Suture-Mediated Intermediate and Terminal Closure When Using the Aortix Percutaneous Mechanical Circulatory Support Device.

ABSTRACT

Background: The Aortix percutaneous mechanical circulatory support (pMCS) 18F micromechanical axial impeller-driven pump is percutaneously placed and retrieved from the descending aorta above the renal arteries. Pump deployment and retrieval use defined steps to allow suture-mediated closure around the exiting power lead and for terminal hemostasis after device retrieval after therapy. The overall procedure was validated preclinically in ovine and porcine models and has since proven reliable in a recently completed IDE feasibility study (NCT04145635). This study describes the steps of a novel technique for reliable suture-mediated vessel closure when using the Aortix pMCS device. Methods: The principal steps associated with the procedure comprised ultrasound-guided access of the femoral artery, preclose placement of 4 Perclose (Abbott) sutures, achievement of intermediate hemostasis by locking 3 of the 4 sutures around the 6F exiting power lead, breaking the 3 locked sutures to permit vessel reentry for device removal, and finally, vessel closure using the fourth preclose suture along with 1 or more postclose suture(s) to close the femoral artery using a hybrid dual-sheath technique. Results: The standardized steps described have been developed and used over the course of 21 clinical cases by 12 operators who were initially procedurally naïve but experienced in large-bore access. Conclusions: Preclose and postclose suture-mediated closure is a reliable means of managing the exiting power lead of the Aortix pMCS and closing the large-bore arteriotomy after pump retrieval. The steps outlined in this study may have applicability to other procedures requiring large-bore access or using suture-mediated closure.