Efficacy and safety of a percutaneous right ventricular assist system.

Abstract

Mechanical right ventricular assistance is necessary in the management of profound right ventricular failure resistant to medical therapy. Conventional right ventricular assistance requires a thoracotomy. We developed a technique for assisting the failing right ventricle without thoracotomy. We implanted the percutaneous right ventricular assist system in animals to test its feasibility and safety. A feasibility study was performed in a right ventricular failure model using 12 open chest dogs, and we examined the effects of the system hemodynamically. Next, the system was implanted into 6 goats and driven for 2 to 8 days. Institution of the percutaneous right ventricular assist system revealed overall hemodynamic improvement on right ventricular failure in dogs. In the goat experiment, no animal died from cannula-related complications. No damage to the intracardiac structures and no pulmonary edema were seen. Plasma free hemoglobin concentration did not exceed 10 mg/dL. The percutaneous right ventricular assist system is safe and effective in the management of right ventricular failure.