Abdominal Positioning of the Next-Generation Intra-Aortic Fluid Entrainment Pump (Aortix) Improves Cardiac Output in a Swine Model of Heart Failure

Abstract

Background Acute heart failure refractory to medical therapy is a major cause of morbidity and mortality. The Aortix device (Procyrion Inc) is a percutaneously delivered, entrainment pump positioned in the descending aorta. Using the newest generation Aortix device in eight adult male Yorkshire swine, we tested the hypothesis that positioning in the abdominal aorta may provide superior hemodynamic effects than thoracic positioning in a swine model of post-infarct LV injury. Abdominal activation generated significantly larger trans-aortic gradients (proximal minus distal mean aortic pressures) than thoracic positioning at all pump speeds. Compared to baseline values, activation in the abdominal, not thoracic, position significantly increased cardiac output, reduced arterial elastance, and systemic vascular resistance at low speeds. Compared to baseline values, abdominal activation also increased trans-pulmonary pressure gradients at medium and high speed, which was driven by trends towards higher mean pulmonary artery pressure and lower pulmonary capillary wedge pressure. This is the first report to determine that in contrast to thoracic positioning, abdominal positioning of the newest generation Aortix device reduces LV afterload and increases cardiac output at low speeds. These findings have potentially important implications for the design of early clinical studies by suggesting that device position and speed are major determinants of improved hemodynamic efficacy.

First-in-Human Experience With the ModulHeart Device for Mechanical Circulatory Support and Renal Perfusion

“…Enrolled patients required nonurgent complex or high-risk PCI, defined as at least 1 of the following: (1) unprotected left main PCI, (2) multivessel (>1 vessel) PCI, (3) bifurcation lesions PCI, (4) severely calcified lesion PCI, (5) last patent conduit to the heart PCI, (6) saphenous graft or arterial bypass PCI, or (7) presence of left ventricular dysfunction (left ventricular ejection fraction, 20%-50%). The exclusion criteria included cardiogenic shock, anatomical characteristics that would preclude safe placement of a 22F sheath, and severe calcification of the descending aorta.…”

A Glimpse Into the Future of Transcatheter Interventional Heart Failure Therapies

“…The device is intended to provide cardiac unloading and augmentation of renal and systemic perfusion ( 21 ). Aortix reduces afterload and increases cardiac output at low speeds; higher speeds seem to increase the mean PA pressure, possibly owing to increased venous return ( 16 , 22 ). The system provides up to 5 L/min of flow at 30,000 rpm, with a mean flow of 3.5 L/min at 25,000 rpm.…”

The sheep as a pre-clinical model for testing intra-aortic percutaneous mechanical circulatory support devices

“… 16 Choosing an animal model, not only of comparable anatomy and size but also reflecting comparable age-related physiologic properties in reserve, resilience and resistance to stressors 17 is essential to avoid conducting costly experiments with misleading and meaningless study results lacking transferability. The pig has been widely used as a model in cardiovascular research, including hemodynamic studies of pMCS devices 18 – 21 and appears to be a valuable alternative to the calf at first glance. Due to the porcine heart bearing a close resemblance to the human heart in terms of size and hemodynamics, 22 it is especially suitable for the testing of intraventricular pMCS devices 19 and with an average mid-descending thoracic aortic diameter of 15.57 ± 0.40 mm 23 smaller intra-aortic balloon pumps expanding to a final diameter of 15–18 mm.…”