Abstract
ObjectivesThe 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).BackgroundTo 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.MethodsIn 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.ResultsAccess-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.ConclusionsThis 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.
Highlights
Transcatheter aortic valve replacement (TAVR) has emerged as the gold standard treatment for symptomatic patients at high surgical risk
A total of 73 patients were included in our study and treated with the MANTA device
In all patients the MANTA 18-Fr device was used for femoral artery closure
Summary
Transcatheter aortic valve replacement (TAVR) has emerged as the gold standard treatment for symptomatic patients at high surgical risk. While the complication rate has decreased as a result of the operators’ growing expertise and knowledge, as well as new valve technology, TAVR is still associated with a significant complication rate [1]. Vascular complications at the access site for transfemoral (TF)-TAVR still remain a problem. These complications are observed in 5–20% of patients and have a significant impact on clinical outcomes [2]. During the early years of TFTAVR, the femoral artery was closed surgically. This method has been replaced by use of a vascular closure device (VCD)
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