Fontan Blood Pump: Advanced Prototype Testing and Optimization

Doctor's Name: 
Dr. Mark Rodefeld
Hospital/Institution: 
Indiana University

Children born with single ventricle congenital heart disease are missing one of the two main pumping chambers of their heart. Surgical palliation is possible; cure is not. Three high-risk staged open-heart procedures are required to reach the end-point of palliative repair, which is known as a Fontan circulation. Beyond this point, a child is left to live the remainder of their life with an inherently inefficient circulation. While it may last for 30 or 40 years, health may be suboptimal and will progressively decline. A full lifespan is impossible. Although lifesaving, Fontan palliation is in essence an imposition of chronic circulatory disease.

Fortunately, more and more single ventricle children survive surgical repair, and are now reaching adulthood. However, this subset of patients now represents the most rapidly growing and most problematic group of adults with congenital heart disease.  As the chronic complications of Fontan are being increasingly confronted, it is now urgently clear there is no way to prevent this disease progression.

A Fontan circulation is identical to a normal 2-ventricle circulation with the exception that it lacks a right-sided pump (the missing ventricle). This results in inherent inefficiencies that can be compensated for - for some time - but will eventually manifest other problems and eventual circulatory failure. Our work has focused over the past 15 years to replace the missing pump and restore the Fontan circulation to a more efficient 2-ventricle circulation. With this, normal health can be maintained and healthy life can be extended to a normal lifespan.

Placing a blood pump into the right side of a Fontan circulation is a highly complex challenge. It has never been accomplished: Nor has it ever been considered realistic. Nonetheless, we are steadfastly identifying and resolving the challenges that must be overcome to accomplish this safely and reliably. If successful, it will represent a significant advance in the care of children and adults with congenital heart disease.

The technology will make it possible to permanently reverse the Fontan paradox, maintain biventricular health, and preempt the relentless progression of Fontan disease. For the single ventricle patient, this translates to an extension of life by decades, at the same time with “normal” biventricular health.

Prior funding of this project by the Children’s Heart Foundation supported the design phase for a 4th-generation advanced Fontan pump prototype. We are now moving forward by putting the design into fabrication. Once complete, testing and optimization will be necessary to ensure that the pump provides low-pressure augmentation of cavopulmonary blood flow without risk of blood damage and without obstruction of the Fontan venous pathway in the event of failure. We seek funding to support testing and optimization of the advanced prototype. Fabrication is expected to be finished at the end of 2017. Data from testing will help us to compete successfully for follow-on NIH R01 funding to finalize device optimization, perform animal studies, reach a design freeze, and proceed to commercialization.

 

Award Date 1: 
2017
Award Amount 1: 
100,000.00