Plug-based vascular closure device in transfemoral transcatheter aortic valve implantation.

Abstract

Objectives: Failure of vascular closure device (VCD) is the most common cause of access-site vascular complications in transfemoral transcatheter aortic valve implantation (TAVI). The authors sought to determine if the systematic use of arteriotomy-site ballooning with concomitant manual compression following the delivery of a plug-based VCD (MANTA, Teleflex) can optimize toggle-plug assembly apposition to the common femoral artery (CFA) wall and improve the final hemostatic efficacy.

Methods: In this prospective, observational, single-center study, 323 consecutive patients undergoing transfemoral TAVI from October 2021 to December 2024 underwent access closure with the MANTA VCD. The primary endpoints were VCD failure rate, predictors of VCD failure, and access-site and access-related major and minor vascular complications, according to the Valve Academic Research Consortium-3 definition.

Results: VCD failure occurred in 12 (3.7%) patients (Failure group). The independent predictors of failure were minimum CFA diameter and patient risk as assessed by the Society of Thoracic Surgeons Predicted Risk of Mortality score. Receiver operating characteristic analysis showed CFA minimum diameter with an area under the curve of 0.77 (0.69-0.86, P less than .001); the best cutoff was 6.30 mm (sensitivity 83%; specificity 59%; positive predictive value 7%; negative predictive value 99%). Access-site vascular complications occurred in 21 (6.5%) patients.

Conclusions: The systematic use of arteriotomy-site ballooning plus concomitant manual compression following MANTA VCD delivery should be considered to improve the final hemostatic efficacy. This device should be avoided when dealing with small (less than 6.3 mm) CFA diameters.