The disease is a congenital condition in which one chamber of the heart is either missing or underdeveloped, causing an overwhelming burden on the remaining chamber to pump blood effectively.

UofL biomedical engineer Guruprasad Giridharan, PhD; Indiana University pediatric surgeon Mark Rodefeld, MD; and Purdue University mechanical engineer Steve Frankel, PhD, lead the project.

“Single ventricle heart disease is the leading cause of death from any birth defect in the first year of life,” said Giridharan, who is UofL’s principal investigator. “The children usually require three major surgeries in the first few years of life to re-route blood flow and lighten the workload of the single ventricle, which pumps blood both to the body and lungs.”

The implantable pump is designed to deliver blood to the lungs and assist the single ventricle, improving the child’s circulatory status, he said.

“We have created pump prototypes of this novel and simple assist device,” Giridharan said. “The funding from the NIH will enable improvement of the prototypes that will hopefully take it that much closer to implantation in humans.”

This work has the potential to, at minimum, provide a crutch for patients who are undergoing the current treatment for this condition.

“This device has the potential to revolutionize the treatment of patients with a single ventricle as the use of this device may reduce the number of surgeries from three to one or two and improve survival and clinical outcomes for these patients,” Giridharan said.

By taking the workload off of the single ventricle, it may be possible to delay subsequent surgery until the patient has improved cardiac function. In some cases, the researchers said, it’s possible that the device may provide patients the support they need to allow their bodies to strengthen and minimize surgeries and use of shunts, which can cause long-term heart and lung dysfunction, neurocognitive deficits and developmental problems.

The catheter-based pump is inserted through the skin into a blood vessel and advanced close to the heart using a simple, minimally-invasive surgical approach,” said Steven Koenig, PhD, professor of bioengineering and surgery in the CII. “Once in place, the pump expands to provide blood flow to the lungs, thereby performing the work of the missing ventricle.”

The recent grant will support the investigators as they work to enhance the design of the pump, especially with regard to its deployment (collapsibility and expandability) inside the blood vessel, Giridharan said.

This project is one of 12 federal- and state-funded grants received over the past three years totaling $8.8 million to support the work of the Division of Artificial Organs and Mechanical Circulatory Support at the CII. CII is a partnership between UofL and Jewish Hospital.