Abstract
Objectives: A continuous-flow centrifugal blood pump
system has been recently developed as an implantable
left ventricular assist device for patients with end-
stage heart failure. The objective of this study was to
evaluate the initial in vivo performance of a newly
developed left ventricular assist device (iHeart or
Istanbul heart; Manufacturing and Automation
Research Center, Koc University, Istanbul, Turkey) in an
acute setting using a pig model.
Materials and Methods: Three pigs (77, 83, 92 kg)
received implants via a median sternotomy, with
animals supported for up to 6 hours. An outflow
cannula was anastomosed to the ascending aorta.
Anticoagulation was applied by intravenous heparin
administration. During the support period, pump
performance was evaluated under several flow and
operating conditions. All pigs were humanely
sacrificied after the experiments, and organs were
examined macroscopically and histopathologically.
Results: Flow rate ranged between 1.5 and 3.6 L/min
with pump speeds of 1500 to 2800 revolutions/min
and motor current of 0.6 to 1.3 A. Initial findings
confirmed that the iHeart ventricular assist device had
sufficient hydraulic performance to support the
circulation. During the experimental period, plasma
free hemoglobin levels were found to be within
normal ranges. Thrombus formation was not observed
inside the pump in all experiments.
Conclusions: The iHeart ventricular assist device
demonstrated encouraging hemodynamic performance
and good biocompatibility in the pig model for use as
an implantable left ventricular assist device. Further
acute in vivo studies will evaluate the short-term pump
performance prior to chronic studies for long-term
evaluation.
Key words: Animal experiment, Centrifugal blood pump,
Heart failure, Mechanical circulatory support
Introduction
Heart failure is a global life-threatening condition that
affects more than 35 million people worldwide.
1,2
In
Turkey, more than 2 million people have heart failure
according to data from the Turkish Cardiology
Association.
3
Although heart transplant is the best
solution for treatment of end-stage heart failure, it is
only available for a limited number of patients (< 100
patients) per year in Turkey.
3
Ventricular assist
devices (VADs) have become an alternative therapy
for patients with end-stage heart failure as a bridge to
transplant, recovery, or destination treatment.
4-8
The
demand for implantable VADs with a hydrodynamic
impeller or magnetic suspension systems has been
increasing worldwide because these devices show
great potential for long-term survival and have
extreme mechanical durability.
9-11
In 2001, Kucukaksu
and associates performed the first application of an
implantable left ventricular assist device (MicroMed
DeBakey LVAD; MicroMed Technology, Houston, TX,
USA) in Turkey.
12
However, the number of LVAD
implantations remains restricted due to high
operational costs. Cost-effective devices are thus
needed to increase the clinical use of LVADs in
Turkey.
13
Given these facts, a new centrifugal flow-
type LVAD, named iHeart VAD (or Istanbul heart;
Manufacturing and Automation Research Center,
Copyright © Başkent University 2019
Printed in Turkey. All Rights Reserved.
A Short-Term In Vivo Evaluation of the Istanbul Heart
Left Ventricular Assist Device in a Pig Model
Ismail Lazoglu,
1
Deniz Suha Kucukaksu,
2
Caglar Ozturk,
1
Ibrahim Basar Aka,
1
Vedat Bakuy,
2
Nurcan Arat,
3
Ozlem Yalcin,
4
Elif Ugurel,
4
Pelin Celikbilek Erkasap,
5
Emin Aksoy,
5
Sevket Ruacan
6
From the
1
Manufacturing and Automation Research Center, College of Engineering, Koc
University, Istanbul, Turkey; the
2
Department of Cardiovascular Surgery, School of Medicine,
Baskent University, Istanbul, Turkey; the
3
Department of Cardiology, School of Medicine,
Istanbul Bilim University, Istanbul, Turkey; the
4
Department of Physiology, School of Medicine,
Koc University, Istanbul, Turkey; the
5
Center of Advanced Simulation and Education, School
of Medicine, Acıbadem University, Istanbul, Turkey; and the
6
Department of Pathology, School
of Medicine, Koc University, Istanbul, Turkey
Acknowledgements: The authors have no sources of funding for this study and have no conflicts
of interest to declare.
Corresponding author: Ismail Lazoglu, Koc University, Rumelifeneri Yolu, 34450, Sariyer,
Istanbul, Turkey
Phone: +90 212 3381587 E-mail: ilazoglu@ku.edu.tr
Experimental and Clinical Transplantation (2019)
ArtIcle
DOI: 10.6002/ect.2019.0110