<em>In vitro</em> and <em>in vivo</em> Evaluation of TONGXIN LVAD

Abstract
Figure/Table
References
Related Citation (15)

Download: PDF (3552 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS)

Abstract Background: Tongxin left ventricular assist device (LVAD), an implantable magnetic suspending VAD developed in China Heart Biomedical Incorporation aiming for clinical use, weighs about 350 g and can deliver 6 L/min for pressures of 145 mmHg at 2500 rpm. Objective: This study aims to investigate the implantation possibility, hemolysis and hemocompatibility of the LVAD before clinic use. Methods: The tests of implantation possibility, hemolysis and hemocompatibility to the LVAD were completed by fitting study, hemolysis test and in vivo experiments respectively. Meanwhile the hemolysis was evaluated by the amount of free hemoglobin in plasma and studied using the normalized index of hemolysis (NIH). Results: The fitting study showed that the blood pump could be implanted in the sheep heart chambers without squeezing the surrounding organs by comparing the preoperative and the postoperative chest X-ray. The NIH value of Tongxin LVAD was (0.00750±0017) g/100 L in vitro hemolysis test. Two sheep in vivo experiments showed the hemolysis in vivo was below 7.5 mg/dL. Hematologic and biochemical test results were within normal limits during the study period. There were no significant complications. Postmortem examination of the explanted organs revealed no evidence of microemboli, ischemia or infarction. The pump's inflow and outflow conduits were free of thrombus. Conclusion: These results indicated that the implantable magnetic suspending LVAD showed exceptional implantation possibility, hemolysis and hemocompatibility, which are crucial to the clinical success of this implantable LVAD.

Key words： ventricular assist device magnetic suspending blood pump implantation possibility hemocompatibility in vivo experiment

Received: 12 January 2018

PACS:

R 318.04

Corresponding Authors: LIN Chang-yan. E-mail: sina@126.com

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	LIN Chang-yan
	WU Guang-hui
	HOU Xiao-tong
	LI Hai-yan
	LIU Xiu-jian
	XU Chuang-ye
	WANG Jin
	CHEN Chen

Cite this article:

LIN Chang-yan,WU Guang-hui,HOU Xiao-tong, et al. In vitro and in vivo Evaluation of TONGXIN LVAD[J]. Chinese Journal of Biomedical Engineering, 2018, 27(1): 16-22.

URL:

http://manu32.magtech.com.cn/Jwk_zgswyx_en/EN/ OR http://manu32.magtech.com.cn/Jwk_zgswyx_en/EN/Y2018/V27/I1/16

[1] Dembitsky WP, Tector AJ, Park S, et al.Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial[J]. Annals of Thoracic Surgery, 2004, 78:2123-2130.
[2] Radovancevic B, Vrtovec B, Frazier OH.Left ventricular assistdevices: an alternative to medical therapy for end-stage heart failure[J]. Current Opinion in Cardiology, 2003, 18:210-214.
[3] Schmid C, Welp H, Klotz S, et al.Outcome of patients surviving to heart transplantation after being mechanically bridged for more than 100 days[J]. The Journal of Heart and Lung Transplantion, 2003, 22:1054-1058.
[4] Wohlschlaeger J, Schmitz KJ, Schmid C, et al.Reverse remodeling following insertion of left ventricular assist devices(LVAD): a review of the morphological and molecular changes[J]. Cardiovascular Research, 2005, 68:376-386.
[5] Birks EJ, Tansley PD, Yacoub MH, et al.Incidence and clinical management of lifethreatening left ventricular assist device failure[J]. The Journal of Heart and Lung Transplantion, 2004, 23:964-969.
[6] Siegenthaler MP, Westaby S, Frazier OH, et al.Advanced heart failure: feasibility study of long-term continuous axial flow pump support[J]. European Heart Journal, 2005, 26:1031-1038.
[7] Martin J, Friesewinkel O, Benk C, et al.Improved durability of the HeartMate XVE left ventricular assist device provides safe mechanical support up to 1 year but is associated with high risk of device failure in the second year[J]. The Journal of Heart and Lung Transplantion, 2006, 25:384-390.
[8] Simon D, Fischer S, Grossman A, et al.Left ventricular assistdevice-related infection: treatment and outcome[J]. Clinical Infectious Diseases, 2005, 40:1108-1115.
[9] Frazier OH, Myers TJ, Westaby S, et al.Clinical experience with an implantable, intracardiac, continuous flow circulatory support device: physiologic implications and their relationship to patient selection[J]. Annals of Thoracic Surgery, 2004, 77: 133-142.
[10] Saito S, Nishinaka T, Westaby S.Hemodynamics of chronic nonpulsatile flow: implications for LVAD development[J]. Surgical Clinics of North Amarica, 2004, 84:61-74.
[11] Tamaki Takano, Sebastian Schulte-Eistrup, Shinji Kawahito, et al.Lnlet port positioning for a miniaturized centrifugal blood pump[J]. Artificial Organs, 2002, 26(1):45-48.