title: One-month biocompatibility evaluation of the pediatric TinyPump in goats.
abstract: The TinyPump is an extracorporeal, magnetically driven centrifugal blood pump with its impeller suspended magnetically and hydrodynamically to provide short-term mechanical circulatory support for children and infants. We have previously demonstrated that the in vivo experiments of the experimental TinyPump showed acceptable stable performance at pump flows averaging around 1.0 L/min with low hemolytic and thrombogenic properties for up to 2 weeks. We present here the 1-month in vivo evaluation of the TinyPump, whose design was modified further for more durable operation. The pump was implanted as a left ventricular assist device in five goats (12.5-26.7 kg), with inflow inserted into the left ventricular apex and outflow anastomosed to the descending aorta. Five animals were supported for 110 pump days, with mean pump flow of 1.19 ± 0.03 L/min at a pump speed of 2679 ± 97 rpm. Two animals reached the scheduled end point of 30 days without device failure, and mean plasma-free hemoglobin was 1.7 ± 0.8 mg/dL. Hematologic and biochemical data of these two animals showed no evidence of cardiovascular, renal, or hepatic dysfunction. Although further experiments are needed, the modified TinyPump offers promise as a short-term mechanical circulatory support device in pediatric population.
authors.affiliation: Department of Artificial Organs, Institute of Biomaterials and Bioengineering, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Ando
authors.forename: Takashi
authors.initials: T
authors.lastname: Kitao
authors.forename: Eiki
authors.initials: E
authors.lastname: Nagaoka
authors.forename: Taro
authors.initials: T
authors.lastname: Kimura
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Yokoyama
authors.forename: Masaharu
authors.initials: M
authors.lastname: Yoshikawa
authors.forename: Ryuji
authors.initials: R
authors.lastname: Tominaga
authors.forename: Setsuo
authors.initials: S
authors.lastname: Takatani
mesh_terms: D000818:Animals; D002648:Child; D005112:Extracorporeal Circulation / Q000295:instrumentation; D006041:Goats; D006353:Heart-Assist Devices / Q000009:adverse effects; D006403:Hematologic Tests; D006439:Hemodynamics; D006801:Humans; D007223:Infant; D008422:Materials Testing; D011474:Prosthesis Design