案，以减少对侵入性程序的需要，提高灵敏度并降低成本。我们最近开发并应用了心脏MRI技术，用于无创评估心肌水肿（T2标测）、弥漫性纤维化（造影前后T1标测）、心肌速度（组织相位标测）和微血管定量灌注。我们已经证明，这些技术可以识别与同种异体移植物状态相关的心脏不同区域的结构和功能改变。基于这些发现，使用马尔可夫模型和决策树分析的详细成本效益分析表明，心脏MR具有巨大的潜力，可在单独Tx后的第一年内将监测成本降低40-50%。该提案建立在这些有希望的发现的基础上，我们的目标是开发一种新的15分钟结构-功能心脏MRI方案，用于改善与ACR（水肿，纤维化，功能障碍）和CAV（灌注，功能障碍）相关的区域异常检测。MRI与超声心动图和血管内超声（IVUS）的结合将为同种异体移植物提供独特的多模态评估。在纵向临床研究中的应用 再加上最先进的成本效益分析，将允许重新定义最有效的Tx后混合监测策略。其目的是帮助临床医生确定最佳的混合监测策略，即多模态成像（结构-功能MRI、回波、IVUS）和侵入性程序（EMB、导管血管造影）的最佳组合，为个体心脏移植患者提供最佳结局（质量调整生命日）和最低成本。