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Pre-clinical Readiness Of A Non-thrombogenic Ventricular Assist Device For Infants
William J. Weiss, PhD, Branka Lukic, MS, Javier Gentile, MD, Jenelle M. Izer, DVM, Matthew Lanza, VMD, John L. Myers, MD.
Penn State College of Medicine, Hershey, PA, USA.
There is currently only one durable VAD approved for infants. Despite excellent survival to transplant, the risk of pump thrombosis, thromboembolism, stroke, and bleeding associated with aggressive anticoagulation are higher than in adult VADs. We have developed an Infant VAD with the goal of reducing these risks. The VAD is a pulsatile pneumatic pump with a stroke volume of 12-14 ml. It uses mechanical tilting disk valves which do not exhibit the stagnation zones in polymer trileaflet valves. The pump geometry promotes a vortex flow pattern with sustained velocity throughout the pump cycle. Development has progressed to pre-clinical readiness.
Methods. Design iterations have undergone extensive testing in lambs (n=54) to develop the animal model and assess thrombogenicity. In 14 recent studies, heparin was given only during the first 2 post-operative weeks during the normal post-surgery hyper-coagulable acute phase response, to maintain normal coagulation (normal TEG R time).
Results. Successful endpoints of elective termination were achieved in 23 studies for durations of 49.7 +/- 15.7 days. There were no thromboembolic events, and pump explant and necropsy results were generally free of thrombi or end organ infarcts, even in the animals with normal coagulation.A portable pneumatic driver has been developed with advanced automatic control features which optimize pump performance over a wide range of inflow and outflow conditions, to support left, right, and biventricular support.
Conclusions. Extensive testing in animals supports the readiness of the Infant VAD for clinical trials.
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