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.

©Cleveland Clinic Foundation 8/04