PREVENTING CONTRAST-INDUCED NEPHROPATHY

描述（由申请人提供）：挽救生命的基于成像的经皮冠状动脉介入（PCI）导管插入术，例如支架植入、血管成形术和诊断血管造影术，需要频繁且大量注射不透射线的造影剂，以便使血管可视化。这些碘化试剂对肾脏有毒性，暴露可导致造影剂肾病（CIN），这是预先存在肾功能不全的患者的一种急性肾衰竭。在美国，每年有18万例新的CIN病例，这可能导致昂贵的长期住院，在极端情况下，终末期肾病需要永久性透析和肾移植。用于预防CIN的预防性手术仅略微有效，并且包括减少原本可以使患者受益的介入手术。使用已建立的筛选标准，目前约有100，000名心脏病患者由于伴随慢性肾脏疾病而不符合PCI手术的条件，并且由于普通人群中慢性肾脏疾病率的“膨胀”发病率，预计这一数字将增加，其中25%的PCI候选人患有慢性肾脏疾病。预计这一发病率在十年内将增加90%。糖尿病是使用造影剂的常见风险因素，目前影响着美国约2000万人，预计到2025年这一数字将增加75%。Catharos正在准备一种新型的造影剂清除系统，SENTINEL系统，用于美国的临床试验。SENTINEL系统使用静脉导管检测并抽吸充满造影剂的血液，然后再进入体循环。可使用市售的细胞回收系统来最小化由于抽吸过程而损失的血液量。该SBIR项目旨在为SENTINEL系统开发一个支持子系统，即造影剂提取监测器（CEM），该监测器可即时监测和报告SENTINEL系统从患者体内去除的造影剂量。CEM是在人体中经济有效地测试SENTINEL导管系统的关键，因为它将提供一种直接的有效性测量方法，否则将无法获得。当批准用于临床使用时，CEM将向心脏病专家提供实时反馈，可用于：（1）确认SENTINEL抽吸系统是否正常工作，（2）描述与CIN风险相关的治疗方案，以及（3）为术后病例管理提供造影剂暴露数据。公共卫生相关性：用于挽救生命的微创导管插入手术的血管可视化需要使用对肾脏有毒的不透射线的造影剂。造影剂提取监测器是SBIR应用的重点，将支持在造影剂到达肾脏之前从患者体内清除充满造影剂的血液的设备的临床测试。造影剂提取监测器获批用于临床后，它将提供有关从患者体内去除的造影剂量的基本信息，这对成功结局至关重要。

DESCRIPTION (provided by applicant): Life saving imaging-based percutaneous coronary intervention (PCI) catheterization procedures such as stent implantation, angioplasty, and diagnostic angiography require frequent and large injections of radiopaque contrast agents in order to visualize the blood vessels. These iodinated agents are toxic to the kidney, and exposure can lead to contrast induced nephropathy (CIN), a form of acute kidney failure, in patients with pre-existing renal insufficiency. There are 180,000 new cases of CIN every year in the United States that can lead to costly prolonged hospital stays and, at the extreme, end-stage kidney disease requiring permanent dialysis and kidney transplantation. Prophylactic procedures for preventing CIN are only marginally effective, and include curtailing interventional procedures that could otherwise benefit a patient. Using established screening criteria, about 100,000 heart disease patients currently are not eligible for PCI procedures due to concomitant chronic kidney disease, and this number is expected to increase due to a "ballooning" incidence of chronic kidney disease rates among the general population, with 25% of PCI candidates having chronic kidney disease. This incidence is expected to increase by 90% within a decade. Diabetes, a common risk factor to the use of contrast agents, currently affects approximately 20 million people in the United States, and the number is anticipated to increase by 75% by 2025. Catharos is preparing a novel contrast removal system, the SENTINEL System, for clinical trials in the United States. The SENTINEL System uses a venous catheter to detect and aspirate contrast-laden blood before it enters the general circulation. A commercially-available cell salvage system can be used to minimize the amount of blood lost due to the aspiration process. This SBIR project is aimed at developing a supporting subsystem, the Contrast Extraction Monitor (CEM), for the SENTINEL System that instantaneously monitors and reports the amount of contrast being removed from the patient by the SENTINEL System. The CEM is pivotal to cost-effectively testing the SENTINEL catheter system in humans, as it would provide a direct measure of efficacy that would not otherwise be available. When approved for clinical use, the CEM will provide real-time feedback to the cardiologist that can be used to: (1) confirm that the SENTINEL aspiration system is functioning, (2) contour the treatment protocol relative to the risk of CIN, and (3) provide contrast exposure data for post- procedure case management. PUBLIC HEALTH RELEVANCE: Visualization of the blood vessels for life saving minimally invasive catheterization procedures requires the use of radiopaque contrast agents that are toxic to the kidneys. The Contrast Extraction Monitor, which is the focus of this SBIR application, will support the clinical testing of a device for removing contrast-laden blood from the patient before the contrast agent can reach the kidneys. After the Contrast Extraction Monitor is approved for clinical use, it will provide essential information about the amount of contrast removed from the patient, which is pivotal to a successful outcome.