Current status and future perspectives of the PumpKIN trial

ISHLT consensus statement for the selection and management of pediatric and congenital heart disease patients on ventricular assist devices Endorsed by the American Heart Association

“…53,54 Similar to the adult intracorporeal devices, a miniature CF axial pump, the Jarvik (Jarvik Heart Inc, New York City, New York, USA), is currently under study through an industry collaboration with the NIH (PumpKIN trial). 55…”

“…146,147 Of note, the newer HM3 has a shorter inflow when compared to the HVAD (22 mm vs 32.2 mm). 55 Alternatively, if the mitral valve is obstructing inflow, excision of the valve may be considered with a CF device.…”

“…8,9 However, there is an ongoing trial (PumpKIN Trial) that is sponsored by NIH on a small CF axial flow pump (Jarvik Heart) for children. 55 There are many limitations to device trials in pediatrics, including patient volume and heterogeneity of population. An additional limitation is understanding the relevance to real-world practice.…”

Developments in Pediatric Ventricular Assist Device Support

“…The redesign of the original pump to new blade design and larger outer diameter with restriction of rotational speeds showed promising ten-fold reduction of hemolysis in animal models. 14 The current PumpKIN study design includes 2 prospective single-arm feasibility trials which include those with standard cardiac anatomy and those with challenging cardiac anatomy. Its enrollment weight range of 8 to 20 kg and BSA 0.4 to 1.0 m 2 continue to leave the smallest population (<5 kg) without implantable CF options.…”

“…As we continue to push the technology and its management to the new levels, an evident mismatch of a patient to device size becomes evident. The benefits of CF technology may not be uniform across all age groups as highlighted by increased risk of thrombosis in children with body surface area (BSA) <1.0 m, as reported by Miera et al 13 Reemergence of PumpKIN trial with redesigned Jarvik 2015 pump 14 opens new hope for reliable CF durable device for infants. The redesign of the original pump to new blade design and larger outer diameter with restriction of rotational speeds showed promising ten-fold reduction of hemolysis in animal models.…”