Intravascular Cardiac Assist System for Decompression and Recovery

用于减压和恢复的血管内心脏辅助系统

• 批准号: 8001340
• 负责人: Caitlyn J Bosecker
• 金额: $ 53.58万
• 依托单位: ABIOMED, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-15 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001340
• 关键词: Abdomen; Acute; Adverse event; Affect; Age; Algorithms; American; Anastomosis - action; Animals; Apical; Blood; Cadaver; Cannulas; Cardiac; Cardiopulmonary; Cardiopulmonary Bypass; Caring; Chronic; Clinical; Computer Analysis; Congestive Heart Failure; Data; Destinations; Development; Devices; Diagnosis; Diastole; Dilatation - action; Early treatment; Echocardiography; Emotional; Exercise; Extracorporeal Circulation; Heart; Heart Transplantation; Heart failure; Hemolysis; Implant; Individual; Intraventricular; Lateral; Left; Left atrial structure; Left ventricular structure; Libraries; Life; MRI Scans; Marketing; Mechanics; Medical; Membrane; Monitor; New York; Operative Surgical Procedures; Optics; Organ; Organ Donor; Pacemakers; Patients; Performance; Pharmaceutical Preparations; Phase; Physiologic intraventricular pressure; Procedures; Publishing; Pulsatile Flow; Pump; Quality of life; Recovery; Respiratory Diaphragm; Right ventricular structure; Risk; Role; Scanning; Side; Staging; Sternotomy; Survival Rate; System; Systems Integration; Systole; Systolic Pressure; Techniques; Technology; Testing; Thoracotomy; Time; Transplantation; United States; Ventricular; Woman; Work; aortic valve; ascending aorta; base; blood pump; commercialization; design; functional restoration; implantable device; improved; in vivo; innovation; light weight; men; mortality; novel; operation; patient population; pressure; programs; prototype; public health relevance; sensor; ventricular assist device; verification and validation

DESCRIPTION (provided by applicant): The objective of this proposal is to develop a less invasive long-term copulsation device to treat patients in late Class III and early Class IV stages of heart failure (HF). Chronic congestive heart failure is the largest unsolved problem in cardiac care today. There are over 5.5 million people in the United States with this diagnosis and the number of patients is expected to double over the course of this decade. ABIOMED's key innovation will be an apically placed implantable partial left ventricular assist device (LVAD) system designed for copulsation, called the Apical Copulsation Device (ACD). Synchronizing assist with the heart will reduce the work required by the heart during systole and unload the left ventricle during diastole. Phase I proved the feasibility of the ACD both in bench testing using a specially designed mock loop and in three in vivo animal studies. The system control is based on the left ventricular pressure and it successfully and consistently ejected 30 ml of blood during systole after the native ventricle opened the aortic valve and completed this ejection before the valve closed. No dilatation was observed and the ACD reduced the mechanical external work required by the ventricle up to 45% with no significant increase in end-systolic pressure compared to baseline. This device can be implanted through a thoracotomy and without cardiopulmonary support, reducing the risks associated with more invasive techniques. Phase II of the program will focus on developing a durable, integrated system for extended use and characterizing its effects on the heart. There is currently no published chronic in vivo data for copulsation therapy and studies will be conducted to assess the system's hemocompatibility and how the body reacts to this type of support over time. PUBLIC HEALTH RELEVANCE: Chronic heart failure (CHF) affects over 5 million Americans, with 550,000 new cases diagnosed annually. The associated mortality rates are high with CHF patients under age 65, 80% of men and 70% of women die within 8 yrs. The 1-yr mortality rate is 20%, and that figure jumps to 60% for patients with end-stage (decompensated or New York Heart Association Class IV) heart failure. There are few treatment options for end-stage CHF and medical management is the first line of treatment with limited results. Heart transplantation can provide significant individual benefit, but its impact is limited by the number of donor organs available; worldwide, less than 2900 heart transplants occurred in 2005. Over the past 15 years, mechanical circulatory support has become an established means of treating end- stage CHF. A ventricular assist device (VAD) is a blood pump that is designed to assist or replace the function of either the left or right ventricle. The device is most commonly deployed on the left side (i.e. as an LVAD), where blood is withdrawn from either the left atrium or the apex of the left ventricle. The blood then passes through the pump and is returned to the ascending aorta. The Apical Copulsation Device (ACD) proposed here affords a very effective ventricular decompression and unloading without requiring cardiopulmonary bypass or a sternotomy. The role of VADs has evolved since their clinical introduction. For end-stage CHF patients, the Thoratec HeartMate LVAD that originally received approval for bridge-to-transplant (BTT) use is now approved for alternative-to-transplant (destination therapy or DT). The results from the REMATCH study showed that for patients who are not candidates for cardiac transplantation, mechanical support increased not only the survival rate, but also scores on physical and emotional tests at one year compared to patients treated with medication. While extending the life of these patients is important, the quality of this life is paramount. Earlier treatment of HF using the ACD approach provides the opportunity to treat many more patients and may also be more effective in preserving end organ function and restoring quality of life. With over 100,000 patients in the United States receiving biventricular pacemakers each year, it is anticipated that up to 50,000 patients may be candidates for chronic copulsation therapy. The market for copulsation technologies is a sizable portion of the moderate to severe HF patient population (represented by approximately 250,000 to 300,000 annual cases in the U.S. alone) and, hypothetically, may have a very significant total market potential (estimated at $0.8 to $1.0 billion).

描述（由申请人提供）：该提案的目的是开发一种侵入性较小的长期串联装置，以治疗晚期III级和早期IV级心力衰竭（HF）的患者。慢性充血性心力衰竭是当今心脏护理中最大的未解决的问题。在美国，有超过550万人的诊断，预计在这十年的时间里，患者的数量预计将翻一番。 Abiomed的关键创新将是一种顶端植入的部分左心室辅助装置（LVAD）系统，该系统设计用于串联，称为顶端串联装置（ACD）。同步辅助与心脏同步会减少收缩期间心脏所需的工作，并在舒张期间卸下左心室。第一阶段证明了使用特殊设计的模拟环和三个体内动物研究中ACD在板凳测试中的可行性。系统控制基于左心室压力，在本机心室打开主动脉瓣后，在收缩期间成功，始终如一地喷出了30 ml的血液，并在阀门关闭之前完成了这种射血。与基线相比，未观察到扩张量，ACD降低了心室所需的机械外部工作，而末端音压的末期压力没有显着增加。可以通过胸腔切开术植入该设备，而无需心肺支撑，从而降低了与更多侵入性技术相关的风险。该计划的第二阶段将着重于开发耐用的集成系统，以扩展使用并表征其对心脏的影响。目前尚无公开的慢性体内数据用于串联疗法，并且将进行研究以评估系统的血液相容性以及身体随着时间的推移对这种类型的支持的反应。 公共卫生相关性：慢性心力衰竭（CHF）影响超过500万美国人，每年诊断出550,000例新病例。与65岁以下的CHF患者相关的死亡率很高，男性的80％和70％的女性在8年内死亡。 1年的死亡率为20％，终阶段患者（代偿失调或纽约心脏协会IV类）心力衰竭的患者该数字跃升至60％。最终阶段的冠心冠军的治疗选择很少，医疗管理是第一道治疗，结果有限。心脏移植可以带来重大的个人利益，但其影响受到可用捐赠者的数量的限制；在全球范围内，不到2900次心脏移植发生在2005年。在过去的15年中，机械循环支持已成为治疗最终阶段CHF的既定方法。心室辅助装置（VAD）是一个旨在帮助或替换左心室或右心室功能的血泵。该设备最常部署在左侧（即作为LVAD），那里的血液从左心房或左心室的顶点中取出。然后，血液通过泵，并将其返回到上升主动脉。这里提出的顶端串联装置（ACD）提供了非常有效的心室减压和卸载，而无需心肺旁路或胸骨切开术。自临床引入以来，VADS的作用就不断发展。对于最终阶段CHF患者，最初获得桥梁到移植物（BTT）使用批准的Thoratec Heartmate LVAD现在被批准用于替代转移植物（目的地治疗或DT）。重赛研究的结果表明，对于非候选心脏移植的患者，机械支持不仅提高了生存率，而且与接受药物治疗的患者相比，一年的身体和情绪测试的评分也提高了。尽管延长这些患者的寿命很重要，但这种生活的质量至关重要。使用ACD方法对HF进行早期治疗提供了治疗更多患者的机会，并且在保持最终器官功能和恢复生活质量方面也可能更有效。美国每年有100,000多名患者患有双室性起搏器，预计最多可容纳50,000名患者可能是慢性连锁治疗的候选者。 Copulsation Technologies的市场是中度至重度HF患者人群的相当一部分（仅在美国，每年约250,000至300,000例），从假设上讲，可能具有很大的总市场潜力（估计为0.8至10亿美元）。