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

项目摘要 在美国，每年有超过300万人被诊断患有射血分数保留的心力衰竭（HFpEF）。 我们尽管HFpEF的发病率很高，但通常直到病程的晚期才被诊断出来，因为原发性HFpEF的发病率很高， 症状，呼吸困难，是包括心房纤维性颤动、肺病和/或肥胖症在内其它病症的常见症状。 因此，医生要求进行多项检查，包括脑利钠肽（BNP）血液检查，胸部X光检查， 心电图、超声心动图和右心导管插入术（RHC），以确定 在开始治疗方案之前，HFpEF最明确的诊断工具是RHC， 将流动导向导管插入颈内静脉（IJ）或股静脉，引导至 心脏，并用于进行右心血流动力学测量。尽管RHC的诊断效用很高，但它 通常是最后的诊断步骤，因为它必须在导管插入实验室（cath lab）中进行， 与有限的可用性和高设施成本相关。这些因素通常导致在获得过程中的长延迟。 RHC诊断程序，可能会延误诊断和治疗。为了满足这一需求，建议 Cygnet™系统是一种流动导向的右心微导管和部署系统，用于测量肺动脉压。 毛细管楔压（PCWP）。它适用于导管室外的床旁右心 通过将无菌微导管通过18- IV号鞘管。心脏病专家控制系统，将微导管推向肺动脉。 Cygnet设计的肘前入路包含在一个小的无菌区域内，使RHC更容易进入 可以在任何非导管室环境中安全进行。范宁创新工作室正在与博士合作。 Reynolds Delgado和得克萨斯心脏研究所合作开发Cygnet微导管系统。Cygnet系统 可以使RHC更容易获得，从而可以在早期进行血流动力学评估， 诊断途径，从而加快HFpEF的诊断和管理。 具体目标：（1）微导管和导引导管设计和开发;（2）压力传感器设计和 开发;（3）实验室模型和急性猪研究验证试验。 该I期项目的完成将证明Cygnet微导管原型用于 在非导管实验室环境中进行RHC，这将为II期项目做准备，以开发展开 系统，完善导管控制软件，开发扭矩组件，执行监管活动，以及 为商业化做准备。Cygnet微导管系统将对早期 HFpEF诊断、分类和管理，使这一重要的诊断工具在床边可用。

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.