Ipsilateral Safety Wire as Bailout for MANTA Failure in Patients Undergoing Transcatheter Aortic Valve Replacement

MANTA is an effective vascular closure device (VCD) in patients undergoing transcatheter aortic valve replacement (TAVR); however, the lack of a convenient bailout for device-related vascular complications is a limitation. The objective of this study is to examine the safety and efficacy of ipsilateral safety wire (ISW) as a bailout for MANTA failure in patients undergoing TAVR.

Our institutional Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry and EPIC chart system were queried to identify patients who underwent TAVR with MANTA and ISW from July 1, 2022, to June 30, 2023. The ISW involves ipsilateral arterial access distal to primary access and placement of a 0.018" wire in a retrograde fashion in the descending aorta. The primary safety outcome was the absence of complications related to the ISW technique. The primary efficacy outcome was successful MANTA closure, with or without the utilization of the ISW technique, defined as achieving hemostasis without impairment of distal perfusion or need for surgical vascular intervention.

Eighty-nine patients were included (mean age 81.1 years, 32.6% women, 98.9% White). Most procedures were performed electively (95.5%) in a hybrid operating room (83.1%) with conscious sedation (82.0%), using balloon-expandable valves (98.9%). The primary safety and efficacy outcomes were achieved in all patients. Two patients (2.2%) required utilization of the ISW technique for bailout; 1 for inadequate hemostasis, and 1 for severe common femoral artery stenosis. No major bleeding or surgical vascular intervention occurred.

The ISW technique is a safe and effective bailout technique for MANTA in patients undergoing TAVR.