Improved Hemodynamics With a Novel Miniaturized Intra-aortic Axial Flow Pump in a Porcine Model of Acute Left Ventricular Dysfunction

Abstract

Currently, long-term mechanical circulatory support (MCS) is limited to large, complex devices that require invasive, high-risk surgical implantation. These devices are mainly used in patients with late stage heart failure (HF). We are developing a novel percutaneous intra-aortic micro-axial fluid entrainment pump intended for long-term MCS in patients with earlier stage HF. This study examined the pump's hemodynamic effects in a porcine model of acute HF. In three porcine experiments, the pump was deployed in the thoracic aorta by standard cardiac catheterization techniques and was anchored with self-expanding struts. Acute cardiac dysfunction was induced by infusing esmolol continuously. Pump support increased cardiac output (+10.4%), stroke volume (+8.9%), and ejection fraction (+10.8%) while decreasing cardiac stroke work (-10.8%) and afterload (-22.7%). Furthermore, pump support significantly enhanced renal perfusion through sustained increases in both renal artery flow (+36.4%) and pressure (+73.6%). In a porcine model of acute HF, the catheter-based intra-aortic fluid entrainment pump improved hemodynamics and renal perfusion. These results suggest that the pump could improve HF outcomes and patients' quality of life by resting the heart, promoting reverse remodeling, and augmenting end-organ perfusion. Furthermore, the enhanced renal perfusion may help disrupt the cardiorenal syndrome cycle and improve HF treatment.

First‐in‐human experience with Aortix intraaortic pump

“…The device is powered and controlled via a 2 mm electrical lead attached to the device, a lead that is envisioned to be tunneled out of the body for short‐term implantation of the device for support therapy in the future. Prior animal studies with this device demonstrated improvement in ejection fraction, cardiac output, and reduced myocardial oxygen extraction, along with improved urine output and renal perfusion . As the device does not traverse the ascending aorta or the great vessels, there is minimal risk of ischemic cerebrovascular accident.…”

“…Following PCI, Aortix is removed in the catheter lab and a percutaneous closure is performed. Initial safety and efficacy data were obtained in a porcine model and demonstrated proof of concept ( n = 9) …”

“…Initial safety and efficacy data were obtained in a porcine model and demonstrated proof of concept (n = 9). 3…”

Percutaneous haemodynamic and renal support in patients presenting with decompensated heart failure: A multi-centre efficacy study using the Reitan Catheter Pump (RCP)

“…While the RCP is designed as a temporary cardiac and renal support device, there are other devices in early development aiming to improve renal blood flow and aid decongestion in the longer term. These include the Procyrion Aortix device (Texas, USA) (25) and the Second Heart Assist device (California, USA). While they share an implantation position within the descending aorta, there are differences in impeller design and therefore operational speeds, and the degree of cardiac and renal support.…”

The Aortix device: Support in a tube

“…Similar to a balloon pump, the device is positioned in the suprarenal portion of the descending aorta. The Aortix can support up to 5.0 L/min of pump flow thus potentially providing tissue perfusion and unloading of the left ventricle not achievable in the same magnitude by IABP.Initial small studies in animal models of the Aortix device confirmed increased cardiac output and renal perfusion and decreased cardiac stroke work and afterload, suggesting that the pump could improve heart failure outcomes and may help disrupt the cardiorenal syndrome cycle 2. The authors were able to show that the device can be implanted quickly and can support high-risk PCI.…”