Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access: A Multicenter Prospective Study.
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.
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl.
Nicolas M
NM
Van Mieghem
Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy; Department of Interventional Cardiology, EMO-GVM Centro Cuore, Milan, Italy.
Azeem
A
Latib
Department of Cardiology and Cardiac Surgery, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Jan
J
van der Heyden
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Lennart
L
van Gils
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Joost
J
Daemen
Essential Medical, Inc, Malvem, Pennsylvania.
Todd
T
Sorzano
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Jurgen
J
Ligthart
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Karin
K
Witberg
Department of Cardiology and Cardiac Surgery, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Thom
T
de Kroon
Essential Medical, Inc, Malvem, Pennsylvania.
Nathaniel
N
Maor
Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy.
Antonio
A
Mangieri
Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy.
Matteo
M
Montorfano
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Peter P
PP
de Jaegere
Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy; Department of Interventional Cardiology, EMO-GVM Centro Cuore, Milan, Italy.
Antonio
A
Colombo
Essential Medical, Inc, Malvem, Pennsylvania; Cardiovascular Associates, Birmingham, Alabama.
Gary
G
Roubin
D000368:Aged; D000369:Aged, 80 and over; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D000072226:Computed Tomography Angiography; D004867:Equipment Design; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011677:Punctures; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D062666:Vascular Access Devices; D065506:Vascular Closure Devices
MANTA; closure device; large-bore arteriotomy