A Novel Approach to Cardiac Replacement with Continuous Flow Pumps

描述（由申请人提供）：心力衰竭是美国死亡的主要原因。如果能找到一种有效、可靠的机械设备来替代人类衰竭的心脏，将对医疗保健产生巨大的影响。然而，迄今为止，开发全人工心脏（TAH）所固有的技术挑战已被证明是令人望而却步的。近年来，连续血流（CF）血泵已被引入临床医学作为心室辅助装置。这些泵比它们的脉动泵更小、更简单、更坚固。此外，cf -泵具有根据流入和流出压力调节泵输出的内在能力。德克萨斯心脏研究所（THI）的研究人员正在利用这些优势，开发一种新型的连续流动全人工心脏（CF-TAH），该心脏由两台串联使用的改良cf泵组成：一台用于全身循环，另一台用于肺循环。CF-泵的流入敏感性使它们特别适合整合到TAH中，因为它们具有自主平衡全身和肺流量的潜力。在THI使用双cf泵进行全心置换术的初步动物研究已经证明了可行性，存活时间长达7周，生理功能正常。该项目的具体目标是：(1)开发一种CF-TAH，使晚期心力衰竭患者能够恢复有意义和可接受的生活质量；(2)开发一种CF-TAH操作控制系统，以响应不断变化的需求。为了实现这些目标，PI O. H. Frazier （THI）将领导一个由德克萨斯医学中心四个机构（THI、MicroMed Cardiovascular, Inc.、休斯顿大学和莱斯大学）组成的合作小组。计算机建模和体外和体内实验将用于改进当前的cf -泵技术，将两个cf -泵集成到CF-TAH设计中，并开发控制系统和患者-泵接口。该团队在医疗器械开发、机械工程、材料科学、生物工程、计算建模、动物研究和心脏外科方面拥有丰富的经验。基于其成功的研究合作历史，地理位置接近，以及丰富和广泛的经验和专业知识，这个多机构小组特别适合于开发有效，可靠和经济的TAH这一具有挑战性但重要的任务。

DESCRIPTION (provided by applicant): Heart failure is the leading cause of death in the United States. The availability of an effective, reliable mechanical replacement for the failing human heart would have an enormous impact on health care. Nevertheless, the technical challenges inherent in developing a total artificial heart (TAH) have, to date, proven prohibitive. Recently, continuous-flow (CF) blood pumps have been introduced into clinical medicine as ventricular assist devices. These pumps are smaller, simpler, and more robust than their pulsatile predecessors. In addition, CF-pumps have the intrinsic ability to adjust pump output based on inflow and outflow pressure. Researchers at the Texas Heart Institute (THI) are capitalizing on these advantages by developing a novel continuous-flow total artificial heart (CF-TAH) comprising two modified CF-pumps used in series: one dedicated to the systemic and the other to the pulmonary circulation. The inflow sensitivity of CF- pumps makes them uniquely suited for integration into a TAH as they have the potential to autonomously balance systemic and pulmonary flow. Preliminary animal studies at THI using dual CF-pumps for total heart replacement have demonstrated feasibility, with up to 7 weeks of survival and normal physiologic function. The specific aims of this program are (1) to develop a CF-TAH that allow patients with advanced heart failure to regain meaningful and acceptable quality of life, and (2) to develop a control system for operation of the CF- TAH that responds to changing demands. To achieve these aims, the PI, O. H. Frazier (THI), will lead a collaborative group of four institutions in the Texas Medical Center (THI, MicroMed Cardiovascular, Inc., University of Houston, and Rice University). Computer modeling and in vitro and in vivo experiments will be used to modify current CF-pump technology, integrate two CF-pumps into a CF-TAH design, and develop the control system and patient-pump interface. The assembled team has extensive experience in medical device development, mechanical engineering, materials science, bioengineering, computational modeling, animal research, and cardiac surgery. On the basis of their successful history of research collaboration, geographic proximity, and wealth and breadth of experience and expertise, this multi-institutional group is uniquely suited for the challenging but important task of developing an effective, reliable, and economical TAH. PUBLIC HEALTH RELEVANCE Heart failure is the leading cause of death in the United States. The goal of this project is to develop a new total artificial heart (TAH) using two continuous-flow blood pumps. These pumps are smaller than the older, pulsatile pumps and can therefore be implanted in children and smaller adults. The continuous-flow TAH would also be simpler to control and would have excellent reliability. The availability of an effective, reliable replacement such as the continuous-flow TAH for the failing human heart would thus have an enormous impact on health care.