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Preclinical animal study of the NIPRO-ventricular assist device for use in pediatric patients

  • Original Article
  • Artificial Heart (Clinical)
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Abstract

Although the outcomes of patients with end-stage heart failure treated with implantable left ventricular assist devices have improved, extracorporeal left ventricular assist devices continue to play an important role, especially in pediatric patients. The present study aimed to examine the long-term biocompatibility of a small-sized extracorporeal pneumatic left ventricular assist device (NIPRO-LVAD) used in a 30- to 90-day animal experiment. The NIPRO-LVAD was designed for pediatric patients or small-sized adults. The left ventricular assist device system was installed in four adult Shiba goats weighing 25.7 ± 4.78 kg via a left thoracotomy. The outflow graft was sewn to the descending aorta and the inflow cannula was placed in the left ventricle through the left ventricular apex. Oral antiplatelet (aspirin) and oral anticoagulation therapies (warfarin) were also administered. Three out of four animals survived for a 30-day period and two goats survived for 90 days. One animal was killed early because of low pump flow due to obstruction of the inflow cannula by a left ventricular endocardial vegetation. The blood pump exhibited sufficient hydrodynamic performance with blood flows of 1.5–2.0 L/min. The animals’ laboratory values were within normal limits by postoperative day 7. There was no significant thrombus formation on the housing, diaphragm, or valves of the explanted pumps. Based on the biocompatibility demonstrated in this animal study, the explanted small-sized pump may be suitable for use in left ventricular assist device systems for pediatric patients.

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Acknowledgements

This study was conducted under a cooperative research and development agreement between the National Cerebral and Cardiovascular Center and NIPRO corporation.

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Authors and Affiliations

  1. Department of Cardiothoracic Surgery, Graduate School of Medicine, University of Tokyo, 7-3-1, Hongo, Bunkyoku, Tokyo, Japan

    Noritsugu Naito & Minoru Ono

  2. Department of Artificial Organs, National Cerebral and Cardiovascular Center, Research Institute, 5-7-1, Fujishirodai, Suita, Osaka, Japan

    Noritsugu Naito, Yoshiaki Takewa, Satoru Kishimoto, Kei Iizuka, Toshihide Mizuno, Tomonori Tsukiya & Eisuke Tatsumi

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  1. Noritsugu Naito
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  2. Yoshiaki Takewa
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  3. Satoru Kishimoto
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  4. Kei Iizuka
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  5. Toshihide Mizuno
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  6. Tomonori Tsukiya
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  7. Minoru Ono
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  8. Eisuke Tatsumi
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Correspondence to Noritsugu Naito or Eisuke Tatsumi.

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Conflict of interest

Eisuke Tatsumi has received research funding from NIPRO corporation. The other authors declare that they have no conflicts of interest.

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Naito, N., Takewa, Y., Kishimoto, S. et al. Preclinical animal study of the NIPRO-ventricular assist device for use in pediatric patients. J Artif Organs 21, 156–163 (2018). https://doi.org/10.1007/s10047-017-1009-y

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  • DOI: https://doi.org/10.1007/s10047-017-1009-y

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