“Cavopulmonary Assist Device Development for Fontan Circulatory Support”

Doctor's Name: 
Rodefeld, Mark, MD
Hospital/Institution: 
Indiana University

This Grant is being funded by the Lauren Elise Memorial Foundation

Children born with single ventricle congenital heart disease are effectively missing half of their hearts, and face lifelong obstacles. Surgical palliation (not cure) is possible, but requires a series of 3 high-risk staged open-heart procedures to reach the final stage of repair. After the final procedure, the patient is left to live the remainder of their life with what is known as a Fontan circulation.

With medical advances, more and more single ventricle children survive surgical repair, and an increasing number are now reaching adulthood. However, this subset of patients constitutes the most rapidly growing and most problematic group of children, and now adults, with congenital heart disease.

A Fontan circulation is identical to a normal 2-ventricle circulation with the exception that it lacks a right-sided power source. Although a Fontan circulation is lifesaving, it has inherent inefficiencies that will eventually lead to circulatory failure. Our work has focused over the past 14 years to replace the missing power source and restore the Fontan circulation to a more efficient 2-ventricle circulation.

To do this requires placing a blood pump into the right-sided circulation in a Fontan patient, which is a tricky and difficult undertaking. We have learned through prior work that a blood pump must be designed specifically for this task: no such pump currently exists. With our effort, we have steadfastly identified the issues and obstacles that must be overcome in order to accomplish assisted Fontan circulation in a way that is safe and reliable.

As a result, we have developed early-stage candidate devices that are capable of performing in this role, either temporarily or permanently. The temporary pump is a catheter-based pump that would be placed by a cardiologist with a needle stick in the neck or groin. It would have an external motor that would drive the pump. The permanent pump has a self-contained motor that will drive rotation of the impeller to provide pumping. The permanent pump would require open-heart surgery for implantation.

If successfully developed for use in humans, the technology would revolutionize the management of patients with single ventricle Fontan circulations. At the current time, there are no therapies that are primarily targeted to support single ventricle patients. This device therapy would constitute a first-ever targeted therapy for Fontan patients. The technology would enable the ultimate treatment strategy for single ventricle heart disease: the restoration and maintenance of 2-ventricle circulatory status.

We seek funding to further develop prototypes of this technology with the goal of getting to a stage sufficient to attract commercialization investment. Funding for device development, especially small-market pediatric devices, is extremely difficult to obtain through more traditional channels. The small market size and complexity of Fontan patients are detractors to potential investors or industry strategic partners. Single ventricle patients are relatively numerous, and deserve better treatment options for their care and long-term health.

The promise that these devices deliver is the restoration of a normal 2-ventricle circulation in patients who are missing one of their ventricles. We seek to further develop these devices toward clinical application, and Children's Heart Foundation funding would bring us much closer to this goal.

Award Date 1: 
2014
Award Amount 1: 
$100,000