NIH
Awards Cleveland Clinic Grant for Unique Heart Device
The
Cleveland Clinic's expertise in implantable pumps to help failing hearts
has earned another major grant from the National Heart, Lung and Blood
Institute of the NIH. The Cleveland Clinic Department of Biomedical
Engineering and Kiyotaka Fukamachi, M.D., Ph.D., have been awarded a
$6.95 million contract to develop and test in clinical trials a right
ventricular assist device for patients with congestive heart failure.
Under
terms of the five-year contract, researchers in The Cleveland Clinic’s
Department of Biomedical Engineering and clinicians in its Department
of Thoracic and Cardiovascular Surgery will work to develop a right
ventricular assist device (RVAD) that will benefit heart failure patients
who need a more comprehensive implantable device than now exists. RVADs
assist the heart in pumping oxygen-depleted blood to the lungs.
This
new project is an extension of the group’s previous success in
developing the implantable CorAideTM left ventricular assist device
(LVAD) for patients with end-stage congestive heart failure. LVADs pump
oxygen-rich blood from the heart to the rest of the body. The CorAide
LVAD is an implantable continuous flow blood pump designed to serve
as a “bridge” for patients awaiting a heart transplant,
a bridge to recovery and, ultimately, an alternative to heart transplantation.
The CorAide project was lead by Leonard A.R. Golding, M.D., with Alex
L. Massiello, MEBME, and David J. Horvath, MSME, in the Clinic’s
Department of Biomedical Engineering.
“If
the CorAide LVAD can be modified and used as an RVAD, the resulting
CorAide biventricular assist device would be an ideal system, for patients
who need additional support for their LVAD to function properly,”
Dr. Fukamachi said. He leads the team of biomedical engineers and researchers
in the Clinic’s Cardiovascular Dynamics Laboratory and CorAide
Laboratory (housed within the Clinic’s Lerner Research Institute)
that will devise the new RVAD.
The
use of LVADs has been increasing to serve the growing population of
patients with end-stage congestive heart failure, Dr. Fukamachi said.
However, up to 40 percent of these patients have significant right ventricular
failure that limits the benefits of LVAD therapy, he said.
“We
have reported a poor prognosis for patients with LVAD support who also
required external RVAD support or prolonged inotropic (drug) support,”
Dr. Fukamachi said. “A safe, implantable RVAD could save the lives
of many patients with right ventricular failure.”
Right
ventricular failure leads to two problems: decreased forward flow and
high right heart pressures that result in passive congestion of the
liver, kidneys and abdominal organs. Both factors contribute to multiorgan
failure, the leading cause of death after the implant of an LVAD.
These
patients often require prolonged support with an RVAD. However, clinically
available RVADs currently are not implantable devices and have several
limitations, including issues with blood compatibility, infection, long-term
durability, mortality and quality of life.
Under
terms of the National Heart, Lung and Blood Institute award, biomedical
engineers will develop, design and clinically evaluate an implantable
RVAD that can be used as a component of an implantable biventricular
assist device for patients with severe biventricular failure.
Heart
failure affects an estimated 4.7 million Americans and is the principal
cause of approximately 51,000 deaths per year. It is a contributing
cause in another 287,000 deaths. The economic costs are estimated at
more than $23 billion annually. The number of heart failure patients
is increasing because of the aging population and more effective palliative
therapies for heart failure patients, including emergency intervention.
