A new pneumatic pump for extracorporeal circulation: TPP (true pulsatile pump). Experimental and first clinical results.

A pulsatile, membrane type pump, TPP, was developed for use in routine cardiac surgery. The artificial ventricle consists of a polycarbonate housing with an inlet and outlet polyurethane tricuspid valve. The membrane is actuated hydraulically. For pre-clinical studies, we designed a study in sheep. After a pump run of 6 hours the animals were allowed to recover and sacrificed after 72 hours. All clinical parameters returned to normal values (p > 0.05 vs. control values). During pump run we found elevated free plasma hemoglobine. However, these values returned to normal until the end of the observation period. Thereafter, the device was used in ten routine cardiac surgery procedures. All patients survived the procedure and were discharged from hospital. The postoperative course of lab parameters (kidney, liver and blood count) was no different to routine cardiac surgical procedures. This pulsatile pump system can thus be safely employed in cardiac surgery.