Abstract

Purpose of the study: To assess the efficacy of a new concept of intracardiac propeller to restore a normal cardiac output in severely altered hearts via a mini-invasive beating heart surgical approach. Methods: A VAD located inside the left ventricle has been developed in order to assist hearts in severe heart failure during the systolic phase. The concept is based on alternative rotation speeds of a specifically designed propeller (length:40mm, diameter:18mm) according to the diastolic and systolic heart phases. Synchronization of the assist device is provided by a programmable identification of the aortic valve opening and closure, in order to automatically respect the cardiac cycle and the physiological ascendant ejection native systolic flow. In-vitro and in-vivo acute animal studies have been achieved. Results: In-vitro studies have demonstrated that cardiac output could be increased from 40% to more than 100%, which was confirmed in 6 sheep with an acute severe heart failure model. The device is well tolerated from 2000 to 8000 rpm and able to identify arrhythmias in order to be switched on in continuous mode in case of ventricular tachycardia or fibrillation. Since the electric consumption is low (< 5 watts), this VAD will be powered via a transcutaneous energy transfer technology without any external cable.

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