New Implantable Childrens VAD for Severe Heart Failure
The number of children with severe heart failure is increasing. Over the last decade, ventricular assist devices (VADs) have become the standard of care in the management of severe heart failure. In adults, implantable VADs (i.e. pumps placed within the chest) are used exclusively, due in part to favorable risk profiles and, more importantly, the opportunity for home discharge and outpatient management. By contrast, no implantable VADs designed specifically for small children (approximately 5 to 20 kg) are currently available. The result is that the vast majority of pediatric patients with severe heart failure are currently managed with paracorporeal VADs (i.e. pumps sitting outside the body), which in general are associated with higher risk profiles and require hospital management. In a presentation at the 96th AATS Annual Meeting, researchers describe testing of a pediatric-specific implantable VAD in living animals.
Baltimore, MD, May 16, 2016 – For children with severe heart failure, the only available means of life support are ventricular assist devices (VADs) placed outside the body. These devices are associated with significant risks and the need for hospital management. In conjunction with the National Heart, Lung and Blood Institute, investigators have now developed a miniaturized implantable VAD for small children (the Infant Jarvik 2015). The results of testing the device in live sheep are presented at the 96th AATS Annual Meeting.
“The very favorable results of this study will be submitted to the U.S. Food and Drug Administration for determination of its suitability to initiate a clinical trial called the PumpKIN (Pump for Kids, Infants, and Neonates) Trial. We are hoping the trial will begin late this year. This study will be an important milestone in the new era of pediatric heart failure management with implantable VADs,” explained lead investigator Iki Adachi, MD, Texas Children’s Hospital, Houston.
While there are VADs designed for adults, there are no implantable VADs specifically designed for small children. The current study aims to address this unmet need. The Infant Jarvik 2015 is an implantable axial-flow VAD. Compared to its predecessor the Infant Jarvik 2000, in vitro testing demonstrated that it offers significantly improved hemolysis profile, which is one of the most important challenges in development of small pumps. The Infant Jarvik 2015 offers up to 3.0 liters per minute flow rate, which is approximately double the flow its predecessor can provide. This important difference in flow capability would suggest that the new pump could be used in wider range of children.