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Aortix (Procyrion, Houston, Texas) is a percutaneous mechanical circulatory support (pMCS) device deployed in the descending aorta via the femoral artery to provide cardiac unloading and augment renal and systemic perfusion. This first-in-human, single-center study (Sanatorio Italiano, Asuncion, Paraguay) aimed to evaluate the safety and feasibility of Aortix in high-risk PCI patients.
Six patients with poor LV function (EF 20-35%), complex coronary lesions, and renal dysfunction (eGFR range 26-67 ml/min) with suitable anatomy (iliac artery ≥6mm, aorta ≤35mm) received Aortix support during PCI.
Aortix delivery (18 Fr sheath) took 4-9 minutes, mean support time was 70 (range 47-95) min, and mean flow rate was 3.5 L/min. There were no device failures and PCI was successful in all patients. Aortix was removed and hemostasis was achieved with Perclose ProGlide (Abbott, Abbott Park, IL) vascular closure device and manual pressure. No patients experienced adverse events or hemodynamic compromise despite high complexity. No clinically significant hemolysis occurred. No vascular access complications were observed. During support, mean rate of urine output increased 10-fold (range 2.5-25.0x, Figure). Estimated GFR improved at discharge compared with baseline (mean increase 6.95 ±8.09 ml/min).
Aortix, a novel pMCS device, was successfully deployed and retrieved in all initial patients undergoing HR-PCI. Improvement in eGFR suggests a potential renal protective effect and the functional improvement in kidney function may be beneficial in heart failure patients.
CORONARY: Hemodynamic Support and Cardiogenic Shock