Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

Abstract

Objectives: The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). Background: To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. Methods: In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. Results: Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. Conclusions: This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.