LARGE SINGLE CENTER EXPERIENCE WITH MANTA VASCULAR CLOSURE DEVICE IN TRANSCATHETER AORTIC VALVE REPLACEMENT AND MECHANICAL CIRCULATORY SUPPORT

Background: Transcatheter aortic valve replacement (TAVR) and mechanical circulatory support (MCS) are common procedures requiring large-bore arterial access. Data on suture-based VCD for large-bore arterial access closure have been comprehensive. The safety and efficacy of the MANTA VCD using real-world data are scarce. The present study aims to evaluate the safety and efficacy of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in arterial transfemoral large-bore sheath size from 14 to 24 Fr using real-world data in a tertiary-care center.Methods: A single-center evaluation of patients who underwent TAVR and MCS with the use of Manta VCD from June 2019 to September 2020. The primary efficacy outcome is defined as immediate hemostasis post closure in absence of major bleeding or access site endovascular or surgical intervention. The secondary safety outcomes assessed using Valve Academic Research Consortium-2 (VARC-2) criteria, including major and minor bleeding and vascular complications.Results: Twelve different operators consecutively treated 174 patients with the MANTA device. TAVR was performed in 94 (54%), percutaneous MCS was performed in 76 (43.6%), and other structural interventions in five (3%) of patients. The 14Fr MANTA was used in 59 cases (34%) and the 18Fr was used in 115 cases (66%). The median sheath size was 14 Fr. A single device was deployed in 173 (99.4%) of cases. The primary efficacy outcome was obtained in 92.6% of cases. The secondary safety outcomes using VARC-2 criteria were major bleeding 0.5%, minor bleeding 4.5%, major vascular complication 1.13%, minor vascular complication 4.5%. To achieve hemostasis 6.7% of the cases required endovascular balloon tamponade and 1.7% required covered stents. There was no access site infection, collagen-plug embolization, surgical repair, and retroperitoneal bleeding.Conclusion: In this single-center experience, the use of MANTA VCD can safely and effectively close large bore arteriotomies, including TAVR and MCS. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed.