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In vivo evaluation of an implantable magnetic suspending left ventricular assist device

Abstract

Purpose

The CH-VAD is an implantable, fully magnetically suspended ventricular assist device developed by the China Heart Biomedical Corporation (Suzhou, China) for full cardiac support. This study was performed to evaluate the reliability, hemocompatibility and end-organ effects of CH-VAD in a 35-day animal model trial.

Methods

The pump was implanted in 6 sheep. The pump inflow was inserted into the left ventricle and the outflow graft was anastomosed to the descending aorta. Data on pump function and the health condition of the animals, including hematologic and biochemical tests, were collected during the study period. When each study was determined to termination, the sheep were humanely euthanized and the end organs were examined macroscopically and histopathologically. Hemolysis was evaluated based on the amount of free hemoglobin in the plasma.

Results

Except for one device that stopped operation on postoperative day 25 because of thrombus formation, the devices functioned normally until the scheduled termination. Gross examination of the pump interiors, inflow and outflow, and of the arterial anastomosis sites showed no significant abnormalities. Hematologic and biochemical test results were within normal limits during the study period. Macroscopic and histopathologic examinations of the explanted organs revealed no evidence of ischemia or infarction associated with the device implantation, except for small foci of infarction in the kidneys of two sheep. The free hemoglobin level in plasma peaked at 9.5 mg/dl on postoperative day 5.

Conclusions

The CH-VAD system demonstrated promising reliability and blood-handling characteristics without obvious damage to end organs during a 35-day implantation in sheep.

Int J Artif Organs 2015; 38(3): 138 - 145

Article Type: ORIGINAL RESEARCH ARTICLE

Article Subject: Cardiac assist and artificial heart

DOI:10.5301/IJAO.2015.14486

Authors

Changyan Lin, Guanghui Wu, Xiujian Liu, Chuangye Xu, Xiaotong Hou, Haiyang Li, Chen Chen, Peng Yang, Jing Wang, Yuyang Liu

Article History

Disclosures

Financial support: This article was supported by the National High Technology Research and Development Program of China (2012AA041605) and the Capital Health Research Fund (2011-1005-02).
Conflict of interest: None.

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Authors

  • Lin, Changyan [PubMed] [Google Scholar] 1, 2
  • Wu, Guanghui [PubMed] [Google Scholar] 1, 2
  • Liu, Xiujian [PubMed] [Google Scholar] 1, 2
  • Xu, Chuangye [PubMed] [Google Scholar] 1, 2
  • Hou, Xiaotong [PubMed] [Google Scholar] 1
  • Li, Haiyang [PubMed] [Google Scholar] 1
  • Chen, Chen [PubMed] [Google Scholar] 3
  • Yang, Peng [PubMed] [Google Scholar] 3
  • Wang, Jing [PubMed] [Google Scholar] 1, 2
  • Liu, Yuyang [PubMed] [Google Scholar] 1, * Corresponding Author ([email protected])

Affiliations

  • Beijing Anzhen Hospital, Capital Medical University, Beijing - China
  • Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing - China
  • China Heart Biomedical Incorporation, Suzhou, Jiangsu Province - China

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