Project: Research project

Project Details


This proposal represents the first totally integrated approach to
developing a suitable mechanical circulatory assist device for use in the
pediatric patient.

Despite technical advances in pediatric cardiac surgery, profound
refractory heart failure following technically successful correction of
congenital lesions remains a significant cause of mortality. The inability
to wean an infant from cardiopulmonary bypass or improve a low-output
syndrome in the immediate postoperative period with medical therapy is
fatal since intra-aortic balloon pumping is not particularly effective in
this age group. Safe effective cardiac assist devices are currently
available for use in small patients. The safety and efficacy of
ventricular assist pumping has been established in the laboratory and in
the clinical setting for treating adult patients with postcardiotomy
cardiogenic shock. These results suggest that ventricular assist pumping
may have a role in the pediatric age group postcardiotomy cardiogenic
shock. Such use may be expected to significantly reduce mortality in these

Through a collaborative effort, we propose modification of the current
angle port pneumatically driven ventricular assist pump and cannulas
developed at The Pennsylvania State University for this application. A
scaled down 10cc stroke volume device capable of supporting an infant's
systemic and/or pulmonary circulation will be fabricated by 3M/Sarns Inc.,
and tested in vitro via mock circulation and flow visualization studies at
The Pennsylvania State University. Short term animal studies utilizing
infant goats (The Pennsylvania State University) and dogs and sheep (Mayo
Foundation) are proposed to test the safety and efficacy in vivo.
Following satisfactory completion of animal studies and appropriate FDA
approval, we propose human application at The Milton S. Hershey Medical
Center and at the Mayo Foundation in pediatric patients who following
technically successful correction of a congenital heart lesion cannot be
separated from cardiopulmonary bypass or who develop low cardiac output
syndrome in the immediate postoperative period. The ability of assist
pumping to temporarily support the systemic and/or pulmonary circulation
while allowing time for myocardial recovery and improved patient survival
will be evaluated. The time course of recovery of ventricular function and
physiologic effects of assist pumping will be studied via standard
laboratory and hemodynamic techniques.
Effective start/end date1/1/901/1/90


  • National Heart, Lung, and Blood Institute


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