A Study Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment (IMMPACT)

摘要 Kanwal M. Farooqi 医学博士是哥伦比亚大学儿科心脏病学部儿科助理教授 欧文大学医学中心。她的长期目标是改变护理标准 复杂先天性心脏病 (CHD) 患者的先进成像。具体来说，她的目标是 展示个性化 3D 打印模型在手术前规划中的实用性和需求 患有复杂心脏异常的患者。为此，她将重点关注患有先心病和心脏病的患者 失败（高频）。冠心病和心力衰竭患者的心室辅助装置 (VAD) 仍未得到充分利用，部分原因是 高度可变的心脏解剖结构和复杂的生理学。尽管结果如下，但这种差异仍然存在 研究表明，患有和不患有先心病的患者的 VAD 放置相似。成像技术如 因为计算机断层扫描 (CT) 或磁共振成像 (MRI) 的局限性在于它们证明 二维平面中的心脏解剖结构。 3D 打印模型使外科医生能够以 3D 形式将心脏解剖结构可视化为 他们将在手术室看到它。 这是一项前瞻性多中心随机对照试验，评估术前使用 3D 打印的效用 用于 VAD 和插管放置规划的个性化模型。本研究的目的是： 1) 评估是否 3D 打印心脏模型改善了 CHD-HF 患者 VAD 和插管放置部位的可视化 与二维成像相比。 2) 确定 CHD-HF 的围手术期因素和患者预后是否有所改善 患者在 VAD 安置计划中使用 3D 打印模型。这些目标将通过 实施手术调查工具并收集临床数据以评估结果的改善。 外科医生将报告调查工具、重要手术标志（例如插管部位）的难易程度 与 3D 打印模型相比，在常规成像模式下可视化。将比较临床数据 在模型组和对照组之间进行评估，以评估心肺等临床变量的改善情况 旁路时间和 VAD 流量。 CUIMC 是这项研究的主要地点，Farooqi 博士是主要研究者。 Farooqi博士的职业发展计划由以下学习模块和培训目标组成： 1）培训 以患者为导向的研究方法和多中心研究进行 2) 手术调查设计和 实施 3) 图像采集和模型创建方法 4) 研究传播和职业生涯 发展。她组织的共同指导和咨询团队将帮助她获得这些技能 并通过这个奖项顺利完成她的学习目标。通过完成这项研究，Farooqi 博士 旨在证明 3D 打印在复杂先心病患者术前规划中的重要性。 这将导致一项独立的 NIH 提案，旨在证明纳入这些的重要性 涵盖更广泛的先天性心脏病病变和手术的模型，改变了我们对标准的看法 复杂 CHD 患者护理中先进影像模式的护理。

Abstract Kanwal M. Farooqi, MD is an Assistant Professor of Pediatrics in the Division of Pediatric Cardiology at Columbia University Irving Medical Center. Her long term goal is to create a shift in what is considered standard of care in advanced imaging for patients with complex congenital heart disease (CHD). Specifically, she aims to demonstrate the utility and need for inclusion of personalized 3D printed models for pre-procedural planning in patients with complex cardiac abnormalities. To that end, she will be focusing on patients with CHD and heart failure (HF). Ventricular assist devices (VAD) in patients with CHD and HF remain underutilized, in part due to the highly variable cardiac anatomy and complex physiology. This disparity exists despite outcomes following VAD placement having been shown to be similar in patients with and without CHD. Imaging technologies such as computed tomography (CT) or magnetic resonance imaging (MRI) are limiting in that they demonstrate cardiac anatomy in 2D planes. 3D printed models allow the surgeon to visualize the cardiac anatomy in 3D as they will see it in the operating room. This is a prospective multicenter randomized control trial assessing the utility of preoperative use of 3D printed personalized models use for VAD and cannula placement planning. The aims of this study are: 1) To assess if 3D printed cardiac models improve visualization of VAD and cannula placement sites in CHD-HF patients as compared to 2D imaging. 2) To determine if perioperative factors and patient outcomes improve in CHD-HF patients with use of 3D printed model in VAD placement planning. These aims will be accomplished through implementation of surgical survey tools and collection of clinical data to assess improvement in outcomes. Surgeons will report on survey tools, the ease with which important surgical landmarks such as cannula sites are visualized on routine modes of imaging as compared to a 3D printed model. Clinical data will be compared between the model and control group to assess improvement in clinical variables such as cardiopulmonary bypass time and VAD flows. CUIMC is the primary site for this study with Dr. Farooqi as the primary investigator. Dr. Farooqi’s career development plan consists of the following learning modules and training goals: 1) Training in patient oriented research methods and multicenter study conduction 2) Surgical survey design and implementation 3) Image acquisition and model creation methods 4) Research dissemination and career Development. The co-mentoring and advisory team which she has organized will help her to acquire these skills and successfully complete her learning goals through this award. Through completion of this study, Dr. Farooqi aims to demonstrate the significance of 3D printed in pre-procedural planning for patients with complex CHD. This will lead to an independent NIH proposal aiming to demonstrate the importance of incorporation of these models across a wider range of congenital heart lesions and procedures, changing the way we think of standard of care for advanced image modality inclusion in the care of patients with complex CHD.