In Vitro Hemocompatibility of the BiVACOR Total Artificial Heart in Continuous and Pulsatile Flow.

IF 2.3 3区医学 Q3 ENGINEERING, BIOMEDICAL

Artificial organs Pub Date : 2025-09-17 DOI:10.1111/aor.70009

Antony P McNamee, Daniel Timms, Frank Nestler, Nicole Bartnikowski, Amanda Smith, Geoff D Tansley, Michael J Simmonds

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引用次数: 0

Abstract

Background: Heart transplantation is curative for advanced heart failure; however, the limited availability of suitable donor organs makes mechanical circulatory support devices a crucial alternative. BiVACOR's total artificial heart (TAH) is a new device that provides full replacement of the organic failing heart to support systemic and pulmonary circulation using a single, magnetically levitated centrifugal rotor. The aim of this study was to assess the in vitro hemocompatibility of the TAH operating in either continuous flow (CF) or pulsatile flow (PF) mode.

Methods: Cattle blood was circulated in an in vitro blood loop at 5 L/min against 100 mmHg for 6 h using the TAH in CF (n = 6) or PF (n = 6), which were compared with a reference pump (CentriMag; n = 6). Blood analysis included hematology, plasma free-hemoglobin, and von Willebrand factor (vWF) multimers.

Results: The normalized indexes of hemolysis were 0.004 ± 0.003 g/100 L for CF, 0.004 ± 0.003 g/100 L for PF, and 0.003 ± 0.002 g/100 L for reference. Basic hematology and vWF multimers were affected in a linear manner, but did not vary between flow regimes or devices.

Conclusions: BiVACOR's TAH operated in a manner requisite of complete heart support, generated comparable in vitro blood compatibility to the clinically approved reference pump, as evidenced by hematological parameters and vWF analyses. The presence of a large pulse pressure did not impact hemocompatibility, which is a positive sign for future applications.

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BiVACOR全人工心脏连续搏动血流的体外血液相容性研究。

背景：心脏移植是治疗晚期心力衰竭的有效方法；然而，合适的供体器官的有限可用性使得机械循环支持装置成为一个重要的选择。BiVACOR的全人工心脏（TAH）是一种新设备，它使用一个单一的磁悬浮离心转子，提供了有机衰竭心脏的完全替代，以支持系统和肺循环。本研究的目的是评估TAH在连续流（CF）或脉动流（PF）模式下的体外血液相容性。方法：采用CF （n = 6）或PF （n = 6）的TAH在体外血环中以5 L/min 100 mmHg循环6 h，并与参比泵（CentriMag; n = 6）进行比较。血液分析包括血液学、血浆游离血红蛋白和血管性血友病因子（vWF）多聚体。结果：CF组溶血归一化指标为0.004±0.003 g/100 L， PF组为0.004±0.003 g/100 L，参比组为0.003±0.002 g/100 L。基础血液学和vWF多计时器以线性方式受到影响，但在流动模式或设备之间没有变化。结论：BiVACOR的TAH以完全心脏支持所需的方式运行，产生了与临床批准的参考泵相当的体外血液相容性，血液学参数和vWF分析证明了这一点。大脉压的存在不会影响血液相容性，这对未来的应用是一个积极的信号。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Artificial organs 工程技术-工程：生物医学

CiteScore

4.30

自引率

12.50%

发文量

303

审稿时长

4-8 weeks

期刊介绍： Artificial Organs is the official peer reviewed journal of The International Federation for Artificial Organs (Members of the Federation are: The American Society for Artificial Internal Organs, The European Society for Artificial Organs, and The Japanese Society for Artificial Organs), The International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, The International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation. Artificial Organs publishes original research articles dealing with developments in artificial organs applications and treatment modalities and their clinical applications worldwide. Membership in the Societies listed above is not a prerequisite for publication. Articles are published without charge to the author except for color figures and excess page charges as noted.