First‐in‐human experience with Aortix intraaortic pump. Issue 3 (11th October 2018)

• Record Type: Journal Article
• Authors: Vora, Amit N.; Schuyler Jones, William; DeVore, Adam D.; Ebner, Adrian; Clifton, William; Patel, Manesh R.
• Is Part Of: Catheterization and cardiovascular interventions. Volume 93:Issue 3(2019)
• Page Start: 428
• Page End: 433
• Publication Date: 2018-10-11
• Subjects: first‐in‐human -- high‐risk PCI -- left ventricular dysfunction -- percutaneous mechanical circulatory support; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.27857
• Languages: English
• ISSNs: 1522-1946

Abstract

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.