{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T03:00:53Z","timestamp":1791946853950,"version":"4.3.4"},"reference-count":27,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,2,28]],"date-time":"2022-02-28T00:00:00Z","timestamp":1646006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cardiovasc. Med."],"abstract":"<jats:sec><jats:title>Backgrounds<\/jats:title><jats:p>Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type \u22652 bleeding. Vessel occlusion\/stenosis (60%), perforation (20%), and pseudoaneurysm\/dissection\/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (<jats:italic>p<\/jats:italic> = 0.04), minimum common femoral artery diameter (CFA) (<jats:italic>p<\/jats:italic> &amp;lt; 0.01), sheath-to-femoral-artery ratio (SFAR) (<jats:italic>p<\/jats:italic> &amp;lt; 0.01), and a lower puncture height (<jats:italic>p<\/jats:italic> = 0.03). A CFA diameter &amp;lt;7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fcvm.2022.832242","type":"journal-article","created":{"date-parts":[[2022,2,28]],"date-time":"2022-02-28T09:19:33Z","timestamp":1646039973000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":16,"title":["Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications"],"prefix":"10.3389","volume":"9","author":[{"given":"Giulia","family":"Masiero","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Livio","family":"D'Angelo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca Nai","family":"Fovino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tommaso","family":"Fabris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Cardaioli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio","family":"Rodin\u00f2","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Benedetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauro","family":"Boiago","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saverio","family":"Continisio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Montonati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tommaso","family":"Sciarretta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vittorio","family":"Zuccarelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Scotti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Lorenzoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Pavei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Napodano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Fraccaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabino","family":"Iliceto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"Marchese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Esposito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Tarantini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,2,28]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"e008203","DOI":"10.1161\/CIRCINTERVENTIONS.119.008203","article-title":"MANTA Dedicated Large-Bore Vessel Closure Device","volume":"12","author":"Tarantini","year":"2019","journal-title":"Circ Cardiovasc Interv."},{"key":"B2","doi-asserted-by":"publisher","first-page":"1043","DOI":"10.1016\/j.jacc.2012.07.003","article-title":"Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial","volume":"60","author":"G\u00e9n\u00e9reux","year":"2012","journal-title":"J Am Coll Cardiol."},{"key":"B3","doi-asserted-by":"publisher","first-page":"1438","DOI":"10.1016\/j.jacc.2012.09.001","article-title":"Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document","volume":"60","author":"Kappetein","year":"2012","journal-title":"J Am Coll Cardiol."},{"key":"B4","doi-asserted-by":"publisher","first-page":"611","DOI":"10.1016\/j.amjcard.2016.11.009","article-title":"Incidence, predictors, and mid-term outcomes of percutaneous closure failure after transfemoral aortic valve implantation using an expandable sheath (from the optimized transcatheter valvular intervention [OCEAN-TAVI] Registry)","volume":"119","author":"Nara","year":"2017","journal-title":"Am J Cardiol."},{"key":"B5","doi-asserted-by":"publisher","first-page":"3370","DOI":"10.1093\/eurheartj\/ehv417","article-title":"Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation","volume":"36","author":"Barbash","year":"2015","journal-title":"Eur Heart J."},{"key":"B6","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1016\/j.jcin.2016.12.277","article-title":"Percutaneous plug-based arteriotomy closure device for large-bore access: a multicenter prospective study","volume":"10","author":"Van Mieghem","year":"2017","journal-title":"JACC Cardiovasc Interv."},{"key":"B7","doi-asserted-by":"publisher","first-page":"e007258","DOI":"10.1161\/CIRCINTERVENTIONS.119.007258","article-title":"Pivotal clinical study to evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device","volume":"12","author":"Wood","year":"2019","journal-title":"Circ Cardiovasc Interv."},{"key":"B8","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1016\/j.jcin.2020.09.052","article-title":"Suture- or plug-based large-bore arteriotomy closure: a pilot randomized controlled trial","volume":"14","author":"van Wiechen","year":"2021","journal-title":"JACC Cardiovasc Interv."},{"key":"B9","doi-asserted-by":"publisher","first-page":"1270","DOI":"10.1002\/ccd.29439","article-title":"Dedicated plug based closure for large bore access -The MARVEL prospective registry","volume":"97","author":"Kroon","year":"2021","journal-title":"Catheter Cardiovasc Interv."},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2021.02.017","article-title":"Frequency, impact and predictors of access complications with plug-based large-bore arteriotomy closure - A patient level meta-analysis","author":"Nuis","year":"2021","journal-title":"Cardiovasc Revasc Med"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2021.06.134","article-title":"Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center","author":"Dumpies","year":"2021","journal-title":"Cardiovasc Revasc Med"},{"key":"B12","doi-asserted-by":"publisher","first-page":"170","DOI":"10.1161\/CIRCULATIONAHA.121.057856","article-title":"Comparison of a pure plug-based versus a primary suture-based vascular closure device strategy for transfemoral transcatheter aortic valve replacement: the CHOICE-CLOSURE randomized clinical trial","volume":"145","author":"Abdel-Wahab","year":"2022","journal-title":"Circulation"},{"key":"B13","doi-asserted-by":"publisher","first-page":"2717","DOI":"10.1016\/j.jacc.2021.02.038","article-title":"Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research","volume":"77","author":"G\u00e9n\u00e9reux","year":"2021","journal-title":"J Am Coll Cardiol"},{"key":"B14","unstructured":"R: A Language and Environment for Statistical Computing [Internet]2019"},{"key":"B15","unstructured":"rms: Regression Modeling Strategies [Internet]\n            JrFEH\n          303486312019"},{"key":"B16","unstructured":"pROC: Display and Analyze ROC Curves [Internet]\n            RobinX\n          231464772020"},{"key":"B17","doi-asserted-by":"publisher","first-page":"294","DOI":"10.1002\/ccd.22827","article-title":"Location of femoral artery access and correlation with vascular complications","volume":"78","author":"Pitta","year":"2011","journal-title":"Catheter Cardiovasc Interv."},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2021.02.013","article-title":"Complications of the MANTA closure device. Insights from MAUDE database","author":"Megaly","year":"2021","journal-title":"Cardiovasc Revasc Med"},{"key":"B19","doi-asserted-by":"publisher","first-page":"207","DOI":"10.1016\/j.jcin.2011.09.020","article-title":"True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications","volume":"5","author":"Hayashida","year":"2012","journal-title":"JACC Cardiovasc Interv."},{"key":"B20","doi-asserted-by":"publisher","first-page":"1361","DOI":"10.1016\/j.amjcard.2012.06.042","article-title":"Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation","volume":"110","author":"Van Mieghem","year":"2012","journal-title":"Am J Cardiol."},{"key":"B21","doi-asserted-by":"publisher","first-page":"954","DOI":"10.1002\/ccd.27595","article-title":"Impact of percutaneous femoral arteriotomy closure using the MANTATM device on vascular and bleeding complications after transcatheter aortic valve replacement","volume":"92","author":"De Palma","year":"2018","journal-title":"Catheter Cardiovasc Interv."},{"key":"B22","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1016\/j.ijcard.2018.04.065","article-title":"MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation","volume":"263","author":"Biancari","year":"2018","journal-title":"Int J Cardiol"},{"key":"B23","doi-asserted-by":"publisher","first-page":"1730","DOI":"10.1016\/j.jcin.2019.06.049","article-title":"Insights from a multidisciplinary introduction of the MANTA vascular closure device","volume":"12","author":"Moccetti","year":"2019","journal-title":"JACC Cardiovasc Interv."},{"key":"B24","doi-asserted-by":"publisher","first-page":"1265","DOI":"10.1016\/j.amjcard.2019.07.030","article-title":"Early outcomes after percutaneous closure of access site in transfemoral transcatheter valve implantation using the novel vascular closure device collagen plug-based MANTA","volume":"124","author":"Gheorghe","year":"2019","journal-title":"Am J Cardiol."},{"key":"B25","doi-asserted-by":"publisher","first-page":"e1558","DOI":"10.4244\/EIJ-D-18-00769","article-title":"Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide","volume":"14","author":"Moriyama","year":"2019","journal-title":"EuroIntervention."},{"key":"B26","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1186\/s42155-018-0026-0","article-title":"Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide","volume":"1","author":"Hoffmann","year":"2018","journal-title":"CVIR Endovasc."},{"key":"B27","doi-asserted-by":"publisher","first-page":"2233","DOI":"10.1016\/j.jcin.2017.08.058","article-title":"Contemporary arterial access in the cardiac catheterization laboratory","volume":"10","author":"Sandoval","year":"2017","journal-title":"JACC Cardiovasc Interv."}],"container-title":["Frontiers in Cardiovascular Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcvm.2022.832242\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,28]],"date-time":"2022-02-28T09:19:37Z","timestamp":1646039977000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcvm.2022.832242\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2,28]]},"references-count":27,"alternative-id":["10.3389\/fcvm.2022.832242"],"URL":"https:\/\/doi.org\/10.3389\/fcvm.2022.832242","relation":{},"ISSN":["2297-055X"],"issn-type":[{"value":"2297-055X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2,28]]},"article-number":"832242"}}