Assessment of the MANTA closure device in real-life transfemoral transcatheter aortic valve replacement: A single-centre observational study.

ABSTRACT

BACKGROUND: Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR). METHODS: This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria. RESULTS: From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%). CONCLUSION: This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.