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

Abstract

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.

The Pulsatile Modification Improves Hemodynamics and Attenuates Inflammatory Responses in Extracorporeal Membrane Oxygenation

“…Other recent examples that generate pulsatility for ECMO were the Medos Deltastream DP3 system (Medos Medizintechnik AG, USA) 10 and the K-Beat system designed by Inamori’s group. 22 …”

Pulsatility protects the endothelial glycocalyx during extracorporeal membrane oxygenation

“…Besides the i-Cor system, other recently reported pulsatile flow generators included the Medos Deltastream DP3 system (Medos Medizintechnik AG, USA) 45 and the K-Beat system by Inamori's group. 8 Overall, the development of future ECMO devices will require the availability of pulsatility to reduce the complication of microcirculatory malperfusion.…”

“…5,6 Recently, several pumps allowing for pulsatile flow have been developed. 3,7,8 The novel i-Cor system (Xenios AG, Heilbronn, Germany) consists of a diagonal blood pump that provides pulsatility triggered by electrocardiogram and has been applied in Europe for several years. 9,10 Ündar's group examined the i-Cor system in animal models and had reported better renal function and more stable hemodynamics in pulsatile circuits.…”

Pulsatility Protects the Endothelial Function During Extracorporeal Membrane Oxygenation

“…In addtion to the i-Cor system, other recent reported pulsatile ow generators included the Medos Deltastream DP3 system (Medos Medizintechnik AG, USA) [42] and the K-Beat system by Inamori's group [8]. Overall, the development of the future ECMO devices will require an aviailability of pulsatility to reduce the complication of microcirculatory malperfusion.…”

“…However, one of its main drawbacks is the typically non-pulsatile ow, of which the non-physiological nature leads to malperfusion to peripheral tissue and microcirculation [6]. Recently, several pumps that can produce pulsatile ow for ECLS circuits have been developed [3,7,8]. The novel i-Cor system (Xenios AG, Heilbronn, Germany) consists of a diagonal blood pump that can provide pulsatile ow triggered by electrocardiogram and has been applied in Europe for several years [9,10].…”