The EVAHEART 2 (Sun Medical Technology Research Corporation, Nagano, Japan) is an investigational centrifugal ventricular assist device in the United States, introduced a new type inflow, named “double cuff tipless” inflow cannula intended to mitigate the risks of cannula malposition and subsequent ischemic stroke events associated with thrombi around the inflow cannula. To achieve these performance benefits of the “tipless” design, however, it is crucial to adhere to the recommended surgical procedure. We introduced a polymer-based patient model that mimics a dilated cardiomyopathy apex for inflow cannula implantation training. Here, we used the model to simulate appropriate and inappropriate techniques for inflow suturing. With the appropriate technique, the inflow ostium is aligned on the endocardial plane, and the cut myocardial surface is not exposed to the bloodstream. By contrast, with the inappropriate technique, which is represented as a worst-case suturing scenario, the inflow ostium is misaligned, thus exposing the cut myocardial cross-section to the bloodstream. This misalignment can predispose to platelet deposition, thrombus formation, and pannus formation with long-term support. Repeated training with this human apex model is important to confirm the inflow position and intraventricular finish before moving on to human cases. Along with rigorous preclinical training, technical adherence will help to ensure better clinical outcomes.
From the Evaheart, Inc., Houston, Texas.
Submitted for consideration July 2018; accepted for publication in revised form October 2018.
Disclosure: Motomura and Kelly are full-time employees of Evaheart, Inc.
This study was funded by Evaheart, Inc.
Correspondence: Tadashi Motomura, Evaheart, Inc., 6655 Travis Street, Suite 590, Houston, TX 77030. E-mail: firstname.lastname@example.org.