Bedside right-heart catheterization for early diagnosis and more effective management of patients with heart failure and primary pulmonary hypertension

床边右心导管检查可对心力衰竭和原发性肺动脉高压患者进行早期诊断和更有效的治疗

• 批准号: 10696663
• 负责人: MICHAEL JOHN HEFFERNAN
• 金额: $ 20万
• 依托单位: FANNIN PARTNERS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-29 至 2024-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10696663
• 关键词: Bedside; right; heart; catheterization; early

PROJECT SUMMARY Over 3 million people are diagnosed with heart failure with preserved ejection fraction (HFpEF) annually in the US. Despite its high incidence, HFpEF is often not diagnosed until late in its course because the primary symptom, dyspnea, is common to other conditions including atrial fibrillation, lung disease, and/or obesity. Therefore, doctors order multiple examinations including brain natriuretic (BNP) blood tests, chest radiography, electrocardiogram, echocardiogram, and right heart catheterization (RHC) to determine underlying causes of symptoms before starting a treatment regimen. The most definitive diagnostic tool for HFpEF is RHC, a procedure in which a flow-directed catheter is inserted into the intrajugular (IJ) or femoral vein, guided to the heart, and used to take right heart hemodynamic measurements. Despite the high diagnostic utility of RHC, it is typically the last diagnostic step, as it must be performed in a catheterization laboratory (cath lab), which is associated with limited availability and high facility costs. These factors typically result in a long delay in obtaining a RHC diagnostic procedure, which can delay diagnosis and treatment. To address this need, the proposed Cygnet™ system is a flow-directed right heart microcatheter and deployment system for measuring pulmonary capillary wedge pressure (PCWP). It is adapted for use outside the cath lab for point-of-care right heart hemodynamic assessment by deploying a sterile microcatheter into an antecubital fossa vein through an 18- gauge IV sheath. A cardiologist controls the system to drive the microcatheter towards the pulmonary artery. The Cygnet design for the antecubital access contained in a small sterile field, enables a more accessible RHC that can be safely performed in any non-cath lab setting. Fannin Innovation Studio is collaborating with Dr. Reynolds Delgado of the Texas Heart Institute to develop the Cygnet microcatheter system. The Cygnet system can enable a more accessible RHC such that a hemodynamic assessment can be performed early in the diagnostic pathway, thus expediting the diagnosis and management of HFpEF. Specific aims: (1) Microcatheter and Guide Design and Development; (2) Pressure Sensor Design and Development; (3) Benchtop Model and Acute Swine Study Verification Testing. Completion of this Phase I project will demonstrate feasibility of the Cygnet microcatheter prototype for performing RHC in a non-cath lab setting, which will prepare for a Phase II project to develop the deployment system, refine catheter controls software, develop a torquing assembly, perform regulatory activities, and prepare for commercialization. The Cygnet microcatheter system will have a substantial impact on the early HFpEF diagnosis, classification, and management by making this important diagnostic tool available at bedside.

项目概要 每年有超过 300 万人被诊断患有射血分数保留型心力衰竭 (HFpEF) 尽管 HFpEF 的发病率很高，但由于原发性，通常要到病程晚期才被诊断出来。 呼吸困难症状是心房颤动、肺部疾病和/或肥胖等其他疾病的常见症状。 因此，医生要求进行多项检查，包括脑钠尿（BNP）血液检查、胸部X光检查、 心电图、超声心动图和右心导管检查 (RHC) 以确定心脏问题的根本原因 开始治疗方案之前的症状 最明确的 HFpEF 诊断工具是 RHC，一种 将血流导向导管插入颈内 (IJ) 或股静脉，引导至股静脉的手术 尽管 RHC 具有很高的诊断效用，但它还是用于进行右心血流动力学测量。 通常是最后的诊断步骤，因为它必须在导管实验室（cath lab）中进行，即 与有限的可用性和高昂的设施成本相关，这些因素通常会导致获取的时间较长。 RHC 诊断程序，可能会延迟诊断和治疗。为了满足这一需求，建议。 Cygnet™ 系统是一种血流导向的右心微导管和用于肺部测量的部署系统 毛细血管楔压 (PCWP) 适合在导管实验室外用于右心护理。 通过将无菌微导管通过 18- 插入肘前窝静脉进行血流动力学评估 心脏病专家控制系统将微导管推向肺动脉。 Cygnet 设计用于肘前通路，包含在一个小型无菌区域中，使 RHC 更容易接近 Fannin Innovation Studio 正在与 Dr. 合作，可以在任何非导管实验室环境中安全地进行。 德克萨斯心脏研究所的 Reynolds Delgado 开发了 Cygnet 微导管系统 Cygnet 系统。 可以实现更容易获得的 RHC，以便可以在早期进行血流动力学评估 诊断途径，从而加快 HFpEF 的诊断和治疗。 具体目标：（1）微导管和导管设计与开发；（2）压力传感器设计与开发； 开发；(3) 台式模型和急性猪研究验证测试。 第一阶段项目的完成将证明 Cygnet 微导管原型的可行性 在非导管实验室环境中执行 RHC，这将为开发部署的第二阶段项目做准备 系统，完善导管控制软件，开发扭矩组件，执行监管活动，以及 Cygnet微导管系统的商业化准备将对早期产生重大影响。 通过在床边提供这一重要的诊断工具来进行 HFpEF 诊断、分类和管理。