{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T18:11:48Z","timestamp":1763057508827,"version":"3.44.0"},"reference-count":30,"publisher":"BMJ","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Heart"],"published-print":{"date-parts":[[2010,1,1]]},"abstract":"<jats:sec>\n                  <jats:title>Background:<\/jats:title>\n                  <jats:p>Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods:<\/jats:title>\n                  <jats:p>To assess the frequency and outcomes associated with \u201coff-label\u201d use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (CRS). Label status (on-label vs off-label) was determined by following (1) inclusion\/exclusion criteria indicated in the 18F CRS safety and efficacy trial and (2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criterion or \u201cnon-acceptable\u201d criteria based on the patient selection matrix.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results:<\/jats:title>\n                  <jats:p>Off-label implantation was identified in 42 patients (67%)\u201440% had one, 19% had two and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8 (11.2) vs 14.5 (7.3), p\u200a=\u200a0.029). There was no significant difference in the procedural success rates between the on-label and off-label groups (91% vs 95%, respectively, p\u200a=\u200a0.47). The frequency of angiographic moderate-severe aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the \u201con-label\u201d and three deaths in the \u201coff-label\u201d group.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion:<\/jats:title>\n                  <jats:p>In this study we found that \u201coff-label\u201d implantation of the CRS was common. Further studies are needed to evaluate the consequences of \u201clabel status\u201d for patients undergoing TAVI.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/hrt.2009.172809","type":"journal-article","created":{"date-parts":[[2009,9,10]],"date-time":"2009-09-10T20:25:12Z","timestamp":1252614312000},"page":"19-26","source":"Crossref","is-referenced-by-count":34,"title":["Adherence to patient selection criteria in patients undergoing transcatheter aortic valve implantation with the 18F CoreValve ReValving System"],"prefix":"10.1136","volume":"96","author":[{"given":"N","family":"Piazza","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A","family":"Otten","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C","family":"Schultz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y","family":"Onuma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H M","family":"Garcia-Garcia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E","family":"Boersma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P","family":"de Jaegere","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P W","family":"Serruys","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2009,9,10]]},"reference":[{"key":"2025092100351158000_96.1.19.1","unstructured":"Food and Drug Administration. 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