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 大学欧文医学中心。她的长期目标是创造一种被认为是医疗保健标准的转变。 复杂先天性心脏病(CHD)患者的高级成像。具体来说，她的目标是 演示个性化3D打印模型的实用性和必要性，以便在 有复杂心脏异常的患者。为此，她将重点关注冠心病和心脏病患者 故障(HF)。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 心脏解剖结构多变，生理结构复杂。尽管结果如下，但这种差异仍然存在 VAD的放置在冠心病患者和非冠心病患者中被证明是相似的。成像技术，如 因为计算机断层扫描(CT)或磁共振成像(MRI)的局限性在于它们显示 心脏解剖的2D平面。3D打印模型允许外科医生在3D中将心脏解剖可视化为 他们将在手术室看到它。 这是一项前瞻性的多中心随机对照试验，评估了术前使用3D打印机的有效性。 个性化模型用于VAD和插管放置规划。这项研究的目的是：1)评估 3D打印心脏模型改善了CHD-HF患者VAD和插管放置位置的可视化 与2D成像相比。2)确定CHD-HF患者的围手术期因素和患者预后是否得到改善 患者使用3D打印模型进行VAD放置规划。这些目标将通过以下途径实现 实施外科调查工具并收集临床数据，以评估结果的改善情况。 外科医生将报告调查工具，即重要的外科标志，如插管地点的容易程度 与3D打印模型相比，在常规成像模式下可可视化。临床数据将进行比较 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，Faroqi博士是主要研究员。 Farooqi博士的职业发展计划包括以下学习模块和培训目标：1)培训 以患者为中心的研究方法和多中心研究2)外科调查设计和 实施3)获取图像和建立模型的方法4)研究传播和职业 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了她的学习目标。通过完成这项研究，法罗基博士 目的探讨3D打印技术在复杂冠心病患者术前计划中的意义。 这将导致一项独立的NIH提案，旨在证明合并这些项目的重要性 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 在复杂的冠心病患者的护理中纳入先进的影像方式。

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.