Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model

Xufeng Wei, Tieluo Li, Shuying Li, Ho Sung Son, Pablo Sanchez, Shuqiong Niu, A. Claire Watkins, Christopher Defilippi, Robert Jarvik, Zhongjun J. Wu, Bartley P. Griffith

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

BACKGROUND: The infant Jarvik 2000 heart is a very small, hermetically sealed, intracorporeal, axial-flow ventricular assist device (VAD) designed for circulatory support in neonates and infants. The anatomic fit, short-term biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model. METHODS: The infant Jarvik 2000 heart with two different blade profiles (low- or high-flow blade design) was tested in 6 piglets (8.8±0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompatibility were studied for 6 hours. RESULTS: All 6 pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics demonstrated stability throughout the 6-hour duration. The pump flow increased from 0.27 to 0.95 liter/min at increasing speeds from 18 to 31 krpm for the low-flow blade design, whereas the pump flow increased from 0.54 liter/min to 1.12 liters/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. At higher speeds, >80% of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for either blade design. CONCLUSIONS: The infant Jarvik 2000 heart is anatomically and biologically compatible with an short-term neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.

Original languageEnglish
Pages (from-to)112-119
Number of pages8
JournalJournal of Heart and Lung Transplantation
Volume32
Issue number1
DOIs
Publication statusPublished - 2013 Jan 1

Fingerprint

Newborn Infant
Hemodynamics
Equipment and Supplies
Heart Ventricles
Heart-Assist Devices
Sternotomy
Cardiopulmonary Bypass
Aorta
Thrombosis
Pathology
Transplants
Wounds and Injuries

Keywords

  • biocompatibility
  • hemodynamics
  • mechanical circulatory support
  • pediatric patients
  • ventricular assist device

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model. / Wei, Xufeng; Li, Tieluo; Li, Shuying; Son, Ho Sung; Sanchez, Pablo; Niu, Shuqiong; Claire Watkins, A.; Defilippi, Christopher; Jarvik, Robert; Wu, Zhongjun J.; Griffith, Bartley P.

In: Journal of Heart and Lung Transplantation, Vol. 32, No. 1, 01.01.2013, p. 112-119.

Research output: Contribution to journalArticle

Wei, X, Li, T, Li, S, Son, HS, Sanchez, P, Niu, S, Claire Watkins, A, Defilippi, C, Jarvik, R, Wu, ZJ & Griffith, BP 2013, 'Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model', Journal of Heart and Lung Transplantation, vol. 32, no. 1, pp. 112-119. https://doi.org/10.1016/j.healun.2012.10.011
Wei, Xufeng ; Li, Tieluo ; Li, Shuying ; Son, Ho Sung ; Sanchez, Pablo ; Niu, Shuqiong ; Claire Watkins, A. ; Defilippi, Christopher ; Jarvik, Robert ; Wu, Zhongjun J. ; Griffith, Bartley P. / Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model. In: Journal of Heart and Lung Transplantation. 2013 ; Vol. 32, No. 1. pp. 112-119.
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abstract = "BACKGROUND: The infant Jarvik 2000 heart is a very small, hermetically sealed, intracorporeal, axial-flow ventricular assist device (VAD) designed for circulatory support in neonates and infants. The anatomic fit, short-term biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model. METHODS: The infant Jarvik 2000 heart with two different blade profiles (low- or high-flow blade design) was tested in 6 piglets (8.8±0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompatibility were studied for 6 hours. RESULTS: All 6 pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics demonstrated stability throughout the 6-hour duration. The pump flow increased from 0.27 to 0.95 liter/min at increasing speeds from 18 to 31 krpm for the low-flow blade design, whereas the pump flow increased from 0.54 liter/min to 1.12 liters/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. At higher speeds, >80{\%} of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for either blade design. CONCLUSIONS: The infant Jarvik 2000 heart is anatomically and biologically compatible with an short-term neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.",
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AU - Li, Tieluo

AU - Li, Shuying

AU - Son, Ho Sung

AU - Sanchez, Pablo

AU - Niu, Shuqiong

AU - Claire Watkins, A.

AU - Defilippi, Christopher

AU - Jarvik, Robert

AU - Wu, Zhongjun J.

AU - Griffith, Bartley P.

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N2 - BACKGROUND: The infant Jarvik 2000 heart is a very small, hermetically sealed, intracorporeal, axial-flow ventricular assist device (VAD) designed for circulatory support in neonates and infants. The anatomic fit, short-term biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model. METHODS: The infant Jarvik 2000 heart with two different blade profiles (low- or high-flow blade design) was tested in 6 piglets (8.8±0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompatibility were studied for 6 hours. RESULTS: All 6 pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics demonstrated stability throughout the 6-hour duration. The pump flow increased from 0.27 to 0.95 liter/min at increasing speeds from 18 to 31 krpm for the low-flow blade design, whereas the pump flow increased from 0.54 liter/min to 1.12 liters/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. At higher speeds, >80% of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for either blade design. CONCLUSIONS: The infant Jarvik 2000 heart is anatomically and biologically compatible with an short-term neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.

AB - BACKGROUND: The infant Jarvik 2000 heart is a very small, hermetically sealed, intracorporeal, axial-flow ventricular assist device (VAD) designed for circulatory support in neonates and infants. The anatomic fit, short-term biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model. METHODS: The infant Jarvik 2000 heart with two different blade profiles (low- or high-flow blade design) was tested in 6 piglets (8.8±0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompatibility were studied for 6 hours. RESULTS: All 6 pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics demonstrated stability throughout the 6-hour duration. The pump flow increased from 0.27 to 0.95 liter/min at increasing speeds from 18 to 31 krpm for the low-flow blade design, whereas the pump flow increased from 0.54 liter/min to 1.12 liters/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. At higher speeds, >80% of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for either blade design. CONCLUSIONS: The infant Jarvik 2000 heart is anatomically and biologically compatible with an short-term neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.

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