Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations

• DOI: 10.1016/j.ijcard.2022.04.033
• Publication Date: 2022-04-13T00:59:18Z
• Authors: Mikael Kastengren; Magnus Settergren; Andreas Rück; Kari Feldt; Nawsad Saleh; Rickard Linder; Dinos Verouhis; Christopher U. Me...; Jessica Bager; Magnus Dalén
• Keywords: Vascular closure device; Closure (psychology)

BackgroundArterial access-site related complications constitute a large proportion of adverse events to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality hospital cost.AimsTo evaluate the safety effectiveness novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI).MethodsA single-center observational study evaluating VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) TAVI at Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major complication according criteria Valve Academic Research Consortium (VARC)-2.ResultsFrom May 2017 September 2020 total underwent with arterial management using MANTA VCD. VARC-2 occurred 42 (4.2%) patients: 17 (1.7%) intraoperatively received covered stent, surgical repair during stay, 3 (0.3%) surgery after discharge, had bleeding 2 (0.2%) symptoms claudication conservative treatment. No differences were seen between individual interventionists irrespective experience device. A larger sheath outer diameter femoral artery inner ratio only factor associated increase complications.ConclusionThis largest ever real-world evaluation for arteriotomy indicates effective safe low rates short learning curve.Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT04392492.