Advanced Ventricular Assist Device with Pulse Augmentation and Automatic Regurgitant Flow Shutoff

具有脉冲增强和自动回流关闭功能的先进心室辅助装置

• 批准号: 9313928
• 负责人: Kiyotaka Fukamachi
• 金额: $ 11.89万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-15 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9313928
• 关键词: 3D Print; Accidents; Acute; Address; Animals; Aortic Valve Insufficiency; Attenuated; Back; Blood; Cardiac; Cessation of life; Chronic; Clinic; Clinical; Data; Destinations; Development; Device Designs; Devices; Diastole; Dimensions; Evaluation; Event; Exploratory/Developmental Grant; Goals; Grant; Heart failure; Hemolysis; Housing; In Vitro; Interruption; Left; Liquid substance; Mechanics; Obstruction; Outcome; Output; Patient-Focused Outcomes; Patients; Performance; Physiologic pulse; Physiological; Plasticizers; Positioning Attribute; Pulsatile Flow; Pump; Risk; Suction; Suspensions; Syncope; System; Systole; Testing; Thrombosis; Titanium; Transplantation; Ventricular; Weaning; aortic valve; biomaterial compatibility; design; experimental study; hemodynamics; improved; improved outcome; in vitro testing; in vivo; innovation; left ventricular assist device; pressure; prevent; prototype; screening; total artificial heart; ventricular assist device

Project Summary Continuous-flow (CF) rotary pumps have been widely used to treat patients with end-stage heart failure. However, all existing or developing CF devices have the following clinical limitations: reduced arterial pulsatility, threat of pump thrombosis or hemolysis, risk of syncope and death from backflow during pump stoppage, inability to non-invasively evaluate weanability by pump-off test, narrow operating specifications meaning there is no universal device for use as both left and right ventricular assist devices (LVAD and RVAD, respectively), and potential inlet obstruction from suctioning of left ventricular wall into the inlet. To eliminate or minimize these drawbacks, we are developing an innovative, advanced ventricular assist devices (AVAD), derived from features of Cleveland Clinic's LVAD, RVAD, and continuous-flow total artificial heart (CFTAH). The following goals are attainable: maintain physiological pulsatility, reduce the risk of pump thrombosis or hemolysis, prevent backflow by enabling automatic shutoff, enable non-invasive evaluation of pump weanability, demonstrate wide operating specifications, enabling use of the AVAD as either an LVAD or RVAD, and avoid suction events by automatically attenuating pump output. The goals of this proposal are to address the feasibility of the proposed concept, take the first steps toward refinement, and demonstrate the intended mechanical function in vivo. The Specific Aims are: (1) analyze and refine the pump design features by a computational fluid dynamics study and in vitro testing in a mock circulatory loop, to simulate varying hemodynamic events, (2) fabricate one pump with three-dimensional (3D) printed plastic housing and impellers suitable for preliminary bench studies and one titanium version pump for acute in vivo experiments, (3) perform in vitro system characterization and hemolysis testing to verify AVAD system performance, and (4) evaluate system performance in three acute in vivo experiments under varying physiological perturbations to demonstrate mechanical functional goals and biocompatibility screening. After proving the feasibility of this totally new VAD design in this R21 program, we will apply for an R01 grant to further refine the device design, perform bench endurance testing, and carry out chronic animal studies for biocompatibility testing. The proposed AVAD, with many advanced features, will improve the outcomes of patients with severe heart failure, providing safe and effective cardiac support as a bridge to transplant and/or destination therapy.

项目概要 连续流（CF）旋转泵已广泛用于治疗终末期心力衰竭患者。 然而，所有现有或正在开发的 CF 装置都具有以下临床局限性：动脉搏动降低、 泵血栓或溶血的威胁、停泵期间回流造成晕厥和死亡的风险， 无法通过停泵测试非侵入性地评估脱机能力，狭窄的操作规范意味着存在 不是可同时用作左心室辅助装置和右心室辅助装置（分别为 LVAD 和 RVAD）的通用装置， 以及左心室壁吸入入口造成的潜在入口阻塞。消除或最小化 针对这些缺点，我们正在开发一种创新的、先进的心室辅助装置（AVAD），源自 克利夫兰诊所的 LVAD、RVAD 和连续流全人工心脏 (CFTAH) 的特点。下列 目标是可以实现的：维持生理搏动，降低泵血栓或溶血的风险， 通过自动关闭来防止回流，实现泵脱机性的非侵入性评估， 展示广泛的操作规范，允许将 AVAD 用作 LVAD 或 RVAD，并避免 通过自动衰减泵输出来减少吸入事件。该提案的目标是解决 提出的概念的可行性，迈出完善的第一步，并展示预期的效果 体内机械功能。具体目标是： (1) 通过以下方法分析和完善泵的设计特征： 计算流体动力学研究和模拟循环回路中的体外测试，以模拟不同的 血流动力学事件，(2) 制造一台带有三维 (3D) 打印塑料外壳和叶轮的泵 适用于初步实验室研究和一个用于急性体内实验的钛泵，(3) 执行 体外系统表征和溶血测试，以验证 AVAD 系统性能，以及 (4) 评估 在不同生理扰动下的三个急性体内实验中的系统性能 展示机械功能目标和生物相容性筛选。证明了这个方案的可行性后 在这个R21计划中全新的VAD设计，我们将申请R01拨款来进一步完善设备设计， 进行台架耐久性测试，并进行长期动物研究以进行生物相容性测试。这 提出的 AVAD 具有许多先进的功能，将改善严重心力衰竭患者的预后， 提供安全有效的心脏支持，作为移植和/或目标治疗的桥梁。

项目成果

Characterization and Development of Universal Ventricular Assist Device: Computational Fluid Dynamics Analysis of Advanced Design.

• DOI: 10.1097/mat.0000000000001607
• 发表时间: 2022-08-01
• 期刊: ASAIO JOURNAL
• 影响因子: 4.2
• 作者: Goodin, Mark S.;Showalter, Michael S.;Horvath, David J.;Kuban, Barry D.;Flick, Christine R.;Polakowski, Anthony R.;Fukamachi, Kiyotaka;Karimov, Jamshid H.
• 通讯作者: Karimov, Jamshid H.

Universal ventricular assist device for right and left circulatory support: the Cleveland Clinic concept.

用于左右循环支持的通用心室辅助装置：克利夫兰诊所的概念。

• DOI: 10.21037/acs-2020-cfmcs-22
• 发表时间: 2021
• 期刊: Annals of cardiothoracic surgery
• 影响因子: 3.1
• 作者: Karimov,JamshidH;Polakowski,AnthonyR;Fukamachi,Kiyotaka;Miyamoto,Takuma;Flick,Christine
• 通讯作者: Flick,Christine

An advanced universal circulatory assist device for left and right ventricular support: First report of an acute in vivo implant.

用于左心室和右心室支持的先进通用循环辅助装置：关于急性体内植入的第一份报告。

• DOI: 10.1016/j.xjon.2020.06.006
• 发表时间: 2020-09
• 期刊: JTCVS open
• 作者: Miyamoto, Takuma;Kado, Yuichiro;Horvath, David J;Kuban, Barry D;Sale, Shiva;Fukamachi, Kiyotaka;Karimov, Jamshid H
• 通讯作者: Karimov, Jamshid H

Effects of blood pump orientation on performance: In vitro assessment of universal advanced ventricular assist device.

血泵方向对性能的影响：通用先进心室辅助装置的体外评估。

• DOI: 10.1111/aor.13690
• 发表时间: 2020
• 期刊: Artificial organs
• 影响因子: 2.4
• 作者: Miyamoto,Takuma;Kado,Yuichiro;Polakowski,AnthonyR;Horvath,DavidJ;Kuban,BarryD;Fukamachi,Kiyotaka;Karimov,JamshidH
• 通讯作者: Karimov,JamshidH