{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T18:53:21Z","timestamp":1782500001289,"version":"3.54.5"},"reference-count":25,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2013,2,12]],"date-time":"2013-02-12T00:00:00Z","timestamp":1360627200000},"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":[[2013,5]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Percutaneous pulmonary valve implantation is now considered feasible and safe. \u201cNative\u201d right ventricular outflow tract (RVOT), small diameter conduits (&lt;16 mm) and relatively large RVOT with a dynamic outflow aneurysm are currently considered off\u2010label uses. Extending indications creates concerns of safety, ethics, reimbursement, and liability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim of study<\/jats:title><jats:p>To report the safety and feasibility of off\u2010label application of percutaneous pulmonary valve implantation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Retrospective analysis of prospectively collected data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p>Off\u2010label indications: conduit\u2010free RVOT or patients with an existing but undersized conduit.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010one Melody\u00ae valves and two Sapien\u00ae valves were successfully implanted in 23 patients (16.9 years; range 6.1\u201380.5 years). In 22 patients, prestenting was performed 4.8 months (range 0\u201369.2) before valve implantation (15 covered and 13 bare stents). Stent endothelial ingrowth was allowed for at least 2 months prior to implantation of the percutaneous valve if stent stability or sealing by the covering was presumed to be insufficient. Group 1 patients (<jats:italic>n<\/jats:italic> = 8) had a \u201cconduit\u2010free\u201d RVOT after transannular\/infundibular patch and after prestenting underwent percutaneous pulmonary valve implantation (PPVI), with a final RVOT diameter of 21.5 mm (range 16\u201326 mm). Group 2 patients consisted of two elderly patients with pulmonary valve stenosis and severe RVOT calcifications. Group 3 (<jats:italic>n<\/jats:italic> = 13) had an existing conduit (nominal 15.9 \u00b1 3.2 mm; range 10\u201320 mm). The conduit was augmented from 14.7 \u00b1 3.5 to 20 \u00b1 1.6 mm with PPVI. The RVOT preparation and valve implantations were uneventful.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>PPVI is safe and feasible in selected patients with an off\u2010label indication. Creating an adequate \u201clanding zone\u201d by prestenting makes the procedure safe and predictable. Updating the indications for PPVI should be considered. \u00a9 2013 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.24594","type":"journal-article","created":{"date-parts":[[2012,8,6]],"date-time":"2012-08-06T10:35:19Z","timestamp":1344249319000},"page":"987-995","source":"Crossref","is-referenced-by-count":51,"title":["Off\u2010label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: Time to rewrite the label?"],"prefix":"10.1002","volume":"81","author":[{"given":"Derize E.","family":"Boshoff","sequence":"first","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bjorn L.M.","family":"Cools","sequence":"additional","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth","family":"Heying","sequence":"additional","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Els","family":"Troost","sequence":"additional","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joelle","family":"Kefer","sequence":"additional","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Werner","family":"Budts","sequence":"additional","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Gewillig","sequence":"additional","affiliation":[{"name":"Paediatric and Adult Congenital Heart Unit University Hospitals KU Leuven and UC Louvain Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,2,12]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02844-0"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2459\/01.JCM.0000247437.05194.8e"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.07.040"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.21697"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.735779"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)01822-3"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.104.523266"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.105.599514"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/10976640601187596"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2008.08.061"},{"key":"e_1_2_6_12_1","first-page":"122","article-title":"Percutaneous fenestration of the atrial septum with a stent: An experimental study","volume":"4","author":"Gewillig M","year":"1995","journal-title":"Cor Europaneum"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2003.10.037"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.110.959502"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejcts.2007.12.034"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.109.921692"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1747-0803.2009.00364.x"},{"key":"e_1_2_6_18_1","first-page":"539","article-title":"Malpractive issues in radiology: Off\u2010label use of interventional medical devices","volume":"173","author":"Smith JJ","year":"1999","journal-title":"Am J Radiol"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1051-0443(07)61272-X"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2008-3726"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2004.058867"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.crad.2011.06.017"},{"key":"e_1_2_6_23_1","unstructured":"FDA. 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