Nicolas M Van Mieghem1, Azeem Latib2, Jan van der Heyden3, Lennart van Gils4, Joost Daemen4, Todd Sorzano5, Jurgen Ligthart4, Karin Witberg4, Thom de Kroon3, Nathaniel Maor5, Antonio Mangieri6, Matteo Montorfano6, Peter P de Jaegere4, Antonio Colombo2, Gary Roubin7. 1. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl. 2. Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy; Department of Interventional Cardiology, EMO-GVM Centro Cuore, Milan, Italy. 3. Department of Cardiology and Cardiac Surgery, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands. 4. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 5. Essential Medical, Inc, Malvem, Pennsylvania. 6. Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy. 7. Essential Medical, Inc, Malvem, Pennsylvania; Cardiovascular Associates, Birmingham, Alabama.
Abstract
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.
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.
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