{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T10:49:43Z","timestamp":1779878983673,"version":"3.53.1"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,12,21]],"date-time":"2020-12-21T00:00:00Z","timestamp":1608508800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The MANTA is a novel plug\u2010based device for large bore arteriotomy closure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity\/cachexia or a systolic blood pressure above 180\u2009mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30\u2009days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC\u20102 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N\u00a0=\u00a0496), Balloon aortic valvuloplasty (BAV, N\u00a0=\u00a02), Mechanical circulatory support (MCS, N\u00a0=\u00a01) or Endovascular aneurysm repair (EVAR, N\u00a0=\u00a01). Mean age was 80.8\u2009\u00b1\u20096.6\u2009years with a median STS\u2010score of 2.7 [IQR 2.0\u20134.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20\u2013120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this study, MANTA appeared to be a safe and effective device for large bore access closure under real\u2010world conditions.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.29439","type":"journal-article","created":{"date-parts":[[2020,12,22]],"date-time":"2020-12-22T04:54:50Z","timestamp":1608612890000},"page":"1270-1278","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Dedicated plug based closure for large bore access \u2013The MARVEL prospective registry"],"prefix":"10.1002","volume":"97","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1866-5855","authenticated-orcid":false,"given":"Herbert G.","family":"Kroon","sequence":"first","affiliation":[{"name":"Department of Cardiology Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pim A.L.","family":"Tonino","sequence":"additional","affiliation":[{"name":"Department of Cardiology Catharina Hospital  Eindhoven The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikko","family":"Savontaus","sequence":"additional","affiliation":[{"name":"Department of Cardiology Turku University Hospital  Turku Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Amoroso","sequence":"additional","affiliation":[{"name":"Department of Cardiology Onze Lieve Vrouwe Hospital  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mika","family":"Laine","sequence":"additional","affiliation":[{"name":"Department of Cardiology Helsinki University Hospital  Helsinki 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Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8628-1410","authenticated-orcid":false,"given":"Joost","family":"Daemen","sequence":"additional","affiliation":[{"name":"Department of Cardiology Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter P.","family":"de Jaegere","sequence":"additional","affiliation":[{"name":"Department of Cardiology Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guus B.R.G.","family":"Brueren","sequence":"additional","affiliation":[{"name":"Department of Cardiology Catharina Hospital  Eindhoven The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Malmberg","sequence":"additional","affiliation":[{"name":"Department of Cardiology Turku University Hospital  Turku 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