'Post-Close' Femoral Arterial Haemostasis at Endovascular Aneurysm Repair using a Dedicated Large-Bore Vascular Closure Device: A Prospective Real-World Audit.

Abstract

Percutaneous access for endovascular aneurysm repair (EVAR) is commonplace, with its attendant benefits. The combination of continued reduction in device profile and evolution of vascular closure device (VCD) design drives successful and safe percutaneous EVAR. A new such VCD is the MANTA Large-Bore Closure Device designed in two iterations for closure of arterial defects from 10 to 25F. We present a prospective audit of 131 large-bore femoral closures using an 'all-comers' approach to device selection. One hundred and thirty-one large-bore femoral arterial defects were analysed. Both 14F and 18F MANTA VCDs were deployed in this series as per instructions for use. Primary objectives were technical success, particularly successful deployment, and haemostasis achieved. Failures were denoted as failure to deploy; failure to achieve haemostasis was denoted as active bleeding, haematoma, or pseudoaneurysm formation requiring intervention. Later complications assessed were vessel occlusion/thrombosis or stenosis. Seventy-six patients (65 males and 11 females, age 75.2 ± 8.7years) underwent a range of procedures including EVAR (n = 66), TEVAR (n = 2), and reinterventions (n = 8) requiring large-bore percutaneous femoral arterial access in 131 groins. Of these, the 14F MANTA VCD was used in 61 closures (defects ranging from 12 to 18F) and the 18F in 70 closures (defects ranging from 16 to 24F). Deployments achieved successful haemostasis in 120 (91.6%), and failures occurred in 11(8.4%) groins. This study indicates that a post-close approach using the novel MANTA Large-Bore Closure Device can be undertaken successfully to close a range of large-bore femoral arterial defects at EVAR/TEVAR with an acceptable rate ofcomplications.