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September 18, 2025Artificial Organs4 citationsOpen Access

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

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AMAntony P. McNameeGriffith UniversityDTDaniel TimmsThe Huntington Library, Art Museum, and Botanical GardensFNFrank NestlerThe Huntington Library, Art Museum, and Botanical Gardens

Key Points

  • BiVACOR's artificial heart showed comparable hemocompatibility to a standard pump across both flow modes.
  • Normalized hemolysis indexes were found to be similar for continuous and pulsatile flow at about 0.004 g/100 L.
  • The study used cattle blood in a controlled in vitro setting, circulating at 5 L/min against 100 mmHg for 6 hours.
  • The findings indicate that a large pulse pressure does not negatively affect hemocompatibility, supporting future use.

Abstract

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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Cite This Study

McNamee et al. (2025) studied this question.

synapsesocial.com/papers/68d462b631b076d99fa61a8dhttps://doi.org/10.1111/aor.70009
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