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

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.