Current status and future perspectives of the PumpKIN trial
Similar to the adult experience, the use of continuous-flow ventricular assist devices (VADs) has been increasing in the pediatric population. According to the PediMACS registry, continuous-flow VAD currently accounts for >60% of the durable device implantations in the U.S. Nonetheless, the continuous-flow VADs currently in use are designed for adults; this inevitably causes the patient-device size mismatch issue, especially when applied for small children. Pulsatile VADs, therefore, represent the only practical option for this group of patients despite the known risk profile of pulsatile VADs. To address such a frustrating reality, the National Heart, Lung, and Blood Institute (NHLBI) launched the Pediatric Circulatory Support Program in 2004, which is the predecessor of the so-called PumpKIN (Pump for Kids, Infants, and Neonates) program. The goal of this program was to develop mechanical circulatory support devices specifically designed for small children. As a result of extensive efforts of the multi-disciplinary team involving clinicians, scientists, manufactures, and federal agencies, the Infant Jarvik 2015, one of the original devices within the Pediatric Circulatory Support Program, has become the first continuous-flow VAD specifically designed for small children that obtained the Investigational Device Exemption (IDEs) from the U.S. Food and Drug Administration (FDA). This approval is a prerequisite to initiate a clinical trial (i.e., the PumpKIN trial). This article describes the history, current status, and future perspectives of this extremely challenging project, with a focus on the lessons we have learned over the decade.