Preclinical animal study of the NIPRO-ventricular assist device for use in pediatric patients
- 147 Downloads
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.
KeywordsLeft ventricular assist device Pediatric cardiothoracic surgery Thrombosis
This study was conducted under a cooperative research and development agreement between the National Cerebral and Cardiovascular Center and NIPRO corporation.
Compliance with ethical standards
Conflict of interest
Eisuke Tatsumi has received research funding from NIPRO corporation. The other authors declare that they have no conflicts of interest.
- 2.The Japanese Society for Heart Transplantation. Registry 2015. http://www.jsht.jp/registry/japan/index.html. Accessed 1 Oct 2017.
- 4.The Japanese Association for Clinical Ventricular Assist Systems.Registry 2016. http://www.jacvas.com/adoutus/registry/. Accessed 1 Oct 2017.
- 6.Booth KL, Roth SJ, Thiagarajan RR, Almodovar MC, dal Nido PJ, Laussen PC. Extracorporeal membrane oxygenation support of the Fontan and bidirectional Glenn circulations. Ann Thorac Surg. 2000;70:1341–8.Google Scholar
- 7.Conway J, Louis JS, Morales DLS, Law S, Tjossern C, Humpl T. Delineating survival outcomes in children < 10 kg bridged to transplant or recovery with the Berlin Heart EXCOR ventricular assist device. JACC Heart Fail. 2015;1:71–7.Google Scholar
- 14.Cassidy J, Dominguez T, Haynes S, Burch M, Kirk R, Hoskote A, Smith J, Fenton M, Griselli M, Hsia TY, Ferguson L, Doorn CV, Hasan A, Karimova A. A longer waiting game: bridging children to heart transplant with the Berlin Heart EXCOR device—the United Kingdom experience. J Heart Lung Trasnplant. 2013;32:1101–6.CrossRefGoogle Scholar
- 16.Morales DLS, Almond CSD, Jaquiss RDB, Rosenthal DN, Naftel DC, Massicotte MP, Humpl T, Kroslowitz R, Devaney EJ, Canter CE, Fynn-Thompson F, Reinhartz O, Imamura M, Ghanayem NS, Buchholz H, Furness S, Mazor R, Gandhi SK, Fraser CD. Bridge children of all sizes to cardiac transplantation: the initial multicenter North American experience with the Berlin Hart EXCOR ventricular assist device. J Heart Lung Transplant. 2011;30:1–7.CrossRefPubMedGoogle Scholar
- 20.Tuzun E, Roberts K, Cohn WE, Sargin M, Gemmato CJ, Radovancevic B, Frazier OH. In vivo evaluation of the HeartWare centrifugal ventricular assist device. Tex Heart I J. 2007;34:406–11.Google Scholar
- 22.Nishinaka T, Tatsumi E, Katagiri N, Ohnishi H, Mizuno T, Shioya K, Tsukiya T, Homma A, Kashiwabara S, Tanaka H, Sato M, Taenaka Y. Up to 151 days of continuous animal perfusion with trivial heparin infusion by the application of a seal-less centrifugal pump and a diffusion membrane oxygenator. J Artif Organs. 2007;10:240–4.CrossRefPubMedGoogle Scholar
- 26.Cardiovascular system. In: Jones TC, Hunt RD, King NW, editors. Veterinary pathology. 6th ed. New Jersey: Wiley-Blackwell; 1997. pp. 992–5.Google Scholar
- 27.Miera O, Schmitt KRL, Delmo-Walter E, Ovroutski S, Hetzer R, Berger F. Pump size of Berlin heart EXCOR pediatric device influences clinical outcome in children. J Heat Lung Transplant. 2014;33:817–21.Google Scholar