Michael Megaly1, Ramy Sedhom2, Peter Abdelmaseeh2, Bishoy ElBebawy3, Sachin S Goel4, Joseph Karam5, Ashish Pershad1, Emmanouil S Brilakis5, Santiago Garcia6. 1. Division of Cardiology, Banner University Medical Center, University of Arizona, Phoenix, AZ, USA. 2. Department of Medicine, Albert Einstein Medical Center, Philadelphia, PA, USA. 3. Division of Cardiology, Arnot Ogden Medical Center- Lake Erie College of Medicine, Elmira, NY, USA. 4. Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, TX, USA. 5. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA. 6. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA. Electronic address: santiagogarcia@me.com.
Abstract
BACKGROUND: The collagen-based MANTA device (Teleflex, PA, USA) is used for closure of large-bore vascular access. There is a paucity of data on complications associated with its use in a real-life setting. METHODS: We queried the "Manufacturer and User Facility Device Experience" MAUDE database between February 2019 and December 2020 for reports on MANTA device. RESULTS: We identified 250 reports in the MAUDE database from February 2019 through December 2020. The most common failure complication of MANTA is persistent bleeding (48.8%) and vessel occlusion or stenosis (29.6%). Most complications were managed successfully with an endovascular approach (48.4%), but a high number of patients required surgical intervention (40.4%). The most commonly reported failure mechanism was the failure of deployment (22%) followed by subcutaneous deployment (7.6%), intraluminal deployment (4.8%) amd detachment of collagen (2.8%). Access site infection was rare (1.2%). The 18 Fr. MANTA was associated with a lower risk of failure of deployment compared with the 14 Fr. device but was associated with a higher risk of vessel occlusion or stenosis (32.4% vs. 16.3%, p = 0.04) and thrombosis (11.6% vs 0%, p = 0.03). CONCLUSIONS: The most common complication of the MANTA device reported to the MAUDE registry was persistent bleeding (48.8% of reports) followed by vessel occlusion (29.6%). These complications were managed successfully using an endovascular approach in 48.4% of the reports.
BACKGROUND: The collagen-based MANTA device (Teleflex, PA, USA) is used for closure of large-bore vascular access. There is a paucity of data on complications associated with its use in a real-life setting. METHODS: We queried the "Manufacturer and User Facility Device Experience" MAUDE database between February 2019 and December 2020 for reports on MANTA device. RESULTS: We identified 250 reports in the MAUDE database from February 2019 through December 2020. The most common failure complication of MANTA is persistent bleeding (48.8%) and vessel occlusion or stenosis (29.6%). Most complications were managed successfully with an endovascular approach (48.4%), but a high number of patients required surgical intervention (40.4%). The most commonly reported failure mechanism was the failure of deployment (22%) followed by subcutaneous deployment (7.6%), intraluminal deployment (4.8%) amd detachment of collagen (2.8%). Access site infection was rare (1.2%). The 18 Fr. MANTA was associated with a lower risk of failure of deployment compared with the 14 Fr. device but was associated with a higher risk of vessel occlusion or stenosis (32.4% vs. 16.3%, p = 0.04) and thrombosis (11.6% vs 0%, p = 0.03). CONCLUSIONS: The most common complication of the MANTA device reported to the MAUDE registry was persistent bleeding (48.8% of reports) followed by vessel occlusion (29.6%). These complications were managed successfully using an endovascular approach in 48.4% of the reports.
Authors: Magnus Dalén; Magnus Settergren; Mikael Kastengren; Pia Ullström; Thomas Fux Journal: Catheter Cardiovasc Interv Date: 2022-01-23 Impact factor: 2.585