A Durability Study of a Paracorporeal Pulsatile Electro-Mechanical Pneumatic Biventricular Assist Device

作者：Choi Hyuk; Lee Heung Man; Nam Kyoung Won; Choi Jaesoon; Lee Jung Joo; Kim Ho Chul; Song Seung Joon; Ahn Chi Bum; Son Ho Sung; Lim Choon Hak; Son Kuk Hui; Park Yong Doo; Jeong Gi Seok; Sun Kyung^*

来源：Artificial Organs, 2011, 35(6): 614-624.

DOI：10.1111/j.1525-1594.2010.01187.x

• Paracorporeal pulsatile electro-mechanical pneumatic ventricular assist device
• Reliability test
• durability

In 2002, the paracorporeal pulsatile electromechanical pneumatic ventricular assist device (VAD) began to be developed by the Korea Artificial Organ Center at Korea University under a Health & Medical Technology Research and Development program which finished in 2008. In vitro durability testing was conducted on the paracorporeal pulsatile pneumatic VAD to determine device durability and to evaluate device failures. The 1- and 2-year reliability of the paracorporeal pulsatile pneumatic VAD was shown to be 91.2% and 54.9%, respectively, with an 80% confidence level. Failure modes were analyzed using fault tree analysis, with customized software continuously acquiring data during the test period. After this period, 21 in vivo animal tests were done, with 14 cases of left atrium to left ventricle (LV) inflow cannulation (36Fr)/outflow grafting to descending aorta, and seven cases of apex cannulation of LV to descending aorta (12 mm). The longest postoperative day (182 days) in Korea was recently recorded in in vivo animal testing (bovine, 90 kg, male, 3.5-4.0 L/min flow rate, and 55 bpm).

• 出版日期2011-6