Investigational Use of a Prototype Pulsatile Mechanical Circulatory Support System for Right Heart Failure in a Large Animal Study

Background: Severe isolated right heart failure (RHF) is a rare and challenging clinical condition, which is strongly associated with decreased outcomes and consecutive adverse events. Mechanical circulatory support devices (MCS) offer an urgent treatment option. Yet, most MCS devices create laminar flows, which compared to pulsatile devices, are often acknowledged as less physiological, and thus, to fewer lead to myocardial recovery. We investigated a novel, pulsatile temporary right ventricular assist device for the treatment of right ventricular failure in a porcine model.

Methods: The novel right ventricular support device´s membrane pump is connected to a T-splitter, which directs the blood flow either through the inlet catheter into the pump or out of the pump into the outlet catheter. A catheter in the jugular vein aspirated the blood. Bypassing the right ventricle, the blood is ejected into the pulmonary artery (PA). The pump was driven by an IABP console providing the pump rate. To simulate RHF, the PA was obstructed by clamping. Subsequently, the MSC was activated, providing a blood flow of 3.2 L/min. Hemodynamic parameters (systolic and diastolic aortic, PA and central venous pressures) and the pump flow were measured before and after activation of the novel device.

Results: The device was tested in six healthy pigs. The novel MSC device was able to provide an output of 38 mL per pump beat, directly proportional to the pump rate investigated from 55 bpm to 85 bpm. PA obstruction drastically worsened the hemodynamic state, which was reflected by a decrease of the pressure in the aortic and PA by around 25%. After activation of the novel device the pressures recovered up to 95% of the healthy initial conditions. The pressure in the central venous system was increased by 25% compared to the initial healthy state. After activation, the CVP recovers to normal hemodynamic conditions.

Conclusion: The data provided by this experiment show that the novel, temporary, pulsatile MCS device improves hemodynamics in a porcine model. However, further thorough investigation is needed prior to the first application of the device in a human study.

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Artikel online veröffentlicht:
13. Februar 2024