Study Background and Disease Burden
Transfemoral transcatheter aortic valve implantation (TF-TAVI) is a widely adopted minimally invasive treatment for severe aortic stenosis, particularly in elderly or high-risk surgical patients. Despite marked advances, access site-related vascular complications remain an important cause of morbidity and mortality, affecting patient outcomes and healthcare resource utilization. Reliable and efficient vascular closure techniques are vital to minimizing bleeding and vascular complications following femoral artery access. Vascular closure devices (VCDs) employ either suture-based, plug-based, or combined mechanisms to achieve hemostasis. However, randomized data comparing various closure strategies remain scarce, limiting evidence-based decisions for optimal access management after TF-TAVI.
