{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T05:40:20Z","timestamp":1693374020243},"reference-count":8,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,4,1]],"date-time":"2014-04-01T00:00:00Z","timestamp":1396310400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2014,7]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>We explored the efficacy, safety, and clinical consequences of on\u2010label and off\u2010label transcatheter aortic valve replacement (TAVR) in the real\u2010world setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The transcatheter heart valve (THV) was initially approved only for transfemoral (TF) delivery (on\u2010label use) during TAVR in inoperable patients with severe aortic stenosis (AS). Because of lack of alternative options in TAVR\u2010eligible patients with inadequate TF access, other routes have been utilized for THV implantation (off\u2010label use), outcomes of which were previously unknown.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Consecutive patients with severe inoperable AS who underwent clinical TAVR at our site were enrolled in a prospective database. Fifty subjects underwent TF\u2010TAVR (on\u2010label group), while non\u2010TF routes were utilized in 60 subjects (off\u2010label group). Procedural events, 30\u2010day clinical outcomes, and 1\u2010year all\u2010cause mortality data were analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Technical device success was similar between on\u2010label and off\u2010label groups (88% vs. 87%, respectively; <jats:italic>P<\/jats:italic>\u2009=\u20090.92), as was the incidence of procedural complications and 30\u2010day clinical events. The on\u2010label group had lower 1\u2010year all\u2010cause death rate (12%) compared to the off\u2010label group (32%; <jats:italic>P<\/jats:italic>\u2009=\u20090.02). The 1\u2010year all\u2010cause mortality in the off\u2010label group was comparable to published clinical trial and registry data on TAVR, and appeared lower than historical outcomes with conservative medical therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>On\u2010label use of the THV in the real\u2010world setting was associated with favorable survival outcomes compared to off\u2010label TAVR and historical data. Off\u2010label use of the THV appeared to be safe and effective when used in select patients with inoperable AS who are not eligible for TAVR via TF approach. \u00a9 2014 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.25489","type":"journal-article","created":{"date-parts":[[2014,3,21]],"date-time":"2014-03-21T08:04:41Z","timestamp":1395389081000},"page":"124-128","source":"Crossref","is-referenced-by-count":3,"title":["Clinical outcomes with on\u2010label and off\u2010label use of the transcatheter heart valve in the United States"],"prefix":"10.1002","volume":"84","author":[{"given":"Joel A.","family":"Lardizabal","sequence":"first","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Conrad J.","family":"Macon","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian P.","family":"O'Neill","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vikas","family":"Singh","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia A.","family":"Martinez","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Alfonso","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mauricio G.","family":"Cohen","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald B.","family":"Williams","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William W.","family":"O'Neill","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan W.","family":"Heldman","sequence":"additional","affiliation":[{"name":"The Multi\u2010Disciplinary Structural Heart Disease Program of the University of Miami, Miller School of Medicine Miami Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,4]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.02.076"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1103510"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25036"},{"key":"e_1_2_6_5_1","unstructured":"FusariM AlamanniF TrabattoniP CappaiA BonaV BiglioliP.New Minimally Invasive Extraperitoneal Access to Iliac Artery in Transcatheter Aortic Valve Implantation (TAVI) with Edwards\u2010Sapien Device. EuroPCR Online. March 2009. Available online at:http:\/\/www.pcronline.com\/Clinical\u2010cases\/Case\u2010submission\/New\u2010minimally\u2010invasive\u2010extraperitoneal\u2010access\u2010to\u2010iliac\u2010artery\u2010in\u2010transcatheter\u2010aortic\u2010valve\u2010implantation\u2010TAVI\u2010with\u2010Edwards\u2010Sapien\u2010device. Last accessed on 11\/01\/2013."},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1008232"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.09.001"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1114705"},{"key":"e_1_2_6_9_1","unstructured":"United States Food and Drug Administration.News Release: FDA approval expands access to artificial heart valve for inoperable patients. Sep2013. Available online at:http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm369510.htm. Last accessed 11\/01\/2013."}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.25489","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.25489","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.25489","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.25489","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T11:14:39Z","timestamp":1693307679000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.25489"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,4]]},"references-count":8,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2014,7]]}},"alternative-id":["10.1002\/ccd.25489"],"URL":"https:\/\/doi.org\/10.1002\/ccd.25489","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,4]]}}}