Development of a Pulsatile Flow-Generating Circulatory Assist Device (K-Beat) for Use with Veno-Arterial Extracorporeal Membrane Oxygenation in a Pig Model Study

Veno-arterial extracorporeal membrane oxygenation (V-A ECMO) preserves the life of heart failure patients by providing an adequate oxygen supply and blood flow to vital organs. For patients with severe cardiogenic shock secondary to acute myocardial infarction or acute myocarditis, V-A ECMO is commonly used as the first choice among cardiac circulatory support devices. While V-A ECMO generates circulatory flow using a centrifugal pump, the provision of pulsatile flow is difficult. We previously reported our development of a new circulatory flow assist device (K-beat) for cardiac management with pulsatile flow. To obtain more efficient pulsatile assist flow (diastolic augmentation), an electrocardiogram (ECG)-analyzing device that can detect R waves and T waves increases the assist flow selectively in the diastole phase by controlling (opening and closing) the magnetic valve of the tamper. Here, we describe the first use of the K-beat on a large animal in combination with a clinical device. In addition, the diastolic augmentation effect of the K-beat as a circulatory flow assist device was examined in a pig V-A ECMO model. The K-beat was stopped every 60 min for a period of a few minutes, and blood pressure waveforms in the pulsatile and non-pulsatile phases were checked. This experiment showed that stable V-A ECMO could be achieved and that hemodynamics were managed in all animals. The pulsatile flow was provided in synchrony with the ECG in all cases. A diastolic augmentation waveform of femoral arterial pressure was confirmed in the pulsatile phase. K-beat could be useful in patients with severe heart failure.