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

Area of Science:

• Cardiovascular Surgery
• Medical Devices
• Interventional Cardiology

Background:

• The Aortix percutaneous mechanical circulatory support (pMCS) device is inserted and removed from the descending aorta.
• The procedure requires specific steps for managing the power lead and achieving hemostasis.
• Previous preclinical validation and a feasibility study (NCT04145635) demonstrated the device's reliability.

Purpose of the Study:

• To describe a novel technique for reliable suture-mediated vessel closure during Aortix pMCS device procedures.
• To outline the standardized steps for deployment and retrieval of the Aortix pMCS device.
• To provide a method for managing the exiting power lead and closing large arteriotomies.

Main Methods:

• Ultrasound-guided femoral artery access was performed.
• Four Perclose sutures were placed for preclosure.
• Hemostasis was achieved by locking three sutures around the 6F power lead, followed by device removal and closure with the remaining sutures using a hybrid technique.

Main Results:

• The described standardized steps were developed and applied in 21 clinical cases.
• Twelve operators, initially new to the procedure but experienced in large-bore access, successfully utilized the technique.
• The method proved reliable for managing the exiting power lead and closing the arteriotomy.

Conclusions:

• Suture-mediated closure, using both preclose and postclose techniques, reliably manages the Aortix pMCS device's power lead and the large arteriotomy after retrieval.
• The described steps may be applicable to other procedures involving large-bore arterial access or requiring suture-mediated closure.