Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI

Abstract

Background The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. Methods This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. Results A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. Conclusions The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

“…In addition, Kmiec al. described female sex, vascular access-site angulation and more than mild vascular calcification of the dorsal vessel segment as other potential predictors of MANTA device failure and vascular complications [29].…”

Cutting balloon for femoral arterial and venus obstructions due to suture‐based closure devices: Case series

“…Another group of closure devices used in common practice is collagen plug-based. [16][17][18][19][20] The choice of device is left to the operator's preference. A collagen plug-based device can also occlude a large-bore artery; however, a CB would not be a good solution in this case.…”

“…Another group of closure devices used in common practice is collagen plug‐based 16–20 . The choice of device is left to the operator's preference.…”

Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique

“…A deeper arteriotomy site has been associated with increased MANTA-related vascular access site complications. 16 Additionally, anterior CFA calcification, 10 peripheral artery disease and vessel diameter < 6 mm, 18 low or high arteriotomies, 19 female gender, left CFA access, vessel angulation, and at least moderate anterior vessel calcification 16,20 have all been independently associated with manta related vascular complications.…”

“…Postclosure options in these instances include balloon tamponade for 30 to 60 minutes or covered stent deployment which are both time and cost inefficient and commit a patient to unnecessary covered stent deployment at the CFA site. 20 While other techniques using either PVCD or ANGIO-SEAL (Terumo Interventional Systems, Somerset, NJ) of various size and numbers have been reported in case reports or small case series, they lack predictability and have not been performed in large numbers in a prospective manner to be considered a reliable method to achieve adequate hemostasis at a high success rate. [21][22][23][24] Hence, this technique can also be successfully employed as postclosure in emergent MCS insertion cases such as Impella (Abiomed, Danvers, MA) or VA-ECMO as long as the initial arterial puncture site is known.…”