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Preclinical Evaluation of the EVAHEART 2 Centrifugal Left Ventricular Assist Device in Bovines

Motomura, Tadashi*; Tuzun, Egemen; Yamazaki, Kenji; Tatsumi, Eisuke§; Benkowski, Robert; Yamazaki, Shunichi

doi: 10.1097/MAT.0000000000000869
Original Article: PDF Only

The EVAHEART 1 left ventricular assist device was miniaturized to the EVAHEART 2, with a new inflow cannula designed to mitigate the risks of malposition. To evaluate the safety of the new double-cuff tipless inflow cannula, in vivo studies were performed in healthy bovines. Eight consecutive studies were done: five short-term studies of hematological adaptation and three long-term studies of tissue adaptation. Each inflow cannula was purposefully implanted in the worst-case setting with marked malposition. Two studies terminated early: one because of an animal-specific ancillary component and one because of an accidental radial fracture. Six studies reached the study endpoint without major adverse events. One animal could not achieve proper anticoagulation because of warfarin resistance. Pump speed and power were maintained within stable, normal ranges. There were no major organ dysfunction or suction events. Necropsy results showed two cases of pannus formation around the inflow ostium because of warfarin resistance and hyperinflammation at the inflow cuff suture line. There was one case of trivial pannus; four cases were pannus-free, with no evidence of ventricular wall suction. No wedge thrombus formation occurred. The EVAHEART 2 tipless inflow cannula may reduce adverse events attributable to the inflow cannula, such as stroke.

From the *Evaheart, Inc, Houston, Texas

Texas A&M Institute for Preclinical Studies (TIPS), Texas A&M University, College Station, Texas

Hokkaido Cardiovascular Hospital, Sapporo, Japan

§National Cerebral and Cardiovascular Center (NCVC), Osaka, Japan

DesignPlex Biomedical, LLC, Fort Worth, Texas

Sun Medical Technology Research Corp., Suwa, Nagano, Japan.

Submitted for consideration April 2018; accepted for publication in revised form July 2018.

Disclosure: Dr Motomura is a full-time employee of Evaheart, Inc., and S. Yamazaki is a full-time employee of Sun Medical Technology Research Corp. Dr Tuzun (Texas A&M Institute for Preclinical Studies) and Dr Tatsumi (National Cerebral and Cardiovascular Center) are the principal investigators of the animal studies. Dr Yamazaki is a medical advisor of Sun Medical Technology Research Corp. R. Benkowski is a technology consultant of Evaheart, Inc.

This animal study was funded by Evaheart, Inc., and Sun Medical Technology Research Corp.

Correspondence: Tadashi Motomura, Evaheart, Inc, 6655 Travis St. Suite 590, Houston, TX 77030. Email: tmotomura@evaheart-usa.com.

Copyright © 2018 by the American Society for Artificial Internal Organs