title: In Vivo Evaluation of a Pneumatic Extracorporeal Ventricular Assist Device for up to 90 Day Support.
abstract: In a previous study, we showed that the Vitalmex Extracorporeal Ventricular Assist Device-Pneumatic (EVAD-P)-a low-cost, pneumatically actuated, pulsatile blood pump-is easy to implant and safe for short-term in vivo support (30 ± 5 days). In the current study, we included additional 30 day experiments and assessed the safety and durability of the EVAD-P for up to 90 days of support. Using the same surgical procedure as in the previous study, we implanted the device into 14 healthy sheep. Group I subjects (n = 7) were evaluated for up to 30 days, and group II (n = 2) and group III (n = 5) subjects were evaluated for up to 49 and 93 days, respectively. After a system redesign, two of the five sheep in group III reached the scheduled end-point without device-related problems at a fixed beat rate of 56 bpm, a stroke volume (SV) of 58.0 ± 2.3 ml, and a flow of 3.5 ± 0.2 L/min. This study shows that the EVAD-P can provide safe pulsatile mechanical circulatory support (MCS) for up to 93 days. To further confirm that the system can consistently provide MCS for this duration, additional studies are recommended.
authors.affiliation: From the *Cardiovascular Research Laboratories, Texas Heart Institute, Houston, Texas; and †Vitalmex Internacional SA de CV, Mexico City, Mexico.
authors.forename: Jeff L
authors.initials: JL
authors.lastname: Conger
authors.forename: Brian W
authors.initials: BW
authors.lastname: Grace
authors.forename: Kelsey L
authors.initials: KL
authors.lastname: Van Noy
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Handy
authors.forename: Gil G
authors.initials: GG
authors.lastname: Costas
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Rodriguez-Sierra
authors.forename: Alejandro
authors.initials: A
authors.lastname: Trejo
authors.forename: Javier
authors.initials: J
authors.lastname: Pinzon
authors.forename: William E
authors.initials: WE
authors.lastname: Cohn
mesh_terms: D000818:Animals; D006353:Heart-Assist Devices; D012756:Sheep; D013318:Stroke Volume