Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
Oliver Klein-WieleBirgit Hailer

Abstract

This study is the first head-to-head analysis of StarClose vs. ProGlide in patients undergoing 5F or 6F percutaneous coronary catheterization or peripheral artery interventions. The clip based StarClose and the suture mediated ProGlide vascular closure device are well established for femoral hemostasis in endovascular therapy. However, until now no prospective randomized study compared the safety and efficacy of the two devices. This prospective, randomized, single-center study enrolled 505 patients (69.6 ± 11.2 years) resulting in 538 procedures due to more than one intervention in several patients: We analyzed 422 cardiac catheterization and 116 peripheral artery interventions via a common femoral artery access. Patients were randomized to StarClose or ProGlide (1:1). In-hospital complications (major bleeding, hematoma, pseudoaneurysm, vessel occlusion, and arteriovenous fistula) and device failure were recorded. The puncture site was assessed by ultrasound in all patients prior to discharge. Overall complication rate was 3.9%. There were more complications after utilization of StarClose compared to ProGlide (5.6 vs. 2.2%, P = 0.064), which was significant in adjusted logistic regression analysis with a 2.9-fold increased ris...Continue Reading

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Citations

Jul 13, 2019·Circulation. Cardiovascular Interventions·Giuseppe Tarantini
Oct 4, 2019·Vascular and Endovascular Surgery·Abdallah NaddafKim J Hodgson
Feb 21, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Zoltan G Turi
Apr 28, 2021·Annals of Vascular Surgery·Emma AfifyHaytham Al-Khaffaf

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