Abstract
We developed a novel endurance test system that can arbitrarily set various circulatory conditions and has durability and stability for long-term continuous evaluation of ventricular assist devices (VADs), and we evaluated its fundamental performance and prolonged durability and stability. The circulation circuit of the present endurance test system consisted of a pulsatile pump with a small closed chamber (SCC), a closed chamber, a reservoir and an electromagnetic proportional valve. Two duckbill valves were mounted in the inlet and outlet of the pulsatile pump. The features of the circulation circuit are as follows: (1) the components of the circulation circuit consist of optimized industrial devices, giving durability; (2) the pulsatile pump can change the heart rate and stroke length (SL), as well as its compliance using the SCC. Therefore, the endurance test system can quantitatively reproduce various circulatory conditions. The range of reproducible circulatory conditions in the endurance test circuit was examined in terms of fundamental performance. Additionally, continuous operation for 6 months was performed in order to evaluate the durability and stability. The circulation circuit was able to set up a wide range of pressure and total flow conditions using the SCC and adjusting the pulsatile pump SL. The long-term continuous operation test demonstrated that stable, continuous operation for 6 months was possible without leakage or industrial device failure. The newly developed endurance test system demonstrated a wide range of reproducible circulatory conditions, durability and stability, and is a promising approach for evaluating the basic characteristics of VADs.
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Frazier OH, Myers TJ, Gregoric ID, Khan T, Delgado R, Croitoru M, Miller K, Jarvik R, Westaby S. Initial clinical experience with the Jarvik 2000 implantable axial-flow left ventricular assist system. Circulation. 2002;105:2855–60.
Wieselthaler GM, Schima H, Hiesmayr M, Pacher R, Laufer G, Noon GP, DeBakey M, Wolner E. First clinical experience with the DeBakey VAD continuous-axial-flow pump for bridge to transplantation. Circulation. 2000;101:356–9.
Frazier OH, Delgado RM 3rd, Kar B, Patel V, Gregoric ID, Myers TJ. First clinical use of the redesigned HeartMate II left ventricular assist system in the United States: a case report. Tex Heart Inst J. 2004;31:157–9.
Griffith K, Jenkins E, Pagani FD. First American experience with the Terumo DuraHeart left ventricular assist system. Perfusion. 2009;24:83–9.
Marlinski E, Jacobs G, Deirmengian C, Jarvik R. Durability testing of components for the Jarvik 2000 completely implantable axial flow left ventricular assist device. ASAIO J. 1998; 44(5):M741–4.
Anderson DW. Blood pumps: technologies and markets in transformation. Artif Organs. 2001;25:406–10.
Mizuguchi K, Damm GA, Bozeman RJ, Akkerman JW, Aber GS, Svejkovsky PA, Bacak JW, Orime Y, Takatani S, Nosé Y, Noon GP, DeBakey ME. Development of the Baylor/NASA axial flow ventricular assist device: in vitro performance and systematic hemolysis test results. Artif Organs. 1994;18:32–43.
Nojiri C, Kijima T, Maekawa J, Horiuchi K, Kido T, Sugiyama T, Mori T, Sugiura N, Asada T, Umemura W, Ozaki T, Suzuki M, Akamatsu T, Westaby S, Katsumata T, Saito S. Development status of Terumo implantable left ventricular assist system. Artif Organs. 2001;25:411–3.
Yamane T, Maruyama O, Nishida M, Kosaka R, Sugiyama D, Miyamoto Y, Kawamura H, Kato T, Sano T, Okubo T, Sankai Y, Shigeta O, Tsutsui T. Hemocompatibility of a hydrodynamic levitation centrifugal blood pump. J Artif Organs. 2007;10(2):71–6. Epub 2007 Jun 20.
Umezu M, Yamazaki K, Yamazaki S, Iwasaki K, Miyakoshi T, Kitano T, Tokuno T. Japanese-made Implantable Centrifugal Type Ventricular Assist System (LVAS): EVAHEART. Biocybern Biomed Eng. 2007;27:111–9.
National Institute of Advanced Industrial Science and Technology. R&D Working Group report for active implants: innovative artificial heart systems. 2006. http://www.aist.go.jp/aist_j/aistinfo/report/entrust/iryoukiki/2006/techrep_artificalheart_ft2006.pdf. Accessed 25 April 2012 (in Japanese).
Yokoyama Y, Kawaguchi O, Shinshi T, Steinseifer U, Takatani S. A new pulse duplicator with a passive fill ventricle for analysis of cardiac dynamics. J Artif Organs. 2010;13:189–96.
Pantalos GM, Koenig SC, Gillars KJ, Giridharan GA, Ewert DL. Characterization of an adult mock circulation for testing cardiac support devices. ASAIO J. 2004;50(1):37–46.
Gibber M, Wu ZJ, Chang WB, Bianchi G, Hu J, Garcia J, Jarvik R, Griffith BP. In vivo experience of the child-size pediatric Jarvik 2000 heart: update. ASAIO J. 2010;56(4):369–76.
Litwak P, Butler KC, Thomas DC, Taylor LP, Macha M, Yamazaki K, Konishi H, Kormos RL, Griffith BP, Borovetz HS. Development and initial testing of a pediatric centrifugal blood pump. Ann Thorac Surg. 1996;61:448–51.
Weiss WJ. Pulsatile pediatric ventricular assist devices. ASAIO J. 2005;51(5):540–5.
Kitao T, Ando Y, Yoshikawa M, Kobayashi M, Kimura T, Ohsawa H, Machida S, Yokoyama N, Sakota D, Konno T, Ishihara K, Takatani S. In vivo evaluation of the “TinyPump” as a pediatric left ventricular assist device. Artif Organs. 2011;35:543–53.
Timms D, Hayne M, McNeil K, Galbraith A. A complete mock circulation loop for the evaluation of left, right, and biventricular assist devices. Artif Organs. 2005;29:564–72.
Fleming S, Thompson M, Stevens R, Heneghan C, Plüddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011;377:1011–8.
Park MK, Menard SW, Schoolfield J. Oscillometric blood pressure standards for children. Pediatr Cardiol. 2005;26(5):601–7.
Ministry of Economy, Trade and Industry. R&D Guidelines for active implants 2007: innovative artificial heart systems. 2007. http://www.meti.go.jp/policy/mono_info_service/service/iryou_fukushi/downloadfiles/200705-2.pdf. Accessed 25 April 2012 (in Japanese).
Kiani A, Gilani Shakibi J. Normal value of left ventricular end-systolic elastance in infants and children. IJMS. 2003;28:169–72.
Smith JJ, Kampine JP. Circulatory physiology: the essentials. Lippincott Williams and Wilkins, Baltimore; 1984.
Acknowledgments
The present study was supported by Grants-in-Aid for Scientific Research A (no. 23249065 and no. 21249076) and B (no. 21390398) from the Ministry of Education, Culture, Sports, Science and Technology of Japan, and by the Intramural Research Fund (22-3-3) for Cardiovascular Diseases from the National Cerebral and Cardiovascular Center.
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Sumikura, H., Homma, A., Ohnuma, K. et al. Development and evaluation of endurance test system for ventricular assist devices. J Artif Organs 16, 138–148 (2013). https://doi.org/10.1007/s10047-013-0687-3
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DOI: https://doi.org/10.1007/s10047-013-0687-3