Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access: A Multicenter Prospective Study

• Published in: JACC. Cardiovascular interventions 2017-03, Vol.10 (6), p.613-619
• Main Authors: Van Mieghem, Nicolas M, Latib, Azeem, van der Heyden, Jan, van Gils, Lennart, Daemen, Joost, Sorzano, Todd, Ligthart, Jurgen, Witberg, Karin, de Kroon, Thom, Maor, Nathaniel, Mangieri, Antonio, Montorfano, Matteo, de Jaegere, Peter P, Colombo, Antonio, Roubin, Gary
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Catheterization, Peripheral - adverse effects; Catheterization, Peripheral - instrumentation; Computed Tomography Angiography; Equipment Design; Europe; Female; Femoral Artery - diagnostic imaging; Hemorrhage - etiology; Hemorrhage - prevention & control; Hemostatic Techniques - instrumentation; Humans; Male; Prospective Studies; Punctures; Time Factors; Treatment Outcome; Ultrasonography; Vascular Access Devices; Vascular Closure Devices
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2016.12.277

The authors sought to study the safety and efficacy of the MANTA Vascular Closure Device (VCD), a novel collagen-based technology dedicated to closure of large-bore arteriotomies. Novel transfemoral therapeutic interventions requiring large-bore catheters have become valid minimally invasive options but have inherent access management challenges. To date, no dedicated vascular closure devices exist for large arteriotomies. A prospective, single-arm clinical investigation enrolling patients who underwent elective percutaneous interventions with large-bore catheters and planned percutaneous arteriotomy closure in 3 European institutions. A total of 50 patients with a mean age of 79.5 ± 8.3 years underwent high-risk percutaneous coronary intervention, balloon aortic valvuloplasty, or transcatheter aortic valve replacement with large-bore catheters sized 12-F to 19-F. MANTA closure was performed by 9 different operators. The 14-F MANTA VCD was deployed in one-third of the overall cohort (16 of 50, 32%), and the 18-F MANTA VCD in the remainder. The MANTA VCD was deployed successfully in all patients. The mean time to hemostasis was 2 min, 23 s. One patient had a major vascular and major bleeding complication with prolonged femoral bleeding that was successfully treated with a covered stent and eventual surgical repair. There were no other access site-related complications. This first multicenter experience demonstrates rapid and reliable hemostasis and low complication rates with the use of the plug-based MANTA VCD for large-bore arteriotomy closure.