TY - JOUR
T1 - Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access
T2 - A Multicenter Prospective Study
AU - Van Mieghem, Nicolas M.
AU - Latib, Azeem
AU - van der Heyden, Jan
AU - van Gils, Lennart
AU - Daemen, Joost
AU - Sorzano, Todd
AU - Ligthart, Jurgen
AU - Witberg, Karin
AU - de Kroon, Thom
AU - Maor, Nathaniel
AU - Mangieri, Antonio
AU - Montorfano, Matteo
AU - de Jaegere, Peter P.
AU - Colombo, Antonio
AU - Roubin, Gary
N1 - Publisher Copyright:
© 2017 American College of Cardiology Foundation
PY - 2017/3/27
Y1 - 2017/3/27
N2 - Objectives 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. Background 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. Methods 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. Results 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. Conclusions 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.
AB - Objectives 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. Background 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. Methods 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. Results 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. Conclusions 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.
KW - MANTA
KW - closure device
KW - large-bore arteriotomy
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U2 - 10.1016/j.jcin.2016.12.277
DO - 10.1016/j.jcin.2016.12.277
M3 - Article
C2 - 28335899
AN - SCOPUS:85015658547
SN - 1936-8798
VL - 10
SP - 613
EP - 619
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 6
ER -