title: A durability study of a paracorporeal pulsatile electro-mechanical pneumatic biventricular assist device.
abstract: In 2002, the paracorporeal pulsatile electro-mechanical 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).
authors.affiliation: Department of Biomedical Engineering, College of Medicine, Korea University, Seoul, Korea.
authors.forename: Hyuk
authors.initials: H
authors.lastname: Choi
authors.forename: Heung-Man
authors.initials: HM
authors.lastname: Lee
authors.forename: Kyoung Won
authors.initials: KW
authors.lastname: Nam
authors.forename: Jaesoon
authors.initials: J
authors.lastname: Choi
authors.forename: Jung-Joo
authors.initials: JJ
authors.lastname: Lee
authors.forename: Ho Chul
authors.initials: HC
authors.lastname: Kim
authors.forename: Seung Joon
authors.initials: SJ
authors.lastname: Song
authors.forename: Chi Bum
authors.initials: CB
authors.lastname: Ahn
authors.forename: Ho Sung
authors.initials: HS
authors.lastname: Son
authors.forename: Choon Hak
authors.initials: CH
authors.lastname: Lim
authors.forename: Kuk Hui
authors.initials: KH
authors.lastname: Son
authors.forename: Yong Doo
authors.initials: YD
authors.lastname: Park
authors.forename: Gi Seok
authors.initials: GS
authors.lastname: Jeong
authors.forename: Kyung
authors.initials: K
authors.lastname: Sun
mesh_terms: D000818:Animals; D002417:Cattle; D004867:Equipment Design; D006353:Heart-Assist Devices; D007723:Korea; D011475:Prosthesis Failure; D011673:Pulsatile Flow