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

先天性心脏病治疗中机械循环支持术前评估模型的研究 (IMMPACT)

• 批准号: 10507509
• 负责人: Kanwal Majeed Farooqi
• 金额: $ 17.09万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-25 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10507509
• 关键词: 3-Dimensional; 3D Print; Advisory Committees; Affect; Anatomic Models; Anatomy; Award; Blood Circulation; Cannulas; Cardiac; Cardiac Output; Cardiopulmonary Bypass; Characteristics; Clinical; Clinical Data; Collection; Common Ventricle; Complex; Congenital Abnormality; Control Groups; Data; Data Set; Development Plans; Diagnosis; Disease; Early Diagnosis; Enrollment; Fontan Procedure; Goals; Heart; Heart Abnormalities; Heart Transplantation; Heart failure; Hospitals; Image; Imaging Techniques; Imaging technology; Intensive Care; Intervention; Investigation; Investigative Reports; Learning; Learning Module; Lesion; Life; Life Expectancy; Longevity; Magnetic Resonance Imaging; Measures; Medical; Medical center; Mentors; Methods; Modeling; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multicenter Studies; Operating Rooms; Operative Surgical Procedures; Outcome; Outcome Measure; Patient Care; Patient imaging; Patient-Focused Outcomes; Patients; Pediatric cardiology; Pediatrics; Perioperative; Physiology; Population; Positioning Attribute; Postoperative Period; Procedures; Questionnaires; Randomized; Randomized Controlled Trials; Reporting; Research; Research Methodology; Research Personnel; Right ventricular structure; Secondary to; Site; Surgeon; Surveys; Techniques; Time; Training; United States National Institutes of Health; Universities; Visualization; Waiting Lists; X-Ray Computed Tomography; career development; congenital heart disorder; design; disorder subtype; effective therapy; experience; high risk; hospital readmission; imaging modality; implantable device; improved; improved outcome; innovative technologies; left ventricular assist device; malformation; mechanical circulatory support; mortality; palliate; patient oriented research; primary outcome; professor; prospective; research data dissemination; response; routine care; skills; standard of care; three-dimensional modeling; tool; two-dimensional; ventricular assist device

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.

抽象的 医学博士Kanwal M. Farooqi是哥伦比亚儿科心脏病学科儿科学的助理教授 大学欧文医学中心。她的长期目标是在被认为是护理标准的转变 患有复杂先天性心脏病（CHD）患者的高级成像。特别是，她的目标是 展示了将个性化的3D印刷模型包含在术前计划的实用性和需求 心脏异常复杂的患者。为此，她将专注于冠心病和心脏的患者 失败（HF）。冠心病和HF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。此差异存在目的地结果 VAD放置在患有和没有CHD的患者中相似。成像技术 由于计算机断层扫描（CT）或磁共振成像（MRI）是有限的，因为它们证明了 2D平面的心脏解剖结构。 3D印刷模型允许外科医生在3D中可视化心脏解剖学 他们会在手术室看到它。 这是一项预期的多中心随机对照试验，评估了术前使用3D打印的效用 个性化模型用于VAD和套管安置计划。这项研究的目的是：1）评估是否是否 3D印刷心脏模型改善了冠心病患者中VAD和套管放置位点的可视化，因为 与2D成像相比。 2）确定周期性因素和患者预后是否有所改善 在VAD放置计划中使用3D打印模型的患者。这些目标将通过 实施手术调查工具和收集临床数据以评估结果的改进。 外科医生将报道调查工具，这是一种重要的外科地标，例如套管网站 与3D打印模型相比，在常规成像模式上可视化。将比较临床数据 在模型和对照组之间评估临床变量（例如心肺）的改进 旁路时间和vad流动。 CUIMC是这项研究的主要地点，而Farooqi博士是主要研究者。 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 在以患者为导向的研究方法和多中心研究传导中2）手术调查设计和 实施3）图像获取和模型创建方法4）研究传播和职业 发展。她组织的联盟和咨询团队将帮助她获得这些技能 并通过此奖项成功完成她的学习目标。通过完成这项研究，Farooqi博士 旨在证明对复杂冠心病患者的3D印刷的3D印刷的意义。 这将导致独立的NIH提议旨在证明保险的重要性 跨越多种先天性心脏病变和程序的模型，改变了我们对标准的看法 护理高级图像方式包含在复杂CHD患者的护理中。