{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T15:35:05Z","timestamp":1789400105647,"version":"build-2803163510"},"reference-count":19,"publisher":"MDPI AG","issue":"16","license":[{"start":{"date-parts":[[2022,8,18]],"date-time":"2022-08-18T00:00:00Z","timestamp":1660780800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001316","name":"Abbott","doi-asserted-by":"publisher","award":["NCT03752866"],"award-info":[{"award-number":["NCT03752866"]}],"id":[{"id":"10.13039\/100001316","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III\/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico\u2122 transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav\u2122 DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico\u2122 THV at 30 days. The study collected \u2018standard-of-care\u2019 clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico\u2122 THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico\u2122 THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico\u2122 THV with either the first-generation DS or FlexNav\u2122 DS.<\/jats:p>","DOI":"10.3390\/jcm11164839","type":"journal-article","created":{"date-parts":[[2022,8,18]],"date-time":"2022-08-18T23:28:41Z","timestamp":1660865321000},"page":"4839","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Procedural Safety and Device Performance of the Portico\u2122 Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry"],"prefix":"10.3390","volume":"11","author":[{"given":"Helge","family":"Mollmann","sequence":"first","affiliation":[{"name":"Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Linke","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Innere Medizin\/Kardiologie, Universit\u00e4tsklinik Technische Universit\u00e4t Dresden, Herzzentrum Dresden Fetscherstra\u00dfe 76, 01307 Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Nombela-Franco","sequence":"additional","affiliation":[{"name":"Cardiovascular Institute, Hospital Clinico San Carlos, Instituto de Investigaci\u00f3n Sanitaria Hospital Cl\u00ednico San Carlos (IdISSC), 28040 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2625-5445","authenticated-orcid":false,"given":"Martin","family":"Sluka","sequence":"additional","affiliation":[{"name":"Department of Medicine-Cardiology, University Hospital Olomouc, 779 00 Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2641-4135","authenticated-orcid":false,"given":"Juan Francisco Oteo","family":"Dominguez","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Hospital Universitario Puerta de Hierro Hospital, 28222 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Montorfano","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, IRCCS Ospedale San Raffaele, 20132 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won-Keun","family":"Kim","sequence":"additional","affiliation":[{"name":"Kerckhoff Heart and Thorax Centre, 61231 Bad Nauheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Arnold","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Friedrich Alexander Universit\u00e4t Erlangen-Nuremberg, 91054 Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariuca","family":"Vasa-Nicotera","sequence":"additional","affiliation":[{"name":"Klinikum der Johann Wolfgang Goethe Universitaet Frankfurt, 60596 Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lenard","family":"Conradi","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, University Heart and Vascular Center, 20251 Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8435-3986","authenticated-orcid":false,"given":"Anthony","family":"Camuglia","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University of Queensland, Brisbane, QLD 4072, Australia"},{"name":"Department of Cardiology, The Wesley Hospital, Brisbane, QLD 4066, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Bedogni","sequence":"additional","affiliation":[{"name":"Department of Cardiology, IRCCS Policlinico San Donato, 20097 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh","family":"Manoharan","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Royal Victoria Hospital, Belfast BT12 6BA, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,8,18]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2187","DOI":"10.1056\/NEJMoa1103510","article-title":"Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients","volume":"364","author":"Smith","year":"2011","journal-title":"N. 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