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

项目总结 每年有300多万人被诊断为心力衰竭并保留射血分数(HFpEF)。 我们。尽管HFpEF的发病率很高，但通常直到病程后期才被诊断出来，因为 呼吸困难是其他疾病的常见症状，包括心房颤动、肺部疾病和/或肥胖。 因此，医生要求进行多项检查，包括脑利钠(BNP)血液测试、胸部X光检查、 心电图、超声心动图和右心导管术(RHC)以确定潜在原因 在开始治疗方案之前出现症状。对HFpEF最权威的诊断工具是RHC，一种 将导流导管插入颈静脉(Ij)或股静脉的过程，引导至 心脏，并用于进行右心血流动力学测量。尽管RHC具有很高的诊断效用，但它是 通常是最后一个诊断步骤，因为它必须在插管实验室(导管实验室)中执行，这是 与有限的可获得性和高昂的设施成本相关。这些因素通常会导致获取 RHC诊断程序，可能会延误诊断和治疗。为应付这方面的需要，拟议的 小天鹅™系统是一种用于测量肺活量的流量导向的右心微导管和展开系统 毛细管楔压(PCWP)。它被改装成在导管实验室外用于右心护理点 将无菌微导管置入肘前窝静脉的血流动力学评估 四号规护套。心脏病专家控制系统将微导管引向肺动脉。 小天鹅设计的前臂通道包含在一个小的无菌区域，使更容易接近的RHC 这可以在任何非导管实验室环境中安全地执行。范宁创新工作室正在与Dr。 德州心脏研究所的雷诺兹·德尔加多开发了小天鹅微导管系统。小天鹅系统 可以实现更易获得的RHC，以便可以在早期执行血流动力学评估 诊断路径，从而加快了HFpEF的诊断和治疗。 具体目标：(1)微导管和导向器的设计和开发；(2)压力传感器的设计和开发 开发；(3)台式模型和急性猪研究验证测试。 这一第一阶段项目的完成将证明小天鹅微导管原型的可行性 在非CASH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，改进导管控制软件，开发扭矩组件，执行调节活动，以及 为商业化做好准备。小天鹅微导管系统将对早期 通过在床边提供这一重要的诊断工具，实现HFpEF的诊断、分类和管理。

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.