Aortix™, a Novel Catheter-Based Intra-Vascular Assist Device, Provides Cardio-Renal Support While Improving Ventriculo-Arterial Coupling and Myocardial Demand in Sheep With Induced Chronic Ischemic Heart Failure

Río, Carlos del; Clifton, William; Heuring, Jace; Hertzog, Benjamin; Ueyama, Yukie; Youngblood, Brad; McConnell, Patrick I.

doi:10.1016/s0735-1097(15)60800-2

Cited by 7 publications

(1 citation statement)

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“…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 3,9,10 . As the device does not traverse the ascending aorta or the great vessels, there is minimal risk of ischemic cerebrovascular accident.…”

Section: Discussionmentioning

confidence: 97%

First‐in‐human experience with Aortix intraaortic pump

Vora

Jones

DeVore

et al. 2018

Cathet Cardio Intervent

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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.

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Section: Discussionmentioning

confidence: 97%