First‐in‐human experience with Aortix intraaortic pump

Abstract

Background There are limited options for percutaneous mechanical circulatory support (pMCS) in patients requiring high‐risk percutaneous coronary intervention. Objectives This first‐in‐human, single‐center study aimed to evaluate the safety and feasibility of a novel pMCS device in high‐risk percutaneous coronary intervention patients. Methods Aortix (Procyrion, Houston, Texas) is a pMCS device deployed in the descending aorta via the femoral artery that uses axial flow to provide cardiac unloading and augment renal and systemic perfusion. We assessed the use and effect of the Aortix device in six patients undergoing high‐risk PCI. All patients had impaired left ventricular function, complex coronary disease, renal dysfunction, and suitable iliofemoral anatomy for Aortix placement via transfemoral approach. We recorded periprocedural events including hemodynamic effects of the device on cardiac output and urine output. We then followed patients up to 30 days following the PCI procedure for adverse events. Results Aortix delivery (18 Fr sheath) took 4–9 min, mean support time was 70 (range 47–95) min, and mean flow rate through the device was 3.5 L/min. During support, mean rate of urine output increased 10‐fold (range 2.5–25.0x). Estimated GFR improved at discharge compared with baseline (mean increase 6.95 ± 8.09 mL/min). There were no device failures and PCI was successful in all patients. Aortix was removed and hemostasis was achieved with a vascular closure device and manual pressure. No patients experienced adverse events or hemodynamic compromise. No clinically significant hemolysis occurred (mean LDH 239.2 ± 73.6 mU/mL at baseline and 206.4 ± 82.2 mU/mL at discharge). No vascular access complications were observed. Conclusions Aortix, a novel pMCS device, was successfully deployed and retrieved in all initial patients undergoing high‐risk PCI. We noted no significant hemolysis with temporary use of this axial flow device. Improvement in eGFR suggests a potential renal protective effect and is an important area for future investigation in patients with impaired left ventricular function and renal dysfunction.

A Glimpse Into the Future of Transcatheter Interventional Heart Failure Therapies

“…The Aortix percutaneous mechanical circulatory support system (Procyrion) is a 6-mm axial flow pump placed via a transfemoral approach in the descending aorta, proximal to the renal arteries. 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 device was tested in a single-center, first-in-human safety and feasibility study enrolling 6 patients with ischemic cardiomyopathy and LVEF between 20% and 28% who were scheduled to undergo complex coronary intervention. It was successfully delivered in all patients within a mean of 5.8 minutes after access was obtained, and it was removed after a successful percutaneous coronary intervention in all patients ( 21 ). No major complications or significant hemolysis occurred, and urine output had a temporary 10-fold increase in the 4 patients in whom urine output was recorded ( 21 ).…”

“…It was successfully delivered in all patients within a mean of 5.8 minutes after access was obtained, and it was removed after a successful percutaneous coronary intervention in all patients ( 21 ). No major complications or significant hemolysis occurred, and urine output had a temporary 10-fold increase in the 4 patients in whom urine output was recorded ( 21 ). A larger (n = 45) multicenter, nonrandomized feasibility study is being planned to test the safety and performance of Aortix system in the management of patients hospitalized with acute decompensated HF and cardiorenal syndrome ( NCT04145635 ).…”

Mechanical circulatory support: complications, outcomes, and future directions

“…The Aortix is likewise retrievable after a period of intended use and can provide up to 5 L of forward flow per minute. 58 This device is FDA approved to provide circulatory support for complex, high-risk PCI in patients with an LVEF <35%. 59 In a 6-patient, singlecenter study, the Aortix was deployed to facilitate high-risk PCI in patients with low LVEF.…”

First‐in‐human experience with occlusion of the superior vena cava to reduce cardiac filling pressures in congestive heart failure

“…Current approaches to reduce cardiac preload focus on diuretic therapy and vasodilators . Device‐based approaches for decongestion of patients with acute heart failure include aquapheresis, hemodialysis, and investigational approaches such as impeller pumps in the descending aorta . No existing device is designed to specifically reduce cardiac preload as a method to unload the heart due to a concern that this approach may decrease cardiac output and systemic blood pressure.…”